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 .
Applicants’ response on 12/24/2025 has been received and entered.
Claims 1, 2, and 4-12 are pending, all of which have been considered on the merits.
Priority
Acknowledgement is made that the instant application is a National Stage of International application No. PCT/CN2020/128782 (filed 11/13/2020), which claims the benefits of US Provisional Application No. 62/934633 (filled 11/13/2019).
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites several cancer types are listed in duplicate (e.g. pancreatic cancer, bladder cancer, Kaposi’s sarcoma, etc.). Appropriate correction is required.
Additionally, claim 1 recites “an uterine” and “an urethral”. The claim should be amended to recite “a uterine” and “a urethral”.
Claim Interpretation
At the time of examination, the term ‘histological type’ refers to a cancer classification based on the type of tissue in which the cancer originates (See NCI Cancer Classification page). From a histological standpoint there are six major categories of cancer: carcinoma (epithelial origin), sarcoma (connective tissue origin), myeloma (plasma cell origin), leukemia (bone marrow origin), lymphoma (lymphatic origin).
Claim 1 recites the limitation of “wherein the xenogeneic tissue cell composition comprises xenogeneic tissue-specific stem cells, xenogeneic tissue progenitor cells, xenogeneic tissue precursors, and xenogeneic tissue mature cells”. The xenogeneic tissue cell composition of claim 1 is therefore understood to require all the cell types listed.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1, 2, and 4-12 are rejected under 35 U.S.C. 112(a).
Applicants have amended the claims to remove limitations which were not supported by the specification. The rejection is withdrawn.
RE: Rejection of claims 1, 2, and 5-8 under 35 U.S.C. 103 over Huang et al 2020 (Cancer Immunol Immunother, 2020) as evidenced by Jafari et al (Mucosal Immunology, 2022) and in view of Hong et al (Clin Cancer Res, 2020).
Applicants amended the claims to remove limitations not supported by the specification. The claims therefore have an effective filing date of 11/13/209. The cited references were published after the effective filing date of the amended claims. The rejection is thus withdrawn.
RE: Rejection of claims 1, 2, and 4-8 under 35 U.S.C. 103 over Huang et al (Cancer Immunol Immunother, 2020) as evidenced by Jafari et al (Mucosal Immunology, 2022) and in view of Hong et al (Clin Cancer Res, 2020) and Tsou et al (Bioactive Materials, 2016).
Applicants amended the claims to remove limitations not supported by the specification. The claims therefore have an effective filing date of 11/13/209. Huang et al, Jafari et al, and Hong et al were published after the effective filing date of the amended claims. The rejection is thus withdrawn.
RE: Rejection of claims 1-2, and 5-12 under 35 U.S.C. 103 over Huang et al (Cancer Immunol Immunother, 2020) as evidenced by Jafari et al (Mucosal Immunology, 2022) and in view of Hong et al (Clin Cancer Res, 2020) and Bicknell and Lee (WO2017158339).
Applicants amended the claims to remove limitations not supported by the specification. The claims therefore have an effective filing date of 11/13/209. Huang et al and Jafari et al were published after the effective filing date of the amended claims. The rejection is thus withdrawn.
New Rejections
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.
Claims 1, 2, and 4-12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a method for treating a cancer… wherein the cancer comprises a squamous cell carcinoma, a lung cancer, a peritoneal cancer… and childhood Wilms tumor…”. It is unclear if the treatment method is used to treat a subject with any of the listed cancers or if the subject is required to have all of the listed cancers. For the purpose of compact prosecution, the claims are being interpreted as a method of treating a cancer wherein the cancer is selected from the group consisting of the cancers listed in claim 1.
Claims 2 and 4-12 depend from claim 1 without further defining the cancer(s) required by the claim and thus inherit the deficiencies of claim 1.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-6, 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harmon et al. (WO2005001079A2).
Harmon et al. teaches using cultured cells derived from human postpartum tissue in cell-based therapies for conditions of the soft tissue and xenogeneic cells may be tolerated in some instances (See pg. 1 Field of the invention and pg. 36, Last paragraph). The post-partum derived cells (PPDCs) can comprise differentiated or undifferentiated cells or a combination thereof, extracellular matrix, cell lysates, conditioned media, or a composition thereof and may be used in the treatment of soft tissue diseases including cancer (See pg. 7 first paragraph). The PPDCs may comprise heterogeneous cell populations comprising undifferentiated or differentiation induced PPDCs, stem cells, epithelial cells, bone marrow cells, adipocytes, keratinocytes, melanocytes, dermal fibroblasts, vascular endothelial cells, coronary artery endothelial cells, pulmonary artery endothelial cells, iliac artery endothelial cells, microvascular endothelial cells, endothelial progenitors, and other soft tissue cells progenitors (See pg. 27 third paragraph). Harmon et al. defines a progenitor cell as a cell that has the capacity to create progeny that are more differentiated than itself and yet retains the capacity to replenish the pool of progenitors and by that definition stem cells themselves are also progenitor cells as are the more immediate precursors to terminally differentiated cells (See pg. 9 second paragraph). The cells of the invention may be surgically implanted or injected directly to the site in need of repair (See pg. 35, third paragraph). Additionally, the PPDCs may be administered with other beneficial drugs including anti-inflammatory agents such as p38 MAPK inhibitors, immunomodulatory agents, and antibodies (See pg. 34 last paragraph – pg. 35 first paragraph).
