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 .
Applicant’s amendment filed 6/23/2026 has been entered. Claims 37, 41 and 45 were amended. Claim 38 was cancelled. Claims 37 and 39-53 are pending examination.
Information Disclosure Statement
The information disclosure statement filed 6/23/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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 37-40, 42 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 7,776,876 (herein ‘876). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to methods of treating peripheral neuropathy with cyclic glycine proline, whereas ‘876 is drawn to cyclic glycyl-2-allyl proline and method of treating abnormalities in neurological function. The compounds cyclic glycyl-2-allyl proline only differs from cyclic glycine proline by the addition of allyl group which renders the claims of ‘876 prima facie obvious.
Claims 37-40, 42 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,791,117 (herein ‘117). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to methods of treating peripheral neuropathy with cyclic glycine proline, whereas ‘117 is drawn to cyclic glycyl-2-allyl proline and method of treating neurotoxic injury. The compounds cyclic glycyl-2-allyl proline only differs from cyclic glycine proline by the addition of allyl group which renders the claims of ‘117 prima facie obvious.
Claim Rejections - 35 USC § 103
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 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.
Claims 37, 39, 40, 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (WO 03/039487; published May 15, 2003) in view of Bansal et al. (Prevalence and risk factors of development of peripheral diabetic neuropathy in type 2 diabetes mellitus in a tertiary care setting, Journal of Diabetes Investigation, 2014, Vol. 5, No. 5, November 2014).
Applicant claims a method for ameliorating the effects of and/or treating peripheral neuropathy, kidney function failure or retinopathy linked to type 2 diabetes mellitus in a subject, comprising administering to the subject a composition comprising a therapeutically effective amount of cyclic Glycine Proline (cGP and cPG). (claim 37)
With respect to claims 37, 39 and 40, Guan et al. teach pharmaceutical compositions comprising cyclo(Pro-Gly) (cPG) which prevents toxic neural degeneration and cell death while promoting neurite outgrowth in neurons and neuroprotective effects (abstract). The cPG is a potent neuroprotective effects and therapeutic agent to treat neural degeneration, damage or neuronal cell death associated with hypoxia (page 4, paragraph 1). The treatments aid in prevention of cell damage and death in animals comprising providing a composition comprising cPG in response to injury or disease (page 6, paragraph 1). Therapeutic applications include treatment in animals, such as humans suffering neural injury or disease including diabetes and chronic neurodegenerative disease (page 8, paragraph 2 through page 9, paragraph 1). Administration routes can vary widely but include oral formulations (page 12, paragraphs 4 and 5). Formulations include adjuvants which are incorporated into tablets and capsules with a binder selected from gelatin and an excipient such as microcrystalline cellulose and when in the form of capsules may also contain a liquid carrier (page 16, paragraph 2).
With respect to claims 42 and 43, Guan teach the suitable dose range may be 1µg to 100,000 µg of cPG per 100g of body weight which can be adjusted with respect to route of administration and the nature of the neurological disorder or condition treated (page 13, paragraph 3 and 4). One of ordinary skill would have been motivated to manipulate ranges during routine experimentation to discover the optimum or workable range since the prior art provides the general range. Therefore, one of ordinary skill would have been motivated to use the appropriate amount of cPG to form a dose of at least 10,000-100,000 ng (10-100 µg) as a daily dose, preferably 20-40 µg.
Guan et al. do not specify ameliorating effects of and/or treating peripheral neuropathy, kidney function failure or retinopathy linked to type 2 diabetes mellitus, however Guan teaches administering cPG to humans suffering from neural injury and diseases including diabetes and chronic neurodegenerative disease. It is for this reason that Bansal et al. is joined.
Bansal et al. studied a high prevalence of diabetic peripheral neuropathy (herein DPN) in type 2 diabetes mellitus patients (abstract). The development of DPN is a well-known microvascular complication of type 2 diabetes mellitus which leads to further infections and approximately 40-50% of patients developing DPN further develop neuropathic pain which affects quality of life (page 714, paragraphs 1-2). Patients were assessed for neuropathy, retinopathy and nephropathy which are all categorized as microvascular complications (page 715, paragraph 8 through page 716, paragraph 3; Table 2: page 717, paragraph 1). The study found that nephropathy and retinopathy are risk factors for DPN and are complications which go hand-in-hand in diabetic patients (page 719, paragraph 6).
