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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 with respect to the claim rejections under 35 U.S.C. 101, 102, and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Applicant’s election without traverse of the species SEQ ID NO: 10 and acute and chronic cutaneous wounds in the reply filed on 11/14/2025 is acknowledged.
Upon further search and examination, the peptide species have been expanded to include SEQ ID NO: 14 in addition to SEQ ID NO: 10.
Claim Status
Claims 1-2, 4-13, and 15-22 are pending. Claims 1, 4, and 11-13 are currently amended. Claims 5-9 are withdrawn. Claims 3 and 14 are cancelled. Claims 15-22 are new.
Priority
The instant application is the 371 national stage entry of PCT/EP2021/074466, filed 9/6/2021, which claims priority to EP20199419.1, filed 9/30/2020, and EP20194685.2, filed 9/4/2020. The priority date of 9/4/2020 is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
See Figure 1
Claim Interpretation
Claim 1 recites a method of treating a medical condition… comprising administering a peptide having an amino acid sequence consisting of any one of SEQ ID NO: 2, 3, 9, 10 or 13-18. The peptide is being interpreted as a peptide consisting of any one of the prior listed SEQ ID NO’s, both in view of the transitional phrase “consisting of” and also based upon the definition of “peptide(s) having a sequence” on Pg 6, second paragraph of the instant specification.
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 1 and 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a subset of medical conditions, does not reasonably provide enablement for treating medical conditions broadly. 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 medical condition comprising administering to a subject in need thereof one of SEQ ID NO: 2, 3, 9, 10, or 13-18. The claims are written such that they include the treatment of any medical condition based upon the administration of one of the polypeptides listed above. The issue is whether any and all medical conditions can be treated via the instantly claimed method steps and peptides, which have the ability to promote angiogenesis.
2) State of the prior art and 4) predictability or unpredictability of the art: At the time of filing, the prior art recognized many medical conditions impacted or caused by increases or decreases in angiogenesis (Carmeliet, P. Angiogenesis in health and disease. Nat Med 9, 653–660 (2003).). Table 1 of Carmeliet describes several medical conditions characterized or caused by abnormal or excessive angiogenesis, such as cancer, infectious diseases, and autoimmune disorders among others. In a situation where a medical condition is caused by excessive angiogenesis, one skilled in the art would reasonably predict that administration of any one of SEQ ID NO: 2, 3, 9, 10, or 13-18 would fail to effectively treat such a medical condition.
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 one of SEQ ID NO: 2, 3, 9, 10 or 13-18 to treat the breadth of medical conditions as claimed.
7) The presence or absence of working examples: The instant specification indicates
diabetic wounds can be treated with SEQ ID NO: 10 and demonstrate a greater percentage of wound closure compared to untreated controls in the same amount of time (Example 9; Figure 16).
8) The quantity of experimentation necessary: Based on the prior art and teachings of
the instant specification, reasonable guidance with respect to treating a medical condition with one of SEQ ID NO: 2, 3, 9, 10, and 13-18 was lacking. Consequently, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively treat all medical conditions with the claimed method steps.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide sufficient information to practice the claimed invention for the treatment of all medical conditions.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-13 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to peptides, which are compositions of matter.
Regarding 2a), the peptides claimed are products of nature and read on the following products:
SEQ ID NO: 2 – UniProt ID’s B9V892_HV1, Q9WND1_HV1, Q9WND2_HV1, others
SEQ ID NO: 3 – UniProt ID’s H2DJV1_HV1, O89454_HV1, B9V8I0_HV1, others
SEQ ID NO: 9 – UniProt ID’s Q9W7Z8_HV1, Q9W7Z7_HV1, O89431_HV1, others
SEQ ID NO: 10 – UniProt ID’s A0A5F8A703_MACMU, EPO_MACFA, others
SEQ ID NO: 14 – UniProt ID’s Q9INA4_HV1, P89773_HV1, W0GQ86_HV1, others
SEQ ID NO: 16 – UniProt ID’s Q7SKN4_9HIV2, Q7SKN5_9HIV2, Q7SKP0_9HIV2, others
SEQ ID NO: 17 – UniProt ID’s C8XQF1_HV1, L7Z8G2_9PLVG, L7ZEG8_9PLVG, others
SEQ ID NO: 18 – UniProt ID’s Q1A241_SIV, E5RDN8_HV1, G8Z0M8_SIV, others
While some of these proteins may be longer than the limit imposed by the claims, in
Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that fragments of a biopolymer still trigger this statute. Thus, the fact that these sequences are longer than those claimed does not make the rejection invalid, unless the fragment is significantly different from the full-length polypeptide.