Harmon et al. further teaches the PPDCs can be suspended in a hydrogel solution for injections and the hydrogel can include polysaccharides (See pg. 41 first paragraph).
Regarding claims 1, 2, 5, and 6: Harmon et al. teaches a human PPDC (reads on isolated from a tissue of a mammal) composition which can be xenogeneic, and is used to treat soft tissue disorders including cancer which reads on using a xenogeneic tissue cell composition to treat a soft tissue sarcoma. The cells of the invention may be surgically implanted or injected directly to the site in need of repair which reads on administered by an intralesional, intratumoral, and peritumoral route. The PPDCs are a heterogeneous mixture of endothelial and soft tissue stem cells, progenitors, and mature cells such as vascular endothelial cells, coronary artery endothelial cells, and pulmonary artery endothelial cells thus using the cells reads on treating a soft tissue cancer of same or similar histological type as the cancer (e.g. treating a soft tissue sarcoma with endothelial cells). Harmon et al. defines progenitor cell populations as including stem cells and precursors, therefore the PPDC composition of Harmon et al. comprises endothelial and soft tissue stem cells, progenitors, precursors, and mature cells. Additionally, Harmon et al. does not disclose a composition comprising tumor cells and thus, the PPDC composition of Harmon et al. does not comprise tumor cells.
Regarding claim 4: Harmon et al. teaches a composition comprising PPDCs, ECM, cell lysates or a combination thereof which can be embedded in a hydrogel solution for injection. The hydrogel can comprise polysaccharides.
Regarding claims 9-11: Harmon et al. teaches the PPDC composition may be administered with other beneficial drugs including anti-inflammatory agents such as p38 MAPK inhibitors (reads on a targeted therapy drug and a mitogen-activated protein kinase inhibitor), immunomodulatory agents, and antibodies.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al. (WO2005001079A2) in view of Bicknell and Lee (WO2017158339).
The teachings of Harmon et al are set forth above.
Harmon et al anticipates claims 1-6 and 9-11.
Regarding claims 7 and 8: Following the discussion of claim 1 above, Harmon et al. teaches a method of treating a soft tissue cancer comprising administration of xenogeneic PPDCs. Additionally the PPDCs can be administered with other beneficial drugs.
Harmon does not disclose the method further comprising administering at least one chemotherapeutic drug to the subject.
Bicknell and Lee teach an antibody which can be used in conjunction with a therapeutic anti-cancer agent which can be used to treat diseases such as cancer. The therapeutic anti-cancer agent can be an immunomodulator such as an immune checkpoint inhibitor, a targeted therapy drug such as a tyrosine kinase inhibitor, or chemotherapeutic drugs such as alkylating agents, topoisomerase I inhibitor, topoisomerase II inhibitor, antimetabolites, antibiotics, platinum coordination complexes.
Given that both Harmon et al. and Bicknell and Lee disclose treatments for cancer, and the method of Harmon et al can further comprise other beneficial drugs, it would have been obvious to combine the antibody and therapeutic agent composition (reads on anti-cancer drug composition) of Bicknell and Lee with the PPDC composition of Harmon et al. to make a more robust cancer treatment. Combining equivalents known for the same purpose in order to form a new composition to be used for the same purpose is prima facie obvious (See MPEP2144.06(I) and in re Kerkhoven, 626 F.2d 274, 126 USPQ 186 (CCPA 1960)).
Claims 1, 2, 4-6 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al. (WO2005001079A2) in view of Huang et al (Cancer Cell International, 2018).
The teachings of Harmon et al are set forth above.
Harmon et al anticipates claims 1-6 and 9-11.
Regarding claim 12: Following the discussion of claims 1 and 9 above, Harmon et al. teaches a method of treating a soft tissue cancer comprising administration of xenogeneic PPDCs. Additionally the PPDCs can be administered with other beneficial drugs.
Harmon et al does not teach administering the PPDC compositions with a cytokine or an immune checkpoint inhibitor.
Huang et al teaches use of xenogeneic cells may improve the therapeutic outcome of cancer patients in combination with anticancer drugs. Huang also teaches immune checkpoint inhibitors (reads on immunomodulator) such as anti-CTLA4 and anti PD/PD-L1 antibodies (read on antibody drugs) can be used to treat recurrent or metastatic cancers (See sections Presentation of the hypothesis and Test of hypothesis).
Given that both Harmon et al teaches a method of treating cancer comprising a xenogeneic cell composition which can further comprise other beneficial drugs and Huang et al teaches immune checkpoint inhibitors such as anti-CTLA4 and PD/PD-L1 antibodies can be used to treat recurrent or metastatic cancers, it would have been prima facie obvious to modify the treatment method of Harmon et al to further include an immune checkpoint inhibitor drug/antibody. One would have been motivated to include an immune checkpoint inhibitor in the treatment method of Harmon et al to treat recurrent or metastatic cancers. There is a reasonable expectation of success because Harmon teaches the PPDCs can be administered with other beneficial drugs and immune checkpoint inhibitors are beneficial drugs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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