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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-17 in the reply filed on 27 February 2025 is acknowledged. Claims 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 February 2025.
Upon reconsideration, the Examiner withdraws the requirement for a species election of Group A, a single specific direct endocannabinoid mimetic or combination thereof; Group B, a single specific indirect endocannabinoid mimetic or combination thereof; Group C, an ECS related pathway anti-inflammatory compound or combination thereof; and Group D, a single specific ECS related TRP pathway compound.
Claims 1-17 are being examined on the merits.
Claim Objections
Claims 4, 7, 9, 11, and 13 are objected to because of the following informalities:
In Claims 4, 7, and 9, “Panax notogensing” should instead be ---Panax notoginseng--- and “Panax gensing” should instead be ---Panax ginseng---.
In Claims 4, 7, 9, 11, and 13, all instances of binomial scientific names should be presented in italics with the genus name capitalized and the species name in lowercase.
In Claim 13, Eugenia caryophyllata and Syzygium aromaticum both refer to cloves and are thus duplicates referencing the same extract.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 1-13, the phrase "i.e., PTGS1" renders the claim indefinite, in addition to the parathesis, because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4, 7, 9, 11, and 13 are rejected because it is unclear to what the phrase “in each instance” is in reference to regarding the compounds. Are all of the listed compounds found in each of the natural extracts? Are multiple natural extracts present for a single compound? Clarification is necessary.
Claim 6 recites the limitation "the composition of claim 7.” There is insufficient antecedent basis for this limitation in the claim. Additionally, regarding Claim 6, the claim recites dependency from the higher numbered Claim 7 and thus it is unclear which composition is intended for reference. For the purposes of examination, it is assumed that Claim 6 depends from Claim 5.
Regarding Claims 2, 4, 7-9, and 11 the parentheticals “preferably…”, “egg oil,” and “root” render the claims indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.
Regarding Claims 14 and 15, the “preferably…” phrasing renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(h).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 17 recites the broad recitation 0.01% to 30%, and the claim also recites 0.01% to 20%, 0.01% to 10%, 0.01% to 5.0%, and 0.01% to 1.0%, which are the narrower statements of the range/limitation. Additionally, the claim (at line 3) lacks a conjunction or other phrasing in the phrase “5.0%, 0.01%”. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 is rejected as depending from rejected Claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 recites dependency from the higher numbered Claim 7. Claims must be previously numbered (originally filed in an ascending order, see also 37 CFR 1.121(c)(1)), and therefore, for the purposes of examination, it is being treated also that Claim 6 as depending from Claim 5. Appropriate correction is still required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 7 is rejected as being dependent from the rejected Claim 6.
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 1-15 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-15 and 17 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite natural extracts from the various plant and animal sources listed in Claims 4, 7, 9, 11, and 13. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a combination of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a combination of ingredients which are naturally-found in or obtainable from the plant material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a combination of the naturally occurring compounds found in the particular plants. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants and the claims are therefore drawn to combinations of naturally occurring products.
There is no indication that combining the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a combination of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a combination of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that combining the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed combination as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of modulating gene expression of the various genes listed in Claims 1, 14, and 15. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Combining specific compounds does not amount to significantly more than a combination of judicial exception because combining compounds is well-understood, routine, and conventional in the field. Thus, combining the ingredients together does not amount to significantly more than a combination of judicial exception because combining compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of modulating gene expression of the various genes listed in Claims 1, 14, and 15 is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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 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.
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, 2, 12-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Choi et al. (US 9,433,564 B2).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to compositions comprising various direct and indirect endocannabinoid mimetic compounds, anti-inflammatory compounds, and ECS-related TRP pathway compounds contained within natural extracts which modulate expression of various genes in cells as measured in comparison to cells not exposed to the compounds.
Choi et al. teach a cosmetic composition for application to the skin comprising hydrophobic extracts from plants and algae, which are present from 25-60% by volume (Choi et al., col. 13, Claim 2), including the following (as required for instant Claims 1, 2, 12 and 13):
Myristica fragrans (direct endocannabinoid mimetic compound; allyl chain substituted guaiacol; eugenol; Choi et al., col. 4, line 42);
Theobroma cacao (indirect endocannabinoid mimetic compound; fatty acid amide; oleamide; arachidonamide; Choi et al., col. 4, lines 2-3; see e.g., specification [00130]);
Vitis vinifera (ECS-related pathway anti-inflammatory compound; monoterpene; diosphenol; resveratrol; Choi et al., col. 4, line 23);
Ginkgo biloba (ECS-related pathway anti-inflammatory compound; terpene lactone; ginkolide B; bilobalide; helenalin; parthenolide; Choi et al., col. 4, line 22);
Salvia officinalis (ECS-related pathway anti-inflammatory compound; diterpene; triptolide; carnosic acid; Choi et al., col. 4, lines 52-53); and
Olea europaea (ECS-related TRP pathway compound; PUFA; oleic acid; palmitoleic acid; vaccenic acid; Choi et al., col. 4, line 44).
