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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant's arguments filed 12/16/2025 regarding the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant’s position is that a prima facie case of obviousness has not been made for claim 1. This is not a persuasive argument because claim 1 is anticipated and, therefore, is also rendered obvious. See 2141.01(I) (“An obviousness rejection is ordinarily based on a disclosure that qualifies as prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102.”).
Claim Status
Claims 1, 9, 14, 15, 18, 19, 21-25, and 28-32 are pending under examination. Claims 2-8, 10-13, 16-17, 20, and 26-27 are cancelled. Claims 1, 18, 19, 21, 22, and 24 are currently amended. Claims 28-32 are new.
Priority
The Application is the 371 national stage entry of PCT/EP2021/052939, filed 2/8/2021, which claims priority to EP20156088.5, filed 2/7/2020. The priority date of 2/7/2020 is acknowledged.
Claim Objections
Claims 1 and 29 are objected to because of the following informalities:
Claim 1 recites that the alterations relative to SEQ ID NO: 1 can be selected from insertions or additions of an amino acid. To reduce redundancy, amend the claim to recite either insertions or additions.
Claim 29 recites that the inflammatory disease or condition can be selected from cerebral inflammation or brain inflammation. To reduce redundancy, amend the claim to recite either cerebral or brain inflammation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21 and 22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 21 and 22 recite that the peptide is selected from SEQ ID NO: 2-87 and 90 or 86 and 87, respectively. SEQ ID NO: 44, 52, 66, 67, 69-72, 74-87, and 90 all have more than 3 alterations relative to SEQ ID NO: 1. Therefore, these claims do not recite all the limitations of their parent claim, claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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 1, 9, 14, 15, 18, 19, 21-25, 28, 29, 31, and 32 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 treatment of some PANX-1-associated inflammatory diseases or conditions, does not reasonably provide enablement for all PANX-1-associated inflammatory diseases or conditions. 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.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of 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.
1) Nature of the invention and 5) breadth of the claims: The invention is a method of
treating a PANX1-associated disease or disorder comprising administering to a patient in need thereof a composition comprising SEQ ID NO: 1 or a variant thereof, wherein the PANX-1 associated disease or disorder is an inflammatory disease or condition.
The claims are written such that the breadth includes any inflammatory disease or condition with any degree or amount of association to PANX-1, no matter how extensive or how limited. Claims 28, 29, and 31 further recite aspects of the inflammatory disease or condition, including that it is characterized by a chronic inflammatory environment; it is derived from the brain, intestines, stomach, or vasculature; and it is caused by an injury, respectively.
The issue is the degree of association required between PANX-1 and the inflammatory disease/condition, and whether such diseases/conditions with limited or indirect association can be treated by practicing this method.
2) State of the prior art and 4) predictability or unpredictability of the art: The instant
specification teaches that SEQ ID NO: 1 can treat diseases or conditions associated with PANX-1 through inhibition of PANX-1 (Pg 3, lines 15-19).
At the time of filing, the art recognized that PANX-1 plays a role in certain inflammatory
diseases/conditions, but not all inflammatory diseases/conditions have such clear connections to PANX-1.
For example, Chen et al. (Pannexin1: insight into inflammatory conditions and its potential involvement in multiple organ dysfunction syndrome. Front Immunol. 2023 Aug 30;14:1217366., published after Applicant’s effective filing date) teaches that MODS (multiple organ dysfunction syndrome) can develop in cases of severe sepsis, for which no treatments are currently available (Pg 02, “Introduction”, left column, first paragraph). Although studies have shown a role for Panx1 in inflammation, and Panx1 has been implicated in the inflammatory response at the organ level in the heart, brain, lungs, kidney and liver, it’s unclear whether Panx1 is a potential therapeutic target for sepsis-induced MODS (Pg 02, “Introduction”, left column, final paragraph). This uncertainty stems in part from the fact that Panx1 impacts sepsis progression in multiple distinct ways. For instance, early stages of sepsis are characterized by an exaggerated inflammatory response coupled with anti-inflammatory regulation; Panx1 indirectly contributes to hyperinflammation by releasing signaling molecules such as ATP that can contribute to the proinflammatory response (Pg 02, “2 Panx1’s contribution to hyperinflammation”, right column, first paragraph). In this instance, it would be unpredictable whether practicing the instant methods claimed would be able to treat PANX-1 associated sepsis and sepsis-induced MODS effectively as inhibition of PANX-1 with the instant SEQ ID NO: 1 may be insufficient to counteract the hyperinflammatory response that contributes to sepsis and sepsis-induced MODS, despite the fact that they are associated PANX-1.
