America-Israel Patent Law

Follow-Up Post: Israel PTO Tightens Criteria For Invoking “Overlap” Between Applicant’s Own Applications

We reported last month on one of the proposed changes in the ILPTO’s examination guidelines, viz. the proposal to stop rejecting applications having claims that “overlap” with claims of an applicant’s own granted patent or pending application, provided the two filings had the same filing date.  On February 10, as expected, the ILPTO announced that it was implementing this change. 

As an epilogue, on February 11 we received confirmation that the ILPTO has indeed implemented the change: we received an allowance in a case that had previously been rejected for “overlap” with one of the applicant’s earlier-issued patents.  This situation was a bit unusual in that the two applications have the same filing dates and same priority dates, but were filed as two separate applications, not as a parent and divisional.  Nevertheless, they fit the criteria of the revised examination guidelines: same filing date, as noted, and the newly-allowed case claims a genus of compounds, whereas the already-granted patent claims a single compound falling within the genus.  In our most recent response, which was filed after the ILPTO announced the proposed examination policy change, we argued that the rejection had no basis in the statute, as evidenced by the proposed change.  The letter from the examiner neither confirms nor denies our argument, but simply states that “In view of the change in the examination guidelines regarding applications having the same filing date, it is now permissible to withdraw the rejection under section 2 of the statute [i.e. double-patenting – DJF].”

Since the change in the ILPTO’s examination guidelines ostensibly reflects a change in the ILPTO’s view regarding section 2 of the statute, and the wording of the statute itself remains unchanged, it will be interesting to see if the ILPTO’s new view is eventually challenged during litigation, and if so, how that plays out.  Until then, applicants will not need to worry about “overlap” between the claims of their parent and divisional applications.

ILPTO Proposes to Stop Rejecting Divisional Applications for “Overlap” with Parent Cases

We have from time to time blogged about the Israel PTO’s obsession with “overlap” between patent claims, an obsession which in our view is unfounded, being based on a far too-expansive reading of section 2 of the Patent statute (see here, here, here, and here).  The problem with the ILPTO’s view is that it lumps statutory double-patenting with obviousness-type double-patenting, and as a result wastes significant amounts of both examiner and applicant time.  The issue can arise in all fields, but particularly affects patent applications in the life sciences, and is often a thorny issue between parent and divisional applications.

To address the issue, we have proposed implementing a system analogous to terminal practice in the US, which would allow applicants to overcome these “overlap” rejections by promising enforceability only as long as the two patents are owned by the same entity, and as long as they expire the same day (excepting any patent term extension time granted in one of them). 

It now appears that at least partial relief may be on the way.  In a notice published last week regarding proposed revisions to the Examination Guidelines (the ILPTO’s equivalent of the MPEP, albeit – thankfully – far less voluminous than the latter), the ILPTO has proposed foregoing the raising “overlap” rejections in cases of patent applications or a patent application and a patent which are (a) owned by the same entity and (b) have the same filing date, provided that the two documents do not contain claims of “literally or substantively” identical scope.  This means that the ILPTO plans to stop raising such rejections in cases of parent and divisional applications, as long as the claims are of different scopes.  The specific proposed wording can be found here beginning at page 30.

The ILPTO has asked for comments on the proposed revisions to the Guidelines, to be sent to [email protected] by January 29, 2020.

It is interesting, but not surprising, to note that the impetus for this proposed change is to save examiner time: making life easier for itself seems to be the overriding rationale behind many changes implemented by the ILPTO in recent years, even if those changes impose excessive burdens on applicants or their representatives.  In the present case, it is expected that the proposed change will ease life for applicants as well.

One other interesting point is that the proposed wording will not require applicants to promise co-ownership of the two patents as a condition for enforceability; the ILPTO will look at co-ownership at the time of examination.  Perhaps, upon further reflection, the ILPTO will realize that adopting a terminal disclaimer practice for all co-owned applications where there is “overlap” between the claims, irrespective of filing date, would achieve an even better result. 

Even if the ILPTO’s proposed change doesn’t go far enough, it is nevertheless a welcome one.

Good Idea, Bad Implementation? ILPTO Changes Procedure for Suspending Examination of Patent Applications

We’ve blogged before about the ILPTO’s policy for suspending examination of patent applications.  In particular we noted how its collection of fees for such suspension is ultra vires, and how a better approach, within the ILPTO’s authority, would be allow applicants to delay their response to pre-examination letters by up to 36 months instead of just 6 months, thereby effectively implementing a delayed examination scheme while legally collecting extension fees.  Such an approach would allow the ILPTO to focus its resources on examining those cases that actually matter to applicants.   

The ILPTO still hasn’t adopted such a scheme.  But it has evidently decided to tweak the existing framework.  Specifically, hitherto (at least for approximately the last 10 years), after an applicant filed its response to the ILPTO’s pre-examination letter, but before the issuance of a first OA, an applicant would request suspension of examination for X months. The ILPTO would then say, “Ok, you can have your suspension, you have one month to pay the suspension fee”.  But given the lag that usually occurs between filing the pre-examination response and the issuance of a first OA – a lag that in some cases can be more than a year – it was never clear if an applicant was paying for a suspension that might have occurred anyway. 

This left applicants desirous of suspension with a choice: wait to request suspension, at the risk of receiving a substantive OA which would, under the ILPTO’s policy, preclude a request that examination be suspended; or request and pay for suspension shortly after filing the pre-examination response, at the risk of paying for a suspension that would have occurred regardless.

