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 .
Status of Claims
The amendment filed on 08/03/2026 amended claims 1, 2, 3, 5, 7, 9, 10, 11, 14, 15, 17, 18, 19, 20, and 23 and cancelled claim 22. Claims 1-21 and 23 are pending and will be examined on the merits.
Response to Amendment
The amendment filed 08/03/2026 in response to the office action mailed 04/03/2026 is acknowledged. The rejections set forth under 35 USC 112(b), 112(d), and 102/103 are withdrawn for the following reasons:
The amendments to claims 5, 9, 10, and 17 overcome the 112(b) and 112(d) rejections recited in the office action dated 04/03/2026.
Applicant’s arguments, see section II, filed 08/03/2026, with respect to the specification demonstrating, in Example 9, intra-lymphatic delivery of an anti-PD-1 agent by the claimed method can produce approximately 50-fold greater tumor growth inhibition at a reduced dose than the same dose administered systemically, confirming the claimed result is a demonstrated property of the claimed method, have been fully considered and are persuasive. The art rejections under 35 USC 102 over NCT04118868 and under 35 USC 103 over Kwon in view of Gu are withdrawn due to the amendments to claims 1, 2, and 3, adding the recitation of up to a 50-fold increase of tumor growth inhibition. Examiner notes that were this limitation to be removed, these art rejections would still apply to the instant claims. Similarly, the double patenting rejections over 17/781,672 and 18/622,067 are withdrawn in view of the arguments of section IV, page 9.
New Claim Rejections - 35 USC § 112
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 1-21 and 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. This is a written description rejection.
The claims amended 08/03/2026 recite a method of treating cancer in a patient comprising placing a device comprising a plurality of microneedles on the skin of a patient, inserting the microneedles, and administering via the needles an anti-PD-1 or anti PD-L1 therapeutic agent, wherein tumor growth inhibition is increased up to 50-fold as compared to tumor growth inhibition following an equivalent amount of the same agent administered by an intravenous delivery route. As recited above, the amendments claim the increase in tumor growth inhibition as a demonstrated property of the claimed method, citing to Example 9 in the specification.
Example 9 of the specification teaches mice inoculated with MC38 tumor cells and thereafter administered a monoclonal anti-PD-1 antibody 4, 7, and 10 days post-inoculation at a dose of 10 mg/kg, 5 mg/kg, or 1 mg/kg, either intraperitoneally (i.p.) or via SOFUSA® DoseConnect™. The mice were euthanized and tumor tissue harvested 13 days post-implant. The administration schedule is shown in Figure 19A and the results are shown in 19B. The specification recites that, at the lowest dose tested, 1 mg/kg, administration via the microneedles increased tumor growth by approximately 50-fold, as compared to the i.p. administered dose. This statement is supported by the 1 mpk data shown in figure 19B, which shows an average increase in % tumor growth inhibition of 50-fold, from about 1% tumor growth inhibition to about 50% tumor growth inhibition. The remaining data do not support the same increase in tumor growth inhibition. The 10 mpk, or mg/kg, data show tumor growth inhibition of about 20% via i.p. administration, and about 40% via microneedle administration. This is an increase of about 2-fold. The 5 mpk, or 5 mg/kg, data appear to show a decrease in the amount of tumor growth inhibition, or, at the very least, no difference between the two. The average line for tumor growth inhibition is about 25% for i.p. administration and 20% for microneedle administration. Additionally, no indication of statistical significance is given in Figure 19B or the corresponding figure legend.
If the 50-fold increase in tumor growth inhibition is indeed a demonstrated property, as argued by Applicant, then the property is clearly very dose dependent, as seen in Figure 19B. While the minor 2-fold increase in tumor growth inhibition observed at a dose of 10 mg/kg may meet the limitation of “an increase of up to 50-fold,” the 5 mg/kg data does not support the claim, as it does not show any increase in tumor growth inhibition. Therefore, the claims as amended recite a limitation that is not fully supported by the instant specification.
Moreover, if the 50-fold increase in tumor growth inhibition is indeed a demonstrated property of the method, it has not been demonstrated for the full breadth of the claims. Instant claims 1, 2, and 3 are drawn to administering any anti-PD-1 therapeutic agent or any anti-PD-L1 therapeutic agent. Example 9 only provides an experiment using a single anti-PD1 antibody (BB9 clone, Sorrento Pharmaceuticals). Example 9 does not provide any data for any anti-PD-L1 antibody, or for a different anti-PD1 antibody. As the demonstrated property incorporated into the instant claims is clearly dose dependent, one cannot be confident that any dose of any anti-PD-1 therapeutic agent or anti-PD-L1 therapeutic agent will result in the same demonstrated property of the method. Therefore, claims 1, 2, and 3 do not have sufficient written description support for a 50-fold increase in tumor growth inhibition at any dose with any therapeutic agent directed against PD-1 or PD-L1. Claims 4-21 and 23 inherit this rejection, as they do not rectify the issues outlined above.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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