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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 Jan, 2026 has been entered.
Election/Restrictions
Applicants elected a formulation of KPYIL with GLP-1 or a bioactive analogue or variant in a pharmaceutically acceptable powder formulation without traverse in the reply filed on 8 Nov, 2024.
Claims Status
Claims 1, 5, 7, 14, 23, 24, 27, 32, 34, 38, 39, 45, 52, and 63-67 are pending.
Claims 1, 5, 7, 14, 23, 24, 27, 32, 38, 52, and 63 have been amended.
Claims 64-67 are new.
Claims 32 and 63 has been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Objections
The objection to the specification for lack of SEQ ID numbers is hereby withdrawn due to amendment.
New Objections
Specification
The amendment filed 2 Jan, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: applicants have amended the sequence at p37, line 28 of the specification as filed. Applicants state that this is correcting an obvious typographic error. To do this, the amendment must satisfy two requirements: 1) the amendment is correcting an obvious typographical error and 2) what the correction must be must be clear from the original disclosure (MPEP 2163(I)(B)). It is not clear that this is a typographic error. Applicants point to the figures, but that part of the spec refers to fig 9, which does not describe either the original or amended sequence.
Applicant is required to cancel the new matter in the reply to this Office Action.
Withdrawn Rejections
The rejection of claims 1, 5, 7, 14, 23, 24, 27, 33, 34, 38, 39, 45, and 52 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph due to uncertainty as to a second peptide is hereby withdrawn due to amendment.
The rejection of claim 52 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to the addition of new matter is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 45, 64, and 66 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a three part test for eligibility under this statute:
1) Is the invention a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there something beyond the judicial exception.
Applying the test:
1) Applicants are claiming a polypeptide composition, a composition of matter, passing the first test.
2a) According to Stagsted et al (WO 2017103200, cited by applicants), at least some of the first polypeptides of claim 1 are fragments of a naturally occurring polypeptide (p33, 3d and 4th paragraphs). Current interpretation of the relevant court cases does not distinguish between fragments of a naturally occurring polypeptide and the entire polypeptide for purposes of patent eligibility unless the fragment has properties different than the parent polypeptide. So, for purposes of patent eligibility, this is a naturally occurring polypeptide sequence. Gut hormones occur naturally to regulate the gut, hence the name.
2b) There does not appear to be any special property or effect resulting in the mixing of the first polypeptide and the second peptide hormone that applies to all embodiments made up of naturally occurring sequences. Thus, the claims are not patent eligible.
response to applicant’s arguments
Applicants argue that the specific fragments are a product of man, that the combination of the first polypeptide and the gut hormone does not occur naturally, and that the combination has synergy.
Applicant's arguments filed 2 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue that the specific claimed fragments do not occur in nature; that the polypeptides that they are part of are much longer than the size limitation of the claims. However, as noted in the rejection, fragments of biopolymers still are ineligible subject matter if the biopolymer is naturally occurring, unless truncation causes it to be significantly more than the full length biopolymer (Ass’n for Molecular Pathology v Myriad Genetics). This has not been demonstrated.
Applicants argue that the full composition is not found in nature. However, the requirement is that the individual components are naturally occurring, not that the formulation as a whole occurs as it is claimed (Funk Bros. Seed Co. v Kalo Inoculant Co). In essence, these two arguments of applicants assume that someone must be able to find the exact formulation as claimed in nature for the claims to be ineligible; that is not what the case law requires.
Finally, applicants argue that the polypeptide and the gut hormone interact synergistically. This has not been demonstrated. Applicants demonstrate that one embodiment gives slightly better results than expected based on the performance of each component separately, but it is not clear if this is a real result or a statistical aberration. Nor have applicants demonstrated that the alleged synergy would cover all embodiments of the rejection, as the different gut hormones have different targets and work by different mechanisms.