Apparently in response to one or more complaints about this, the ILPTO decided that a change was in order.  However, we learned of the change not via a “Commissioner’s Circular” letter or an ILPTO “notice” posted on the ILPTO’s web site and circulated via the ILPTO’s email distribution list, the normal channels by which this would happen.  Rather, we learned about it when we recently requested suspension of an application, and received the following reply from the ILPTO (with identifying information redacted):

1. We confirm receipt of your request to suspend examination of the above-referenced application from the date above.
2. Your application was filed on [date of national phase entry], and the team in [technology area X] to which this application has been assigned, is presently examination applications that were filed in [month/year].
3. Therefore, the suspension will take effect from the moment that the application’s turn for examination arrives, and you are requested to make payment for the suspension at that time.
4. Please note: these figures and the advancement of examination in this team may be also be checked in the examination advancement file on the ILPTO’s web site, and you may avail yourselves of it.

What we gathered from this letter was that we don’t have to pay any fees just yet.  But would the ILPTO warn us when the application was coming due for examination?  Or was it warning us, ominously, that we need to track the examination queue ourselves – something that’s more guesswork than science, since the “examination advancement file” is only published by the ILPTO quarterly? 

We tried contacting the person whose name appears on the letter, but her phone is either out of commission or permanently off the hook; and she didn’t respond to our email inquiry.  So we spoke to some examiners and learned that they’ve been given as much guidance in this matter as applicants have, i.e. none.  Fortunately, we spoke with the head of the team to which this application was assigned, and after discussing the matter with the ILPTO's chief examiner, the team head told us that (a) he won’t further assign this case to a specific examiner until the matter of the suspension is resolved (he doesn’t want his examiners wasting time examining worthless applications any more than our clients want to spend money prosecuting applications that eventually prove to be worthless) and (b) the chief examiner told him they’ll adjust the policy to request payment shortly before the commencement of examination, but applicants should still independently monitor the status of applications.

Assuming the ILPTO gets in the habit of sending suspension payment demand letters before examination begins, we still wonder what will happen when such a letter mistakenly isn’t sent, and an OA then issues before the applicant has paid a suspension fee – will the ILPTO still allow the applicant to pay the fee and suspend examination?  Or what if the applicant decides to pay the suspension fee immediately – will the ILPTO tack on the suspension period only when the application’s turn actually comes up in the examination queue, or will it run from the date of payment, thereby possibly going to waste?

All in all, while the ILPTO is trying to achieve a desirable result, the way in which its doing so creates more work and more uncertainty for both the office and applicants.  And it doesn’t resolve the problem of the office collecting fees it’s not authorized to collect.  So we’ll say it again: just allow applicants to take 36 months’ extension to respond to pre-examination letters rather than 6 months.  This will be less work for everyone; and it will still allow the ILPTO to collect fees, but to do so in an unquestionably legal manner.

Examination under Section 17(c): Be Careful What Statutes You Wish For

This is a story about how a good idea that originated in the Israel PTO tripped over its own shoelaces (in a manner of speaking) when it was eventually enacted into law.

The story begins in the late 1980’s, when the Israel PTO had a significant backlog in the examination of patent applications.  The Commissioner at the time had (or had suggested to him) a bright idea: why carry the load all by yourselves when there are other patent offices examining related applications? 

Thus was born Commissioner’s Circular no. 9, which said that if applicants for Israel patents amended their claims to correspond to claims granted in corresponding patents in certain other jurisdictions, notably the USA and the EPO, then the ILPTO would view those claims as meeting local criteria for novelty, inventive step, unity of invention, sufficiency of description and clarity of the claims.

The idea proved to be so good that in 1995, during major round of statutory amendments, this policy was written into the statute as §17(c). 

Neither Circular no. 9, nor §17(c) after it, solved all of an applicant’s problems, however.  In particular, section 7 of the Israel statute forbids the patenting of methods of treatment of the human body.  So those granted US claims reciting “A method of treating X, comprising administering to a patient in need thereof drug Y…” can’t be granted in Israel.

Under Circular no. 9, the ILPTO was willing to allow applicants to convert such method of treatment claims to “Swiss” style claims or purpose-directed product claims, and to proceed in accordance with the Circular.  This was true as well for many years under §17(c). 

More recently, however – perhaps as a result of the ILPTO’s effort to draft written examination guidelines, perhaps due to changes over time in senior ILPTO personnel, perhaps owing to both – the ILPTO has taken a stricter view of the application of §17(c) with respect to method of treatment claims.  In particular, sub-section 4 of §17(c) states that one of the requirements is that:

“(4) the claim or claims in the application are identical to the claims in the parallel patent, but the application can include fewer claims that those in the parallel patent;”

In recent years, the ILPTO has taken this literally, and will not allow applicants seeking to invoke §17(c) to amend method of treatment claims to “Swiss” or purpose-directed product format.  If such method of treatment claims appear alongside claims on compounds and/or pharmaceutical compositions, the method of treatment claims will need to be cancelled if §17(c) is to be used, and a divisional with the claims rewritten in an acceptable format filed.  The divisional will not be able to benefit from §17(c). 

When this practice was initiated by the ILPTO, the Office maintained flexibility in the application of the practice with respect to method of treatment claims – Circular no. 9 was simply a way for the Office to say, “We’ll accept the word of the USPTO or the EPO regarding these claims and this application if you, the applicant, want us to. To the extent this may call the validity of the patent into question, caveat emptor.”  And that was the way the statutory provisions were viewed by the PTO in the years after their enactment, likely because the same Commissioner who issued Circular no. 9 was in office for several years after §17(c) was enacted. 