Both Guan and Bansal are drawn to methods of treating patients with diabetes. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Guan and Bansal et al. to treat peripheral neuropathy, retinopathy and nephropathy in diabetes mellitus patients with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings Guan et al. and Bansal et al. to further include treating peripheral neuropathy, nephropathy or retinopathy with cPG because Guan teach administering cPG to humans suffering from neural injury and diseases including diabetes and chronic neurodegenerative disease and Bansal et al. links peripheral neuropathy, nephropathy and retinopathy to complications associated with diabetes mellitus.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive. Applicant first argues that Guan does not suggest treating peripheral neuropathy, kidney failure or retinopathy that are linked to type 2 diabetes mellitus. Applicants’ arguments with reference to Roth have been considered but are moot because the new ground of rejection necessitated by amendment.
Applicant further argues that a known association between diabetes and peripheral neuropathy is not a teaching that Guan’s cGP treatment would be effective for that condition because the cited references do not establish that administering cGP to a subject with diabetes necessarily treats peripheral neuropathy. The Examiner is not persuaded by this argument because the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 139. Guan et al. teach pharmaceutical compositions comprising cyclo(Pro-Gly) (cPG) which prevents toxic neural degeneration and cell death while promoting neurite outgrowth in neurons and neuroprotective effects (abstract). Therapeutic applications include treating humans suffering neural injury or disease including diabetes (page 8, paragraph 2 through page 9, paragraph 1). Bansal et al. studied a high prevalence of diabetic peripheral neuropathy (herein DPN) in type 2 diabetes mellitus patients (abstract). The development of DPN is a well-known microvascular complication of type 2 diabetes mellitus along with retinopathy and nephropathy (page 715, paragraph 8 through page 716, paragraph 3; Table 2: page 717, paragraph 1). Therefore, Guan teaches treating diabetes with cPG and Bansal link treating peripheral neuropathy, nephropathy and retinopathy as diabetes mellitus complications. Therefore, one of ordinary skill would have been motivated to treat diabetes mellitus with cPG to aid in treating peripheral neuropathy, retinopathy and nephropathy with a reasonable expectation of success because the disorders are linked to microvascular complications in diabetes patients.
Claims 44-46 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (WO 03/039487; published May 15, 2003) in view of Bansal et al. (Prevalence and risk factors of development of peripheral diabetic neuropathy in type 2 diabetes mellitus in a tertiary care setting, Journal of Diabetes Investigation, 2014, Vol. 5, No. 5, November 2014), as applied to claims 37, 39, 40, 42 and 43 in view of Hayasaka et al. (Production Method for Cyclic dipeptide derived from native collagen, Food Science and Technology Research, 22 (4), 477-483, 2016).
Applicant claims a method for ameliorating the effects of and/or treating peripheral neuropathy, kidney function failure or retinopathy linked to type 2 diabetes mellitus in a subject, comprising administering to the subject a composition comprising a therapeutically effective amount of cyclic Glycine Proline (cGP and cPG). (claim 37)
With respect to claims 44-46 and 48, the teachings of Guan et al. and Bansal et al. are addressed in the above 103 rejection.
With respect to claims 44-46 and 48, Guan et al. and Bansal et al. do not specify cPG is derived from any animal, marine and/or fungal source, specifically by hydrolyzation of collagen from the skin of a mammal. It is for this reason that Hayasaka et al. is joined.
Hayasaka et al. teach methods of producing cyclo-gly-pro using collagen as a raw material wherein the collagen is enzymatically hydrolyzed and purified and then cyclized (abstract). Cyclic dipeptides are synthesized from fungi, bacteria and mammals (page 477, paragraph 1). Porcine skin collagen was used as a source to synthesis and purify cyclo-gly-pro (page 478, paragraph 2).
Both Guan and Hayasaka are drawn to methods of using cyclo-gly-pro. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Guan et al., Bansal et al. and Hayasaka et al. to treat peripheral neuropathy with cGPs derived from porcine skin collagen a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings Guan et al., Bansal et al. and Hayasaka et al. to further include treating peripheral neuropathy with cGPs derived from porcine skin collagen because Hayasaka teaches that porcine(pig) skin collagen has been used as a source to synthesis and purify cyclo-gly-pro.
