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 .
Status of the Claims
Claims 1-12 and 16-19 are currently pending.
Claims 1-4 and 16 are amended.
Claims 9-12, 14-15, and 19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 13-15 are canceled.
Claims 1-8, 13, and 16-18 have been considered on the merits.
Withdrawn Objections/Rejections
The objection made onto claim 1 is withdrawn in light of the amendments submitted on 05/01/2026.
The objections made onto the specification are withdrawn in light of the substitute specification submitted on 05/01/2026.
The objections made onto the drawings are withdrawn in light of the substitute specification submitted on 05/01/2026.
The 112(b) rejections made onto claims 4, 13, and 16 are withdrawn in light of the amendments submitted on 05/01/2026.
Maintained Rejections
Claim Interpretation
Claim 1 contains the limitations wherein the population of cancer cells and immune cells are present in “at least one tissue of said embryo”. Claim 7 contains the phrase “wherein said at least one embryo tissue in which cancer cells are present is representative of tissues/organs in which primary and/or secondary tumor(s) form(s) in cancer patients”. This phrase contains the term “representative of” which is defined in the specification as follows: “[a] ‘representative tissue’ or ‘equivalent tissue’, both terms being used interchangeably, designates a gallinaceous bird embryo tissue that is equivalent to a non-embryonic mammalian tissue, but in its embryonic state and in the configuration of a gallinaceous bird organism… [f]or example, embryonic colon issued from endoderm is representative of the colon organ of a mammal; when exogenous cancer cells are cancer color cells, they are present in said endodermic germ layer” (Spec, pg. 16, para 6-7). Thus, the claim is being interpreted to mean that any specific cancer cell type which is inserted into the embryo reads on a representative model of the specific cancer type of the patient’s cancerous tissues/organs.
Claim 13 contains the phrase “[a]nimal model for the study of human cancers consisting in a gallinaceous bird embryo according to claim 1” which includes an intended use of the animal model of claim 1. The phrase “for the study of human cancers” is being interpreted as an intended use of the animal model and therefore does not carry patentable weight.
Claim 18 contains the phrase “wherein said at least one embryo tissue in which cancer cells are present is representative of tissue/organs in which primary and/or secondary tumor(s) form(s) in the cancer patient whose tumor originates. This phrase contains the term “representative of” which is defined in the specification as follows: “[a] ‘representative tissue’ or ‘equivalent tissue’, both terms being used interchangeably, designates a gallinaceous bird embryo tissue that is equivalent to a non-embryonic mammalian tissue, but in its embryonic state and in the configuration of a gallinaceous bird organism… [f]or example, embryonic colon issued from endoderm is representative of the colon organ of a mammal; when exogenous cancer cells are cancer color cells, they are present in said endodermic germ layer” (Spec, pg. 16, para 6-7). Thus, the claim is being interpreted to mean that any specific cancer cell type which is inserted into the embryo reads on a representative model of the specific cancer type of the patient’s cancerous tissues/organs.
Claim Rejections - 35 USC § 103
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 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.
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 1-8, 13, and 16-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Castellani et al (US20170156297A1), in view of Goldstein (WO2020075168A1). Although maintained, the rejection below has been updated to reflect amendments made onto the claims.
Castellani teaches a chimeric gallinaceous bird embryo comprising cancer cells ([0008]), which are present in the tissue of the embryo through being grafted into the embryo as required by claim 1 ([0049]). Castellani teaches wherein said embryo tissue designated any tissue of the embryo with the exception of the extra-embryonic annexes and the lumen of tubes and vessels through Fig. 3 which demonstrates that the cancer cells are located in the trunk of the embryo, further Castellani teaches injecting the cells into the embryo directly (See Fig. 3 and [0010]). Castellani teaches that the cancer cells are derived from a tumor of a patient as required by claim 4 ([0018]). The cancer cells are taught to be human cancer cells as required by claim 5 ([0008]). Castellani teaches that the cancer cell population is labelled as required by claim 8 ([0058]/[0059]). Castellani teaches that the embryo is a model of a pediatric solid tumor “representing 10% of the cancers in children” which reads on the embryo being “representative” of tissues/organs in which primary/secondary tumors form in cancer patients as required by claim 7 and 18 ([0002]).
