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
The office acknowledges Applicants filing of the claim amendments and arguments on 01/21/2026. Claims 1, 3 has been amended and claims 25-28 has been added new. Claims 4-5, 12, 23, 24 have been cancelled. Applicants arguments regarding the rejections have been fully considered. Arguments, which are directed to withdrawn rejections, are thus rendered moot. The arguments in regards to the reiterated rejections/references from the previous office action are addressed below. In view of Applicant's claim amendments, the following rejections have been modified. The action is made final.
Claims 1-3, 6-11, 13-22, 25-28 are pending. Claims 13-22 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are 1-3, 6-11, 25-28 and are herein acted on the merits.
Response to Applicants Arguments
103 rejection: Kurzchalia in view of Huang:
Applicants’ argue that Kurzchalia fails to teach glycolic acid as a general neuro-therapeutic agent to be combined with any other compound. Kurzchalia teaches a specific combination of glycolic acid and D-lactic acid for treating a decline in mitochondrial activity (para. [0007]).
In response, Kurzchalia is explicit in teaching the use of glycolic acid, its salt or its ester by itself or in combination with D-lactic acid. The combination of glycolic acid with lactic acid is one of the embodiments taught by the reference. Kurzchalia teaches not just the specific combination as applicants have argued. The reference teaches the agents to be used separately and as a combination. Further the reference is explicit in teaching the glycolic acid combination with other agents such as pyruvic acid (to have an additive effects) [0041], other antioxidants [0042], one or more Vitamins [0046] to have additive beneficial or even synergistic effect [0048]. Also taught is combination with other amino acids such as L-arginine, and other agents, L-carnitine or L-creatine [0054], [0058]. The agents may be co-formulated or separately administered [0059].
Applicants argue that Huang does not teach L- alanine as a standalone neuro-therapeutic agent. Huang, in contrast, consistently and exclusively discloses compositions of keto acids (e.g., a-ketoisocaproate or a-ketoisovalerate) in combination with alanine. The central teaching of this disclosure is the synergistic effect of this specific combination to reduce A3 toxicity in an Alzheimer's model (see para. [0013]-[0015] and Fig. 7- 15).
In response, Huang teach alanine in combination with other agents. It is noted that the claims examined are to a pharmaceutical combination with a comprising language and is not limited to specific agents or just glycolic acid and L-alanine. It is noted the combination composition can be as an admixture with all active agents or can be separately placed and used in combination for administration. The admixture or the composition(s) placed separately can contain glycolic acid, L-alanine and other agents as claimed. Hence a skilled artisan from Huang would have found it obvious to use a composition that comprises L-alanine and other agents in combination with a composition that comprises glycolic acid by itself or comprising other agents taught by Kurzchalia to arrive at the claimed pharmaceutical combination. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Applicants argue that the only motivation for such a combination comes from the pending claims: this has been repeated noted as improper hindsight in looking to the claims for a synergistic effect and then cherry-picking keywords from references. Instead, it is respectfully submitted that a PHOSITA would have been motivated to pursue one of two mutually exclusive paths: (1) use the glycolic acid/D-lactate pair taught by Kurzchalia to address mitochondrial dysfunction, or (2) use the a-ketoisocaproate/alanine pair taught by Huang to address A3 toxicity. A PHOSITA would not have been motivated to replace the D-lactic acid of the specific combination disclosed in Kurzchalia with the alanine from Huang's entirely different keto-acid-based combination; and at best this reference combination is an invitation to experimentation with no reason to arrive at the claimed invention from the myriad possible combinations; based on the lack of suggestion in either reference that alanine and D-lactic acid are interchangeable, or that alanine would work synergistically with glycolic acid to address mitochondrial dysfunction. Thus, the synergistic effects being claimed merits patentable weight.
