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. Responses to Election/Restrictions filed on 6/23/2026 and 8/26/2026 are acknowledged.
4. Claim filed on 8/17/2023 is acknowledged.
5. Claims 5, 8, 12-14, 19, 24, 27 and 29 have been cancelled.
6. Claims 1-4, 6, 7, 9-11, 15-18, 20-23, 25, 26 and 28 are pending in this application.
7. Claims 15-18, 20-23, 25, 26 and 28 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claim 6 is withdrawn from consideration as being drawn to non-elected species.
8. Claims 1-4, 7 and 9-11 are under examination.
Election/Restrictions
9. Applicant’s election without traverse of Group 1 (claims 1-4, 6, 7, 9-11) and election of P16 with the amino acid sequence RGAHIKGRWKSRCHRF that binds to a virus upon contact with the virus as species of antiviral agent; and a composition comprising such peptide for intranasal delivery as species of composition in the replies filed on 6/23/2026 and 8/26/2026 are acknowledged. The requirement is made FINAL in this office action.
Group 1 is drawn to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSRCHRF (SEQ ID NO:1) or a P16-like peptide derived from P16; and a composition comprising a therapeutically effective amount of such antiviral agent and a pharmaceutically acceptable carrier, optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery. A search was conducted on the elected species; and these appear to be free of prior art. A search was extended to the genus in claims 1 and 10; and prior art was found. Claim 6 is withdrawn from consideration as being drawn to non-elected species. Claims 1-4, 7 and 9-11 are examined on the merits in this office action.
Objections
10. The specification is objected to for the following minor informality: There appears to be an improper line break between lines 30 and 31 on page 52 of instant specification. 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).
11. The drawings are objected to for the following minor informality:
Figures 1B, 1C, 1E, 4E and 5A: It is impossible to tell which bar is corresponding to which treatment condition.
Figures 2B-2D: The legend of Y-axis is missing.
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.
12. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “An antiviral agent comprising one or more copies of P16 peptide or a P16-like peptide derived from P16, wherein the P16 peptide consists of the amino acid sequence RGAHIKGRWKSRCHRF (SEQ ID NO:1)”.
13. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…wherein the P16-like peptide is about 15-25 amino acids in length and/or comprises the amino acid sequence that is at least 75% identical to the amino acid sequence of SEQ ID NO:1”.
14. Claim 3 is objected to for the following minor informality: Applicant is suggested to amend claim 3 as “…wherein the P16 or P16-like peptide has a net positive charge of at least 1”.
15. Claim 4 is objected to for the following minor informality: Applicant is suggested to amend claim 4 as “…wherein the P16 or P16-like peptide has a net positive charge of at least about 6.1”.
16. Claim 7 is objected to for the following minor informality: Applicant is suggested to amend claim 7 as “…or combinations thereof, and wherein the contacting occurs…”.
17. Claim 9 is objected to for the following minor informality: Applicant is suggested to amend claim 9 as “The antiviral agent of claim 1, wherein the antiviral agent consists of the amino acid sequence of SEQ ID NO: 1”.
Furthermore, claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
18. 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.
19. Claims 1, 3, 4, 10 and 11 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 pre-AIA the applicant regards as the invention.
20. Claim 1 recites the limitation “P16-like peptide derived from P16”. With regards to the term “P16-like peptide derived from P16”, the instant specification fails to define it. Therefore, it is unclear what is encompassed within the recited “P16-like peptide derived from P16”. Thus, the metes and bounds of instant claim 1 is vague and indefinite. Because claims 10 and 11 depend from indefinite claim 1 and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Furthermore, for the purpose of this examination and in the broadest reasonable interpretation, the Examiner is interpretating any antiviral peptide is a “P16-like peptide derived from P16” recited in instant claim 1. Such interpretation applies to all the rejections set forth below.
21. Claim 3 recites the limitation “wherein the P16 or P16-like peptide has a net positive charge of at least 1, 2, 3, 4, 5 or 6”; and claim 4 recites the limitation “wherein the P16 or P16-like peptide has a net positive charge of at least 6 and/or about 6.1”. With regards to the net positive charge of any compound, including peptide, it is well known in the art that the net positive charge of any compound depends on both the structure and the pH. Therefore, it is unclear what is encompassed within the recited “wherein the P16 or P16-like peptide has a net positive charge of at least 1, 2, 3, 4, 5 or 6” and/or “wherein the P16 or P16-like peptide has a net positive charge of at least 6 and/or about 6.1”. Thus, the metes and bounds of instant claim 3 or 4 is vague and indefinite.
Furthermore, for the purpose of this examination and in the broadest reasonable interpretation, the Examiner is interpretating any antiviral peptide that has a number which the number of positive charged amino acids minus the number of negative charged amino acids above 1 or above about 6.1 meets the limitations of the antiviral agent recited in instant claim 3 or 4. Such interpretation applies to all the ejections set forth below.