Regarding 2b), there is nothing significantly more recited in the claims that would distinguish the claimed peptides from the natural products described above. As such, the claims do not contain elements added to the judicial exception to render the claims significantly more than the exception.
In sum, the claims are drawn to patent ineligible subject matter and are rejected here.
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, 11-13, and 15-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sette et al. (US20050271676A1, published 12/8/2005).
Sette teaches identification and preparation of human immunodeficiency virus (HIV) epitopes to develop epitope-based vaccines as well as pharmaceutical compositions and methods for the prevention and treatment thereof (medical condition; Abstract).
Regarding claims 1 and 13, Sette teaches the HIV gag epitope SEQ ID NO: 114, which is identical to the instant SEQ ID NO: 14 (Table 7; Sequence Listing; [0120-0121]).
Regarding claim 11, as described above, Sette teaches pharmaceutical compositions (Abstract).
Regarding claim 12, Sette also teaches nucleic acid compositions of the invention ([0064, 0100, 0150]).
Regarding claims 15-22, Sette teaches modification of the immunogenic peptides through terminal-NH2 acylation, e.g., by alkanoyl (C1-20) or thioglycoyl acetylation, terminal-carboxylamidation, e.g., ammonia, methylamine, etc. ([0262]).
Claim Rejections - 35 USC § 103
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 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, 2, 11-13, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sette et al. (US20050271676A1, published 12/8/2005) in view of Caccuri et al. (HIV-1 matrix protein p17 promotes angiogenesis via chemokine receptors CXCR1 and CXCR2. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14580-5.; cited on IDS filed 8/1/2023).
The teachings of Sette have been set forth above. Sette does not expressly teach the medical condition is associated with or caused by deficient angiogenesis or is a condition benefitting from increased angiogenesis.
Caccuri teaches a number of primary vascular diseases supported by aberrant angiogenesis have increased incidence in HIV-1–infected patients. In particular, imaging studies have shown evidence of premature subclinical atherosclerosis and increased intima-media thickness, a condition linked to vasa vasorum angiogenesis and medial infiltration (Pg 14580, left column, Introduction, second paragraph).
To summarize, Sette teaches a method of treating HIV via peptide vaccines derived from HIV epitopes, and Caccuri teaches HIV-positive patients have increased rates of developing certain vascular diseases caused by aberrant angiogenesis.
Based on these teachings, regarding claim 2, it would be prima facie obvious to apply the method of treatment taught by Sette to treat both HIV and the primary vascular diseases associated with HIV. One skilled in the art would be motivated do so in order to treat both the core of the disease as well as the symptoms associated with the disease. One would have a reasonable expectation of success given that Sette teaches treating HIV and Caccuri teaches HIV patients have increased rates of primary vascular diseases caused by aberrant angiogenesis.
Claim(s) 1, 4, 11-13, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sette et al. (US20050271676A1, published 12/8/2005) in view of Tuthill et al. (A clinical guide to supportive and palliative care for HIV/AIDS, 1999, TheBodyPro, accessed from https://www.thebodypro.com/article/clinical-guide-supportive-palliative-care-hiv-aids-chapter-25-pre on 9/15/2026).
The teachings of Sette have been set forth above. Sette does not expressly teach the method is for the treatment of acute and chronic cutaneous wounds.
Tuthill teaches maintenance of skin integrity in people with HIV poses a number of challenges to health care practitioners and caregivers. Because of the nature of HIV, it can be difficult, if not impossible, to heal open wounds or ulcers once they appear. It is for this reason that clinicians must work closely with patients and their caregivers in instructing them in principles of skin care. The clinician should teach symptomatic relief of some of the more common skin problems and also address basic assessment of skin so that the caregiver can report problems as soon as they occur. Vigilant caregivers in the home are the patient's best defense against the long-term complications of pressure or decubitus ulcer formation (chronic cutaneous wounds; first paragraph).
