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 .
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 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.
Previous Rejections
Applicant’s arguments, filed September 12, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claim 7 is cancelled.
Claims 1-6 and 8 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claims 3-5 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 3 and 4 recite the term “about.” In the instant case, the specification does not provide any standard for measuring the degree intended for the term “about.” As such, the term is considered indefinite. See MPEP 2173.05(b)(I). In the present case, the term “about” is interpreted broadly since no criticality is ascribed to the amounts of each ingredient in the claimed composition.
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Medical News Today (“Semenax Review: Does it work?”, downloaded 6-9-2025 from https://www.medicalnewstoday.com/articles/semenax, dated 3-15-2022, cited herein as “Medical News”), in view of Male Enhancement Sexual Tonic (Zola's Original Herbal Remedies, downloaded 6/6/2025 from httP-s://ohremedies.com/wp-content/uploads/2022/11/Malesexual-enhancement-tonic-1.png>, available 1-23-2022, cited herein as “Zola’s Original”), Miller (US 2016/0206673 A1), Septiyorini (“The Effect of Black Pepper Fruits (Piper nigrum L.) on the Increase of Erection,” Adv Health Sci Res 20, 2019, 1-5), Cuscada Xtreme (Power Max Wholesale Marketplace, downloaded 6-8-2025 from https://www.pmwholesale.com/product.asp?PID=84162; available 3-21-2018), and Baban (US 2017/0252388 A1).
Medical News teaches a composition for impaired ejaculation and erectile dysfunction that improves blood flow to the penis and provides nutrients to the male reproductive glands including the seminal vesicle, prostate gland, and the bulbourethral gland (pg 2, pg 5). Medical News teaches the composition boosts the male libido, sexual performance, and testosterone levels (pg 5).
Medical News teaches the composition comprises hawthorn berry extract, muira puama extract, catuaba bark extract, epimedium sagittatum “horny goat” extract, butea superba extract, maca extract, pine bark extract, cranberry extract, avena sativa (oat straw) extract, sarsaparilla root extract, Swedish flower pollen, pumpkin seed, vitamin E, zinc aspartate, L-carnitine, lysine, and L-arginine.
Medical News does not teach a composition for sexual enhancement comprising saw palmetto extract, damiana leaf extract, piper nigrum fruit extract, Korean red ginseng extract, ginkgo biloba leaf extract, cuscata leaf extract, tribulis terrestris vine extract or Tong-Kat Ali extract
Zola’s Original, Septiyorini, Cuscada Xtreme, and Baban teach the missing elements of Medical News.
Zola’s Original teaches an herbal supplement used to help male reproductive system and increase libido that is high in minerals, iron, vitamins, and nutrients (pg 3). Zola’s Original teaches the composition contains saw palmetto extract, tribulis terrestris extract, damiana leaf extract, Siberian ginseng, damiana leaf extract, muira puma bark extract, hawthorn berry extract, maca root extract, catuaba bark extract, horny goat weed (epimedium sagittatum) extract, and gingko biloba leaf extract (pgs 3-4).
Miller teaches a composition for improving sexual performance comprising: horny goat weed; “one or more components selected from among a group comprising various forms of ginseng, the forms including Asian ginseng, Siberian ginseng, red white Ginseng and American ginseng; one or more components selected from among ginger root, carob bean, lady's mantle and cayenne pepper; l-arginine, chaste tree berry and nitric oxide; one or more components selected from among black cohosh, guarana and kola nut; oat straw; damiana leaf; sarsaparilla root; and sassafras root; saw palmetto; one or more components selected from among maca root, suma, parsley and muira puama; tribulus terrestres; and one or more components selected from among cnidium momier, tonka bean and vanilla grass. As such, Miller teaches the Siberian ginseng taught by Zola’s Original can be substituted with Asian ginseng.
Septiyorini teaches that black pepper fruit extract has “erotogenic effect on the increase of testosterone level of male animals” (Abstract).
Cuscada Xtreme teaches an herbal supplement for erection enhancement as well as improvement of capillary circulation of erectile tissues. Cuscada Xtreme teaches the herbal supplement contains cuscata extract, butea superba, panax (Asian) ginseng, sarsaparilla extract, and maca extract.
Baban teaches a beverage for enhancing sexual performance in men comprising Korean ginseng, maca root, L-arginine, Tongkat Ali, and damiana leaf (Abstract; pg 3, [0022]).
For claims 2 and 5, Medical News teaches Semenax in the form of a capsule (pg 2).
