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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5 and 7-12, in the reply filed on 3/23/2026 is acknowledged.
Applicant’s species election is shown as follows.
Genus P: a type-2 diabetic subject;
Genus G: recombinantly produced GM-CSF. Thus, claim 4 is further withdrawn.
Genus E: reduces pancreatic islet amyloid deposition in the subject (claim 7). Thus, claims 8-9 are withdrawn for not reading on Genus E.
Genus R: subcutaneous administration
Genus M: abdominal obesity
Genus A: pancreatic islet amyloid deposits
Claim Status
Claims 1-5, 7-14, 16-18, and 21-22 are pending.
Claims 6, 15, 19-20, and 23-24 are cancelled.
Claims 4 and 8-9 are withdrawn as being directed to a non-elected invention, the election having been made on 3/23/2026 without traverse.
Claims 1-3, 5, 7, 10-14, 16-18, and 21-22 have been examined.
Priority
This application is a CON of PCT/US2022/017845 02/25/2022
PCT/US2022/017845 has PRO 63/159,380 03/10/2021
PCT/US2022/017845 has PRO 63/154,546 02/26/2021
Priority
This application is a CON of PCT/US2022/017845 02/25/2022
PCT/US2022/017845 has PRO 63/159,380 03/10/2021
PCT/US2022/017845 has PRO 63/154,546 02/26/2021
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/01/2023, 3/8/2025, and 3/23/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 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 22 is unclear with respect to the phrase “at least one other standard treatment for the condition”. Neither the specification nor claim 22 distinctly defines a “standard treatment” rendering the metes and bounds of claim 22 indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7, 10-14, 18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rivest (WO 2009/069002 A2).
Claim 1 is drawn to a method of reducing the risk of, preventing, or treating a pathologic entity of Type 2 diabetes in a subject comprising administering a composition comprising granulocyte macrophage colony stimulating factor (GM-CSF) or an mRNA construct encoding GM-CSF.
Rivest teaches a method of treating or preventing amyloidosis and diseases/disorders associated with amyloid plaque formation [Abstract, 0019]. Rivest teaches the treated amyloidosis associated diseases including Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18]. Rivest teaches administration of a low dose of growth factor polypeptide of granulocyte macrophage colony stimulating factor (GM-CSF) or functionally equivalent polypeptide for treating disorders associated with amyloid plaques (e.g., amyloidosis) [0235], reading on claims 1 and 13.
With respect to claims 2, 7, and 21, Rivest teaches administration of a colony stimulating factor (GM-CSF) for reducing amyloid deposition or plaques of islet amyloid precursor protein [0018] in pancreas [0016] or other tissue/organ, reading on pancreatic islet amyloid depositions. Rivest teaches the reduces amyloid deposits, plaques or aggregates can also be β2-microglobulin, gelsolin, and other amyloid deposits further reading on claim 21 [0018, claim 17].
With respect to claims 3 and 14, Rivest teaches colony stimulating factor polypeptides of M-CSF, GM-CSF, and G-CSF [0226] are recombinant polypeptides made by routine techniques comprising in vitro recombinant DNA, synthetic techniques, and expression of a nucleic acid sequence encoding a polypeptide in a host transformed with the recombinant DNA molecule [0161].
With respect to claim 10, Rivest teaches the composition of colony stimulating factor polypeptides dispersed in a biocompatible carrier material that functions as a suitable delivery or support system for the compounds [0204].
With respect to claim 11, Rivest teaches the route of administration comprising subcutaneous, intramuscular or intravenous injections [0202].
With respect to claim 12, Rivest teaches colony stimulating factor polypeptides formulated into pharmaceutical compositions for administration to animals, including humans [0189].
With respect to claim 18, Rivest teaches the treated subject comprising type II diabetes [0237; p90, claim 18].
With respect to claim 22, Rivest teaches the administered growth factor, colony stimulating factor polypeptide of GM-CSF, can be administered alone or in combination with stem cell factors and/or therapeutic agents effective to treat amyloid related diseases or disorders [p22, 0080, last 3 line to p23, line 1-2], reading on at least one other standard treatment for the condition.
Claims 13-14 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Potter et al. (US 2017/0189490 A1).
Claim 13 is drawn to a method of preventing, reducing, or treating amyloid depositions in a subject having a condition, the method comprising administering to the subject a composition comprising granulocyte macrophage colony stimulating factor (GM-CSF), recombinantly produced molecule thereof, or biologically active fragment thereof, or an analog thereof, wherein the subject has amyloid depositions or is suspected of developing amyloid depositions.
Potter et al. teach administration of granulocyte colony-stimulating factor to a person in need of treatment (Abstract). Potter et al. teach administration of GM-CSF to treat reducing amyloid beta levels in plasma or brain caused by Alzheimer's disease [0030, 0131, claims 3-5 and 6-7]. Potter et al. teach subcutaneous GM-CSF injection to mice [0022] with amyloid deposition [0028], reading on claim 13.
