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 of Application
The Amendments and Remarks filed on 03/10/26, and the Request for Continued Examination filed on 04/08/26 are acknowledged.
Claims 1-28 and 42-44 were previously cancelled.
Claims 29 and 49 were amended.
Claims 29-41 and 45-51 are included in the prosecution.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/08/26 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 04/08/26 and 04/21/26 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 103
Applicant’s arguments (Pages 5-7, filed 03/10/26) with respect to the rejection of claims 29, 45, and 49 under 35 U.S.C. 103 as being unpatentable over Shirahase et al. (US 6,262,108 B1 – “Shirahase”) have been fully considered and are persuasive. Since Shirahase is silent about treating any condition other than rheumatoid arthritis and certain types of dermatitis, the obviousness rejection based on this reference is withdrawn.
However, upon further consideration, a new ground(s) of rejection is made over Chianelli et al. (WO 2009/026204 A1 – “Chianelli”) in view of Shirahase et al. (US 6,262,108 B1 – “Shirahase”).
Maintained Claim Objections
Claims 30-41, 46-48, and 50-51 are again objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 29, 45, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Chianelli et al. (WO 2009/026204 A1 – “Chianelli”) in view of Shirahase et al. (US 6,262,108 B1 – “Shirahase”).
Instant claim 29 is drawn to a method of treatment of a disease or disorder comprising administering a composition comprising a pharmaceutically acceptable ester of cromolyn to a subject in need thereof, wherein the disease or disorder is selected from idiopathic myeloma, Down's syndrome, Huntington's disease (HD), medullary carcinoma of the thyroid, prolactinoma, frontotemporal lobar degeneration-tau, familial British dementia, familial Danish dementia, motor neuron disease, and lattice corneal dystrophy, wherein the pharmaceutically acceptable ester of cromolyn is a propyl or butyl ester of cromolyn.
Chianelli teaches methods for treating a disease or condition wherein therapeutic agents which may be used in combination with a compound of the invention include a cromolyn ([0015], [0120], claims 1, 13, and 15). Examples of neurodegenerative disorder which may be treated include Huntington’s disease (HD) and motor neuron disease (MND) ([0029]).
Chianelli does not teach a propyl or butyl ester of cromolyn.
Shirahase teaches medicinal use of cromoglycic acid compounds of formula (I) (Title, Abstract, claim 6). An effective amount of a cromoglycic acid compound of formula (I) is disclosed
PNG
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470
766
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Greyscale
and a pharmaceutically acceptable carrier (claim 6). Examples of the unsubstituted lower alkyl at R1 and R2 in formula (I) include propyl, butyl, and tert-butyl alkyl esters (Col. 5, lines 17-20).
Please note that the acetoacetyl esters of cromolyn are not excluded from instant claim 29.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method for treating neurodegenerative diseases such as HD and MND by using therapeutic agents in combination with cromolyn, as taught by Chianelli, in view of the propyl, butyl, and tert-butyl alkyl esters of cromolyn, as taught by Shirahase, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references teach the use of cromolyn and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 29, the limitation of the treatment of HD and MND would have been obvious over the cromolyn ([0015], [0120], claims 1, 13, and 15) used for the treatment of a neurodegenerative disorder such as HD and MND ([0029]), as taught by Chianelli.
Regarding instant claims 29 and 49, the limitations of administering a propyl or butyl ester of cromolyn would have been obvious over administering cromoglycic acid compounds of formula (I) (Title, Abstract, claim 6, Experimental Example 2 - Col. 7, line 33 to Col. 9, line 31, Col. 11, lines 38-47) wherein R1 and R2 are each unsubstituted lower alkyl groups which include propyl and butyl alkyl esters (Col. 5, lines 17-20), as taught by Shirahase.
Regarding instant claim 45, the limitation of a tert-butyl ester of cromolyn would have been obvious over the tert-butyl ester (Col. 5, lines 17-20), as taught by Shirahase.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-6023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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