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 .
DETAILED ACTION
2. The election filed 11/13/2025 in response to the Office Action of 08/27/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 3-4, drawn to a method for predicting whether a subject suffers from or is susceptible to suffer from a cancer and/or metastatic cancer expressing CD70 and treating the subject, comprising i) determining the level of soluble CD27 (sCD27) in a biological sample from the subject; ii) determining that the level of sCD27 in the biological sample is higher than a corresponding predetermined reference value; and iii) treating the subject determined to have a level of sCD27 that is higher than its corresponding predetermined reference value with a therapeutically effective amount of an inhibitor of interaction of CD27/CD70.
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
3. Claims 3-14 are pending in the application. Claims 5-14 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Claims 3-4 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of applications is acknowledged.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112
7. The following is a quotation 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.
8. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
9. Claims 3-4 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
The claims 3-4 are herein drawn to a method for treating cancer in a subject, comprising administering an inhibitor of interaction of CD27/CD70.
In this instance, the claims are directed to a genus of inhibitor of interaction of CD27/CD70.
A genus of inhibitor of interaction of CD27/CD70 may include, for example, a polypeptide, an antibody, a nucleic acid, or small molecule.
Although the specification teaches anti-CD27 antibody and anti-CD70 antibody (see [0080-0086] of the published application), it is not representative of the claimed a genus of inhibitor of interaction of CD27/CD70; this is because the claimed inhibitor of interaction of CD27/CD70, for example, a polypeptide, an antibody, a nucleic acid, or small molecule have markedly different structures. The artisan would not expect that any given inhibitor of interaction of CD27/CD70 would have activity of treating cancer.
There is no correlation between any one particularly identifying structural feature that is shared by at least a substantial number of the members of the claimed a genus of inhibitor of interaction of CD27/CD70; because each inhibitor of interaction of CD27/CD70 is structurally and functionally different. Although the artisan could potentially screen inhibitor of interaction of CD27/CD70, it cannot be predicted whether or not one will be successful. The written description provision set forth under 35 USC 112(a) is severable from its enablement provision, so that written description requirement cannot be met by describing how one might make the invention – rather the invention must be described in such clear and particular terms so as to reasonably convey to the skilled artisan that applicant had possession of the claimed invention as of the filing date of the application (i.e., the earlier effective US filing date sought).
The skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of the members of the claimed genus of inhibitor of interaction of CD27/CD70.
The specification therefore would not reasonably convey to the skilled artisan Applicant's possession of the claimed invention as of the filing date of the application.
Notably, the Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Furthermore, Applicant is reminded that “generalized language may not suffice if it does not convey the detailed identity of an invention.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1892 (CAFC 2004).
In this instance, there is no language that adequately describes with any of the requisite clarity or particularity the claimed a genus of inhibitor of interaction of CD27/CD70 would have activity for treating cancer. A description of what a material does, rather than of what it is, does not suffice to describe the claimed invention.
While the written description requirement can by satisfied without an actual reduction to practice, the disclosure of a catalog of potentially effective substances that might be found to be useful in practicing the claimed invention does not fulfill the written description requirement.
Recognizing that the claims are drawn to a genus of inhibitor of interaction of CD27/CD70 would have activity for treating cancer, it is aptly noted that the Federal Circuit has decided that a generic statement that defines a genus of substances by only their functional activity, does not provide an adequate written description of the genus. See The Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure, formula, chemical name, or physical properties of those members, rather than by merely reciting a wish for, or even a plan for obtaining a genus of molecules having a particular functional property. The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members.
Finally, Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of inhibitor of interaction of CD27/CD70 would have activity for treating cancer, but which otherwise vary materially, structurally and/or functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Turning to a different issue, claims are drawn to a method for treating cancer in a subject, comprising administering an inhibitor of interaction of CD27/CD70 to the subject. However, the specification does not provide any data for treating cancer using an inhibitor of interaction of CD27/CD70.
It is well known that therapeutic art is highly unpredictable. For example, Schlom et al. (US 20140341931, published on 11/20/2014) teach a method for diagnosing a subject as having a solid tumor or a predisposition to developing a solid tumor, the method, comprising: detecting an amount of soluble CD27 (sCD27) present in a serum sample obtained from a subject; and comparing the amount of sCD27 in the serum sample with a control value indicative of the basal level of sCD27 present in the serum of a subject that does not have a solid tumor or a predisposition to developing a solid tumor, wherein a reduction of the amount of sCD27 relative to the control value indicates that the subject has the solid tumor or the predisposition to developing the solid tumor; and administering to the subject an effective amount of a therapeutic agent to treat the tumor if the amount of sCD27 in the serum of the subject is reduced as compared to the control; see entire document, e.g., abstract claims 1-23.
Thus, it seems the instant claimed method with the method of Schlom et al. is opposite. Given the unpredictability of therapeutic art and the teachings of the specification, it is clear that it is not possible to predictably extrapolate the claimed invention base on no experimental data for treating cancer using an inhibitor of interaction of CD27/CD70. Therefore, it is submitted that the claimed treating cancer using an inhibitor of interaction of CD27/CD70 is not adequately described with the requisite clarity and particularity to reasonably convey to the skilled artisan that Applicant had possession of the claimed invention as of the filing date of the application.
The Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
10. 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 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.
Claim Rejections - 35 USC § 102
11. 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.
12. Claims 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Haard et al. (US 20190106498, published on 04/11/2019).
Claims 3-4 are herein drawn to a method for predicting whether a subject suffers from or is susceptible to suffer from a cancer and/or metastatic cancer expressing CD70 and treating the subject, comprising i) determining the level of soluble CD27 (sCD27) in a biological sample from the subject; ii) determining that the level of sCD27 in the biological sample is higher than a corresponding predetermined reference value; and iii) treating the subject determined to have a level of sCD27 that is higher than its corresponding predetermined reference value with a therapeutically effective amount of an inhibitor of interaction of CD27/CD70.
Haard et al. teach a method of monitoring treatment efficacy in acute myeloid leukemia (AML) patient, comprising detecting serum sCD27, when high levels of soluble CD27 in serum is detected, administering an anti-CD70 antibody, wherein the anti-CD70 antibody block the interaction of CD27 and CD70; see entire document, e.g., [0128], [0130], [0132-0138], claims 1-5 and 45.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642