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 .
The Applicants’ Amendment to the Claims filed on 10/31/2025 is entered.
Claims 1-17 are pending and under examination.
This is the First Office Action on the Merits of US18/013,479 filed on 12/28/2022 which is a 371 of PCT/EP2020/068747 filed on 07/02/2020. The most recent Filing Receipt received on 05/02/2023 is controlling.
Election/Restrictions
Applicant’s election without traverse of the following Species in the reply filed on 10/31/2025 is acknowledged.
For species A): X1 is H; X10 is K; X12 is K; X13 is Q; X15 is E; X16 is E; X17 is E; X18 is A; X19 is V; X20 is R; X21 is L; X23 is I; X27 is K; X28 is A; and X29 is G;
For species A1): SEQ ID NO: 262;
For species B): SEQ ID NO: 598 (PKKIRYS), which is the peptide extension for SEQ ID NO: 262.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete because the term “Kilobytes” should be in “bytes”.
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Information Disclosure Statement
The IDS statements filed on 10/31/2025, 09/18/2024, and 12/28/2022 have been considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: For improved clarity claim 3 should be amended to: …wherein the at least one additional amino acid residue at its N-terminus is G or A.
Claim Rejections - 35 USC § 112
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.
Claims 1-17 are 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.
Claims 1, 5, and 6, recite the term “native GLP-1(7-36) (SEQ ID NO: 260)” which is indefinite regarding the scope of the native GLP-1 amino acid sequence structure required by the claims. Note that instant SEQ ID NO: 260 is a thirty amino acid protein sequence with amino acid position #1 being a His residue. The term "native GLP-1(7-36)" is defined in the Specification in page 14 (lines 32-33):
The term "native GLP-1(7-36)", as used herein, refers to a peptide having the amino acid sequence of SEQ ID NO: 260, which, optionally, comprises an amide group at its C-terminus.
It is unclear whether the native GLP-1 recited in the claims is specific to instant SEQ ID NO: 260, shown in parenthesis in the claims, or whether it includes an amide group at its C-terminus. Claims 2-17 are indefinite as they depend from claim 1 and are not remedial.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 11-12 fail to include all the limitations of the claim 1 upon which they depend. For example, claim 11, is drawn to a nucleic acid molecule encoding a GLP-1R agonistic peptide according to claim 1 but does not actually require the peptide of claim 1. Also, claim 12, is drawn to a host cell containing a nucleic acid molecule according to claim 11 but does not actually require the peptide of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Claims 1-6, and 9-17 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 are drawn to pharmaceutical compositions with the intended use of treating a treating a disease or disorder in a subject including treating atherosclerosis and diabetes. Claims require the critically essential element of a Glucagon-Like Peptide-1 Receptor (GLP-1R) agonistic peptide with the functional requirement of having a GLP-1R agonistic activity which is about 9- to about 531-fold reduced as compared to a native GLP-1 comprising instant SEQ ID NO: 260. The critically essential peptide requires the property of being able to treat a disease or disorder in a subject including treating atherosclerosis and diabetes. The peptide structure is claimed as having an amino acid sequence of SEQ ID NO: 635. SEQ ID NO: 635 is a thirty amino acid peptide having 15 amino acid residues with variable residues. Claims 7 and 8 are excluded from this rejection regarding the elected species of instant SEQ ID NO: 262 which is a 38 amino acid GLP peptide with no variable residues. However, the number of variant structures requiring the functional language in the claims encompassed by the claim language of claims 1-6 and 9-17 is extremely large. Claims must be given their broadest reasonable interpretation consistent with the specification during examination. Even peptide variants of SEQ ID NO: 636 which recites four variable amino acid residues encompass a large number of variants. However, a review of the state of the art of peptides correlated to function shows that even a one amino acid change may have an effect on the peptide function. While having possession of this claimed pharmaceutical composition where the peptide comprises/consists of SEQ ID NO: 262, neither the specification as originally filed nor the state of the art before the effective filing date show a sufficient correlation of amino acid variants of the peptide comprising SEQ ID NO: 262 correlated to the required property of having a reduced agonist activity as compared to a GLP-1R agonistic activity of a native GLP-1 (7-36) (SEQ ID NO: 260) so that one of ordinary skill in the art would have been able to envision whether a given variant of SEQ ID NO: 262 would possess the required properties.
