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 .
Information Disclosure Statement
Three information disclosure statements (IDS) submitted: one on 09/06/2024; one on 09/12/2024; and one on 09/20/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited in the IDS or by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the description of the Drawings (starting on page 3) does not show a definition for the terms “CIA” – from figure 2, Examiner believes this means “collagen-induced arthritis”, however, definition should be included in the description of the Figures for clarity . . . e.g. “collagen-induced arthritis (CIA)”.
Appropriate correction is required.
Status of Claims
Claims 47-64 are pending in this application. Claims 1-46 have been cancelled by applicant.
Examiner Notes
Claims 49, 57, and 61-64 are free of the prior art but stand objected over formal matters.
Claim Interpretation
The term “providing” is not defined in the specification, therefore, the term will simply be interpreted simply as ‘supplying’ the therapeutic composition or effective dosage to the patient. Thus, it follows from the art and common sense that if a treatment is being administered it must have been ‘provided’ to the subject in need thereof first.
Claim Objections
Claims 49, 51, 57, 60-61, and 64 are objected to because of the following informalities:
Claims 51, 60, and 64 need a colon ‘:’ after “wherein the administering includes at least one of:”
In claims 49, 57, and 61, please remove the “PubChem” from the parentheses, as references to outside sources is not allowed in the claims.
Appropriate correction is required.
Claims 62-64 are objected to as being dependent upon an objected/ 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.
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.
Claims 47-48, 50, 52-56, and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (Front. Immunol., 2020, 11:499. doi: 10.3389/fimmu.2020.00499) (“Smith”); in view of Venkatesh et al. (Nature. 2017, 549: 533-537) (“Venkatesh”).
Regarding claims 47-48, 50, 52, 55-56, Smith discloses ADAM10 is upregulated in synovial joint biopsies from RA patients compared to healthy controls (para. Bridging pages 5-6). Smith teaches that, to date, the evidence regarding the role of ADAM10 in rheumatoid arthritis (RA) indicates that ADAM10 inhibitors would likely be a useful therapeutic target. Furthermore, Smith teaches INCB7839 as an ADAM10 inhibitor that it is safe and well-tolerated for systemic use; indicating that this class of drugs may have promise in the management of RA (page 6, col. 1-2). Smith also teaches in vitro siRNA knockdown of ADAM10 in RA-patient derived synovial fibroblasts also suppressed the release of the proinflammatory cytokines TNF-a, IL-6, and IL-8 (reading on reduction of inflammatory biomarkers – claims 53-54, 58-59) (page 6, col. 1, para. 1).
While Smith does not specifically teach providing the therapeutically effective dose further comprising a pharmaceutically acceptable carrier, the teachings of Venkatesh are relied upon for these disclosures.
Venkatesh teaches INCB7839 is formulated in 2% DMSO, 2% Tween 80, 48% PEG300, 48% water (reading on pharmaceutically acceptable carriers) (page 540, col. 1, Mouse drug treatment studies).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to ‘provide’ a dosage amount of INCB7839, an ADAM10 inhibitor, in a pharmaceutically acceptable carrier, and administer this composition for administration in the treatment of inflammation in a subject, wherein the inflammation is due to RA, as taught by Smith in view of Venkatesh. One of ordinary skill would have been motivated to do so because Smith discloses ADAM10 is upregulated in synovial joint biopsies from RA patients compared to healthy controls and teaches that the evidence regarding the role of ADAM10 in rheumatoid arthritis (RA) indicates that ADAM10 inhibitors would likely be a useful therapeutic target. One of ordinary skill would have had a reasonable expectation of success because Smith teaches INCB7839 as an ADAM10 inhibitor that it is safe and well-tolerated for systemic use; and Venkatesh discloses formulations of INCB7839 for administration.
Regarding claims 53-54, 58-59, Smith teaches inhibition of ADAM10 may be effective in the treatment of RA by suppressing pro-inflammatory signaling within synovial tissue; therefore, it would have been prima facie obvious to one of ordinary skill to expect reduction of inflammatory biomarkers TNF-a, IL-6, and IL-8 upon treatment of RA with INCB7839.
Claims 51 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (Front. Immunol., 2020, 11:499. doi: 10.3389/fimmu.2020.00499) (“Smith”); in view of Venkatesh et al. (Nature. 2017, 549: 533-537) (“Venkatesh”); as applied to claims 47-48, 50, 52-56, and 58-59; further in view of Huskisson et al. (Ann. rheum. Dis. (1970), 29, 393) (“Huskisson”).
The teachings of Smith and Venkatesh are disclosed above and incorporated herein.
While Smith in view of Venkatesh do not teach administration of indomethacin for the treatment of RA; the teachings of Huskisson are relied upon for these disclosures.
Huskisson teaches a large dose of indomethacin, given at night, has been found to be effective in relieving the morning pain and stiffness which are such prominent features of active rheumatoid arthritis (first 3 lines).
Therefore, regarding claims 51 and 60, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer an effective dose of indomethacin to a subject suffering from RA, in before, in combination with, or concurrently with Smith’s and Venkatesh’s ADAM10 inhibitor. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Smith discloses their INCB7839, an ADAM10 inhibitor therapeutic for the treatment of RA; Venkatesan teaches pharmaceutical compositions of INCB7839; and Huskisson teaches indomethacin can relieve pain and stiffness associated with RA.
Applicant is advised; with respect to a mixture of the two claimed reagents, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
With regards to the order of administration; it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). In the instant case, administration of two agents can occur only one of two ways-simultaneously, or sequentially (i.e., not simultaneously). Therefore, administration of the two therapeutic agents sequentially or in combination is obvious in the absence of unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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