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 .
Status
Pursuant to preliminary amendment, claims 1, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 are pending.
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.
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.
Claim(s) 1, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clunas et al. (US 9,283,230 B2; issued 15 March 2016) in view of Grimm et al. (WO 2010/104394 A1; published 16 September 2010).
Clunas et al. discloses use of phenothiazine diaminium salt compounds for treating tauopathies such as Alzheimer’s disease (column 1 lines 5-13) and Pick’s disease (i.e., behavioral variant frontotemporal dementia, bvFTD) (column 37 lines 31-33; column 40 lines 3-6) and semantic dementia and progressive non-fluent aphasia (i.e., a type of primary progressive aphasia) (column 40 lines 3-45) and Huntington’s disease and spinal bulbar muscular atrophy and dentatorubropallidoluysian and spinocerebellar ataxias (column 37 lines 63-67) and Parkinson’s disease (column 37 lines 61-62) and dementia with Lewy bodies (column 37 line 43) and multiple system atrophy and hereditary cerebral angiopathy and amyotrophic lateral sclerosis and familial encephalopathy with neuronal inclusion bodies (column 33 table) and Lafora disease (column 42 lines 7-29) and chronic traumatic encephalopathy and MCI (i.e., mild cognitive impairment) (column 37 lines 44-47) wherein treatment may be therapeutic or prophylactic (column 7 lines 46-50) wherein treatment comprises administering to a patient in need of treatment a prophylactically or therapeutically effective amount of compound (column 30 lines 53-57) wherein a particular compound is LMTM (column 17 lines 40-64) wherein the compound may alternatively be another member of the leuco-methylthionium family of salts such as LMT.2HBr or LMT.2HCl (column 49 line 36 to column 50 line 28) or LMT-2EsOH or LMT-2TsOH or LMT-2BSA or LMT-EDSA or LMT-PDSA or LMT-NDSA (column 16 line 22 to column 17 line 40) wherein a route of administration is oral (column 45 lines 20-21) and preferred compositions are oral compositions (column 45 line 35) wherein the subject/patient may be human (column 45 line 49) wherein a suitable dose of the compound is typically about 1 µg to about 10 mg per kilogram of body weight of the subject per day (column 57 lines 7-9) wherein administration can be in one dose (column 56 line 64) or 2 times daily (column 57 lines 13-18) wherein treatment may optionally be combined with a cholinesterase inhibitor such as donepezil or rivastigmine or galantamine or an NMDA receptor antagonist such as memantine or an inhibitor of amyloid precursor protein processing that leads to enhanced generation of beta-amyloid (column 38 lines 6-15) wherein treatment includes combination treatments sequentially or simultaneously wherein the compound and other agent(s) may be administered in individually varying dose schedules (column 44 line 50 to column 45 line 1) wherein optimal dosage balances therapeutic benefit against side effects and methods of determining dosage are well known to those of skill in the art (column 56 lines 45 to column 57 line 6).
Clunas et al. does not specifically disclose a total daily dose of 20.5-60 mg as claimed.
Grimm et al. teaches treatment of Alzheimer’s disease (title) or amyloidosis (page 1 lines 1-3) wherein a human adult average weight is disclosed as about 70 kg (page 7 lines 26-27).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Clunas et al. and Grimm et al. by practicing the method of therapeutic or prophylactic treatment of Clunas et al. for therapeutic or prophylactic treatment of a disease as discussed above wherein the subject/patient is of human adult average weight of about 70 kg as taught by Grimm et al., and thus the daily dosage in the method of Clunas et al. is about 70 µg to about 700 mg (i.e., about 1 µg to about 10 mg per 70 kilograms of body weight, or about 1 µg times 70 to about 10 mg times 70), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to combine the teachings because Clunas et al. teaches a daily dosage based on total body weight of a patient and thus practicing the method of Clunas et al. on a typical or average patient would naturally have led a person of ordinary skill in the art to include in the method the body weight of an average person. Such daily dosage of about 70 µg to about 700 mg overlaps the claimed ranges of 20.5-60 mg, 20.5-40 mg, 21-40 mg, 21-32 mg, 24-32 mg, and about 30 mg, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I). Furthermore, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the therapeutic or prophylactic efficacy of the method of Clunas et al. as discussed above by varying the daily dosage of the compound used in such method through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Clunas et al. teaches that optimal dosage balances therapeutic benefit against side effects and methods of determining dosage are well known to those of skill in the art, and also given that dosage amounts are known result effective variables. See, e.g., Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
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, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,065,256.
Although the claims at issue are not identical, they are not patentably distinct from each other because the daily dose range in the ‘256 claims (0.5-20 mg) is so close to the instantly claimed daily dose range (20.5-60 mg) that a prima facie case of obviousness exists per MPEP 2144.05(I). See also, e.g., In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%).
Claims 1, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,759,469.
Although the claims at issue are not identical, they are not patentably distinct from each other because the daily dose range in the ‘469 claims (0.5-20 mg) is so close to the instantly claimed daily dose range (20.5-60 mg) that a prima facie case of obviousness exists per MPEP 2144.05(I). See also, e.g., In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%).
Claims 1, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,128,051.
Although the claims at issue are not identical, they are not patentably distinct from each other because the daily dose range in the ‘051 claims (0.5-20 mg) is so close to the instantly claimed daily dose range (20.5-60 mg) that a prima facie case of obviousness exists per MPEP 2144.05(I). See also, e.g., In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%).
Claims 1, 4, 6-8, 21, 26-29, 44, 47-49, 51-53, 56, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,263,175.
Although the claims at issue are not identical, they are not patentably distinct from each other because the bvFTD of the ‘175 claims is merely a type of FTD encompassed by the instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
