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 1-4 remain pending and are currently under consideration.
Objections and Rejections Maintained
Specification
Idiomatic English
A substitute specification in proper idiomatic English and in compliance with 37 CFR 1.52(a) and (b) is required. The substitute specification filed must be accompanied by a statement that it contains no new matter. The instant specification includes numerous typographical errors and illogical/incomprehensible sentences.
Use of Tradenames
The use of the term “abilify”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 4 is rejected under 35 U.S.C. 101 because the invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a use without providing a clear, active method step.
The claim recites using Zinc without any indication of the method(s) step required. MPEP 2173.05(q) states:
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
Claim Rejections - 35 USC § 112
Rejections under 112(a) or 35 USC 112 (pre-AIA ), First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without special knowledge not included in the claims or specification such as A) defining Abilify, B) indicating what tablet/pill/capsule/powder/cream/gel/drops are to be taken, C) what it means to “improve erecting/erection at people,” D) how to define the population that “wants better sex life,” E) the dosage of Abilify that are used for mental patients, F) the definition of “law grades,” G) how one “talks the Abilify,” H) the definition of mounts, I) the definition of pines, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). Applicant’s Specification does not cure any of said deficiencies.
Rejections under 112(b) or 35 USC 112 (pre-AIA ), Second Paragraph
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.
Claim 3 is 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.
112(b) rejection 1 of 2
Claims 3 contains the trademark/trade name Abilify. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular undefined species of polymeric polyphenolic substances and, accordingly, the identification/description is indefinite.
It is noted that MPEP 2173.05(u) states that “[i]f the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.”
112(b) rejection 2 of 2
Claims 1-4 (all claims currently under consideration) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: A) a definition of the terms Abilify, pines, mounts, and law grades, B) indicating what tablet/pill/capsule/powder/cream/gel/drops are to be taken, C) what it means to “improve erecting/erection at people,” D) how to define the population that “wants better sex life,” E) the dosage of Abilify that are used for mental patients, G) how one “talks the Abilify.” Without said elements, it is not possible to determine what is intended by the claims. At best, one can understand that an ingredient of lemon pulp, an ingredient of chocolate chips, Abilify (undefined), or a zinc supplement are in some way used, and some type of tablet/pill/capsule/powder/cream/gel/drops of unknown composition is taken.
Claim Objections
Claim 2 is objected to because of the following informalities: the claim recites “ingredients ingredients.” This is deemed to be a typographical error. Appropriate correction is required.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mir et al (Journal of Psychopharmacology, 2008) as evidenced by Abilify (aripiprazole) Official Site (December 2014), Lemon Parts (2021), Bjarnadottir (2019), and Barisic et al (Molecules, 2019).
Mir teaches that switching patients to Abilify (aripiprazole) significantly reduces erectile difficulties (see entire document, for instance, Abstract and page 253, declaration of interest). Abilify (aripiprazole) Offical Site evidences that Abilify Oral Solution comprises fructose, sucrose, and water (see as evidence entire document, for instance, page 50, second to last paragraph). It is noted that lemon pulp comprises water and carbohydrates (see as evidence, Lemon Parts, page 3, section titled “Endocarp [Pulp]”), wherein the carbohydrates in lemons are fructose, sucrose, and glucose (see as evidence Bjarnadottir, page 2, section titled “Carbs”). Barisic evidences that chocolate comprises sucrose and fructose (see as evidence, entire document, for instance, page 9, second to last paragraph).
Claim(s) 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benckini (US 20160038458).
Benckini teaches a method for stimulating penile erections, comprising administering 75-100 mg of zinc (see entire document, for instance, claims 1 and 7).
Response to Arguments
Applicant provides argument that they filed information similar to the instant invention with the Israeli Patent Office back in 2018. It is noted that Applicant has not provided evidence of said earlier filing. Further, the instant Application does not claim priority to said filing, and as such, should said earlier filing have been published, it would constitute 102 prior art. Additionally, the majority of the art filed in prior to 2018. Further, Applicant’s argument does not address any of the non-art related rejections. For at least these reasons, Applicant’s arguments are not found persuasive and the rejections of record are maintained.
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611