It’s ironic that the ILPTO now views itself as constrained by a statutory provision that was intended to enshrine in the statute the practice that the ILPTO itself initiated and applied with a greater measure of flexibility than is presently the case.

So when making statutory amendments, as in many other things, be careful what you wish for.

Final Versions of New Circulars: Is the ILPTO Ignoring Court Precedents?

Last month the ILPTO published final versions of two circular notices; the drafts of these notices were discussed at length here, here, here, here and here.  The final versions aren’t terribly different from the draft versions, with the most noticeable change coming in the parts that relate the claiming of nucleic acid or protein sequences, but that’s a topic for another post.

One of the things that didn’t change from the proposed circulars was the announcement by the ILPTO that it would limit the use of “Swiss”-style claims (but continue to allow purpose-directed product claims).  This particular change in ILPTO policy is interesting in two respects.  First, it’s not clear that it accords with case law. And second, if not, it evinces an inconsistency between the ILPTO’s position on Swiss claims and its position on “overlap” between claims.

First, a word on “Swiss” claims.  As is well-known to practitioners who prosecute pharma patents, few countries allow claims on methods of treatment of people, the USA being the most notable exception.  In those jurisdictions where such claims aren’t allowed, a common practice that developed over the years was to allow claims of at least one of two formats: purpose-directed product claims, and “Swiss claims”.  The former are of the format, “Compound X for use as a medicament [for the treatment of disease Y]”.  The latter are of the format, “Use of compound X in the preparation of a medicament [for the treatment of disease Y]”.

Hitherto, the ILPTO has allowed claims of both formats; in the case where a medical use for the compound had never been suggested before, it wasn’t even necessary to include “for the treatment of …”.  The justification for “Swiss” claims was that they recited a process.  Indeed, in ex parte proceedings from the early 1990’s, the ILPTO ruled that the claim “Use of 3’-azido-3’-deoxythymidine in the preparation of a medicament for the treatment or prophylaxis of a human retrovirus infection” was, in substance, the same claim as “A process for the preparation of a formulation according to any one of claims 1 to 14 which comprises bringing 3’-azido-3’-deoxythymidine into association with the said pharmaceutically acceptable carrier”.  Upon appeal to the Tel-Aviv district court, the court upheld that finding – thus implicitly giving its imprimatur to the “Swiss” claim format.

Such claims have likewise been found in numerous patent applications that were subject to opposition proceedings before the ILPTO, and in numerous patents asserted in infringement proceedings in District Courts (some of which were subsequently appealed to the Supreme Court).  At no point has a court in Israel held that “Swiss” type claims are per se deficient.

In the new circular, however, as in the draft, the ILPTO states,

“9. Section 3 of the statute establishes that a patentable invention must be a product or process.  Therefore claims of the form “X for use as a paint” are not allowable.

“10. In claims for a process it is required that the novel and inventive steps for effecting the process be recited. Therefore claims of the format “Use of X in the manufacture/preparation of Y” will not be allowed unless they recite novel and inventive steps.

“11. Claims for the new use of a known product may be worded “Product X for use as a medicament”.”

As I noted when commenting on the draft circular, sections 9 and 11 just re-state what has been long-standing policy, and section 10 introduces serious mischief potential.  As I said previously:

Section 10 … seems to imply that process steps need to be included in Swiss-type claims.  But if we’re already going to avail ourselves of the fiction that this type of claim describes a process – and in every country that accepts Swiss-type claims, it is that fiction that makes that claim format acceptable – then why require the recitation of process steps?  Only two possibilities exist for Swiss claims: they recite the use of compound as a medicine, period (i.e. either the compound itself is new compound, or its use as a medicine is new), or they recite a new use of a compound already known as a medicine.  In the first case, the novelty of the compound per se, and/or the novelty and inventiveness of using the compound in preparing a medicine, would seem to be sufficient to confer novelty and inventiveness to the claim as a whole. Yet I can foresee some examiners saying that the claim must nevertheless include process steps for formulating the medicine.  Likewise, in the case of a known pharmaceutically active compound, hitherto the addition of the words “for the treatment of Y” have been considered by the ILPTO to be sufficient to confer novelty and inventive step. It’s not clear if section 10 is meant to change that or be a restatement of existing practice. 

If section 10 is meant to be a deviation from existing practice, then on what basis has the ILPTO arrogated to itself the authority to ignore court rulings?  Well, there’s a possible answer to that: the AZT case the case where the question of the validity of “Swiss” claims per se came closest to being front-and-center.  But that was a district court case which wasn’t appealed, and the ILPTO is only bound by district court decisions in the particular matter hand; district court decisions don’t create binding precedent on the ILPTO.  Only Supreme Court decisions do that.

But if that’s so, then the ILPTO is being pretty selective about when it chooses to ignore district court instructions as being limited to the particular case, and when it enshrines such rulings as if they’re Torah-mi-Sinai.  Because that same district court decision was the one where the judge said an applicant can’t have “overlap” between two applications, and the ILPTO, as we’ve noted several times on this blog, has turned that particular molehill into a large mountain that needlessly consumes significant amounts of examiner and applicant time. 

Why the inconsistency?  I don’t know.  Maybe there isn’t any, and section 10 of the circular cited above really doesn’t change anything.  But if section 10 is now viewed by the ILPTO as requiring the recitation of process steps in Swiss claims, then the ILPTO is being intellectually dishonest.

Comments on Draft “Circular” Notices, Part 5 – Suspension of Examination of Later Application Because of Claims of Earlier Application

This is the fifth installment of our discussion of the first of two recent draft circulars, “Draft Circular 34/2016”.

Part G is directed to the suspension of examination of a later application due to an earlier application.

