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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/26 has been entered.
Maintained rejections
Rejections under 35 USC 103 as set forth in the final office action mailed on 10/20/26 are maintained. Reply to applicant’s arguments filed on 2/20/26 follows the text of the rejection of record.
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) 94-103 and 105-119 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinsby et al (US 2019/0111041; published 4/18/19).
In paragraph [0163] Hinsby teaches N-[2-hydroxy-3-{1-piperdinyl)-propoxy]-pyridine-1-oxide-3-carboxymidoyl chloride (arimoclomol), including its stereoisomers and acid addition salts. Hinsby teaches that arimoclomol can be used in a method of reducing risk in an individual of developing GBA-associated Parkinson’s disease wherein said individual is a patient with type I, II or III Gaucher’s disease.
Hinsdy’s teaching of administration of arimoclomol to a subject with Gaucher’s disease meets the limitation of current claims directed to treatment of Gaucher disease because the sole active step of the claims is practiced when arimoclomol (the claimed agent) is administered to a subject with Gaucher Disease (the claimed subject population).
Regarding therapeutically effective dose, route and frequency of administration:
Hinsby teaches that the therapeutically effective dose for a specific subject depends on various parameters including severity of the condition, weight and general state of the subject (paragraph [0181]). The recommended daily dose recited in paragraph [0181] encompasses all of the currently claimed doses. In paragraph [0183] art teaches various frequencies of administration including 1-3 times per day. Oral administration is described as a suitable route in paragraph [0186].
Regarding specific stereoisomers of arimoclomol, and specific acid addition salts:
In paragraph [0163] Hinsby teaches that stereo isomers and acid addition salts are within scope of agents that are suitable for administration to a subject with Gaucher disease. The (+)-R and (-)-S isomers as either citrate or maleate acid addition salts for use in the disclosed method are recited in paragraphs [0055] and [0176].
Regarding GBA activity, Hinsby teaches treatment of GBA-associated Parkinson’s disease with reduced GBA enzyme activity and/or levels (paragraph [0112].
Regarding limitations directed to signs of brain involvement:
Hinsby teaches treatment of GBA-associated Parkinson’s disease in a subject with reduced GBA enzyme activity. Since reduced GBA enzyme activity is a feature of Gaucher’s Disease, and Goucher’s disease is taught to be a contributing factor to GBA-associated Parkinson’s disease, it would have been obvious to treat GBA-associated Parkinson’s disease in a subject with Gaucher’s disease by administering to said subject an effective amount of arimoclomol. Examiner is interpreting GBA-associated Parkinson’s disease to meet the limitation directed to “with brain involvement”, “with clinical signs of brain involvement”, and “with at least 1 neurological symptom”.
Regarding subject not having been treated for Gaucher’s disease:
Hinsby does not recite whether subjects with Goucher’s disease to whom arimoclomol is administered have received prior treatment for Goucher’s disease. Examiner is interpreting this lack of teaching directed to prior treatment to imply that both treated and untreated groups are withint he scope of Hinsby’s disclosure. It would have been obvious to treat any subject with Gaucher’s disease by administering an effective amount of arimoclomol with an expectation that treatment will result in reduction of risk of developing GBA-associated Parkinson’s disease (paragraph [0163]).
Regarding subject’s age:
Gaucher’s disease is a genetic disorder which can affect subjects at very early age. It would have been obvious to administer arimoclomol to any subject with Gaucher’s disease with an expectation that treatment will result in reduction of risk of developing GBA-associated Parkinson’s disease.
The rejection above argues that it would have been obvious to treat and to reduce likelihood of GBA-associated Parkinson’s disease in a subject with Goucher’s disease. However, based on the disclosure of Hinsby, it would also be obvious to directly treat Gaucher’s disease in a subject in need of such treatment.
Interpretation of art’s disclosure with regards to treatment of Gaucher’s disease:
Hinsby teaches that they have discovered that arimoclomol increases GBA levels and increases GBA activity (paragraph [0010]). Hainsby also teaches that this activity in subjects presenting with Gaucher’s disease who have markedly reduced GBA activity and that arimoclomol increases GBA activity in subjects with Gaucher’s disease to clinically unaffected activity level. While the document as a whole focuses on treatment of other diseases that are associated with decreased GBA activity, paragraph [0010] clearly teaches that arimoclomol can restore GBA activity in patients presenting with Gaucher’s disease. In view of this teaching, it would have been obvious to administer arimoclomol to subjects presenting with Gaucher’s disease with an expectation that subject’s GBA activity will be restored to clinically unaffected levels.
Regarding limitations directed to treatment of symptoms of GD:
By treating GD it is inherent that an improvement in symptoms of GD is achieved.
