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 .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 05/19/23 and 11/27/23.
Election
2) Acknowledgment is made of Applicants’ election filed 02/16/26 in response to the restriction and the species election requirement mailed 10/22/25. Applicants have elected, without traverse, invention II, and the urine biological sample species, the anti-LAM mAb species binding to a D-mannan core structure (the other species relate to the arabinan-branches), the magnetic bead support species, and the mAb species binding to a D-mannan core structure.
Status of Claims
3) Claims 7-11, 13, 15, 18, 20 and 25 have been amended via the preliminary amendment filed 11/27/23.
Claims 4, 12, 14, 19 and 24 have been canceled via the preliminary amendment filed 11/27/23.
Claims 1-3, 5-11, 13, 15-18, 20-23 and 25 are pending.
Claims 1-3, 5-11, 13, 15, 21-23 and 25 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 16-18 and 20 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 05/19/2023. The use of trademark recitation “Emulsiflex” in Figure 1 drawing is objected to. See paragraph 7 below.
Information Disclosure Statement
5) Acknowledgment is made of Applicants’ information disclosure statement filed 10/14/24. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
6) The instant AIA application, filed 05/19/2023, is the national stage 371 application of PCT/US2021/059448 filed 11/16/21, which claims priority to the U.S. provisional application 63/116,646 filed 11/20/20 and the United Kingdom application 2105804.5 filed 04/23/2021. It is noted that a certified copy of the foreign priority application is of record.
Objection(s) to Specification
7) The specification is objected to for the following reason(s):
The use of trademark recitations in the instant specification has been noted. For example, see “Emulsiflex” in Figure 1 drawing and on pages 6 and 22; “Tween” on page 16; “Tween 20” on pages 23-25; and “Sephadex” on page 19 of the specification. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety 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 trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
8) 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) Claims 17, 18 and 20 are rejected under 35 U.S.C § 112(b) or 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 Applicants regard as the invention.
Claims 17, 18 and 20 are indefinite for including the limitation “such as” because from this limitation it is not clear whether the limitations recited following ‘such as’ are optional, or included or excluded from the claimed invention. MPEP 2173.05(d).
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis 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.
Claim(s) Interpretation
10) Due to the indefiniteness associated with the claim limitation “such as” as set forth supra, the element(s) recited following the claim limitation “such as” are interpreted as being optional element(s) in the art rejection set forth below.
Rejection(s) under 35 U.S.C § 103
11) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied 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 unobviousness.
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicants are 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 at the time a later invention was effectively filed 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.
12) Claims 16 and 20 are rejected under 35 U.S.C § 103 as being unpatentable over WO 2015/009734 A2 (Applicants’ IDS) in view of Singh et al. (Int. J. Biol. Macromol. 102: 475-496, 2017).
WO ‘734 taught the mannose binding C-type lectin FcMBL beads or supermagnetic beads that bind to mannose-containing carbohydrates, such as the mannose-capped lipoarabinomannan (ManLAM) of M. tuberculosis, and contacting the beads with a biological sample in a FcMB-based detection method to detect binding of the FcMBL lectin to mannose-containing carbohydrate moieties of microbes and microbial products in biological fluids. WO ‘734 taught the detection or identification of mannose-capped lipoarabinomannan (ManLAM) of Mycobacterium tuberculosis or intact Mycobacterium tuberculosis containing ManLAM using the MBL capture beads. WO ‘734 taught capturing of the ManLAM and/or the Mycobacterium tuberculosis from a buffer or a biological sample by the FcMBL supermagnetic beads. The binding of the FcMBL to the ManLAM in the biological sample (i.e., the FcMBL-ManLAM complex) indicated that the subject from whom the biological sample was obtained was infected with M. tuberculosis. See Example 6; sections [0013], [00147] to [0149], [0202], [00268], [0269], [0045] and [0274]; the last sentence of sections [0087] and [0094], 5th sentence in section [00234], and the last but one full sentence of sections [0075] and [0087].
WO ‘734 is silent on the ManLAM-binding lectin being microvirin-N lectin.
