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 Non-final office action filed on 10/16/2025 is acknowledged.
3. Claim filed on 10/16/2025 is acknowledged.
4. Claims 1-20 are pending in this application.
5. Applicant elected with traverse of a kit consisting of: a polypeptide derived from a reactive center loop of a serine protease inhibitor with an amino sequence with at least 99% sequence identity SEQ ID NO: 2, instructions of use, a saline solution as the carrier and no additional composition as species of kit; and elected without traverse a subject at risk of or having acquired an immune disorder as species of subject in the reply filed on 6/10/2025. Applicant further elected on the phone that a subject at risk of or has an inflammatory vasculitic syndrome (recited in instant claim 14) as the elected species of subject; and a kit comprising a composition comprising a polypeptide consisting of SEQ ID NO: 2, instructions for use, saline and no additional composition as the elected species of kit on 7/2/2025.
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 1-20 are drawn to a kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder, the kit comprising a composition comprising a polypeptide derived from a reactive center loop of a serine protease inhibitor or a biologically active variant thereof, and instructions of use, wherein the instructions for use indicate that the subject must not have been administered antibiotics within 24 hours prior to administration of the kit composition to preserve therapeutic efficacy. 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 claim 1; and this too appears to be free of prior art. Therefore, the withdrawn claims 7, 10, 13, 15 and 18-20 are hereby rejoined. Claims 1-20 are examined on the merits in this office action.
Application Data Sheet
6. As stated in the previous office action, based on the Requirements for Restriction/Election in US application No. 17/422718, the instant application should be a divisional application of US application No. 17/422718. Applicant is required to update the Application Data Sheet.
Terminal Disclaimer
7. The terminal disclaimers filed on 10/10/2025 and 10/16/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US patent 5686409 A, US patent 5917014 A, US patent 5939525 A, US patent 7285530 B2, US patent 7419670 B2, US patent 7514405 B2, US patent 7745396 B2, US patent 7906483 B2, US patent 10550172 B2, US patent 12029777 B2, US patent 12296066 B2, co-pending Application No. 17/997239, co-pending Application No. 18/844561, co-pending Application No. 18/845915, and co-pending Application No. 19/173750 have been reviewed and are accepted. The terminal disclaimers have been recorded.
Claim Interpretations
8. The instant claim 1 recites “A kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder…”. Since the subject recited in instant claim 1 includes a subject at risk of a viral or immune disorder, for the purpose of this examination and in the broadest reasonable interpretation, the Examiner is interpretating the recited “A kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder” broadly includes preventing a viral or immune disorder. Such interpretation applies to all rejections set forth below.
Withdrawn Objections and Rejections
9. Objection to the specification is hereby withdrawn in view of Applicant's amendment to the specification.
10. Objection to claims 2, 3 and 16 is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claims 1-6, 8, 9, 11, 12, 14, 16 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Lucas (WO 2016/154041 A1), and as evidenced by the Saline solution document (from https://www.biologyonline.com/dictionary/saline-solution, pages 1-8, accessed 9/12/2023) is hereby withdrawn in view of Applicant's amendment to the claim and Applicant’s persuasive arguments.
12. All ODP rejections set forth in the previous office action are hereby withdrawn in view of the terminal disclaimers filed on 10/10/2025 and 10/16/2025.
Maintained/Revised Objections
13. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A kit…immune disorder, wherein the kit comprises a composition comprising a polypeptide derived from a reactive center loop of a serine protease inhibitor or a biologically active variant thereof, and instructions of use; and wherein the instructions for use...”.
14. (Revised due to Applicant’s amendment to the claim) Claim 5 remains objected to for the following minor informality: Applicant is suggested to amend claim 5 as “…5% or 10% dextrose in normal saline (D5NS or D10NS)…”.
Response to Applicant's Arguments
15. Applicant either fails to address all the minor issues or Applicant’s amendment introduces additional minor issues into these claims. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
16. 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.
17. (Revised due to Applicant’s amendment to the claim) Claims 1-14 and 16-20 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 kit for reducing or inhibiting a viral or immune disorder in a subject having acquired a viral or immune disorder, the kit comprising a composition comprising a polypeptide derived from a reactive center loop of a serine protease inhibitor or a biologically active variant thereof, and instructions of use, wherein the instructions for use indicate that the subject must not have been administered antibiotics within 24 hours prior to administration of the kit composition to preserve therapeutic efficacy, does not reasonably provide enablement for a kit for reducing or inhibiting a viral or immune disorder in a subject at risk of a viral or immune disorder, the kit comprising a composition comprising a polypeptide derived from a reactive center loop of a serine protease inhibitor or a biologically active variant thereof, and instructions of use, wherein the instructions for use indicate that the subject must not have been administered antibiotics within 24 hours prior to administration of the kit composition to preserve therapeutic efficacy. 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 1-14 and 16-20 are drawn to a kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder, the kit comprising a composition comprising a polypeptide derived from a reactive center loop of a serine protease inhibitor or a biologically active variant thereof, and instructions of use, wherein the instructions for use indicate that the subject must not have been administered antibiotics within 24 hours prior to administration of the kit composition to preserve therapeutic efficacy.
