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 the First Office Action on the Merits of US 18/029,124 filed on 03/29/2023 which is a 371 of PCT/GB2021/052554 filed on 10/04/2021 which claims foreign priority to UNITED KINGDOM 2015755.8 filed on 10/05/2020. The Filing Receipt filed on June 13, 2024 is controlling.
Election/Restrictions
Applicant’s election without traverse of Invention Group II (claims 42-44) in the reply filed on November 25, 2025 is acknowledged.
Claims 27-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 25, 2025.
Claim status
Claims 1-26 are cancelled.
Claims 27-44 are pending.
Claims 27-41 are withdrawn to non-elected invention group.
Claims 42-44 are under examination in this office action.
Information Disclosure Statement
The IDS filed on March 29, 2023 has been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Requirements for patent applications containing nucleotide and/or amino acid sequence disclosures: Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. (See pages 36 & 37). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Also, a heading for the “Brief Description of the Drawings” section is missing from page 24.
Claim Objections
Claim 44 is objected to because of the following informalities: In line 1, the term “peptid2” appears to intend “peptide”. Appropriate correction is required.
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.
Claims 42-44 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.
Regarding claim 42, in line 6, the term “an amino acid sequence substantially as set out in SEQ ID NO: 1” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification, on page 23, lines 21-22, describes an example for the meaning of the term “substantially” as it relates to an amino acid sequence: “a substantially similar peptide may differ by at least 1, 2, 3, 4 or 5 amino acids from the sequences shown in SEQ ID No: 1-3”. However, the specification does not provide a limiting definition of the term “substantially” as it relates to SEQ ID NO: 1. Because instant SEQ ID NO: 1 of the present claims is only a nine amino acid peptide, a difference of five amino acids would be more than a 50% change. Generally, such peptide would not be considered substantially similar. Thus, the scope of the required similarity to amino acid sequence of SEQ ID NO: 1 is indefinite and thus one of ordinary skill in the art would not be able to determine the metes and bounds of the claim.
Claims 43-44 are indefinite as they depend from claim 42 and are not remedial.
Also, regarding claim 44, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 44 recites the broad recitation “wherein the peptide or the nucleic acid is used in the effective prophylaxis, amelioration, or treatment of a coronavirus infection or symptoms in an infected subject”, and the claim also recites “preferably by reducing and/or inhibiting ACE2 expression in a subject compared to the level of ACE2 expression in an untreated subject” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Also, claim 44 is an improper use claim. See MPEP § 2173.05(q). An active, positive method step is required (e.g. the administering step is administering to a subject with a coronavirus infection or symptoms in a subject infected with a coronavirus...) or language limiting the method of claim 44 (e.g. wherein the subject has a coronavirus infection...) is required. Absent such limitation, for purpose of examination, prior art which applies to base claim 42 is construed to apply to claim 44.
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.
Scope of enablement
Claims 42-44 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 a method of reducing glucagon and glutamate secretion levels in rat islet cell cultures and of reducing soluble ACE2 levels in human islet cell cultures from Type 2 diabetes tissue donors by administering the peptide of instant SEQ ID NO: 1, does not reasonably provide enablement for the breadth of the present claims including a method of preventing or ameliorating hyperglucagonemia or hyperinsulinemia using a variant of instant SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The following factors have been considered in the analysis of enablement: (1) the nature of the invention, (2) the breadth of the claims, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The invention is drawn to treating and preventing a myriad of conditions including hyperinsulinemia (i.e., insulin resistance), Parkinson’s disease, and a coronavirus infection using therapeutic peptides and nucleic acids encoding such. The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
(2) The breadth of the claims: The claims are broad to the conditions being ameliorated or prevented including any condition characterized by high or excessive glutamate in a subject. The conditions listed in claim 43 include Parkinson’s disease, chronic schizophrenia, and cancer. The claim 33 recites an intended use of prophylaxis of a coronavirus infection or any symptoms in an infected subject. The critical element used to effect such treating or prevention is a therapeutic peptide having the sequence of instant SEQ ID NO: 1. However, the claims are broad to a variant of such therapeutic peptide having only two amino acids corresponding to the nine amino acid peptide of SEQ ID NO: 1. Further, the claims are broad to methods of administering, doses, and methods to facilitate administering a nucleic acid encoding the therapeutic peptide.
(3) The state of the prior art: A review of the patent and non-patent literature indicates that the state of the art is unpredictable for treating and preventing the myriad of conditions recited in the claims by administering a peptide of instant SEQ ID NO: 1 or variant of such. Matossian-Rogers (2009/0304577 published December 10, 2009) disclose administering a peptide comprising an identical sequence to instant SEQ ID NO: 1 for treating but insulin resistance but do not disclose preventing such, or treating a coronavirus infection, for example. Also, Matossian-Rogers does not disclose using variants of SEQ ID NO: 1.
(4) The level of one of ordinary skill: The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant' s invention would generally be a physician with a M.D. degree and several years of experience.