Although Choi et al. teaches the ingredients of the claimed composition, they are silent regarding the intended use of the composition, i.e. modulating gene expression of the various named genes as measured in comparison to a negative control group. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not gene expression is identical between compositions. The compositions are the same, and thus the properties of modulating gene expression are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the compositions of the claimed invention and the prior art are either identical or sufficiently similar that whatever differences exist, they are not patentably significant.
The cited reference discloses the compositions as described above, which appears to be identical to the presently claimed compositions since it is formulated and/or obtained from the same component materials. Consequently, the claimed compositions appear to be anticipated by the reference. Thus, the claimed composition and effects intrinsic thereto would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Claims 1-11 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rebmann (US 8,652,494 B2).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to compositions comprising various direct and indirect endocannabinoid mimetic compounds, anti-inflammatory compounds, and ECS-related TRP pathway compounds contained within natural extracts which modulate expression of various genes in cells as measured in comparison to cells not exposed to the compounds.
Rebmann teaches compositions for cosmetic applications comprising 0.5-40% vegetable extracts (at least one compound contained in a natural extract; as required for instant Claim 17) including the following:
Curcuma longa extract (direct endocannabinoid mimetic compound; curcuminoid; Rebmann, col. 2., lines 42-43; as required for instant Claims 1-11);
Thebroma cacao extract (indirect endocannabinoid mimetic compound; fatty acid amide; OEA; PEA; Rebmann, col. 2, line 59; as required for instant Claims 1-11);
Panax ginseng extract (indirect endocannabinoid mimetic compound; ginsenoside; ginsenoside RC; Rebmann, col. 2, lines 48-49; as required for instant Claims 1-9);
Magnolia flower extract (Magnolia officinalis extract; ECS related pathway anti-inflammatory compound; biphenol; honokiol; magnolol; Rebmann, col. 2, line 66; as required for instant Claims 1-11);
Piper nigrum (ECS related pathway anti-inflammatory compound; sesquiterpene; β caryophyllene; Rebmann, col. 3, line 21; as required for instant Claims 1-11);
Matricaria chamomila extract (ECS related pathway anti-inflammatory compound; hyroxyflavone; apigenin; Rebmann, col. 2, lines 60-61; as required for instant Claims 1-11);
Echinacea purpurea (ECS related TRP pathway compound; N-alkylamide; dodeca-2E,4E,8Z,10Z-tetraenoic acid isobutylamide; dodeca-2E,4E-dienoic acid isobutylamide; Rebmann, col. 2, line 44; as required for instant Claims 1-9); and
Sea alga extracts (Schizochytrium aggregatum; ECS related TRP pathway compound; DHA; EPA; as required for instant Claims 1, 10, and 11).
Additionally, the composition comprises phospholipid-fractions from vegetable resources (natural extracts) from soya beans (Glycine max), peanut (Arachis hypogaea), or egg yolk (Gallus gallus domesticus egg oil; indirect endocannabinoid mimetic compound; PEA; Rebmann, col. 4, lines 5-7; as required for instant Claims 1, 10, and 11). The compositions can be in the form of creams or lotions (Rebmann, col. 5, line 5; as required for instant Claim 16).
Although Rebmann teaches the ingredients of the claimed composition, they are silent regarding the intended use of the composition, i.e. modulating gene expression of the various named genes as measured in comparison to a negative control group. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not gene expression is identical between compositions. The compositions are the same, and thus the properties of modulating gene expression are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the compositions of the claimed invention and the prior art are either identical or sufficiently similar that whatever differences exist, they are not patentably significant.
The cited reference discloses the compositions as described above, which appears to be identical to the presently claimed compositions since it is formulated and/or obtained from the same component materials. Consequently, the claimed compositions appear to be anticipated by the reference. Thus, the claimed composition and effects intrinsic thereto would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
With respect to the 35 USC §102 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use (e.g., modulation of gene expression of the various genes described therein, including those of Claims 14 and 15) does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants' composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655