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 .
Response to Arguments
Applicant's arguments filed July 21, 2025 have been fully considered but they are not persuasive.
Applicant has amended independent claim 1 to recite a trap that consists essentially of a material selected from a group of materials, and argued that the prior art does not meet the claim limitation. Specifically, Applicant has argued that reference to Fitzpatrick et al., teach a trap having an immobilized ligand that binds free receptor that is excluded based on the amendment. As set forth in the MPEP, the transitional phrase “consisting essentially of” limits a claim to the specified materials or steps, and those that do not materially affect the basic and novel characteristics of the invention. The Examiner contends that the immobilized ligand of Fitzpatrick et al., does not materially change the characteristics of the invention as the instant specification states that the claimed trap may comprise a “chemical modification or addition to the trap material” (Pre-grant publication paragraph 0046). The instant specification does not provide any limits regarding the “chemical modification or addition” thus the Examiner contends that it is reasonable to read the immobilized ligand of Fitzpatrick et al., as a chemical modification or addition that does not materially affect the basic and novel characteristics of the claimed invention. Applicant has also argued that the cited prior art utilizes a detection method that is different from that of the instant claims. The Examiner notes that in claims directed to a device, patentability is based on the structural elements of the device, and not the manner in which they are used. As such, the Examiner contends that Applicant’s arguments regarding the detection methods are not persuasive. Therefore, in light of the teachings of the prior art, and the arguments provided here, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the rejection is maintained.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the phrase “permits flow of detection reagent bound to said at least one protein in said biological sample through said trap” is not a structural element of the test strip, but instead recites the intended use of the claimed test strip. Also, the Examiner notes that the phrase “configured to” does not denote a structural element of the test strip as the claim does not recite a specific configuration by which the capillary bed contains a biological sample after the sample flows through the trap.
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.
Claim(s) 1, 3, 9-13, 16, 17, 23-25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick et al., (US 5,451,504) in view of Ohman et al., (US 2010/0041154).
Regarding claims 1 and 3, Fitzpatrick et al., teach a test strip comprising a mobilization zone (sample receiving material), a trap, and a detection zone (display strip) wherein the zones are arranged in sequence (column 2 lines 26-32, figure 1), and the detection zone displays a signal if a protein is detected (column 4 lines 16-25). Fitzpatrick et al., do not teach the trap made of the materials recited in claim 1.
Ohman et al., teach that most common disposable assay devices (test strip) utilizes nitrocellulose, cellulose, wool, and glass fibers as a trap (paragraph 0005). Ohman et al., teach that it is advantageous to utilize nitrocellulose, cellulose, wool, and glass fibers as a means of providing a porous material capable of trapping red blood cells (paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fitzpatrick et al., to form the trap from nitrocellulose, cellulose, wool, or glass fibers in order to trap red blood cells as taught by Ohman et al.
Regarding claim 9, Fitzpatrick et al., teach a control reagent (column 3 lines 38-49).
Regarding claim 10, Fitzpatrick et al., teach a housing containing the test strip (column 10 lines 37-40).
Regarding claims 11 and 12, Fitzpatrick et al., teach the housing having an opening (well) and a window (column 10 lines 43-46).
Regarding claim 13, Fitzpatrick et al., teach a kit (column 1 lines 6-8, column 2 lines 20- 22).
Regarding claims 16 and 17, the Examiner notes that the test strip of Fitzpatrick et al., comprises control and detection reagents (column 3 lines 38-49, column 8 lines 30-35). The Examiner notes that the test strip is a component of the kit, thus the prior art kit comprises the control and detection reagents.
Regarding claims 23-25, the Examiner notes that the protein is not a structural element of the test strip, but instead represents the material worked upon by the test strip (MPEP 2115). As such, the protein is not given patentable weight in the claims.
Regarding claim 27, the claim does not provide a structural limitation of the test strip, but instead recites the intended use of the claimed test strip. The test strip of Fitzpatrick et al., meets the structural limitations of the instant claims, thus it would be capable of performing the functions recited in claim 27.
Claim(s) 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick et al., (US 5,451,504) in view of Ohman et al., (US 2010/0041154) as applied to claim 3 above, and further in view of Raj (US 7,901,949).
Regarding claims 4-8, Fitzpatrick et al., in view of Ohman et al., teach that any arrangement that provides three or more zones in communication is within the scope of the invention (Fitzpatrick et al., column 3 lines 27-31). This teaching meets the limitations regarding first and second sample receiving materials and traps in that Fitzpatrick et al., recognizes that the test strip may comprise three or more zones without limiting the number and types of zones that may be utilized. Fitzpatrick et al., in view of Ohman et al., do not teach the three or more zones overlapping.
Raj teaches a test strip having a reagent zone, trapping zone, and a detection zone wherein the zones may fully or partially overlap (column 4 lines 4-16). The Examiner is reading this limitation as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III A). Raj teaches that overlapping materials allows sample to pass from one section to another, thus one of ordinary skill in the art would have found it obvious to provide overlapping materials for each zone. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fitzpatrick et al., in view of Ohman et al., to have overlapping materials for the reagent, trapping, and detection zones taught by Raj as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick et al. (US 5,451,504) in view of Ohman et al., (US 2010/0041154) as applied to claim 13 above, and further in view of Khan et al., (US 2002/0072124).
Regarding claims 14 and 15, Fitzpatrick et al., in view of Ohman et al., do not teach a kit comprising instructions and an applicator.
Khan et al., teach a kit comprising a test strip, instructions, and a means for obtaining a sample (paragraph 0054). The Examiner is reading this limitation as combining prior art elements according to known methods to yield predictable results (MPEP 2141 III A). One of ordinary skill in the art would have recognized that providing instructions allows for a user to utilize the components in the proper manner thereby generating accurate results when measuring an analyte. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fitzpatrick et al., to include instructions and an applicator in a kit as taught by Khan et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Claim(s) 18-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick et al. (US 5,451,504) in view of Ohman et al., (US 2010/0041154) as applied to claims 1 and 17 above, and further in view of Buhimschi et al., (US 2011/0280863).
Regarding claims 18-20 and 22, Fitzpatrick et al., in view of Ohman et al., do not teach a detection reagent being an azo dye, nor do they teach a sample receiving material made of nitrocellulose.
Buhimschi et al., teach detection and treatment of preeclampsia comprising applying a biological sample to a substrate having a nitrocellulose membrane (paragraph 0244 step 8, paragraph 0247) and detecting the presence of Congo Red on the membrane (paragraph 0244 step 11). Buhimschi et al., teach that it is advantageous to utilize nitrocellulose as a means of providing a membrane that binds proteins (paragraph 0135). Buhimschi et al., also teach that it is advantageous to utilize Congo Red as a means of providing a dye having affinity of abnormal or misfolded protein aggregates (paragraphs 0005, 0009, 0010).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fitzpatrick et al., in view of Ohman et al., wherein nitrocellulose and Congo Red are utilized in order to provide a membrane having an affinity for proteins, and a dye the binds misfolded or abnormal proteins as taught by Buhimschi et al.
Conclusion
THIS ACTION IS MADE FINAL. 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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797