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
Applicant’s election without traverse of compound 58 to induce weight loss (interpreted as treating obesity) in the reply filed on 9 Dec, 2025 is acknowledged.
Applicants have elected treatment of obesity with compound 58. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 1, 2, 4-10 and 13 were examined and claims 3, 11, and 12 were withdrawn from consideration. Applicants state that they believe their election reads on all claims, but claim 3 requires a C-terminal sulfur containing amino acid not found in their elected species, and claims 11 and 12 are drawn to treatment of disorders other than obesity. Thus, they are properly withdrawn.
During examination, a reference was discovered that anticipated at least one non-elected embodiment. This reference is discussed below.
Claims Status
Claims 1-13 are pending.
Claims 3, 11, and 12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 Dec, 2025.
Specification
first objection
The disclosure is objected to because of the following informalities: applicants have not supplied a proper sequence listing. While applicants have submitted multiple sequence listings, none of them meet the requirements for a sequence listing set by the office, note the CRFD files of 10 Dec, 2025 and 29 Dec, 2025.
Appropriate correction is required.
second objection
The disclosure is objected to because of the following informalities: the specification has sequences without their associated SEQ ID number. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03).
Appropriate correction is required.
third objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The current title merely states that the subject matter of the application comprises a pharmaceutical polypeptide; this provides little information for someone searching for their claimed subject matter.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities: these claims give sequences with at least 4 identifiable amino acids, but have no SEQ ID numbers. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03). Appropriate correction is required.
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.
Claims 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of disorders associated with inappropriate inflammation, does not reasonably provide enablement for preventing all diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The MPEP states “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: Applicants do not state what receptors the claimed sequences bind to, but, by comparison with Kadereit et al (US 20150166627), they appear to be GLP-1 or GLP-1/GIP agonist sequences. Claim 8 is a method of treating or preventing any disease or condition, claim 9 restricts the conditions treated to a long Markush group that includes Lyme disease and disorders associated with obesity.
3) the state of the prior art: Peters et al (Expert Rev. Respir. Med. (2018) 12(9) p755-767) teaches that obesity can cause wheezing and dyspnea (3d page, 1st paragraph). This reference links obesity to dyspnea.
Huizen (Med. News Today (2023)) discusses dyspnea upon exertion (title). This is a common, usually harmless condition (2nd page, 6th paragraph), which could be due to the subject being unaccustomed to exercise (3d page, 9th paragraph).
Berardi et al (Diagnostics (2021) 11(116)) discusses cachexia (title); a disorder characterized by weight loss and declining muscle mass(1st page, 1st paragraph).
Aguero-Rosenfeld et al (Clin. Microbiol. Rev. (2005) 18(3) p484-509) states that Lyme disease is caused by a bacterium transmitted by a tick (p484, 1st column, 1st paragraph).
4) the level of one of ordinary skill: The level of skill in the art is high.
5) the level of predictability in the art: This invention is in the field of biotechnology, which is inherently less predictable (MPEP 2145(X)(E)).
6 and 7) the amount of direction provided by the inventor and the existence of working examples: Applicants test their invention on animal models of diabetes (example 7, p44) and obesity (example 8, p45). The direction given is merely a list of disorders (p34, almost all of page, continues to p35, 1st paragraph), similar to the claim language.
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: Applicants have claimed prevention and treatment of all disorders in claim 8. It is not clear how a pharmaceutical that causes weight loss (note claim 10) is useful for treating cachexia, a disorder characterized by excessive weight loss. Claim 9 is drawn to treating and preventing a Markush group of disorders, including disorders associated with obesity and Lyme disease. Dyspnea is associated with obesity, but is not limited to overweight people; it is not clear how applicant’s claimed therapeutic will prevent or treat dyspnea caused by exercise while out of shape. Lyme disease is caused by a bacterium spread by a tick. It is not clear how applicant’s invention will prevent tick bites, or prevent transmission of the disease during a tick bite. This means it will take undue experimentation to use applicant’s invention for the full scope of the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is drawn to treatment and prevention of a Markush group of disorders. However, many do not seem to be actual disorders, such as “delaying or preventing disease progression in type 2 diabetes” or “treating binge eating.” It is not clear if applicants are trying to limit the scope of these embodiments to preventing progression of type 2 diabetes or treatment of binge eating (rather than treating or preventing, respectively) or if they are treating side effects of a treatment or some other interpretation. The English grammar is incorrect, and not clearly interpretable.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadereit et al (US 20150166627).
Kadereit et al discuss dual GLP-1/GIP agonists (title). Among the sequences described by the reference is SEQ ID 10, Y-Aib-EGTFTSDLSIQLEKEAVRLFIEWLKAGGPSSGAPPPS-NH2 (table 8, p14). Note that this reads on the sequences of claim 1, with X1=L, X11=I, X2=Q, X12=L, X3=K, X4=E, X5=V, X6=R, X13=L, X7=I, X8=E, X9=K, X14=A, and X10=GPSSGAPPPS. Formulations of these sequences with a carrier are contemplated (paragraph 118), anticipating claim 7. They can be used to reduce the body weight of a patient (paragraph 47), anticipating claims 8-10. The sequence was made by chemical synthesis (paragraph 291), anticipating claim 13.
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) 1, 2, 4-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kadereit et al (US 20150166627) in view of Kolterman (US 20060069029) and Just et al (US 20160257729).
