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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 03/01/2024.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 03/01/2024 and 12/22/2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings are objected to because the pages are not numbered, which would follow MPEP guidelines. 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 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.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products “a cell-free composition, comprising biomolecules extracted from a fruit together with at least one carrier, excipient or diluent, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants because the claims are directed to biomolecules extracted from plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
The claims also broadly recite a diluent or carrier which with the broadest reasonable interpretation can simply be water which is another judicial exception that can be found in the same plant from which the biomolecules come from.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant merely claims the judicial exceptions without any other limitations except that the biomolecules exert some specific property. Those properties are natural activities of the biomolecules and nothing has been done to alter them in any way to afford them some change in structure or function.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
There are no other additional elements to consider that are sufficient to amount to significantly more than the judicial exceptions.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
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.
Claims 1-3, 5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azeddine Si Ammour et. al. (WO 2015166060 A1).
Regarding claims 1-3, Ammour describes plant extracts comprising of sRNAs for use as immunosuppressive agents (see claim 1), and wherein the sRNA is miRNA (see claim 4), and wherein the plant extracted components are from fruit such as strawberry and blueberries (see claim 5 and claim 6). Ammour describes “in a preferred embodiment, the pharmaceutical composition comprises at least one plant miRNA or plant sRNA extract, or a composition comprising 2 or more plant sRNA extracts and at least one carrier” (see page 24, lines 26-29). Ammour does not require cells to be in the composition as the composition is directed to biomolecules such as miRNAs from the fruits of plants as just described.
Regarding claims 5 and 7, Ammour describes the invention for treating skin inflammatory diseases such as psoriasis, atopic dermatitis, eczema, rosacea, urticaria and acne (see page 16, line 5) and when considered with the broadest reasonable interpretation these are considered cosmetical as the treatments would improve the appearance of the skin.
Regarding claims 7-9, pertaining to the limitation wherein the composition is used for anti-inflammatory, antioxidant and anti-aging purposes, these are intended uses of the composition and do not functionally or structurally change the components of the composition itself. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the prior art meets the limitations and meets the claims requirements.
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Azeddine Si Ammour et. al. (WO 2015166060 A1) and Huang-Ge-Zhang (WO2020180801A1).
Regarding claims 1-3, Ammour describes plant extracts comprising of sRNAs for use as immunosuppressive agents (see claim 1), and wherein the sRNA is miRNA (see claim 4), and wherein the plant extracted components are from fruit such as strawberry and blueberries (see claim 5 and claim 6). Ammour describes “in a preferred embodiment, the pharmaceutical composition comprises at least one plant miRNA or plant sRNA extract, or a composition comprising 2 or more plant sRNA extracts and at least one carrier” (see page 24, lines 26-29). Ammour does not require cells to be in the composition as the composition is directed to biomolecules such as miRNAs from the fruits of plants as just described.
Ammour teaches that the composition can be a food composition which can be orally administered.
Ammour does not specifically teach that the composition comprises of aly-miR-159a-3p.
Zhang teaches of compositions which are useful for preventing and/or treating oral diseases (see abstract). Zhang teaches that “Gingipains are the most powerful weapons within the P. gingivalis arsenal of virulence factors, as they are responsible for nearly 85% of the total P. gingivalis proteolytic activity. They are responsible for a variety of pathogenic functions such as colonization, nutrition, neutralization of host defenses, and alteration of the inflammatory response, which all lead to massive oral tissue destruction (i.e., periodontitis) during prolonged infection. The Lys-X (Lys- gingipain) and Arg-X (Arg-gingipain) cysteine proteases of P. gingivalis bind and degrade erythrocytes, resulting in formation of black-pigmented colonies on TSB blood agar. Unexpectedly, GELN treatment inhibited the formation of black-pigmented colonies. This result was further supported by the fact that the activities of both arginine-specific (Rgp) and lysine-specific (Kgp) gingipains were significantly decreased in P. gingivalis treated with GELNs (Rgp: p < 0.01 at 2 c 108 particles/ml and p < 0.001 at 4 c 108 particles/ml compared to PBS control; Kgp: p < 0.01 at both 2 c 108 particles/ml 4 c 108 particles/ml compared to PBS control), GELN lipids (p < 0.01 at both 2 x 108 particles/ml 4 x 108 particles/ml compared to PBS control), PA(34:2; p < 0.01 for both Rgp and Kgp as compared to control), and GELN- derived aly-miR159a (p < 0.01 for both Rgp and Kgp as compared to control) contributed to inhibit Rgp and Kgp activities” (see page 46, lines9-24). Zhang also teaches that These results indicated that GELNs and aly-miR159a strongly inhibited gliding motility of P. gingivalis (see page 47, lines 11-12).
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to add aly-miR-159a-3p in the composition taught by Ammour as it is known to inhibit gingipains and gliding motility of pathogenic oral bacteria which causes gingivitis. Ammour teaches a composition for treating of skin diseases and teaches oral food composition formulations, thus adding aly-miR-159a-3p in the composition would create a composition which can treat both oral pathogenic bacteria and skin diseases, especially since the instant claims are broad and are not to any particular treatment etc.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655 /ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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