22. Claim 10 recites the limitation “optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery”; and claim 11 recites the limitation “optionally, wherein the unit dosage form is selected from the group consisting of a table or capsule, or the unit dosage form is an injectable, wherein the composition further comprises a pharmaceutically acceptable carrier for injection to a human”. In the instant case, it appears such recitations are preferred embodiments. Therefore, the metes and bounds of instant claim 10 or 11 is vague and indefinite.
Furthermore, for the purpose of this examination and in the broadest reasonable interpretation, the Examiner is interpretating such recitation does not further limit the composition recited in instant claim 10 or 11. Such interpretation applies to all the rejections set forth below.
Claim Rejections - 35 U.S.C. § 101
23. 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.
24. Claims 1-4, 7, 10 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-4, 7, 10 and 11 are directed to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSRCHRF (SEQ ID NO:1) or a P16-like peptide derived from P16; and a composition comprising a therapeutically effective amount of such antiviral agent and a pharmaceutically acceptable carrier, optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery.
As evidenced by Urmi et al (Peptides, 2023, 166, pages 1-15), the antiviral agent recited in instant claims 1-4, 7, 10 and 11 can be either a naturally occurring peptide or a fragment of naturally occurring peptide, such as indolicidin, apelin-12, apelin-13, apelin-17, apelin-36 and many others, for example, page 4, Table 1; and page 5, Table 2.
In the broadest reasonable interpretation, water is a pharmaceutically acceptable carrier recited in instant claim 10. And as evidenced by the Water document (2014, from http://www.biology-online.org/dictionary/Water, enclosed pages 1-3), water is a natural product.
The instant claims 1-4, 7, 10 and 11 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed antiviral agent and composition in instant claims 1-4, 7, 10 and 11 do not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed antiviral agent and composition in instant claims 1-4, 7, 10 and 11 do not recite meaningful limitations that add something of significance to the judicial exception. Therefore, the claimed antiviral agent and composition in instant claims 1-4, 7, 10 and 11 are not significantly different than a judicial exception (natural product).
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
25. 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.
26. Claims 1-4, 7, 10 and 11 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 1-4, 7, 10 and 11 are drawn to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSRCHRF (SEQ ID NO:1) or a P16-like peptide derived from P16; and a composition comprising a therapeutically effective amount of such antiviral agent and a pharmaceutically acceptable carrier, optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery.
With regards to the recited “P16-like peptide derived from P16”, the instant specification fails to define it.
The genus of instant claimed “P16-like peptide derived from P16” is extremely broad, including any possible peptide/protein.
The instant specification discloses P16 peptide of instant SEQ ID NO: 1 inhibits influenza A(H1N1), influenza A(H3N2), influenza B and SARS-CoV-2 virus infections. The instant specification further discloses Urumin (SEQ ID NO: 2) and its variants U1-U5 (SEQ ID NOs: 3-5); and Urumin, U4 and U5 exhibits antiviral effect against influenza A(H1N1) virus infection. Urumin (instant SEQ ID NO: 2) and U5 (instant SEQ ID NO: 4) comprises the amino acid sequence that is 75% identical to P16 of instant SEQ ID NO: 1.
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 P16-like peptide derived from P16 to have the functional characteristics of being an antiviral agent.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, with regards to the recited “P16-like peptide derived from P16”, the instant specification fails to define it.
The instant specification discloses P16 peptide of instant SEQ ID NO: 1 inhibits influenza A(H1N1), influenza A(H3N2), influenza B and SARS-CoV-2 virus infections. The instant specification further discloses Urumin (SEQ ID NO: 2) and its variants U1-U5 (SEQ ID NOs: 3-5); and Urumin, U4 and U5 exhibits antiviral effect against influenza A(H1N1) virus infection. Urumin (instant SEQ ID NO: 2) and U5 (instant SEQ ID NO: 4) comprises the amino acid sequence that is 75% identical to P16 of instant SEQ ID NO: 1, as shown below with Qy being instant SEQ ID NO: 1, and Db being Urumin or U5:
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.
Taken all these together, other than the limited examples, the instant specification fails to describe a general correlation between structure and function for the instant claimed P16-like peptide derived from P16 to have the functional characteristics of being an antiviral agent.
(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 instant claimed P16-like peptide derived from P16 to have the functional characteristics of being an antiviral agent.
With regards to the instant claimed P16-like peptide derived from P16 to have the functional characteristics of being an antiviral agent:
First, the Examiner would like to point out that there are many types of virus, as indicated in the Human Viruses document (from https://viralzone.expasy.org/678, 2026, pages 1-32) and many others.
