DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1 and 10-13 in the reply filed on 10/3/2025 is acknowledged.
Response to Arguments
Applicant’s arguments with respect to claims 1-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 and 10-13 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 recites the limitation of “the compression corresponding to application of a pressure of 20-110 kgf during manufacture of the device," however it is unclear whether this limitation is required to be taught as a pore reduction or as a requirement of the manufacture of the device where the pore comes pre-compressed according to the claim limitation. Further, it is unclear as to whether the step is a required manufacturing step or a structural property. Clarification on the relationship between the listed pressure and the applied pressure to the porous membrane is suggested to advance prosecution.
Claim 1 also recites the unit of “kgf.” Kilogram-force is a unit of force rather than pressure. The unit of measurement should represent force/area, i.e., kgf/cm2, psi, atm, bar, Pa. Appropriate correction of the unit is required.
Claims 10-13 are dependent on claim 1, and are therefore rejected for the same reasons as above.
Claim Rejections - 35 USC § 103
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.
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 as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is 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 as of the effective filing date of the later invention 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.
Claims 1 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR20190114631A) (References herein made with respect to English Machine Translation) in view of Siciliano et al. (US 2012/0301893).
Regarding claim 1, Lee teaches a method for detecting C-reactive protein (CRP) or SARS-CoV-2 spike protein (a method for detecting a peptide, where proteins are peptide sequences, see [0026]), the method comprising providing a lateral flow immunoassay device (immunochromatographic test strip) with an increased detection signal intensity (method of using an immunochromatographic test strip to increase analysis signal strength, or intensity, see Fig. 4, [0035], and [0051]) comprising:
a sample pad for introducing a sample containing C-reactive protein (CRP) or SARS- CoV-2 spike protein as a target material (a sample pad 6 for accepting sample containing the target analyte, where the target analyte is a peptide, or protein, see Fig. 4 and [0032]);
a conjugate pad including a first conjugate bound with a marker (conjugate pad 5 with antibodies conjugated to gold nanoparticles, see Fig. 4 and [0031]);
a porous membrane (2) having of which a test line to which a second conjugate is immobilized and a control line to which a third conjugate is immobilized (porous membrane has test line and control line, where the test line contains a second antibody and the control line contains a second antibody-analyte-first antibody conjugate, see Fig. 4, [0005], [0041], and [0046]), the test line and control line being spaced apart (the two lines are spaced apart from each other, see Fig. 4)
wherein a region of the porous membrane located between the test line and the control line is compressed to have a reduced pore size relative to regions of the porous membrane upstream of the test line and downstream of the control line (the measurement area 3 is compressed to have a reduced pore size to reduce the movement of fluid from the first capture area to the second, see Fig. 5a-b, [0056] where pressure is applied to area outlined by reference number 3, and [0059] – [0060]), and
an absorption pad (7, see Fig. 4)),
introducing the sample into the sample pad (sample is introduced to the sample pad 6, see Fig. 4a);
and detecting binding of the target material at the test line (binding of the target analyte is detected at the test line, see Fig. 4b-e), and while the invention of Lee teaches a compression of the porous membrane (the pore size is reduced, which would correspond to an application of pressure, see [0059] – [0060]), it does not explicitly teach that the compression corresponds to application of a pressure of 20-110 kgf during manufacture of the device.
However, in the analogous art of analyte detection devices, Siciliano et al. teaches a device where the analyte membranes are constructed of nitrocellulose, nylon, polyvinylidene fluoride, or polyethersulfone, see [0100], which is analogous to the test membrane of Lee et al., where the test strips can withstand a force of 5-100lbf (2.27 – 45.36 kgf), see [0113], which overlaps the instant range and therefore renders it obvious, see MPEP 2144.05.
The modification of the method of using a test strip to include applying a force to the porous membrane prior to sample contact was known in the art before the effective filing date as evidenced by Siciliano et al., see [0195] – [0198]. Because the application of pressure to a porous membrane was known in art as evidenced by Lee et al., it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to modify the pressure applied to the test strip to fall between the claimed range as evidenced by Siciliano et al. for the benefit of controlling the flow rate of sample to subsequent absorbent layers of a test strip, see [0195]. The modification of the method of using the test strip to include applying the specified pressure of 2.27 – 45.36 kgf have had the reasonable expectation of controlling the flow rate of sample through adjacent areas of flow, see [0195] – [0197] in Siciliano.
Regarding claim 10, Lee teaches the method of claim 1, wherein the first conjugate, the second conjugate or the third conjugate is at least one selected from the group consisting of an antibody, an antigen, a nucleic acid aptamer, a hapten, an antigen protein, a DNA, and a DNA-binding protein (the conjugate on the test line is an antibody, see [0041]).
Regarding claim 11, Lee teaches the method of claim 1, wherein the first conjugate and the second conjugate specifically bind to the target material, and the third conjugate binds to the first conjugate (the first and second antibody bind to the target analyte and the control line antibody binds to the first antibody-gold nanoparticle, see [0041]).
Regarding claim 12, Lee teaches the method of claim 1, wherein the marker is at least one selected from the group consisting of nanoparticles, chromogenic enzymes, and fluorescent materials (the marker is a gold nanoparticle, see [0041]).
Regarding claim 13, Lee teaches the method of claim 1, wherein the target material is an antibody, an antigen, a nucleic acid aptamer, a hapten, an antigen protein a DNA, a DNA-binding protein, and a tissue- specific marker (the target analyte is an antibody, see [0026]).
Conclusion
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 ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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, Maris Kessel can be reached at (571)270-7698. 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.
/A.N.M./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758