With respect to claim 14, Potter et al. teach GM-CSF polypeptide can be made from polynucleotides in an expression vector introduced into a producing cell [0060].
With respect to claim 21, Potter et al. teach reduced amyloid deposition in GM-CSF-injected left hemispheres, reading on other amyloid deposits.
With respect to claim 22, Potter et al. teach GM-CSF can be used in combination with a stem cell factor [0102], reading on undergoing at least one other standard treatment.
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.
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.
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.
Claims 1-3, 7, 10-14, 16-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rivest (WO 2009/069002 A2) as applied to claims 1-3, 7, 10-14, 18, 21-22, and further in view of Ohsawa et al. (Diabetes Res Clin Pract. 1992 Jan;15(1):17-21) and Freemantle et al. (Int J Clin Pract. 2008 Sep;62(9):1391–1396).
Claim 16 is drawn to the treated patient with type II diabetes having at least one metabolic risk factor.
Rivest teaches administration of granulocyte macrophage colony stimulating factor (GM-CSF) to treat a patient with type II diabetes having amyloid deposition/plaques of islet amyloid precursor protein [0018] in pancreas [0016].
Rivest did not teach a metabolic risk factor of type II diabetes.
Ohsawa et al. teach “Islet amyloid polypeptide-derived amyloid deposition increases along with the duration of type 2 diabetes mellitus” (Title; p17, Introduction, col 1-2). Ohsawa et al. teach islet amyloid polypeptide (IAPP) derived amyloid deposition increases along with the duration of type 2 diabetes mellitus and obesity may further enhance these deposits (Abstract and p20, col 2, In conclusion), reading on one metabolic risk factor of obesity in claim 16.
Similarly, Freemantle et al. teach there is a substantial literature referring to obesity as a major risk factor in the development of diabetes (p1931, Introduction, col 1), consistent with Ohsawa et al. Freemantle et al. teach there is a strong association between measures reflecting abdominal obesity and the development of type 2 diabetes. Reducing waist circumference (WC) may reduce the risk of developing type 2 diabetes (p1931, Summary), reading on one metabolic risk factor comprising abdominal obesity in claim 17.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Rivest and (ii) Ohsawa et al. in view of Freemantle et al. because (a) Rivest teaches administration of granulocyte macrophage colony stimulating factor (GM-CSF) to treat a patient with type II diabetes having amyloid deposition/plaques of islet amyloid precursor protein [0018] in pancreas [0016], (b) Ohsawa et al. teach islet amyloid polypeptide (IAPP) derived amyloid deposition increases along with the duration of type 2 diabetes mellitus and obesity may further enhance these deposits (Abstract and p20, col 2, In conclusion), and (c) Freemantle et al. teach there is a strong association between measures reflecting abdominal obesity and the development of type 2 diabetes. Reducing waist circumference (WC) may reduce the risk of developing type 2 diabetes (p1931, Summary). The combination would have reasonable expectation of success because all three cited references teach type 2 diabetes.
Claims 1-3, 5, 7, 10-14, 18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rivest (WO 2009/069002 A2) as applied to claims 1-3, 7, 10-14, 18, 21-22 and further in view of Boyd et al. (Alzheimer's & Dementia. 2018; 14: P1517-P1518.).
Claim 5 is drawn to a dosage range of administered GM-CSF from about 10 µg/m2/day to about 1,000 µg/m2/day.
Rivest suggests the therapeutically effective amount of GM-CSF is a result effective variable can be optimized about 400 µg/kg per week [0030]. Similarly, Boyd et al. teach subcutaneous administration of an effective amount of a recombinant human GM-CSF (at a dose of 250 mg/m2/day) to treat amyloid depositions, e.g., Alzheimer's disease, via clinical trials (S1518, col 1, para 1), reading on claim 5. See MPEP 2144.05 II.A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. "In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Rivest with (ii) Rivest et al. because (a) Rivest teaches administering an effective amount of granulocyte macrophage colony stimulating factor (GM-CSF) to treat amyloidosis associated diseases including Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18] and (b) Boyd et al. teach an effective amount of a recombinant human GM-CSF (e.g., 250 mg/m2/day) to treat amyloid depositions via subcutaneous injection to treat Alzheimer's disease can be optimized by routine experimentation of clinical trials (S1518, col 1, para 1). The combination would have reasonable expectation of success because both references suggest subcutaneous administration of a recombinant GM-CSF to treat amyloidosis associated diseases (e.g., Alzheimer's disease).
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3, 5, 7, 10-14, 16-18, and 21-22 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3, 5, 7, 10-14, 16-18, and 21-22 of copending Application No. PCT/US22/17845 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 10-14, 18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 21-22 of U.S. Patent No. 9,682,124 B2 (the ‘124 patent) in view of Rivest (WO 2009/069002 A2).
Claim 1 of the ‘124 patent disclosed a method for treating pathological amyloid beta (Aβ) peptide accumulation in the brain of a person comprising administering to the person or animal an effective amount of a granulocyte/ macrophage colony-stimulating factor (GM-CSF).
