DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 2/5/2026 is acknowledged.
4. Claim filed on 2/5/2026 is acknowledged.
5. Claim 1-69 have been cancelled.
6. Claims 70-89 are pending in this application.
7. Claims 70-81 and 85-89 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
8. Claims 82-84 are under examination.
Election/Restrictions
9. Applicant’s election with traverse of Group 3 (claims 82-84) and election without traverse of SCLLADDN (SEQ ID NO: 2) as species of decoy peptide; and a subject having a neurologic disease or disorder as species of subject in the reply filed on 2/5/2026 is acknowledged. The traverse is on the ground that “the Examiner has not shown that a serious burden would result if all of the claims are examined together”. This is not found to be persuasive because: for US 371 of PCT application, burden is not a reason for traverse. Therefore, Applicant’s arguments are moot. And the requirement is deemed proper and is made FINAL in this office action.
Group 3 is drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier. A search was conducted on the elected species; and prior art was found. Claims 82-84 are examined on the merits in this office action.
Claim Interpretations
10. With regards to the decoy peptide recited in instant claim 84, the Examiner is interpreting the decoy peptide recited in instant claim 84 is identical to instant SEQ ID NO: 2 without any type of modification (see MPEP § 2111.03 II).
Objections
11. The specification is objected to for the following minor informality: The specification recites “peptide 2is” on page 4, lines 5 and 7 of instant specification. There appear to be a space missing in this recitation. Applicant is suggested to amend this recitation as “peptide 2 is”.
12. The specification is objected to for the following minor informality: The specification recites “seleno-L- cysteine” on page 10, line 29 of instant specification. This appears to be an extra space in this recitation. Applicant is required to correct this error.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
13. The drawings are objected to for the following minor informality:
The words in all Figures are in poor quality and difficult to read. Applicant is suggested to amend all the words in these figures to be clear to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
14. Claim 82 is objected to for the following minor informality: Applicant is suggested to amend claim 82 as “A method of reducing or preventing cardiac hypertrophy in a subject, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a decoy peptide and a pharmaceutically acceptable carrier, and wherein the decoy peptide comprises the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or a fragment thereof”.
15. Claim 83 is objected to for the following minor informality: Applicant is suggested to amend claim 83 as “…wherein the subject has type 2 diabetes, a neurologic disease or disorder, a microvascular disease or disorder, hypertension…type 2B hyperlipidemia, has had a stroke or a traumatic brain injury, or a combination thereof”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
16. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
17. Claims 82 and 83 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, claims 82 and 83 are drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier.
With regards to the term “decoy peptide”, the instant specification discloses that “the term "decoy peptide" or "decoy polypeptide" refers to a peptide or polypeptide designed to contain a partial peptide sequence in the second extracellular loop region of the 5-HT2A receptor, and the decoy peptide or polypeptide can block the action of 5-HT2A receptor autoantibodies by binding to the 5-HT2A receptor autoantibodies.” (see page 8, lines 9-12 of instant specification).
With regards to the term “fragment”, the instant specification discloses that “The term “fragment" can refer to a portion (e.g., at least 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15 14, 15, 16, 17, etc. amino acids) of a peptide that is substantially identical to a reference peptide and retains the biological activity of the reference.” (see page 10, lines 14-16 of instant specification). In the instant case, the Examiner would like to point out that example and/or preferred embodiment is not a definition. Therefore, in the broadest reasonable interpretation, the fragment therefore recited in instant claim 82 can be any two consecutive amino acids of instant SEQ ID NO: 1.
The genus of instant claimed decoy peptide is extremely broad, including any peptide comprising two consecutive amino acids of instant SEQ ID NO: 1. The length of the decoy peptide can be any number ≥ 2 amino acid (as a fragment).