Moreover, based on the mechanism of SEQ ID NO: 1 described in the instant application, in order for SEQ ID NO: 1 to effectively treat a PANX-1-associated inflammatory disease/condition, the disease/condition would necessarily need to be associated with PANX-1 hyperactive signaling; administering SEQ ID NO: 1 as part of a method of treating a disease/condition associated with loss of PANX-1 signaling would not yield any beneficial results. As the art indicates that the connections between PANX-1 and some inflammatory diseases/conditions are not always clear or direct, how could one skilled in the art know which of the many inflammatory diseases/conditions associated with PANX-1 could be successfully treated?
3) The relative skill of those in the art: The relative skill of those in the art is high.
6) The amount of direction or guidance presented: At the time of filing, no direction or
guidance was presented in either the prior art or the instant specification that would enable one to administer SEQ ID NO: 1 to treat the breadth of PANX-1-associated inflammatory diseases/conditions as claimed.
7) The presence or absence of working examples: The instant specification provides
only a few examples wherein SEQ ID NO: 1 displays anti-fibrotic activity, but there are no examples of treating an inflammatory disease/condition.
8) The quantity of experimentation necessary: As no working examples are disclosed in
either the instant specification and only a few in the prior art, reasonable guidance with respect to treating PANX-1-associated inflammatory diseases/conditions through administration of SEQ ID NO: 1 or a variant thereof was limited. Consequently, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively treat all PANX-1-associated inflammatory diseases/conditions.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for the treatment of all PANX-1 associated inflammatory diseases/conditions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 14, 15, 18, 21, 23-25 and 28-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP-3329930-A1 (EP ‘930, published 6/6/2018), as evidenced by Tavakoli et al. (A Review of Inflammatory Bowel Disease: A Model of Microbial, Immune and Neuropsychological Integration. Public Health Rev. 2021 May 5;42:1603990.) and Cleveland Clinic (Emphysema; 11/29/2022; accessed 2/13/2026).
EP ‘930 teaches a pharmaceutical composition comprising a pharmaceutically effective amount of a peptide comprising an amino acid sequence of SEQUENCE ID NO. 1 or a variant thereof. Uses of the pharmaceutical composition in the treatment of metabolic disorders, diseases characterized by muscle wasting or reduced protein synthesis, and diseases mediated by oxidative stress, are also disclosed (Abstract).
SEQUENCE ID NO. 1 of EP ‘930 and the instant SEQ ID NO: 1 are identical (Sequence Listing). EP ‘930 also teaches variants of SEQUENCE ID NO. 1 that have 1-3 alterations, including SEQ ID NO: 2-12, 14-19, 21-23, 25-36, 38, 39, 50, 52, 55-57, 62, 64, and 73 (Sequence Listing). SEQ ID NO: 1 and its variants exhibit a number of different characteristics, such as metabolism stimulating bioactivity, anti-oxidation activity, GLUT4 translocation activity, anti-inflammation activity ([0099]).
Additionally, EP ‘930 teaches that the disclosed and claimed peptide SEQ ID NO: 1 can be used in methods of treatment of a variety of diseases and conditions, including tissue fibrosis, inflammatory disorders, and neurodegenerative disease ([0072], [0074], [0119], [0125], [0126], [0214]). Thus, EP ‘930 anticipates the instant claims 1, 14, and 32.
Regarding claim 15, EP ‘930 teaches that a “variant” of the peptide shall be taken to mean a peptide having an amino acid sequence that is substantially identical to SEQUENCE ID NO. 1, but which is altered in respect of one or more amino acid residues. Preferably such alterations involve the insertion, addition, deletion and/or substitution of 11 or fewer amino acids, more preferably of 10 or fewer, 9 or fewer, 8 or fewer, 7 or fewer, 6 or fewer, preferably 5 or fewer, 4 or fewer, even more preferably 3 or fewer, most preferably of 1 or 2 amino acids only ([0067]). Also see SEQ ID NO: 2-12, 14-19, 22, 23, 25-36, 39, 50, 55-57, 50, 62, 64, 73, as described above (Sequence Listing).
Regarding claim 18, EP ‘930 teaches that peptide structure modifications can include the generation of retro-inverso peptides comprising the reversed sequence encoded by D-amino acids ([0066], [0132], [0160]).
