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 Claims
Claims 1-20 are currently pending and under examination.
Priority
No priority has been claimed. Therefore the effective filing date of the instant invention is 06/13/2024.
Information Disclosure Statement
No Information Disclosure Statements have been filed.
Claim Rejections – 35 USC § 112(b)
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 contains numerous trademark/trade names. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. As an example, in the present case, the trademark/trade names are various immunoimaging agents, including affibody, affimer, DARPin, and fynomer. Applicant is informed that the rejection of the claim under 35 U.S.C. 112(b) may be overcome by removing the recited trademarks.
Claim 17 recites a method of diagnosing a disease or selecting a treatment based upon an immune score, but the claims provide no means for using an immune score to diagnose a disease or select a treatment. Given that essential method steps are not provided, the claim is deemed indefinite.
35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Specifically the claims are drawn to the correlation between an immune score and the presence of an immune property of an immune cell. Furthermore the claims do not integrate said judicial exception in to practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
With respect to Step 1, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because the claims are drawn to a natural phenomenon, specifically, the correlation between an immune score and the presence of an immune property of an immune cell.
With respect to prong two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite methods of medical imaging (claims 3 and 4), immunotherapy (claim 16), and collecting a biopsy combined with downstream analysis (claim 20). These steps primarily relate to routine laboratory practices, and as such these steps do not integrate the judicial exception into a practical application. The claims also do not recite any additional method steps that would integrate the recited judicial exception, for example, by applying or using said judicial exception as an indicator to determine whether a particular treatment or prophylaxis for a disease or medical condition should be administered. Therefore the answer to prong two of the Step 2A analysis is “No.”
With respect to claim 17, this claim is directed to judicial exceptions (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Specifically the claims are drawn to the correlation between 1) an immune score and the diagnosis of a disease or 2) an immune score and an appropriate cancer treatment. The claims do not integrate said judicial exceptions in to practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
With respect to Step 2B, as indicated above, the claims recite steps related to routine laboratory practices involving medical imaging (claims 3 and 4), immunotherapy (claim 16), and collecting a biopsy combined with downstream analysis (claim 20); however these steps were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps, alone or in combination, fail to qualify as to additional elements that amount to significantly more than the recited judicial exception. Accordingly the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
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.
Claim(s) 1-17 are rejected under 35 U.S.C. 102a1 as being anticipated by Chanier et al (Chanier et al, antibodies, 2019,8,13,1_21; published 2019).
Regarding claims 1-18 Chanier et al teach a method of imaging utilizing 89Zr anti-CD8 nanobody to monitor the CD8+ T-cell infiltration within tumors by PET/CT (Chanier et al, pg. 13, Section 6.3-6.3.1). The subjects were treated with anti-CTLA4 and partial regression was observed as well as detection of the anti-CD8 nanobody in PET/CT correlation with anti-CTLA4 responsiveness (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claim 1, Chanier et al teach a method of A) administering an anti-CD8 nanobody, which is an immunoagent that generates a targeted signal observable by PET, and imaging technique; B) acquiring an image by PET; C) analyzing infiltration, which is done by assessing distribution, position and intensity of the signal in the tumor; and D) Assessing the CD8+ infiltrate, which is an immune score assessing the type of T-cells in the tumor. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claim 2, Chanier et al teach assessing the CD8+ cells that have infiltrated the tumor. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claims 3 and 4, Chanier et al teach imaging by PET, a nuclear medicine imaging technique. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claim 5, Chanier teach the method is done in a tumor, and tumors are generally either primary or secondary tumors (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claims 6, 7, and 8, Chanier et al discloses a method of imaging cytotoxic T-cells. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claims 9 and 10, Chanier et al teach the imaging agent is a nanobody, which meets the limitation of an antibody. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claim 11, Chanier et al teach imaging agents but do not teach the imaging agents crosslink, block, or activate. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claims 12-14, Chanier et al teach an immunoimaging agent comprising 89ZR. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claims 15-16, Chanier et al teach the subjects received CTLA4, an immune checkpoint inhibitor. (Chanier et al, pg. 13, Section 6.3-6.3.1).
Regarding claim 17, Chanier et al teach nanobodies can be used to deliver the right treatment to patients (Chanier et al, pg. 13, Section 6.3-6.3.1)
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chanier et al (Chanier et al, antibodies, 2019,8,13,1_21; published 2019) in view of Ma et al (Ma et al, American Journal Cancer Research, 2019, 9, 1546_1553; published 08/07/2019).
Chanier et al teach a method of imaging utilizing 89Zr anti-CD8 nanobody to monitor the CD8+ T-cell infiltration within tumors by PET/CT (Chanier et al, pg. 13, Section 6.3-6.3.1). The subjects were treated with anti-CTLA4 and partial regression was observed as well as detection of the anti-CD8 nanobody in PET/CT correlation with anti-CTLA4 responsiveness (Chanier et al, pg. 13, Section 6.3-6.3.1). Chanier et al do not teach the method wherein the anti-CD8 89Zr nanobody is used in conjunction with biopsies to determine pseudoprogression. This deficiency is remedied by Ma et al.
Ma et al teach immunotherapies, including CTLA4, cause pseudoprogression. Additionally, Ma et al teach that biopsies and PET imaging can be used to identify pseudoprogression.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Chanier et al with those of Ma et al to arrive at a method wherein the anti-CD8 89Zr nanobody is used in conjunction with biopsies to determine pseudoprogression. One of ordinary skill in the art would have been motivated to do so because Chanier et al teach a method of imaging utilizing 89Zr anti-CD8 nanobody to monitor the CD8+ T-cell infiltration within tumors by PET/CT wherein the subjects were treated with anti-CTLA4 and partial regression was observed as well as detection of the anti-CD8 nanobody in PET/CT correlation with anti-CTLA4 responsiveness. Furthermore, Ma et al teach CTLA-4 may cause psuedoprogression, and pseudoprogression can be diagnosed by biopsy and PET imaging. As such one of ordinary skill in the art would have been motivated to modify the invention of Chanier et al, which teaches the administration of 89Zr anti-CD8 nanobody to further include the diagnosis of pseudoprogression with biopsy, because there would have been a reasonable expectation that the resultant invention, which comprises the administration of a nanobody for imaging and biopsy to diagnose pseudoprogression. The invention of Chanier et al and Ma et al meets the limitations of claims 19 and 20.
With respect to claim 18, one of ordinary skill in the art would have been motivated to repeat the invention of Chanier et al and Ma et al during cancer treatment in order to determine whether treatment is influencing CD8+ T-cell infiltration within tumors.
Therefore the claims as a whole were prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Conclusion
No claims are allowed.
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642