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 .
DETAILED ACTION
Response to Election/Restriction filed on July 16, 2026 is acknowledged. Claims 1-15 were canceled and claims 16-28 were newly added. Claims 16-28 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group I (claims 16-18, 25-26) drawn to a polypeptide in the reply filed July 16, 2026. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.03(a)).
The restriction is deemed proper and is made FINAL in this office action. Claims 19-24, 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Claims 16-18 and 25-26 are examined on the merits of this office action.
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 therefore, subject to the conditions and requirements of this title.
Claims 16-17, 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, Claims 16-17, 25-26 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on MPEP2106.03-MPEP2106.05.
Claim Interpretation
Claim 16 claims “A polypeptide against novel coronavirus, which is any one selected from the group consisting of polypeptides selected from SEQ ID Nos:1-6”. Claims 25-26 are drawn pharmaceutical formulations thereof including an excipient and further oral preparation (see claims 25-26).
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see MPEP
2106.03)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea
(see 2106.04)?
Yes, the claims are directed to a natural phenomenon, namely a naturally-occurring spike protein peptides (see attached handout). For example, SEQ ID NO:3 is a fragment of a naturally occurring spike glycoprotein (Uniprot Protein Accession number A0A0U1WJY8_SARS, see attached handout),
Accordingly, the pending claims are directed to naturally occurring peptides and pharmaceutical formulations thereof.
As the product is found in nature, consideration is given to whether it is integrated into a practical application or contains other elements that provide a marked difference as compared to the natural counterpart.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application? (see MPEP 2106.04 (d)) NO. This judicial exception is not integrated into a practical application because it does not provide a treatment that affirmatively recites an action that effects a particular treatment for a disease or medical condition. The limitation of an intended use “..against novel coronavirus…” is not an active method step and thus does not meet the integration into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see MPEP 2106.05))?
No, the claim does not recite additional elements that amount to significantly more than the judicial exception, as explained below. Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in MPEP 2106. Instant claims 25-26 are drawn to a pharmaceutical formulation. Given the broadest reasonable interpretation, this could be water in combination with the peptide which is naturally occurring and there is no evidence that the combination of the peptide and water results in a different property or function of the peptide. The peptide of the instant claims (and in combination with water which also meets an oral preparation) does not amount to significantly more than the exception.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 16-17, 25-26 do not qualify as eligible subject matter.
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 16-18, 25-26 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 16 recites “a polypeptide against novel coronavirus…”. The metes and bounds of the limitation “against novel coronavirus” are unclear. First, it is unclear what is encompassed by the term “novel coronavirus”. The claims does not identify the coronavirus or otherwise provide an objective boundary for determining which coronaviruses are encompassed by the term. Although the specification states “preferably, the novel coronavirus is a SARS-CoV-2 original strain and/or SARS-CoV-2 variant and or sarbecovirus” ( see e.g. paragraphs 0032-0035), the use of “preferably” identifies preferred embodiments rather than establishing the limits of the term. The specification further refers to “new variant strains that will appear in the future and the sarbecovirus” (see paragraph 0037). Thus, it is unclear whether “novel coronavirus” is limited to SARS-CoV-2 and the specifically disclosed variants, encompasses future SARS-CoV-2 variants and other sarbecoviruses, or encompasses additional coronaviruses. In addition, the term “against” does not provide an objective boundary for determining what relationship or activity between the recited polypeptide and the “novel coronavirus” is required by the claim. Claim 16 does not specify whether against requires binding, inhibition of viral infection or replication, neutralizing activity, or some other activity, nor does the claim recite a measurable degree or threshold of activity sufficient to satisfy the limitation. Taken as a whole, when claim 16 is read in light of the specification, the scope of the phrase “a polypeptide against novel coronavirus” cannot be determined with reasonable certainty. Claims 17-18 and 25-26 are also rejected due to their dependence on claim 16 and not clarifying these points of confusion.
Regarding claim 18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 26, the phrase "preferably" in lines 4-6 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 16-18 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tripet (WO2005077103 A2, cited in Applicant’s IDS).
Regarding claims 16-17, Tripet teaches a coronavirus polypeptide inhibitor comprising a peptide comprising instant SEQ ID NO:3 (see claims 1-2, 5; SEQ ID NO:40). Regarding claims 25-26, Tripet teaches use of the peptides in pharmaceutical formulations (see paragraph 0210) with a pharmaceutical acceptable carrier and as an oral preparation (see paragraph 0210). Regarding claim 18, Tripet teaches conjugation of the peptide to a carrier protein (see paragraph 0190) and in particular, a diphtheria toxin thus meeting the limitations of instant claim 18.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-18 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No.18/756768 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims A peptide against a novel coronavirus comprising one of SEQ ID Nos:1-6; conjugation to a carrier protein (claim 18); pharmaceutical formulations thereof including for oral use (claims 25-26).
Co-pending AN 18/756768 an anti-coronavirus peptide comprising instant SEQ ID NO:3 (see claim 1, SEQ ID NO:2 is identical); use in a pharmaceutical formulation and in particular oral form (see claims 12-13); conjugates of the peptide (claim 13). Co-pending AN 18/756768 is silent to a carrier protein conjugate. However, Tripet teaches a coronavirus polypeptide inhibitor comprising a peptide comprising instant SEQ ID NO:3 (see claims 1-2, 5; SEQ ID NO:40). Tripet teaches use of the peptides in pharmaceutical formulations (see paragraph 0210) with a pharmaceutical acceptable carrier and as an oral preparation (see paragraph 0210). Tripet teaches conjugation of the peptide to a carrier protein (see paragraph 0190) . It would have been obvious before the effective filing date of the claimed invention to conjugate the therapeutic anti covid protein of the copending application to a carrier protein to enhance stability and increase immunogenicity. One of ordinary sill in the art would have reasonably expected such conjugation to improve or prolong immune response.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16-18 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No.19/765990 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims A peptide against a novel coronavirus comprising one of SEQ ID Nos:1-6; conjugation to a carrier protein (claim 18); pharmaceutical formulations thereof including for oral use (claims 25-26).
Co-pending AN 19/765990 claims a peptide for treating coronavirus infections comprising instant SEQ ID NO:1 (see claim 1, claims 6-7); use in a pharmaceutical formulation and in particular in a spray (see claims 8, claims 22-23); conjugates of the peptide (claim 1). Co-pending AN 19/765900 is silent to a carrier protein conjugate and sequences in claim 17 (which are variants of instant SEQ ID NO:1). However, Tripet teaches a coronavirus polypeptide inhibitor comprising a peptide comprising instant SEQ ID NO:3 (see claims 1-2, 5; SEQ ID NO:40). Tripet teaches use of the peptides in pharmaceutical formulations (see paragraph 0210) with a pharmaceutical acceptable carrier and as an oral preparation (see paragraph 0210). Tripet teaches conjugation of the peptide to a carrier protein (see paragraph 0190) . It would have been obvious before the effective filing date of the claimed invention to conjugate the therapeutic anti covid protein of the copending application to a carrier protein to enhance stability and increase immunogenicity. One of ordinary sill in the art would have reasonably expected such conjugation to improve or prolong immune response. Furthermore, it would have been obvious before the effective filing date of the claimed invention to use the same peptides of Tripet interchangeably with the peptide of the copending application as they are structurally very similar and have the same intended use/function of inhibiting coronaviruses.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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