Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
1. Claims 1-13 are the original claims filed 9/22/2021. In the Preliminary Amendment of 12/28/2021, Claims 1-13 are canceled and new Claims 14-29 are added. In the Response of 6/11/2024, Claims 14-27 and 29 are amended. In the Response of 11/18/2024, Claims 26-27 are amended and Claim 29 is canceled. In the Response of 3/3/2025, Claims 14-18, 20-24 and 27 are amended. In the Response of 10/7/2025, claims 14, 20-23, 25, and 27-28 are amended. In the Response of 1/16/2026, claims 21 and 27 are amended.
Claims 14-28 are all the claims under examination.
This Office Action is final.
Priority
2. USAN 17481578, filed 09/22/2021, and having 2 RCE-type filing therein is a Continuation of 15769800, filed 04/20/2018, now U.S. Patent # 11142569 and having 1 RCE-type filing therein, 15769800 is a National Stage entry of PCT/EP2016/076088, International Filing Date: 10/28/2016, PCT/EP2016/076088 Claims Priority from Provisional Application 62254813, filed 11/13/2015.
Information Disclosure Statement
3. As of 3/12/2026, a total of four (4) IDS are filed for this application: 12/28/2021; 6/11/2024; 10/7/2025; and 1/16/2026. The corresponding initialed, signed and dated 1449 form is considered and of record.
Withdrawal of Objection(s)
Claim Objections
4. The objections to Claims 20-21 because of informalities is withdrawn.
-) Claim 21 is amended to recite the sequences in abbreviated format as in claim 20.
Withdrawal of Rejection(s)
Claim Rejections - 35 USC § 112(b)
5. The rejection of Claim 17 [actually claim 27] under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claim 17 [actually claim 27] is amended to recite “fusion protein” to comport with the parent claims.
Rejections Maintained
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. The rejection of Claims 14-28 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11142569 is maintained.
a) Applicants allege the first argument is irrelevant to a NSDP analysis citing the decision from Pfizer, Inc. v. Teva Pharms. 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008): Is any invention claimed in the application anticipated by or an obvious variation of an invention claimed in the patent? The analysis does not involve a determination whether claim amendments are adequately supported by the original claims.
Response to Arguments
First is whether Pfizer provides relevant guidance to the outstanding NSDP rejection as a direct continuation to an allowed parent case. Yes, because the facts in Pfizer focus on what is new subject matter in a CIP application from that subject matter which is present in a DIV application or of the parent application versus what is claimed.
The basis for the Federal Circuit’s decision that the ‘068 patent was invalid for obviousness-type double patenting was that the designation of this patent as a "continuation-in-part" was not merely semantic but had substantive repercussions regarding whether the ‘068 claims were entitled to the "safe harbor" provisions of 35 U.S.C. § 121. These provisions entitle a divisional application filed as the result of a restriction requirement (a Patent Office determination that an applicant has filed claims directed to more than one invention) to be exempt from obviousness-type double patenting. These provisions illustrate a Congressional intention, from the legislative history of the 1952 Patent Act, to prevent the unfairness of forcing an applicant to be required to file a divisional application based on claiming "independent inventions" through restriction while permitting the original application to be used as "prior art" in a obviousness-type double patenting rejection. The Federal Circuit noted, however, that Congress also evinced the intention to restrict the safe harbor to divisional applications (which have an identical specification to the originally-filed application) and keep any claims in such a divisional application strictly within the bounds of what had been determined to be a separate invention. This intention meant, for example, that an applicant would not be able to include claims in a divisional that were within the scope of any claims previously elected for examination. In this way applicants would be precluded from inequitably increasing patent term while not being penalized for electing one invention and pursuing additional inventions in divisional applications.
The Federal Circuit found that the ‘068 application did not fall within the safe harbor because it was a continuation-in-part application, not a divisional. Such a "CIP" application by definition contains some of the disclosure of an earlier-filed application in addition to new disclosure. Because of this distinction, the Federal Circuit found that CIP applications could not fall within the safe harbor because they could encompass additional information (and patentable inventions) that were not a part of the original, restricted claims.
In this case, however, the CAFC has applied the rubric to the application rather than to the claims. A review of the claims of the ‘165 patent, as originally filed, shows that the application contains a claim (claim 29) that recites the same method as the ‘068 patent and a list of species of the generic formula, expressly reciting celecoxib. This claim was subjected to a restriction requirement and the applicants elected to forego prosecution of these method claims until filing the CIP application that resulted in the ‘068 patent. However, the specification of the ‘068 patent is much more extensive than the earlier-filed ‘823 and ‘165 patents; in particular, the ‘068 patent specifically discloses celecoxib synthesis, and contains biological data relating to the specificity of celecoxib for COX2 over COX1 (the biological basis for its advantages as an anti-inflammatory agent). Without specifying any rationale other than the noted distinction between divisional and CIP applications, it appears that these differences in the specification may provide additional support for the Federal Circuit’s determination.
Second is that here is the case where the instant application is neither a CIP nor a DIV of the parent application, and the instant application vs parent application disclose the same subject matter.
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Third is that here is the case where both the instant and parent applications teach a fusion protein: see ‘569 teaching:
(5) Preferably, the polypeptides of the invention are fusion proteins.
(84) As further described herein, the serum albumin binders of the invention can be used with advantage as a moiety, binding unit or fusion partner in order to increase the half-life of therapeutic moieties such as polypeptides, proteins, compounds (including, without limitation, small molecules) or other therapeutic entities.
