DETAILED ACTION
Claims 1-30 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-22 in the Reply filed on 1/7/2026, is acknowledged.
Claims 23-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-22 are present for Examination and the subject of the Office Action below.
Priority
The instant application filed 6/2/2022 is a Continuation of 17169271, filed 2/5/2021, now U.S. Patent 11,351,143 and having 1 RCE-type filing therein.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 6/30/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
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 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shchepinov US 10,052,299 issued 8/21/2018.
Claim 1 is directed towards a method for reducing disease progression of ALS in a patient, the method comprising: administering an effective amount of a deuterated arachidonic acid, an ester thereof, or a prodrug thereof, to reduce the disease progression in the patient; wherein a therapeutic concentration of deuterated arachidonic acid in the motor neurons is sufficient to reduce disease progression, wherein the reduction is measured to be at least about 30% reduction relative to the rate of disease progression during the natural history of the patient.
Claim Interpretation, “to reduce the disease progression in the patient,” is the intended use;
“wherein a therapeutic concentration of deuterated arachidonic acid in the motor neurons is sufficient to reduce disease progression,” this simply informs the public as to “an effective amount” in the claim noting that the level in the motor neurons will occur based on the amout in the dose and the overall timeframe of repeated dosing;
“wherein the reduction is measured to be at least about 30% reduction relative to the rate of disease progression during the natural history of the patient,” this is simply a recitation of the outcome of the method step positively recited, this clause does not require measuring, as no measuring step is in the claim.
Therefore the claim requires administration of a deuterated arachidonic acid (or an ester thereof, or a prodrug thereof) to an ALS patient in an amount that will produce a slowing of the disease progression versus without treatment.
Shchepinov teaches a method of treating or inhibiting the progression of neuromuscular disease… treating a patient having Amyotrophic Lateral Sclerosis (ALS)…(Claim 1) with…
the deuterated polyunsaturated fatty acid or fatty acid ester is selected from the group consisting of 11,11-D2-linolenic acid, 14,14-D2-linolenic acid, 11,11,14,14-D4-linolenic acid, 11,11-D2-linoleic acid, 11-D-linolenic acid, 14-D-linolenic acid, 11,14-D2-linolenic acid, and 11-D-linoleic acid (these are AA prodrugs, see claim 5).
Shchepinov teaches the amount of the deuterated compound stating, “wherein the amount of deuterated polyunsaturated fatty acid or fatty acid ester administered to or ingested by the patient is in the range of about 5% to about 75% of the total amount of polyunsaturated fatty acid or fatty acid ester delivered to the patient's body, such that over the treatment period the body of the patient incorporates significant amounts of deuterated polyunsaturated fatty acid or fatty acid ester and undeuterated polyunsaturated fatty acid or fatty acid ester, such that the amount of deuterated polyunsaturated fatty acid or fatty acid ester in the patient's body is sufficient to reduce or prevent autoxidation and cancel toxicity of undeuterated polyunsaturated fatty acid or fatty acid ester in the patient's body.” This amount is anticipatory to the instant “effective amount.”
Instant claim 1 is anticipated.
Instant claim 2 requires, “wherein the therapeutic concentration of deuterated arachidonic acid is determined by its concentration in red blood cells.” This claim does not require the determination of the concentration, only that the “effective amount” on instant claim 1 results in a concentration in red blood cells. This is simply a result of administration. Looking to the MPEP 2111.04 discussing Claim Interpretation, we see this quote about interpreting Contingent Clauses (Wherein): The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In this method, the wherein clause is simply expressing the intended result of a process step positively recited. When a patient with ALS is administered a therapeutically effective amount of a deuterated arachidonic acid, an ester thereof, or a prodrug thereof, the amount in the RBC will rise. As such the clause is not given weight beyond informing the public of the effective amount.
Instant claim 4 requires the prodrug of a deuterated arachidonic acid or ester thereof is a deuterated linoleic acid or ester thereof. This is taught by Shchepinov, see claim 5.
Instant claim 5 requires the deuterated linoleic acid or ester thereof is 11,11-D2-linoleic acid or ester thereof. This is taught by Shchepinov, see claim 5.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shchepinov US 10,052,299 issued 8/21/2018;l in view of Simon et al. “Quantifying Disease Progression in Amyotrophic Lateral Sclerosis,” ANN NEUROL 2014;76:643–657.
Instant claim 3 requires wherein a percent reduction in the rate of disease progression is determined by: measuring a natural rate of disease progression in a patient or an average natural rate of disease progression in a cohort of patients; measuring the rate of disease progression in said the patient or cohort of patients during a period of compliance with the administering step; and calculating the difference between the natural rate and the rate during the period of compliance, dividing the difference by the rate of disease progression during the natural history of the patient, and multiplying by 100.