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.
first rejection
Claim 38 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 38 specifies the energy content of the composition. The issue is that what the energy content is of is not described. The claim states “wherein the energy content derived through the process of cellular respiration is less than . . .” This could be all cellular respiration during the dosage period, this could be the energy content of the powder formulation plus the liquid it is dissolved in (note claim 45), it could be the energy content of the powder formulation before mixing, or some other interpretation.
response to applicant’s arguments
Applicants argue that the claim language is clear that the energy content is the oral dosage form
Applicant's arguments filed 2 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue that the preamble of the claim makes it clear that the energy content refers to the oral composition. There are two issues with this argument. First, there is no link between the energy content language and the preamble, so it is not clear that one is discussing the other. The second is that applicant’s elected species, and many conceivable embodiments are intended to be mixed with other ingredients. This makes it unclear if the energy content is just the starting composition, or includes whatever it is mixed with (which is a composition). Even if applicant’s argument was persuasive, that does not avoid this issue.
Improper Markush
Claims 1, 5, 7, 14, 23, 24, 27, 33, 34, 38, 39, 45, and 52 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of the gut hormone of claim 1 and the disorders of claim 52 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: For the gut hormone, the only commonality appears to be that the hormone is made or used in the gut. There is no significant sequence identity, and these hormones hit different receptors and have different effects. With respect to the disorders of claim 52, there does not seem to be much commonality between atherosclerosis, hepatosteatosis, cancer, and diabetes, for example. They are different disorders with different etiologies, and have different standard therapies.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
response to applicant’s arguments
Applicants argue that they have narrowed the list of hormones, and that they are all small peptides (common structure) that travel freely in the bloodstream and bind to receptors on the outside of target cells to control digestive processes.
Applicant's arguments filed 2 Jan, 2026 have been fully considered but they are not persuasive.
Applicants point to similarities between the various components of the Markush group and argue these are common features and common use. However, the structural similarity must be essential to the common use (MPEP 2117(II), and the various components of the Markush group must be substitutable for each other (MPEP 2117(II)). Neither is the case here.
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.
first rejection
Claim(s) 1, 5, 7, 14, 23, 24, 27, 34, 39, 45, 52, 64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Stagsted et al (WO 2017103200, cited by applicants) in view of DiMarchi et al (US 6,191,102).
Stagsted et al discusses polypeptides that induce satiation and satiety and to reduce obesity (p1, 1st paragraph). Various gut hormones, including GLP-1 will also lead to satiation (1st page, 5th paragraph). The peptides of Stagsted appear to be identical to the first peptide of applicants (2nd page, 7th paragraph, continues to 3d page), and among the specific sequences the authors discuss is SEQ ID 9 (3d page, 3d paragraph), identical with SEQ ID 9 of the examined application and applicant’s elected species KPYIL. Dosages will vary depending on the patient, and will have to be optimized by the physician (p15, 3d paragraph). The material can be in the form of a powder which is dissolved into a liquid for oral dosing (p31, 3d paragraph).
The difference between this reference and the examined claims is that this reference does not discuss dosing with GLP-1.
DiMarchi et al discuss GLP-1 analogs for regulation of obesity (title), the same application as Stagsted et al. Note that GLP-1 analogs, derivatives, and variants are all considered suitable (column 3, line 27-29). This can cause significant reductions in body weight (column 2, line 62-65). A number of variables will affect the dose, so this will need to be optimized (column 14, line 59-column 15, line 8). Oral administration is a preferred route of administration (column 14, line 29-30). This reference teaches GLP-1 analogs for treatment of obesity.
The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06). The formulations of Stagsted et al and the formulations of DiMarchi et al are both taught for reducing weight, and both can be orally administered, rendering the combination of the two obvious.
Stagsted et al and DiMarchi et al render obvious a formulation comprising applicant’s elected polypeptide, KPYIL (SEQ ID 9) and a GLP-1 analog, a gut hormone. Thus, the combination of references renders obvious claims 1, 5, 7, 14, 27, 64, and 67.
KPYIL is Lys, Pro, Tyr, Ile, and Leu, all naturally occurring amino acids, rendering obvious claim 23.
KPYIL has 5 amino acids, rendering obvious claim 24.
Stagsted et al discusses oral dosage forms, including powders that can be dissolved in a liquid. Thus, the combination of references renders obvious claims 34, 39, and 45.
The goal of the exercise is weight loss, rendering obvious claim 52.
response to applicant’s arguments
Applicants argue synergy between the two polypeptides of the formulation.
Applicant's arguments filed 2 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue synergy between the two polypeptides of the formulation. This has not been demonstrated. It is the burden of applicants to establish results are significant (MPEP 716.02(b)(I)). This has not been done. In addition, unexpected results must be commensurate in scope with the claimed invention. Applicants have no evidence that, even if their single example demonstrated synergy, that it could be extrapolated to every hormone of claim 1. Jia et al (Nat. Rev. Drug Discov. (2009) 8 p111-129) demonstrates that at least some mechanisms of synergy are dependent on the mechanism of action of the drugs (note table 2, p113, for example). The various hormones of claim 1 bind to different receptors to work by different pathways to exert different effects from each other. That makes it impossible to extrapolate from one to all of them.
second rejection
Claim(s) 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 45, 52, 64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Stagsted et al (WO 2017103200, cited by applicants) in view of DiMarchi et al (US 6,191,102) and Le Tourenau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
The teachings of Stagsted et al and DiMarchi et al were given above, and will not be repeated here. Please note that these references render obvious claims 1, 5, 7, 14, 23, 24, 27, 34, 39, 45, 52, 64, and 66.
The difference between these references and the remaining claim is that they do not specify the energy content of the formulation.
Le Tourneau et al discusses the phase I clinical trial (title). The main goal of these studies is to establish the dose and dose schedule of any new drug or drug combination (abstract). A number of different ways of performing this optimization are discussed (fig 2, p711, top of page). This allows for have as many patients as possible in the therapeutic dose range while preserving safety (p708, 1st column, 2nd paragraph).
Therefore, it would be obvious to optimize the dose of the therapeutics of Stagsted et al and DiMarchi et al, to have as many patients as possible within the therapeutic dose range while preserving patient safety, as discussed by Le Tourneau et al. As every drug used has to have the dosage optimized, a practitioner in this field will be familiar with the process, leading to a reasonable expectation of success.
response to applicant’s arguments
Applicants used the same arguments for both rejections under this statute, which were answered above.
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 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 52, 64, and 66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-9 of U.S. Patent No. 11,259,554 in view of DiMarchi et al (US 6,191,102).
Competing claim 1 describes an oral dosage form comprising a genus of peptides that is a subgenus of that of examined claim 1, while competing claim 7 lists specific sequences that match those of examined claim 27. Competing claim 5 specifies only natural amino acids, similar to examined claim 23. Competing claim 6 specifies that the sequences be between 6 and 50 amino acids in length, while competing claim 8 specifies the dosage (relevant to examined claim 38). Competing claim 9 specifies reduction of food intake upon consumption (relevant to examined claim 52).
The difference between the competing claims and the examined claims is that the competing claims do not have a gut hormone.
DiMarkchi et al discuss GLP-1 analogs for regulation of obesity (title), the same application as the competing claims. This can cause significant reductions in body weight (column 2, line 62-65). A number of variables will affect the dose, so this will need to be optimized (column 14, line 59-column 15, line 8). Oral administration is a preferred route of administration (column 14, line 29-30). This reference teaches GLP-1 analogs for treatment of obesity.
The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06). The formulations of the competing claims and the formulations of DiMarchi et al are both taught for reducing weight, and both can be orally administered, rendering the combination of the two obvious.
response to applicant’s arguments
Applicants refer to the arguments presented with respect to the rejections under 35 USC 103, which were answered above.
second rejection
Claims 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 45, 52, 64, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 16-19 of U.S. Patent No. 12,295,397 in view of DiMarchi et al (US 6,191,102).