(5) The level of predictability in the art: While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. For example, it was unpredictable before the effective filing date of the claimed invention whether a given variant of instant SEQ ID NO: 1 would possess the properties to treat or prevent the myriad of conditions recited in the claims. As evidenced by the state of the art, even a single amino acid substitution in a therapeutic peptide can change the function of such peptide. Further, neither the instant Specification nor the state of the art shows how one of ordinary skill in the art would be able to envision whether a given amino acid substitution in the claimed peptides could tolerate such substitutions and still possess the required therapeutic functional properties. For example, the post-filing art of Slansky et al titled “Peptide mimotopes alter T cell function in cancer and autoimmunity” (Semin Immunol 2020 Feb: Vol 47, epub March 20, 2020), disclose that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract). In addition, Sengupta et al in “Site-specific amino acid substitution in dodecameric peptides determines the stability and unfolding of c-MYC quadruplex promoting apoptosis in cancer cells” (Nucleic Acids Res 2018 Nov 2 Vol 46 No. 19: pages 9932-9950) discloses that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract).
(6) The amount of direction provided by the inventor & (7) The existence of working examples: Because the state of the prior art does not provide evidence of the degree of predictability for using a peptide variant of instant SEQ ID NO: 1 to treat and or prevent the myriad of conditions recited in the claims, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
(7) The existence of working examples: The working embodiment in the instant application describes a method of reducing glucagon and glutamate secretion levels in rat islet cell cultures and of reducing soluble ACE2 levels in human islet cell cultures from Type 2 diabetes tissue donors by administering the peptide of instant SEQ ID NO: 1. The instant specification does not show application of variants of SEQ ID NO: 1 to islet cells. The instant specification does not show application to in vivo models. Thus the instant specification lacks a working example of the invention as now claimed. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Written Description
Claims 42-44 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.
Present claims are drawn to a method of treating, preventing or ameliorating hyperglucagonemia, hyperinsulinemia and/or a condition characterized by high or excessive glutamate in a subject, the method comprising, administering, or having administered, to a subject in need of such treatment, a therapeutically effective amount of a peptide which comprises an amino acid of SEQ ID NO: 1 or a variant of such, or a nucleic acid encoding such peptide.
Thus the claims require the critically essential element of a therapeutic peptide (or nucleic acid encoding such) which has the required property of preventing hyperinsulinemia (e.g., claim 42), Parkinson’s disease (e.g., claim 43), and a coronavirus infection (e.g., claim 44). The peptide structure is claimed as a variant of instant SEQ ID NO: 1. The specification, on page 23, lines 21-22, describes an example for the meaning of the term “substantially” as it relates to an amino acid sequence: “a substantially similar peptide may differ by at least 1, 2, 3, 4 or 5 amino acids from the sequences shown in SEQ ID No: 1-3”. Thus section (i) of claim 42 reads on at least five amino acid changes from the nine amino acid sequence of instant SEQ ID NO: 1. Section (ii) of claim 42 recites “an amino acid sequence that has at least 80% sequence identity to SEQ ID NO: 1”. An amino acid sequence reads on a sequence of only two amino acids. Thus, an amino acid sequence having only two amino acids aligned with instant SEQ ID NO: 1 meets the limitation as presently written.
Applicant shows possession of instant SEQ ID NO: 1 but not the myriad of variants encompassed by the claims. Applicant has not shown how one of ordinary skill in the art would be able to envision whether a given variant encompassed by the claims would possess the required properties of being capable of treating or preventing the myriad of conditions recited in the claims. The working embodiment in the instant application describes a method of reducing glucagon and glutamate secretion levels in rat islet cell cultures and of reducing soluble ACE2 levels in human islet cell cultures from Type 2 diabetes tissue donors by administering the peptide of instant SEQ ID NO: 1. The instant specification does not show application of variants of SEQ ID NO: 1 to islet cells. The instant specification does not show application to in vivo models. Thus the instant specification lacks a working example of the invention as now claimed.
In addition, a review of the state of the art discloses methods of treating humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes with homodimers of SEQ ID NO: 161 (CQQYNSYPLT; 100% identity to present SEQ ID NO: 1). See Matossian-Rogers (prior art rejection below). However, Matossian-Rogers does not provide a representative set of species of variants of the peptide of instant SEQ ID NO: 1 so that a skilled artisan would be able to envision whether a given variant would possess the required properties of the claims. Further, Matossian-Rogers does not disclose preventing such conditions in the subjects.
As evidenced by the state of the art, even a single amino acid substitution in a therapeutic peptide can change the function of such peptide. Further, neither the instant Specification nor the state of the art shows how one of ordinary skill in the art would be able to envision whether a given amino acid substitution in the claimed peptides could tolerate such substitutions and still possess the required therapeutic functional properties. For example, the post-filing art of Slansky et al titled “Peptide mimotopes alter T cell function in cancer and autoimmunity” (Semin Immunol 2020 Feb: Vol 47, epub March 20, 2020), disclose that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract). In addition, Sengupta et al in “Site-specific amino acid substitution in dodecameric peptides determines the stability and unfolding of c-MYC quadruplex promoting apoptosis in cancer cells” (Nucleic Acids Res 2018 Nov 2 Vol 46 No. 19: pages 9932-9950) discloses that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract).
