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 . Claims included in prosecution are claims 15-20.
Restriction Requirement
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-14, drawn to a tissue treatment system.
Group II, claim(s) 15-20, drawn to a method of preparing tissues.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
I-II lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tascilar et al. (WO 2014/204416, Dec. 24, 2014) (hereinafter Tascilar).
Tascilar discloses hemorrhoid treatment solution that provides instant and permanent pain relief in the hemorrhoid area and helps facilitate defecation by relaxing the anal sphincter (satisfies relaxation). The composition includes menthol and Lavandula stoechas extract (satisfies natural substance). The composition is included in a colored glass bottle with a spray head (satisfies applicator) (Abstract).
In view of this document, the common technical feature linking Groups I-II does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over prior art for the reasons set forth above.
During a telephone conversation with Nicole Ressue on 5/19/26 a provisional election was made without traverse to prosecute the invention of Group II, claims 15-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
1. Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crosby et al. (US 6,737,084, May 18, 2004) (hereinafter Crosby).
Crosby discloses methods for enhancement of sexual pleasure and disorders related to sexual pleasure especially in mammalian females. The invention relates to all aspects of modulating the female sexual response, including female sexual dysfunction such as female sexual arousal disorders (FSAD), orgasmic disorders, sexual pain disorders and enhancing female sexual pleasure and satisfaction. The compositions, for topical use, comprise botanical extracts which are useful to treat or affect any of the aforementioned conditions (Abstract). Suitable actives include borage seed oil and Coleus forskohlii extract (satisfies natural substance of claim 15 and 19-20) (col 1, line 25-35). Borage seed oil can be used or other parts of the borage plant (col 1, line 44-46). Coleus forskohlii can be utilized in any form which is effective (col 3, line 24-25). In preferred embodiments of the invention, compositions are administered to the external female genitalia and/or vaginally, e.g., as a vaginal cream, foam, gel, jelly, liquid, emulsion, solution, suspension, cream, spray, powder, suppository, tablet, device, etc. (satisfies target tissue of claim 15-16 and topical application of claim 15) (col 4, line 59-63). The invention methods comprise using any of the aforementioned compositions for treating or affecting diseases and conditions associated with sexual function, especially associated with the female reproductive system such as facilitating sexual arousal (col 7, line 35-40). The arousal response is a physiological and psychological process involving muscle relaxation (col 7, line 50-53). The compositions are useful for enhancing or improving sexual response and/or enhancing or improving sexual pleasure and sensation. This involves vaginal smooth muscle relaxation (col 8, line 18-29). The compositions may be administered to horses, pigs, cows, sheep, and other domestic animals (satisfies claim 17) (col 8, line 40-45).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have formulated a method comprising administering a natural substance to a target tissue of a domestic animal and relaxing said target tissue, as instantly claimed, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 18, as discussed above, Crosby discloses that the arousal response is a physiological process and does not disclose wherein the composition works by affecting the hormonal response of the subject. As such, a response not dependent on hormonal influences would have been obvious.
Accordingly, the teachings of Crosby render obvious claims 15-20.
2. Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibong et al. (US 2019/0201464, Jul. 4, 2019) (hereinafter Archibong).
Archibong discloses an artificial cervical fluid that contains a mucilaginous extract from the okra plant (Abstract). In an aspect, Archibong discloses a method of providing artificial
vaginal lubrication, comprising applying a mucilaginous extract of the fruit of A. esculentus (i.e., okra plant) vaginally to a subject (satisfies target tissue of claim 15-16 and natural substance of claim 15 & 19) (¶ [0014]). The term "subject” refers to any animal, including mammals, such
as swine, cattle, sheep, or horses (satisfies mammal of claim 15 and 17) (¶ [0037]). In the method of lubrication, the extract can be applied directly to the genitalia of the subject (¶ [0057]).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have formulated a method comprising administering a natural substance to a target tissue of a domestic animal and relaxing said target tissue, as instantly claimed, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 15 reciting relaxing the target tissue, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). The method/composition of Archibong is substantially the same as the claimed method/composition where Archibong’s method comprises substantially the same steps of providing a target tissue and topical application to said target tissue with substantially the same natural substance. As such, it would be reasonable for one of ordinary skill in the art to conclude that the method/composition of Archibong would result in the same property, the temporary relaxation of the target tissue, as the method/composition of the instant claims.
Regarding claim 18, as discussed above, Archibong makes no mention of hormonal influences with respect to response caused by the composition and does not disclose wherein the composition works by affecting the hormonal response of the subject. The disclosed method is a method of lubrication (i.e., a physical process). As such, a response not dependent on hormonal influences would have been obvious.
Accordingly, the teachings of Archibong render obvious claims 15-19.
Conclusion
Claims 1-14 are withdrawn.
Claims 15-20 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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