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 .
DETAILED ACTION
Applicant’s amendment of 22 May 2026, in which claims 1, 9 have been amended, and claim 12 has been cancelled, is acknowledged.
Claims 1-4, 9-11, 13-16 are pending in the application.
Claims 13-16 are withdrawn, as being drawn to a non-elected invention.
Claims 1-4, 9-11 are being examined herewith.
Response to arguments of 22 May 2026
In view of Applicant’s amendment of 22 May 2026, the objection to claim 9 is herein withdrawn.
On 22 May 2026, Applicant has amended independent claim 1 to recite a method of preventing or treating RSV infection in a subject in need thereof comprising altering the gut microbiota of the subject by administering to the subject a composition of at least two short fatty acids selected from acetate, butyrate and propionate, wherein the composition is encapsuled within a nanoparticle.
A modified rejection is made below, based on Applicant’s amendment of 22 May 2026.
Applicant’s arguments (Remarks of 22 May 2026, pages 4-5) against the rejection of claims 1-4, 9-11 under AIA 35 U.S.C. 103 over Antunes, in view of Louis, in further view of Ernst, have been considered.
Applicant argues (page 5, second paragraph) that none of the cited prior art, alone or in combination, teach altering the gut microbiota of the subject by administering a composition comprising at least two short fatty acids.
In response, these arguments are not persuasive. The instant claims are drawn to a method of treating RSV, which includes prophylactic treatment, with a combination of acetate and butyrate, or acetate and propionate or propionate and butyrate. Prior art by Antunes teaches that each of acetate, butyrate or propionate, alone, is effective to treat/prophylactically treat RSV. One of ordinary skill in the art would have reasonably expected that combining acetate and propionate, or acetate and butyrate, or propionate and butyrate, known to be useful for the same purpose, will result in a composition useful for preventing/treating RSV. Since each of acetate, propionate, and butyrate are known to be active ingredients useful in preventing/treating RSV, it is considered prima facie obvious to combine them into a single composition useful for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980). Applicant has not shown unexpected results (better than additive) in treating RSV with a combination of acetate and propionate, or acetate and butyrate, or propionate and butyrate.
Even though Antunes does not specifically teach altering the gut microbiota of the patient in the method of treating RSV with acetate, butyrate, propionate, the ability to alter the gut microbiota in a patient upon oral administration is an inherent property of the short-chain fatty acids acetate, butyrate, propionate. In the instant case, altering the gut microbiota is inherently associated with treatment of RSV by orally administering a composition comprising acetate, butyrate, propionate. Therefore, practicing the method of Antunes would inherently practice the method herein claimed.
Since Antunes teaches oral administration of the very same composition, namely a composition comprising acetate, butyrate, propionate, to the very same patient population, patients suffering from RSV, to treat said patients, said composition, upon oral administration, will elicit the same effect on the gut microbiota in said patients.
While Antunes does not explicitly teach that acetate, propionate, butyrate, alter the gut microbiota in the method of treating RSV, the claimed limitation appears to be a result or property of the oral administration of the effective amount of the short-chain fatty acids acetate, propionate, butyrate. As such, the claimed limitations appear to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For this reason, the rejection is herein maintained, and a modified rejection is made below, based on Applicant’s amendment of 22 May 2026.
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.
Claims 1-4, 9-11 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Antunes et al. (Nature Communications 2019, 10, 3272, p. 1-17, published on line 22 July 2019, cited in IDS), in view of Louis et al. (Environmental Microbiology 2017, 19 (1), 29-41, cited in PTO-892 of 30 July 2025), in further view of Ernst, B. (WO2012/131069, cited in IDS).
Antunes discloses a method of treating RSV infection in a subject in need thereof, comprising administering to the subject a therapeutically amount of short chain fatty acid acetate.
Antunes teaches that oral administration of acetate, which is a short chain fatty acid, resulted in reduction of viral load and pulmonary inflammation in RSV-infected mice (Abstract).
Antunes teaches (page 12, left column, second paragraph under Discussion) prophylactic effect (method of preventing RSV) after oral supplementation with propionate, acetate, or butyrate before RSV infection (sodium acetate, sodium propionate, or sodium butyrate in sterile drinking water at a final concentration of 200 mM for 3 weeks before the RSV infection, page 13, right column, second paragraph). Antunes also teaches beneficial effects when treating mice with acetate by oral route simultaneously with RSV infection and by intranasally 24 h after infection; this latter result indicates that acetate is useful in the treatment of RSV infection in a subject.