Claim 14 of the ‘124 patent disclosed the Aβ peptide is present as an extracellular amyloid plaque.
Claims 1 and 14 of the ‘124 patent did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claims 1 and 14 of the ‘124 to treat type II diabetes.
Thus, claims 1 and 14 of the ‘124 patent in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
Claims 1-3, 7, 10-14, 18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 21-22 of U.S. Patent No. 11,267,859 B2 (the ‘859 patent) in view of Rivest (WO 2009/069002 A2).
Claim 15 of the ‘859 patent disclosed a method of administering GS-CSF to treat a subject.
Claims 21-22 of the ‘859 patent disclosed the treated disease comprising Alzheimer's Disease.
Claims 15 and 21-22 of ‘the 859 patent did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claims 15 and 21-22 of the ‘859 patent to treat type II diabetes.
Thus, claims 15 and 21-22 of the ‘859 patent in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
Claims 1-3, 7, 10-14, 18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 of U.S. Patent No. 11,896,647 B2 (the ‘647 patent) in view of Rivest (WO 2009/069002 A2).
Claims 6-7 of the ‘647 patent disclosed a method of administering granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease.
Claims 6-7 of the ‘647 patent did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claims 6-7 of the ‘647 patent to treat type II diabetes.
Thus, claims 6-7 of the ‘647 patent in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
Claims 1-3, 7, 10-14, 18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 of U.S. Patent No. 11,993,638 B2 (the ‘638 patent) in view of Rivest (WO 2009/069002 A2).
Claim 15 of the ‘638 patent disclosed a method of using granulocyte macrophage colony stimulating factor (GM-CSF) to treat a subject in need.
Claim 19 of the ‘638 patent disclosed the treated subject having treat Alzheimer's disease.
Claims 15 and 19 of the ‘638 patent did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claims 15 and 19 of the ‘638 patent to treat a subject having type II diabetes.
Thus, claims 15 and 19 of the ‘638 patent in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
Claims 1-3, 7, 10-14, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/946,816 (the ‘816 application, 4/28/2026) in view of Rivest (WO 2009/069002 A2).
Claim 1 of the ‘816 application disclosed a method of administering a composition consisting essentially of granulocyte macrophage colony stimulating factor (GM-CSF) to treat infection.
Claim 1 of the ‘816 application did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claim 1 of the ‘816 application to treat a subject having type II diabetes.
Thus, claim 1 of the ‘816 application in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 7, 10-14, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of copending Application No. PCT/US22/16219 (the ‘219 application) in view of Rivest (WO 2009/069002 A2).
Claims 1 and 6-7 of the ‘219 application disclosed a method of administering granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease.
Claims 1 and 6-7 of the ‘219 application did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to administer GS-CSF taught by claims 1 and 6-7 of the ‘219 application to treat a subject having type II diabetes.
Thus, claims 1 and 6-7 of the ‘219 in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 7, 10-14, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of copending Application No. 17/589,154 (the ‘154 application, 4/16/2024) in view of Rivest (WO 2009/069002 A2).
Claims 21 and 36-37 of the ‘154 application disclosed a method of administering a granulocyte macrophage colony stimulating factor analog compound (GM-CSF) to treat a subject in need.
Claim 41 of the ‘154 application disclosed the treated subject is a patient with Alzheimer's disease.
Claims 21, 36-37, and 41 of the ‘154 application did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to either substitute or combine the GS-CSF analog taught by claims 21, 36-37, and 41 of the ‘154 application to treat a subject having type II diabetes or Alzheimer's disease.
Thus, claims 21, 36-37, and 41 of the ‘154 in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 7, 10-14, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of copending Application No. 17/227,184 (the ‘184 application, 7/27/2023) in view of Rivest (WO 2009/069002 A2).
Claim 1 of the ‘184 application disclosed a method of administering granulocyte macrophage colony stimulating factor (GM-CSF) to treat a neurodegenerative condition.
Claim 7 of the ‘184 application disclosed the treated neurodegenerative condition is Alzheimer's disease.
Claims 1 and 7 of the ‘184 application did not teach administration of GS-CSF to treat Type 2 diabetes.
The relevancy of Rivest as directed to claims 1-3, 7, 10-14, 18, and 21-22 is described above not repeated here.
Because Rivest teach beneficial use of granulocyte macrophage colony stimulating factor (GM-CSF) to treat Alzheimer's disease (AD) and type II diabetes [0237; p90, claim 18], one of ordinary skill in the art would have found it obvious to either substitute or combine the GS-CSF analog taught by claims 1 and 7 of the ‘184 application to treat a subject having type II diabetes or Alzheimer's disease.
Thus, claims 21, 36-37, and 41 of the ‘154 in view of Rivest are obvious to the instant claims 1-3, 7, 10-14, 18, and 21-22.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
03-May-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights