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
Status of Claims
Claims 1-18, 21-25, 27-28, 30 and 32-34 are pending. Claims 17-18, 21-25, 27-28 and 32-34 are withdrawn as drawn to non-elected inventions. Claims 1-16 have been examined.
Election/Restriction
Applicant’s election of Group I, claims 1-16, in the reply filed on 04/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application, Serial No. 17/324,010 (PGPub: US2023/0184785) was filed 11/08/2022. This application is a 371 of PCT/US2021/033012 filed 05/18/2021 which claims benefit of U.S. Provisional Application 63/026,549 filed 05/18/2020.
Information Disclosure Statements
The Information Disclosure Statements filed 11/08/2022 and 04/20/2026 have been considered by the Examiner.
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 9-11 and 14 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 9 recites “the first mobile detection reagent” and this limitation lacks antecedent basis as no first mobile detection reagent has previously been claimed.
Claim 10 recites “the first detectable label” and this limitation lacks antecedent basis as no first detectable label has previously been claimed.
Claim 11 recites “the end flow region” and this limitation lacks antecedent basis as no end flow region has been claimed in any of the claims from which claim 11 depends.
Claim 14 recites “indicator region” and this limitation lacks antecedent basis as no indicator region has been claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-6, 8-10, 12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (CN-110488005, Pub Date: 11/22/2019, IDS, citations taken from attached English translation).
Regarding claim 1, Lin teaches throughout the publication a lateral flow device (See Figures 1-2A) for detection of an analyte comprising one or more circulating fins-like tyrosine kinase 1 (Flt-1) protein isoforms in a biological sample (abstract and document in it’s entirety), wherein the lateral flow device comprises: a substrate (PVC plate 1) comprising a sample receiving region (sample pad 9), a development region (label pad 3), an indication region (coating pad 2), and a quality control region (quality control line 6), wherein the substrate comprises a porous material and each region are in capillary contact with at least one other region thereby permitting a sample fluid to wick from the sample receiving region to the indication region (see Figure 1); a first capture reagent or a modification capable of immobilizing the first capture reagent at a first location of the indication region, wherein the first capture reagent is capable of forming a complex binding a first epitope of the Flt-1; and a first detection reagent comprising a detectable label attached to an anti-Flt-1 antibody, wherein the first detection reagent is capable of forming a complex binding a second epitope of the Flt-1 and being transported from the development region to the indication region (see entirety of Example 1).
Regarding claim 2, Lin teaches the device wherein the indication region further comprises a second capture reagent or a modification capable of immobilizing the first capture reagent at a second location of the indication region (see Example 1, part 1 – section 4 and 5).
Regarding claim 3, Lin teaches the device further comprising a second capture reagent comprising an antibody capable of binding the first detection reagent, the first detection reagent is capable of being transported from the development region to the quality control region, and the second capture reagent binds to a non-epitope binding domain of the first capture reagent but is not cross-reactive with the analyte (see Example 1, part 1 – section 4 and 5).
Regarding claim 4, Lin teaches the device wherein the first detection reagent, the analyte, and the first capture reagent form a complex and give off a signal to indicate the presence and/or level of the analyte in the biological sample based on the presence and/or intensity of the detectable label (see Example 1, part 1, sections 4-6 and parts 2-3).
Regarding claim 5, Lin teaches the device wherein the first detection reagent, the analyte, and the first capture reagent form a first complex and give off a first signal at the first location in the indication region, and the first detection reagent and the second capture reagent form a second complex and give off a second signal at the quality control region, and wherein the presence of both the first signal at the first location in the indication region and the second signal at the quality control indicates the presence of the analyte in the sample (see Example 1, part 1, sections 4-6 and parts 2-3).
Regarding claim 6, Lin teaches the device wherein the sample receiving region when contacted with the biological sample takes up the biological sample and permits release of the biological sample towards the indication region (Example 1).
Regarding claim 8, Lin teaches the device further comprising an end flow region comprising a porous material which conducts flow of the biological sample in the lateral flow device (Figure 1, water absorbing pad 4; Example 1, part 1, section 6).
Regarding claim 9, Lin teaches the device wherein the analyte is all isoforms of soluble Flt-1, membrane-bound Flt-1, or a combination of both; and the first mobile detection reagent is a monoclonal or polyclonal antibody immunoreactive with the Flt-1 (Example 1, part 1, sections 1- 5).
Regarding claim 10, Lin teaches the device wherein the first detectable label is a fluorescent latex microsphere (Example 1, part 1).
Regarding claim 12, Lin teaches the device further comprising a housing having a cavity and an inspection site on the housing, wherein the indication region extends into the cavity along the housing to the inspection site to enable visual inspection of the first location and/or the second location of the indication region (Example 1, part 1, section 6; observing window 14).
Regarding claim 15, Lin teaches the device wherein the sample receiving region, the development region and the indication region are in the form of a strip positioned above a base (see Figure 1).
Regarding claim 16, Lin teaches the device configured for collecting the biological sample, wherein the biological sample is plasma, serum or whole blood from a pregnant woman (abstract).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (CN-110488005, Pub Date: 11/22/2019, IDS, English translation attached), as applied to claim 1 above, and further in view of Xiang (US 2019/0346452, IDS).
Regarding claim 7, Lin teaches that a variety of sample types can be used such as plasma, serum and whole blood and wherein the sample receiving region when contacted with the sample takes up the fluid and is saturated with the fluid to permit release of the fluid towards the indication region (see Example 1) but does not teach that the biological sample is obtained from an oral mucosa.
Xiang teaches throughout the publication methods for providing a preeclampsia assessment for diagnosis of preeclampsia by evaluating a panel of preeclampsia markers (abstract). More specifically, Xiang teaches that preeclampsia markers can be determined from fluid samples such as blood, saliva and urine (paragraph 0082).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the blood sample in the device of Lin, a saliva sample as taught by Xiang because one having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent sample type and since the same expected detection of preeclampsia markers would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired device orientation and sample collection tools.
Claim(s) 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (CN-110488005, Pub Date: 11/22/2019, IDS, English translation attached), as applied to claim 1 above.
Regarding claims 11 and 13-14, Lin teaches the test strips, types of labels and manufacturing methods for the test strip as described above at Example 1 and within the entirety of the publication.
Although Lin does not teach the specific types of materials for the sample receiving region, development region, indication region, end flow region and pad treatment options as required in claims 11 and 13-14, one skilled in the art would have been motivated to choose the claimed Ahlstrom Grade pads with pad treatment options as a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular materials and treatments of the claimed pads were significant. See MPEP 2144.04.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Buhimschi et al. (US 2006/0183175) teaches kits related to detection of sFlt-1 from pregnant women at risk of developing pregnancy complications (abstract) and more specifically teaches for antibody-based kits, the kit can comprise, for example: (1) a first antibody (e.g., attached to a solid support) which binds to a polypeptide corresponding to an angiogenic marker of the invention; and, optionally, (2) a second, different antibody that binds to either the polypeptide or the first antibody and is conjugated to a detectable label (paragraph 0043).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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, Bao-Thuy L Nguyen can be reached at 571-272-0824. 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.
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
Prosecution Insights