Second, Jacob et al (US 2019/0367567 A1), throughout the patent, teach certain peptides are useful for managing certain viral infections; and Urumin treatment significantly reduces titers of H1N1 and H1N2 influenza viruses, while the H3N1 and H3N2 influenza viruses are unaffected, which indicates the Urumin peptide inhibits influenza viruses that bear H1 HA but not H3 HA, or N1/N2 NA, for example, Abstract; Figure 4B; and page 10, paragraph [0101]. Jacob et al further teach Urumin variants of peptide # 1-3, 12 and 19-23 exhibit less or no antiviral activity, in comparison to Urumin, for example, Figures 2A, 3A and 5A. The Urumin variants of peptide # 1-3, 12 and 19-23 in Jacob et al comprise the amino acid sequence that is 75% identical to the amino acid sequence of P16 peptide of instant SEQ ID NO: 1.
Furthermore, it is well known in the peptide/protein art that even single amino acid changes or differences in the amino acid sequence of a protein/peptide can have dramatic effects on the protein/peptide’s function and/or properties. As an example of the unpredictable effects of mutations on protein/peptide’s function and/or properties, Drumm et al (Annu. Rev. Pathol. Mech. Dis., 2012, 7, pages 267-282) teach cystic fibrosis is an autosomal recessive disorder caused by mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene, for example, page 268, Section “CYSTIC FIBROSIS”. Drumm et al further teach several mutations can cause cystic fibrosis, including two mutations G551D and G551S; and clinical consequences are quite different for these two changes, as the G551D variant has virtually no detectable activity, and consequently a classic, severe phenotype is associated; G551S, however, has reduced but clearly detectable function and is associated with a much milder presentation of CF, for example page 269, left column, the last paragraph. Drumm et al also teach that in the most common cystic fibrosis mutation ΔF508 (the absence of amino acid 508 of the normally 1,480-amino acid protein) gives rise to the cystic fibrosis phenotype, for example, page 268, right column, the 2nd paragraph. Thus, even the substitution or deletion of a single amino acid can have dramatic and unpredictable effects on the function of the protein/peptide. The unpredictability of the effect of amino acid substitution on the function and/or property of peptide/protein is further confirmed and discussed in Yampolsky et al (Genetics, 2005, 170, pages 1459-1472). Yampolsky et al teach even conservative substitution can significantly affect the function of the protein/peptide, for example, page 1465, Table 3. Although the disclosures of Drumm et al and Yampolsky et al are directed to proteins/peptides other than an antiviral agent/peptide, they illustrate the inherent unpredictability with respect to the function and/or property of a given protein/peptide after even minor changes to the primary amino acid sequence.
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 instant claimed P16-like peptide derived from P16 to have the functional characteristics of being an antiviral agent.
(d) representative number of samples:
In the instant case, with regards to the recited “P16-like peptide derived from P16”, the instant specification fails to define it. The genus of instant claimed “P16-like peptide derived from P16” is extremely broad, including any possible peptide/protein.
And, as discussed in (a) and (b) above, the instant specification discloses P16 peptide of instant SEQ ID NO: 1 inhibits influenza A(H1N1), influenza A(H3N2), influenza B and SARS-CoV-2 virus infections. The instant specification further discloses Urumin (SEQ ID NO: 2) and its variants U1-U5 (SEQ ID NOs: 3-5); and Urumin, U4 and U5 exhibits antiviral effect against influenza A(H1N1) virus infection. Urumin (instant SEQ ID NO: 2) and U5 (instant SEQ ID NO: 4) comprises the amino acid sequence that is 75% identical to P16 of instant SEQ ID NO: 1.
Considering the broadness of the genus of instant claimed P16-like peptide derived from P16, the instant specification fails to provide sufficient examples to describe the entire genus of P16-like peptide derived from P16 being an antiviral agent 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 P16-like peptide derived from P16 being an antiviral agent 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. § 102(a)(1)
27. 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.
28. Claims 1-3, 7, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacob et al (US 2019/0367567 A1).
The instant claims 1-3, 7, 10 and 11 are drawn to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSR CHRF (SEQ ID NO:1) or a P16-like peptide derived from P16; and a composition comprising a therapeutically effective amount of such antiviral agent and a pharmaceutically acceptable carrier, optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery.