For claims 3 and 4, the term “about” is defined broadly. As set forth in MPEP 2144.05(II)(A),
It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
In the instant case, one of ordinary skill in the art can determine workable proportions utilizing routine optimization techniques given the teachings of Medical News, Zola’s Original, Septiyorini, Cuscada Xtreme, and Baban since each of these compositions is directed to the same result, namely the enhancement of male sexual response and performance.
For claim 6, Miller teaches the form of an oral spray or tincture (pg 2, [0023]).
For claim 7, Medical News teaches a composition for impaired ejaculation and erectile dysfunction; Zola’s Original teaches an herbal supplement used to help male reproductive system and increase libido; Miller teaches a composition for improving sexual performance; Septiyorini teaches a composition that increases the erotogenic effect due to an increase of testosterone level of males; Cuscada Xtreme teaches an herbal supplement for erection enhancement as well as improvement of capillary circulation of erectile tissues; and Baban teaches a beverage for enhancing sexual performance in men. See citations above.
For claim 8, it is within the skill of an ordinary practitioner to determine dosage of a pharmaceutically active composition; determine the amount of active agent in each pill or capsule; and further determine the number of pills or capsules required to administer an effective dosage.
The skilled artisan would have expected success in combining the composition of Medical News, comprising hawthorn berry extract, muira puama extract, catuaba bark extract, epimedium sagittatum “horny goat” extract, butea superba extract, maca extract, pine bark extract, cranberry extract, avena sativa (oat straw) extract, sarsaparilla root extract, Swedish flower pollen, pumpkin seed, vitamin E, zinc aspartate, L-carnitine, lysine, and L-arginine, with the compositions of Zola’s Original, comprising saw palmetto extract, tribulis terrestris extract, damiana leaf extract, Siberian ginseng, damiana leaf extract, muira puma bark extract, hawthorn berry extract, maca root extract, catuaba bark extract, horny goat weed (epimedium sagittatum) extract, and gingko biloba leaf extract; Miller, comprising horny goat weed; Asian ginseng, l-arginine, oat straw; damiana leaf, sarsaparilla root, saw palmetto, maca root, muira puama, and tribulus terrestres; Septiyorini, comprising black pepper fruit extract (piper negrum); Cuscada Xtreme comprising cuscata extract, butea superba, panax (Asian) ginseng, sarsaparilla extract, and maca extract; and Baban comprising Korean ginseng, maca root, L-arginine, Tongkat Ali, and damiana leaf since each of the compositions of Medical News, Zola’s Original, Septiyorini, Cuscada Xtreme, and Baban are directed toward male sexual enhancement and generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Examiner’s Reply to Attorney Arguments dated 9/12/2025
1. Rejection of claims 3 and 4 under 35 U.S.C. 112(b)
The applicant argues that the “fact that claim language, including terms of degree, may not be precise, does not automatically render the claim indefinite under 35 U.S.C. 112(b).” The applicant further argues: “Acceptability of the claim language depends on whether one of ordinary skill in the art would understand what is claimed, in light of the specification,” and “The test is whether one of ordinary skill in the art, in view of the prior art and the status of the art, would be nevertheless reasonably apprised of the scope of the invention.” The applicant further argues that, in W.L. Gore & Associates, Inc. v. Garlock, Inc., the court held that a limitation defining the stretch rate of a plastic as “exceeding about 10% per second” is definite because infringement could be assessed through the use of a stopwatch.” The applicant finally argues that “the term ‘about’ is as accurate as the subject matter permits, considering that Applicant has also disclosed acceptable ranges of components within the claimed compositions.”
The Examiner acknowledges the arguments presented, but does not consider them persuasive. While a term of degree may not render a claim indefinite, in the instant case it does for the following reasons: first, the disclosure does not define the term “about” nor provide any guidance in the terms of explanation or examples what an effective range of each of the 25 elements present in the claimed mixture.
It is noted that Fig.1 (shown below), allegedly “depicts observed enhancement in key areas in participants receiving administration of the method as described herein.” However, applicant has not provided necessary information to substantiate the “results” depicted in Fig. 1, such as how each enhancement was measured, what amounts of each element was present in the tested composition, the dosage, or a route of administration. Finally, the disclosure states: “The drawings are not necessarily to scale, and certain features and certain views of the drawings may be shown exaggerated in scale or in schematic in the interest of clarity and conciseness.” As such, one of ordinary skill cannot reasonably draw any conclusion of efficacy from the depiction in Fig. 1.
PNG
media_image1.png
670
1127
media_image1.png
Greyscale
Secondly, the claimed mixture is complex, and one of ordinary skill in the art could ascertain a workable scope in view of that complexity. Put another way, one of ordinary skill cannot a priori determine the effect of changing one to twenty-five of the variables when the term “about” is recited twenty-five times with respect to the amounts of each variable. As such, more accuracy regarding the amounts of each component is required to support the claim of “sexual enhancement” given the large number of variables.