Regarding claim 21, EP ‘930 teaches that therapeutically effective variants of the peptide SEQUENCE ID NO. 1 include the peptides SEQ ID NO: 2-85, which are identical to the instant SEQ ID NO: 2-85 ([0097]-[0102]); Sequence Listing starting on Pg 33).
Regarding claims 23-25, EP ‘930 teaches that the peptides taught can be chemically modified to increase their stability. The modifications can include, but are not limited to, modifications to side chains, incorporation of unnatural amino acids and/or their derivatives during peptide synthesis and the use of cross-linkers and other methods that impose conformational constraint on the peptides or their analogs ([0066], with detailed examples provided starting on line 24). Other types of modifications taught by EP ‘930 include conjugating the peptide with a binding partner, cyclisation, addition of N- or C-terminal, or side chain, protecting groups, replacing L-amino acids with D-isomers, amino acid modification, increased plasma protein binding, increased albumin binding ([0132]-[0156], [0163], [0165], [0167]-[0184]).
Regarding claims 28 and 30, EP ‘930 teaches treating inflammatory bowel disease ([0072], [0125]); inflammatory bowel disease is a chronic inflammatory disorder of the GI tract (chronic inflammatory environment), as evidenced by Tavakoli et al. (Objective, first page).
Regarding claim 29, EP ‘930 teaches both inflammatory disorders of the cardiovascular system (vascular inflammation) as well as intestinal inflammatory disorders ([0072]).
Regarding claim 31, EP ‘930 teaches treating emphysema ([0125]). As evidenced by the Cleveland Clinic, emphysema is a lung disease that results from damage to the walls of the alveoli in your lungs (injury) that is most often caused by smoking (Pg 1, first paragraph; Pg 7, first and second paragraphs).
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.
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.
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.
Claim(s) 1, 9, 14, 15, 18, 21, 23-25 and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over EP-3329930-A1 (EP ‘930, published 6/6/2018) in view of Isakson (WO-2017019952-A1, filed 7/29/2016, published 2/2/2017, as listed on IDS).
The teachings of EP ‘930 have been set forth above. EP ‘930 teaches administering the instant SEQ ID NO: 1 to treat neurodegenerative diseases, but does not specifically teach treating Huntington’s disease or multiple sclerosis.
Isakson teaches a method for treating inflammation at a site of tissue injury, disease, or infection by inhibiting activation of venous endothelial cell Pannexin1 (PANX1), said method comprising administering to a subject in need thereof a pharmaceutical composition comprising an effective amount of an inhibitor of Pannexin1 activation, thereby treating said inflammation at a site of tissue injury, disease, or infection (claim 1). Isakson further teaches that the method can be used to treat multiple sclerosis (Pg 41, lines 23 and 29).
Thus, regarding claim 9, EP ‘930 teaches a method of treating PANX-1-associated neurodegenerative diseases by administering the instant SEQ ID NO: 1 to a subject in need thereof. Isakson teaches treating PANX1-associated diseases such as multiple sclerosis; the instant specification states that multiple sclerosis is a neurodegenerative disease (Pg 8, lines 30-31). Therefore, it would be obvious to use the method taught by EP ‘930 to treat multiple sclerosis. One skilled in the art would be motivated to do so in order to effectively treat other neurodegenerative disease associated with PANX-1. One would have a reasonable expectation of success because EP ‘930 taught that PANX-1 associated diseases could be treated with the instant SEQ ID NO: 1 and Isakson established multiple sclerosis could be treated with other PANX-1 inhibitors.
Claim(s) 1, 9, 14, 15, 18, 19, 21-25 and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over EP-3329930-A1 (EP ‘930, published 6/6/2018) in view of Khaldi et al. (WO-2021078912-A1, effectively filed 10/22/2019).
The teachings of EP ‘930 have been set forth above. EP ‘930 does not teach administering a variant of SEQ ID NO: 1 wherein at least two residues selected from residues 1, 2, 5, 10, and 11 are substituted with the D-form of the amino acid.
Khaldi teaches treating non-alcoholic fatty liver disease with the peptide SEQUENCE ID NO: 1 (WKDEAGKPLVK) or a variant thereof (Abstract). SEQUENCE ID NO: 1 of Khaldi is identical to the instant SEQ ID NO: 1, which is also identical to SEQUENCE ID NO. 1 of EP ‘930. The instant specification indicates that PANX-1 is expressed in the liver (Pg 1, line 27), and the instant method and peptides can be used to treat non-alcoholic fatty liver disease (Pg 9, lines 14-20).