“30. Section 19 [of the statute] establishes that an examiner may suspend examination of an application if the invention claimed therein is unpatentable due to an application that has not yet published under section 16A [viz. publication 18 months after the earliest priority date]. Section 19 also establishes that the applicant may request suspension of examination until after publication of the earlier application under section 26 [viz. publication for opposition upon the conclusion of ex parte examination – DJF]

“31. In situations in which the examiner finds a defect under sections 2 or 9 of the statute [i.e. double-patenting with an applicant’s own earlier pending application (section 2), or the existence of an earlier still-pending application or application of a third party that claims the same invention (section 9) – DJF], as well as additional defects under chapters B and C of the statute [which deal with the substantive requirements for patentability and the requirements of the patent application itself – DJF], the applicant may respond to the additional defects only and request that his response to the defects under section 2 or 9 be postponed until after the other defects are fixed. If an applicant asks that the order of examination be in accordance with this paragraph, the additional defects will be dealt with first, and the reply will not be deemed unresponsive under section 45 of the statute.

“32. If the applicant’s reply to the additional defects satisfies the examiner but reply to the defects under section 2 or 9 has not yet been submitted, the examiner will revisit the question of whether a rejection under section 2 or 9 is in order.

“33. It will be noted that the foregoing does not derogate from the applicant’s right to request suspension of the application under Regulation 39(b) [which says that an applicant may request suspension of examination of his later application until after publication under S.26 of an earlier application identified by the examiner that ostensibly claims a closely-related invention – DJF].

“34. It will be noted that a request to deal with a rejection under section 2 or 9 after other defects have been address does not entitle an applicant to additional extensions beyond those enumerated in Circular 35/2016 [which sets a maximum of 12 months’ total extensions over the course of substantive prosecution – DJF].”

As I’ve blogged about in the past, the ILPTO has an obsession with “overlap” between the claims of applications. In the case of applications to different applicants, there’s a certain amount of sense in this – section 9 constrains the ILPTO from granting claims on the same invention to more than one party. Although the fact that Israel law allows for the granting of “selection patents”, in which what is claimed in a later patent application falls within the scope of the claims of an earlier patent, shows that cries of “overlap” per se being verboten are overblown. And in the case of the same applicant, this concern has been blown out of all proportion, because there’s an easy solution to what bothers the ILPTO, a point to which I’ll return below.

This part of the proposed circular seeks to enable substantive examination of the claims of a later application to proceed during the pendency of an earlier application having claims of overlapping scope (i.e. to determine patentability with respect to prior art and compliance with disclosure requirements), instead of having to wait for the conclusion of prosecution of the earlier case before proceeding.  Although I suspect this proposed policy is motivated primarily by a desire to keep the ILPTO’s docket moving, nevertheless this proposed policy makes some sense for the later applicant as well, as it will allow the applicant, if it so chooses, to assess its status vis-à-vis the prior art and the earlier claims. Inasmuch as the applicant will still be able to invoke Regulation 39(b) in order to obtain a suspension of prosecution until prosecution of the earlier application concludes the applicant’s rights won’t be impaired.

However, what’s more critical from this proposed section is what’s missing from it, namely something that would obviate the need for such vigilance against “overlap” on the part of the ILPTO in the case of “overlap” with the claims of an applicant’s own earlier application. Section 2 of the statute says that an applicant may only receive a patent on its invention – emphasis on the singular – but section 13 says it’s the claims that define the invention for which exclusivity is granted. Which means that if the claims are not of identical scope, section 2 should not be invoked against an applicant’s own later application, even if there is “overlap” between the claims.  If the earlier application was published before the priority date of the later application, then it can be cited as prior art, and the later claims can be allowed if they meet the criteria for a selectin invention. If, however, as is commonly the case, the later application is a divisional of the earlier application, the statute doesn’t preclude “overlap” between the claims of the two documents, and as the parent application isn’t available as prior art, there’s no basis to reject the latter claims on the basis of overlap with the parent.

What bothers the ILPTO is the potential for mischief should a single patentee be granted two different patents with claims of overlapping scope, as the patentee could assign one of the patents to a third party, forcing potential licensees to negotiate with two entities rather than one entity.  One solution to that difficulty, the one currently employed by the ILPTO, is to take a magnifying glass to the claims and force examiners, applicants and their attorneys to waste time and money attempting to eliminate the “overlap”.  However, a more elegant solution to situations of partial overlap (as opposed to claims of identical scope), is to allow the applicant to put a statement in the application file that the later patent, if granted, will only be enforceable while it is co-owned by the owner of the earlier application.  As I’ve argued elsewhere, the Commissioner does have the power to do this, as it falls within his power to record licenses, liens and the like against patents.  Such an approach would involve far less effort for all parties concerned, and would facilitate licensing negotiations with a single party.

In cases where the later application is not a divisional of the earlier application, but the earlier application is not available as prior art, then the applicant should be able to put an additional statement in the file saying that the term of the later patent will not extend beyond the term of the earlier patent. (Ideally this should also include a statement that any patent term extension granted in the later patent will run from the end of the 20-year term of the earlier patent, but I’m not sure the statute allows for that.)

Given the predilection for issuing “circular” letters shown by the present commissioner and his predecessor, a circular facilitating such a practice is long overdue.

Comments on Draft "Circular" Notices, Part 4 - Sequences and Omnibus Claims

This is the fourth installment in our discussion of the first of two recent draft circulars, “Draft Circular 34/2016”.

