Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Amendment Entry
1. Applicant's amendment / response filed December 1, 2025 is acknowledged and has been entered. Claims 1, 3, 8, 9, and 19 have been amended. Claims 20-22 have been added. Claims 6 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Accordingly, claims 1-22 are pending. Claims 1-5, 7-10, and 12-22 are under examination.
Withdrawn Rejections / Objections
2. Any objection or rejection not reiterated herein, has been withdrawn.
Priority
3. The application is a continuation of U.S. Patent Application (ASN) 16/371,432 filed 04/01/2019; which is a continuation of ASN 15/699,664 filed 09/08/2017; which is a continuation of ASN 14/181,661 filed 02/15/2014; which claims the benefit of Provisional Application 61/765,370 filed 02/15/2013. Based on the filing receipt, the effective filing date of this application, therefore, is February 15, 2013 which is the filing date of Provisional Application 61/765,370 from which the benefit of priority is claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
4. Claims 1-5, 7-10, and 12-22 are rejected under 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In this case, the specification does not appear to provide literal or descriptive support for the recitations of "wherein the measurement … is independent of any alteration of the gene encoding the protein" and “without altering the gene encoding the protein” in claims 1 and 9; and “wherein the alteration of the gene encoding the protein comprises a mutation” in claims 20 and 21. Applicant points to paragraphs [0005, 0019, 0023, 0031, 0071, 0074] for support which provides in [0005] that all phenotypes are due to change in protein function that occur directly at protein level without genomic damage but fails to provide adequate description for such recitations in claims 1, 9, 20, and 21. Applicant also points to paragraph [0071] for support wherein the example shows that mistakes in amino acid sequence lead to increased oxidative susceptibility; and the two point mutations associated with PD in the gene coding for α-synuclein, A30P and A53T, are studied in comparison to WT α-synuclein; although nowhere in Example 1 provides the required literal or descriptive support for such recitations in claims 1, 9, 20, and 21. Furthermore, none of the originally filed claims recited the new limitation, in question. Recitation of claim limitations lacking literal or adequate description in the specification or originally filed claims constitutes new matter.
Claim Rejections - 35 USC § 102
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
5. Claims 1-5, 7-10, and 12-22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Esteves et al. (Oxidative stress involvement in alpha-synuclein oligomerization in Parkinson’s disease cybrids. Antioxid Redox Signal. 11 (3): 439-448 (Abstract Only)) for reasons of record and as follows.
Esteves et al. teach screening for degenerative Parkinson’s disease (PD) therapies and treating the PD in mammals. Esteves et al. teach (1) performing a measurement of protein-specific oxidative damage (oxidative stress) in a protein which is specifically α-synuclein, wherein the measurement is a phenotypic assessment at the protein level. Esteves et al. teach measuring an elevated protein-specific oxidative damage, wherein the protein-specific oxidative damage measured is protein carbonylation (protein carbonyl level). Esteves et al. further teach (2) screening for a treatment of PD by reducing the level of protein-specific oxidative damage to α-synuclein, intracellular reactive oxygen species (ROS) production, and protein carbonylation. The treatment used are antioxidants C0Q10 and GSH. Esteves et al. specifically teach that treatment with antioxidants C0Q10 and GSH reduces the level of ROS and protein carbonylation. Indeed, Esteves et al. conclude that the two different antioxidants can decrease α-synuclein as measured by phenotypic assessment at the protein level of α-synuclein, independent of any alteration of the gene encoding the protein, specifically only by preventing protein carbonylation. See entire Abstract. Accordingly, the teaching of Esteves et al. appears to read on Applicant’s claimed invention.
6. Claims 1-5, 7, 9, 10, 12-18, 20-22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Moinard et al. (US 2010/0093863) for reasons of record and as follows.
Moinard et al. disclose a method of screening (preventing) for neurodegenerative disease therapies and treating the neurodegenerative disease in a mammal diagnosed with the neurodegenerative disease comprising the steps of: (1) performing a diagnostic measurement of protein-specific oxidative damage in cerebral proteins, wherein the measured protein-specific oxidative damage is increased, and wherein the measured protein-specific oxidative damage is shown as increased protein carbonylation [0002, 0003, 0017, 0018, 0063, 0065]. The method further comprises (2) screening for a preventative treatment of the neurodegenerative disease such as L-citrulline which is found to reduce or inhibit an increase in the level of relevant protein carbonylation observed in mammals having the PD or Alzheimer’s Disease (AD) and treating the PD or AD such as by way of L-citrulline dietary supplement [0017, 0018, 0020, 0025, 0065]. Indeed, Moinard et al. measured protein assessment at the protein level, independent of any discussion of alteration of the gene encoding the protein, wherein the protein-specific oxidative damage reverses the phenotype at the protein level without apparent alteration of the gene encoding the protein. Accordingly, the teaching of Moinard et al. appears to read on Applicant’s claimed invention.
Response to Arguments
7. Applicant's arguments filed December 1, 2025 have been fully considered but they are not persuasive.
A) Applicant argues that Esteves et al. does not teach the limitation “phenotypic assessment at the protein level” which is “independent of any alteration of the gene encoding the protein" and “reducing the measured protein-specific oxidative damage reverses the phenotype without altering the gene encoding the protein.”
Applicant’s argument is not persuasive because as set forth herein supra, Esteves et al. does not exclude the limitations of amended claim 1. In particular, Esteves et al. teach conclude that the two different antioxidants can decrease α-synuclein as measured by phenotypic assessment at the protein level of α-synuclein, independent of any alteration of the gene encoding the protein, specifically only by preventing protein carbonylation. Accordingly, the rejection is maintained for reasons of record.
B) Applicant argues that Moinard et al. does not teach the limitation “phenotypic assessment at the protein level” which is “independent of any alteration of the gene encoding the protein" and “reducing the measured protein-specific oxidative damage reverses the phenotype without altering the gene encoding the protein.”
Applicant’s argument is not persuasive because Esteves et al. does not exclude the limitations of amended claim 1. In particular, Moinard et al. teach measuring protein assessment at the protein level, independent of any discussion of alteration of the gene encoding the protein, wherein the protein-specific oxidative damage reverses the phenotype at the protein level without apparent alteration of the gene encoding the protein. Accordingly, the rejection is maintained for reasons of record.
8. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
April 4, 2026