DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-2,6,19 and 22-23) in the reply filed on 1/20/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-9, 12-13 and 19-23 are pending.
Claims 3-5, 7-9, 12-13 and 20-21 are withdrawn for being drawn to non-elected inventions (i.e., Groups 2-8).
Claims 1-2, 6,19 and 22-23 are under consideration.
Information Disclosure Statement
The Information Disclosure Statement filed on 3/2/2023 has been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d) (see page 5, line 1).
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 sequence identifiers, 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.
Claim Objections
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d) (see claim 1, line 2). After a careful review of sequence listing, it seems like the sequence in claim 1 may be the amino acid sequence of SEQ ID NO: 2. Applicant are required make an appropriate correction.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marx et al. (US Pub. No. 20190250145.
The instantly claimed invention is broadly drawn to any variant of peptides of SEQ ID NO:4-7, wherein the peptide does not consist of SEQ ID NO: 1.
Marx et al teach a peptide having amino acid sequence of QQLEEDLKGALDAATQAE (see Fig. 6A). The amino acids in bold differ from amino acid of SEQ ID NO:1 and they differ from amino acid sequences of SEQ ID NO:4-7. Therefore, the prior art implicitly or explicitly anticipates the instantly claimed invention.
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.
Claims 1, 6 and 19 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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted element is: sequence identifier number (SEQ ID NO: ), and therefore, a proper search cannot be performed.
Claim 19 is rejected for depending from a rejected claim (i.e., claim 1).
Regarding claim 6, the phrase "modulating movement" renders the claim indefinite because it is unclear whether the limitation(s) “modulating movement” is meant to increase the movement or decrease the movement. Therefore, it is confusion and Applicant should make an appropriate correction. See MPEP § 2173.05(d).
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.
Claims 6, 9, and 22-23 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 or reducing myocardial damage by administering a composition comprising amino acid sequence of SEQ ID NO: 4-7, does not reasonably provide enablement for preventing cardiac hypertrophy or modulating movement of a beta subunit of the L-type Ca2+ channel in any cardiac cell of any subject (who many not even be in such a need) comprising administering by any route of administration a composition comprising the amino acid sequence of SEQ ID NO: 4-7 or a kit comprising the same. 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/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a method of preventing cardiac hypertrophy or modulating movement of a beta subunit of the L-type CA2+ channel in a cardiac cell of any subject (who may not even be in such need) comprising administering by any route of administration a composition comprising the amino acid sequence of SEQ ID NO: 4-7.
The state of the prior art and the predictability or lack thereof in the art: With regards to the preventing cardiac hypertrophy or modulating movement of a beta subunit of the L-type Ca2+ channel cardiac cell in any subject (who may not even be in need for such) comprising administering a composition of claim 1 by any route of administration, the specification does not disclose sufficient guidance or objective evidence that such peptides, analog or derivatives would predictably prevent damage to the myocardium after having myocardial infarction or control all metabolic pathways that exacerbate infarct damage in a patient need thereof. Marx et al. (IDS, US Pub. No. 2019/0250145) teach a method of treating or ameliorating the effects of a heart condition caused by the effects of abnormal beta adrenergic receptor on calcium levels in cardiomyocytes in a subject (abstract). They teach using a variant peptide of alpha interacting domain (AID) comprising amino acid sequence of AALEEDLKGALDAATQAE, which is a mutant of the amino acid sequence of QQLEEDLKGYLDWITQAE (wild type AID peptide) for the treatment of calcium related myocardial disorder (Figure 6A). The art does not teach that a peptide having amino acid sequence of QQX1EEDX2KGYLDWITQAE wherein X1 is an amino acid selected from the group comprising: Q, E or R; and wherein X2 is an amino acid selected from the group comprising: L or E; can modulate movement of a beta subunit of the L-type Ca2+ channel in a cardiac cell or can prevent myocardial damage and/or oxidative stress in any subject. Therefore, it is unpredictable and would require a large amount of experimentation to prevent damage to the myocardium or modulate the movement of a beta subunit of the L-type Ca2+ channel in a cardiac cell of any subject by administering a composition comprising the peptides of claim 1 in a patient need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification at pg. 7 discloses the primary structure of pore forming L-type Ca2+ channel alpha -1 subunit is composed of 4 homologous repeating motifs (I-IV), each of which consist of 6 putative segments (S1-S6). α2δ consists of a transmembrane protein (δ) and extracellular α2 protein linked via a disulfide bond. β2 is an intracellular protein bound to the linker between motifs 1 and 2 of α1c via the α-interacting domain (AID). The specification at pg. 44 discloses that the treatment of pre-cardiomyopathic cTnI-G203S mice with AID variants reduces hypertrophic cardiomyopathy but the specification does not disclose that the reduction in cardiac hypertrophy is forever (prevented) and the subject does not develop the condition ever after the treatment. Additionally, the specification does not disclose whether the administration was done orally, intravenously or by inhalation. The specification does not disclose whether the administration of the peptide increases movement or decreases movement of a beta subunit of L-type Ca2+ channel in a cardiac cell of a subject. The art or the specification is devoid of any example where the administration of AID mutant can prevent myocardial damage or modulate movement of beta subunit of the L-type Ca2+ channel in a cardiac cell of any subject (not a subject who is not in need of such treatment). Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to prevent cardiac hypertrophy in any subject or to modulate (increase or decrease) movement of a beta subunit of the L-type Ca2+ channel in any cardiac cell of any subject comprising administering the peptide of claim 1 via any route (oral, intravenous, intramuscular, intraperitoneal, or others ) in a patient who may not be in need of such treatment, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about preventing cardiac hypertrophy or modulating movement of a beta subunit of the L-type Ca2+ channel in a cardiac cell of any subject, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
No claim is allowed.
It is noted to applicant that the amino acid sequences of SEQ ID NO: 4-7 are free of prior art.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674