Part E concerns “Claims that refer to drawings and examples to define properties or technical aspects of the invention”, i.e. omnibus claims. Until sometime during the tenure of the Commissioner who served from 2003-2011, the ILPTO allowed omnibus claims, e.g. “A composition/device/process substantially as hereinbefore described with reference to any of the drawings.” Then the Commissioner issued a circular saying such claims wouldn’t be accepted, as they were indefinite. The proposed circular seeks to bring back omnibus claims in a limited fashion, by requiring such claims to explicitly recite the specific properties or aspects of the claimed invention.  Having said this, the circular then needs to clarify the confusion it has sown:

“25. The following references shall not be considered omnibus claims: a claim on genetic sequences that refers to a sequence that appears in the specification; a claim on a crystalline structure of material that is characterized by physical properties that the result of their measurement appears in the drawings, to which the claim refers [i.e. you can claim a crystalline polymorph by referring to an XRD shown in the drawings]; a claim on a product or apparatus characterized by a functional form that cannot be described in words and the form appears clearly in a drawing to which the claim refers.

“26. The examples listed above [viz. in par. 25 – DJF] are not exhaustive and are intended to ease the understanding of this circular.”

Inasmuch as I don’t think anyone ever included an omnibus claim thinking they would actually seek to enforce it, I don’t think anyone cared when the ILPTO did away with omnibus claims (even if it may have – surprise! – exceeded its authority in doing so), and I wonder why the ILPTO is bothering to bring them back in a way that seems likely to be more confusing than helpful.

Part F concerns claims on sequences and portions thereof.

“27. Sequences per se will be allowed on condition that the specification describes the activity of the biological sequence [this should probably read, “the biological activity of the sequence” – DJF], as required by section 3 of the statute.  If the examiner requires it, applicant will refer to the place where the activity of the sequence is specified.

“28. Claims on sections, derivatives and homologues of the claimed sequence will not be accepted unless the structure is defined. Such claims shall be considered unclear since the number of possible combinations in such claims is extremely large, and it is not possible to conduct a prior art search concerning every one of the possibilities within such claims.  Furthermore, in order to ascertain the boundaries of the invention, many experiments are required.

“29. To the extent a claim on a sequence recites it as part of a larger sequence by use of the word “comprising”, “containing” and the like, if the activity of the sequence is not recited in the claim, the search will be conducted according to the broad claim.”

I’ll leave it to the true biologists to comment on the (un)reasonableness of these proposed rules as they affect claims on DNA and RNA sequences, but with respect to proteins section 28 is both ambiguous and, at first glance, seems overly harsh, if not – again – going beyond what the statute empowers the ILPTO to do.

Section 28 is ambiguous because it’s unclear what’s meant by “structure”: the sequence itself is sometimes called the primary structure. So what’s meant by “structure” in section 28?  If what’s meant is three-dimensional structure, requiring that is ridiculous, as the 3D structure of many proteins is never elucidated, and even when it has been determined, the particular conformation may be condition-dependent, e.g. dependent on the solvent used in the crystallization process. Moreover, requiring 3D protein structure as part of a claim will make it difficult if not impossible to enforce the claim, as in many cases it won’t be possible to determine the 3D structure of an allegedly infringing protein.

If, on the other hand, what is meant is that the sequence of every section, derivative or homologue to be claimed must be recited, then section 28 should clearly state that. Assuming that that’s what was intended, such a requirement seems overly harsh. If, for example, a claim recites a protein having a molecular weight within a given range, a particular sequence for at least a portion thereof, and a particular activity, claiming homologues having X percent homology and retaining the activity is long-standing way of claiming proteins. Why deviate from that practice now? 

This is particularly clear with respect to antibodies, where most of the molecule is merely a scaffold, and what is critical are the six “complementarity determining regions” (CDRs), three on the light chain, three on the heavy chain.  Once the sequence of the CDRs has been elucidated, it’s not too much work for competitors – or the patent office – to figure out a priori which variations might plausibly be made that share the activity. One is unlikely, for example, to substitute an amino acid with a hydrophilic side chain for one having a hydrophobic side chain.  More practically, it’s not difficult for a competitor to determine if an antibody having the recited activity falls within the scope of the claims – after screening an antibody library for the recited activity, determining the amino acid sequences of the CDRs is routine.  Of course, those antibody variants lacking the activity won’t fall within the scope of the claim.

In this respect, section 28 seems to attempt to restrict applicants’ rights in a way that contravenes section 13(b) of the statute, which says that the claims can define an invention functionally. Here, where both the activity and sequence of the CDRs is recited, if the specification defines “homologues” in a clear way (and the ILPTO itself says in section 4.3.3.10 of Appendix K of its Examination Guidelines exactly how to define homology clearly), that meets the requirements of Section 13(b) of the statute. The ILPTO is not empowered to deny applicants their rights under 13(b).

Comments on Draft "Circular" Notices, Part 3 - incorporation by reference

Continuing with discussion of the first of two recent draft circulars, “Draft Circular 34/2016”, Part C pertains the order of examination of “Green” patent applications, viz. “those patent applications that the invention described therein assists in improving the environment, inter alia by preventing causes of global warming, reduce pollution of the atmosphere or water, advance non-polluting agriculture etc.” The idea is straightforward: examination of applications that the ILPTO classifies as “green” per Regulation 34(a) [which says that applications will be examined in the order in which they were submitted] will begin within three months of being so classified. Applicants wishing to have their applications deemed “green” will send a letter to the ILPTO, briefly explaining the reasons why the application should be considered a “green” application. Unlike a request to examine an application out of turn, requests to be considered “green” will not involve payment of a fee.