Castellani does not teach that the embryo contains a population of immune cells and wherein the population of immune cells are present in at least one tissue or said embryo or circulate in the blood vessels of said embryo as required by claim 1. Castellani does not teach that the immune cells are PBMCs as required by claim 2. Castellani does not teach that the immune cells are lymphocytes as required by claim 3. Castellani does not teach that the cancer cells and immune cells are present in the same embryo tissue as required by claim 6. Castellani does not teach that the embryo of claim 1 including both cancer and immune cells are a model as required by claim 13. Castellani does not teach that the immune cells are CAR-T cells as required by claim 16. Castellani does not teach that the immune cells are present in the tumors formed by the cancer cells as required by claim 17.
However, Goldstein discloses a model system comprising a gallinaceous bird embryo which contains a population of cancer cells and a population of immune cells within the chorioallantoic membrane of the embryo as required by claims 1 and 13 ([0008]/[0013]-[0014]). Goldstein discloses that the immune cells can be PBMCs ([0049]-[0050]) or lymphocytes, even more specifically tumor infiltrating lymphocytes (TIL), which are present in the tumor(s) formed by the population of cancer cells as required by claims 2-3, and 17 ([0166]/[0173]). Goldstein discloses that both the cancer and immune cells are human cells as required by claim 5 ([0166]). Goldstein discloses that both the immune cells and cancer cells are present in the same tissue as required by claim 6 ([0008]/[0013]-[0014]). Goldstein also discloses that the immune cells are CAR-T cells as required by claim 16 ([0050]).
One of ordinary skill in the art would find it obvious before the effective filing date of the instant invention to combine the gallinaceous bird embryo containing cancer cells within taught by Castellani with the gallinaceous bird embryo containing cancer and immune cells together on the CAM of the embryo taught by Goldstein to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Goldstein teaches that prior to their disclosure there was no method for studying the interactions between multiple types of exogenously introduced cells, such as the combination of cancer and immune cells, however a feature of xenograft tumors is the formation of the tumor micro environment by the cancer cells and the surrounding stroma cells ([0003]-[0005]) and Castellani teaches that an advantage of their model which contains cancer cells within the embryo is that this “study model has the advantage of reproducing tumors in an environment similar to that of origin” and that the grafted cancer cells “migrate in the animal embryo in the same way as in the human pathology” ([0010]). Further, it would be obvious to graft both the immune and cancer cells within the tissues of the embryo as taught by Castellani because Castellani teaches that “the grafted human neuroblastoma cells migrate in the animal embryo in the same way as in the human pathology, and form tumors” ([0010]). One of ordinary skill in the art would have a reasonable expectation of success when combining Castellani and Goldstein because both teach gallinaceous bird embryos which contain cancerous tumors on or within the embryo and the methods required to produce the models.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 05/01/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 11-12) that Castellani does not teach the inclusion of immune cells and that Goldstein does not teach the newly added limitation of including the cancer and immune cells within tissues of the embryo and not on the CAM as demonstrated by Goldstein.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Castellani teaches the formation of tumors with cancer cells within the embryo tissues. Castellani is combined with Goldstein who teaches the combination of cancer cells and immune cells present on the embryo within the CAM. Together, Castellani and Goldstein render the inclusion of cancer and immune cells within the gallinaceous bird embryo obvious. Further, it would be obvious to graft both the immune and cancer cells within the tissues of the embryo as taught by Castellani because Castellani teaches that “the grafted human neuroblastoma cells migrate in the animal embryo in the same way as in the human pathology, and form tumors” ([0010]). One of ordinary skill in the art would have a reasonable expectation of success when combining Castellani and Goldstein because both teach gallinaceous bird embryos which contain cancerous tumors on or within the embryo and the methods required to produce the models. Therefore, the argument is not found persuasive.
Applicant argues (Remarks, pg. 12) that the results of forming tumors within the gallinaceous bird embryo by the combination of cancer cells and immune cells within the tissue of the embryo are unexpected.
In response, this argument is not found persuasive. Both Castellani and Goldstein demonstrate tumor formation. Castellani demonstrates cancer cells provided within the embryo migrate to form tumors ([0010] of Castellani). Goldstein demonstrates that the combination of cancer cells and immune cells provided on the CAM of the embryo forms tumors ([0003] and claim 10 of Goldstein). Thus, the combination of Castellani and Goldstein would reasonably result in the formation of a tumor in the embryo. Therefore, the augment is not found persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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