The instant Specification shows the GLP-1 attenuation factor for HbA1c, adipose mass, Non-HDL, Fatty Acids, Triglycerides, and GE-Rate. (See FIGs 1-4). Further, data is shown for instant SEQ ID NO:s 252, 2, 7, and 8 (FIGs 5-15). Table 3 shows values of the G-FGF21 (SEQ ID NO: 252) fusion protein. The specification discloses exendin derived peptides with the amino acid sequences of SEQ ID NO:25-26, 28, 30-33 and 35-36 with reduced GLP-1R agonistic activity which fall in between the 9- to 531-fold range (see Table 3 at page 42 of the specification). Claim 6 includes a formula for GLP-1R agonist molecules, however, this formula does not necessarily result in molecules which have the recited activity range (for example, SEQ ID NO:24, 27, 29 and 34). Claim 7 recites a number of molecules with the amino acid sequences of SEQ ID NO:9, 10, 12, 14, 15, 16, 17, 19 and 20, but there is no disclosure in the specification as to what activity level is possessed by proteins with these amino acid sequences. Example 4 shows in vitro cellular assay for GLP-1 R efficacy using human GLP-1(7-36)(SEQ ID NO:260) as control. The results are shown in Table 4 showing SEQ ID NO: 262 and the peptide of SEQ ID NO: 262 including variants comprising SEQ ID NO:s 1-8, 18-97, 100-109, and several up until SEQ ID NO: 301. Further, Working Example 7 shows in vivo efficacy in murine models using GLP-1RA/FGF21 Fc fusion proteins. However, he specification shows no other examples, shows no other variants of SEQ ID NO: 262, having the required properties of the claims.
The state of the art shows unpredictability in whether a variant of GLP-1R agonist encompassed by the present claim language would have the required property of reduced agonist activity compared to a native GLP-1 (7-36) (SEQ ID NO: 260) and further possess the ability to treat diseases including Type 2 diabetes mellitus, hyperglycemia, and atherosclerosis as recited in the claims. For example, the state of the art for GLP-1R agonists for such use is reviewed in the Sfairopoulos et al Review Article “Clinical pharmacology of glucagon-like peptide-1 receptor agonists” (Hormones 2018: Vol 17: pages 333-350). Sfairopoulos et al discloses that regarding the known GLP-1 Ras, “there are unique features and fundamental differences among them related to fasting and postprandial hyperglycaemia reduction, weight loss potency, cardiovascular protection efficacy, and adverse events profile.” (See Abstract). Regarding Sfairopoulos et al informs that
It is imperative that current evidence be integrated and applied in the context of an individualised patient-centred approach. This should include not only glucose management but also targeting as many as possible of the pathophysiologic mechanisms responsible for type 2 DM development and progression.
Thus it is considered that one of ordinary skill in the art would not be able to envision whether a given species of GLP-1R agonist peptide encompassed by the claims would possess the required functional properties without performing trial and error experimentation.
Thus, in view of the state of the art and the instant Specification it is considered that it is unpredictable whether the variants of the GLP-1R peptide agonist sequence encompassed by the claims meet the functional limitations of the present claims of being being a pharmaceutical for treating disease and for having reduced agonist activity as compared to “native GLP-1(7-36) (SEQ ID NO: 260)”.
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original).
To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
While having written description of the claims drawn to the pharmaceutical comprising the peptide consisting SEQ ID NO: 262, the specification does not provide sufficient descriptive support for the myriad of embodiments embraced by the claims. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Given this lack of description of representative species encompassed by the genus of the claim, the specification does not sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the entire scope of the claimed invention.
For inventions in an unpredictable art, adequate written description of a genus, which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph. In the instant case, the unpredictability of the art is evidenced by the cited references, above.
Adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating a compound. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Scope of enablement
Claims 1-17 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 treating obesity, NASH and effecting blood glucose levels in a mouse obesity/NASH model using GLP-1RA/FGF21 Fc fusion proteins, does not reasonably provide enablement for treating the disease or disorders in human subject using the GLP-1RA peptides encompassed by the claims. 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.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988). They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The nature of the invention: The invention is drawn to treating diseases in human subjects including atherosclerosis, dyslipidemia and type 2 diabetes mellitus. The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The breadth of the claims. The claims are broad to use of GLP-1R agonist peptides having the structure of instant SEQ ID NO: 635 with the caveats for variable residues shown in instant claim 1. Further, the claims are broad to treating any disease or disorder by administering such peptide to a subject in need.
The state of prior art, the relative skill of those in the art, and predictability or unpredictability of the art. The state of the art shows unpredictability in whether a variant of GLP-1R agonist encompassed by the present claim language would have the required property of reduced agonist activity compared to a native GLP-1 (7-36) (SEQ ID NO: 260) and further possess the ability to treat the breadth of diseases encompassed by the claims and including Type 2 diabetes mellitus, hyperglycemia, and atherosclerosis as recited in the claims. For example, the state of the art for GLP-1R agonists for such use is reviewed in the Sfairopoulos et al Review Article “Clinical pharmacology of glucagon-like peptide-1 receptor agonists” (Hormones 2018: Vol 17: pages 333-350). Sfairopoulos et al discloses that regarding the known GLP-1 Ras, “there are unique features and fundamental differences among them related to fasting and postprandial hyperglycaemia reduction, weight loss potency, cardiovascular protection efficacy, and adverse events profile.” (See Abstract). Regarding Sfairopoulos et al informs that
It is imperative that current evidence be integrated and applied in the context of an individualised patient-centred approach. This should include not only glucose management but also targeting as many as possible of the pathophysiologic mechanisms responsible for type 2 DM development and progression.
The amount of direction or guidance presented and the existence of working examples. The instant Specification shows the GLP-1 attenuation factor for HbA1c, adipose mass, Non-HDL, Fatty Acids, Triglycerides, and GE-Rate. (See FIGs 1-4). Further, data is shown for instant SEQ ID NO:s 252, 2, 7, and 8 (FIGs 5-15). Table 3 shows values of the G-FGF21 (SEQ ID NO: 252) fusion protein. Example 4 shows in vitro cellular assay for GLP-1 R efficacy using human GLP-1(7-36)(SEQ ID NO:260) as control. The results are shown in Table 4 showing SEQ ID NO: 262 and the peptide of SEQ ID NO: 262 including variants comprising SEQ ID NO:s 1-8, 18-97, 100-109, and several up until SEQ ID NO: 301. Further, Working Example 7 shows in vivo efficacy in murine models using GLP-1RA/FGF21 Fc fusion proteins. However, he specification shows no other examples, shows no other variants of SEQ ID NO: 262, having the required properties of the claims.
Thus, in view of the overly broad scope of the claims, the lack of guidance and insufficient working examples provided in the specification to practice the full-scope of the claimed invention, the high level of unpredictability of the prior art in regard to structural changes and their effect on function and the lack of knowledge about a correlation between structure and function, an undue experimentation would be necessary one having ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims.
The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of polypeptides having the desired biological characteristics recited in the claim is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988).
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Pat. No. 11,136,364 (Kim et al.).
Regarding instant claims 1-8, Kim et al. teach that the FGF21 mutant protein is part of a dual function protein which also comprises a biologically active protein which may be one of a number of proteins (see column 8, beginning at line 58). Kim et al. preferably teach that the biologically active protein may be selected from GLP-1, a mutant thereof and exendin-4. The amino acid sequence for Extendin-4 is: Extendin-4 comprises the HGEGTFTSDLSKQMEEEAVRLFTEWLKNGGPESGAPPPS amino acid sequence of reference SEQ ID NO:37 which encompasses embodiment of instant SEQ ID NO: 262 of the instant application. Further, regarding claims 1-8, Kim et al discloses a GLP-1R (Glucagon-Like Peptide-1 Receptor) agonistic peptide having a GLP-1R agonistic activity which is about 9- to about 531-fold reduced as compared to GLP-1R agonistic activity of a native GLP-1(7-36) (SEQ ID NO: 260), wherein the GLP-1R agonistic peptide comprises or consists of comprising or consisting of the amino acid sequence H-G-E-G-T-F-T-S-D-XIo-S-K-Q-L-E-E-E-XIS-V-X2o-L-F-I-E-W-L-K-A-X29-G (SEQ ID NO: 636), wherein X10 is K or L, X18 is A or R, X20 is R or Q, and X29 is G or T. Regarding the functional claim language, while Kim et al. do not specifically state the agonistic activity of the GLP-1 mutant (extendin-4) in relation to native GLP-1 but the instant application requires the GLP-1R agonist to have an activity which is 9 to 531-fold reduced compared to native GLP-1, Kim et al discloses the formula of ref SEQ ID NO:37 (and which encompasses exendin-4 and encompasses the embodiment of instant SEQ ID NO: 262) and therefore, exendin-4 would necessarily have an activity which is 9 to 531-fold reduced compared to native GLP-1, absent evidence to the contrary.
