DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of recombinant antibody in the reply filed on 03/11/26 is acknowledged. However, upon further consideration the restriction requirement is withdrawn. Currently, claims 1-18 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the terms Tween 20 & Triton X-100 (e.g. page 48, para. 00130; page 50, para 00133; page 52, para 00136), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3, line 2 the recitation “anybody” should be –antibody--. Appropriate correction is required.
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 1-18 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.
Claim 1, line 8 is indefinite in reciting “determining the level of the CB-CAP in at least one or more analytes” because the term “determining” appears to intend a mental step; hence it is unclear if applicant actually intends a positive method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --measuring--. See also deficiency found in line 9 “determining a level”.
Claim 9 is vague and indefinite because the claim does not end in a period (.) and therefore it is unclear if the applicant intends the claim to comprise anything after the recitation “an antibody C4d antibody”. Please clarify.
Claim 10 is indefinite in reciting improper Markush language in reciting “the cell-bound C4d is a complement activation product selected from” because it appears to intend to limit the scope of the complement activation product recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “complement activation product selected from the group consisting of”.
Claim 11 is vague and indefinite in reciting “the detection antibody binds to the anti-T cell antibody” because the detection antibody in claim 1 specifically binds to the CB-CAP. Thus, it is unclear if the applicant intends the detection antibody binds both to the CB-CAP and the anti-T cell antibody, if a second detection antibody is added which specifically binds to the anti-T cell antibody or if the Applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims. Please clarify.
Claim 15 is vague and indefinite in reciting “The method of claim 15” because the claim depends from itself and therefore it is unclear what the applicant intends or what claim it should actually depend from. Please clarify.
Allowable Subject Matter
Claims 1-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and the claim objections, set forth in this Office action. The prior art of record does not teach nor fairly suggest drawing into a microcapillary tube a sample comprising the recited analytes and detection agent and measuring the level of the CB-CAP by measuring a level of distribution of the plurality of cells on a side of the microcapillary tube as instantly recited.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ahearn et al discloses methods of detecting cell-bound complement activation product (CB-CAP) by detecting levels of C4d bound to erythrocytes with indirect immunofluorescence and flow cytometry (e.g. page 7).
Ramsey-Goldman et al (Lupus Science & Medicine 2017, pages 1-8) discloses the detection of EC4d levels in blood of SLE patients (e.g. page 4).
Shinefeld et al (WO 88/01374) discloses a method of detecting the presence of analytes in a sample by drawing a sample into a capillary tube and observing agglutination reactions (e.g. abstract pgs 6, 9, 11).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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