The instant specification discloses that peptides of instant SEQ ID NOs: 1-4 as a decoy peptide. And peptides of instant SEQ ID NOs: 10-33 have the same amino acid sequence as instant SEQ ID NO: 1; peptides of instant SEQ ID NOs: 5, 6, 9 and 34-57 have the same amino acid sequence as instant SEQ ID NO: 2; peptides of instant SEQ ID NOs: 58-81 have the same amino acid sequence as instant SEQ ID NO: 3; and peptides of instant SEQ ID NOs: 82-105 have the same amino acid sequence as instant SEQ ID NO: 4.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide to have the functional characteristics of being a decoy peptide.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses peptides of instant SEQ ID NOs: 1-4 as a decoy peptide. And peptides of instant SEQ ID NOs: 10-33 have the same amino acid sequence as instant SEQ ID NO: 1; peptides of instant SEQ ID NOs: 5, 6, 9 and 34-57 have the same amino acid sequence as instant SEQ ID NO: 2; peptides of instant SEQ ID NOs: 58-81 have the same amino acid sequence as instant SEQ ID NO: 3; and peptides of instant SEQ ID NOs: 82-105 have the same amino acid sequence as instant SEQ ID NO: 4.
Furthermore, peptide 2 of instant SEQ ID NO: 9 is tested in the working examples in instant specification. Peptide 2 of instant SEQ ID NO: 9 consists of the amino acid sequence of instant SEQ ID NO: 2 with a myristic acid attached to the N-terminus of the peptide.
Taken all these together, other than the limited examples, the instant specification fails to describe a general correlation between structure and function for the claimed genus of decoy peptide.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, based on the disclosure of instant specification, other than the limited examples, a person of ordinary skilled in the art would not be able to determine a general correlation between structure and function for the claimed genus of decoy peptide.
With regards to the instant claimed decoy peptide, Paterno et al (US 2016/0376340 A1), throughout the patent, teach a peptide comprising the amino acid sequence LQDDSKVFKEGSCLLADDN (SEQ ID NO: 8), a peptide comprising the amino acid sequence DDSKVFKEGS (SEQ ID NO: 157), and various peptides comprising the amino acid sequence VFKEG as decoy peptides that bind to the 5-HT2A receptor autoantibodies in a subject having multiple sclerosis (MS) and as therapy of multiple sclerosis; and such peptides are identified by screening 5-HT2AR library for peptides that bind to MS sera, for example, Abstract; page 1, paragraph [0002]; page 2, paragraphs [0033]; [0035]-[0037]; page 3, paragraphs [0040] and [0051]; page 4, paragraphs [0065], [0066] and [0079]; and pages 16-19, SEQ ID NO: 8 and Table 1. Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS), throughout the literature, teaches peptide 1 consisting of the amino acid sequence QDDSKVFKEGSC LLADDN (identical to the decoy peptide of instant SEQ ID NO: 1) binds to autoantibodies in type-2 diabetes having neurovascular complications, wherein such autoantibodies cause 5-HT2A receptor activation via binding to the second extracellular loop region of the 5-HT2A receptor, for example, page 1, the 1st and 2nd paragraphs in Section “Introduction”; and page 2, Section “Synthetic peptide synthesis”. Zimering further teaches QDDSKVF (peptide 3), VFKEGSC (peptide 4), SCLLADDN (peptide 2, identical to the decoy peptide of instant SEQ ID NO: 2) as fragments of peptide 1, wherein Peptide 3 or 4 has no significant effect on IgG autoantibody-induced neurite withdrawal, for example, page 2, Section “Synthetic peptide synthesis”; page 5, Section “Epitope mapping of region within 5-HT2AR, ECL2 peptide targeted by autoantibodies”; page 13, Figure 3; and page 24, Table 11.
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine a general correlation between structure and function for the claimed genus of decoy peptide.
(d) representative number of samples:
In the instant case, the genus of instant claimed decoy peptide is extremely broad, including any peptide comprising two consecutive amino acids of instant SEQ ID NO: 1. The length of the decoy peptide can be any number ≥ 2 amino acid (as a fragment).
