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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/16/2026 has been entered.
Status of the Claims
2. 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. In the Response of 6/16/2026, claim 14 is amended.
Claims 14-28 are all the claims under examination.
The amendment of the claims raises new grounds for rejection.
Priority
3. USAN 17481578, filed 09/22/2021, and having 3 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
4. As of 7/10/2026, 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.
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.
5. 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.
Applicants allege in amending claim 14 to recite “wherein the second immunoglobulin single variable domain does not bind to serum albumin” overcomes the rejection.
Response to Arguments
Applicants do not assert that the 1st ISVD (serum albumin binder) is differentiated from the patent reference ISVD of claims 1-11 to any degree.
Applicants assert a single claimed anti-serum albumin ISVD from the patent reference is different from a fusion protein comprising the identical overlapping ISVD (1st) of the instant claims. Applicants arguments, and their prosecution of the claims, are ex post facto to the original grounds for restriction of the claims in the patent ref. No original claims in the instant application were drawn to a fusion protein much less restricted or speciated. See the detailed arguments presented by the Office in the OA of 3/16/2026.
The rejection is maintained.
New Grounds for Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
6. Claims 14-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 14-28 are amended in generic claim 14 to recite the negative proviso “wherein the second immunoglobulin single variable domain does not bind to serum albumin.”
The specification does not teach or disclose, per se, a negative proviso. The specification does not teach examples of a second ISVD to exclude from the invention. The specification does teach a single example of a second ISVD to include with a fusion to the serum albumin binder that comprises binding to a “therapeutic target” at
[0076] Also, generally, when a compound or polypeptide of the invention has a heavy-chain ISVD at its C-terminal end (which may be a serum albumin binder of the invention but for example also an ISVD binding to a therapeutic target), then said C-terminal ISVD (and by extension, the compound or polypeptide of the invention) preferably has a C-terminal extension X(n) as described herein. Similarly, when a compound or polypeptide of the invention has a heavy chain ISVD at its N-terminal end (which may be a serum albumin binder of the invention but for example also an ISVD binding to a therapeutic target), then said N-terminal ISVD (and by extension, the compound or polypeptide of the invention) preferably has a D at position 1.
[0077] Also, preferably, when a compound or polypeptide of the invention contains one or more other ISVDs besides the albumin binder(s) of the invention (which other ISVD(s) may for example be one or more ISVD's against a therapeutic target), then preferably all ISVD's present in said compound or polypeptide contain within their sequence one or more framework mutations that reduce binding by pre-existing antibodies. In particular, when these other ISVDs are Nanobodies or (single) domain antibodies that is, essentially consist of and/or is derived from a VH domain, they may contain (a suitable combination of) amino acid residues/mutations at positions 11, 89, 110 and/or 112 that are as described in PCT/EP2015/060643 and/or that essentially are as described in PCT/EP2015/060643 and/or as described herein for the albumin binders of the invention.
[0252]… An ISVD-based biological or Nanobody-based biological is preferably a therapeutic or intended for use as a therapeutic (which includes prophylaxis and diagnosis) and for this purpose preferably contains at least one ISVD against a therapeutically relevant target (such as for example RANK-L, vWF, IgE, RSV, CXCR4, IL-23 or other interleukins, etc.). For some specific but non-limiting examples of such ISVD-based or Nanobody-based biologicals, reference is to Examples 8 to 18 and also for example made to the various applications by Ablynx N.V. (such as for example and without limitation WO 2004/062551, WO 2006/122825, WO 2008/020079 and WO 2009/068627), as well as for example (and without limitation) to applications such as WO 2006/038027, WO 2006/059108, WO 2007/063308, WO 2007/063311, WO 2007/066016 and WO 2007/085814.
So, while alternative elements for a 2nd ISVD are positively described in the specification, they cannot be explicitly excluded in the claims where the requirement is that the “therapeutic” ISVD is both prophylactic and therapeutic as taught in the specification at [0252]. The specification does not support any fusion protein of the instant claims that comprises any therapeutic 2nd ISVD to any target much less one being prophylactic.
In the decision from Santarus, Inc. et al., v. Par Pharmaceutical, Inc., Case No. 10-1360 (Fed. Cir., Sept. 4, 2012), the Court stated that negative limitations are adequately supported when the specification describes a reason to exclude the relevant limitation. Such written description support need not even rise to the level of a disclaimer> (In re Santarus where the claim was drawn to a method for treating an acid-caused gastrointestinal disorder by administering to a subject suffering from such disorder a solid composition of omeprazole and sodium bicarbonate,”wherein the composition contains no sulfacrate.” The specification taught that “omeprazole represented an advantageous alternative to the use of H2 antagonists, antacids and sulfacrate as a treatment for complications related to stress-related mucosal damage.”).
Conclusion
7. No claims are allowed.
8. 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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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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