Shchepinov teaches treating ALS with deuterated polyunsaturated fatty acid or fatty acid ester is selected from the group consisting of 11,11-D2-linolenic acid, 14,14-D2-linolenic acid, 11,11,14,14-D4-linolenic acid, 11,11-D2-linoleic acid, 11-D-linolenic acid, 14-D-linolenic acid, 11,14-D2-linolenic acid, and 11-D-linoleic acid (these are AA prodrugs, see claim 5).
Shchepinov teaches the method involves, “treating or preventing the progression of a neurodegenerative disease,” see the Summary.
Shchepinov teaches, “Identifying a subject having or at risk for developing ALS may be determined using diagnostic methods known in the art. For example, one or a combination of tests may be used such as upper and lower motor neuron signs in a single limb; electromyography (EMG); nerve conduction velocity (NCV) measurement to rule out peripheral neuropathy and myopathy; magnetic resonance imaging (MRI); and/or blood and urine testing to eliminate a possibility of other diseases.”
Shchepinov doesn’t teach comparison of progression of the treatment group versus a cohort of patients not receiving treatment, though this is standard practice in the art.
Simon teaches quantifying disease progression in Amyotrophic Lateral Sclerosis (ALS). Simon does standard diagnostic measurements known for ALS and compared them to control groups.
A person of ordinary skill in the art would look to see if the therapeutic treatment is having an effect and would look to use standard methods of indicating success and use the method of Simon in the use of deuterated polyunsaturated fatty acid as taught by Shchepinov, because one would want to use the progress as an indicator of efficacy of dose and how to proceed with the patient to optimize care. Therefore claim 3 is obvious based on the art.
Claim Rejections - 35 USC § 103
Claims 1-1 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shchepinov US 10,052,299 issued 8/21/2018;l in view of Shchepinov WO 2018094116 A1.
Instant claims 6-8 are directed to the method of claim 1, wherein the deuterated arachidonic acid or ester thereof is 13,13-D2-arachidonic acid. Instant claims 9-10 refine the deuterated polyunsaturated fatty acid to 7,7,10,10,13,13-D6-arachidonic acid or ester thereof.
‘299 teaches treating ALS with deuterated polyunsaturated fatty acid or fatty acid ester is selected from the group consisting of 11,11-D2-linolenic acid, 14,14-D2-linolenic acid, 11,11,14,14-D4-linolenic acid, 11,11-D2-linoleic acid, 11-D-linolenic acid, 14-D-linolenic acid, 11,14-D2-linolenic acid, and 11-D-linoleic acid (these are AA prodrugs, see claim 5).
‘299 teaches deuterated polyunsaturated fatty acid like LA convert to AA, “ LA, by further enzymatic desaturation and elongation, is converted into higher n-6 PUFAs such as arachidonic (AA; 20:4; n-6)” Noting the produg LA will then form AA in the body of the treated subject.
‘299 teaches D-Arachidonic acids include:
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The per-deuterated arachidonic acid below may be produced by microbiological methods, such as by growing in media containing D and 13C.
‘299 teaches in claim 19 that the AA can be given directly, or as the treatment, “wherein the isotopically modified polyunsaturated fatty acid or ester thereof is an arachidonic acid or ester thereof.”
‘299 doesn’t name the compounds required by the instant claims 6-10, though the are drawn.
‘116 names them, stating [0194], 13,13-D2 arachidonic acid. This is the compound required by instant claims 6-8. ‘116 names 7, 10, 13- D6 arachidonic acid. [0194], the compound of the instant claims 9-10.
A person of ordinary skill in the art would look to use the compounds of ‘299 and ‘116 to treat ALS as they are taught as equivalent in treating the disease. Their equivalence is taught as they all show efficacy as being found in the neurons and displacing the non-deuterated forms in the membranes, as such claims to these specific compounds are prima facie obvious.
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.
U.S. Patent No. 11351143
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11351143. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘143 method of treating ALS anticipates the instant, the ‘143 is directed to using 11,11-D2-linoleic acid in a primer and maintenance dosing method.
U.S. Patent No. 11510889
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 14 of U.S. Patent No. 11510889. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘889 method of treating ALS (claim 2) anticipates the instant, the ‘889 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
U.S. Patent No. 11491130
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11491130. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘130 method of treating ALS (claim 2) anticipates the instant, the ‘130 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
Copending Application No. 17938256
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17938256 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘256 method of treating ALS (claim 2) anticipates the instant, the ‘256 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17949713
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-12, and 18-21 of copending Application No. 17949713 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘713 method of treating ALS anticipates the instant, the ‘713 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17938256
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17938256 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘256 method of treating ALS anticipates the instant, the ‘256 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 18275972
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18275972 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘972 method of treating ALS anticipates the instant, the ‘972 is directed to using deuterated arachidonic acid in a primer and maintenance dosing method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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