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 1-15 in the reply filed on 07/20/2026 is acknowledged. Claims 1-20 are pending; claims 16-20 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1-15 are examined.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 01/17/2025 were considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
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 9 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. Specifically, it is not understood how a dormant cancer cell comprises at least one metastasis. In the best case scenario the dormant cancer cell may be comprised in a metastasis.
As such, the metes and bounds of the claims could not be determined.
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, 2 and 4-15 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 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.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). (emphasis added). See also MPEP 2163.04.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to a method of inhibiting growth of a dormant cancer cell comprising administering an effective amount of any DKK3 inhibitor to a subject in need thereof to inhibit growth of the dormant cell of any cancer.
In the art, the treatment of DKK3 expressing cancer cells (lung, Pancreatic, breast, and ovarian) with or without checkpoint inhibitors was known (see for instance Jeong et al. KR 1020100020363, Hwang et al. U.S. Pub No. 20210340232- which use siRNA against DKK3 or monoclonal antibodies against DKK3).
The specification disclose treatment of dormant breast cancer cells both in vitro and in vivo, treatment that inhibited or retarded the growth of dormant breast cancer cells by using anti-DKK3 antibodies with or without checkpoint inhibitors.
However, the claims are drawn, as indicated supra, to a method of inhibiting growth of a dormant cancer cell comprising administering an effective amount of any DKK3 inhibitor to a subject in need thereof to inhibit growth of the dormant cell of any cancer.
Cancer is the name given to a collection of related diseases characterized by
cellular out of control division and spreading in the surrounding or distant tissues. Any type of cell in the organism (there are more than 100) may become cancerous. Thus, given the great variability of the types and subtypes of cancer cells, it is clear that Applicant was in possession of a method of treatment for breast cancer cells only, or in the more general consideration of cancer cells expressing DKK3 with anti-DKK3 antibodies.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang et al. (U.S. Pub No. 20210340232- cited Applicant).
The reference discloses methods of treating cancer comprising administering to a patient in need thereof an effective amount of an DKK3-neutralizing agent, such as a DKK3-neutralizing antibody. The methods can further include administering an effective amount of chemotherapy or immunotherapy to said patient (abstract).
The methods are further defined as methods for increasing sensitivity to chemotherapy or for increasing sensitivity to immunotherapy. The cancer is a pancreatic cancer, breast cancer, ovarian cancer, gastric cancer, bladder cancer, or sarcoma. The breast cancer may be triple-negative breast cancer. The methods are further defined as methods of inhibiting cancer metastasis and inhibiting cancer growth ([0013]). The methods further comprise administering at least a second anti-cancer therapy. The second anti-cancer therapy is a chemotherapy, immunotherapy, radiotherapy, gene therapy, surgery, hormonal therapy, anti-angiogenic therapy or cytokine therapy. The immunotherapy comprises an immune checkpoint inhibitor: a CTLA-4 antagonist, a PD-1 antagonist, a PD-L1 antagonist, an OX40 agonist, a LAGS antagonist, a 4-1BB agonist, or a TIM3 antagonist ([0014]).
Treatment with a DKK3 blocking monoclonal antibody inhibited pancreatic ductal adenocarcinoma (PDAC) progression and chemoresistance and prolonged survival. The combination of DKK3 inhibition with checkpoint control inhibition was more effective in reducing tumor growth than either treatment alone and resulted in a durable improvement in survival, suggesting that DKK3 neutralization is effective as a single targeted agent or in combination with chemo-or immuno-therapy for cancer ([0036]). DKK3 displayed an immuno-modulatory role for including induction of CD8+ T-cell tolerance. Exogenous DKK3 inhibited T-cell activity and when DKK3 function was blocked, CD8+ T-cell proliferation and IL-2 production was restored ([0039]).
While the reference does not indicate inhibiting the growth of a dormant cell, it is submitted that by administering the anti-DKK3 inhibitor (with or without the checkpoint inhibitor or other anti-cancer treatments) the antibody would inherently act upon any cell that expresses the DKK3 protein, and thus fulfill the method claimed instantly.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
Prosecution Insights