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 .
THIS IS A TRACK ONE APPLICATION.
Priority
The instant application, filed 02/12/2025 is a Continuation of 17551701, filed 12/15/2021, now U.S. Patent # 12371464.
17551701 Claims Priority from Provisional Application 63125996 , filed 12/16/2020.
Claim Status
Claims 94, 96, and 98-125 are pending and under consideration, this claim set including new claims 111-125.
Claims 1-93, 95, 97 are cancelled.
Claims 94, 96, and 98-125 are rejected.
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 12/17/25 Information Disclosure Statement, and provides a signed and dated copy of such herewith.
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.
Response to Arguments
Applicant’s arguments, see page 11, filed 12/17/25, and claim amendments including claim cancellations, with respect to the rejection(s) of claim(s) 95-97under 5 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendments to the remaining claims.
Claims 94, 96, 98-101, 107, 109 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.
Claim 94 is now directed to a method of treating “an obesity-related condition” but does not list what these are.
Claims 96 lists a number of conditions that its states are “the obesity-related condition” but this claim depends from cancelled claim 95.
Claims 98-101, 107 or 109 do not further clarify what is encompassed by “an obesity-related condition”.
The specification provides multiple lists of conditions/diseases stated to be treated by the claimed polypeptides having amino acid sequences corresponding to SEQ ID Nos. 15-18. See paras 231-237, in these lists distinguishing between specifically stated “obesity-related conditions” and other conditions treated such as metabolic diseases such as diabetes, and separately listing diseases/conditions that include, per para 237, “Alzheimer's disease, hepatic steatosis (“fatty liver”), kidney failure, arteriosclerosis (e.g. atherosclerosis), cardiovascular disease, macrovascular disease, microvascular disease, diabetic heart (including diabetic cardiomyopathy and heart failure as a diabetic complication), coronary heart disease, peripheral artery disease or stroke, cancer, dumping syndrome.”
With regard to claims 94, 98-101, 107 or 109, the metes and bounds of what is claimed when claiming to treat “obesity-related conditions” is not clear to one of ordinary skill in the art given the potential influence of obesity on a range of conditions and diseases, such as those listed in para 237. Because the metes and bounds are not reasonably ascertainable by one of ordinary skill in the art at the time of applicant’s filing, claims 94, 98-101, 107 or 109 are rejected as indefinite.
Additionally, claim 96 is rejected as unclear and indefinite based on depending from a cancelled claim.
Claim Rejections - 35 USC § 112
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.
Response to Arguments
Applicant's arguments filed 12/17/25 have been fully considered but they are not persuasive.
While applicant cancelled claims 95 and 97, applicant introduces amendments to claim 94 that necessitates the new rejections, below (also applicant did not properly amend claim 96, leaving it to depend from now-cancelled claim 95 (see above)).
A new rejection below for new matter is necessitated by claim amendments, these including introducing new claims.
Claims 118, 120-125 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 disease in a subject that is responsive to amylin as well as pramlintide and pramlintide analogs, when administering an effective dose of one of the polypeptides that consist of an amino acids sequence selected from the group consisting of SEQ ID Nos. 15-18, does not reasonably provide enablement for treating any metabolic disease in a subject.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation." These factors include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure, see MPEP 2164.01(a)
In considering the factors for the instant claims:
The breadth of the claims: In order to use the claimed invention one of skill in the art must per claim 118 be able to treat any metabolic disease in a subject with a polypeptide “consisting essentially of” one of four similar pramlintide polypeptide analogs.
The nature of the invention: therapeutic, involving administering the polypeptide analogs to subjects having a condition encompassed by claim 118.
The state of the prior art: Pramlintide and analogs thereof were known in the art to treat conditions related to control of blood glucose levels. See Hoogwerf et al., Vascular Health and Risk Management 2008:4(2) 355–362, copy provided. However, there are metabolic diseases that are genetically inherited and not disposed, by their causes and metabolic dysfunction(s), to effective treatment by pramlintide nor its analogs such as those claimed. One of these is phenylketonuria, see Hafid, Transl Pediatr 2019;8(1):304-317, copy provided. There is no reasonable, technical basis for effective treatment of genetically caused metabolic diseases such as phenylketonuria with the claimed polypeptides based on the knowledge in the art, including known causes of such metabolic diseases and the known effects of pramlintide and its analogs.
The level of one of ordinary skill: high.
The level of predictability in the art: predictable for specific agents based on in vivo evaluations for conditions where the effect of the agent is based on known properties of the agent combined with known etiologies of the respective condition(s).
The amount of direction provided by the inventor: Statements in the specification focus on treating metabolic diseases and conditions that relate to conditions known to be treated by amylin and pramlintide and its analogs, not the full range of metabolic diseases. The description describes treating a range of diseases and conditions that are reasonably related to treatment by amylin or an analog thereof, including diseases such as those listed in claim 119 for which the administering of the SEQ ID Nos. 15-18 polypeptides, being similar to pramlintide, would reasonably be expected to have a therapeutic effect.
