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 II, (drawn to a method of treating inflammation in a subject), and the species of reducing inflammasome-mediated inflammation, in the reply filed on 10/29/2024 is acknowledged.
Claim 1-16 and 18-22 are pending of which (claims 1-11 (Group I)) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 15-19 read upon the elected species, however, the additional claims rejected herein are rejected to demonstrate the non-allowability of the generic claims. The restriction requirement is still deemed proper and is made Final.
Pending claims 12-15, 18-19 and 22-23 have been examined on the merits.
Withdrawn Rejections
The rejection of claims 12-16, 19-22 are rejected under 35 U.S.C. 112(a) is withdrawn in view of the claim amendment and cancellation.
New Grounds of Rejection due to claim amendment
Claim Rejections - 35 USC § 112 (New Matter)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-15, 18-19, and 22-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly added limitation in claim 12 “inflammation-related pain in a subject,” is not supported by the Application as filed. The added language does not appear in any of the original claims, specification, or drawings as asserted by Applicant in the 05/15/2026 Remarks. As such, a person of ordinary skill in the art (POSITA) would not have recognized possession of “inflammation-related pain in a subject.” Furthermore, the specification does not disclose any properties, or experiment indicating “inflammation-related pain in a subject.” The absence of any mention of “inflammation-related pain in a subject” in the specification, drawings, and provisional application supports the conclusion that “inflammation-related pain in a subject” are newly added subject matter.
Note: Claims 13-15, 18-19 and 22-23 are also rejected for depending from a rejected base claim and will remain rejected unless the issue of new matter is resolved (i.e., narrow the scope such that the new matter is no longer claimed).
Written Description
Claims 13 recites “a method to treat pain associated with osteoarthritis” and “identifying a subject who presents with osteoarthritis” or a “symptom of osteoarthritis, wherein the osteoarthritis or the symptom is localized to at least one region of the body of the subject.”.
However, specification (page 30, Example 7; emphasis added), while no data provided, only mentions of a composition administered to a human subject suffering from knee pain associated with osteoarthritis”
It is important to note that osteoarthritis is a degenerative joint disease that may affect multiple anatomical joint area, including but not limited to the knees, hips, spine, and hands. However, the specification did not describe treatment of osteoarthritis-related pain across these diverse anatomical locations. Therefore, the specification lacks representative species, and examples demonstrating possession of treatment of the full scope of “pain associated with osteoarthritis.” The specification also provides examples relating to back pain, peripheral neuropathy, and psoriasis pain which are not directly caused by or linked to osteoarthritis. Furthermore, the specification also discloses general statements regarding pain pathways do not provide adequate written description support for the claimed disease-specific limitation. Therefore, it is clearly evident that the specification fails to demonstrate possession of the claimed method at the time of filing the instant application.
Claim 15 recites “the effective amount is effective to reduce interleukin-1 beta (IL-lB) and the effective amount is effective to inhibit inflammasome-mediated signaling.”
Claim 19 recites “the effective amount is effective to reduce IL-lB release from macrophage-like cells.” While the specification (page 6, [0020], Figure 4) discloses IL-1beta reduction, but the specification does not define the level of IL-1beta reduction or inhibition would be considered therapeutically effective. This is because, Figure 4 shows large error bars and overlap with control values at several concentrations, including 0.75 mM and 3 mM, suggesting that the observed reduction would not be statistically distinguishable from baseline. Therefore, a POSITA would not consider treatment effect at those concentrations to be meaningful or effective. Moreover, a POSITA would not recognize that Applicant was in possession of an “effective amount” capable of achieving the claimed biological effect. Furthermore, although the specification makes references to inflammatory pathways and inflammasome-related signaling, however, the specification does not provide sufficient representative examples or defines correlation between composition doses of IL-1beta and/or inhibition of inflammasome-mediated signaling to demonstrate possession of the full scope of “effective mount” that reduces IL-1beta and inhibits inflammasomes-mediated signaling. Therefore, there is no reliable evidence that Applicant was in possession of the invention at the time of filing of the instant claim.
Claim 18 recites “the effective amount is effective to increase alpha-ketoglutarate concentration in cells contacted by the free fatty acid.” Although the specification discusses anti-inflammatory analgesic composition, however, the specification (page 6-30) does not provide any data, assay or examples showing that the disclosed free fatty acids increase alpha-ketoglutarate concentration in any cell type. The specification never measures or reports levels of alpha-ketoglutarate before or after treatment or even in the presence of a baseline. The only mechanistic data provided only relate to IL-1beta in THP1 macrophages, and yet alpha-ketoglutarate levels were not measured. Therefore, absence of any measurements and dose response data, would infer that a POSITA would not have recognized that Applicant was in possession of a composition or a method capable of increasing alpha-ketoglutarate in cells.
Claim 22 recites “treating increases expression of one or more of SOX9, aggrecan (ACAN), or collagen type II alpha (Col2al) in the osteoarthritic chondrocytes.” Although Examples 1 and 2 (specification, page 25-27) disclose experiments demonstrating an increase in
SOXA9, ACAN, and Col2a1; however, the specification does not adequately describe the data to demonstrate possession across the scope of the claim. For example, according to the specification, Figure 1 discloses strongest data for ACAN, but there is no baseline or quantitative data to evaluate the degree of increase in the treated vs control groups. Establishing such a difference is important because prior data, such as Figure 4, reveal discrepancies between the claimed effect “effective amount” and the disclosed dosing, calling into question whether the specification demonstrates possession of the invention. Additionally, although the specification mentions SOX9 and Col2a1 expression, however, there is no representative data set or confirmation that the experiments were actually performed as described and as claimed. Therefore, without statistical validation comparing the treated and control groups to establish the levels of “an increase in expression,” that are considered therapeutic benefits and effective, POSITA would not infer possession of a method to re-differentiate osteoarthritic chondrocytes through increases expression of one or more of SOX9, aggrecan (ACAN), or collagen type II alpha (Col2al).
Therefore, because the specification provides no representatives and example of possessing the full scope of the claim limitation, clearly demonstrates that Applicant was not in possession of the claimed invention at the time of filing the instant application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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