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 .
Claim Rejections - 35 USC § 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 1-5, 7, and 9-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition comprising Complement Component C7, which is a product of nature. “The claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called “judicially recognized exceptions” or simply “exceptions”) are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.” MPEP 2106, I. Regarding claim 2, the embodiment wherein the composition of claim 1 further comprises Complement Component C5 is also a product of nature, as mixtures of complement component C5 and complement component C7 exist in nature as part of the terminal complement pathway in the form of intermediate complexes during the assembly of the Membrane Attack Complex. Regarding dependent claims 5, 7, and 9-21, although they recite properties, product-by-processes, and intended uses of the composition, they are still drawn to a composition of claim 1, and therefore directed to a product of nature. Regarding the kit comprising the composition of claim 1 as recited in claim 22, the inclusion of a natural product into a kit does not make it patent eligible unless the kit exhibits markedly different characteristics in structure and function compared to the natural components themselves. In the present instance, the inclusion of the present composition of claim 1 into a kit would not make the composition exhibit markedly different characteristics compared to the natural components themselves.
Claim Rejections - 35 USC § 112
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 1-5, 7, and 9-22 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. The claims are directed to a composition which “predicts the reactivity of at least one immune checkpoint inhibitor… against cancer cells.” Predicting the reactivity of at least one immune checkpoint inhibitor against cancer cells is not a term of art. Although the application describes predicting a therapeutic response in response to an immune checkpoint inhibitor, predicting a patient’s therapeutic response is not the same as predicting the reactivity between two chemical moieties. Although the application describes predicting a patient’s response, it does not describe how the invention could be used to predict the reactivity between two chemical moieties, nor protocols or methods are presented in the application for predicting chemical reactivity. Although page 30 at lines 20 and 23 recites “reaction” in the context of a kit, and page 34 at line 25 recites “reactivity,” there is no description in the specification of a method of predicting the reactivity of at least one immune checkpoint inhibitor against cancer cells, nor methods of carrying out the same. Further, regarding claim 10, the recitation “solid tumors of childhood” does not have support in the application. “Solid tumors of childhood” is not a term of art. There is not description of this genus in the application so as to demonstrate what solid tumors are included in the genus and what solid tumors are not. Therefore, the genus “solid tumors of childhood” is not adequately described. Therefore, the artisan would not accept that applicant had possession of the invention at the time of filing.
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 1-5, 7, and 9-22 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 “predicts the reactivity of at least one immune checkpoint inhibitor… against cancer cells.” It’s unclear what reactivity with cancer cells is considered to be “against” cancer cells and what reactivity is considered to be not “against” cancer cells. The terms reactivity against and not against cancer cells is not a term of art, nor does the application does not clarify this ambiguity. Further regarding claims 10-13, claims 10 and 12 recite “the responsiveness to the PD-L1 immune checkpoint inhibitor for the cancer cells is low.” Claims 13 and 11 recite “the responsiveness to the PD-L1 immune checkpoint inhibitor for the cancer cells is high.” The terms “high” and “low” are relative term which renders the claim indefinite. The terms “high” and “low” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, there is insufficient antecedent basis for the term “the responsiveness.” The recitation does not appear prior in the claims nor or in the claims from which they depend.
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 1-5, 7, and 9-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2016049385 to Francois (WO’385; IDS filed 7/6/2022). Francois discloses a method for measuring the level of an immune checkpoint protein or measuring a biomarker associated with a response to an immune checkpoint inhibitor treatment, wherein a complement system biomarker determines the classification, the likelihood of responsiveness to treatment, and/or whether a patient, such as a cancer patient, is an appropriate candidate for treatment with an immune checkpoint inhibitor (for example, PDl or PD-Ll), one or more of polymorphisms or mutations is in a complement-related gene, one or more of the polymorphisms or mutations is in a complement-related gene selected from the group consisting of complement factor H (CFH), complement factor I (CFI), complement component C3 (C3), complement component C2 (C2), complement factor B (CFB), complement component C7 (C7), and mannose binding lectin 2 (MBL-2), and a kit or an assay to be performed using the kit is a companion diagnostic (see paragraphs [0026], [0126], and [0349]). This is a companion diagnosis biomarker composition comprising Complement Component C7, wherein the companion diagnosis biomarker composition predicts the reactivity of at least one immune checkpoint inhibitor from among a programmed cell death protein I (PD- 1) immune checkpoint inhibitor and a programmed death-ligand I (PD-LI) immune checkpoint inhibitor against cancer cells. The composition may further comprise Complement Component C5 ([0040]). Claims 3-4, 14-16 are product-by-process claims. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113, I. In the present case, whether the protein amount of Complement Component C7 was measured by the means presented in claims 3 or 4, the composition would still be the same. Further, the extraction means for producing Complement Component C7 in claims 14-16 would produce the same product, that is, Component C7. Claims 5-13 and 17-21 recite properties and intended uses of the claimed composition. As a composition cannot be separated from its properties, and as the composition of Francois is structurally identical to the claimed composition, the composition Francois would inherently exhibit the same properties as the present composition and be fully capable of carrying out the intended uses recited in the claims. Claim 5 recites the amount of protein is decreased in a group of responders who show an effect in anticancer treatment through the PD-I immune checkpoint inhibitor compared to a group of non-responders who do not show an effect in the anticancer treatment through the PD-I immune checkpoint inhibitor:-; or wherein for Complement Component C7, the amount of protein is increased in a group of nonresponders who do not show an effect in anticancer treatment through the PD-I immune checkpoint inhibitor compared to a group of responders who show an effect in the anticancer treatment through the PD-I immune checkpoint inhibitor. This is a property of the composition. As a composition cannot be separated from its properties, the composition of D1 must inherently possess the same properties as the instant composition. Claim 7 recites the companion diagnosis biomarker composition of claim 1, wherein for Complement Component C7, the amount of protein is decreased in a group of responders who show an effect in anticancer treatment through the PD-LI immune checkpoint inhibitor compared to a group of non-responders who do not show an effect in the anticancer treatment through the PD-LI immune checkpoint inhibitor:·; or wherein for Complement Component C7, the amount of protein is increased in a group of nonresponders who do not show an effect in anticancer treatment through the PD-LI immune checkpoint inhibitor compared to a group of responders who show an effect in the anticancer treatment through the PD-LI immune checkpoint inhibitor. This is a property of the composition. As a composition cannot be separated from its properties, the composition of D1 must inherently possess the same properties as the instant composition. Claims 9-13 recite the companion diagnosis biomarker composition of claim 1, limiting the cutoff value. This is an intended use of the composition. As a composition cannot be separated from its properties, the composition of D1 must inherently be fully capable of being used in the claimed intended uses. Claims 14-16 limit the method that the composition of claim 1 has been prepared by. As the composition of claim 1 is a composition comprising Complement Component C7, regardless of the method of preparing, the composition of claim 1 is deemed to read on claims 14-16. Claims 18-20 limit the type of cancer cells that the composition of claim 1 is capable of predicting the reactivity against. The companion diagnosis biomarker composition comprising Complement Component C7, is structurally identical to the claimed composition, and must therefore be capable of carrying out the claimed uses of the claimed composition, including predicting the reactivity of at least one immune checkpoint inhibitor against the cancer cells enumerated in claims 18-20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
February 20, 2026