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 .
Claim Status
Claims 1, 3-17, 21-22 and new claim 23 are under consideration in this office action.
Withdrawn Rejections
The rejection of claims 1, 4, 7-14, and 20 under 35 U.S.C. 103 as being unpatentable over Panchapakesan in view of Das et al and Zhang et al are withdrawn in view of applicant’s amendment to limit claim 1 to a CNT sponge that does not comprise an agent specific for a cancer biomarker.
New Rejections
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 is limited to a cancer biomarker specific to tumor cells and claim 6 is limited to a cancer biomarker selected from the group consisting of EpCAM, cytokeratins, CD45, and HER2. Since claim 1, from which both claim 3 and 6 depend, is directed to a CNT sponge that does not comprise an agent specific for a cancer biomarker, the limitations of claims 3 and 6 for the types of biomarkers not present do not limit the scope of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejection Necessitated by Amendment
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.
Written Description
Claims 1, 3-17, 21-22 and new claim 23 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
The claims are drawn to a method of capturing CTCs using a CNT sponge, wherein the CNT sponge does not comprise an antibody against a cancer biomarker. The claimed method is nonobvious because of the unique physical features of the 3-D CNT sponge and the ability of the CNT sponge to exploit the adhesive characteristics of CTCs; there is no evidence in the prior art that a 3-D CNT sponge could selectively bind CTCs without a biomarker. The CNT suitable for the present invention has an outstanding binding affinity with CTCs, as cells tend to grow dendrites surrounding the CNTs” (pg 5). The specification defines CNT sponge as an allotrope of carbon with a porous cylindrical nanostructure with an outstanding binding affinity with CTCs (pg 5). Although the CNT sponge has a generalized structure, the specification does not set forth a specific structure that correlates with the required function. For example, the specification does not provide details for the 3-D architecture that gives the claimed CNT sponge its properties. Physical parameters related to the ability to bind cells, which may include pore size, density, or strength, are not set forth. It is noted that a method of making (as detailed on pg 8 of the spec) is not sufficient for written description purposes.
The University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: …To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an Applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2dat1966. In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure and the property of binding to CTCs to demonstrate possession of the breadth of the genus CNT sponge.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the 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 inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). See MPEP 2163.02.
Here, the new functional property that was not identified in the prior art must be described in detail so that one would understand how it is distinguished from the CNT sponges already described.
The specification must set forth the precise invention for which a patent is solicited, in such manner as to distinguish it from other invention and from what is old. It must describe completely a specific embodiment of the process, machine, manufacture, composition of matter or improvement invented, and must explain the model of operation or principle wherever applicable. The best most contemplated by the inventor of carrying out this invention must be set forth. 36 C.F.R. 1.71.
Therefore, claims 1, 3-17, 21-22 and new claim 23 do not meet the written description requirement.
Response to Amendment
The Declaration under 37 CFR 1.132 filed February 11, 2026 is sufficient to overcome the rejections of claims 1, 4, 7-14, and 20 under 35 U.S.C. 103; these rejections are withdrawn.
Response to Arguments
Applicant's arguments filed February 11, 2026 (pg 5-6) regarding the rejection of the claims under 35 U.S.C. 112(a) for failing to comply with the written description requirement have been fully considered but they are not persuasive. As detailed above in the rejection under 35 U.S.C. 112(a), there is insufficient description of the CNT sponge in the specification to meet the written description requirement. The scope of the claimed CNT sponge potentially includes many embodiments, especially given applicant’s broad definition of CNT sponge. New limitations directed to chemical vapor deposition, ferrocene, and dichlorobenzene do not remedy this deficit, because, as applied in the method of making, do not point to a clear structure-function relationship that would yield a CNT sponge with the desired traits. If applicant concludes that the CNT sponge is adequately described in the specification, applicant is encouraged to amend the claims to include specific limitations that sufficiently set forth the unique characteristics of CNT sponge without an agent specific for a biomarker that binds to CTCs.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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