Even though Antunes does not specifically teach altering the gut microbiota of the patient in the method of treating RSV with acetate, butyrate, propionate, the ability to alter the gut microbiota in a patient upon oral administration is an inherent property of the short-chain fatty acids acetate, butyrate, propionate. In the instant case, altering the gut microbiota is inherently associated with treatment of RSV by orally administering a composition comprising acetate, butyrate, propionate. Therefore, practicing the method of Antunes would inherently practice the method herein claimed.
Since Antunes teaches oral administration of the very same composition, namely a composition comprising acetate, butyrate, propionate, to the very same patient population, patients suffering from RSV, to treat said patients, said composition, upon administration, will elicit the same effect on the gut microbiota in said patients.
While Antunes does not explicitly teach that acetate, propionate, butyrate, alter the gut microbiota in the method of treating RSV, the claimed limitation appears to be a result or property of the oral administration of the effective amount of the short-chain fatty acids acetate, propionate, butyrate. As such, the claimed limitations appear to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 2-4, even though Antunes does not teach that the short chain fatty acid is produced by Bacteroidetes or Firmicutes, the ability to produce short chain fatty acid propionate, butyrate is a property inherent to Bacteroidetes or Firmicutes, as taught by Louis. Louis teaches (Title) formation of propionate and butyrate by the human colonic microbiota. Louis teaches (Table 1, page 32) that bacteria belonging to the class of Bacteroidetes or Firmicutes have the ability to produce propionate or butyrate.
Antunes does not teach a method of treating /prophylactically treating RSV in a subject in need thereof with a mixture of acetate and butyrate, or acetate and propionate, or butyrate and propionate, as in instant claims 1, 9-11.
Antunes does not teach that the short chain fatty acids acetate, butyrate or propionate, or a mixture thereof, are encapsulated within a nanoparticle, as in instant claims.
Ernst, B. (WO2012/131069) teaches short chain fatty acids (formula (I), page 5), including acetate, propionate (Ernst exemplifies antiviral effect of propionate, Figure 1, page 39), butyrate, used in the treatment of viral infections (page 4, paragraph 8) such as RSV (page 4, paragraph 6).
Ernst teaches (page 32, last paragraph) that the SCFA of the invention are formulated, for example, as liposomal formulations; the SCFA can be incorporated into lipid vesicles; the liposomes can be reduced in size using standard sonication and homogenization techniques (page 32, last paragraph, page 33, first paragraph). Thus, Ernst teaches encapsulation of SCFA of the invention into lipid vesicles.
Ernst teaches (page 34, 4th paragraph) that the SCFA compound of the invention may be encapsuled within a nanoparticle, as in instant claims.
It would have been obvious to a person of ordinary skill in the art to use the teachings of Antunes to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to administer a combination of acetate, propionate, or acetate and butyrate, or propionate and butyrate, in a method of treating RSV, because Antunes teaches a method of treating or prophylactically treating RSV comprising administering to a subject in need thereof a SCFA acetate, butyrate or propionate. One of ordinary skill in the art would have reasonably expected that combining acetate and propionate, or acetate and butyrate, or propionate and butyrate, known to be useful for the same purpose, will result in a composition useful for preventing/treating RSV. Since each of acetate, propionate, and butyrate are known to be active ingredients useful in preventing/treating RSV, it is considered prima facie obvious to combine them into a single composition useful for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Futher, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Antunes and Ernst to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to administer a SCFA such as acetate, propionate, butyrate, encapsulated into a nanoparticle in a method of treating RSV, because Antunes teaches acetate, propionate, butyrate as SCFA effective to treat RSV, and Ernst teaches formulations of SCFA where SCFA may be encapsuled within a nanoparticle, or encapsulated into lipid vesicles, used to treat viral infections, such as, for example, RSV. As such, a person of ordinary skill in the art would have formulated SCFA acetate, propionate, butyrate, by encapsulation within a nanoparticle, or encapsulation into lipid vesicles, with the expectation of seeing therapeutic effect in treating RSV.
As such, claims 1-4, 9-11 are rejected as being prima facie obvious.
Conclusion
Claims 1-4, 9-11 are rejected.
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 IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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