Competing claim 1 describes a method of promoting satiety, comprising administering a peptide selected from a subgenus of those of the examined claims. Competing claim 13 specifies a Markush group of peptides (using comprise or consist language) that includes KPYIL, applicant’s elected species. Competing claim 16 specifies a dosage of at least 5 mg, which presumably is less than 50 KJ of energy, while competing claims 17-19 specify a pharmaceutical composition, an oral dosage form, and a powder formulation that can be dissolved in a liquid.
The difference between the competing claims and the examined claims is that the competing claims do not have a gut hormone.
DiMarkchi et al discuss GLP-1 analogs for regulation of obesity (title), the same application as the competing claims. This can cause significant reductions in body weight (column 2, line 62-65). A number of variables will affect the dose, so this will need to be optimized (column 14, line 59-column 15, line 8). Oral administration is a preferred route of administration (column 14, line 29-30). This reference teaches GLP-1 analogs for treatment of obesity.
The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06). The formulations of the competing claims and the formulations of DiMarchi et al are both taught for reducing weight, and both can be orally administered, rendering the combination of the two obvious.
response to applicant’s arguments
Applicants refer to the arguments presented with respect to the rejections under 35 USC 103, which were answered above.
third rejection
Claims 1, 5, 7, 14, 23, 24, 27, 34, 39, 45, 52, 64, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 54, 64, and 67 of copending Application No. 17/438,762 (US 20230042729) in view of DiMarchi et al (US 6,191,102).
Competing claim 1 describes a genus of peptides that overlap with that of the examined claims, while competing claim 54 specifies a powder formulation to be dissolved in a liquid, such as milk, juice, or yogurt (which means oral administration). Competing claim 64 is a method of treating a Markush group of disorders, including obesity, by administering the peptide of competing claim 34, while competing claim 67 gives a Markush group of sequences, including SEQ ID 9; the same polypeptide sequence as applicant’s elected species.
The difference between the competing claims and the examined claims is that the competing claims do not have a gut hormone.
DiMarkchi et al discuss GLP-1 analogs for regulation of obesity (title), the same application as the competing claims. This can cause significant reductions in body weight (column 2, line 62-65). A number of variables will affect the dose, so this will need to be optimized (column 14, line 59-column 15, line 8). Oral administration is a preferred route of administration (column 14, line 29-30). This reference teaches GLP-1 analogs for treatment of obesity.
The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06). The formulations of the competing claims and the formulations of DiMarchi et al are both taught for reducing weight, and both can be orally administered, rendering the combination of the two obvious.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants refer to the arguments presented with respect to the rejections under 35 USC 103, which were answered above.
New Rejections
Claim Rejections - 35 USC § 103
The legal basis for rejections under this statute was given above, and will not be repeated here.
Claim(s) 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 45, 52, and 64-67 are rejected under 35 U.S.C. 103 as being unpatentable over Stagsted et al (WO 2017103200, cited by applicants) in view of DiMarchi et al (US 6,191,102), Le Tourenau et al (J. Natl. Cancer Inst. (2009) 101 p708-720), and Briones et al (Expert Opin. Pharmacother. (2006) 7(8) p1055-1064).
The teachings of Stagsted et al, DiMarchi et al, and Le Tourneau et al were given above, and will not be repeated here. Please note that these references render obvious claims 1, 5, 7, 14, 23, 24, 27, 34, 38, 39, 45, 52, 64, and 66.
The difference between these references and the remaining claims is that they do not define the GLP-1 agonist.
Briones et al discuss exenatide (title), which is a GLP-1 receptor agonist that inhibits food uptake in humans (abstract). This reference teaches exenatide is a species of the genus of GLP-1 variants discussed by DiMarchi et al.
Therefore, it would be obvious to use the exenatide of Briones et al, as a substitution of one known element (the GLP-1 agonists of DiMarchi et al) for another (the exenatide of Briones et al) yielding expected results (treatment of obesity). As DiMarchi et al states that variants are useful in the invention, and Briones et al mentions inhibition of food uptake, an artisan in this field would attempt this substitution with a reasonable expectation of success.
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
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