DETAILED ACTION
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 .
Claims 1-13 and 17 are pending.
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.
Claim(s) 1-13, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2012/148926 (‘926), from IDS filed 11/7/2024 in view of Kollewe et al., Journal of the Neurological Sciences 275 (2008) 69–73.
‘926 teaches the deuterated linoleic acid such as 11,11-D2-linoleic acid as effective in treating ALS by attenuating the lipid peroxidation associated oxidative stress (see example 14, [0044]-[0045], [0189]-[0190]). ‘926 teaches other D2-lnioleic acids as useful in reducing oxidative stress (see claim 10) for example).
‘926 does not teach the use of ALSFS-R test for assessing the severity of ALS.
Kollewe et al. teaches ALSFRS-R score and its change over time can be a predictor for ALS prognosis (see the abstract). Kollewe et al. teaches “The mean ALSFRS-R score was 38.3 (SD 1.4, median 39, minimum 26, maximum48).For analysis, patients with an ALSFRS-R score below the median of 39 points were separated from those with a score above 39 points (Fig. 6). A low rank of ALSFRS-R score at the first visit correlated with a shorter survival time (log-rank p b 0.01). Patients with a value lower than 39 had a median survival time of 28 months (95% CI 21–35). However, patients with a value higher than 39 points had a longer median survival time of 59 months (95% CI 45–64).” (see page 71, col. 1, Section 3.3).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38.
One of ordinary skill in the art would have been motivated to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38. Since with ALSFRS-R score below 38 would indicates worse survival time, treating the patients suffered with ALS would be a priority. Such treatment would be reasonably expected to have prolonged the patients’ survival rate.
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 1-13, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,491,130 (‘130) in view of Kollewe et al. ‘130 teaches the use of 11,11-D2 linoleic acid in a method of treating neurodegenerative disease ALS (see claim 1).
‘130 does not expressly teach the use of ALSFS-R test for assessing the severity of ALS.
Kollewe et al. teaches ALSFRS-R score and its change over time can be a predictor for ALS prognosis (see the abstract). Kollewe et al. teaches “The mean ALSFRS-R score was 38.3 (SD 1.4, median 39, minimum 26, maximum48).For analysis, patients with an ALSFRS-R score below the median of 39 points were separated from those with a score above 39 points (Fig. 6). A low rank of ALSFRS-R score at the first visit correlated with a shorter survival time (log-rank p b 0.01). Patients with a value lower than 39 had a median survival time of 28 months (95% CI 21–35). However, patients with a value higher than 39 points had a longer median survival time of 59 months (95% CI 45–64).” (see page 71, col. 1, Section 3.3).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38.
One of ordinary skill in the art would have been motivated to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38. Since with ALSFRS-R score below 38 would indicates worse survival time, treating the patients suffered with ALS would be a priority. Such treatment would be reasonably expected to have prolonged the patients’ survival rate.
Claims 1-13, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,351,143 (‘143) in view of Kollewe et al. ‘143 teaches the use of 11,11-D2 linoleic acid in a method of treating neurodegenerative disease ALS (see claim 1).
‘143 does not expressly teach the use of ALSFS-R test for assessing the severity of ALS.
Kollewe et al. teaches ALSFRS-R score and its change over time can be a predictor for ALS prognosis (see the abstract). Kollewe et al. teaches “The mean ALSFRS-R score was 38.3 (SD 1.4, median 39, minimum 26, maximum48).For analysis, patients with an ALSFRS-R score below the median of 39 points were separated from those with a score above 39 points (Fig. 6). A low rank of ALSFRS-R score at the first visit correlated with a shorter survival time (log-rank p b 0.01). Patients with a value lower than 39 had a median survival time of 28 months (95% CI 21–35). However, patients with a value higher than 39 points had a longer median survival time of 59 months (95% CI 45–64).” (see page 71, col. 1, Section 3.3).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38.
One of ordinary skill in the art would have been motivated to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38. Since with ALSFRS-R score below 38 would indicates worse survival time, treating the patients suffered with ALS would be a priority. Such treatment would be reasonably expected to have prolonged the patients’ survival rate.
Claims 1-13, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,673,037 (‘037) in view of Kollewe et al. ‘037 teaches the use of 11,11-D2 linoleic acid in a method of treating ALS (see claim 1).
‘037 does not expressly teach the use of ALSFS-R test for assessing the severity of ALS.
Kollewe et al. teaches ALSFRS-R score and its change over time can be a predictor for ALS prognosis (see the abstract). Kollewe et al. teaches “The mean ALSFRS-R score was 38.3 (SD 1.4, median 39, minimum 26, maximum48).For analysis, patients with an ALSFRS-R score below the median of 39 points were separated from those with a score above 39 points (Fig. 6). A low rank of ALSFRS-R score at the first visit correlated with a shorter survival time (log-rank p b 0.01). Patients with a value lower than 39 had a median survival time of 28 months (95% CI 21–35). However, patients with a value higher than 39 points had a longer median survival time of 59 months (95% CI 45–64).” (see page 71, col. 1, Section 3.3).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38.
One of ordinary skill in the art would have been motivated to employ the herein claimed deuterated linoleic acids to treat ALS in patients with ALSFRS-R score below 38. Since with ALSFRS-R score below 38 would indicates worse survival time, treating the patients suffered with ALS would be a priority. Such treatment would be reasonably expected to have prolonged the patients’ survival rate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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