DETAILED ACTION
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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 12 March 2026, in which claims 1-2 and 4-9 are amended to change the scope and breadth of the claim, and claim 3 is canceled.
This application is a domestic application, filed 22 March 2024; claims benefit as a CON of 17/248,465, filed 26 Jan 2021, now abandoned; which claims benefit as a DIV of 16/002,078, filed 07 June 2018, issued as PAT 10987371; which claims benefit of provisional application 62/517,562, filed 09 June 2017.
Claims 1-2 and 4-9 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 12 March 2026, with respect that claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been fully considered and is persuasive, as claim 3 is canceled, amended claims 1-2 do not recite and analogue, and amended claim 1 clarifies the components in the kit.
This rejection has been withdrawn.
Applicant’s amendment, filed 12 March 2026, with respect that claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Antiviral Research, 2010, 88, p227-235, provided by Applicant in IDS filed 22 March 2024) in view of FDA Guidance (FDA Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics, May 1999, 56 pages, provided by Applicant in IDS filed 22 March 2024), and Pandol et al. (US 2004/0063648 A1, published 01 Apr 2004, provided by Applicant in IDS filed 22 March 2024) has been fully considered and is persuasive, as claim 3 is canceled, and amended claim 1 further recites the antiviral agent is selected from the group consisting of ribavirin, lamivudine, and a vaccine. Upon reconsideration, the combined teachings of Kim et al. in view of FDA Guidance and Pandol et al. do not provide guidance for the kit comprising the combination of agents as claimed.
This rejection has been withdrawn.
The following are modified grounds of rejection necessitated by Applicant’s amendment, filed 12 March 2026, in which claims 1-2 and 4-9 are amended to change the scope and breadth of the claim, and claim 3 is canceled.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Amended Claims 1-2 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lines (US 2017/0216246, filed 31 Jan 2017, cited in PTO-892) in view of FDA Guidance (FDA Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics, May 1999, 56 pages, provided by Applicant in IDS filed 22 March 2024).
Lines teaches a method for treating Zika virus infection with a composition containing quercetin or isoquercetin, together with one or more of vitamin B3, vitamin C, and a folate compound (abstract), implying possession of the composition. Zika virus belongs to the Flavivirus genus (page 1, paragraph 3). In some embodiments the compositions are combined with another anti-viral drug as a separate composition or as a single composition (page 1, paragraph 15 to page 2, paragraph 16). In some embodiments, the anti-viral drug is selected from the group including lamivudine and ribavirin (page 2 paragraph 16), addressing limitations of claim 1. The term “quercetin” used therein refers to quercetin aglycon and quercetin derivatives including, but not limited to, quercetin-3-O-glucoside (isoquercetin) and quercetin-3-O-β-D-glucopyranoside (isoquercitrin), addressing limitations of claims 1 and 3. In some embodiments the composition provides about 20 mg to about 5 g or about 100 mg to about 1 g of quercetin per day, such as in the amount of about 20 mg. (page 2, paragraph 21), addressing limitations of claim 2. In some embodiments, the composition may be administered once, twice, thrice, or periodically per day. In some embodiments, the composition of embodiments herein may be administered over a 1, 2, 3, or 4 week period (page 3, paragraph 28), addressing the number of daily doses limitation of claim 2. The composition may be prepared as a pharmaceutical composition for oral or parenteral administration (page 4, paragraph 43), addressing limitations of claims 8-9.
Lines does not specifically disclose a kit comprising the composition and instructions for use (claim 1).
FDA Guidance teaches guidance for industry regarding packaging of drugs. FDA Guidance teaches packaging components include container labels. (page 2, paragraph 4; page 3, paragraph 1) FDA Guidance teaches the label specifies the route of administration, (page 10, paragraph 1) interpreted as instructions for use.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Lines in view of FDA Guidance to formulate the pharmaceutical composition of Lines in the form of a kit based on FDA Guidance, and to select the additional anti-viral drug to be lamivudine or ribavirin. One of ordinary skill in the art would have been motivated to combine Lines in view of FDA Guidance with a reasonable expectation of success because FDA Guidance provides guidance for industry regarding packaging of drugs, and it would have been obvious for the ordinary artisan to follow such guidance. Regarding selection of the additional anti-viral drug to be lamivudine or ribavirin, Lines teaches a finite list of embodiments that are all known for the same purpose as anti-viral drugs, suggesting it would have been obvious to select from the embodiments of anti-viral drug listed in Lines to predictably formulate the composition or kit with a reasonable expectation of success. Regarding the number of doses, for example, Lines teaches the composition administered daily over a 1, 2, 3, or 4 week period, making obvious a number of 7, 14, 21, or 28 doses.
Regarding the descriptive material of (iii) instructions for use recited in instant claim 1, MPEP 2111.05 at I.B. provides "Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864." In this case the claims recite a kit containing chemicals and instructions for using the claimed chemicals, and by the same reasoning the instructions are not related to that particular set of chemicals and no functional relationship exists. In this case, the descriptive material relates to an intended use of a claimed product, and the claims are properly rejected on prior art because there was no new feature of physical structure and no new relation of printed matter to physical structure.
Regarding claims 4-7, the claimed invention is drawn to the kit and not a method of treatment of a disease or host subject. In this case Lines in view of FDA Guidance teaches a pharmaceutical kit making obvious all structural limitations of the claimed kit, such as the amount of the agent and number of doses in the kit, and teaches the anti-viral selected as ribavirin or lamivudine. In this case the particular disease treated or particular host subject treated are related to an intended use of the claimed product, does not structurally limit the kit beyond those structural limitations made obvious by the combined teachings of Lines in view of FDA Guidance.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 March 2026, have been fully considered and not found to be persuasive.
Applicant notes that the amended claim recites “A kit for use in the prevention or treatment of a filovirus hemorrhagic disease” and that Lines teaches a composition for treating Zika virus infection, where Zika virus is not a filovirus. Applicant remarks that a person of skill in the art would have recognized that a treatment for one virus would not automatically treat other viruses. However, in this case the claims are drawn to the manufacture or composition of matter that is “A kit”, and not the process or method of prevention or treatment of a filovirus hemorrhagic disease. This recitation in the preamble is interpreted as describing the intended use of the claimed kit. MPEP 2111.02 provides “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)” Further, MPEP 2111.04 at I. provides “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” In this case prior art teaches a kit that is capable of being used for treating Zika virus infection comprising the same components in the same dosages and amounts as claimed, meaning that the prior art teaches a kit having all of the particular structural features of the claimed kit, even if the intended use was different.
Applicant remarks that the teachings of Lines detailed in the previous rejection were not cited to teach the antiviral agent selected from ribavirin, lamivudine, and a vaccine. However, upon reconsideration, Lines is further cited to teach the other antiviral agent selected to be ribavirin or lamivudine in the modified rejection detailed above. While this section of Lines was broadly cited in the previous rejection, the rejection detailed above is modified in order to particularly address the specificity of the features now claimed.
Conclusion
No claim is found to be allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. 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.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights