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 .
This second non-final rejection is being sent out to the Applicant since Examiner misinterpreted the recitation ‘aderbasib.’
Support for the amendments is within the instant application specification.
Claims 1, 5-9 are pending and examined on the merits.
Claims 2-4, 10 are cancelled.
New 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 1, 5-9 are newly rejected under 35 U.S.C. 103 as being unpatentable over Li et al (WO 2015/031119A1, Date of Publication: 5 March 2015, Examiner cited) {herein Li} as applied to claims 1-3, 5-12, in view of NIH et al (Inxight Drugs, Date Published: Sep 1, 2008, Examiner cited) {herein NIH} as evidenced by Willis et al (2026, College of American Pathologists, Examiner cited) {herein Willis} and Ooyama et al (2008, ScienceDirect, Examiner cited) {herein Ooyama}. The new rejection is necessitated by Examiner’s misinterpretation of ‘aderbasib.’
Claims 1, 5-9 are drawn to a method for inhibiting growth of cancer in an individual comprising administering to the individual an effective amount of a combination comprising peptidase D (PEPD) comprising a mutation of G at position 278 of SEQ ID NO:1 wherein the mutation is a change of glycine at position 278 to an amino acid other than aspartic acid, a sheddase inhibitor comprising aderbasib, a chemotherapeutic agent, and a coagulation inhibitor.
With respect to claims 1, 5-9, Li teaches a method wherein peptidase (PEPD), a sheddase inhibitor (page 7, lines 27), a coagulation inhibitor (Enoxaparin) (Li page 22, line 12; Li: claim 8, page 47, lines 26-27) and a chemotherapeutic agent (page 48, lines 10-11) are administered to a subject diagnosed with ErbB2-positive cancer to slow the growth of cancer (page 8, lines 15). It would be obvious to one of ordinary skill in the art that said composition could be used to treat colorectal cancer as the evidentiary reference of Willis demonstrates that ErbB2 is associated with rectal cancer (page 3, paras 2-3). As such, absence evidence otherwise, it is the Examiner’s position that the ErbB2-positive cancers taught by Li include colorectal cancer. Since the art teaches a subject diagnosed with ErbB2-positive cancer (page 8, line 15), it is the Examiner’s position that the ErbB2-positive cancer would necessarily be resistant to a therapeutic antibody that specifically binds to Epidermal growth factor receptor (EGFR) as recited in the instant application claim 9. Additionally, Li teaches said PEPD is the same as the instant application SEQ ID NO: 1 (appendix A). It is noted that the sequence taught by Li in appendix A has a mutation of G278D, however, Li explicitly teaches the mutation change of glycine at position 278 is also to an amino acid other than aspartic acid (page 13, lines 34-35). However, Li teaches non-limiting examples of such substitutions include gly or ser for ala, which teaches the limitation of ‘a mutation of gly 278 to an amino acid other than aspartic acid’ (instant application claim 1) (page 14, lines 30-31). A mutation of gly for ala is a different amino acid than aspartic acid, as recited in the instant application claim 1. In addition, Li teaches any anti-angiogenic agent can be the chemotherapeutic agent. As such, absent evidence otherwise, it is the Examiner’s position that the recitation ‘any anti-angiogenic agent’ necessarily includes fluorouracil (5-FU) agents, as the evidentiary reference if Ooyama is recited to demonstrate that 5-Fluorouracil (5-FU)-based drugs have anti-angiogenic properties (abstract). Li further teaches the subjects of the experiment are diagnosed with cancers that are resistant to trastuzumab, of which is a humanized antibody that binds to the HER2 receptor (page 32, lines 14-16), an anticancer agent.
However, Li does not teach wherein the sheddase inhibitor comprises aderbasib (claim 1).
With respect to claim 1, NIH teaches Aderbasib, also known as INCB007839, is an orally bioavailable low nanomolar hydroxamate-based inhibitor of the ADAM (A Disintegrin And Metalloprotease) family of multifunctional membrane-bound proteins with potential antineoplastic activity (sheddase inhibitor) (page 1, para 1). Aderbasib represses the metalloproteinase "sheddase" activities of ADAM10 and ADAM17, which may result in the inhibition of tumor cell proliferation (page 1, para 1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Li of a method wherein peptidase (PEPD), a sheddase inhibitor (Enoxaparin) (page 7, lines 27), a coagulation inhibitor(Li claim 8, page 47, lines 26-27) and a chemotherapeutic agent (page 48, lines 10-11) are administered to a subject diagnosed with ErbB2-positive cancer to slow the growth of cancer (page 8, lines 15) or combine the teachings of NIH because NIH teaches a method wherein Aderbasib, also known as INCB007839, is an orally bioavailable low nanomolar hydroxamate-based inhibitor of the ADAM (A Disintegrin And Metalloprotease) family of multifunctional membrane-bound proteins with potential antineoplastic activity (sheddase inhibitor) (page 1, para 1).