In response, as stated above Kurzchalia teaches the use of glycolic acid by itself for the treatment of neurodegenerative diseases. The combination of glycolic acid with lactic acid is one of the embodiments taught by the reference. “in a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
As to the motivation, the motivation in the prior art to combine the references does not have to be identical to that of the applicant or as applicants have argued to establish obviousness. As above, a person skilled in the art would have found it obvious to combine a pharmaceutical composition comprising glycolic acid and other agent(s) and a composition that comprises alanine and other agent(s) to treat neurodegenerative diseases.
In regards to the hindsight, no hindsight reasoning was employed in rejecting the claims over the prior art because it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Kurzchalia has been relied upon to teach glycolic acid composition for treating neurodegenerative disease. Huang for the use of a composition comprising ketoisocaproate and alanine for treating neurodegenerative disease. A person skilled in the art would have found it obvious to formulate a pharmaceutical combination of the two compositions to treat neurodegenerative diseases.
Applicants argue that Kurzchalia, makes the explicit and surprising finding that while D-lactic acid is effective in its combination, the optical isomer thereof, L-lactic acid, is 'surprisingly not suitable' for the intended treatment (see para. [0011]). Alanine and lactic acid are both simple, small organic acids. If a skilled person cannot predictably substitute one stereoisomer of lactic acid for another stereoisomer in the formulation described in Kurzchalia, there is no basis to believe they could predictably substitute the structurally different amino acid, L-alanine, and achieve a successful result. As such, the prior art fails to teach, suggest, or motivate all elements recited in currently amended instant claim 1. Based on the amendments and remarks, independent claim 1 and all claims dependent are in allowable form over the outstanding obviousness rejection of Kurzchalia in view of Huang.
In response, Kurzchalia is explicit in teaching the composition comprising just glycolic acid or in combination with lactic acid for use in the method of treating neurodegenerative diseases. There is no reason to interpret that alanine was substituted for lactic acid in the method. Kurzchalia has been relied upon to teach glycolic acid composition for treating neurodegenerative disease. Huang for the use of a composition comprising ketoisocaproate and alanine for treating neurodegenerative disease. A person skilled in the art would have found it obvious to formulate a pharmaceutical combination of the two compositions to treat neurodegenerative diseases with a reasonable expectation of success.
(ii) ODP rejection:
Applicants argue that as the scope of the claims is sufficiently different and indeed could not have been made in U.S. Patent No. 10434077, it is submitted that no public policy concern exists. Furthermore, Huang is deficient is bolstering the findings of U.S. Patent No. 10434077 for the reasons detailed above. In light of the amendments and remarks, the nonstatutory double patenting rejection has been obviated and the rejection be withdrawn.
In response, for the reasons cited in the rejection below and above in regards to Huang the rejection has been maintained and modified in light of the amendments. The rejection is proper and thus maintained.
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.
Claim(s) 1-3, 7-11, 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kurzchalia (IDS: US 20170326085 A1) in view of Huang (IDS: WO 2019038655).
Kurzchalia teach a composition comprising glycolic acid and/or lactic acid or a pharmaceutically acceptable salt in a method of treating neurodegenerative diseases, e.g. Alzheimer's disease, Huntington's disease, Amyotrophic lateral sclerosis (See claims 28, 16, 17, abstract, title). The pharmaceutical formulation is formulated for oral administration [0067] and can be formulated as a simple mixture with water [0036]. The composition can comprise an amount of at least 0.005% to at least 0.01 % (w/w) of glycolic acid ([0032], [0065]). The reference teach glycolic acid solution wherein pH is 7.4 [0105]. The formulation can additionally comprise Vitamins [0046-0047]).
Kurzchalia is not explicit in teaching alanine in the composition.
Huang teach compositions comprising alanine in the treatment of neurodegenerative diseases, e.g. Alzheimer's disease, Parkinson's disease, or Huntington disease; the composition can be administered for oral or parenteral administration (claims 1, 14-18). The reference teach that the alanine used in the composition can include L-alanine (A4349, Sigma) [0123]. Huang teach compositions may also include one or more pH adjusting agents or buffering agents, including acids such as acetic, boric, citric, lactic acid [0063]. The pharmaceutical compositions invention may be administered by any suitable route including oral, parenteral (intravenous). It is taught that the concentration of alanine is about 1 μΜ to about 16 mM [0007].