Regarding new claim 119, directed to a method of decreasing chitotriosidase activity in a patient in need thereof. As applicants have demonstrated, reduction in chitotriosidase activity is achieved by performing the step of administrating arimoclomol to the subject. Since Hinsby teaches the step of administering arimoclomol to subject with GD, it is inherent that chitotriosidase activity in said subject is decreased. Subjects with GD represent a group that in need of reduction of chitotriosidase activity.
Same argument applies to the new limitation of 94 directed to “wherein the method decreases a chitotriosidase activity by at least 10%”. Since Hainsby teaches administration of the claimed active agent (arimoclomol) to the same subject population (subjects with GD), the claimed decrease in chitotriosidase activity is inherent.
Claim(s) 94-103 and 105-119 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinsby et al (WO 2016/041561; published 3/24/2016).
Hinsby teaches pharmaceutical formulations comprising arimoclomol including its stereoisomers and addiction salts. On page 1, lines 23-26 Hinsby teaches that oral doses from 50 to 800mg are well tolerated. On page 33, lines 9-14 art teaches the (+)-R and (-)-S stereoisomers of arimoclomol as citrate or maleate addition salts. Regarding administration and dosage art teaches that effective dose is to be determined based on disease and condition of the subject. Art also teaches administration one to three times a day (page 33, lines 17-28). Hinsby also teaches treatment of lysosomal storage disease by administering to a subject an effective amount of arimoclomol, and specifically teaches Gaucher disease types I, II, and III (page 39, lines 6-15).
A person of ordinary skill would have found it obvious to treat Gaucher’s disease types I, II or III in a subject in need by administering an effective dose of arimoclomol, it’s stereoisomer or/and citrate or maleate addition salt. It would have been obvious to determine the optimal amount and dosing schedule within the ranges taught by Hinsby. Since Hinsby teaches that 50-800mg of arimoclomol were well tolerated, it would have been obvious to determine effective dose within well tolerated range.
Regarding age, prior treatment and brain involvement, it would be obvious to treat any subject of any age who presents with Gaucher’s disease with an expectation that the disease and accompanying conditions would be improved. It would also be obvious to treat subjects who have not previously received treatment for Gaucher’s disease. A close inspection of the current specification does not reveal any special feature associated with lack of prior treatment. Any subject with Gaucher’s disease would be expected to benefit from administration of arimoclomol.
Regarding limitations directed to treatment of symptoms of GD:
By treating GD it is inherent that an improvement in symptoms of GD is achieved.
Regarding new claim 119, directed to a method of decreasing chitotriosidase activity in a patient in need thereof. As applicants have demonstrated, reduction in chitotriosidase activity is achieved by performing the step of administrating arimoclomol to the subject. Since Hinsby teaches the step of administering arimoclomol to subject with GD, it is inherent that chitotriosidase activity in said subject is decreased. Subjects with GD represent a group that in need of reduction of chitotriosidase activity.
Same argument applies to the new limitation of 94 directed to “wherein the method decreases a chitotriosidase activity by at least 10%”. Since Hainsby teaches administration of the claimed active agent (arimoclomol) to the same subject population (subjects with GD), the claimed decrease in chitotriosidase activity is inherent.
Reply to applicant’s remarks
Remarks in response to the rejection above, filed on 2/20/26, have been fully considered and found to be not persuasive.
Applicants argue that their discovery of the relationship between chitotriosidase activity and GD as well as activity of arimoclomol in lowering chitotriosidase activity levels in GD patients was unknown in the art prior to filing of the current application. Examiner has conceded this point in the Advisory Action mailed on 2/2/26. However, Examiner maintains that the above discoveries fail to distinguish the currently claimed method from the method taught by Hinsby. The subject population of the current method and of Hinsby method is the same, subjects with GD. The active agent arimoclomol is also the same. The amount of the active agent administered is the amount sufficient to treat GD. Therefore the sole active step of the claimed method is taught by Hinsby. Applicant’s discovery of activity of arimoclomol in lowering chitotriosidase activity levels in GD patients is realized by practicing the method of administering arimoclomol to the subject, a method which is taught by Hinsby. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.1985). Applicants have discovered a new benefit derived from practicing a known method. It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable. In re Woodruff. 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Applicants also argue that Examiner has failed to provide evidence that the effects of arimoclomol on subjects with GD are inherent to the method of Hinsby. This argument is not persuasive. As argued above, and in the text of the rejection, the effects are inherent because the claimed method shares the same steps as the method of suggested by Hinsby. The fact that the same method step is practiced is in itself evidence of inherency. The effects are derived from physiological activity of arimoclomol and since both Hinsby and current claims comprise administration of arimoclomol, it is inherent that the effects of practicing this step are the same.
Conclusion
Claims 94-103 and 105-119 are pending
Claims 94-103 and 105-119 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628