DETAILED ACTION
Applicant’s response filed 8/26/2026 has been received and entered into the application file. All arguments have been fully considered. Claims 16, 19-23, 25-28 and 31-33 are currently pending. Claims 1-15, 17-18, 24, and 29-30 are cancelled. Claims 21-23, 25-28 and 31-33 are withdrawn. Claims 16, 19, 21, 22, and 31 are currently amended.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/26/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The corrected drawing sheets submitted 8/26/2026 are in compliance with 37 CFR 1.121(d). Therefore, the previous objection to the drawings is withdrawn.
Specification -Objection
Applicant’s amendment to the specification submitted 8/26/2026 is accepted.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 101
RE: Rejection of Claims 16-20 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more:
Applicant’s arguments submitted 8/26/2026, in view of the cited reference to Yusuf et al, have been carefully considered. It is further noted that, in additional consideration of the teaching of Joudeh et al., (Journal of Nanobiotechnology (2022) 20:262, 29 pages; see PTO-892), specifically noting that nanoparticles have distinct physiochemical properties, as compared to their bulk counterparts (Abstract; page 2 at Why nanomaterials are different), Applicant’s arguments are found persuasive in showing that formulation as nanoparticles provides a markedly different biological and/or pharmacological function to the claimed composition.
Therefore, the previous rejection of record is withdrawn.
Claim Rejections - 35 USC § 102
RE: Rejection of Claim(s) 16 and 20 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bell, as evidenced by Kawai:
The rejection of record is withdrawn in view of Applicant’s amendment submitted 8/26/2026. Applicants have amended claim 16 to recite the short chain fatty acids are butyric acid and propionic acid, and the butyric acid is present at a concentration of at least 40 mM.
However, new grounds of rejection are set forth below specifically addressing the newly amended limitations.
Claim Rejections - 35 USC § 103
RE: Rejection of Claim(s) 17-19 under 35 U.S.C. 103 as being unpatentable over Bell, as evidenced by Kawai:
Claims 17-18 are cancelled.
Claim 19 depends from claim 16. The rejection of claim 19 is withdrawn in view of Applicant’s amendment to claim 16, submitted 8/26/2026. However, new grounds of rejection are set forth below specifically addressing the newly amended limitations.
NEW GROUNDS OF REJECTION, NECESSITATED BY AMENDMENT
Claim(s) 16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al., (W0 2014/003453, previously cited; IDS 5/31/2024) (“Bell”), as evidenced by Kawai et al. ((1995), Breakdown of plastics and polymers by microorganisms. In: Microbial and Enzymatic Bioproducts. Advances in Biochemical Engineering/Biotechnology, vol 52. Springer, Berlin, Heidelberg. https://doi.org/10.1007/BFb0102319, previously cited) (“Kawai”).
Bell is directed to nanoparticle formulations suitable for the delivery of one or more therapeutic agents, the formulations comprising: a cationic cholesterol derivative; a neutral phospholipid; cholesterol or a neutral cholesterol derivative; and a saturated fatty acid, PEGylated neutral derivative of phosphatidylethanolamine or phosphatidylcholine. Bell teaches the nanoparticle formulations are suitable for the treatment of metabolic and oncogenic diseases (Abstract and page 2, lines 5-7).
Regarding claims 16 and 19, it is noted that Example 2 of Bell (pages 21-22) exemplifies the preparation of liposome nanoparticles comprising the short-chain fatty acid acetic acid by combining CDAN, DSPC, cholesterol and DSPE-PEG2000 (PEGylated DSPE, i.e., polymer) to produce a thin film, wherein the thin-film was then re-hydrated with a defined volume of a solution of acetic acid (1M, CH3CO2H, pH 2.0), there after sonicated to produce a lipid dispersion, buffered to pH 7, and purified by dialysis filtration to give a liposome suspension. The liposome encapsulated acetate nanoparticles are referred to as “LITA”.
Therefore, Bell teaches an embodiment of a pharmaceutical composition comprising a nanoparticle, wherein the nanoparticle comprises acetic acid (i.e., a short chain fatty acid) and DSPE-PEG2000 (PEGylated DSPE, i.e., a polymer).
