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
2. Applicant’s election without traverse of Group I (claims 16, and 19-35), in the reply filed on 5/29/2026 is acknowledged.
Claim 36 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-15, and 17-18 have been canceled.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 5/11/2023, is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 U.S.C. § 112 second paragraph
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4a. Claims 16, 19-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 16 is vague and indefinite for several reasons.
Claim 16, lines 3, 7, and 7, is vague and indefinite because it recites, for example “about 0.5mg of tasquinimod”, and it is unclear if this limitation encompasses “0.1 mg” or “1mg”.
Similarly, claims 33-35 are rejected as vague and indefinite for the recitation of the term “about”.
Claim 16, lines 4, 6, 8 and 9, are rejected as vague and indefinite for the recitation of “and/or” because it is unclear if both PD-1 antibodies and PD-L1 antibodies are administered and if the antibodies recited in lines 9-10 are PD-1 antibodies or PD-L1 antibodies..
Similarly, claims 33-35 are rejected as vague and indefinite for the recitation of “and/or”.
Claims 19-32 , are rejected as vague and indefinite insofar as they depend on the above rejected claim 16 for their limitations.
Claim rejections-35 U.S.C. 103
5. 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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
5a. Claims 16 and 19-35 are rejected under 35 U.S.C. 103 as being unpatentable over Svensson et al (WO 2012/175541) in view of Freeman et al (US 2015/0210769) (priority to 1/24/2014) and Korman et al (US 8383796), Applicant’s specification on page 19 and Appendix A.
Svensson et al discloses the use of ABR-215050 (which is tasquinimod which is an angiogenesis inhibitor—as per appendix A, page 1) for the treatment of cancers such as bladder cancer (see Table 1, pages 14-15 and entire reference). The dose of tasquinimod is 1-10 mg/kg (para 87) and a specific dose of 2.5 mg/kg (Table 6). The reference also discloses dosages of 0.0001-.5 mg/kg and a smaller range of .001-0.05 mg/kg (para 101).
The only difference between the reference and the instant invention is the combination with anti-PD-1 or anti-PD-L1 antibodies, antibodies nivolumab, pembrolizumab, MDX-1105, YW243.55.S70 and MPDL3280A, the stages of bladder cancer and the bladder cancer being non-muscle invasive, muscle invasive or metastatic and the order of administration.
Freeman et al discloses the use of anti-PD-1 antibodies either alone or in combination with other agents for the treatment of cancers such as bladder cancer and metastasis thereof (see summary and para. 145-148, 164+ and entire reference). The order of administration can be separate or sequential (para graph 164, 175) and the additional agent can be an angiogenesis inhibitor (paragraph 191). In paragraphs 516-518, the reference also discloses that nivolumab, pembrolizumab, MDX-1105, YW243.55.S70 and MPDL3280A (which is atezolizumab as per Applicant’s specification on page 19) are all known anti-PD-1/PD-L1 antibodies. The dose of the antibody is 1-5 mg/kg or about 3 mg/kg and can be determined by a skilled artisan (para 162).
Korman et al discloses the use of anti-PD-L1 antibodies either alone or in combination with other agents for the treatment of cancers such as bladder cancer and metastasis thereof (see summary, abstract, col. 55, lines 10+, col. 60, lines 24+ and entire reference). The order of administration can be separate or sequential (col. 60, lines 23+). Korman also discloses dosing of the antibodies and these include specific dosages of 1, 3 or 5 mg/kg (col. 51, lines 49-64).
Since both Freeman et al and Korman et al discloses that the anti-PD-1 or anti-PD-L1 antibodies, respectively, can be administered in combination with other anti-cancer agents and since Freeman et al discloses that antibodies, nivolumab, pidilizumab, pembrolizumab, MDX-1105, and MPDL3280A are known in the art, it would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to combine said antibodies with ABR-215050 because both the antibodies and the ABR-215050 are used for the treatment of the same types of cancers and “it 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).
With respect to claims 19-25, the combination of references disclose using the same compounds for the treatment of bladder cancer and metastasis thereof and it is the Examiner’s position that “bladder cancer” would include the different types and stages of bladder cancer.
With respect to claim 32, since the combination of references uses tasquinimod and anti-PD-1 or anti-PD-L1 antibodies to treat bladder cancer, and since the anti-PD-1 or anti-PD-L1 antibodies would need to bind to their antigens on the bladder cell, it is expected the bladder cancers express PD-1 or PD-L1. Additionally, it appears that Applicant is trying to claim a mechanism of action in which the tasquinimod increases the level of PD-1 and PD-L1 on the cells. The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
With respect to claim 30, the combination of references results in a treatment and treatment read on inhibiting the progression of the disease.
With respect to claim 31, the references do not state that the treatments are for patients that have been previously treated, thus it is the Examiner’s position that the treatment is a first line treatment.
It is noted that with respect to Examples 1 and 4-7 (pages 40-42; pages 45-52), the unexpected results are unclear and not commensurate in scope with the claimed invention. Example 1 is directed to bladder cancer using tasquinimod at 30 mg/kg and anti-PD-1 antibody (clone 10F.9G2) at 200ug (Table 2, page 41). First, it is unclear if clone 10F.9G2 is any of the antibodies recited in the claims, and even if it were, it would only read on one of the antibodies and the independent claims and dependent claims are directed to anti-PD-1/PD-L1 antibodies in general and the use of either anti-PD-1/PD-L1 antibodies. Second, the only dosage tested was tasquinimod was 30 mg/kg and the only dosage tested for the antibody was 200ug. The claims encompass more dosages than just those two. Thus, from Example 1 it is unclear if clone 10F.9G2 is any of the antibodies in claim 16. Example 7 has similar issues. It is directed to bladder cancer using tasquinimod at 30 mg/kg and anti-PD-1 antibody (clone 10F.9G2) at 200ug. Thus, in this Example it is also unclear if clone 10F.9G2 is any of the antibodies recited in claim 16. While the Example does mention tasquinimod at doses of 0.1, 1 and 10 mg/kg, it is unclear if any of these dosages were used in the combination experiments (i.e. Fig 6B). Examples 4-6 suffer from the same deficiencies as Examples 1 and 7. Thus, the unexpected results are not clear from the Examples in the specification.
Therefore, claims 16 and 19-35 are rendered obvious in view of the combination of Svensson et al (WO 2012/175541), Freeman et al (US 2015/0210769) and Korman et al (US 8383796), in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Claims 16, and 19-35 are rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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