Part D relates to the use of the phrase “incorporated by reference” to refer to outside material.

“17. Sometimes applicants refer in the specification to outside documents, such as prior publications and the priority document upon which the application is based, using the expression “incorporated by reference”, as part of the background, or as part of the description of the invention or ways of practicing the invention.

“18. With respect to reference to prior publications for purposes of describing the invention or ways of practicing the invention, the applicant will be required, at the examiner’s discretion, to amend the specification to include the relevant portion of the document referred to. The examiner will require such amendment if he believes the reference to the prior publications makes it difficult to understand how to practice the invention, inter alia in cases in which reference is made to many publications. Generally, such an amendment will constitute an amendment under section 22 of the statute [which says that an applicant may amend its application, sua sponte or in response to an office action, at any time before the acceptance of the application, which occurs upon publication under section 26]

“19. In cases in which the reference to prior publications is made using the expression “incorporated by reference” in the background section, the applicant will be requested to delete the expression, in accordance with Regulation 20(a)(1) [which says that the application shall contain a background section setting forth the purpose of the invention and brief description of the state of knowledge against which the invention was made]

“20. Regarding reference to the priority document, the applicant will be requested to delete the expression “incorporated by reference”. If the applicant wishes to amend the specification to include the relevant portion of the priority document referred to, such an amendment will be considered an amendment of substantive character under section 23 of the statute [which says that an applicant may make amendments “of a substantive nature” to the application, but that the ILPTO may require that the amended passages be post-dated to the date of their inclusion in the application].

“21. No reference to unpublished documents will be permitted.”

Incorporation by reference is an accepted technique in Israeli law, and for over 40 years the ILPTO had no problem with the expression “incorporated by reference” in patent applications. Indeed, the Patent Statute itself incorporates portions of other statutes by reference. Apparently taking its cue from the EPO, a few years ago the ILPTO began waging a war on incorporation by reference, asserting that i-b-r rendered the disclosure indefinite and unclear, and therefore contravened the statute and regulations. Thus, in a circular published on November 8, 2010 (MN 85), the commissioner said that incorporation by reference was verboten, but that the relevant parts of the documents referred to, whether prior art documents or the priority document(s), could be copied into the specification and would not be considered new matter. The proposed wording continues in this vein, but seeks to break new ground in stating that copying parts of a priority document, previously incorporated by reference, into the specification, will constitute the addition of new matter.

I thought the ILPTO was substantively wrong when it first started complaining about “incorporation by reference”, and that it overstepped its authority in deciding sui generis to completely ban the use of incorporation by reference. The new proposals only confirm my views.

On the substantive side, the question of whether not the incorporation by reference of another document renders a disclosure unclear is something that should be decided on a case-by-case basis, not as a hard and fast rule. Yes, it’s possible that the incorporation by reference of a 1000-page book in order to explain how one might, for example, form a circuit board or formulate a tablet of aspirin could create some confusion; but by the same token, it may be abundantly to clear persons skilled in that area of technology just which passages from this book are relevant to the discussion at hand. Additionally, in many instances, reference is made to an industry standard published by standard-setting organization, as a criterion by which the inclusion or exclusion of a particular product or process within the scope of a claim is decided. There’s nothing confusing about that. And with respect to priority documents, these are present in the application file anyway, which means that people wishing to view them don’t even need to avail themselves of a library.

It’s also absurd to say that copying a document incorporated by reference, viz. the priority document, into the specification, constitutes addition of new matter. That document is already present in the application by way of the incorporation by reference, which, as noted, is an accepted mechanism in Israel law, so the explicit copying of portions of that document into the specification cannot constitute the addition of new matter. Indeed, the ILPTO itself set forth this very view in its previous circular regarding incorporations by reference, and that remains the practice today. Much as someone in the ILPTO would now like to pretend otherwise, the ILPTO cannot change the meaning of the substantive law because doing so suits the (unstated) agenda of the Commissioner.

Because, in many if not most instances, incorporation by reference doesn’t lead to confusion, and should be judged on an individual case, the ILPTO acts beyond its authority in creating a non-rebuttable presumption that all incorporations by reference are improper, in that it fails to exercise the discretion which it is charged to exercise.

The statutory requirements for the application are that it set forth the invention in a manner that enables a professional in the field to practice the invention, and that the claims defining the scope of exclusivity “reasonably arise” from the specification. Thus the fact that it might be absolutely clear what parts of a document that is incorporated by reference are germane to the application is not necessarily a fatal flaw in a patent application. Consequently, a better approach than the one now proposed by the ILPTO would be to allow incorporations by reference, regarding them as presumptively ok, and allowing for challenges to the propriety of any particular after the conclusion of ex parte prosecution. Applicants who do not want to risk such challenges will remove the incorporations at an appropriate time.

Finally, with regard to the incorporation of unpublished documents, in such cases the applicant should be given the opportunity to provide a copy of the unpublished document, to become a part of the file history. Only if the applicant fails to do so should it be required to remove the incorporation by reference.

I would also recommend that the ILPTO familiarize itself with 37 C.F.R. 1.57, which deals with incorporation by reference of material in US patent applications. Among other things, while the USPTO is liberal with allowing incorporations by reference, even going so far as to recognize priority claims as incorporations by reference for purposes of completing an application if material was inadvertently omitted from a new patent application (1.57(b)). Also, the USPTO distinguishes between incorporation of “essential” material, which can only be made by reference to a granted US patent or published US patent application, and incorporation of non-essential material, which can be made by reference to any publication (1.57(d) and (e), respectively).