From Huang a skilled artisan before the effective filing date of the invention would have found it obvious to add alanine in Kurzchalia pharmaceutical composition. A person skilled in the art would have been motivated to add alanine in the composition comprising glycolic acid with a reasonable amount of success and use it in the treatment of neurodegenerative diseases, e.g. Alzheimer’s disease. Further it is within the skill of an artisan to combine agents (e.g. alanine and glycolic acid) known in the art for the treatment of a disease, e.g. herein neurodegenerative condition to provide synergistic or additive therapeutic effects. As to L-alanine it would have been obvious to add that in the composition because the reference teach that L-alanine (A4349, Sigma) is commercially available and can be used in formulation of the composition. As to the ratio of glycolic acid: L-alanine, Kurzchalia teach 0.005% -0.01 % (w/w) of glycolic acid and Huang teach an amount of 1uM-16mM of alanine that can be added to a composition to treat neurodegenerative disorders. For example if 0.009% of glycolic acid and 1 mM of alanine (equivalent to 0.0891) is formulated in combination or separate for the use of treating neurodegenerative disorders the ratio of glycolic acid: alanine will be 1:1. Further it is within the skill of an artisan to adjust the amounts in a composition and arrive at the claimed ratio and it is routine. Where 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). As to the administration oral and parenteral administration of the active agents are taught by the prior art. Thus claims 1, 3, 7, 8, 25-28 would have been obvious over the prior art teachings.
As to claims 2, 9 the reference teaches lactic acid and citric acid can be added to the composition. A person skilled in the art would have found it obvious to add salts of citric acid and/or lactic acid to the composition as salts to improve solubility, stability, absorption, and manufacturability by modifying the physicochemical properties of the active(s).
As to claims 10-11, Kurzchalia teach glycolic acid solution in the composition, pH 7.4. Though the reference is not explicit in teaching the glycolic acid solution is 5-30 wt% it is within the skill of an artisan to adjust the concentration of the agent and it is routine. It is noted that claim 10 has been interpreted as glycolic acid present as a solution and not as the combination that comprises additionally glycolic acid solution.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kurzchalia (IDS: US 20170326085 A1) in view of Huang (IDS: WO 2019038655) and further in view of Steffan et al. (US 20040142859).
Kurzchalia and Huang teachings as discussed above. The above rejection is incorporated herein. The references do not teach phenylbutyrate and/or tauroursodeoxycholic acid in the pharmaceutical combination comprising alanine and glycolic acid.
Steffan teach the use of sodium phenylbutyrate in the treatment of Alzheimer’s disease (See claims 33, 36).
From Steffan a skilled artisan before the effective filing date of the invention would have found it obvious to add phenylbutyrate in the pharmaceutical composition comprising alanine and glycolic acid. A person skilled in the art would have been motivated to add phenylbutyrate in the composition with a reasonable amount of success and use it in the treatment of neurodegenerative diseases, e.g. Alzheimer’s disease. Further it is within the skill of an artisan to combine the agents (alanine, glycolic acid and phenylbutyrate) known in the art for the treatment of a disease, e.g. herein neurodegenerative condition, Alzheimer’s disease to provide synergistic or additive therapeutic effects. Thus claim 6 is addressed.
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 28 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.
Claim 28 is directed to:
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A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 28 recites broader and narrower limitations, for example, sublingual can be oral type administration, rectal and intranasal can be transmucosal type, intrathecal, intramuscular, intraperitoneal etc. are parenteral types, intravitreal is an intraocular type etc.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction and clarification is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7-9, 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10434077 in view of Huang (WO 2019038655).
The instant claims are directed to:
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The dependent claims are limited to the combination mixtures, admixture of alanine and glycolic acid, the composition further comprising phenylbutyrate and/or tauroursodeoxycholic acid, pyridoxine and/or citrate, the composition suitable for oral, injection administration, the glycolic acid solution (5-30%), pH, 3-9, glycolic acid: L-alanine is 50:1 to 1:1 or 5:1 to 1:1 and to select administration forms.
