A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/14/2025 has been entered.
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. Amendment after Final office action filed on 4/14/2025 is acknowledged.
3. Claims 1-14, 17-19, 22, 27, 29 and 30 have been cancelled.
4. New claims 34-37 have been added.
5. Claims 15, 16, 20, 21, 23-26, 28 and 31-37 are pending in this application.
6. Applicant elected without traverse of ATCYCRTGR (SEQ ID NO: 1) as species of peptide or peptidomimetic; human cytomegalovirus as species of virus; and an immuno-compromised subject as species of subject in the reply filed on 7/22/2024.
Restriction requirement was deemed proper and made FINAL in the previous office actions. The instant claims 15, 16, 20, 21, 23-26, 28 and 31-37 are drawn to a method for treatment or inhibition of a cytomegalovirus infection in a subject in need thereof, wherein the method comprises administering a peptide to the subject, and wherein the peptide is 9 to 13 amino acids in length and comprises an amino acid sequence that has at least 80% identity to SEQ ID NO:1 (ATCYCRTGR), wherein the corresponding cysteine and arginine residues of SEQ ID NO:1 are not substituted; a method for the treatment or inhibition of a viral infection in a subject comprising administering a peptide to the subject, wherein the viral infection is caused by a member of Herpesviridae family, and wherein the peptide consists of ATCYCRTGR (SEQ ID NO: 1); and a method for blocking attachment of a viral particle of a member of Herpesviridae family to a host cell, the method comprising administering a peptide consisting of ATCYCRTGR (SEQ ID NO: 1) to a subject in need thereof. 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 15, 31 and 35; and these too appear to be free of prior art. Claims 15, 16, 20, 21, 23-26, 28 and 31-37 are examined on the merits in this office action.
Withdrawn Rejections
7. Rejection to claims 15-21, 23-26, 28 and 31-33 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant's amendment to the claim.
8. Rejection to claims 15-21, 23, 24 and 31-33 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16 and 20 of co-pending Application No. 17/420155 is hereby withdrawn in view of Applicant's amendment to the claim.
Maintained/Revised Objections
9. (Revised due to Applicant’s amendment to the claim) Claim 15 remains objected to for the following minor informality: Applicant is suggested to amend claim 15 as “A method for treatment or inhibition of cytomegalovirus infection…wherein the peptide is 9 to 13 amino acids in length and comprises the amino acid sequence that is at least 80% identical to ATCYCRTGR (SEQ ID NO: 1)…”.
Furthermore, Applicant is required to delete the extra period at the end of instant claim 15.
10. (Revised due to Applicant’s amendment to the claim) Claim 16 remains objected to for the following minor informality: Applicant is suggested to amend claim 16 as “…wherein the peptide comprises the amino acid sequence of ATCYCRTGR (SEQ ID NO: 1)”. In the instant case, since the peptide of instant SEQ ID NO: 1 is 9 amino acids in length, a sequence having at least 90% identity to instant SEQ ID NO: 1 can only be the sequence of instant SEQ ID NO: 1.
11. (Revised due to Applicant’s amendment to the claim) Claim 31 remains objected to for the following minor informality: Applicant is suggested to amend claim 31 as “A method for treatment or inhibition of viral infection in a subject in need thereof, wherein the method comprises administering to the subject a peptide consisting of ATCYCRTGR (SEQ ID NO: 1), and wherein the viral infection is caused by a member of Herpesviridae family”.
12. (Revised due to Applicant’s amendment to the claim) Claim 32 remains objected to for the following minor informality: Applicant is suggested to amend claim 32 as “…wherein the member of the Herpesviridae family is selected from the group consisting of cytomegalovirus (HCMV; HHV-5)…”.
Response to Applicant's Arguments
13. Applicant fails to address all the minor issues in these claims; and Applicant’s amendment to the claim introduces additional minor issues into claims 15 and 16. Therefore, these objections are deemed proper and are hereby maintained.
New Objections
14. Claim 35 is objected to for the following minor informality: Applicant is suggested to amend claim 35 as “A method for blocking attachment of viral particle of a member of Herpesviridae family to a host cell, wherein the method comprises administering a peptide…”.
15. Claim 36 is objected to for the following minor informality: Applicant is suggested to amend claim 36 as “…wherein the member of the Herpesviridae family is selected from the group consisting of…”.
16. Claims 33 and 37 are 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.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
17. 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.
18. (Revised due to Applicant’s amendment to the claim) Claims 31, 32, 35 and 36 remain/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treatment or inhibition of CMV infection in a subject in need thereof and/or a method of blocking attachment of CMV to a host cell in a subject in need thereof with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1, does not reasonably provide enablement for a method for treatment or inhibition of viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or a method of blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell in a subject in need thereof with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner's position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The instant claims 31, 32, 35 and 36 are drawn to a method for the treatment or inhibition of a viral infection in a subject comprising administering a peptide to the subject, wherein the viral infection is caused by a member of Herpesviridae family, and wherein the peptide consists of ATCYCRTGR (SEQ ID NO: 1); and a method for blocking attachment of a viral particle of a member of Herpesviridae family to a host cell, the method comprising administering a peptide consisting of ATCYCRTGR (SEQ ID NO: 1) to a subject in need thereof.
Instant claims 31 and 35 broadly include all member of Herpesviridae; and instant claims 32 and 36 limit the virus to members of Betaherpesviridae.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regards to treatment or inhibition of viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1, the art is unpredictable.