Comments on Draft "Circular" Notices, Part 2

Yesterday I noted that the ILPTO had published draft "circular notices" and requested comments on them.  Today we continue with discussion of the first of these draft circulars, “Draft Circular 34/2016”. Part B of this draft circular is directed to "use" claims.

“9. Section 3 of the statute establishes that a patentable invention must be a product or process.  Therefore claims of the form “X for use as a paint” are not allowable.

“10. In claims for a process it is required that the novel and inventive steps for effecting the process be recited. Therefore claims of the format “Use of X in the manufacture/preparation of Y” will not be allowed unless they recite novel and inventive steps.

“11. Claims for the new use of a known product may be worded “Product X for use as a medicament”.”

A word of background: Israel, like most countries, has an anachronistic provision in the patent statute that prohibits claims on methods of treatment of humans, and, like many countries, has until now allowed both “Swiss-type claims” (Use of X in the preparation of a medicament [for the treatment of Y]” and purpose-directed product claims (X for use as a medicament [for the treatment of Y]).  It appears that these proposed sections will obfuscate rather than clarify anything in this regard, and consequently, in the tradition of “if it ain’t broke, don’t fix it”, it would be prudent to omit these sections. 

Proposed sections 9 and 11 reiterate statements made in earlier circulars, most notably circular MN 30 of August 17, 2004, which these sections are evidently meant to replace. But why replace those earlier statements? MN30 seems to have operated just fine for the past 12+ years.  Moreover, the proposed replacement sections 9 and 11 seem to contradict each other: what’s the difference between, for example, a claim reading “AZT for use as a medicament [for treating AIDS]” (wording per proposed section 9 and apparently not permissible) and “The product AZT for use as a medicament [for treating AIDS”? (wording per proposed section 11 and hence permissible).  What’s magic about the inclusion of the word “Product” at the beginning of the claim? Introduction of these new sections will only sow confusion.

Section 10 also appears to muddy the waters rather than provide clarification, as it seems to imply that process steps need to be included in Swiss-type claims.  But if we’re already going to avail ourselves of the fiction that this type of claim describes a process – and in every country that accepts Swiss-type claims, it is that fiction that makes that claim format acceptable – then why require the recitation of process steps?  Only two possibilities exist for Swiss claims: they recite the use of a compound as a medicine, period (i.e. either the compound itself is new, or its use as a medicine is new), or they recite a new use of a compound already known as a medicine.  In the first case, the novelty of the compound per se, and/or the novelty and inventiveness of using the compound in preparing a medicine, would seem to be sufficient to confer novelty and inventiveness to the claim as a whole. Yet I can foresee some examiners saying that the claim must nevertheless include process steps for formulating the medicine.  Likewise, in the case of a known pharmaceutically active compound, hitherto the addition of the words “for the treatment of Y” have been considered by the ILPTO to be sufficient to confer novelty and inventive step. It’s not clear if section 10 is meant to change that or be a restatement of existing practice.  Aside from pointing to the ridiculousness of proposing such statements without explaining what the office’s goal in proposing the statements, it again leads to the question, “If it ain’t broke, why fix it?”

There is also a more subtle point here: do Swiss claims and purpose-directed product claims reciting the same material for the same use (e.g. “Use of azithromycin in the preparation of a medicament” and “Azithromycin for use as a medicament”) have the same scope?  Rightly or wrongly, for roughly 25 years, the position of the ILPTO has been yes: in the early 1990’s, in a case involving the use of the already-known AZT to treat AIDS, the commissioner ruled that while both forms of claim are permissible, in the case before him they were of the same scope and therefore could not be allowed in separate applications due to double-patenting concerns.  If process steps need to be explicitly incorporated into Swiss claims, but not into purpose-directed product claims, then adoption of this circular as proposed would seem to change the ILPTO’s position, with concomitant effect on double-patenting determinations.

FWIW, I think a better approach would be to get the Knesset to rescind section 7(1) of the statute, the section that prohibits the patenting of methods of treatment of humans. The world-wide use of Swiss claims and purpose-directed product claims shows there is a need to provide patent protection for such methods, and that forbidding claims on methods of treatment of humans is dumb. Repeal of section 7(1) would obviate the need to engage in legal and semantic gymnastics in order to provide such patent protection. Inasmuch as the MOJ is currently considering legislation that would amend other parts of the patent statute, repeal of 7(1) should be a goal.

ILPTO Asks for Input on Two Draft "Circular" Notices

The Israel PTO recently published two draft “Commissioner’s circular notices” (hozrei rasham in Hebrew available here and here), requesting comment by January 19, 2017 (to be sent to [email protected]).  No explanations of the proposed circulars were provided by the ILPTO, although each one concludes with a list of earlier circulars that will be superseded by the new circulars.  The new circulars state that they will have effect from the date of their publication.

Traditionally, such circular notices were used by the ILPTO to clarify various office practices under the statute and regulations. For example, the statute empowers the commissioner to grant extensions to respond to examination reports (office actions), but the statute and regulations leave to the commissioner’s discretion the conditions for granting such extensions. Thus for many years, the ILPTO would grant up to four months of extension for a response without a show of cause (upon payment of the requisite fee, which is set by the regulations), with additional extensions for any individual response being available upon a show of cause, and with no limit on the total number of extensions during the course of prosecution.  Currently the ILPTO will grant up to 6 months of extension, with a limit of 15 months total extension during the course of prosecution.  Presumably either of those limits could be extended if the Commissioner could be convinced to grant further extensions, although I personally am unaware of any cases in which that occurred.