Fourth is that here is the case that the instant claimed fusion protein comprises a first ISVD and a second ISVD that share the same properties claimed in Claim 14:
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Accordingly, the 1st and 2nd ISVDs are NOT differentiated from each other to any appreciable degree in order for applicants to assert that a single claimed ISVD is different from a fusion protein comprising two overlapping ISVDs. The claimed invention focuses on the 1st and 2nd ISVDs and the variants comprised and shared within each of the ISVDs as excerpted above. The POSA could reasonably conclude that the respective ISDVs of the fusion construct are variants amongst themselves but that they share common and identical amino acid residues excerpted above in the variation.
b) Applicants allege none of the reference claims recite a nucleic acid encoding a fusion protein.
Response to Arguments
A single inventive group was identified in the corresponding parent application for ‘569 that does not include claims drawn to a fusion protein or a nucleic acid but to a domain corresponding to the first Ig SVD that binds SA of the instant claimed fusion protein:
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Are inventions to an ISVD, a fusion of ISDVs and a nucleic acid encoding the fusion of ISDVs related under restriction?
(Form paragraph 8-14-01) Inventions _ and _ are directed to related _. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed _. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
It is asserted that the three products are related and are not sufficient in their distinctness because (1) the inventions as claimed do not have a materially different design, mode of operation, function, or effect; (2) the inventions overlap in scope; and (3) the inventions as claimed are obvious variants that share the same variation as excerpted above.
Further, no claims were present in any one of the claims sets of 4/20/2018; 4/20/2018; 12/10/2019; 4/23/2020; 9/4/2020; and 4/30/2021 from the parent application to ‘569 for a fusion protein.
As regards the scope of the ref claims the POSA can reasonably ascertain the instant claimed 1st ISVD encoded by a nucleic acid corresponds to instant claim 14. Instant claim 14 does not recite the CDRs for the 2nd ISVD but does require that is share its variation with the 1st ISVD. Under the BRI standard, the POSA can reasonably interpret the 2nd ISDV share the same CDR1-3 absent a showing to the contary:
Ref 1. An immunoglobulin single variable domain that binds to serum albumin, comprising: a CDR1 according to Abm that is the following sequence: GFTFDTSSML (SEQ ID NO:13); and a CDR2 according to Abm that is the following sequence: VIHQSGTPTY (SEQ ID NO:14); and a CDR3 according to Abm that is the following sequence: FPSSRMKFDY (SEQ ID NO: 15); and having: an amino acid residue L or V at position 11; and an amino acid residue T, V or L at position 89; and an amino acid residue T, K or Q at position 110; and an amino acid residue S, K or Q at position 112; such that (i) position 89 is T; or (ii) position 89 is L and position 11 is V; or (iii) position 89 is L and position 110 is K or Q; or (iv) position 89 is L and position 112 is K or Q; or (v) position 89 is L and position 11 is V and position 110 is K or Q; or (vi) position 89 is L and position 11 is V and position 112 is K or Q; or (vii) position 11 is V and position 110 is K or Q; or (viii) position 11 is V and position 112 is K or Q, and wherein the positions are according to Kabat numbering.
Ref 2. The immunoglobulin single variable domain according to claim 1, which comprises the following amino acid residues at positions according to Kabat numbering: 11V in combination with 89L; or 11V in combination with 110K or 110Q; or 11V in combination with 112K or 112Q; or 11V in combination with 89L and 110K or 110Q; or 11V in combination with 89L and 112K or 112Q.
Ref 3. The immunoglobulin single variable domain according to claim 1, which comprises the following amino acid residues at positions according to Kabat numbering: 89L in combination with 11V; or 89L in combination with 110K or 110Q; or 89L in combination with 112K or 112Q; or 89L in combination with 11V and 110K or 110Q; or 89L in combination with 11V and 112K or 112Q.
Ref 4. The immunoglobulin single variable domain according to claim 1, which comprises the following amino acid residues at positions according to Kabat numbering: 110K or 110Q in combination with 11V; or 110K or 110Q in combination with 89L; or 110K or 110Q in combination with 11V and 89L.
Ref 5. The immunoglobulin single variable domain according to claim 1, which comprises the following amino acid residues at positions according to Kabat numbering: 112K or 112Q in combination with 11V; or 112K or 112Q in combination with 89L; or 112K or 112Q in combination with 11V and 89L.
Ref 6. The immunoglobulin single variable domain according to claim 1, which comprises the following amino acid residue at a position according to Kabat numbering: 89T.
Ref 7. The immunoglobulin single variable domain according to claim 1 further comprising a C-terminal extension (X).sub.n, in which n is 1 to 10; and each X is an amino acid residue that is independently chosen, and optionally independently chosen from the group consisting of alanine (A), glycine (G), valine (V), leucine (L) or isoleucine (I).
Ref 8. The immunoglobulin single variable domain according to claim 1 further comprising a D and/or E1D mutation at position 1 according to Kabat numbering.
Ref 9. Immunoglobulin single variable domain that binds to serum albumin, wherein the immunoglobulin single variable domain comprises an amino acid sequence that is chosen from the amino acid sequences of SEQ ID NOs: 72 to 99.
Ref 10. The immunoglobulin single variable domain of claim 9 consisting of an amino acid sequence that is one of the following sequences: SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, SEQ ID NO:75, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83, SEQ ID NO:84, SEQ ID NO:85, SEQ ID NO:86, SEQ ID NO:87, SEQ ID NO:88, SEQ ID NO:89, SEQ ID NO:90, SEQ ID NO:91, SEQ ID NO:93, SEQ ID NO:94, SEQ ID NO:95, SEQ ID NO:96, SEQ ID NO:97, SEQ ID NO:98 or SEQ ID NO:99.
Ref 11. The immunoglobulin single variable domain of claim 9 having an amino acid sequence that is one of the following sequences: SEQ ID NO: 78 or SEQ ID NO: 92.
The rejection is maintained.
Conclusion
7. No claims are allowed.
8. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643