2. Rejection of claims 1-8 under 35 U.S.C. 103 as being unpatentable over Medical News Today, Male Enhancement Sexual Tonic, Miller, Spetiyorini, and Cuscada Xtreme.
The applicant argues that the rejection of claims 1-8 is fundamentally flawed because the rejection lacks a reason with rational underpinning as to why one of ordinary skill in the art would combine the named references. Applicant contends that the Examiner has not articulated a reason with a rational underpinning to support the proposed combination. The applicant argues “One of ordinary skill in the art, upon reading the named references would not be led to modify the references to arrive at the present claim 1 as suggested by the Examiner, as the references makes no apparent suggestion to do so, and the Examiner has provided to no rational to support the combination.”
The remarks of September 12, 2025, have been fully considered. However, the rejection of the claims under 35 U.S.C. § 103 as unpatentable over the recited combination of references is determined to be proper and is, therefore, maintained.
On pages 7-8 of the remarks, applicant argues that the examiner has not established the obviousness of the claims. The requirements for a proper response to a rejection may be found in 37 CFR 1.111(b) and MPEP § 707.07. The remarks do not provide any specific reasons as to why either the findings of fact or the legal conclusion of obviousness is allegedly in error. The legal decisions cited discuss various aspects of an obviousness analysis, but applicant’s remarks are only generalizations not tied to the facts of the cases. Thus, the remarks in response to the obviousness rejection do not comply with 37 CFR 1.111(b) and MPEP § 707.07. However, Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response.
Regarding the substance of the examiner’s obviousness rejection as argued in the remarks, the requirements for obviousness are discussed in MPEP § 2142. As explained in the rejection above, the cited references teach each and every limitation of the claims. Specifically, the Office Action explains that Medical News teaches a composition boosts the male libido, sexual performance, and testosterone levels that comprises hawthorn berry extract, muira puama extract, catuaba bark extract, epimedium sagittatum “horny goat” extract, butea superba extract, maca extract, pine bark extract, cranberry extract, avena sativa (oat straw) extract, sarsaparilla root extract, Swedish flower pollen, pumpkin seed, vitamin E, zinc aspartate, L-carnitine, lysine, and L-arginine. Zola’s Original teaches an herbal supplement used to help male reproductive system and increase libido comprising saw palmetto extract, tribulis terrestris extract, damiana leaf extract, Siberian ginseng, damiana leaf extract, muira puma bark extract, hawthorn berry extract, maca root extract, catuaba bark extract, horny goat weed (epimedium sagittatum) extract, and gingko biloba leaf extract. Miller teaches a composition for improving sexual performance comprising: horny goat weed; ginseng, including the forms including Asian ginseng, Siberian ginseng, red white Ginseng and American ginseng; one or more components selected from among ginger root, carob bean, lady's mantle and cayenne pepper; l-arginine, chaste tree berry and nitric oxide; one or more components selected from among black cohosh, guarana and kola nut; oat straw; damiana leaf; sarsaparilla root; and sassafras root; saw palmetto; one or more components selected from among maca root, suma, parsley and muira puama; tribulus terrestres; and one or more components selected from among cnidium momier, tonka bean and vanilla grass. Septiyorini teaches that black pepper fruit extract has “erotogenic effect on the increase of testosterone level of male animals.” Cuscada Xtreme teaches an herbal supplement for erection enhancement as well as improvement of capillary circulation of erectile tissues comprising cuscata extract, butea superba, panax (Asian) ginseng, sarsaparilla extract, and maca extract; and Baban teaches a beverage for enhancing sexual performance in men comprising Korean ginseng, maca root, L-arginine, Tongkat Ali, and damiana leaf. As such, each and every element is taught as an element useful for providing male enhancement, as defined in the instant specification (see Table 1, above, and ¶¶ [0014], [0019]).
Thus, as explained in the Office Action, one of ordinary skill in the art would reasonably have expected that by selecting the compositions taught by the cited prior art, a composition would be obtained that was effective for male sexual enhancement. As set forth in MPEP 2144.06(I), “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." Furthermore, MPEP 2143(A) states that it is prima facie obvious to combine prior art elements according to known methods to yield predictable results: “The rationale to support a conclusion that the claim would have been obvious is that 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.” KSR, 550 U.S. at 416, 82 USPQ2d at 1395. In the instant case, each of the 25 elements recited in claims 1, 3, and 4 are known in the prior art for the purpose of sexual enhancement as defined by the applicant.
CONCLUSION
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL P COHEN/Primary Examiner, Art Unit 1612