And, as discussed in (a) and (b) above, the instant specification discloses peptides of instant SEQ ID NOs: 1-4 as a decoy peptide. And peptides of instant SEQ ID NOs: 10-33 have the same amino acid sequence as instant SEQ ID NO: 1; peptides of instant SEQ ID NOs: 5, 6, 9 and 34-57 have the same amino acid sequence as instant SEQ ID NO: 2; peptides of instant SEQ ID NOs: 58-81 have the same amino acid sequence as instant SEQ ID NO: 3; and peptides of instant SEQ ID NOs: 82-105 have the same amino acid sequence as instant SEQ ID NO: 4.
Furthermore, peptide 2 of instant SEQ ID NO: 9 is tested in the working examples in instant specification. Peptide 2 of instant SEQ ID NO: 9 consists of the amino acid sequence of instant SEQ ID NO: 2 with a myristic acid attached to the N-terminus of the peptide.
Considering the broadness of the genus of instant claimed peptide, the instant specification fails to provide sufficient examples to describe the entire genus of a decoy peptide comprising the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or a fragment thereof claimed.
Taken all these together, considering the state of the art and the disclosure in instant specification, it is deemed that the instant specification fails to provide adequate written description for the claimed genus of a decoy peptide comprising the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or a fragment thereof claimed; and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
18. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
19. Claims 82 and 84 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 or preventing cardiac hypertrophy in a subject having 5-HT2A receptor autoantibody that binds to the second extracellular loop region of the 5-HT2A receptor via administering to the subject a therapeutically effective amount of a decoy peptide comprising the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), a method of reducing or preventing cardiac hypertrophy in a subject having multiple sclerosis via administering to the subject a therapeutically effective amount of a peptide comprising the amino acid sequence LQDDSKVFKEGSCLLADDN (SEQ ID NO: 8), a peptide comprising the amino acid sequence DDSKVFKEGS (SEQ ID NO: 157), and various peptides comprising the amino acid sequence VFKEG as disclosed in Paterno et al (US 2016/0376340 A1), and/or a method of reducing or preventing cardiac hypertrophy in a subject disclosed in claims 6-18 of Zimering (US patent 11306122 B2) via administering to the subject a therapeutically effective amount of a decoy peptide comprising the amino acid sequence SCLLADDN (SEQ ID NO: 2), does not reasonably provide enablement for a method of reducing or preventing cardiac hypertrophy in ALL subject via administering to the subject a therapeutically effective amount of a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof. The specification does not enable any person skilled in the art to which it pertains to make and/or use the invention commensurate in scope with the claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or 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. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The instant claims 82 and 84 are drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier; and claim 84 limits the decoy peptide to instant SEQ ID NO: 2.
The rejection to the recited “fragment thereof” under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) has been set forth in Section 17 above.
With regards to the term “subject”, the instant specification discloses that “As used herein, the term "subject" refers to the target of administration, e.g., a human. Thus the subject of the disclosed methods can be a vertebrate, such as a mammal, a fish, a bird, a reptile, or an amphibian. The term "subject" also includes domesticated animals (e.g., cats, dogs, etc.), livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), and laboratory animals (e.g., mouse, rabbit, rat, guinea pig, fruit fly, etc.).” (see page 7, lines 29-33 of instant specification).
Furthermore, the instant specification disclose the term “preventing” broadly includes ameliorating or controlling (see page 11, lines 5-6 of instant specification).
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regarding to reducing or preventing cardiac hypertrophy in ALL subject via administering to the subject a therapeutically effective amount of a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof, the art is unpredictable.
Caturano et al (Rev. Cardiovasc. Med., 2022, 23, pages 1-16), throughout the literature, teach pathophysiological mechanisms of cardiac hypertrophy (CH) are very complex; there are many different factors such as cell death, fibrosis, mitochondrial dysfunction, dysregulation of Ca2+-handling proteins, metabolic changes, fetal gene expression reactivation, impaired protein and mitochondrial quality control, altered sarcomere structure, and inadequate angiogenesis; and the pathophysiology of CH, as well as diabetic cardiomyopathy development and progression is still far from being fully explained, for example, Abstract; page 2, Figure 1; and page 9, the 1st paragraph in Section “4. Conclusions”.
