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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of marine collagen peptides, L-glutamine, L-cysteine, L0selenomethionine, boron citrate, and wherein the composition does not further comprise other agents in the reply filed on 4/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/20/2026.
Status of the Claims
Claims 1-20 are pending in this application.
Claims 10-20 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-9 are presently under consideration as being drawn to the elected species/invention.
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.
Claims 1 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Crum (US 2012/0029082) in view of Health Co Ltd (CN111569052A), Han et al. (Biomedicine & Pharmacotherapy 128 (2020) 110305) and Okzan et al. (Vet Hekim Der Derg 91 (1): 25-35, 2020).
With respect to claim 1, Crum teaches composition for increasing the level of glutathione in a mammal consisting essentially of (A) an anabolic precursor of glutathione, consisting of glutamic acid or a salt, an ester, or an anhydride thereof, cystine or a salt, an ester, or an anhydride thereof and glycine or a salt, an ester, or an anhydride thereof, which collectively convert to glutathione; and (B) a source of selenium, wherein said source of selenium is selenium methionine, (claim 1).
Crum does not teach the claimed collagen source and boron source.
Health Co Ltd teaches a composition for increasing bone density of climacteric women is characterized by being prepared from the following components: milk mineral salt, soybean extract, collagen powder, colostrum basic protein powder (claim 1).
Health Co Ltd also teaches that “[c]ollagen is rich in 18 amino acids except tryptophan and cysteine, contains 7 essential amino acids, has glycine content of 27% and proline and hydroxyproline content of 25%” (page 2, 12th para).
Han et al. teach that glutathione reduced LPS-induced bone loss (i.e. increases bone density) (para bridging pages 3-4; Fig. 5A).
Okzan et al. teach that “[B]oron increases the amount of glutathione and its derivatives in the body or induces antioxidants against reactive oxygen species and shows protective effect against oxidative damage (page 26, 2nd para).
It would have been obvious, with a reasonable expectation of success, to one of ordinary skill in the art to include the collagen source of Health Co Ltd and boron in the composition of Crum in order to make a composition that increases bone density.
The skilled artisan would have reasonably expected the resulting composition to increase bone density because Han et al. teach that glutathione increases bone density, Health Co Ltd teaches that collagen increases bone density, and Okzan et al. teach that boron increases the amount of glutathione.
With respect to claim 5, the MPEP 2144.05 A states that “[G]enerally, 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amounts of the collagen source, the glutamate source and the cysteine source by normal optimization procedures known in the pharmaceutical art.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Crum (US 2012/0029082) in view of Health Co Ltd (CN111569052A), Han et al. (Biomedicine & Pharmacotherapy 128 (2020) 110305) and Okzan et al. (Vet Hekim Der Derg 91 (1): 25-35, 2020) as applied to claims 1 and 5-9 above, and further in view of Drake (Curr Osteoporos Rep. 2013 September; 11(3): 163-170) and University of Florida (Cancer Vaccine to Treat Melanoma and Osteosarcoma; February 11, 2022).
The teachings of Crum, Health Co Ltd, Han et al. and Okzan et al. with respect to claims 1 and 5-9 have been discussed above.
Crum, Health Co Ltd, Han et al. and Okzan et al. do not teach administering the glutathione support composition to a subject at least 5 days before or after receiving a vaccine.
Drake teaches that “[C]ancer is a major risk factor for bone loss and fractures. This is due both to direct effects of cancer cells on the skeleton and to deleterious effects of cancer-specific therapies on bone cells. Marked improvements in survival for many cancers mean that strategies to limit bone loss and reduce fracture risk must be incorporated into the care plans for nearly all patients with cancer” (abstract).
University of Florida teaches a cancer vaccine to treat melanoma and osteosarcoma (title; passim).
It would have been obvious to one of ordinary skill in the art concerned with the treatment of a cancer such osteosarcoma to administer the claimed glutathione support composition to a subject before or after receiving a vaccine Drake teaches that strategies to limit bone loss and reduce fracture risk must be incorporated into the care plans for nearly all patients with cancer.
The skilled artisan would have reasonably expected to limit bone loss and reduce fracture risk in a patient with cancer because the composition obvious over Crum, Health Co Ltd, Han et al. and Okzan et al. increases bone density.
With respect to the claimed time of administration (i.e. at least 5 days before or after the vaccine), since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum time of administration by normal optimization procedures known in the pharmaceutical art (see MPEP 2144.05 A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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