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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Application EP22185100, of which applicant claims priority, discloses the present claimed invention. The current claimed invention is considered to have the effective filing date of 7/15/2022.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 24 lines 11 and 15). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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, 3-5, 7, and 10-17 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 claims contain 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.
Claim 1 describes the genus of TRAILR2 antigen binding domains without sufficient description of a representative number of species. Similarly, claim 17 describes the genus of the TRAILR2 binding domain and the EC1 domain of the CDH3 antigen binding domain. When there is substantial variation within the genus, as exists with antibodies to TRAILR2 and CDH3, one must describe a sufficient variety of species to reflect the variation within the genus. Both claims 1 and 17 lack sufficient written description to reasonably convey to one of ordinary skill in the relevant art that the inventor had possession of the claimed invention. Therefore, claims 1 and 17 fail to have adequate written description under 35 U.S.C. 112(a).
Claims 3-5, 7, and 10-16 are rejected under 35 U.S.C. 112(a) based on their dependency on claim 1 and are not limited to subject matter that meets the written description requirement.
Claims 14-15 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 enablement requirement. The claims recite the use of a TRAILR2 and CDH3 bispecific molecule for treatment of cancer. The scope of the claims are not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention without undue experimentation.
The present claims are drawn to a method of treatment for cancer comprising administering an effective amount of the bispecific antigen binding molecule to TRAILR2 and CDH3. However, the specification does not provide sufficient enabling description for the treatment of cancer as encompassed by the claims. Without undue experimentation the present specification does not provide sufficient evidence in vitro or in vivo to support administering the molecule to lessen or ameliorate the symptoms of any cancer.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to the rejection of the present claims are the breadth of the claims, the nature of the invention, the level of predictability in the art, and the amount of direction provided by the inventor.
Claim 14 is drawn to a method for the treatment of cancer. Construing the claims using the broadest reasonable interpretation would apply the present invention to all cancer types and further all forms of pancreatic, lung, or head and neck cancers. The specification provides no evidence or information that would enable a person of ordinary skill to use the present invention with any type of cancer. The breadth of the claims is too broad for a person of ordinary skill to make or use the present invention without undue experimentation.
The present invention is drawn to the use of a bispecific antigen binding molecule comprised of TRAILR2 and CDH3. TRAILR2 has been widely documented in use with various cancer treatments, but not along with CDH3. Prior art discloses that CDH3 has been documented as expressing tumor promotion and suppression according to the type of cancer studied. (Vieira, et. al. pg. 3, Table 1). The specification provides no further evidence that the present invention is capable of applying to a broad definition of “cancer.” The nature of the invention as disclosed by the prior art would not enable a person of ordinary skill in the art to make or use the present invention without undue experimentation.
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). In view of the lack of predictability in the art (e.g. the treatment of cancer) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any cancer with a reasonable expectation of success. The present application does not provide a specific and detailed description or working example of an effective use of the claimed agent for treating any cancer commensurate in scope with the claimed invention.
Furthermore, knowledge in the state of the art provides a basis for undue experimentation to treat any cancer with the claimed invention. Concerning carcinogenesis, CDH3 is known to have different effective roles depending on the molecular context and tumor cell studied. (Vieira, pg. 2, column 2, paragraph 3, lines 1-4). Claim 15 specifically recites pancreatic and lung cancer as being effective targets for treatment using the claimed invention. CDH3 has been associated with aggressive tumor expression in pancreatic cancer providing evidence that it would make a good target for the claimed invention (Vieira, pg. 4 column 1, paragraph 2, lines 1-5). However, CDH3 has been associated with tumor suppressive behavior in non-small cell lung carcinoma (Vieira, pgs. 2-3, paragraph 1, lines 4-7). The specification fails to provide guidance or direction on how the claimed invention could treat all lung cancers and all head and neck cancers. The lack of unpredictability in the art and the information known about the tumor associated activity for CDH3 would require thorough guidance and direction to enable one of ordinary skill in the art to make or use the claimed invention.
The specification fails to provide sufficient evidence that the claimed invention in claims 14-15 would enable a person of ordinary skill in the art to effectively use the claimed invention in treating all cancers. Applicant is advised to amend the claims to recite specific cancers in which targeting CDH3 expression has proven successful to overcome this rejection.
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.
Claim 4 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 4, the term “preferably” is used. The use of the word, “preferably” does not make clear whether the claimed language is a limitation or an option. Therefore, the claim is indefinite. It is suggested that Applicant remove the word or replace it with “optionally” to overcome this rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kuenkele (US 2018/0179287) in view of Abrams (US 2016/0137730).
In regards to claim 17, Kuenkele discloses a, “a bispecific binding molecule comprising at least one antigen binding site that binds specifically to TNF-related apoptosis-inducing ligand receptor 2 (TRAILR2)” (see abstract). Kuenkele does not disclose a second binding site that binds specifically to the EC1 domain of cadherin-3 (CDH3).
Abrams discloses antigen binding sites that bind specifically to the EC1 domain of cadherin-3 (CDH3) (see abstract and Figs. 1 and 2).
A person of ordinary skill in the art would be motivated to combine the CDH3 binding site of Abrams to the bispecific binding molecule of Kuenkele to create the invention of claim 17. Kuenkele teaches a bispecific molecule for the treatment of cancer that works by targeting both TRAILR2 and another molecule. Kuenkele teaches that cancer cells are stimulated to undergo apoptosis only when both targets are bound. Abrams teaches antigen binding fragments to CDH3 that target the EC1 domain for the treatment of cancer. Abrams also teaches that CDH3 is overexpressed in certain cancers. One of ordinary skill in the art would be motivated to combine the teachings of Abrams with the teachings of Kuenkele to create a bispecific molecule that targets overexpression of CDH3 in certain cancers.
Therefore, it would be obvious to a person of ordinary skill in the art at the time of the effective filing date to combine the antigen binding site of Abrams to the bispecific molecule of Kuenkele to create the invention of claim 17.
Allowable Subject Matter
Claims 2, 6, and 8-9 objected to as being dependent upon a 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.
Conclusion
In summary, claims 1, 3-5, 7, and 10-17 are rejected. Claims 2, 6, and 8-9 are objected to based on their dependency.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644