Furthermore, Paterno et al (US 2016/0376340 A1), throughout the patent, teach a peptide comprising the amino acid sequence LQDDSKVFKEGSCLLADDN (SEQ ID NO: 8), a peptide comprising the amino acid sequence DDSKVFKEGS (SEQ ID NO: 157), and various peptides comprising the amino acid sequence VFKEG as decoy peptides that bind to the 5-HT2A receptor autoantibodies in a subject having multiple sclerosis (MS) and as therapy of multiple sclerosis; and such peptides are identified by screening 5-HT2AR library for peptides that bind to MS sera, for example, Abstract; page 1, paragraph [0002]; page 2, paragraphs [0033]; [0035]-[0037]; page 3, paragraphs [0040] and [0051]; page 4, paragraphs [0065], [0066] and [0079]; and pages 16-19, SEQ ID NO: 8 and Table 1.
In addition, Zimering (US patent 11306122 B2) teach a decoy peptide comprising SCLLADDN (SEQ ID NO: 2) for treating various conditions recited in claims 6-18; and such decoy peptide inhibits binding of 5-HT2A autoantibodies to a second extracellular loop region of the 5-HT2A receptor, for example, Abstract; and claims 6-18.
And, Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS), throughout the literature, teaches peptide 1 consisting of the amino acid sequence QDDSKVFKEGSC LLADDN (identical to the decoy peptide of instant SEQ ID NO: 1) binds to autoantibodies in type-2 diabetes having neurovascular complications, wherein such autoantibodies cause 5-HT2A receptor activation via binding to the second extracellular loop region of the 5-HT2A receptor, for example, page 1, the 1st and 2nd paragraphs in Section “Introduction”; and page 2, Section “Synthetic peptide synthesis”. Zimering further teaches QDDSKVF (peptide 3), VFKEGSC (peptide 4), SCLLADDN (peptide 2, identical to the decoy peptide of instant SEQ ID NO: 2) as fragments of peptide 1, wherein Peptide 3 or 4 has no significant effect on IgG autoantibody-induced neurite withdrawal, for example, page 2, Section “Synthetic peptide synthesis”; page 5, Section “Epitope mapping of region within 5-HT2AR, ECL2 peptide targeted by autoantibodies”; page 13, Figure 3; and page 24, Table 11.
Taken all these together, considering the state of art, one of ordinary skilled in the art would understand and reasonably expect that not all type of cardiac hypertrophy are caused by 5-HT2A autoantibodies that bind to a second extracellular loop region of the 5-HT2A receptor; and even in conditions caused by 5-HT2A autoantibodies that bind to a second extracellular loop region of the 5-HT2A receptor, depend on the condition, the fragment of instant SEQ ID NO: 1 that inhibits binding of such autoantibodies can be different.
(3) The relative skill of those in the art:
The related skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
With regarding to reducing or preventing cardiac hypertrophy in ALL subject via administering to the subject a therapeutically effective amount of a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof, the instant specification discloses peptides of instant SEQ ID NOs: 1-4 as a decoy peptide. And peptides of instant SEQ ID NOs: 10-33 have the same amino acid sequence as instant SEQ ID NO: 1; peptides of instant SEQ ID NOs: 5, 6, 9 and 34-57 have the same amino acid sequence as instant SEQ ID NO: 2; peptides of instant SEQ ID NOs: 58-81 have the same amino acid sequence as instant SEQ ID NO: 3; and peptides of instant SEQ ID NOs: 82-105 have the same amino acid sequence as instant SEQ ID NO: 4.
Furthermore, peptide 2 of instant SEQ ID NO: 9 is tested in the working examples in instant specification. Peptide 2 of instant SEQ ID NO: 9 consists of the amino acid sequence of instant SEQ ID NO: 2 with a myristic acid attached to the N-terminus of the peptide.