Jacob et al, throughout the patent, teach Urumin as an antiviral agent against certain type of influenza viruses, wherein Urumin binds to the conserved stalk region of H1 HA to inhibit influenza viruses, and wherein Urumin comprises the amino acid sequence IPLRGAFINGRWDSQCHRFSNGAIA CA (SEQ ID NO: 1), for example, Abstract; Figures 2A, 4A, 4B, 5A and 5B; and page 10, paragraphs [0101]-[0103]. Urumin in Jacob et al is 27 amino acids in length and comprises the amino acid sequence that is 75% identical to the P16 peptide of instant SEQ ID NO: 1, as shown below with Qy being instant SEQ ID NO: 1, and Db being Urumin:
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. It meets the limitations of the antiviral agent recited in instant claims 1-3 and 7. Jacob et al further teach a pharmaceutical composition comprising a therapeutically effective amount of Urumin and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is used for intranasal administration, and wherein the pharmaceutical composition can be a unit dose form, for example, Figure 6; and page 7, paragraphs [0072]-[0075]. It meets the limitations of instant claims 10 and 11.
Since the reference teaches all the limitations of instant claims 1-3, 7, 10 and 11; the reference anticipates instant claims 1-3, 7, 10 and 11.
29. Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zou et al (FEBS Letters, 2000, 473, pages 15-18), and as evidenced by Urmi et al (Peptides, 2023, 166, pages 1-15).
The instant claims 1-4 and 7 are drawn to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSRCHRF (SEQ ID NO:1) or a P16-like peptide derived from P16.
Zou et al teach apelin-36, apelin-17, apelin-13 and apelin-12 are antiviral agents that block infection of target cells by HIV, for example, Abstract; page 16, Figure 2; and pages 16-17, Section “3.3. Blocking of HIV infection by apelin peptides”; and page 17, Table 1. And as evidenced by Urmi et al, apelin-36 has a net positive charge of 10; apelin-17 has a net positive charge of 6; and apelin-13 or apelin-12 has a net positive charge of 3 (see page 5, Table 2). Therefore, apelin-36 in Zou et al meets the limitations of the antiviral agent recited in instant claims 1, 3, 4 and 7; apelin-17 in Zou et al meets the limitations of the antiviral agent recited in instant claims 1-4 and 7; apelin-13 in Zou et al meets the limitations of the antiviral agent recited in instant claims 1-3 and 7; and apelin-12 in Zou et al meets the limitations of the antiviral agent recited in instant claims 1, 3 and 7,
Since the reference teaches all the limitations of instant claims 1-4 and 7; the reference anticipates instant claims 1-4 and 7.
Obviousness Double Patenting
30. 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.
31. Claims 1, 3, 4, 7 and 10 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 5 ang 9-13 of US patent 9464123 B2.
32. Instant claims 1, 3, 4, 7 and 10 are drawn to an antiviral agent comprising one or more copies of P16 comprising the amino acid sequence of RGAHIKGRWKSRCHRF (SEQ ID NO:1) or a P16-like peptide derived from P16; and a composition comprising a therapeutically effective amount of such antiviral agent and a pharmaceutically acceptable carrier, optionally, wherein the composition is in a form suitable for intranasal or pulmonary delivery.
33. Claims 1, 2, 5 ang 9-13 of US patent 9464123 B2 are drawn to a peptide synthesized through a chemical route or by a genetic engineering process, characterized in that the peptide has a functional domain capable of binding to a surface glycoprotein of a respiratory virus and has an activity of inhibiting infection of the respiratory virus, wherein the peptide has 5 or more basic amino acids among which 2 or more basic amino acids are in N-terminal region or C-terminal region of the peptide; and wherein the N-terminal region comprises a sequence of no more than 10 amino acids counting from the N-terminal amino acid of the peptide, and the C-terminal region comprises a sequence of no more than 10 amino acids counting from the C-terminal
amino acid of the peptide; and wherein the peptide consists of an amino acid sequence that is at least 90% identical to SEQ ID NO: 10; a composition comprising such peptide and a pharmaceutically acceptable excipient; a method of blocking infection of a respiratory virus in a target cell with such peptide; and a method of therapeutically treating a subject infected by a respiratory virus with such peptide.
Peptide of SEQ ID NO: 10 recited in claims of US patent 9464123 B2 is a P16-like peptide derived from P16 recited in instant claims 1, 3, 4 and 7.
34. For the same/similar reasoning and/or rational as the rejection set forth in Sections 31-33 above, instant claims 1, 3, 4, 7 and 10 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US patent 9822155 B2.
35. For the same/similar reasoning and/or rational as the rejection set forth in Sections 31-33 above, instant claims 1, 3, 4, 7, 10 and 11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US patent 12472231 B2 (filed with IDS).
36. For the same/similar reasoning and/or rational as the rejection set forth in Sections 31-33 above, instant claims 1, 3, 4, 7, 10 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11, 16-19, 22-26 and 28-32 of co-pending application No. 18/249926; and claims 1-20 of co-pending application No. 18/735027.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
37. For the same/similar reasoning and/or rational as the rejection set forth in Sections 31-33 above, instant claims 1-4, 7, 10 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 6, 8, 9, 11, 14, 18-24, 26-29, 33, 34, 36 and 39 of co-pending application No. 18/724569.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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