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 .
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 45 and 61 are 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.
The claim defines the amount of each component based on a subject’s nutritional requirement for the same, wherein the subject’s nutritional requirement has been determined using a genetic profile of the subject. It is unclear how a genetic profile relates to a patient’s nutritional requirement, given genetics can predict but cannot actually measure current nutritional needs.
Additionally, the claims 45 and 61 require the active step of finding the patients genetic profile, which is a method step, but the claim is directed to a composition. A claim is indefinite if it has both a product and process step in the same claim. MPEP 2173.05(II).
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.
Claims 44-54 and 62-63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rabovsky et al (WO 2016/109856).
Rabovsky et al discloses start at pg 44 a dietary supplement of Formulation F, comprising:
Vitamin A (as beta carotene) 1-5000IU, with embodiments of 1000IU and 3000 IU
Vitamin B6 (as pyridoxine HCl) 2-20mg, with embodiments of 10 and 21 mg
Folate (as folic acid) 200-800µg, with embodiments of 650, 800, and 1000 µg
Vitamin B 12 (as cyanocobalamin) 6-18 µg, with embodiments of 15, 16 µg
Vitamin C (as ascorbic acid) 30/240 mg, with embodiments of 150, 450 mg
Vitamin D (as cholecalciferol) 1-600 IU, with embodiments of 200 IU and 8.7µg
Vitamin E (as d-alpha tocopheryl succinate) 15-60 IU, with embodiment of 30 IU
Calcium 200-1000 mg (as calcium carbonate, dicalcium phosphate, calcium citrate, calcium gluconate, calcium amino acid polyfructose 300 mg complex), 450mg; and
Selenium (as selenium amino acid polyfructose complex) 35-150 µg, with embodiments of 3 and 105 µg,
where the supplements are taught to be provided in daily dosage forms.
With regards to claim 45, the claims are directed to a composition, not a method. As such, the claims will be defined based on the ranges given in claim 44 and the genetic testing limitation does not appear to further limit the claims.
With regards to claims 46-54, it appears the claims are the same as claim 44, with the ranges broken up into various smaller ranges and varying relations.
With regards to claim 62, the claim is directed to a kit comprising the nutritional compositions in a container and directions for use.
With regards to claim 63, where the prior art teaching the formulation comprising the components instantly claimed, it appears the admixing is inherent in the preparation of the daily dosage forms.
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.
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.
Claims 44-54 and 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky et al (WO 2016/109856).
Rabovsky is discussed above for being anticipatory. In the event that one of the ranges was not anticipated, given the large number of optional ranges claimed, the ranges appear to overlap the broader teaching of Rabovsky for each component. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I).
Claims 55-61 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky et al (WO 2016/109856) in view of Prins et al (US 20190045827).
Rabovsky is discussed above but does not teach the addition of protein.
Prins et al teaches it was known to formulate nutritional compositions comprising proteins and vitamin nutritional compositions (claims 1 and 5).
It would have been obvious to add protein to the nutritional formulations of Rabovsky based on the teaching of Prins et al. When adding the protein, it would then have been obvious to optimize the amount based on the amount of nutritional benefits desired based on each component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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, Sahana S. Kaup can be reached at (571) 272-6897. 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.
/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
Prosecution Insights