It’s worth noting that in the past, circulars usually issued without requests for input beforehand, and often they arose as a result of clarification of some practice point during the course of inter partes or ex parte proceedings before the commissioner, such as the question of whether or not “Swiss” style claims would be accepted by the ILPTO. 

I’m fine with the ILPTO from time to time explaining its practices in writing.  Unfortunately, the ILPTO staff tends to relate to these circulars as if they were statutes, even though they are meant to be expressions of policies developed by the ILPTO – i.e. administrative conveniences – within the bounds of the statute and regulations.  Moreover, in recent years, the ILPTO has attempted to use circulars to implement substantive changes in practice, in effect trying to do an end-run on the legislative process.  A case in point was the ill-fated attempt of the current commissioner to issue a circular stating that the ILPTO would recognize priority claims to design applications filed under the Hague agreement, even though Israel has yet to ratify the Hague agreement.

In the next several posts, I’ll relate to many parts of the draft circulars.

The first of these documents is styled “Draft Circular 34/2016”, and contains 7 parts, A through G.  Part A seeks to set forth procedures for dealing with multiple inventions in the claims:

“1. As a general rule, if more than one invention is claimed in a patent application, the examiner shall examine the first invention per the order of the claims.

“2. An exception to said rule is the case in which the examiner allows the applicant to give notice as to which invention among the claimed inventions should be examined first.

“3. There are cases in which the description discloses more than one invention and the applicant chose to claim only one of them.

“4. In each of cases 1-3 above, in accordance with Regulation 41 the examiner must notify the applicant of defect found in the application in the examined invention.

“5. Regulation 42 establishes that in its response, the applicant may rectify the defects of which it was notified, with an explanation how the amendment rectifies the defect. [Yes, the singular/plural don’t match up here…and there are other problems with the language…DJF]

“6. The applicant may rectify the defects by amending the specification per section 22 of the statute.  Per regulation 42, such an amendment must address the defects found. Amendment of the specification by way of substituting the examined invention in respect of which the defect was found with a different invention, even if it [the latter invention] arises from the description, does not constitute a rectification of the defect.

“7. In accordance with regulation 45, in such circumstances the examiner will establish that the answer does not remove the defects and send the applicant a notice before refusal.

“8. Per section 24 of the statute, the applicant may claim the other invention in a separate application.”

Thus, in cases in which the examiner finds that multiple inventions are present, the ILPTO proposes to do two things that it hitherto has not done. First, if multiple inventions are claimed, the examiner will now be allowed to examine the first invention per the order of the claims. (This sounds similar to EPO practice.) Second, if in response to an office action the claims are changed to refer to an unexamined invention, such a reply will be considered non-responsive. (Readers familiar with US restriction and election practice, particularly “election by initial presentation”, will find its echoes here.)

While I don’t find fault with the general idea that once an examiner has begun substantive examination, the applicant shouldn’t be able to change the claims to claim a different invention, I think the proposed procedure is deficient in at least two respects. First, I don’t think the ILPTO should presumptively examine the “first invention”. Rather, as per current practice, the default setting should be that the ILPTO identify what it considers to be the separate inventions, and to give the applicant the opportunity to choose which invention is to be examined – or to argue that there really aren’t two or more different inventions.  If the examiner nevertheless wishes to include substantive rejections against some of the claims, the examiner should be allowed to do so.

Second, a notice before refusal under section 45 of the statute is a heavy-handed response to a first “offense”. Consider, for example, a case in which only one invention was initially claimed, and in response to an OA the applicant substitutes in a new set of claims, thinking in good faith that the same invention is being claimed, but in a different way.  If the examiner disagrees, and believes the new claims are directed to a different invention, it’s absurd to threaten the applicant at that point in time with refusal of the application.  The proper response of the ILPTO in that situation is not to issue a notice before refusal under section 45, but for the examiner to inform the applicant that the claims are directed to a separate invention and therefore will not be considered, and to give the applicant additional time to respond. (Think of the standard USPTO letter stating that “the reply is non-responsive” but giving additional time to respond because “it appears to be a bona fide attempt to reply”.)  If the applicant does not subsequently replace the claims or convince the examiner that the claims are directed to the originally-examined invention, then a notice before refusal under section 45 should be mailed, giving the applicant yet one more chance to present claims directed to the already-examined invention.

Potential Snow Closure of ILPTO: This Time Deadlines Will Be Pushed Off

A major snowstorm arrived along the east coast of the USA over the weekend, dumping more snow than the "Snowmaggedon" that struck in 2010.  The USPTO was closed yesterday and will evidently be closed again today.

Jerusalem is also subject to snow from time to time. We wrote about the snow in January 2013 that resulted in a closure of the ILPTO, except for the filing of papers - as if couriers carrying new patent applications would fare better on unplowed roads than ILPTO employees.  (A similar thing happened last year on Memorial Day, when the ILPTO announced a closure for staff but not for filers.)

Evidently, the ILPTO is slowly learning from its mistakes: this week there's the potential for snow in Jerusalem, although as of this writing it hasn't materialized.  And this time around, the ILPTO announced that if the office closes because of snow, it won't be open for the filing of documents either, i.e. applicants will get a day's extension for Israel-related filings.  

As appreciated as this improvement is, there's one more improvement we hope the ILPTO will make in future: the next time this happens, the ILPTO should publish the announcement on its website, rather than just by email to those on its email distribution list.

Better Late Than Never: ILPTO Rescinds "No Second Generation Divisional" Practice

As we predicted last week, the ILPTO Commissioner today published an announcement in which he rescinded the "no second generation divisonal" practice that had been in place since mid-2010.  All's well that ends well, although it would have been nice if had he admitted that the practice was ultra vires.