DETAILED ACTION
Claims 16-23, and 25-33 are currently pending. Claims 1-15 and 24 are cancelled.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 16-21), and Group I species butyric acid (claim 17), in the reply filed on 10/23/2025 is acknowledged.
Claims 21-23, and 25-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/23/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/31/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” View numbers must be preceded by the abbreviation “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification -Objection
The use of the terms Qiagen®, RNeasy® Mini Kit, and Synbiotic2000™, for example, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized (e.g., QIAGEN®) wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) short-chain fatty acids in combination with a polymer.
The rationale set forth below conforms to current Office practice for examination of claims under § 101.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition (Step 1: YES).
The next part of the analysis involves whether the claimed invention recites or is directed to one or more judicial exceptions (Step 2A, prong one).
Claim 1: Claim 1 is directed to a pharmaceutical composition comprising a nanoparticle, wherein the nanoparticle comprises:
Short-chain fatty acids or pharmaceutically acceptable salts thereof; and
A polymer.
As is indicated by the instant specification (page 3), the short-chain fatty acids include acetic acid, propionic acid, butyric acid and lactic acid, for example, and as recognized by the instant specification (page 34), lactic acid is produced by naturally occurring Lactobacillus probiotics. Additionally, Cummings et al., (see PTO-892) teaches short-chain fatty acids occur naturally in the human gut and specifically include acetic, propionic and butyric acids (Summary and page 1221, left col).
Further, regarding the recited polymer, it is noted the claims as currently drafted encompass any pharmaceutically acceptable (biocompatible) polymer, including naturally occurring protein polymers, e.g., collagen, or naturally occurring polysaccharide polymers e.g., cellulose. Thus, the claim recites a combination of natural products.
Although the claim recites the nanoparticle comprises the short-chain fatty acid and polymer, it is noted the claim as currently drafted does not recite any specificity as to the nanoparticle, such as imparting a markedly different time release property, and thus merely indicates the size of the formulation.
Therefore, the claim as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than the natural short-chain fatty acid, in combination with a naturally occurring polymer, e.g., collagen or cellulose. There is no indication in the specification that, in combining the short-chain fatty acid with the recited polymer, that any characteristics (structural, functional, or otherwise) are developed by either the short-chain fatty acid or the polymer that are not present in the individual parts. The combination does not improve or change in any way each components natural functioning. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES). Thus, the claim does not qualify as eligible subject matter, and is rejected under 35 U.S.C. 101.
Claims 17-19: Claims 17-19 depend directly from claim 16 and further define the types of short-chain fatty acid, e.g., butyric, propionic, acetic. For the reasons discussed above, regarding the short-chain fatty acids, these limitations do not limit the claimed composition in such a way that is markedly different in structure or biological and/or pharmacological function from their natural counterparts.
Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
Regarding claim 20, claim 20 depends directly from claim 16 and further defines the polymer is biodegradable. For the reasons discussed above, regarding the recited polymer, this limitation does not limit the claimed composition in such a way that is markedly different in structure or biological and/or pharmacological function from their natural counterpart such as collagen or cellulose.
Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
The next part of the analysis involves whether the claimed invention recites additional elements that integrate the judicial exception into a practical application (Step 2A, prong two).
Given the claims are directed to a composition, the claims do not recite additional steps that integrate the judicial exception into a practical application (Step 2A, prong two: No).
The final part of the analysis involves whether the claimed invention, as a whole, recites something “significantly more” than the judicial exceptions (Step 2B).
In view of the above and considered as a whole, the claimed composition does not have markedly different characteristics from what occurs in nature and such elements discussed above are not significantly more than the indicated judicial exceptions. Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101 (Step 2B: NO).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bell et al., (W0 2014/003453; 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; see PTO-892) (“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 claim 16, 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 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), thus anticipating claim 16.
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 anticipates claim 20.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bell, as evidenced by Kawai, as applied to claims 16 and 20 above.
Bell, in view of Kawai, anticipates claims 16 and 20.
Regarding claims 17-19, it is noted that Bell’s Example 2 does not exemplify the nanoparticle further comprising butyric acid (claim 17), or further comprising butyric acid and propionic acid (claim 18), or further comprising the combination of acetic acid, butyric acid and propionic acid (claim 19). However, Bell (page 5, lines 22-23) teaches the nanoparticle composition may comprise more than one therapeutic gent and Bell, at page 6 (lines 13-22), specifically teaches that acetate, propionate and butyrate are favored as the therapeutic short-chain fatty acids.
Thus, 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 claims 17-19 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to include all three short-chain fatty acids in the nanoparticle composition. 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.
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).
Conclusion
No claim is allowed. No claim is free of the prior art.
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