Regarding claim 3, note that the at least one additional amino acid residue is G or A is optional in claim 1 and thus is optional in claim 3. However, Kim et al. disclose linkers which may be present on the N- or C-terminus of the FGF-21 mutant and depending on the orientation of the fusion protein, these linkers would also end up on the N- or C-terminus of the GLP-1 mutant, thereby meeting the limitation of claim 3.
Regarding claim 4, note that the peptide extension is optional in claim 1 and thus is optional in claim 4.
Regarding claim 5, Kim et al discloses the GLP-1R agonistic peptide according to claim 1, wherein the GLP-1R agonistic peptide has a GLP-1R agonistic activity which is about 9- to about 531-fold reduced as compared to the GLP-1R agonistic activity of the native GLP-1(7-36) (SEQ ID NO: 260) when the GLP-1R agonistic peptide is in its isolated form and/or when the GLP-1R agonistic peptide is part of a fusion molecule. Kim et al. teach a dual function protein which comprises an FGF21 mutant protein and a biologically active protein wherein the FGF21 mutant protein has improved pharmacokinetic parameters, high stability, low possibility of forming aggregation complexes and reduced potential immunogenicity (see col. 4, lines 25-30).
Regarding claims 11-12, Kim et al discloses a nucleic acid molecule encoding a GLP-1R agonistic peptide and a host cell containing such nucleic acid molecule. (See col 5, lines 6-9).
Regarding claims 9-10, 13-14, Kim et al disclose a pharmaceutical composition comprising the GLP-1R agonistic peptide and an additional active pharmaceutical ingredient. Kim et al discloses a fusion molecule comprising a GLP-1R agonistic peptide according to claim 1 and at least one other active pharmaceutical ingredient. For example, Kim et al additionally teach pharmaceutical compositions which comprise the FGF21 and GLP-1R combination of the instant claims and teach that the composition may be administered and that a carrier or vehicle "may be added to the composition and be delivered to a patient" (see column 12, lines 8-26). While Kim et al. does not explicitly recite a "kit" (instant claim 15), the disclosure of a kit in clearly provided as the composition in addition to a carrier or vehicle is described in Kim et al. and such would be construed as a "kit" as it has all the components recited in the instant claim.
Regarding claims 15-17, Kim et al discloses a method of treating type 2 diabetes mellitus comprising administering to a subject in need thereof the GLP-1R agonistic peptide (See col 11, lines 8-22).
Thus Kim et al anticipates instant claims 1-17.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Pat. No. 10,583,174 (Göbel et al).
