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 Applicant’s response to the office action filed on November 20, 2025 is acknowledged.
Status of the Application
2. Claims 1, 4, 9, 11, 13, 19, 21, 26, 46-47, 49-51, 58, 61-62, 66, 68 are pending under examination. New claims 75-77 are added. Claims 2-3, 5-8, 10, 12, 14, 15-18, 20, 22-25, 27-45, 48, 52-57, 59-60, 63-65, 67, 69-74 were canceled. The Applicant’s arguments have been fully considered and found persuasive for the following reasons.
Response to Arguments:
3. The rejection of claims under 35 USC 112(a) has been withdrawn in view of the persuasive arguments.
4. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
5. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Striemer et al. has been withdrawn in view of the amendment.
New Rejections Necessitated by the Amendment
Claim Rejections - 35 USC § 112
6. 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 75 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. Claim 75 recites the limitation "the one or more analyte of interest" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim 1 upon which the claim 75 depends, lacks support for one or more analytes. It is not clear and indefinite what the limitations are referring to.
Claim Rejections - 35 USC § 102
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 76-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrath et al. (US 2011/0152107).
McGrath et al. teach a method of claims 76-77, preparing, detecting or assaying an analyte of a sample comprising: contacting the sample with a fluidic device (microfluidic device) comprising a biomolecule functionalized silicon nanomembrane (nanoporous membrane functionalized with cell adhesion molecule or protein), wherein the biomolecule functionalized silicon nanomembrane is functionalized with one or more antibodies or peptides, the sample flows through the functionalized silicon nanomembrane and the fluidic device selectively captures the analyte from the sample, wherein the analyte of interest does not comprise a nucleic acid (para 0155-0161, 0141-0144, 0029, 0054-0057, 0189-0198, 0221-0222, 0226-0028);
passing a wash solution through the fluidic device (para 0190-0198);
passing a solution of one or more detection reagent (fluorescent species or dye) through the fluidic device, wherein the detection agent is not a DNA oligonucleotide or an RNA oligonucleotide (para 0190-0198);
wherein the sample comprises a biological sample and the functionalized silicon membrane is a functionalized silicon nanomembrane comprising a nanoporous silicon nitride membrane and the functionalized silicon nanomembrane is not functionalization with a biomolecule comprising a DNA oligonucleotide nor an RNA oligonucleotide (para 0133, 0141-0144, 0155-0161, 0093-0094).
With reference to claim 77, McGrath et al. teach that the contacting results in a sample flow that is not diffusion limited (para 0039-0040, 0133-0136-indicating sample flow is not limited to diffusion). For all the above, the claim is anticipated.
Claim Rejections - 35 USC § 103
8. 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.
The factual inquiries 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 nonobviousness.
Claims 1, 4, 9, 11, 13, 19, 21, 26, 46-47, 49-51, 58, 61-62, 66, 68 and 75-77 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (WO 2014/031532) in view of Bruening et al. (WO 2016/073565).
Note: claims recite ‘optional’. The limitations followed by optional are considered as optional and said limitations are not necessarily required by the claims.
Johnson et al. teach a method of claims 1, 75-77, preparing, detecting or assaying an analyte of a sample comprising: contacting the sample with a fluidic device (microfluidic device) comprising a biomolecule (retention or retentive agent) adjacent to functionalized silicon nanomembrane (nanoporous membrane), the sample flows through the functionalized silicon nanomembrane under convection and the sample flow is not diffusion limited and the fluidic device selectively captures the analyte from the sample, wherein the analyte of interest does not comprise a nucleic acid (para 0006-0013, 0042-0049, 0059-0061, 0071-0074);
passing a wash solution through the fluidic device (para 0059-0074, 0022-0023);
passing a solution of one or more detection reagent (fluorescent) through the fluidic device, wherein the detection agent is not a DNA oligonucleotide or an RNA oligonucleotide (para 0072-0074);
wherein the sample comprises a biological sample and the functionalized silicon membrane is a functionalized silicon nanomembrane comprising a nanoporous silicon nitride membrane and the functionalized silicon nanomembrane is not functionalization with a biomolecule comprising a DNA oligonucleotide nor an RNA oligonucleotide (para 0059-0074).
With reference to claim 4, Johnson et al. teach that the fluidic device further comprises one or more fluidic channels in fluidic contact with each other via one or more apertures and micropores and the contacting comprises the sample with a first membrane surface and a first fluidic channel or chamber (para 0006-0013).
With reference to claim 9, Johnson et al. teach a wash buffer (PBS) comprising solution of salt or detergent (para 0022-0024, 0057-0062).
With reference to claim 11, Johnson et al. teach adding detection reagent comprises labeled proteins (para 0072-0074).
With reference to claim 13, Johnson et al. teach measuring a signal comprises an optical modality of emission or absorbance signal at a defined wavelength (para 0057-0064).
With reference to claim 19, Johnson et al. teach that the method further comprising sequential or concurrent addition of one solution of detection reagents, wherein the detection reagents are non-conjugated or conjugated detection reagent (para 0072-0074).
With reference to claims 49-51, Johnson et al. teach that the functionalized silicon membrane is a microporous silicon nitride membrane, wherein the nanopore or micropore have a diameter of 1nm to 10um, density of 102 to 1010 pores/mm2 and a thickness of 20nm to 10um; wherein the functionalized silicon membrane further comprises one or more surfaces and plurality of nanopores or micropores, wherein an aperture extends through the thickness of the silicon substrate such that a first membrane is formed by the aperture and plurality of pores are connected to the aperture and one or more apertures extend through the thickness of the silicon membrane such that additional membrane surfaces are formed by the one or more apertures (para 0023, 0031-0043, 0064).
With reference to claims 58, 61-62, 66, 68, Johnson et al. teach that the method further comprises disposition of one or more biomolecules in solution onto membrane surface or aperture using discrete dispensing technique, dispensing in a droplet volumes of 10 pl to 10 ul continuous disposition of droplets on to the membrane and said disposition comprises disposition of multiple biomolecules using multiple droplet technique and disposition of stabilizer or passivation solution (para 0037, 0073-0074).
However, Johnson et al. did not specifically teach nanomembrane functionalized with one or more antibodies or one or more peptides.
Bruening et al. teach a method for affinity-based purification of proteins using biomolecule functionalized porous membrane, the method comprises a porous membrane functionalized with biomolecules or capture agents, wherein the biomolecule includes proteins such as antibodies wherein the porous membrane comprises nanopores, passing the biological sample through the affinity column, capturing an analyte of interest and detecting the capture analyte (para 0072-0074). Bruening et al. teach that the functionalized silicon membrane comprises a silicon membrane and functionalized by contacting the silicon membrane with a chemical oxidation reagent, epihalohydrin, a catalyst and one or more biomolecules, wherein the method comprises gas-phase, a spacer compound which is an amine group, carbon molecules or surface property modifying groups (para 0020-0035, 00134-0136).
It would have been prima facie obvious to one skilled in the art before the effective filing date of the invention to modify the method of Johnson et al. with functionalized surface with antibodies or peptides as taught by Bruening et al. to develop an improved method for analyzing an analyte. The ordinary person skilled in the art would have motivated to combine the method of Johnson et al. with a biomolecule functionalized membrane as taught by Bruening et al. and have a reasonable expectation of success that the combination would improve the method for capturing and analyzing an analyte because Bruening et al. explicitly taught use of biomolecule functionalized membrane for specific analyte capture and purification that results in rapid protein transport under convection and improves selective capture of a protein analyte (para 0073) and such a modification of the method is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681