Khaldi further teaches the peptide SEQUENCE ID NO. 2, wherein the residues at positions 1, 2, 5, 10 and 11 are provided as D-amino acids, as compared to SEQ ID NO. 1 (Pg 2, lines 1-6). Khaldi states that this peptide variant SEQUENCE ID NO. 2 significantly enhances glucose uptake into skeletal muscle cells compared with insulin, significantly reduces HbA1c% (amount of glucose attached to the body’s red blood cells) compared with Liraglutide, and exhibits an optimized PK (pharmacokinetics) profile of T1/2 = 93 minutes. SEQUENCE ID NO: 2 of Khaldi and the instant SEQ ID NO: 86 are also identical.
Thus, regarding claim 19, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the SEQ ID NO: 2 (instant SEQ ID NO: 86) taught by Khaldi in the method of treating PANX-1-associated diseases and conditions of EP ‘930. One would be motivated to do so in order because SEQ ID NO: 2 exhibited improvements over SEQ ID NO: 1, as described above. One would have a reasonable expectation of success given that SEQ ID NO: 1 could successfully treat PANX-1-associated diseases or conditions; consequently, SEQ ID NO: 2, an improved version of SEQ ID NO: 1, could also successfully treat PANX-1-assocaited diseases or conditions. Additionally, given that PANX-1 is expressed in the liver and Khaldi teaches that SEQ ID NO: 1 and 2 can be used to treat liver diseases, one would reasonably expect that SEQ ID NO: 2 could similarly be used to treat other PANX-1-associated diseases.
Regarding claims 21 and 22, Khaldi teaches the peptides 1) SEQUENCE ID NO. 2, which, as disclosed above, is identical to the instant SEQ ID NO: 86; and 2) SEQUENCE ID NO: 3, which is identical to the instant SEQ ID NO: 87 (Pg 2, lines 1-10 and 35-51; claims 12 and 15).
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, 14, 15, 21, 23-25 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-12 of U.S. Patent No. 10,729,636 B2 (US ‘636).
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 specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Claim 1 of US ‘636 recites a composition comprising a peptide of up to 50 amino acids, the peptide comprising the amino acid sequence of SEQ ID NO: 1, or a variant thereof, the variant comprising no more than 3 amino acid alterations relative to SEQ ID NO: 1. SEQ ID NO: 1 of US ‘636 and the instant SEQ ID NO: 1 are identical. The instant specification teaches the instant SEQ ID NO: 1 can be used to treat diabetes (Pg 3, lines 5-8).
Dependent claims include species of SEQ ID NO: 1 (claims 2 and 6), modifications to SEQ ID NO: 1 (claims 3, 4, 11, and 12), and a pharmaceutical composition thereof for use a method of treating diabetes or pre-diabetes (claim 5).
Claims 1, 14, 15, 18, 19, 21, 22, 25, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5-10 and 15 of U.S. Patent No. 12,9398,180 B2 (US ‘180; formerly copending Application No. 17/768,356). Although the claims at issue are not identical, they are not patentably distinct from each other because they claim overlapping subject matter.
Claim 1 of US ‘180 recites a method for the treatment of non-alcoholic fatty liver disease (NAFLD) in a mammal having NAFLD, the method comprising: administering: (a) a peptide having up to 50 amino acids and comprising SEQ ID NO: 1, or (b) a therapeutically effective variant of SEQ ID NO: 1 comprising 1 to 5 alterations compared with SEQ ID NO: 1, in which each alteration is independently selected from insertion of an amino acid, addition of an amino acid, deletion of an amino acid, and conservative substitution of an amino acid, to the mammal.
SEQ ID NO: 1 of US ‘180 and the instant SEQ ID NO: 1 are identical. The instant specification teaches the instant SEQ ID NO: 1 can be used to treat liver diseases such as NAFLD (Pg 9, lines 14-20).
Dependent claims include the species of SEQ ID NO: 1 (claim 3), D-amino acid substitutions (claims 5-8) and modifications to the peptides (claims 9 and 10). SEQ ID NO: 2 and 3 of US ‘180 are identical to the instant SEQ ID NO: 86 and 86, respectively.
Prior Art Cited but not Referenced
EP 3 329 905 A1 (EP ‘950, published 6/6/2018) teaches a topical cosmetic composition comprising a cosmetically or pharmaceutically effective amount of a peptide comprising an amino acid sequence of SEQUENCE ID NO. 1 or a variant thereof. SEQUENCE ID NO. 1-85 of EP ‘905 are identical to the instant SEQ ID NO: 1-85.
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 Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658