The specification does not enable any person skilled in the art to which it pertains to make and/or use the invention commensurate in scope with the claims. The lack of adequate guidance from the specification or prior art with regard to the actual method of reducing or preventing cardiac hypertrophy in ALL subject via administering to the subject a therapeutically effective amount of a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof. Applicants fail to provide the guidance and information required to ascertain which particular type of subject and which particular fragment of instant SEQ ID NO: 1 will be effective without resorting to undue experimentation. Applicant's limited disclosure is noted but is not sufficient to justify claiming a method of reducing or preventing cardiac hypertrophy in ALL subject via administering to the subject a therapeutically effective amount of a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof.
(8) The quantity of experimentation necessary:
Considering the state of prior arts and the disclosure in instant specification, one of ordinary skill in the art would be burdened with undue experimentation to reduce or prevent cardiac hypertrophy in ALL subject with a decoy peptide comprising QDDSKVFKEGSCLLADDN (SEQ ID NO: 1) or fragment thereof.
Claim Rejections - 35 U.S.C. § 102(a)(1)
20. 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.
21. Please note: During the search for the elected species, prior art was found for the non-elected species of decoy peptide.
Claims 82 and 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paterno et al (US 2016/0376340 A1).
The instant claims 82 and 83 are drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier.
Paterno et al, throughout the patent, teach a peptide comprising the amino acid sequence LQDDSKVFKEGSCLLADDN (SEQ ID NO: 8, comprising the amino acid sequence of instant SEQ ID NO: 1, underlined), a peptide comprising the amino acid sequence DDSKVFKEGS (SEQ ID NO: 157), and various peptides comprising the amino acid sequence VFKEG as decoy peptides that bind to the 5-HT2A receptor autoantibodies in a subject having multiple sclerosis and as therapy of multiple sclerosis (a neurologic disease or disorder); and a method of treating multiple sclerosis comprising administering a therapeutically effective amount of such peptide and a pharmaceutically acceptable carrier, for example, Abstract; page 1, paragraph [0002]; page 2, paragraphs [0033]; [0036] and [0037]; page 3, paragraphs [0040] and [0051]; page 4, paragraphs [0065], [0066] and [0079]; page 7, paragraph [0115]; page 8, paragraph [0121]; pages 16-19, SEQ ID NO: 1 and Table 1; and claims 1-7 and 9.
With regards to the limitation “a method of reducing or preventing cardiac hypertrophy in a subject” recited in instant claim 82, this is a result-oriented limitation. In the instant case, the method in Paterno et al comprises administering the same decoy peptide to the same subject, therefore, the method in Paterno et al would result in the same effect, i.e. reducing or preventing cardiac hypertrophy in a subject. And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Thus, the method in Paterno et al reads on a subject having a neurologic disease or disorder as the elected species of subject; and meets the limitations of instant claims 82 and 83.
Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (See MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 82 and 83; the reference anticipates instant claims 82 and 83.
22. Claims 82-84 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS).
The instant claims 82-84 are drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier.
Zimering, throughout the literature, teaches diabetes is associated with a substantially increased risk of certain neurovascular and neurodegenerative complications, e.g. stroke, dementia, Parkinson’s disease, major depressive disorder; peptide 1 (Q..N-18) consisting of the amino acid sequence QDDSKVFKEGSCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 1) binds to IgG autoantibodies in type-2 diabetes having neurovascular complications, wherein such IgG autoantibodies cause 5-HT2A receptor activation via binding to the second extracellular loop region of the 5-HT2A receptor, for example, page 1, the 1st and 2nd paragraphs in Section “Introduction”; and page 2, Section “Synthetic peptide synthesis”. Zimering further teaches associations among diabetic angiopathy, neurodegenerative disorders and certain systemic autoimmune diseases with increased level of IgG autoantibodies that binds to 5-HT2A receptor, second extracellular loop region, and linear synthetic peptide; and peptide 1 (Q..N-18) inhibits DM autoantibody-induced N2A neurite retraction, for example, page 4. Section “Increased 5-HT2AR synthetic peptide binding in protein-A eluates from subsets of diabetic angiopathy and/or neurovascular complications” and “Dose-dependence and titer of diabetic protein-A eluate binding to Q..N-18”; page 5, Section “Soluble ECL2 peptide inhibits DM autoantibody-induced N2A neurite retraction”; and pages 19-23,Tables 6-10. Zimering also teaches peptide 2 consisting of the amino acid sequence SCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 2) protects against autoantibody neurotoxicity, in that it nearly completely prevents (99%) IgG-induced acute neurite withdrawal induced by pathologies’ IgG autoantibodies in ten of ten patients tested and provides substantial neuro protection against accelerated neuron loss, for example, page 5, Section “Sub region-specific 5-HT2AR, ECL2 peptide protects against autoantibody neurotoxicity”; and pages 24-26, Tables 12-14. Although Zimering is silent about the carrier used to dissolve either peptide 1 (Q..N-18) or peptide 2, since both peptides are used to treat cells, one of ordinary skilled in the art would understand and reasonably expect these peptides are dissolved in a pharmaceutically acceptable carrier.
