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 .
Claims Status
The remarks filed 11/03/2025 are acknowledged.
Claims 1-20 are canceled.
Claims 21-37 are new and pending.
Applicant’s election without traverse of Group II, claims 22-37, in the reply filed on 11/03/2025 is acknowledged. Applicant’s election of the following species without traverse in the reply filed 11/03/2025 is acknowledged: SEQ ID NO: 4, about 0.1 mg/kg to about 1.0 mg/kg, and obesity.
The elected species are free of the art, and consistent with MPEP 803.02, the examiner has extended the search and examination to the non-elected species. Therefore, the election of species is withdrawn. In view of the withdrawal of the election of species requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is
allowable in the present application, such claim may be subject to provisional statutory
and/or nonstatutory double patenting rejections over the claims of the instant
application. Once the election of species requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ
129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claims 22-37 are under examination.
Priority
The instant application is a 371 of PCT/US2021/046602 and claims priority to provisional application 63/067,675. Priority is given with the earliest effective filing date of 08/19/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/16/2023 and 09/03/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Written Opinion of a Search Report. The listing of the references cited in a Written Opinion and/or Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
(1) Figure 4 comprises 2 panels. 37 CFR 1.84(u)(1) requires that partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. Figure 4 should be Figures 4A-4B.
(2) The drawings do not meet the requirements of 37 CFR 1.84(a)(1) which requires that “india ink, or its equivalent that secures solid black lines, must be used for drawings”. The lines are pixelated and not solid in Figures 2 and 4-36, making the legends and results uninterpretable.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 29-32 and 36-37 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 29-32 and 37 recite the limitation ”said active ingredient”. There is insufficient antecedent basis for this limitation in the claims. The lack of antecedent basis arises from claims 29-32 and 37’s dependence on claim 22, wherein the “active ingredient” is not mentioned. For examination purposes, the Examiner has interpreted “said active ingredient” as referring to the FGF-7 fusion protein(s) of SEQ ID NOs: 2, 3, 4, 5, 6, and/or 7.
Claims 31 and 37 recite the limitation “about”. Applicant has provided an explicit definition for “about” meaning “numbers that fall within a range of 1%, 5%, 10%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context” (see paragraph 72 of the Specification). However, the metes and bounds for “about” are dependent on the interpretation of others for determining what the acceptable range is. Given a single value, one person of ordinary skill in the art could determine that the value is acceptably in the range. Yet, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.”
Additionally, claims 31 and 37 recite the limitation the/a “therapeutically effective amount of said active ingredient in humans (that) ranges from: a) about 0.1 mg/kg to about 1.0 mg/kg; or b) about 0.2 mg/kg to about 2 mg/kg.” The “therapeutically effective amount” is dependent on the weight of each individual person that the composition would be administered to. Therefore, since weight is highly variable, it is unknown what a “therapeutically effective amount” would be. Therefore, the scope of these claims is indefinite.
Claim 36 recites the limitation “…wherein the metabolic disorder is one or more of…neurodegenerative diseases, and Alzheimer’s disease.” A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 36 recites the broad recitation “neurodegenerative diseases”, and the claim also recites “Alzheimer’s disease” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 35-36 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 a metabolic disorder wherein the metabolic disorder is obesity, overweight, type II diabetes, insulin resistance, hyperinsulinemia, hyperglycemia, prediabetes, hypertension, hyperlipidemia, hepatosteatosis, fatty liver, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, acanthosis nigricans, hyperphagia, triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, and Prader-Willi syndrome, does not reasonably provide enablement for modulating any metabolic response, treating or preventing any metabolic disorder or any endocrine abnormality, treating Alzheimer’s disease, or specifically preventing Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome, neurodegenerative diseases, and Alzheimer's disease. 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.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
The claims are drawn to modulating a metabolic response in the subject and/or preventing or treating a metabolic disorder in the subject. Claim 36 adds the limitation wherein the metabolic disorder is one or more of obesity, overweight, type II diabetes, insulin resistance, hyperinsulinemia, hyperglycemia, prediabetes, hypertension, hyperlipidemia, hepatosteatosis, fatty liver, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, acanthosis nigricans, hyperphagia, endocrine abnormalities, triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome, neurodegenerative diseases, and Alzheimer's disease.
