DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 10, 2026 has been entered.
Claims 1-15 and 25-30 have been canceled. Claims 16-24 and 31-32 are pending, Claims 17-22 have been withdrawn, and Claims 16, 23-24 and 31-32 have been considered on the merits, insofar as they read on the elected species of delaying muscle atrophy and muscle strength loss and plasminogen. All arguments have been fully considered.
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 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 of this title, 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.
Claims 16, 23-24 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2018/0369345 A1; 12/27/2018. Cited on IDS) in view of Chio et al (Lancet Neurol. 2017;16:144-57.) and Andersen et al (Diabetologia. 1997;40(9):1062-1069.).
The instant claims recite a method for treating amyotrophic lateral sclerosis (ALS), comprising administering a therapeutically effective amount of a plasminogen pathway activator to a subject suffering from amyotrophic lateral sclerosis (ALS), wherein the plasminogen pathway activator is plasminogen, wherein the plasminogen has (i) an amino acid sequence having at least 80% sequence identity with SEQ ID NO: 2 and (ii) plasminogen activity comprises delaying muscle atrophy and muscle strength loss.
Li teaches a method for treating and/or preventing a diabetic nerve injury-related disorder and/or a diabetic complication, comprising administering a therapeutically effective amount of plasminogen to a subject, wherein the diabetic nerve injury-related disorder includes limb pain (para 0011), and the diabetic complication is diabetic neuropathy (para 0035). The plasminogen can be administered in combination with other drugs or therapies, and the plasminogen is administered by intravenous, intramuscular, inhalation, or local injection (para 0011). The plasminogen has at least 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity with SEQ ID No. 2 and has the activity of plasminogen, and the plasminogen is selected from Glu-plasminogen, Lys-plasminogen, mini-plasminogen, micro-plasminogen, and delta-plasminogen (the plasminogen is the same as claimed, therefore, the plasminogen has the activity of delaying muscle atrophy and muscle strength loss) (para 0011). The plasminogen is a human natural plasminogen (para 0014). Before the effective filing date of the claimed invention, it was well-known in the art that types of pain in amyotrophic lateral sclerosis (ALS) include limb pain (p.146 Figure of Chio). Chio teaches a subject diagnosed with ALS complained of persistent and severe limb pain (p.149 Panel 2). Chio teaches the ultimate need of patients with ALS experiencing pain is to reduce pain intensity (p.150 col right – para 2). In addition, before the effective filing date of the claimed invention, it was well-known in the art that muscular atrophy underlies motor weakness at the ankle in diabetic patients with polyneuropathy and that the atrophy is most pronounced in distal muscles of the lower leg indicating that a length dependent neuropathic process explains the motor dysfunction, as evidenced by Andersen (p.1062 Summary, p.1068 col left – last para). Since Li teaches the use of the plasminogen for treating diabetic neuropathy, and Andersen teaches diabetic neuropathy patients have muscle atrophy and a loss in muscle strength. Therefore, the plasminogen of Li delays muscle atrophy and muscle strength loss.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer plasminogen to a subject suffering from ALS, since Chio discloses that ALS patients suffer from limb pain and that the ultimate need of patients with ALS experiencing pain is to reduce pain intensity, and Li discloses that the administration of plasminogen treats limb pain. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to administer plasminogen to a subject suffering from ALS with a reasonable expectation for successfully treating and/or preventing a diabetic nerve injury-related disorder includes limb pain.
Response to Arguments
Applicant argues that the claimed disclosure is directed to a fundamentally different disease with a distinct pathophysiology, and the references provide no motivation to treat ALS with plasminogen.
These arguments are not found persuasive because the instant specification discloses that “the terms “treatment/treating” refer to obtaining a desired pharmacological and/or physiologic effect. The effect may be complete or partial prevention of a disease or its symptoms, and/or partial or complete cure of the disease and/or its symptoms, and includes: (a) prevention of the disease from occurring in a subject, which may have a predisposition to the disease but has not been diagnosed as having the disease; (b) suppression of the disease, i.e., blocking its development; and (c) alleviation of the disease and/or its symptoms, i.e., eliminating the disease and/or its symptoms.” on p.24 para 2. Li does teach the administration of plasminogen treats limb pain, and Chio does teach ALS patients suffer from limb pain and the ultimate need of patients with ALS experiencing pain is to reduce pain intensity. Therefore, a skill in the art would administer the plasminogen of Li to ALS patients to reduce pain, with a reasonable expectation of success.
Applicant argues that applicant's specification demonstrates unexpected therapeutic effects in a validated ALS model, which are not taught or suggested by the applied references.
These arguments are not found persuasive because rejected claims only require treating ALS, comprising administering a therapeutically effective amount of a plasminogen pathway activator to a subject suffering from ALS, wherein the plasminogen pathway activator is plasminogen, wherein the plasminogen has (i) an amino acid sequence having at least 80% sequence identity with SEQ ID NO: 2 and (ii) plasminogen activity comprises delaying muscle atrophy and muscle strength loss. Li does teach the administration of plasminogen treats limb pain, and Chio does teach ALS patients suffer from limb pain and the ultimate need of patients with ALS experiencing pain is to reduce pain intensity. Applicant’s arguments regarding “Neither the Li reference nor the other references teach/suggest or even hint at neuroprotection, neurorepair, or disease modification in an ALS setting” appear to have no connection to the subject at issue.
Applicant argues that the Office’s unexpected results analysis is inconsistent with MPEP 716.02.
These arguments are not found persuasive because rejected claims only require administering a therapeutically effective amount of a plasminogen pathway activator to a subject suffering from ALS, wherein the plasminogen pathway activator is plasminogen, wherein the plasminogen has (i) an amino acid sequence having at least 80% sequence identity with SEQ ID NO: 2 and (ii) plasminogen activity comprises delaying muscle atrophy and muscle strength loss. Li does teach the administration of the claimed plasminogen treats limb pain. The instant specification demonstrates results produced between a vehicle control group (PBS) and a plasminogen group. There was no comparison of the claimed invention with the closest prior art, and thereby lack of basis for judging the practical significance of data with regard to the disclosed unexpected results.
Applicant argues that the Office’s rejection relies on impermissible hindsight and a missing rationale to combine the references.
These arguments are not found persuasive 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).
Conclusion
No claims are allowed.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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