One of ordinary skill in the art would be motivated to either use the teachings of Li et al. by itself or combine the teachings of NIH because NIH provides the motivation for Li to combine aderbasib with PEPD (instant application SEQ ID NO: 1; appendix A), a trastuzumab, a chemotherapeutic agent, and a coagulation inhibitor as NIH teaches Aderbasib in combination with trastuzumab increased the response rate in cancer patients with advanced disease, relative to historical controls. (page 1, para 1). MPEP 2143.I.A. states “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).” One of ordinary skill in the art knowing the benefit of sheddase inhibitors such as aderbasib for the treatment of colorectal cancer (Her2 cancer) based on the teachings of Li and NIH would have a reasonable expectation of success to combine aderbasib with the aderbasib as NIH teaches ErbB2-targeted therapies, particularly humanized monoclonal antibody trastuzumab in combination
with chemotherapy, show considerable clinical efficacy (page 2, lines 6-8). Furthermore, NC7839 also improved progression-free survival in a subset of the patients expressing the p95 fragment of HER2 (NIH: page 1, para 1). As such, combining aderbasib taught by NIH with the therapeutic composition taught by Li would provide an extended therapeutic effect while easing its administration to subjects.
One of skill in the art would have a reasonable expectation of success to make and use the claimed method for inhibiting the growth of cancer because Li provides the basic method for treating cancer and its uses and methods of making it. Reference of NIH provides the teachings of a method wherein Aderbasib, also known as INCB007839, is an orally bioavailable low nanomolar hydroxamate-based inhibitor of the ADAM (A Disintegrin And Metalloprotease) family of multifunctional membrane-bound proteins with potential antineoplastic activity (sheddase inhibitor) (page 1, para 1). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of claims
Claims 1-12 are pending
Claims 1-12 are rejected
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Li et al SEQ ID NO: 1 with mutation at position 278 (STIC search result number 3) vs instant application SEQ ID NO: 1
Query Match 99.7%; Score 2593; Length 493;
Best Local Similarity 99.8%;
Matches 492; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MAAATGPSFWLGNETLKVPLALFALNRQRLCERLRKNPAVQAGSIVVLQGGEETQRYCTD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAAATGPSFWLGNETLKVPLALFALNRQRLCERLRKNPAVQAGSIVVLQGGEETQRYCTD 60
Qy 61 TGVLFLQESFFHWAFGVTEPGCYGVIDVDTGKSTLFVPRLPASHATWMGKIHSKEHFKEK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TGVLFLQESFFHWAFGVTEPGCYGVIDVDTGKSTLFVPRLPASHATWMGKIHSKEHFKEK 120
Qy 121 YAVDDVQYVDEIASVLTSQKPSVLLTLRGVNTDSGSVCREASFDGISKFEVNNTILHPEI 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YAVDDVQYVDEIASVLTSQKPSVLLTLRGVNTDSGSVCREASFDGISKFEVNNTILHPEI 180
Qy 181 VESRVFKTDMELEVLRYTNKISSEAHREVMKAVKVGMKEYGLESLFEHYCYSRGGMRHSS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VESRVFKTDMELEVLRYTNKISSEAHREVMKAVKVGMKEYGLESLFEHYCYSRGGMRHSS 240
Qy 241 YTCICGSGENSAVLHYGHAGAPNDRTIQNGDMCLFDMGGEYYSVASDITCSFPRNGKFTA 300
||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||
Db 241 YTCICGSGENSAVLHYGHAGAPNDRTIQNGDMCLFDMDGEYYSVASDITCSFPRNGKFTA 300
Qy 301 DQKAVYEAVLLSSRAVMGAMKPGDWWPDIDRLADRIHLEELAHMGILSGSVDAMVQAHLG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DQKAVYEAVLLSSRAVMGAMKPGDWWPDIDRLADRIHLEELAHMGILSGSVDAMVQAHLG 360
Qy 361 AVFMPHGLGHFLGIDVHDVGGYPEGVERIDEPGLRSLRTARHLQPGMVLTVEPGIYFIDH 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AVFMPHGLGHFLGIDVHDVGGYPEGVERIDEPGLRSLRTARHLQPGMVLTVEPGIYFIDH 420
Qy 421 LLDEALADPARASFLNREVLQRFRGFGGVRIEEDVVVIDSGIELLTCVPRTVEEIEACMA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LLDEALADPARASFLNREVLQRFRGFGGVRIEEDVVVIDSGIELLTCVPRTVEEIEACMA 480
Qy 481 GCDKAFTPFSGPK 493
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Db 481 GCDKAFTPFSGPK 493
Prosecution Insights