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 .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 06/08/2026 in response to the non-final Office Action mailed 01/28/26.
Status of Claims
2) Claims 3 and 21-22 have been canceled via the amendment filed 06/08/2026.
Claims 1, 2, 4, 5, 8 and 19 have been amended via the amendment filed 06/08/2026.
Claims 1, 2 and 4-20 are pending and are under examination.
Prior Citation of Title 35 Sections
3) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action.
Prior Citation of References
4) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Rejection(s) Moot
5) The rejection of claim 3 set forth in paragraph 8 of the Office Action mailed 02/19/26 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is moot in light of Applicants’ cancellation of the claim.
6) The rejection of claim 3 set forth in paragraph 8 of the Office Action mailed 02/19/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is moot in light of Applicants’ cancellation of the claim.
7) The rejection of claim 3 set forth in paragraph 12 of the Office Action mailed 02/19/26 under 35 U.S.C § 102(a)(1) as being anticipated by Brock et al. (Diagn. Microbiol. Infect. Dis. 96: #114937, 1-5, available online 13 November 2019, of record) is moot in light of Applicants’ cancellation of the claim.
Rejection(s) Withdrawn
8) The rejection of claims 1, 2 and 4-20 set forth in paragraph 8 of the Office Action mailed 01/28/26 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is withdrawn in light of the claim amendments. The internal inconsistency and the indefiniteness associated with the amended claim 1 and those dependent therefrom as set forth in this Office Action render the claims not meaningfully analyzable under 35 U.S.C § 101.
9) The rejections of claim 1 set forth in paragraphs 10(c), 10(d), 10(e) and 10(f) of the Office Action mailed 02/19/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicants’ claim amendment.
10) The rejection of claims 1, 2 and 4-13 and 15-20 set forth in paragraph 12 of the Office Action mailed 02/19/26 under 35 U.S.C § 102(a)(1) as being anticipated by Brock et al. (Diagn. Microbiol. Infect. Dis. 96: #114937, 1-5, available online 13 November 2019, of record) is withdrawn in light of Applicants’ amendments to the base claim. The internal inconsistency and the indefiniteness associated with the amended claim 1 and those dependent therefrom as set forth in this Office Action render the claims not meaningfully analyzable and/or mappable under 35 U.S.C § 102.
11) The rejection of claims 13 and 14 set forth in paragraph 14 of the Office Action mailed 02/19/26 under 35 U.S.C § 103 as being unpatentable over Brock et al. Diagn. Microbiol. Infect. Dis. 96: 1-5, 13 November 2019 as applied to claims 3 and 1 above is withdrawn in light of Applicants’ amendments to the base claim. The internal inconsistency and the indefiniteness associated with the amended claim 1 and those dependent therefrom as set forth in this Office Action render the claims not meaningfully analyzable and/or mappable under 35 U.S.C § 103.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
12) 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.
13) Claims 1, 2 and 4-20 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 1, as amended, is ambiguous, confusing, indefinite and is internally inconsistent. For example, step (a) of the claimed method for diagnosis is of contacting a subject sample suspected of containing “ (LAM) .... or Ag85B (Rv1886c)” [Emphasis added], i.e., either LAM or Ag85B (Rv1886c), the Ag85B (Rv1886c) being the elected species. However, the last paragraph of the amended claim 1 includes the limitations “wherein steps (a)-(g) are performed for each of the LAM and Ag85B (Rv1886c) antigens; wherein concentrations of LAM and Ag85B (Rv1886c) antigens ...... indicates the presence of Mycobacterium tuberculosis infection” [Emphasis added], thus requiring steps (a)-(g) to be performed on both of LAM and Ag85B (Rv1886c) antigens, not on either LAM or Ag85B (Rv1886c) as recited in step (a). One of skill in the art cannot understand in an unambiguous way what is being claimed and/or the metes and bounds of the claim.
(b) Claim 1, as amended, is further ambiguous and indefinite in the limitations: allow binding of the plurality of capture objects to the antigen contained in the sample, thereby creating a plurality of complexes of the capture object ......”. See lines 2-3 of step (b). It is unclear how binding of plural capture objects can create the non-plural capture object. One of skill in the art cannot understand in an unambiguous way what is being claimed.
(c) Analogous rejection applies to claim 1, as amended, with regard to the inconsistent plural and non-plural limitations: “the detectable moiety ..... the detectable moiety” and “detectable moieties” and the antecedence issue therein. See line 1 of step (e) and line 2 of step (f).
(d) Claim 1, as amended, is indefinite because of the antecedence issue with regard to the limitation: wherein “detecting” the detectable moiety at line 1 of part (e) of claim 1. For proper antecedence, it is suggested that Applicants replace the limitation “detecting” with the limitation --detecting of the--.
(e) Claim 1, as amended, is indefinite for lacking sufficient antecedence in the limitations “LAM” and “Ag85 (Rv1886c)” in line 4 of part (g) of the claim and the limitation “Mycobacterium tuberculosis infection” in line 5 of the claim. For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to each of said limitations.
(f) Claim 4, as amended, is indefinite for lacking sufficient antecedence in the 2nd recitation of the limitation “capture objects” in line 2 of the claim. For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to said limitation.
(g) The dependent claims 2 and 4-20, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Conclusion
14) No claims are allowed.
15) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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
16) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). 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 (571) 273-8300.
17) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2026
Prosecution Insights