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 .
Status of Claims
Claims 1-9, 13, 16, and 19-21 are pending in the instant application.
Claims 10-12, 14-15, and 17-18 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-7, 9, and 16 under 35 U.S.C. 112(a). This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the objection to Claim 8 on the grounds that it depends from a rejected claim. This objection is hereby withdrawn.
Election/Restrictions
Claims 1-9, 16, and 20 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 13, 19, and 21, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on January 10th, 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 13, 19, and 21 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 treating a subject suffering from an RSV infection, does not reasonably provide enablement for a method for treating a subject susceptible to an RSV infection. 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 use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of treating a subject suffering from or susceptible to an RSV infection.
Breadth of the invention:
The scope of the claimed invention is very broad, as it drawn to the treatment of RSV in anyone that is susceptible to an RSV infection. The broadest reasonable interpretation of who would be considered susceptible to an RSV infection is anyone. The specification does not provide any further clarification on who is intended to be encompassed by the limitation “a subject … susceptible to an RSV infection”. As evidenced by the Mayo Clinic (https://www.mayoclinic.org/diseases-conditions/respiratory-syncytial-virus/symptoms-causes/syc-20353098; obtained from the internet September 18th, 2025; Web Page Dated October 4th, 2023; hereinafter referred to as Mayo Clinic), under “Prevention”, Mayo Clinic states, “Respiratory syncytial virus can infect anyone.”
State of the prior art and predictability in the art:
With regard to treating subjects susceptible to RSV, Wiseman et. al. (“Immunological and Inflammatory Biomarkers of Susceptibility and Severity in Adult Respiratory Syncytial Virus Infections”, The Journal of Infectious Diseases, 2020; hereinafter referred to as Wiseman) represents the state of the art.
At the first page, under “Conclusions”, Wiseman states “Factors determining susceptibility to and severity of RSV disease in adults have not been well defined. Respiratory mucosal antibodies and CD8+ T cells appear to contribute to preventing infection and modulation of disease severity. Studies of RSV pathogenesis in at-risk populations are needed.”
From this, a person having ordinary skill in the art would conclude that treatment of subjects susceptible to RSV is unpredictable, as factors determining susceptibility are not well defined.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 79 of the instant specification, Applicant sufficiently discloses in Example 60 results from an in vitro assay demonstrating the efficacy of the instantly claimed compounds in treating RSV. Subsequent examples sufficiently demonstrate the pharmacokinetic characteristics of the instantly claimed compounds and various pharmaceutical compositions thereof.
No examples have been provided that would instruct a person having ordinary skill in the art to understand the result of the claimed limitation of treating a subject susceptible to RSV, nor is it readily understood from the instant disclosure the intended result of doing so.
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or us ethe full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for treating a subject susceptible to an RSV infection.
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 13, 19, and 21 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.
Claims 13, 19, and 21 are rendered indefinite due to the recitation of the limitation of treating a subject susceptible to an RSV infection. As noted above, anyone is susceptible to an RSV infection, and the instant specification does not provide any guidance that would reasonably allow a person having ordinary skill in the art to understand the metes and bounds of this limitation. Appropriate clarification is required.
Conclusion
Claims 1-9, 16, and 20 are allowable.
Claims 13, 19, and 21 are rejected.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624