And as stated in Section 8 above, the Examiner is interpretating the recited “A kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder” broadly includes preventing a viral or immune disorder.
The term “prevent” implies a complete block of getting a viral or immune disorder.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regards to “preventing a viral or immune disorder”, the art is unpredictable.
There are many different types of viral disorder and/or infection. Using COVID-19 as an example, the Coronavirus document (from Cleveland Clinic, 2022, pages 1-8, cited and enclosed in the previous office action) explicitly states that the best defense to prevent getting COVID-19 is to get vaccinated; however, it’s possible to get COVID-19 even if you’ve been vaccinated since no vaccines are 100% effective, for example, page 6, Sections “Can vaccinated people still get COVID-19?” and “How can I keep from getting COVID-19?”. This also applies to other types of viral disorder and/or infection.
Similarly, there are many different types of immune disorder. Using autoimmune disease as an example, the Autoimmune Diseases document (from Cleveland Clinic, 2021, pages 1-10, cited and enclosed in the previous office action) explicitly states that an autoimmune disease is the result of the immune system accidentally attacking your body instead of protecting it, and it's unclear why your immune system does this, for example, page 1, Section “What are autoimmune diseases?”. The Autoimmune Diseases document further states that it may not be possible to prevent autoimmune diseases, for example, page 7, Section “Can autoimmune diseases be prevented?”. Considering the in-complete understanding of the mechanism and development of autoimmune disease, one of ordinary skilled in the art would not be able to complete block an autoimmune disease. This also applies to other types of immune disorder.
(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 “preventing a viral or immune disorder”, the instant specification fails to define it. There is no guidance on “preventing a viral or immune disorder” with instant claimed composition. There is no clear guidance as to how to determine the patient population. A viral or immune disorder can be treated once it is diagnosed; however, it cannot be prevented since the patient population is unknown.
(8) The quantity of experimentation necessary:
Considering the state of the art, and in view of the unpredictable nature of preventing a viral or immune disorder with instant claimed composition, one of ordinary skilled in the art would be burdened with undue experimentation to prevent viral or immune disorder.
Response to Applicant's Arguments
18. Applicant argues that “independent claim 1 is amended herein to recite a kit for "reducing or inhibiting" a viral or immune disorder.”
19. 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 instant claim 1 does not recite the term “preventing’. However, in the instant case, as stated in Section 8 above, the Examiner is interpretating the recited “A kit for reducing or inhibiting a viral or immune disorder in a subject at risk of or has acquired a viral or immune disorder” broadly includes preventing a viral or immune disorder. Therefore, the rejection is deemed proper and is hereby maintained.
New Objections
20. Claim 9 is objected to for the following minor informality: Applicant is suggested to amend claim 9 as “…wherein the herpesvirus infection is gammaherpesvirus (GHV) infection”.
21. Claim 11 contains the acronym “MHV-68”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, murine gammaherpesvirus-68 (MHV-68). The abbreviation can be used thereafter.
22. Claim 13 is objected to for the following minor informality: Claim 13 recites “inflammatory bowel disease, ulcerative colitis, Crohn's disease” and “Buerger's disease (thromboangiitis obliterans)”. However, inflammatory bowel disease includes ulcerative colitis and Crohn's disease only; and Buerger's disease and thromboangiitis obliterans are the same disease. Therefore, Applicant is suggested to amend these recitations as “inflammatory bowel disease” or “ulcerative colitis, Crohn's disease”; and “Buerger's disease” or “thromboangiitis obliterans”.
23. Claim 15 is objected to for the following minor informality: Applicant is suggested to amend claim 15 as “…wherein the subject has acquired a viral or immune disorder; wherein the kit further comprises a composition comprising a drug for treating, inhibiting and/or reducing the viral or immune disorder; and wherein the drug for treating, inhibiting and/or reducing the viral or immune disorder does not comprise an antibiotic”.
24. Claim 20 is objected to for the following minor informality: Applicant is suggested to amend claim 20 as “…wherein the composition for identifying the subject's gut microbiome further detects the presence or absence of SEQ ID NO: 7 and/or SEQ ID NO: 9 in the subject's gut microbiome, and wherein the instructions indicate the subject is not a candidate for using the composition if the presence of bacteria expressing 16S rRNA comprising the sequence of Amplicon Sequence Variant 1 (ASV1) or Amplicon Sequence Variant 123 (ASV123) being detected in the subject's gut microbiota”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (d)
25. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
26. Claim 10 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
27. Claim 10 depends on claim 9; and claim 10 recites “The kit of claim 9, wherein the herpesvirus infection is acute or chronic”. However, the herpesvirus infection can only be either acute or chronic. Therefore, the scope of claim 10 is identical to the scope of claim 9; thus, claim 10 is improper dependent form for failing to further limit the subject matter of claim 9.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is 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 at 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