Bell’s Example 2 does not further exemplify the nanoparticle further comprising butyric acid and propionic acid, or wherein butyric acid is present at a concentration of 40 mM, as recited in amended claim 16.
However, Bell clearly teaches that one group of therapeutic agents which are particularly suitable for treating diabetes and obesity, and associated cancers, are the short chain fatty acids acetic acid, propionic acid, butyric acid and/or valeric acid. Bell notes that these four short chain fatty acids have a favorable toxicological profile in humans, as compared to other small molecule therapeutics (page 6, lines 13-22). Thus, Bell clearly suggests nanoparticles comprising a combination of the short chain fatty acids acetic acid, butyric acid and propionic acid.
Hence, Bell does render obvious a pharmaceutical composition comprising nanoparticles, wherein the nanoparticles comprise combinations of short chain fatty acids, specifically including butyric acid, propionic acid and acetic acid, that is, Bell teaches the limitations required by the current claims and as all limitations are found in one reference it is held that nanoparticles comprising butyric acid, propionic acid and acetic acid is within the scope of the teachings of Bell, and thus renders the invention of claims 16 and 19 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to combine butyric acid, propionic acid and acetic acid as the therapeutic agents within the nanoparticle. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Bell.
Further regarding the limitation that the butyric acid is present at a concentration of at least 40 mM, it is noted that Bell’s Example 2 does not further teach butyric acid at a concentration of at least 40 mM. However, Example 2 exemplifies the acetic acid concentration was 1M (i.e., at least 40 mM) and Example 4 teaches acetic acid concentrations of 1 mM, 10 mM, 100 mM and 1M. Bell further teaches the concentration of the one or more therapeutic agents (short chain fatty acids) is in the range of 1 mM to 1M, preferably 50 mM to 2 M (page 13, lines 30-34). Bell’s claim 30 teaches the therapeutic agents (short chain fatty acids) are present at concentrations ranging from 1 mM to 1 M, preferably 50 mM to 2 M (i.e., at least 40 mM).
Hence, Bell does render obvious the concentrations of the short chain fatty acids, e.g., butyric acid, propionic acid and acetic acid, are present at concentrations of at least 40 mM, that is, Bell teaches the limitations required by the current claims and as all limitations are found in one reference it is held that butyric acid concentrations of at least 40 mM is within the scope of the teachings of Bell, and thus renders the invention of claim 16 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to provide butyric acid, propionic acid and acetic acid at concentrations of at least 40 mM. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Bell.
Regarding claim 20, it is noted that Kawai (page 164) discloses the following:
“Since the first report on microbial degradation of PEG 400 by Fincher and Payne [82], extensive studies have been done on a series of PEGs which have different average molecular weights, as shown in Table 3. Thus, PEGs up to 20 000 are thought to be sufficiently biodegradable.”
Therefore, Kawai evidences that the polyethylene glycol (PEG) disclosed by Bell (DSPE-PEG2000) is biodegradable. Thus, Bell’s teaching meets the limitation of claim 20.
Further regarding claim 19, it is noted as set forth above regarding the rejection of claims 16 and 19 that Bell does render obvious the composition comprising more than one short-chain fatty acid, specifically acetate, propionate and butyrate, that is, Bell teaches the limitations required by the current claims and as all limitations are found in one reference it is held that the nanoparticle pharmaceutical composition comprising acetate, propionate and butyrate is within the scope of the teachings of Bell, and thus renders the invention of claim 19 prima facie obvious.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Response to Remarks
Rejections under 35 USC 101 and 102:
As set forth above, the previous rejections of record have been withdrawn.
Rejection under 35 USC 103:
Applicant’s remarks have been carefully considered but are not found persuasive in view of the new grounds of rejection specifically addressing amended claim 16.
Although Bell teaches embodiments wherein the therapeutic agent is acetic acid,
it is noted that “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (MPEP 2123). In the instant case, Bell clearly teaches and suggests the combination of four specific therapeutic short chain fatty acids (page 6, lines 13-22).
Conclusion
No claim is allowed. No claim is free of the prior art.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