Krummenacher et al (from https://www.ncbi.nlm.nih.gov/books/NBK6257/, 2013, enclosed pages 1-20) teach “All herpesvirus particles consist of an icosahedral capsid which contains the linear DNA genome and is surrounded by layers of tegument proteins…The particle is enveloped by a lipid bilayer acquired from the host cell during egress. The envelope contains a dozen or more viral glycoproteins, several of which play a role in entry…The process is divided into distinct steps: attachment to the cell surface, interaction with a specific entry receptor, internalization of the particle, and membrane fusion.”; and “The attachment glycoproteins vary amongst HV, as do their cell surface ligands. In most cases the attachment protein binds to ubiquitous glycosaminoglycans such as heparan sulfate. These glycoproteins are not essential for entry but this initial interaction tethers the particle to the cell surface, thereby favoring an encounter with a less available entry receptor.”, for example, page 2, Section “STEPS OF HERPESVIRUS ENTRY”; and page 18, Figure 1.
Furthermore, Whitley (Chapter 68 Herpesviruses, cited and enclosed in the previous office actions, from https://www.ncbi.nlm.nih.gov/books/NBK8157/, 1996, pages 1-18) teaches there are more than 100 known herpesviruses; and all herpesviruses can establish latent infection within specific tissues, which are characteristic for each virus, for example, page 1, Section “General Biology of Human Herpesviruses”. Whitley further teaches the characteristics of certain herpesviruses; and states that the glycoproteins in herpesviridae confer distinctive properties to each virus and provide unique antigens to which the host is capable of responding, for example, page 5, Section “Structure”; and pages 5-16, Section “Classification”.
Taken all these together, considering the diversity of Herpesviridae or Betaherpesviridae, one of ordinary skilled in the art would not be able to treat or inhibit viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1.
(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 and (7) The presence or absence of working examples:
With regards to treatment or inhibition of viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1, the instant specification discloses antiviral activity of the peptide of instant SEQ ID NO: 1 against HCMV; and the peptide of instant SEQ ID NO: 1 blocks attachment of HCMV to a host cell.
(8) The quantity of experimentation necessary:
Considering the state of the art regarding viral infection caused by ANY member of Herpesviridae or Betaherpesviridae, attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell, and the function/property of peptide of instant SEQ ID NO: 1, one of ordinary skilled in the art would be burdened with undue experimentation to treat or inhibit viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1.
Response to Applicant's Arguments
19. Applicant argues that “a peptide having SEQ ID. NO 1 "blocks the attachment of viral particles."; and “"entry" and "attachment" are separate steps in the viral cycle.”
20. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner understands that the peptide of instant SEQ ID NO: 1 blocks attachment of HCMV to host cell. The Examiner also understands that "entry" and "attachment" are separate steps in the viral cycle. However, in the instant case, as stated in Section 18 above, there are more than 100 known herpesviruses; and “The attachment glycoproteins vary amongst HV, as do their cell surface ligands. In most cases the attachment protein binds to ubiquitous glycosaminoglycans such as heparan sulfate. These glycoproteins are not essential for entry but this initial interaction tethers the particle to the cell surface, thereby favoring an encounter with a less available entry receptor”. Therefore, in the instant case, considering the state of the art regarding viral infection caused by ANY member of Herpesviridae or Betaherpesviridae, attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell, and the function/property of peptide of instant SEQ ID NO: 1, one of ordinary skilled in the art would be burdened with undue experimentation to treat or inhibit viral infection caused by ALL member of Herpesviridae or Betaherpesviridae and/or blocking attachment of ALL member of Herpesviridae or Betaherpesviridae to a host cell with a peptide consisting of the amino acid sequence of instant SEQ ID NO: 1.
Taken all these together, the rejection is deemed proper and is hereby maintained.
Allowable Subject Matters
21. The methods recited in instant claims 15, 16, 20, 21, 23-26, 28, 33, 34 and 37 are free of prior art. The closest prior art is Wang et al (Journal of Virology, 2013, 87, pages 2835-2845, filed with IDS). Wang et al, throughout the literature, teach a method of treating HSV-2 infection in a mice in need thereof, wherein the method comprises administering to the mice infected with HSV-2 either a chemically synthesized peptide HD5 consisting of the amino acid sequence ATCYCRTGRCATRESLSGVCEISGRLYRL CCR or a chemically synthesized peptide E21R-HD5 consisting of the amino acid sequence ATCYCRTGRCATRESLSGVCRISGRLYRLCCR at a concentration of 10 mg/ml, for example, page 2836, left column, Section “Peptide preparation”, and Figure 1; page 2837, right column, Section “In vivo efficacy studies against HSV-2”; and page 2840, left column, Section “In vivo efficacy studies against HSV-2”. However, Wang et al fail to teach the peptide in the methods recited in instant claims 15, 16, 20, 21, 23-26, 28, 33, 34 and 37. And there is no teaching, motivation, or other type of suggestion to modify the peptides in Wang et al and arrive at the peptide recited in instant claims 15, 16, 20, 21, 23-26, 28, 33, 34 and 37. Therefore, the methods recited in instant claims 15, 16, 20, 21, 23-26, 28, 33, 34 and 37 are both novel and unobvious over the prior arts of record.
Conclusion
Claims 15, 16, 31-33 and 35-37 are objected. Claims 31, 32, 35 and 36 are rejected. Claims 20, 21, 23-26, 28 and 34 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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, Melissa Fisher can be reached on 5712707430. 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.
/LI N KOMATSU/Primary Examiner, Art Unit 1658