Therefore, in view of the teachings of Zimering as a whole, one of ordinary skilled in the art would immediately envision a method of protecting against accelerated neuron loss in diabetic subject having neurovascular and neurodegenerative complications, e.g. stroke, dementia, Parkinson’s disease, major depressive disorder, wherein the method comprises administering to the subject a therapeutically effective amount of a decoy peptide 1 (Q..N-18) consisting of the amino acid sequence QDDSKVFKEGSCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 1) or its fragment peptide 2 consisting of the amino acid sequence SCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 2) and a pharmaceutically acceptable carrier.
With regards to the limitation “a method of reducing or preventing cardiac hypertrophy in a subject” recited in instant claim 82, this is a result-oriented limitation. In the instant case, the method above comprises administering the same decoy peptide to the same subject, therefore, the method above would result in the same effect, i.e. reducing or preventing cardiac hypertrophy in a subject. And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Thus, the method above reads on SCLLADDN (SEQ ID NO: 2) as the elected species of decoy peptide; and a subject having a neurologic disease or disorder as the elected species of subject. And it meets the limitations of instant claims 82-84.
Since the reference teaches all the limitations of instant claims 82-84; the reference anticipates instant claims 82-84.
Obviousness Double Patenting
23. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
24. Claims 82-84 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6-20 of US patent 11306122 B2.
25. Instant claims 82-84 are drawn to a method of reducing or preventing cardiac hypertrophy in a subject, the method comprising: administering to the subject a therapeutically effective amount of a decoy peptide, wherein the decoy peptide comprises or consists of the sequence QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, and a pharmaceutically acceptable carrier.
26. Claims 6-20 of US patent 11306122 B2 are drawn to a method of treating a subject with a disease or disorder, the method comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising the sequence of SEQ ID NO: 2 and a pharmaceutically acceptable
carrier, wherein the disease or disorder is a metabolic disease or disorder, a cardiovascular or a microvascular disease or disorder, or a neurodegenerative disease or disorder; a method of treating a subject with a neurologic disease or disorder, the method comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising the sequence of SEQ ID NO: 2 and a pharmaceutically acceptable carrier, wherein the neurologic disease or disorder is neuropathy, dementia, major depressive disorder or Parkinson's disease; and a method of inducing sedation in a subject, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising SEQ ID NO: 2, and a pharmaceutically acceptable carrier.
With regards to the limitation “a method of reducing or preventing cardiac hypertrophy in a subject” recited in instant claim 82, this is a result-oriented limitation. In the instant case, the methods recited in claims 6-20 of US patent 11306122 B2 comprise administering the same decoy peptide to the same subject, therefore, the methods recited in claims 6-20 of US patent 11306122 B2 would result in the same effect, i.e. reducing or preventing cardiac hypertrophy in a subject.
27. For the same/similar reasoning/rational as the rejection set forth in Sections 24-26 above, instant claims 82 and 83 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 4-14 of US patent 12122853 B2.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658