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
1. The examiner to whom the case has been docketed in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner M. Franco Salvoza in Art Unit 1672.
Claims 1-25 are canceled. Claims 26-40, 45 are withdrawn. Claims 26, 41, 43, 44, 45 are amended. Claims 41-44 are under consideration.
Specification
2. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Objections
3. (previous objection, withdrawn) Claim 41 was objected to because of informalities. Applicant contends: the claims have been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claims 41-44 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
5. (previous rejection, withdrawn) Claims 41-43 were rejected under 35 U.S.C. 103 as being unpatentable over Charpentier et al (US20130273525A1- included on IDS) and Bio-Rad (ELISA Formats 2018; previously recited).
Applicant contends: claim 1 has been amended; none of the cited references teach or suggest this claim limitation; in Charpentier et al., the IgM and IgG results are obtained separately through the reading of the signals by the two appropriate laser beams of the flow cytometer; each group of particles is manufactured producing a unique identification code assigned to each group of particles; Charpentier et al. focuses on differentiating detection results of each single format by obtaining values representative of each single format; in the claimed embodiments, only one label is contained in the detection system, the total signal generated is detected in one system; to differentiate values individually representative of each single format, there is not reason or motivation to add anti-IGG antibody having the same label as the labeled antigen; Bio-Rad fails to cure the deficiencies; the data supports the nonobviousness of the claims.
Applicant’s arguments are considered and found persuasive in view of the claim amendments, and the rejection is withdrawn.
6. (previous rejection, withdrawn) Claim 44 was rejected under 35 U.S.C. 103 as being unpatentable over Charpentier et al and Bio-Rad as applied to claim 43 above and further in view of Yuki et al (Journal of Hepatology 1994; previously cited).
In view of the withdrawal of the rejection over Charpentier et al and Bio-Rad on which the instant rejection depends, the instant rejection is also withdrawn.
7. Claims 41-44 are allowable as to the elected species. Claim 45, previously withdrawn from consideration as a result of a restriction requirement, contains all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement as to species inventions, as set forth in the Office action mailed on 3/3/2025, is hereby withdrawn and claim 45 is hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
8. (new objection) Claim 43 is objected to because of the following informalities: For improved grammar, claim 43 should recite “wherein the pathogen is … or another microorganism.”
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.
9. (new, necessitated by amendment) Claim 45 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.
See claim 45 as submitted 8/27/2025.
As to claim 45, the claim recites “the at least one antigen coated on a solid phase support” in line 2. It is unclear if the solid phase support is the same as the one established in claim 41 or if claim 45 intends to introduce a new solid phase support. If applicant intends for the solid phase support to be the same one established in claim 41, it is suggested to amend the claim to read “the at least one antigen coated on the solid phase support”. Further, the claim recites wherein the pathogen is Treponema pallidum. It is unclear based on the instant claim language what the antecedent basis is in relation to claim 43, whether Treponema pallidum refers to the spirochete or other microorganism or not.
Conclusion
10. Claim 44 is objected to for depending on an objected to claim. Claims 41, 42 are allowed.
11. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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