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 .
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 01/14/2026; has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Claims 1-10 are pending and under current examination.
Applicants' arguments and amendments filed 10/07/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained and modified rejections in view of claim amendments
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kanbara et al. (United States patent Publication 2014/0178890) in view of Tanaka et al. (United States Patent Publication 20190091380).
Kanbara et al. teach a cancer cell enrichment filter for collecting cancer cells that has a polymer coating, see paragraphs [0001], [0020], [0080] and [0082] and claims 7-11. The composition has moderate hydrophilicity and enables blood platelets to only be slightly adhered, thus providing excellent blood compatibility, see paragraph [0076]. The agent is applied to the surface of a substrate to reduce blood cell components and platelet adhesion, see paragraph [0077]. Kanbara et al. teach a method for detection of cancer cells by utilizing a filtration step and culturing cells that have been enriched during filtration, see claims 1 and 12-14 and paragraphs [0091]-[0092]
Kanbara does not expressly teach that the polymer adhered to the filter is the same polymer as instantly claimed in claim 1.
However, Tanaka et al. teach a polymer composition as follows:
A repeating unit (A) represented by formula 1:
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Wherein R2 represents an aliphatic hydrocarbon group, see claim 1. The polymers of Tanaka reduce platelet adhesion when applied to as surface, see paragraph [0084]. The polymers can be used in a variety of medical devices including filters, see paragraph [0002]. The coating prevents adhesion of biocomponents including cells, see paragraph [0034]. Examples 15-18 demonstrate some cancer cell adhesion (paragraphs [0085]-[0806].
It would have been prima facie obvious to substitute the biocompatible polymers of Kanbara that coat the surface of cell collection filters in the method of detecting cancer cells by utilizing a filtration step for the polymers of Tanaka et al.
One of ordinary skill in the art would have been motivated to do so because the polymers of Tanaka are taught to reduce cell components and platelet adhesion and are suggested to adhere cancer cells. There would have been a reasonable expectation of success as both Kanbara and Tanaka teach polymers that reduce platelet and cell component adhesion.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of U.S. Patent No. 9372136 in view of Tanaka et al. (United States Patent Publication 20190091380).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Both the instant claims and that of Patent ‘136 claim a cancer cell collecting filter and detecting the presence of cancer cells via a method of culturing cells that are enriched by the filter.
The difference between the instant claims and the claims of Patent ‘136 is the type of polymers used in the method to detect cancer cells and for use with a cancer cell filter.
However, Tanaka et al. teach a polymer composition as follows:
A repeating unit (A) represented by formula 1:
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Wherein R2 represents an aliphatic hydrocarbon group, see claim 1. The polymers of Tanaka reduce platelet adhesion when applied to as surface, see paragraph [0084]. The polymers can be used in a variety of medical devices including filters, see paragraph [0002]. The coating prevents adhesion of biocomponents including cells, see paragraph [0034]. Examples 15-18 demonstrate some cancer cell adhesion (paragraphs [0085]-[0806].
It would have been obvious to substitute the biocompatible polymers of Patent ‘136 that coat the surface of cell collection filters in the method of detecting cancer cells by utilizing a filtration step for the polymers of Tanaka et al.
One of ordinary skill in the art would have been motivated to do so because the polymers of Tanaka are taught to reduce cell components and platelet adhesion and are suggested to adhere cancer cells.
There would have been a reasonable expectation of success as both Patent ‘136 and Tanaka utilize polymers that reduce platelet and cell component adhesion. (column 2, lines 58-64, column 8, lines 5-15, and 43-50 of Patent ‘136).
Response to remarks
Applicants argue that Tanaka teaches away from sufficiency adhering copolymer to cancer cells because Tanaka discloses that a coating film of the copolymer of the present invention prevents adhesion of biocomponents and that cell adhesion numbers were found to be very small in the cancer cell adhesion test (paragraphs 0085 and 0086).
Examiner respectfully submits that Applicant’s remarks are considered unpersuasive because the cancer cell adhesion test showed some adhesion of the cancer cells to the instantly claimed polymers even if it is a small amount. Thus, there is a detection of at least one cancer cell from the teaching of Tanaka. Tanaka at example 15-18 demonstrates at least some cell adhesion of cancer cells. Notably, the instant claims do not require any degree of adhesion of the cells, and adhering even a very small sample of cells meets the limitation required by claims 1 and 8. Furthermore, Tanaka teaches identical polymers as claimed, thus it is unclear why Tanaka would not at least suggest some cancer cell adhesion utilizing the same polymers with their cancer cell adhesion test performed.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive. 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).
Currently, no claims are allowed and all claims are rejected.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619