The applied reference (U.S. Pat. No. 10,583,174) has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
The subject matter of a combination comprising an FGF21 compound and a glucagon-like peptide-1 receptor (GLP-1R) agonist wherein the GLP-1R agonist has the amino acid sequence of SEQ ID NO:262 is fully disclosed in '174. U.S. Pat. No. 10,583,174 (Göbel et al.) teaches a combination of FGF21 compound with a GLP-1R agonist wherein and wherein the GLP-1R agonist has a GLP-1R agonistic activity which is 9- 531-fold reduced compared to the GLP-1R agonistic activity of native GLP-(7-36) and wherein the GLP-1R agonist comprises or consists of the amino acid sequence of SEQ ID NO:37 with "X" amino acids as recited in claim 1 of '174 which encompasses instant SEQ ID NO: 262 Göbel et al. additionally claim the same activity ranges for the GLP-1R agonist as in instant claims (see claims 2-3 of '174). Göbel et al. also claim the GLP-1R agonist by amino acid sequence (claim 5) which corresponds to the instant claims, as well as N-terminal and C-terminal additional amino (claims 6-8 of '174). Göbel et al. teaches a kit which includes one or more containers (see column 23, lines 8-26). Göbel et al. teaches that "the GLP-1R agonist having a GLP-1R agonist activity which is reduced as compared to that of native GLP-1(7-36) as defined herein comprises or consists of an amino acid sequence selected from the group consisting of SEQ ID Nos: 9, 10, 12, 14, 15, 16, 17, 19 and 20" (see column 15, lines 19-24). Göbel et al. teaches that "the FGF21 compound is an FGF21 variant comprising or consisting of an amino acid sequence selected from the group consisting of SEQ ID Nos: 3, 4, 5 and 6" (see column 11, lines 48-51). Therefore, Göbel et al. clearly teaches a combination comprising an FGF21 compound and a GLP-1R agonist having the amino acid sequence of SEQ ID NO:262 (the elected species) wherein the GLP-1R agonistic activity is the same as recited in the instant claims. Göbel et al. additionally teaches pharmaceutical compositions and kits as described above and therefore, Göbel et al. anticipates the instant claims (as they are directed to the elected species of FGF21 and GLP-1R).
In the event that Göbel et al. does not anticipate the instant claims with respect to a GLP-1R agonist having the amino acid sequence of SEQ ID NO:262 (the elected species), Göbel et al. makes obvious the combination because the recited species are clearly disclosed in Göbel et al. and it is taught that the FGF21 compound and the GLP-1R compound can be any of those which are disclosed in Göbel et al. as well as selected from compounds known in the art. One would be motivated to select the specific FGF21 compound and GLP-1R compound (SEQ ID NO:262) because they were specifically defined and recited compounds in the disclosure of Göbel et al.
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.
Claim 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 15, and 19-23 of copending Application No. 18/600,883 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of copending claims anticipates or renders obvious the present claims.
Regarding instant claims 1-8, copending claims 6 and 23 recite embodiments that comprise instant SEQ ID NO: 262.
Regarding instant claim 9, copending claim 9 recites a combination of the GLP-1R agonist and another active pharmaceutical ingredient.
Regarding instant claims 10-12, copending claim 15 recites a fusion molecule comprising the GLP-1R agonist, a nucleic acid encoding such and a host cell comprising such.
Regarding instant claims 13-14, copending claims 12 and 15 recite a pharmaceutical and a kit.
Regarding instant claims 15-17, copending claim 20 recite a method of treating diabetes mellitus type I or II.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-20 of copending Application No. 18/607,983 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of copending claims anticipates or renders obvious the present claims.
Regarding instant claims 1-8, copending claims 5 and 19 recite embodiments that comprise instant SEQ ID NO: 262.
Regarding instant claim 9, copending claim 7 recites a combination of the GLP-1R agonist and another active pharmaceutical ingredient.
Regarding instant claim 10, copending claim 8 recites a fusion molecule comprising the GLP-1R agonist.
Regarding instant claims 11-12, copending claims 10-11 recite a nucleic acid encoding the GLP-1R agonist, and a host cell comprising such.
Regarding instant claims 13-14, copending claims 9 and 12 recite a pharmaceutical and a kit.
Regarding instant claims 15-17, copending claim 17 recite a method of treating diabetes mellitus type I or II.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, and 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,583,174. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of copending claims anticipates or renders obvious the present claims.
Regarding instant claims 1-8, patented claims 1, 12, and 18 recite embodiments that comprise a GLP-1R agonist peptide comprising instant SEQ ID NO: 262.
Regarding instant claim 9, patented claim 1 recites a combination of the GLP-1R agonist and another active pharmaceutical ingredient.
Regarding instant claims 13-14, patented claim 12 recites a pharmaceutical and a kit.
Regarding instant claims 15-17, patented claim 11 and 17 recite a method of treating diabetes mellitus type I or II.
Conclusion
No claim is allowed.
WO2011/063414 to REF (published May 26, 2011)
WO2018/115401 to REF (Sanofi) published June 28, 2018
WO2019/243557 REF (Sanofi) published December 25, 2019
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658