Claims 41, 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (WO 03/039487; published May 15, 2003) in view of Bansal et al. (Prevalence and risk factors of development of peripheral diabetic neuropathy in type 2 diabetes mellitus in a tertiary care setting, Journal of Diabetes Investigation, 2014, Vol. 5, No. 5, November 2014). in view of Hayasaka et al. (Production Method for Cyclic dipeptide derived from native collagen, Food Science and Technology Research, 22 (4), 477-483, 2016), as applied to claims 44-46 and 48 in view of Spragg (WO 2021/205167; published October 14, 2021).
Applicant claims a method for ameliorating the effects of and/or treating peripheral neuropathy, kidney function failure or retinopathy linked to type 2 diabetes mellitus in a subject, comprising administering to the subject a composition comprising a therapeutically effective amount of cyclic Glycine Proline (cGP and cPG). (claim 37)
With respect to claim 41, 47 and 49, the teachings of Guan et al., Bansal et al. and Hayasaka et al. are addressed in the above 103 rejection.
With respect to claims 41 and 49, Guan et al., Bansal et al. and Hayasaka et al. do not specify micronized powder with a particle size between 1 to 1000 micron. With respect to claim 47, Guan et al., Bansal et al. and Hayasaka et al. do not specify cPG is derived from collagen marine skin powder. It is for this reason that Spragg et al. is joined.
Spragg teach the use of jellyfish collagen in the treatment of wounds (abstract). The compositions can be formulated into membranes using polymeric nanocapsules (page 12, lines 27-35). Carriers include gelatin (page 13, lines 1-14). The jellyfish collagen is in the form of a micronized polymers with a particle size preferably between 1-1000 microns (page 14, lines 6-10). The jellyfish collagen has improved wound treatment over other collagen sources, such as bovine collagen (page 14, lines 14-17).
Hayasaka and Spragg et al. are drawn to collagens derived from different sources. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Guan et al., Bansal et al., Hayasaka et al. and Spragg et al. to use micronized jellyfish collagen as a source of cGP with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings Guan et al., Bansal et al., Hayasaka et al. and Spragg et al. to further include cGPs derived from micronized jellyfish collagen because Spragg et al. teach micronized jellyfish collagen is a known aid in the treatment of wounds and is more effective than mammalian collagen from bovine.
Claims 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (WO 03/039487; published May 15, 2003) in view of Bansal et al. (Prevalence and risk factors of development of peripheral diabetic neuropathy in type 2 diabetes mellitus in a tertiary care setting, Journal of Diabetes Investigation, 2014, Vol. 5, No. 5, November 2014), in view of Hayasaka et al. (Production Method for Cyclic dipeptide derived from native collagen, Food Science and Technology Research, 22 (4), 477-483, 2016) in view of Spragg (WO 2021/205167; published October 14, 2021), as applied to claims 41, 47 and 49, in further view of Jaffe et al. (US 2016/0022594; published January 28, 2016).
Applicant claims a method for ameliorating the effects of and/or treating peripheral neuropathy, kidney function failure or retinopathy linked to type 2 diabetes mellitus in a subject, comprising administering to the subject a composition comprising a therapeutically effective amount of cyclic Glycine Proline (cGP and cPG). (claim 37)
With respect to claims 50-53, the teachings of Guan et al., Bansal et al., Hayasaka et al. and Spragg are addressed in the above 103 rejection.
Claims 52 and 53 are drawn to inherent properties of the soft gels in claim 51.
With respect to claims 50 and 51, the teachings of Guan et al., Bansal et al., Hayasaka et al. and Spragg, Guan et al. teach cGP is incorporated into and capsules and Spragg teach encapsulation of the micronized collagen powders but they do not specify the micronized powder is encapsulated within soft gels. It is for this reason that Jaffe is joined.
Jaffe teach stable soft gel dosage forms for micronized magnesium complex comprised of gelatin which has a stable shelf life (abstract). Soft gelatin capsules are preferred because the soft gelatin shell makes them easy to swallow for the elderly or infirmed and the active ingredients are more bioavailable following ingestion due to rapid rupture of the capsule [0004]
Spragg et al. and Jaffe both drawn to encapsulation micronized powders. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Guan et al., Bansal et al., Hayasaka et al., Spragg et al. and Jaffee to encapsulate micronized powders in soft gels with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings Guan et al., Bansal et al., Hayasaka et al., Spragg et al. and Jaffee to further include encapsulating micronized jellyfish collagen because Jaffee teach micronized powders are encapsulated into soft gelatin shells to make them easy to swallow and more bioavailable following ingestion.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/KYLE A PURDY/ Primary Examiner, Art Unit 1611
Prosecution Insights