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
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed April 24, 2026 has been received and entered into the present application.
Status of claims
The amendment filed on April 24, 2026 is acknowledged. Claims 1-8 and 10-11 have previously been canceled. Claims 9 and 12-17 are under examination in the instant office action.
Applicants' arguments, filed on April 24, 2026, have been fully considered but they are moot in view of a new ground of rejection necessitated by the newly added limitations. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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
New matter Rejection
Claims 9 and 12-17 are rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. All the dependent claims are included.
Claim 9 is amended to recites “wherein the glutamine is administered at a dose of 18-45 mg/kg/day. However, the original application provides no support for the newly recited dose range. The specification only discloses orally administering glutamine for 1 week (45 mg glutamine/kg body weight/day) to mice in the example for testing the cognitive ability ([0067]-[0072]). Also, Applicant asserted that the minimum glutamine intake observed during the experimental period was 18 mg/kg/day, which was calculated from body weight and food intake change data on Fig. 1 at page 4 of Applicant’s remark filed on 4/24/2026. However, those two doses disclosed in the examples do not support the entire range as claimed, which encompass any dose amounts between 18 mg/kg/day and 45 mg/kg/day. Also, Applicant did not clearly explain how the minimum dose was calculated. In addition, the disclosed dose is for administering to mice, not any other subject including human. However, the claimed method is not limited to mice but encompass administering to any subject including human. There is no sufficient disclosure for the generic dose range, which is intended for all of the subjects, including human encompassed by the claim. Therefore, it is considered as new matter.
It should be noted that the range is not necessarily described by a species upon which it reads. The written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 (a) to § 608.04(c).
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 9 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0016207 (hereafter, Wurtman) in view of Dong et al. (Journal of Alzheimer’s Disease, 18: 459–469, 2009) and Chen et al. (PloS One, 7(3), e33177, March 2012; cited in IDS filed on 3/3/2023).
Wurtman teaches a method for treating a cognitive or memory disturbance (mild cognitive impairment) or an Alzheimer's disease in a subject in need thereof, comprising administering to said subject a composition comprising a glutamine, a salt thereof, or a glutamine-rich peptide, thereby treating a cognitive or memory disturbance or an Alzheimer's disease in a subject in need thereof (abstract, [0048] and claim 19). Wurtman further teaches that Alzheimer's disease is at a mild stage or a moderate stage, which is characterized by decline in cognitive function or memory (mild cognitive impairment).
Wurtman further teaches a use of glutamine in the manufacture of a medicament, pharmaceutical composition, or nutritional supplement ([0057]). Wurtman discloses that the pharmaceutical compositions contain an active component and excipients that are pharmaceutically acceptable and compatible with the active ingredient ([0102]).
Also, Wurtman discloses that the composition is formulated in a form suitable for oral administration, i.e. as a solid or a liquid preparation wherein suitable solid oral formulations include tablets, capsules, pills, granules, and pellets and suitable liquid oral formulations include solutions, suspensions, dispersions, emulsions, and oils ([0088]). The nutritional supplement composition reads on a quasi-drug recited in claim 16 since it is defined as non-prescription products that have therapeutic or preventive effects on the human body, but are not as potent as prescription drugs.
Wurtman does not specifically teach that the brain damage and mild cognitive impairment (MCI) are caused by stress or accumulation of amyloid-beta 42 (Aβ42).
However, it was known in the art that increasing levels of amyloid beta peptide including Aβ42 have been correlated with cognitive impairments in AD patient and higher levels of chronic psychological distress (stress) were associated with an increased incidence of mild cognitive impairment (MCI) as evidenced by Dong et al. (p461, col 1 para 2-col 2, para 2). Dong et al. further teach that stress and stress hormones may increase production of Aβ and its incorporation into Aβ plaques and stress could also enhance Aβ-mediated neuronal toxicity or increase tau accumulation or phosphorylation and tangle formation (p462, col 2, para 3). Thus, one of ordinary skill in the art would have recognized that the subject with Alzheimer's disease is a subject having brain damage (neuronal loss) and mild cognitive impairment caused by accumulation of amyloid-beta 42 (Aβ42)/stress as evidenced by Dong et al.
Also, Chen et al. teaches that glutamine acts as a neuroprotectant against DNA damage, beta-amyloid and H2O2-induced stress and the neuroprotective effects of glutamine supplementation may prove beneficial in the treatment of AD (Title and abstract). Chen et al. further teach that cells in low glutamine are more sensitive to the effects of a variety of different stressors (p4, col 2, para 1) and glutamine is essential for the stress-response and post damage survival of cells (p5, col 2, para 1). Chen et al. also teach that glutamine supplementation protects neuronal cells against the amyloid peptide (Aβ1–42) (abstract and p2, col 2, para 1) and neurons in AD mouse models in vivo (p9, Fig. 6). Chen et al. further discloses two different mouse models of familial AD responded in positive ways to a relatively short (10-day) nutritional supplement of glutamine in their drinking water (drink) (p10, col 2, para 2). In addition, Chen et al. teaches that glutamine supplementation in vitro enables nerve cells to resist stresses similar to those that affect the human brain during the course of Alzheimer's disease and glutamine supplementation may have a protective effect on AD pathogenesis in vivo (p10, col 2, para 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use glutamine for treating brain damage and MCI caused by stress or accumulation of amyloid-beta 42 (Aβ42) because of the following reasons. Wurtman already teaches the use of a food supplement comprising glutamine for treating a cognitive or memory disturbance or an Alzheimer's disease, which has MCI and brain damage. Also, Dong et al. further teach that stress and stress hormones was taught to be associated with an increased incidence of MCI and Aβ-mediated neuronal toxicity. In addition, Chen et al. teach that glutamine is essential for the stress-response and post damage survival of cells and glutamine supplementation protects neuronal cells against the amyloid peptide (Aβ1–42). Chen et al. further teach that glutamine supplementation in vitro enables nerve cells to resist stresses similar to those that affect the human brain during the course of Alzheimer's disease and glutamine supplementation may have a protective effect on AD pathogenesis in vivo. Thus, one of ordinary skill in the art would have been motivated to use the glutamine formulation of Wurtman for ameliorating brain damage and MCI caused by stress or accumulation of amyloid-beta 42 (Aβ42) with a reasonable expectation of success based on its neuroprotective effects against Aβ-mediated neuronal toxicity and stress responses as evidenced by Chen et al.
As to the dosage range (18-45 mg/kg/day) recited in claim 9 as amended, Wurtman teaches that the dosage range of glutamine is 1 g/day, 1.5 g/ day, 2 g/day, 3 g/day, 5 g/day, 6 g/day, 8 g/day or 10 g/day ([0073]). For example, “1.5g/day” is about 21.4 mg/kg/day and 3g/day is about 43 mg/kg/day when the average human weight is 70 kg. Thus, the prior art teaches and suggests the dosage overlapping those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 Obviousness of Ranges. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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); 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.”) See MPEP 2144.05 IIA.
As to the limitations (i.e., reduction of reactive oxygen or nitrogen species in brain tissue and restoring cognitive function), those are intended results of the active method step and as such are non-limiting since the language does not result in manipulative difference in steps of claims. The prior art references in combination teach, suggest and motivate administering the same compound (i.e., glutamine) in an overlapping dose range to the same patient (AD patient) as claimed, such intended results necessarily occur since such effects are inherent properties of glutamine. It should be noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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