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 .
Election/Restrictions
Applicant’s election without traverse of Group IV (drawn to a method of treating a sunburn or skin photosensitivity disorder), in the reply filed on 03/17/2026 is acknowledged.
Claims 1-9 and 17-23 are pending of which claims 1-9 and 17-19 in Group I-III, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 20-23 have been examined on the merits.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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 20-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sontheimer et al., Arthritis Rheumatol. 2017 Apr;69(4):826-836 in view of Fröhlich et al. Annals of the Rheumatic Diseases, vol. 70, no. 7, July 2011, pp. 1344–45.
Regarding claims 20-21 and 23, Sontheimer (page 830-833) teaches that repeated skin exposure to UVB induces cutaneous inflammation. Sontheimer (page 826-827) discloses that UVB used in the lupus models is delivered as artificial UVB irradiation. Sontheimer (page 826-833) discloses that exposure triggers cutaneous inflammation in patients with systemic lupus erythematosus (SLE) and systemic disease. Given that exposure to sunlight is a major, common cause of lupus flares, known as photosensitivity. Therefore, it would have been obvious to a person of ordinary skill in the art (POSITA) to recognize lupus patients exposed either to solar UVB or artificial UVB, the disease pathology would still provoke the same photosensitive response. Moreover, because UVB triggers skin photosensitivity, which involves inflammation and immunomodulation, this suggests that a POSITA would explore anti-inflammatory inhibitors as a potential treatment for UVB-induced inflammation.
Sontheimer, however, does not explicitly teach a method of treating a skin photosensitivity disorder caused by UVB irradiation with NLRP1 inhibitor.
Fröhlich (page 1345) discloses bortezomib is a reversible and selective proteasome inhibitor, and patient received an effective amount of bortezomib at a dose of 1.5 mg on days 1, 4, 8 and 11 of each 28-day cycle to reduce inflammation. Fröhlich (page 1345) discloses bortezomib was effective to treat systemic lupus erythematous (SLE), a chronic, systemic autoimmune inflammatory disease. Given that bortezomib is known in the art to suppress NF-κB signaling pathway, critical in SLE pathogenesis and chronic inflammation; and that UVB-provokes lupus flares, it would have been obvious with a reasonable expectation of success to a POSITA before the effective filing date of the claimed invention to administer bortezomib as a treatment regimen for patients with SLE or UVB-triggered inflammation.
Fröhlich does not explicitly teach “a NLRP1 inhibitor for inhibiting NLRP1-driven pyroptosis in a cell caused by ribosome stalling and/or ribosome collisions within said cell.”
However, Fröhlich discloses that bortezomib belongs to the family of proteasome inhibitors and does not explicitly mention it as a NLRP1 inhibitor. Therefore, given Fröhlich discloses the same compound as the claimed invention for the same treatment such as SLE, thus the exclusion of the functional language does not render Fröhlich’s teachings nonobvious. Therefore, products of identical chemical composition cannot have mutually exclusive properties. See MPEP 2112.01
Therefore, it would have been obvious to a POSITA to combine the teachings of Sontheimer and Fröhlich to arrive at the claimed invention, because the prior art discloses bortezomib is already known in the art to treat SLE or UVB-triggered inflammation.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over
Sontheimer and Fröhlich as applied to claim 20 above, and in further view of Sandstrom et al., Science, vol. 364, no. 6435, Apr. 2019, p. eaau1330.
The combined teachings of Sontheimer and Fröhlich disclose bortezomib can be administered against SLE triggered by UVB. The combined prior art, however, does not explicitly mention “inflammatory pathology is due to a microbial ribotoxin.”
Regarding claim 22, and as applied to claim 20 above, Sandstrom (page 1-7) discloses that microbial pathogens activate NLRP1 inflammasome pathway through a mechanism involving proteasome-dependent degradation of NLRP1, which is required for downstream inflammatory signaling and cytokine production. This suggests that inflammatory pathology driven by microbial enzymatic, including ribotoxin-like damage to cellular component, proceeds through a proteasome dependent step that this essential for inflammasome activation. Therefore, given that bortezomib is a well-known proteasome inhibitor, thus a POSITA would expect bortezomib to block this microbial degradation step and thereby suppress activation of the NLRP1 inflammasome and its associated response and arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
