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 with traverse of Group I, claims 1-8, 13, and 16-18, in the reply filed on 09/09/2025 is acknowledged. The traversal is on the ground(s) that Goldstein teaches that the exogenous cells are deposited into the chorioallantonic membrane (CAM) and the instant disclosure defines the “embryo tissue” as any tissue of the embryo with the exception of the “extra-embryonic annexes and the lumen of tubes and vessels” (Election, pg. 1). Therefore, the traversal is on the grounds that the groups of inventions share the special technical feature. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
More specifically, the argument is not found persuasive because Goldstein teaches the addition of exogenous cancer and immune cells into the CAM ([013]-[014]) and Castellani (US20170156297A1) teaches the injection of cancer cells into the embryotic tissue of a gallinaceous bird embryo. Castellani teaches that “this study model has the advantage of reproducing tumors in an environment similar to that of origin, namely an embryonic environment” ([0010]). Therefore, Goldstein in view of Castellani renders the technical feature obvious and thus it does not make a contribution over the art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-12, 14-15, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/09/2025.
Status of the Claims
Claims 1-19 are currently pending.
Claims 3-9 and 12-14 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Claims 9-12, 14-15, and 19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claim(s) 1-8, 13, and 16-18 have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “a.” and “b.” need to be amended to “a)” and “b)” or similar. A claim may only contain a single period. Appropriate correction is required.
Specification
The use of the terms FICOLL® (pg. 22, pg. 26), PERCOLL® (pg. 22), GLO™ (many instances; pg. 24-25), IMARIS® (pg. 28), KEYTRUDA (many instances; pg. 27-29), which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Information Disclosure Statement
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.
Drawings
Supplemental drawings were received on 09/09/2025 to correct a typographical error. These drawings are acceptable.
The specification contains a description of color on pg. 7 in the description of Figure 5. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 16 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.
Claim 4 contains the phrase “wherein cancer cells are issued from a tumor of a patient” which is indefinite. It is unclear what limitation the term “issued” imparts on the claim, as it suggests an active process in which the tumor provides the cells, which is unclear. Appropriate clarification is required and may include amending the claim to read “wherein cancer cells are derived from a tumor of a patient” or similar.
Claim 13 contains the phrase “animal model for the study of human cancers consisting in a chimeric gallinaceous bird embryo”, which is indefinite. It is unclear what is meant by the phrase “consisting in a chimeric gallinaceous bird embryo”. It is not clear if the phrase is intended to mean that the claimed “animal model” is being regarded as only the cells which are within the embryo or if the “animal model” is the embryo which contains the human cancer cells within. Appropriate clarification is required.
Claim 16 contains the phrase “wherein the population of immune cells consists in genetically engineered CAR-T cells” which is indefinite. It is unclear what “consists in genetically engineered CAR-T cells” is intended to mean. Appropriate clarification is required. For the sake of compact prosecution the claim is being interpreted to mean that the immune cells are genetically engineered CAR-T cells.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Castellani et al (US20170156297A1), in view of Goldstein (WO2020075168A1).
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 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]). 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.
Conclusion
No claims are allowed.
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
/ANOOP K SINGH/Primary Examiner, Art Unit 1632