‘077 reference claims are directed to:
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The reference claims are not explicit in teaching alanine in a pharmaceutical combination as claimed.
Huang teach compositions comprising alanine in the treatment of neurodegenerative diseases, e.g. Alzheimer's disease, Parkinson's disease, or Huntington disease; the composition can be administered for oral or parenteral administration (claims 1, 14-18). The reference teach that the alanine used in the composition can include L-alanine (A4349, Sigma) [0123]. Huang teach compositions may also include one or more pH adjusting agents or buffering agents, including acids such as acetic, boric, citric, lactic acid [0063]. The pharmaceutical compositions invention may be administered by any suitable route including oral, parenteral (intravenous). It is taught that the concentration of alanine is about 1 μΜ to about 16 mM [0007].
From Huang a skilled artisan before the effective filing date of the invention would have found it obvious to add alanine in the reference claim pharmaceutical composition with a reasonable amount of success and use it in the treatment of neurodegenerative diseases, e.g. Alzheimer’s disease. Further it is within the skill of an artisan to combine agents (e.g. alanine and glycolic acid) known in the art for the treatment of a disease, e.g. herein neurodegenerative condition to provide synergistic or additive therapeutic effects. As to L-alanine it would have been obvious to add that in the composition because the reference teach that L-alanine (A4349, Sigma) is commercially available and can be used in formulation of the composition. As to the ratio of glycolic acid: L-alanine, the reference claims teach an amount of 0.005% (w/w) of glycolic acid and Huang teach alanine can be added in a concentration of about 1 μΜ to about 16 mM to treat neurodegenerative disorders. For example if 0.009% of glycolic acid and 1 mM of alanine (equivalent to 0.0891) is formulated in combination or separate for the use of treating neurodegenerative disorders the ratio of glycolic acid: alanine will be 1:1. Further it is within the skill of an artisan to adjust the amounts in a composition and arrive at the claimed ratio and it is routine. Where 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). As to the administration, Huang teach oral or parenteral (injection) administration of the active agent(s). Thus a skilled artisan would have found it obvious to administer the pharmaceutical combination that comprises glycolic acid and L-alanine orally to subject to derive therapeutic effects. Thus claims 1, 3, 7, 8, 25-28 would have been obvious over the prior art teachings.
As to claim 2, the reference claim teaches lactic acid can be added to the composition. As to claim 9, Huang teach that citric acid and lactic acid agents can be added to the composition. A person skilled in the art would have found it obvious to add salts of citric acid and/or lactic acid to the composition as salts to improve solubility, stability, absorption, and manufacturability by modifying the physicochemical properties of the active(s).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over claims 1-12 of U.S. Patent No. 10434077 (‘077) in view of Huang (WO 2019038655) and further in view of Steffan et al. (US 20040142859).
The instant claims as above.
‘077 reference claims and Huang teachings as discussed above. The above rejection is incorporated herein. The reference claims and Huang do not teach phenylbutyrate and/or tauroursodeoxycholic acid in the pharmaceutical combination comprising alanine and glycolic acid.
Steffan teach the use of sodium phenylbutyrate in the treatment of Alzheimer’s disease (See claims 33, 36).
From Steffan a skilled artisan before the effective filing date of the invention would have found it obvious to add phenylbutyrate in the pharmaceutical composition comprising alanine and glycolic acid. A person skilled in the art would have been motivated to add phenylbutyrate in the composition with a reasonable amount of success and use it in the treatment of neurodegenerative diseases, e.g. Alzheimer’s disease. Further it is within the skill of an artisan to combine the agents (alanine, glycolic acid and phenylbutyrate) known in the art for the treatment of a disease, e.g. herein neurodegenerative condition, Alzheimer’s disease to provide synergistic or additive therapeutic effects. Thus claim 6 is addressed.
Conclusion
Applicant's amendment necessitated the modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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