Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTION
2. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Methods for detecting lung cancer by CTC enrichment and hybridization of labeled probes.
NON-PRIOR ART REJECTIONS
3. 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.
Claim 36 is 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. This claim is indefinite because ‘the subject with a CTC count greater than 5 CTC/10,000 cells’ and ‘the nodule’ lack proper antecedent basis. Correction is required.
4. 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, 3-6, 13, 20-28, 30, 36, and 39-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or correlation without significantly more. The claims recite a natural correlation between number of CTC cells in a subject sample and risk for lung cancer. This judicial exception is not integrated into a practical application because data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all of the recited active steps, including obtaining a blood sample, enriching for CTC, and using labeled probes to detect enriched CTC were routine and conventional in the prior art, as evidenced by Katz, Karabacak et al., and CN 107475202, as detailed below.
PRIOR ART REJECTION
5. 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.
6. 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.
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.
7. Claims 1, 3-6, 13, 20-28, 30, 36, and 39-43 are rejected under 35 U.S.C. 103 as being unpatentable over Katz (US 2018/0127829) in view of CN 107475202 (2017), and further in view of Karabacak et al. (2014).
Regarding independent claims 1 and 39, Katz discloses a method comprising: obtaining a blood sample; performing CTC enrichment comprising removing plasma, contacting with an affinity agent including a CD3 antibody, and contacting with streptavidin-coated magnetic particles to deplete undesirable cells; hybridizing enriched cells with labeled probes; evaluating the signal pattern using FISH, detecting CTC based on the hybridization pattern; and identifying a subject at risk for lung cancer based on the detected number of CTC. See paragraphs 0006-0008, 0012-0016, 0043-0045, 0082-0099, 0175-0179, and 0286.
Katz does not explicitly disclose removing erythrocytes from the blood sample, nor specifically using a biotinylated affinity reagent.
CN 107475202 discloses removing erythrocytes from a blood sample prior to enrichment for CTC. See claims 1 and 4 of the attached English translation.
Karabacak discloses the use of biotinylated antibodies for use in enriching blood samples for CTC by binding to and depleting undesirable non-CTC cells, including CD66b antibodies. See pages 694-695 and ‘Reagents’ section on page 701.
One of ordinary skill in the art would have been motivated to modify the method of Katz by removing erythrocytes from the blood sample because CN 107475202 discloses removing erythrocytes from a blood sample prior to enrichment for CTC. The skilled artisan would have been motivated to modify the method of Katz by using a biotinylated antibody because Karabacak discloses the use of biotinylated antibodies for use in enriching blood samples for CTC by binding to and depleting undesirable non-CTC cells. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
Regarding claims 3 and 4, CN 107475202 discloses removing erythrocytes from a blood sample prior to enrichment for CTC by lysing cells using an ammonium chloride lysis buffer. See claims 1 and 4 of the attached English translation.
Regarding claim 5, Katz discloses removing plasma by centrifugation. See paragraph 0013.
Regarding claims 6, 13, and 40, Katz discloses an antibody to CD3, and Karabacak discloses an antibody to CD66b, see previously-noted portions.
Regarding claim 20, Katz discloses depleting neutrophils and monocytes. See paragraphs 0006 and 0013.
Regarding claims 21-25, selection of additional antibodies for CTC enrichment would have merely involved routine optimization of known-important reaction parameters, which as well established in U.S. patent practice does not support unobviousness (M.P.E.P. 2144.05).
Regarding claim 26, Katz discloses a probe comprising 3p22.1. See paragraph 0016.
Regarding claims 27-28, 30, 36, and 41-43, the further limitations also merely involve routine optimization of known-important reaction parameters or factors, such as optimizing which cell surface markers and antibodies to use.
CONCLUSION
8. No claims are free of the prior art.
9. The Office now makes of record EP 3 132 267 and Mao et al. (US 2019/0262836) as references of interest.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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04/01/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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