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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/27/2025 has been entered.
Request for Reconsideration
Applicant's reply filed 6/27/2025 has been entered. The claims were not amended. Claims 25-38 remain pending, of which claims 25-28, 37, and 38 are being considered on their merits. Claims 29-36 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
Applicant’s arguments on page 6 of the reply regarding Choi’s chitinase being heat-inactivated is found persuasive, and the obviousness rejections of record over Choi are withdrawn. New grounds of rejection are set forth below.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
The factual inquiries 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.
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.
Claims 25-28 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Elias (US 2013/0156750; Reference A).
Elias teaches a method treating or preventing acute lung injury in a subject, the method comprising administering an effective amount of a chitinase-like protein molecule and wherein the chitinase-like protein molecule is inclusive of catalytically active chitinases, acidic mammalian chitinases (i.e. AMCases) and chitotriosidases (claims 1 and 2; ¶0027; ¶0107), reading in-part on claims 25, 27, and 28. In a separate embodiment, Elias teaches treating or preventing pulmonary fibrosis (¶0018 and ¶0058), reading on claims 25, 26, and 37.
Regarding claims 25-28, and 37, while Elias does not teach every element of the claims in a single embodiment It would have been obvious to a person of ordinary skill in the art before the invention was filed to treat or prevent pulmonary fibrosis in a subject by administering an effective amount of the AMCase or chitotriosidase of Elias. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because and the skilled artisan would have been motivated to do so because Elias expressly contemplates the combination of treating or prevent pulmonary fibrosis in a subject by administering an effective amount of the AMCase or chitotriosidase.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Elias as applied to claims 25 and 37 above, and further in view of Caplan-Shaw et al. (JOEM (2011), 53(9), 981-991)
The teachings of Elias are relied upon as set forth above. Elias further teaches treating or preventing acute lung injury in human subjects (claim 8), reading in-part on claim 8.
Regarding claim 38, Elias does not teach a subject 50 years of age or older.
Caplan-Shaw teaches that a subject population exposed to particulate matter at the World Trade Center attack on 9/11 and with a median age range of 53 is at risk for developing interstitial (pulmonary) fibrosis (Abstract; also p983, Table 1 and the immediate paragraph after Table 1), reading on claim 38.
Regarding claim 38, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further preventatively treat the subjects of Caplan-Shaw with the chitinase(s) of Elias. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because the subjects of Elias and Caplan-Shaw are related as either having pulmonary fibrosis or being at risk for developing pulmonary fibrosis. The skilled artisan would have been motivated to further treat the subjects of Caplan-Shaw because the preventative treatment with Elias’ chitinase(s) would likely reduce the risk of Caplan-Shaw’s subjects to further develop pulmonary fibrosis thus improving the health of the subjects.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 4-11 of the reply have been fully considered, but not found persuasive of error over the new grounds of rejection set forth above.
Affidavit/Declaration
The Declaration under 37 CFR 1.132 filed 6/27/2025 has been fully considered, but is insufficient to overcome the new grounds of rejection set forth above.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:00am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653