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117. The limited disclosure of the specification in view of the vast genus of therapeutic functional peptides encompassed by the claims does not adequately describe the entire genus of molecules encompassed by the claims.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that the inventor(s) invented what is claimed.” (See Vas-Cath at page 1116).
For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eh Lily & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (‘In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. ..."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eh Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
Thus, one of skill at the time of the invention could not have concluded that the inventor(s) were in possession of the genus of variant functional peptides encompassed by the claims.
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.
Claims 42-44 are rejected under 35 U.S.C. 102(a)(1) under 35 U.S.C. 102(a)(1) as being anticipated by Matossian-Rogers U.S. Patent Application Publication 2009/0304577 published December 10, 2009.
Regarding claims 42-43, Matossian-Rogers teaches methods of treating humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes with homodimers of SEQ ID NO: 161 (CQQYNSYPLT; 100% identity to present SEQ ID NO: 1) via oral administration at dosages of 0.0001 mg/kg to 50 mg/kg wherein the homodimers are made via forming disulfide bonds between cysteines (please refer to the entire specification particularly paragraphs 25, 26, 101-104, 111-118, 266-270, 273-275; Examples 6, 7; claims 13, 22, 25-27). Matossian-Rogers also teaches SEQ ID NOs: 16, 36, 66, and 150 (QQYNSYPLT) wherein modifications of cysteines at the N-terminus can be utilized to make homodimers which can also be utilized in methods of treating humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes (please refer to the entire specification particularly Figure 12E; paragraphs 3, 9, 10, 20, 22, 23, 25-31, 37, 50, 51, 57, 101-104, 111-118, 266-270, 273-275; Examples 2 and 6; claims 9-13, 22, 25-27).
Regarding claim 44, Matossian-Rogers does not teach or suggest using their therapeutic peptide(s) for treating a coronavirus infection or symptoms thereof. However, as noted above, as presently written, the limitations to coronavirus are only as an intended use. The claim as written does not recite a require an active method step comprising a subject having a coronavirus infection. Claims must be given their broadest reasonable interpretation for purpose of applying prior art and thus it is considered that since claim 44 depends from claim 42, Matossian-Rogers also anticipates claim 44.
Therefore, the teachings of Matossian-Rogers anticipate the presently claimed method.
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 42-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9, 10, 21-25, and 27-29 of U.S. Patent No. 9,243,062 in view of Matossian-Rogers U.S. Patent Application Publication 2009/0304577 published December 10, 2009. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims in view of Matossian-Rogers renders obvious the instant claims.
Regarding base claim 42, patented claims recite homodimers of SEQ ID NO: 16 (QQYNSYPLT) linked together with cysteines at the N-terminus and homodimers of SEQ ID NO: 161 (CQQYNSYPLT) and pharmaceutical compositions thereof.
For present claims, Matossian-Rogers teaches methods of treating humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes with homodimers of SEQ ID NO: 161 (CQQYNSYPLT; 100% identity to present SEQ ID NO: 1) via oral administration at dosages of 0.0001 mg/kg to 50 mg/kg wherein the homodimers are made via forming disulfide bonds between cysteines (please refer to the entire specification particularly paragraphs 25, 26, 101-104, 111-118, 266-270, 273- 275; Example 6; claims 13, 22, 25-27). Matossian-Rogers also teaches SEQ ID NOs: 16, 36, 66, and 150 (QQYNSYPLT) wherein modifications of cysteines at the N-terminus can be utilized to make homodimers which can also be utilized in methods of treating humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes (please refer to the entire specification particularly Figure 12E; paragraphs 3, 9, 10, 20, 22, 23, 25-31, 37, 50, 51, 57, 101-104, 111-118, 266-270, 273-275; Examples 2 and 6; claims 9-13, 22, 25-27).
Regarding claim 44, Matossian-Rogers does not teach or suggest using their therapeutic peptide(s) for treating a coronavirus infection or symptoms thereof. However, as noted above, as presently written, the limitations to coronavirus are only as an intended use. The claim as written does not recite a require an active method step comprising a subject having a coronavirus infection. Claims must be given their broadest reasonable interpretation for purpose of applying prior art and thus it is considered that since claim 44 depends from claim 42, the patented claims in view of Matossian-Rogers also renders obvious claim 44.
The claims would have been obvious because a particular known technique (orally administering homodimers of CQQYNSYPLT to humans with hyperinsulinemia, hyperglucagonemia, glucose, tolerance, insulin resistance, and/or diabetes) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense". See KSR International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
No claim is allowed.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658