DETAILED ACTION
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicants elected treating type 2 diabetes with (Ac-Lys-Lys)Lys-desPro38 exendin-4 without traverse in the reply filed on 30 Dec, 2025.
Claims Status
Claims 68-87 are pending.
Claims 68, 82-85, and 87 have been amended.
Claims 79, 81, and 82 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
Claim 87 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement for infections and inflammatory and metabolic conditions is hereby withdrawn due to amendment.
The rejection of claims 68-78, 80, and 83-87 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what function must be maintained is hereby withdrawn due to amendment.
The rejection of claims 83-85 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.
The rejection of claim(s) 68-78 and 83-86 under 35 U.S.C. 102(a)(1) as being anticipated by Boesen (US 20150297671) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 68-78, 80, and 83-87 are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al (US 20110245165) in view of Boesen (US 20150297671, cited by applicants).
Larson et al discuss GLP-1 agonists (title). A most preferred embodiment is des Pro36 exendin-4(1-39) (paragraphs 72 and 73). Note that exendin 4 has prolines at positions 36, 37, and 38 (note SEQ ID 102 of Larson et al), so des Pro36 exendin 4(1-39) is identical to des Pro39 exendin 4(1-39), which is the base peptide of applicant’s elected species. Additional sequences may be attached to either the C-terminus or the N-terminus of these sequences (paragraph 61), with short oligolysine sequences used as examples (paragraphs 64 and 65). These compounds can be used to treat type 2 diabetes (paragraph 121), applicant’s elected disorder. Pharmaceutical compositions for injection are contemplated (paragraph 126).
The difference between this reference and the examined claims is that this reference does not discuss branched amino acid probes.
Boesen discusses peptide analogs with branched amino acid probes (title). These can alter the inherent effect of the peptide, for example, increasing affinity (paragraph 9), and can be placed on the N-terminus of the sequence (paragraph 12). An example is given of (Ac-Lys-Lys)Lys (paragraph 92), identical with applicant’s elected branched amino acid probe. Boesen describes embodiments where the probe is attached to exendin-4 and variants (paragraph 159). A number of examples are given where this probe is attached to the N-terminus of a polypeptide (paragraphs 317-331). Examples are given of GLP-1 analogs modified at the C-terminus (paragraphs 351, 352, 376). This reference discusses attaching branched amino acid probes to peptides.
Therefore, it would be obvious to attach a branched amino acid probe of Boesen, to modify the properties of the exendin analogs of Larson et al in a beneficial manner. As Boesen explicitly discusses modification of exendin 4 and variants, an artisan in this field would attempt this modification with a reasonable expectation of success.
Larson et al discuss des Pro36 exendin-4(1-39), identical to the base sequence of applicant’s elected species. Boesen discusses attaching (Ac-Lys-Lys)Lys to the N-terminus, generating applicant’s elected species and rendering obvious claims 68-78, 80, and 83-86.
Larson et al mentions treatment of type 2 diabetes, rendering obvious claim 87.
response to applicant’s arguments
Applicants argue that there is no motivation to combine, that Larson et al does not mention the branched oligolysine modification, that Boesen does not discuss des Pro38 exendin-4, that there is no reasonable expectation of success, and that the rejection is based on hindsight.
Applicant's arguments filed 20 May, 2026 have been fully considered but they are not persuasive.
Applicants state that there is no motivation to combine, but do not describe why the motivation in the rejection, to modify the properties of the exendin 4 variants of Larson et al in a beneficial manner, is improper or incorrect.
Applicants argue that Larson et al does not mention the claimed modification. While true, that deficiency is made up by Boesen.
Applicants argue that Boesen does not describe their elected exendin analog sequence except as a laundry list. However, that limitation is made up by Larson et al.
Applicants argue that there is no expectation of success, because their data shows that the modification of Boesen does not reliably improve all properties. A determination of patentability under 35 USC 103 is based on what a person of skill in the art would think at the time of applicant’s priority date (text of 35 USC 103). Except for potentially secondary considerations, applicant’s data is not relevant to this determination, because as of that date, a person of skill in the art would not have access to that data. Larson et al states that similar constructs (oligilysine units) can be added to exendin 4 variants for similar purposes, and Boesen teaches that the branched unit works with exendin variants. Based on this data, an artisan in this field would have believed that the modification would have a reasonable expectation of success.
Finally, applicants argue that the rejection is based on hindsight. The courts have determined that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as the rejection takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicants argue that the selection of the sequence is based on their data. However, that sequence came from Larson et al, not their data.
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.
first rejection
Claims 68-78, 80, and 83-87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35, 43, and 49 of copending Application No. 17/470,310 (US 20220133839) in view of Larson et al (US 20110245165).
Competing claim 35 describes attachment of a branched peptide probe to the N or C terminus of a non-specified sequence. Competing claim 43 specifies that the starting residue be Lys or Orn, while competing claim 49 gives a Markush group of branch sequences, including Ac-Lys-Lys (combined with the Lys of the starting residue, this is applicant’s elected species).
The difference between the competing claims and the examined claims is that the competing claims do not specify the sequence it is attached to, or the utility of the material.
Larson et al discuss GLP-1 agonists (title). A most preferred embodiment is des Pro36 exendin-4(1-39) (paragraphs 72 and 73). Note that exendin 4 has prolines at positions 36, 38, and 38 (note SEQ ID 102 of Larson et al), so des Pro36 exendin 4(1-39) is identical to des Pro39 exendin 4(1-39), which is the base peptide of applicant’s elected species. Additional sequences may be attached to either the C-terminus or the N-terminus of these sequences (paragraph 61), with short oligolysine sequences used as examples (paragraphs 64 and 65). These compounds can be used to treat type 2 diabetes (paragraph 121), applicant’s elected disorder. Pharmaceutical compositions for injection are contemplated (paragraph 126).
Therefore, it would be obvious to attach the branched probes of the competing claims to the exendin analog of Larson et al, as a substitution of one element (the unspecified sequence of the competing claims) for another (the sequence of Larson et al) yielding expected results (a conjugate). As Larson et al discusses similar modifications, an artisan in this field would attempt this modification with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants argue that the competing reference is the same patent family as Boesen, so the same arguments used with respect to the rejection under 35 USC 103, above apply. These arguments were answered at that rejection.
second rejection
Claims 68-78, 80, and 83-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 17 of U.S. Patent No. 11,141,455.
Competing claim 1 describes a peptide analog of exendin-4 (a functional variant of the exendin-4 variants of the examined claims) with a branched amino acid probe attached to the N or C terminus. Competing claim 4 lists a Markush group of probes, including (Ac-Lys-Lys)Lys, applicant’s elected probe. Competing claim 17 describes a method of treatment that overlaps with examined claim 87.
response to applicant’s arguments
Applicants argue that the competing reference is the same patent family as Boesen, so the same arguments used with respect to the rejection under 35 USC 103, above apply. These arguments were answered at that rejection.
New Rejections
Claim Rejections - 35 USC § 112(a)
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.
Claim 87 is 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.
Claim 87 has been amended to include “reducing inflammation” to the list of desired effects of administering the peptide. However, while applicants have written description for treating an inflammatory condition, nowhere in the disclosure is there any mention of reducing inflammation. Thus, this amendment constitutes new matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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