The claims are broad and inclusive of any metabolic response, any metabolic disorder, any endocrine abnormality, and any neurodegenerative disease. The breadth of the claim exacerbates the complex nature of the subject matter to which the present claims are directed. The claims are extremely broad due to the vast number of possible metabolic responses, metabolic disorders, endocrine abnormalities, and neurodegenerative diseases. The instant specification does not provide any evidence that the administration of the composition comprising the FGF-7 fusion protein(s) (i.e. SEQ ID NOs: 2-7) would prevent or treat any metabolic response, any metabolic disorder, any endocrine abnormality, and any neurodegenerative disease, let alone prevent triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome, and Alzheimer's disease, as listed in claim 36. There is no support provided in the instant specification or in the prior or instant art that teaches or supports the ability to prevent any metabolic disorder, any endocrine abnormality, and any neurodegenerative disease, encompassed by these broad claims.
Additionally, the term "preventing" is generally understood in the art to encompass a total protection from disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. As noted above, however, there are no working examples in the instant specification demonstrating therapy using the claimed composition for any metabolic response, any metabolic disorder, any endocrine abnormality, and/or any neurodegenerative disease, nor any examples directed to the palliative, preventative, or curative treatment any metabolic disorder, any endocrine abnormality, and/or any neurodegenerative disease, and more specifically, preventing triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome, all of which are genetic disorders, and Alzheimer's disease. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the broadly claimed method and pharmaceutical composition in how to use the method to prevent any metabolic disorder, any endocrine abnormality, and/or any neurodegenerative disease.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
While the state of the art is relatively high with regard to modulating specific types of metabolic responses and treating specific metabolic disorders, and endocrine abnormalities, the state of the art with regard to modulating any metabolic response, and treating or preventing any metabolic disorder, any endocrine abnormality, and/or any neurodegenerative disease is underdeveloped. One such disease encompassed by the broad claims is Alzheimer’s disease. The field of proteinopathy prevention and treatment is highly unpredictable. The causes of proteinopathies are still largely unknown today. For example, the Mayo Clinic, 2015 (instant PTO-892) states that scientists believe that for most people, Alzheimer's disease results from a combination of genetic, lifestyle and environmental factors that affect the brain over time and that less than 5 percent of the time, Alzheimer's is caused by specific genetic changes that virtually guarantee a person will develop the disease [page 1, paragraphs 1-2]. The National Institute of Neurological Disorders and Stroke, 2015 (instant PTO-892) indicates that no treatments are available to slow progression of Alzheimer’s, although treatments do exist to help treat AD symptoms to improve quality of life (see page 1, last paragraph-page 2, first paragraph).
In addition, predicting the success of a treatment for neurodegenerative disease presents challenges beyond initial screening, because success rates for identifying therapeutics that can treat any central nervous system disease fall below the average for other diseases. Screening in animal models, such as mice, does not necessarily yield translatable results to other subjects such as humans, even if the mice duplicate some histopathological and biochemical features of a particular proteinopathy. Gotz et al., 2018 (instant PTO-892) teaches that there is a lack of success in translating rodent data into therapeutic outcomes for Alzheimer’s disease [see Abstract].
Specifically regarding the metabolic disorder of Alzheimer’s disease, for the skilled artisan to practice the claimed invention, a demonstration of therapeutic or preventative effects of the FGF-7 fusion proteins (i.e. SEQ ID NOs: 2-7), in a subject and/or an in vivo model known to translate to treating humans or other encompassed subjects is required. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the claimed method, largely due to the lack of reliable animal models for proteinopathy.
(6) the amount of direction or guidance presented; (7) the presence or absence of working examples:
There is a lack of working examples in the specification for modulating all types of metabolic responses and/or preventing or treating all types of metabolic disorders, endocrine abnormities, and neurodegenerative diseases. Applicant has provided evidence of the administration of the FGF-7 fusion proteins (i.e. SEQ ID NOs: 2-7) resulting in body weight loss and insulin sensitivity improvement due to an increase in energy expenditure and an improvement of metabolic health [see Examples 5-6 of the instant specification] of which would be treatment for obesity, overweight, type II diabetes, insulin resistance, hyperinsulinemia, hyperglycemia, prediabetes,
hypertension, hyperlipidemia, hepatosteatosis, fatty liver, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, acanthosis nigricans, hyperphagia, triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome because unhealthy body weight and insulin sensitivity are symptoms and/or causes of these disorders. However, Applicant has not provided any substantive evidence of modulating any metabolic response and/or treating or preventing any metabolic disorder, any endocrine abnormality, any neurodegenerative disease, or Alzheimer’s disease using the claimed method. Because the metabolic responses, metabolic disorders, endocrine abnormalities, and neurodegenerative diseases encompassed by the instant claims are so disparate, and no single metabolic responses, metabolic disorders, endocrine abnormalities, and neurodegenerative diseases can be representative of all other encompassed metabolic responses, metabolic disorders, endocrine abnormalities, and neurodegenerative diseases, a demonstration of treatment or support of a given condition does not provide support for the breadth of the claim.
