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 by Original Presentation
Newly submitted claim 23 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted:
Group I, claims 1, 2, 4, 5, 7-13 and 18-22, drawn to a companion diagnosis marker composition.
Group II, claim 23, drawn to a method of treating cancer.
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: The common technical feature is a Complement Component C7. This cannot be a special technical feature because it is not novel. WO2016049385 to Francois (WO’385; IDS filed 7/6/2022) teaches a companion diagnosis biomarker composition comprising Complement Component C7 ([0040]).
Since Applicant’s inventions do not contribute a special technical feature when viewed over the prior art they do not have a single general inventive concept and so lack unity of invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 23 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 extracted from blood, 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.
Applicant’s argument have been fully considered but are not found persuasive. Regarding applicant’s arugments that the claims are directed to a free, blood-derived, quatitativley-measurable form of Complement Component C that has been isolated from blood and processed so as to permit quantitative analysis of its protein amount, the examiner’s response is that applicant is arguing limitations not in the claims. The claims are directed to Complement Component C extracted from blood, which is fundamentally a product of nature. Under patent law and scientific classification, simply isolating or extracting a naturally occurring biological molecule—such as a serum protein or glycoprotein—does not change its base structural identity or origin; it remains a naturally occurring substance created by the body. As Complement Component C extracted from blood is a product of nature, the rejection is proper.
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 responsiveness of at least one immune checkpoint inhibitor… against cancer cells.” There is insufficient support for how this term is used in the claims.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s arguments that “responsiveness” is an interchangeable term with “reactivity,” the examines’ response is that responsiveness is not an interchangeable term with reactivity. Responsiveness is how fast or well something reacts to an action or change. Reactivity is how a component interacts with another component. 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.
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 10-13 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. Claims 10 and 12 recite “predicted to be low,” and claims 11 and 13 recite “predicted to be high.” The terms “low” and “high” render the claim indefinite. The terms “low” and “high” 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, it’s unclear what it means to be “predicted to be low” (claims 10 and 12) and “predicted to be high” (claims 11 and 13) and how this differs simply from being “low” and “high.”
Applicant’s arguments have been fully considered but are not found persuasive. Applicant argues that claim 10 is anchored in claim 9, and therefore the artisan would understand that when the protein amount is equal to or more than the cufoff value, the responsiveness is low, and when the protein amount is less than the cutoff value, the responsiveness is high. This not found persuasive because none of claims 9-12 recite the language applicant has stated. Further, its’ unclear what it means for responsiveness to be “predicted to be low” or “predicted to be high,” and what the difference is between “predicted to be low” and “low” is, and what the difference is between “predicted to be high,” and “high is.”
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 (abstract; paragraphs 3-27) 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, extracted from blood (paragraph 49), 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 (claims). 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.
Applicant arguments have been fully considered but are not found persuasive. Regarding applicant’s arguments that claim 1 is directed to proteomic-level quantitative analysis of the Complement C7 protein, the examiner’s response is that the proteomic-level quantitative analysis isn’t in the claimed invention. The claims are directed to a composition comprising Complement Component C7 extracted from blood, wherein the composition has the property that it predicts the responsiveness of cancer cells to at least one immune checkpoint inhibitor. This is met in the rejection as set forth above.
Conclusion
Applicant’s amendment have necessitated this final office action. THIS ACTION IS THEREFORE MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
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