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 .
Applicant’s amendments filed 12/30/2025 have been entered.
Claims 1, 3-15 are pending.
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.
Claim(s) 1, 3-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2010/0278939 (‘939) in view of US 2006/0204557 (‘557) and US2012/0141611 (‘611).
‘939 teaches a method of treating male infertility by administering a composition containing antioxidant (see claims 25-26, [0072]).
‘939 does not expressly teach the excipients of the composition herein claimed. ‘939 does not expressly teach the use of ergothionine.
‘611 teaches ergothionine as an antioxidant and known to be involved in “a critical protective role in seminal fluid (21, 22). Ergothioneine is the predominant sulfhydryl in human, horse and pig semen. Its role is evidently to protect spermatozoa from oxidative stress, given the exceptionally high metabolic rate in sperm. Ergothioneine, as consequence of its antioxidant properties, counteracts the effects of hydrogen peroxide on spermatozoa viability and survival while also enhancing the viability of sperm during storage.” (see [0110]).
‘557 teaches a “water-based compositions comprise of an aqueous solution with optimum pH and osmolality to mimic biological fluids. In a preferred embodiment, such water-based compositions are useful as non-spermicidal vaginal lubricants that are sperm friendly, egg friendly and facilitate fertilization.” (see [0011]). ‘557 teaches the aqueous lubricant base including polyacrylic acid and hydroxypropyl methylcellulose (see [0017]). ‘557 teaches the composition having a balanced pH and osmolality; or specifically, an aqueous salt solution with balanced pH and osmolality, wherein the pH of the solution is between 7.2 and 8.5, and the osmolality of the solution is between 200 mOsm/kg and 500 mOsm/kg. (see claims 4 and 59). ‘557 also teaches the osmolyte as sodium ion and the buffer agent including phosphate (see for example [0058]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to employ ergothionine in the method of treating male infertility. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the herein claimed excipients, in the herein claimed amount, into the composition.
One of ordinary skill in the art would have been motivated to employ ergothionine in the method of treating male infertility. It is well-known that antioxidant as effective in treating male infertility. Therefore, employing any known antioxidant, including ergothinonine, in a method of treating male infertility would be reasonably expected to be effective. Furthermore, ergothionine is well-known to have protective properties for sperms. Therefore, it would be reasonably expected to impart beneficial effects on the sperms.
One of ordinary skill in the art would have been motivated to incorporate the herein claimed excipients, in the herein claimed amount, into the composition. It is known that the herein claimed excipients as suitable for use in formulating the water-based compositions of ‘577 that facilitate fertility. The viscosity is the function of the concentration of the polymer employed. Same is true for the osmolality depending the concentration of the sodium ions and pH depending on the concentration of buffering agent. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). It is routine for one of ordinary skill in the art to formulate a composition with the correct physical forms for delivering the active to treat a disease. Adjusting and optimizing the amounts of excipients to arrive at herein claimed invention.
Response to Arguments
Applicant's arguments filed 12/30/2025 averring ergothionine being in garlic and ‘939 excluding garlic, have been fully considered but they are not persuasive. Applicant’s reasoning being that since ‘939 excludes garlic and ergothionine is in the garlic, then the cited prior art as a whole teaches away of using ergothionine in the method of treating infertility. However, such reasoning is flawed. ‘939 excludes garlic as a whole, not the specific compounds in the garlic. Garlic itself contains selenium, vitamin C and vitamin E, which are used in ‘939 (see USDA Nutrient Database for Standard Reference, Release 12 (1998) – Garlic, raw). And within the content of ‘939, the use of antioxidants is the novelty. Therefore, without explicitly excluding ergothionine, taking the cited prior art as a whole would still render the instant invention obvious.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627