To summarize, Sette teaches a method of treating HIV via peptide vaccines derived from HIV epitopes, and Tuthill teaches HIV patients experience chronic wound healing challenges.
Based on these teachings, regarding claim 4, it would be prima facie obvious to apply the method of treatment taught by Sette to treat both HIV and the acute and chronic cutaneous wound associated with HIV. One skilled in the art would be motivated do so in order to treat both the core of the disease as well as the symptoms associated with the disease. One would have a reasonable expectation of success given that Sette teaches treating HIV and Tuthill teaches HIV-positive individuals face chronic wound healing challenges.
Claim(s) 1, 10-13, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sette et al. (US20050271676A1, published 12/8/2005) in view of Semprini et al. (Infertility treatment for HIV-positive women, Sage Journals, 2008, pp. 369-382).
The teachings of Sette have been set forth above. Sette does not expressly teach the peptide is used as adjuvant therapy in assisted reproduction technology (ART).
Semprini teaches women with HIV can attempt to conceive naturally or through simple self-insemination to minimize the risk of horizontal HIV transmission. Assisted reproduction technology is necessary in couples with infertility, which can either be independent of HIV infection and its treatment or be associated with it (Abstract).
Semprini teaches HIV infection interferes with sexual and reproductive choices in a variety of ways, including concerns regarding sexual transmission to the uninfected man, vertical transmission to the child, and fears regarding declining health and shortened lifespan. In addition, HIV has been shown to impair fertility for a number of reasons, including the effect of advanced HIV disease, interaction with antiretroviral medication and a higher frequency and severity of genital tract infections. As far as fertility is concerned, HIV infection in women is also characterized by unique gynecologic manifestations, such as cervical dysplasia or severe pelvic inflammatory disease (PID), which may impact fertility or complicate the course of pregnancy.
The offer of advice on reproductive options and services available to all HIV-infected individuals, independent of their HIV disease status or life conditions, is a central means to combat HIV infection as it may lead to a reduction in rates of horizontal and vertical transmission, help women achieve pregnancy by overcoming fertility problems, promote improved health in pregnancy and reduce the risk during childbirth (Pg 369-370, Introduction).
Semprini further teaches that it has been repeatedly shown that infertility and subfertility are common in HIV-positive women based upon a variety of factors; HIV itself may have an additional impact on fertility, including effects on ovarian reserve (Pg 371, right column, “Fertility in HIV-positive women”).
To summarize, Sette teaches a method of treating HIV via peptide vaccines derived from HIV epitopes, and Semprini teaches infertility can be common in HIV-positive women, which can be overcome in part through ART.
Based on these teachings, regarding claim 10, it would be prima facie obvious to treat HIV-positive women with SEQ ID NO: 14 as an adjuvant therapy in ART. One skilled in the art would be motivated do so in order to treat both the core of the disease as well as the symptoms associated with the disease, such as infertility. One would have a reasonable expectation of success given that Sette teaches treating HIV and Semprini teaches HIV-positive individuals can face infertility challenges requiring ART.
Allowable Subject Matter
A method of treating a medical condition comprising administering SEQ ID NO: 10 is free of the art. The closest art is US20040063917A1 (published 4/1/2004), which teaches erythropoietin (EPO)-derived peptides, such as SEQ ID NO: 4, to treat medical conditions. Compared to the instant SEQ ID NO: 10, SEQ ID NO: 4 has two additional amino acid residues at the N-terminus of its sequence. US20040063917A1 only teaches modification of SEQ ID NO: 4 through general additions, substitutions, or deletions but makes no mention of specifically removing the first two amino acid residues. Although the art recognizes that SEQ ID NO: 4 is derived from the N-terminal portion of EPO, which is capable of engaging its receptors to promote angiogenesis (see, for instance, Figure 1 of Wen et al., Erythropoietin structure-function relationships. Identification of functionally important domains. Journal of Biological Chemistry, 1994; 269, 22839-22846.; and Introduction of Kimáková et al. Erythropoietin and Its Angiogenic Activity. Int. J. Mol. Sci. 2017, 18, 1519.), there is nothing specific in the art that would guide one skilled in the art to select the exact peptide fragment that is the instant SEQ ID NO: 10. For these reasons, the method is novel and non-obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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