DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed February 26, 2026 has been received and entered.
3. Claims 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, 36, 37, and 40 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, and 40, Abelmoschus esculentus for species A and Linum usitatissimum for species B, in the reply filed on February 26, 2026 is acknowledged.
5. Claims 36 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, and 40 are examined on the merits.
Claim Objections
7. Claim 14 is objected to because of the following informalities: in line 3, “/fragrance” appears to be a typographical error and in line 4, “andor” appears to be missing a “/”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, and 40 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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.
8. Claim 1 is indefinite because it is unclear what characteristics a composition must have in order to be considered “water-based.” In addition, the claim is indefinite because it states that it comprises “at least a part or extract from an okra plant species; or at least a part or extract from an okra plant species and optionally a part or extract from a flaxseed plant species (emphasis added).” The use of “or” and “optionally” together is confusing because if the option for flaxseed is not taken, then the second portion of the claim is the same as the first portion, i.e. both are just a part or extract from an okra plant species.
9. Claim 6 is indefinite because the antecedent basis for “the extract or part thereof” is unclear. Claim 1 can include an extract and part from okra and an extract and part from flaxseed. It is unclear which “extract” and “part” are referred to in claim 6.
10. Claim 7 is indefinite because the antecedent basis for “the extract or part thereof” is unclear. Claim 1 can include an extract and part from okra and an extract and part from flaxseed. It is unclear which “extract” and “part” are referred to in claim 7.
11. 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 8 recites the broad recitation “natural ingredient” and the claim also recites “or a natural ingredient which is a natural gum” which is the narrower statement of the range/limitation. The claim(s) are 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. In addition, it is unclear what characteristics an ingredient must have in order to be considered “natural.”
12. Claim 11 is indefinite because it does not state which claim it depends from. It appears that it should depend from claim 10; however, correction and clarification is needed. In addition, claim 11 is indefinite because it is unclear what characteristics an ingredient must have in order to be considered “natural.”
13. Claim 14 is indefinite because the multiple uses of “and/or” make it unclear which ingredients can be selected as alternatives.
14. 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, claims 15, 17, and 25 recite the broad recitation “comprises” and the claim also recites “consists of” which is the narrower statement of the range/limitation. The claim(s) are 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.
15. Claim 17 is also indefinite because applicant has not provided a copy of “ISO16128-2:2017.” Thus, the standard used to determine the “natural” content of the composition is unclear.
16. Claim 25 is indefinite because the use of “and/or” in combination with “and a mixture thereof” is redundant and confusing.
17. 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 26 recites the broad recitation “a contraception device” and the claim also recites “optionally a condom” which is the narrower statement of the range/limitation. The claim(s) are 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 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.
18. Claim 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more.
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 a part or an extract from okra (A. esculentus) optionally in combination with a part or an extract from flaxseed (L. usitatissium). Okra and flaxseed are both naturally occurring plants. 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, claim 1 states that the composition can comprise only a part from okra. This embodiment reads directly on a product of nature, i.e. the okra plant itself. Thus, this embodiment in claim 1 cannot be distinct from the naturally occurring counterpart because they are one and the same. Claim 1 also encompasses an extract from okra and combination of okra and flaxseed parts or extracts. However, 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 mixture 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 mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture 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. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified plant parts or 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 plant part is a the plant part itself. In addition, the closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture 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 mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts.
The dependent claims state that the composition can be in forms such as liquid, oils, gels, powders, or granules. These structures are naturally occurring and are not considered to lend a markedly distinct characteristic to the composition. In addition, the inclusion of other naturally occurring ingredients such as gums, emollients, water etc., as claimed in claims 8, 14, and 15 is not considered to create a distinct characteristic other than a combination of natural ingredients. 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 as a lubricating composition, formulated for penile or vaginal applications, formulated for application to skin, and compatible with articles and condoms. 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 the ingredients. 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. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended uses are 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
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.
19. Claim(s) 1, 6, 7, 8, 11, 13, 14, 17, 22, 24, 25, 26, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Archibong (US 2019/0201464).
This reference teaches a liquid lubricating composition comprising an extract from okra (A. esculentus). The extract is an aqueous, mucilaginous extract which is considered to meet the limitation of “water-based.” The reference teaches that the okra extract can be used alone (i.e. over 0.1%) or in combination with additional ingredients such as carrageenan (a naturally occurring ingredient), fragrances, lubricants, gelling agents, and moisturizers. The reference teaches that the extract has elastic qualities (i.e. is non-Newtonian). In addition, the composition is used as a sexual lubricant or a coating for a condom (see paragraphs 8, 11, 14, 39, 45, 57, 59).
20. Claim(s) 1-3, 8, 14, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Innisfree Relaxing Hand Cream, Innisfree; GNPD Mintel Record ID: 1847650 (Aug 2012).
This reference teaches a topical composition which comprises A. esculentus extract and L. usitatissimum extract in combination with water and other ingredients which overlap with those claimed by applicant in claims 8 and 14.
Claim Rejections - 35 USC § 103
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.
21. Claims 1-3, 6-8, 11, 13-15, 17, 19, 20, 22, 24-26, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibong (US 2019/0201464) in view of Altunkaya (WO 2006/075236).
The teachings of Archibong are discussed above in paragraph 19. The reference does not teach including a L. usitatissimum extract in the composition.
However, Altunkaya teaches using a L. usitatissimum extract to formulate a personal lubricant for sexual activity in combination with water and other naturally occurring ingredients (see pages 1 and 2).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in personal lubricant compositions. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in personal lubricant compositions, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating a single personal lubricant composition. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach formulating the composition using the concentrations, pHs, osmolalities, or viscosities claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Altunkaya teaches varying the concentration of the ingredients, the pH, and viscosity of the composition (see pages 5 and 8). In addition, varying the physical characteristics of the composition is not considered to be inventive unless particular parameters are demonstrated as critical. In this particular case, there is no evidence that the claimed parameters produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
22. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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