The existence of working examples: description provides working examples of food intake by rats. The description does not provide working examples of treating the range of claimed diseases and conditions.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: given the known effects of pramlintide and its analogs on modulating glucose metabolism, and the disparate and unrelated-to-glucose-metabolism etiologies of genetically-based metabolic diseases such as phenylketonuria, a huge quantity of experimentation would be required to be enabled for the full scope of claim 118, with a very low likelihood of ultimate success.
The skilled practitioner would first turn to the instant description for guidance in using the claimed invention. However, the description lacks clear evidence that what is claimed can treat the extent of what is stated as being treated. As such, the skilled practitioner would turn to the prior art for such guidance, however the prior art does not discuss these or other amylin analogs treating the claimed range of diseases and conditions. Finally, said practitioner would turn to trial and error experimentation to determine a relationship between the effectiveness of the four specified peptides, for the diseases and conditions encompassed by the claimed invention. Such amounts to undue experimentation.
For the reasons above, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. Accordingly, claims 118, 120-125 are rejected.
Claims 94, 96, and 98-125 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.
This is a new matter rejection necessitated by claim amendment on 12/17/25.
Claim 94 is directed to a method of treating an obesity-related condition in a subject, the method comprising administering a polypeptide or a pharmaceutically acceptable salt thereof to the subject, wherein the polypeptide consists essentially of the amino acid sequence selected from a group of four specified pramlintide analogs corresponding to SEQ ID Nos. 15-18.
Previously claim 94 used the transition phrase “comprising”, which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps., see MPEP 2111.03 I. Previous independent claim 102 also used the transition phrase “comprising” but now, as for instant claim 94, states “consists essentially of”. New claim 118 uses “consists essentially of”.
The specification supports “comprising” and also “consisting of”, see para 248 of corresponding PGPUB 20250289860, “Embodiments described herein as “comprising” one or more features may also be considered as disclosure of the corresponding embodiments “consisting of” such features”. However there is no express, implicit or inherent disclosure basis of support for “consisting essentially of” in the application as filed. Although the attorney for applicant stated on page 11 of the 12/17/25 Remarks that “Support for the amendments and new claims can be found throughout the specification, inter alia, in the claims as originally filed,” a text search by the examiner indicated no use of “essential” in the specification, and the examiner did not find support in the original claims filed 12/15/21 in the parent, nor the two claim sets filed 2/12/25 in the instant application.
From MPEP 2111.03, the difference between “consisting of” and “consisting essentially of” follow:
The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). But see Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d 1508, 1516 (Fed. Cir. 2004) (holding that a bone repair kit "consisting of" claimed chemicals was infringed by a bone repair kit including a spatula in addition to the claimed chemicals because the presence of the spatula was unrelated to the claimed invention). A claim which depends from a claim which "consists of" the recited elements or steps cannot add an element or step.
…
When the phrase "consisting of" appears in a clause of the body of a claim, rather than immediately following the preamble, there is an "exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements.(citations omitted)
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The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. (citations omitted)
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"A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format. (citations omitted)
Because there is no express, implicit or inherent disclosure basis of support for “consisting essentially of” in the application as filed, claims 94, 96, and 98-125 are rejected under this section for the presence of new matter. The rejection of claim 96 under is based on an interpretation that it should depend from claim 94.
Additionally, based on the MPEP meanings above the examiner notes that there is a clear and substantive difference between “consisting of” and “consisting essentially of” at least with regard to the metes and bounds of what is encompassed by claims using these different transitions, this further supporting the need for and appropriateness of the instant rejection.
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.
Response to Arguments
Applicant's arguments filed 12/17/25 have been fully considered but they are not persuasive.
Applicant page 13 first states:
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This is not persuasive because it is the status of the instant application as a DIV, divisional application, in the filing receipt that confers the safe harbor status. See 35 U.S.C. 121.
Applicant also argues that the claimed method claims are not unpatentable over the ‘361 combination therapy method claims. This is not persuasive because such combination therapy claims administer what is instantly claimed.
Claims 94, 96, and 98-125 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12371464 (Reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are method claims that administer the same compounds of the Reference patent claims.1
Regarding this point, in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in its specification, and later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Here the Reference patent specification, the same as the instant specification, clearly discloses the utility of the same claimed compounds/peptides in its specification to treat some of the same diseases and conditions now claimed to be treated by the same peptide compounds. See paras 79-90 of the Reference patent, which include pertaining to the treatment of one or more of the instantly claimed “obesity-related” diseases and conditions, and routes and types of administering the same peptides as instantly claimed, these also encompassed by the new claims having broader scope of treatment range.
Based on the above and use of the reasoning applied in Sun Pharmaceutical Industries Ltd., all of claims 94, 96, and 98-125 are rejected under this section.