Kadereit et al discuss dual GLP-1/GIP agonists (title). Among the sequences described by the reference is SEQ ID 10, Y-Aib-EGTFTSDL SIQLEKEAVR LFIEWLKAGG PSSGAPPPS-NH2 (table 8, p14). Note that this reads on the sequences of claim 1, with X1=L, X11=I, X2=Q, X12=L, X3=K, X4=E, X5=V, X6=R, X13=L, X7=I, X8=E, X9=K, X14=A, and X10=GPSSGAPPPS. This sequence is explicitly claimed by the inventors (claim 13), making it clear that the inventors were interested in this sequence, and making it a reasonable sequence as a starting point for further modification. Formulations of these sequences with a carrier are contemplated (paragraph 118). They can be used to reduce the body weight of a patient (paragraph 47). The sequence was made by chemical synthesis (paragraph 291).
As noted above, this reference anticipates claims 1, 7-10, and 13.
The difference between this reference and the remaining claims, and applicant’s elected species, is that this reference has a few mutations compared to the elected species, and lacks a fatty acid based plasma lifetime extension moiety.
Kolterman et al discuss exendin analogs (title), which is also a GLP-1 agonist (paragraph 9). By alanine mutation studies, it was determined that the Glu residue at position 24 (corresponding to position 24 of applicant’s elected species) can be mutated to a Lys residue to provide a location to attach a PEG or equivalent (paragraph 213). This reference suggests amending position E24 of Kadereit et al to Lys to provide an attachment point for a plasma lifetime extending moiety.
Just et al also discusses GLP-1/GIP agonists (title). Position 13 can be Ala (paragraph 11), and numerous examples have Ala in that position (paragraphs 19-26). A lipophilic group can be attached to a Lys residue to increase binding to albumin, shielding the compound from enzymatic degradation and renal clearance, enhancing the plasma lifetime of the material (paragraphs 67 and 68). Among the linker/fatty acid moieties expressly discusses is [19-carboxy-nonadecanoyl]-isoGlu-Peg3-Peg3, with the structure
PNG
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312
514
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Greyscale
(paragraph 118, p14). Note that this is identical to the moiety that applicants have attached to position 24 of their elected species. This reference discusses attachment of a fatty acid-amino acid-PEG group to a lysine to increase plasma lifetime, and mutating position 13 to Ala.
Therefore, it would be obvious to mutate position 24 of Kadereit et al to Lys, to provide an attachment point for a plasma lifetime extension moiety, as discussed by Kolterman et al. As these peptides are for the same purpose (GLP-1 agonism), an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to use the plasma lifetime extension moiety of Just et al instead of the PEG of Kolterman et al, as a simple substitution of one known element (the PEG of Kolterman et al) for another (the fatty acid-AA-PEG of Just et al) yielding expected results (plasma lifetime extension). As plasma extension moieties similar to Just et al are common in the art, an artisan in this field would attempt this modification with a reasonable expectation of success.
Finally, it would be obvious to make a Q13A mutation in the sequence of Kadereit et al as a substitution of one known element (the Gln of Kadereit et al) for another (the Ala of Just et al) yielding expected results (GLP-1 binding). As both references discuss GLP-1 and GIP binding, an artisan in this field would attempt this substitution with a reasonable expectation of success.
The combination of references renders obvious applicant’s elected species, compound 58, rendering obvious claims 1, 2, and 4-6.
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.
Claims 1, 2, 4-10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 17/421,297 (US 20220127323) in view of Kadereit et al (US 20150166627).
Competing claim 1 describes a genus of sequences comprising a genus of sequences, while claim 6 describes a Markush group of peptides, including compound 30, which is almost identical to compound 15 of the examined claims, save for a slightly longer fatty acid, which is not a patentable distinction (MPEP 2144.09(II)), anticipating examined claims 1, 2, 4, and 5, and rendering obvious examined claim 6.
The difference between the competing claims and the remaining examined claims is that the competing claims do not discuss utility or synthesis.
Kadereit et al discuss dual GLP-1/GIP agonists (title). Among the sequences described by the reference is SEQ ID 10, Y-Aib-EGTFTSDL SIQLEKEAVR LFIEWLKAGG PSSGAPPPS-NH2 (table 8, p14). Note that this is very similar to the sequence of competing claim 1, with only one mutation, and presumably has similar properties (MPEP 2144.09(II). Formulations of these sequences with a carrier are contemplated (paragraph 118). They can be used to reduce the body weight of a patient (paragraph 47). The sequence was made by chemical synthesis (paragraph 291).
Therefore, it would be obvious to use the compound of the competing claims to reduce the body weight of a patient, as described as Kadereit et al, as a substitution of one element (the unspecified utility of the competing claims) for another (the weight loss of Kadereit et al) yielding expected results, as the sequences are very similar. Alternatively, applicant’s specification gives a utility of these sequences as reducing body weight (3d page, 3d paragraph). This is one of the few places where applicant’s specification can be used for a double patenting rejection (MPEP 804(II)(B)(1)).
Furthermore, it would be obvious to use the synthesis method of Kadereit et al, as a substitution of one element (the unspecified synthesis method of the competing claims) for another (the synthesis method of Kadereit et al) yielding expected results (a polypeptide). As this is a very common synthesis method, an artisan in this field would attempt this method with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658