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 .
Acknowledgement is made to Applicant’s response filed 12/10/2025.
Claims 1-16, 18, and 19 are pending and are currently under consideration.
Claim 17 is cancelled.
Claims 4-6, 10-15, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Claims 1-3, 7-9, and 16 are currently under consideration to the extent that they read upon Applicant’s elected species.
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.
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.
Claim 3 recites that “the urea and its derivatives are selected from” followed by a list of urea derivatives, wherein it is unclear if the claim is directed to urea or one of the recited derivatives, or if the claim is intended to require the presence of one of the derivatives. For the sake of compact prosecution, the claim is being interpreted as requiring either urea or one of the recited derivatives. Appropriate correction is required.
Claim 9 requires the limitation “the ratio of said composition and adjuvants/surfactant/excipients is about 1:0.25” wherein it is unclear how to interpret said limitation since the adjuvants/surfactant/excipients are part of the composition. Based on the specification and the fact that Applicant appears to believe that an election of the amounts of claim 8 and 9 are not in conflict, the claim is being interpreted as requiring an amount of about 0.25% by weight of the total composition as this falls within the range of claim 8. It is noted that the Instant Specification does not define the term “about” and as such, about 0.25 is deemed to read upon at least from 0.1 to 5%.
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.
Claims 1-3 7-9, and 16 (all claims currently under considerion) are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims, as written, do not sufficiently distinguish over compositions comprising urea, melatonin, water, and surfactants as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed composition and the naturally occurring compositions. The claimed composition reads upon naturally occurring soybean, which comprises urea (see as evidence Barcelos et al, Plant Pathology), melatonin (see as evidence Sangsopha et al, J Food Sci Technol), and Lysophosphatidylinositol sodium salt (an anionic surfactant) (see as evidence SigmaAldrich, L7635).
In the absence of the hand of man, naturally occurring compositions (e.g. red clover) are considered non-statutory subject matter (Diamond v. Chakrabarty, 206 U.S.P.Q. 193 (1980)). It should be noted that the mere purity of a naturally occurring product does not necessarily impart patentability (Ex parte Siddiqui, 156 U.S.P.Q. 426 (1996)). However, when purification results in a new utility, patentability is considered (Merck Co. v. Chase Chemical Co., 273 F. Supp 68 (1967), 155 U.S.P.Q. 139, (District Court, New Jersey, 1967)). The examiner suggests narrowing the scope of claim 1 to require the presence of N, N’-diformyl urea to indicate the hand of the inventor. See MPEP 2105.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3, 7-9, and 16 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Sangsopha et al (J Food Sci Technol) and Barcelos et al (Plant Pathology) as evidenced by Sigma Aldrich (L7635).
Sangsopha teaches that soybeans comprise melatonin. Sigma Aldrich evidences that soybeans comprise the anionic surfactant Lysophosphatidylinositol sodium salt (see as evidence Sigma Aldrich, entire document, for instance, Title).
Sangsopha, while teaching that soybeans comprise melatonin, does not expressly teach that the soybeans comprise urea or the ratio of the melatonin to urea.
Barcelos teaches that soybeans comprise urea (see entire document, for instance, Abstract). Barcelos further teaches that the amount of urea is a result effective variable that can be readily manipulated by controlling the Nickle and urease amounts in the composition (see entire document, for instance, Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to optimize the amount of urea in the soybeans of Sangsopha. One would have been motivated to do so since Barcelos teaches that by optimizing the amount of urea, one of ordinary skill in the art is able to maintain healthier soybean plants. There would be a reasonable expectation of success since both prior art references are directed to soybean plants. It is noted that MPEP 2144.05 states: "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).”
Claim(s) 1-3, 7-9, and 16 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Granger et al (US 2022/0175712).
Granger teaches a composition comprising melatonin (0.05%), tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate (1-11%), caprylic and capric triglycerides (adjuvant/excipient, 2%), and polysorbate 20 (non-ionic surfactant) (see entire document, for instance, [0059], [0083], and [0084]).
Granger, while teaching all of the instantly claimed components and amounts that directly overlap the instantly claimed ratio, does not provide a singular example wherein all of said elements are expressly articulated.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to optimize the amounts of the components present within the parameters set forth by Granger. One would have been motivated to do so since the prior art teaches amounts that directly overlap the instantly claimed amounts. Further, one would have optimized the amount of the polysorbate 20 in order to achieve the desired surfactant action of lowering the surface tension to arrive at an easier spreading of the composition (see entire document, for instance, [0043]). It is noted that MPEP 2144.05 states: "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).”
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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