Claims 94, 96, and 98-125 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 88, 90, 91, 95-101 of copending Application No. 18257756 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same peptides, for SEQ ID Nos. 15, 17 and 18, as instantly claimed, and administering these to treat the same diseases and conditions as instantly claimed, see reference application claim 98 in particular, and also because instant SEQ ID NO:16 is an obvious variant of reference application SEQ ID NO:18 (see MPEP 2144.09, here based on chemical compounds that have very close structural similarities and similar utilities – SEQ ID NO:18 comprising an additional linker molecule, 2 instead of 1 in instant SEQ ID NO:16, resulting in a reasonable expectation that compounds similar in structure will have similar properties, and so are obvious variants).
Instant claims 94 and 96 (this interpreted to depend from instant claim 94) are rejected over reference application claims 88 and 96-99 (claim 98 in particular).
Instant claim 98 is rejected over reference application claims 88, 90, 96 and 98.
Instant claims 99 and 101 are rejected over reference application claims 88, 91, 96 and 98, noting per above the basis for SEQ ID NO:16 being an obvious variant of reference application SEQ ID NO:18.
Instant claim 100 is rejected over reference application claims 88 and 96.
Instant claims 102-106 are rejected over reference application claims 88 and 96-98, applying again per above, for instant claim 104, that SEQ ID NO:16 is an obvious variant of reference application SEQ ID NO:18.
Instant claim 107 is rejected over reference application claims 88, 96, 98 and 100.
Instant claim 108 is rejected over reference application claims 88, 96, 98 and 100.
Instant claim 109 is rejected over reference application claims 88, 96, 98 and 101.
Instant claim 110 is rejected over reference application claims 88, 96, 98 and 101.
New independent claims 111 and 118, these including treating obesity (per se in claim 111, encompassed in claim 118), and all claims depending from claims 111 and 118, also are rejected applying the same bases as applied above, over reference application claims 88, 90, 91, 95-101, and recognizing that at least some of the broader metabolic diseases of claim 119 encompass and render obvious those when considering the prevalence of obesity in those listed metabolic diseases. Reference application method claims 99 includes being directed to treating the metabolic disease which includes “disease states associated with elevated blood glucose levels”, this corresponding with the same language in instant claim 119, rendering both claims 118 and 119 obvious and rejected under this section. The particularly claimed polypeptide species of new instant claims 120-123 are listed in reference application claim 88, reference application claim 100 renders obvious new instant claim 124, and reference application claim 101 renders obvious new instant claim 125.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 94, 96, and 98-106, 111-116, and 118-124 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-15, 30, 36 and 42 of copending Application No. 19212361 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same peptides, for SEQ ID Nos. 15, 17 and 18, as instantly claimed, these corresponding with reference application claim 15’s SEQ ID Nos. 9, 10 and 11, respectively, and administering these to treat diseases or disorders which are more limited that reference application claim 1 per reference application claim 30, wherein the disease or disorder is obesity, so this pertaining to instant independent claims 94, 102, 111 and 118 when considering instant claim 119 and reference application claim 36 which includes “improving glycemic and/or metabolic control”, see also instant claim 96, and also because instant SEQ ID NO:16 is an obvious variant of reference application SEQ ID NO:11 (see MPEP 2144.09, here based on chemical compounds that have very close structural similarities and similar utilities – SEQ ID NO:11 comprising an additional linker molecule, 2 instead of 1 in instant SEQ ID NO:16, resulting in a reasonable expectation that compounds similar in structure will have similar properties, and so are obvious variants).
Instant claims 94, 96, 98 and 100 are rejected over reference application claims 1, 11-15 and 30.
Instant claims 99 and 101 are rejected over reference application claims 1, 11-15 and 30, noting per above the basis for SEQ ID NO:16 being an obvious variant of reference application SEQ ID NO:18.
Instant claims 102-106 are rejected over reference application claims 1, 11-15 and 30, applying again per above, for instant claim 104, that SEQ ID NO:16 is an obvious variant of reference application SEQ ID NO:18.
More particularly as to new instant claims 111-116, 118-124, these are rejected on the same bases applied above to claims of corresponding limitations, noting however that new instant claim 118 is directed broadly to treating any metabolic disease in a subject, per claim 119 this including “disease states associated with elevated blood glucose levels”, so considering reference application claim 36 which includes “improving glycemic and/or metabolic control”, the base claim 118 as well as its dependent claim 119 are rejected as obvious. The particularly claimed polypeptide species of new instant claims 120-123 are listed in reference application claim 15, and reference application claim 42 renders obvious new instant claim 124.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is 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 JOSEPH FISCHER whose telephone number is (571)270-7925, and whose direct facsimile number is (571)270-8925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Monday/Tuesday and on Wednesday-Friday on alternating weeks, but will promptly answer messages upon his return to work.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
1 Please note that the 6/5/25 Application Data Sheet indicates the instant application is a continuation application of the parent 17551701, which issued as U.S. Patent No. 12371464, and the latest instant Filing Receipt mailed 6/10/25 states that the instant application is a CON of 17551701. Because the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications, there is no such safe harbor against nonstatutory double patenting rejections for the instant continuation application. See MPEP 804.01 and related sections. (The examiner also notes that in the parent the method claims were cancelled prior to any opportunity to rejoin.)