However, along with the teaching of the expression of mannosylated surface structures with mannose-capped lipoarabinomannan (ManLAM) by M. tuberculosis, Singh et al. taught that CVN cyanovirin, i.e., an alternate lectin, specifically interacts with M. tuberculosis since it binds specifically to the mannose capped lipoarabinomannan. Singh et al. identified microvirin or MVN as a lectin that is a homolog of CVN also having specificity to alpha(1-2) linked mannose residues. See 2nd and 3rd full sentences of the paragraph bridging the two columns on page 479; top portion of Table 3; 1st sentence of the 2nd full paragraph under section 6.1 on page 481; and 1st full sentence of the paragraph bridging the two column on page 491.
Given the art-known fact that MVN is a homolog of CVN also having binding specificity to Man-LAM of M. tuberculosis as taught by Singh et al., it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to use Singh’s alternate ManLAM-binding MVN lectin in place of the ManLAM-binding FcMBL lectin of WO ‘734’s complex to produce the instant invention with a reasonable expectation of success. Substitution of one art-known lectin having ManLAM specificity with another, art-known, functionally equivalent lectin such as MCN already demonstrated in the art as having ManLAM specificity would have been well within the realm of routine experimentation, would have been obvious, and would have yielded similar predictable results. Substitution of one element for another known equivalent element in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc. 82 USPQ2d 1385 (US 2007) at page 1395. To those of ordinary skill in an art, it is generally obvious to replace a known product by substituting a known equivalent for one of its components. See e.g., Hotchkiss v. Greenwood, 52 U.S. 248 (1850) (substitution of porcelain door knob in known process of making metal or wood door knobs held obvious); In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) ("Because the applicants merely substituted one element known in the art for a known equivalent, this court affirms [the rejection for obviousness])." As set forth in KSR Int'l Co. v. Teleflex Inc., 27 S. Ct. 1727, 1741-42, 82 USPQ2d 1385, 1397 (2007), [i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103"; see also In re Beattie, 974 F.2d 1309, 1312, 24 USPQ2d 1040, 1042 (Fed. Cir. 1992) ("[T]he law does not require that the references be combined for the reasons contemplated by the inventor.").
Claims 16 and 20 are prima facie obvious over the prior art of record.
13) Claims 17 and 18 are rejected under 35 U.S.C § 103 as being unpatentable over WO 2015/009734 A2 (Applicants’ IDS) as applied to claim 16 above as modified by Singh et al. (Int. J. Biol. Macromol. 102: 475-496, 2017) and further in view of Brock et al. (Diagn. Microbiol. Infect. Dis. 96: 114937, pages 1-5, 13 November 2019).
The disclosure of WO ‘734 as modified by Singh et al. is set forth supra which is silent on having an anti-LAM antibody or anti-LAM mAb bound thereto.
However, attaching to by coating with an anti-LAM monoclonal antibody such as FIND 28, the same monoclonal used by Applicants in the instant application, to magnetic beads was well known in the art. For instance, Brock et al. taught magnetic beads coated with an anti-LAM monoclonal antibody such as FIND28, the same monoclonal used by Applicants in the instant application, further comprising a labeled anti-LAM antibody as well as a purified M. tuberculosis lipoarabinomannan (LAM). Brock et al. taught such reagents or elements for detection of LAM in a biological sample. See ABSTRACT; title; paragraph bridging pages 1 and 2; 1st full paragraph on page 2; and section 3.2 on page 2.
Given the teachings of Brock et al., it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to include by attaching an art-known anti-LAM antibody or a labeled anti-LAM antibody in WO ‘734’s complex to produce the instant invention. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of further facilitating the ManLAM-specific detection of M. tuberculosis.
Claims 17 and 18 are prima facie obvious over the prior art of record.
Relevant Art
14) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicants’ disclosure:
t Mazur-Marzec et al.(Biomolecules 11(3): 474, pages 1 of 17 to 17 of 17, 22 March 2021) identified both cyanovirin (CV-N) and microvirin (MVN) as cyanobacterial lectins having affinity for Man alpha(1-2)Man disaccharide. See Abstract; and Figure 3 description.
Conclusion
15) No claims are allowed.
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 Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. 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
March, 2026
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