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 1-18 are pending.
Claims 3-5, 9-16, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/30/2025.
Claims 1-2, 6-8, and 17 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 8 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.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 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, 2, 6-8, and 17 (all claims currently under consideration) 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 vitamin A, carnosic acid, and carnosol 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 rosemary, which comprises vitamin A, carnosic acid, and carnosol (see Hedges et al, page 10, table 6 and the table bridging pages 69-70).
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 include components that are not naturally occurring so as to indicate the hand of the inventor. See MPEP 2105.
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, 2, and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birtic et al (Phytochemistry, 2015) as evidenced by Hedges et al (New Zealand Institute for Crop & Food Research Limited, 2007).
Birtic teaches ground rosemary leaves as tested by Birtic comprise 6% carnosol, being defined as the percentage of carnosol/(carnosic acid + carnosol) (see entire document, for instance, page 11, right column, first paragraph). It is noted that this represents 6% carnosol and 94% carnosic acid based on the carnosol and carnosic acid. Hedges evidences that rosemary comprises vitamin A (see Hedges as evidence, table bridging pages 70-71).
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, 2, 6-8, and 17 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Betancourt et al (WO 2016/189345)(IDS Reference) and Birtic et al (Phytochemistry, 2015).
Betancourt teaches a composition comprising 0.005 to 0.15% of at least one of Vitamin A and Vitamin D in combination with 0.02 to 0.2 % tocopherol, ascorbyl palmitate, rosemary extract, and mixtures thereof (see entire document, for instance, Abstract and claim 1).
Betancourt, while teaching the presence of Vitamin A and rosemary extract in amounts that directly overlap the instantly claimed ranges, does not exemplify the amounts with sufficient specificity to rise to the level of anticipation regarding the amount of Vitamin A.
Birtic teaches ground rosemary leaves comprise a relative amount of carnosol of 6% as defined by the percentage of carnosol/(carnosic acid + carnosol) (see entire document, for instance, page 11, right column, first paragraph). It is noted that this represents 6% carnosol and 94% carnosic acid based on the carnosol and carnosic acid. Birtic further teaches that carnosic acid is present in rosemary leaves in an amount of 3%, and in some newer cultivars, up to 10% (see entire document, for instance, page 9, left column, last paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize 0.15% Vitamin A in combination with 0.02% rosemary extract (noting that this rosemary extract comprises, at most about 0.0032% carnosic acid and carnosol (assuming 10% carnosic acid, and therefore, about 0.6% carnosol), which would result in an amount of about 97% (.15%/.1532%) Vitamin A with regard to the combination of Vitamin A to carnosic acid and carnosol.
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.
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.
/TREVOR LOVE/Primary Examiner, Art Unit 1611