In conclusion, the claimed invention does not provide enablement for modulating any metabolic response and/or treating or preventing any metabolic disorder, any endocrine abnormality, or any neurodegenerative disease encompassed by the instant claims. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, and the lack of guidance and working examples provided in the specification and the art. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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 22-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28, 35-36, 39, and 42-49 of copending Application No. 18/561,769 (‘769; reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 22-28 of the instant application, claim 28 of ‘769 teaches a pharmaceutical composition comprising: a) bezafibrate as a first active ingredient, oxaprozin as a second active ingredient, and a glucagon-like peptide-1 (GLP-1) receptor agonist as a third active ingredient and a pharmaceutically acceptable carrier; or b) a GLP-1 receptor agonist as a first active ingredient, fibroblast growth factor 7 (FGF7) or analogs thereof as a second active ingredient and a pharmaceutically acceptable carrier and claim 42 of ‘769 teaches wherein the FGF7 or analog thereof comprises SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, or 8.
SEQ ID NOs: 2, 3, 4, 5, 6, and 7 of ‘769 have 100% sequence identity to SEQ ID Nos: 2, 3, 4, 5, 6, and 7 of the instant claims, respectively.
Regarding claims 29, 30, and 32 of the instant application, since ‘769 teaches a composition comprising a FGF7 protein with 100% sequence identity to the instant claims, than SEQ ID NOs: 2, 3, 4, 5, 6, and 7 of ‘769 must have the same functions as recited in instant claims 29, 30, and 32 since function flows from structure. See MPEP 2112.01(II).
Regarding claim 31 of the instant application, claim 35 of ‘769 teaches the pharmaceutical composition comprising a GLP-1 receptor agonist and FGF-7, and claim 36 of ‘769 teaches the pharmaceutical composition of claim 35, wherein the therapeutically effective amount of said GLP-1 receptor agonist is about 10% to about 100% of the clinically approved dosage of said GLP-1 receptor agonist and the FGF-7 dosage is about 0.02 to about 0.1 mg/kg, about 0.04 to about 0.08 mg/kg or about 10% to about 100% of said FGF-7 dosage.
Regarding claim 33 of the instant application, claim 39 of ‘769 teaches the pharmaceutical composition of claim 28, wherein said composition has one or more biological activities selected from the group consisting of: (a) an increase in thermogenesis in brown adipose tissue, skeletal muscle tissue and/or white adipose tissue; (b) an increase in insulin sensitivity of skeletal muscle, white adipose tissue, or liver; (c) an increase in glucose tolerance; (d) an increase in basal respiration, maximal
respiration rate, or uncoupled respiration; (e) an increase in metabolic rate; (f) a decrease in hepatosteatosis; (g) a decrease in body weight; (h) a decrease in body fat mass; (i) a decrease in plasma leptin levels; (j) a decrease in glycemia; (k) a decrease in plasma insulin levels; (l) a decrease in insulin resistance; (m) a decrease in circulating lipid levels; or a combination thereof.
Regarding claim 34 of the instant application, claims 43 and 47 of ‘769 teach a method of promoting brown adipogenesis in a subject in need thereof, the method comprising administering to the subject the pharmaceutical composition of claim 28, and claim 46 teaches the method of claim 43, wherein the FGF7 or analog thereof comprises SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, or 8.
SEQ ID NOs: 2, 3, 4, 5, 6, and 7 of ‘769 have 100% sequence identity to SEQ ID Nos: 2, 3, 4, 5, 6, and 7 of the instant claims, respectively.
Regarding claim 35 of the instant application, claims 44 and 48 teach the method of claim 43 and 47, respectively, further comprising modulating a metabolic response in the subject and/or treating a metabolic disorder in the subject.
Regarding claim 36 of the instant application, claims 45 and 49 teach wherein the metabolic disorder is one or more of obesity, overweight, type II diabetes, insulin resistance, hyperinsulinemia, hyperglycemia, prediabetes, hypertension, hyperlipidemia, hepatosteatosis, fatty liver, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, acanthosis nigricans, hyperphagia, endocrine abnormalities, triglyceride storage disease, Bardet-Biedl syndrome, Laurence-Moon syndrome, Prader-Willi syndrome, neurodegenerative diseases, and Alzheimer's disease.
Regarding claim 37 of the instant application, claim 36 teaches wherein the therapeutically effective amount of said GLP-1 receptor agonist is about 10% to about 100% of the clinically approved dosage of said GLP-1 receptor agonist and the FGF-7 dosage is about 0.02 to about 0.1 mg/kg, about 0.04 to about 0.08 mg/kg or about 10% to about 100% of said FGF-7 dosage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675