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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See paragraphs 4, 77, 392, and 394 of the PG Publication (only one specification filed).
Claim Objections
Claims 1-17 are objected to because of the following informalities: The abbreviation “HR-1” should be spelled out at first occurrence. Appropriate correction is required.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claims 1-4, 7, and 9 recite a natural product. The instant peptide is indistinguishable from a naturally-occurring peptide as evidenced by Watanabe et al. (Vaccines 2023, 11(2), 287; doi.org/10.3390/vaccines11020287) that teach 10 or more consecutive residues of SEQ ID# 5 and 8, see Table 2 epitope 103. A fragment within a longer protein or nucleic acid does not change that is a product of nature. The virus contains a ribonucleic acid that encodes the peptide. For claims 5 and 6, the isolation by severing chemical bonds naturally linking the SARS-CoV-2 peptides from the remainder of the naturally-occurring virus vector or the host cell infected with said vector does not in itself provide a markedly different characteristic from any ASFV peptide and oligonucleotide encoding it found in nature since there are no chemical changes resulting from the isolation. Since an assumption cannot be made that a vector comprises heterologous sequences, a vector comprising a naturally-occurring gene linked to its naturally-occurring promoter reads on the gene and the promoter as they exist in nature (the virus itself). Furthermore, because host cell is not limited in definition or isolated, it includes humans as indicated in the specification of broad consideration of host (see para 1181- “The host is also described as a “subject”. Most preferably, any of the hosts or subjects described or mentioned herein are human individuals.) Therefore, the instant claims recite a natural phenomenon according to Step 2A in MPEP § 2106.04(II).
For claim 8, the carrier molecule is not limited to heterologous or specific molecule. “In some embodiments, the said carrier molecule may be a carrier protein.” )PG Pub 0159) thus the carrier can be the whole native protein.
Similar to the fact pattern described in Myriad, the genetic information or genetic structure of the instant peptide comprising SEQ ID NO: 2 is not created or altered upon isolation from its native environment. Finding or discovering an important structure does not satisfy the §101 inquiry. Isolation by severing chemical bonds naturally linking the instant peptide subunit from the remainder of the naturally-occurring viral protein does not in itself provide a markedly different characteristic from any peptide found in nature since there are no chemical changes resulting from the isolation. Therefore, the instant claims recite a natural phenomenon according to Step 2A in MPEP § 2106.04(II). Accordingly, analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two requires eligibility analysis to evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. The instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the sequences are natural viral sequences. This judicial exception is not integrated into a practical application because it is just the peptide by itself (in claims 1-4, 5, and 7), reads on a virus (claim 5), reads on any cell containing the nucleic acid (claim 6) and naturally linked to a carrier (claim 8). Accordingly, recitation the carrier protein does not integrate the recited judicial exception into a practical application that is patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. -U.S.—(June 13, 2013).
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 11-12 and 15-17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims 11-12 and 15-17 are drawn to treating or preventing SARS-CoV-2 using an HR-1 peptide as claimed.
There is no showing of prevention or treatment in the specification.
The art teaches 10 or more consecutive residues of SEQ ID# 5 and 8, see Table 2 epitope 103 (Watanabe et al., Vaccines 2023, 11(2), 287; doi.org/10.3390/vaccines11020287) that that fail to generate antibodies and fail to be recognized by convalescent serum (Table 2).
Thus, the art shows there is unpredictability with peptides to the HR-1 region including the peptides encompassed by the claims.
Thus, the lack of working examples, lack of guidance in the specification and the prior art, the unpredictability of the art of peptides to HR-1 and the great breadth of the claims greatly reduces the probability that one of skill In the art would successfully obtain the claimed invention without undue experimentation.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
For claim 14, there is no showing that products found will treat or prevent a disease caused by SARS-CoV-2. Vieillard et al. (NPJ Vaccines. 2019 Jun 3;4:25. doi: 10.1038/s41541-019-0117-5) teach that NKp44L is associated with natural killer cells and is a marker in HIV immune responses (Abstract, Introduction, and Discussion). Thus, art does not recognize an association with SARS-CoV-2 or that inhibiting the NKp44L expression treats or prevents a disease caused by SARS-CoV-2. There is no showing in the specification that such compounds found will treat or prevent a disease caused by SARS-CoV-2.
Thus, the lack of working examples, lack of guidance in the specification and the prior art, the unpredictability of the art of peptides to HR-1 and the great breadth of the claims greatly reduces the probability that one of skill in the art would successfully obtain the claimed invention without undue experimentation.
Claim 10 is 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. The claim is drawn the genus of antibodies that bind peptides that are 10 or more residues of SEQ ID# 8.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of antibodies that bind peptides that are 10 or more residues of SEQ ID# 8. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[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.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
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. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe any a representative number of the members of the genus of antibodies that bind peptides that are 10 or more residues of SEQ ID# 8 and thus does not satisfy either the Lilly nor Enzo standards. There are insufficient structural features common to all members of the genus of antibodies. The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus.
Thus, the specification does not provide an adequate written description of the genus of antibodies that bind peptides that are 10 or more residues of SEQ ID# 8 that is required to practice the claimed invention. Applicants have not described the genus of of antibodies that bind peptides that are 10 or more residues of SEQ ID# 8 sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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 1-17 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.
For claims 1-17, the claims use or depend from claims that use the term “derivative” and the term is not specifically defined in the specification. On pages 9-11, various modification are discussed but specific definition is provided (including additions of un-natural aa, D and L aa, conservative substitutions, changes that have the same structure function etc.). It is not clear how derived the peptide can be and still be the peptide and it is not clear if the dependent claims are further limiting.
Claim 14 refers to the disclosure. "Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table 'is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s)).
In this case the whole disclosure is referred to and thus the claim is incomplete. Here the sequences can be referred to as in claims 1-3, for example.
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)(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) 1-2, 7, and 13 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Altin et al. (12247978).
For claims 1-2, Altin et al. teach SEQ ID# 401 that is a peptide that is 10 or more residues of SEQ ID# 2 (see comparison sheet), for claim 7 immunogenic compositions (column 5 lower), and for claim 14 SEQ ID# 401 can detect antibodies (column 3 lower).
Thus, Altin et al. anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671