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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Withdrawn Rejection
In light of the amendments and arguments, the enablement rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7-9, 11-14 and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
MPEP § 2163 further states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus:
The claims are drawn to a method of detecting aberrant results caused by incomplete delivery of a polyhapten reagent used in an immunoassay by reacting and forming soluble target analyte/target analyte-specific binding partner complexes; adding and forming insoluble polyhapten /target analyte analyte-specific binding partner complex; irradiating and measuring absorbance values of the insoluble complex, polypeptide, and blank at specific wavelength through turbidimetric detection; extrapolating an absorbance value for the polyhapten reagent at the time of delivery with a regression that measures absorbance values form any protein and blanks ( minimal to no protein/peptide) to flag unacceptable concentration values based on the extrapolation step.
The claims as a whole cover a genus of polyhapten to produce flaggable and unacceptable concentration values of the target analytes. Implicit in the claims is that such method as a whole would flag unacceptable values through structure and function relationship detected by the absorbance values; namely, the polyhapten and blank would produce absorbance values such that are extrapolatable to be associated in flagging unacceptable concentration value for the target analyte at the time of delivery.
Level of skill and knowledge in the art:
Voutsinas et al. teach that in turbidimetric method the source that is being measured is dependent on wavelength and affected by the protein that is associated with the source (see abstract and pg. 61, left col., para. 3;“A simple Turbidimetric Method for Determining the Fat Binding Capacity of Proteins”, J. Agric. Food Chem., Vol. 31, No. 1, pgs. 58-63, published 1983.
(2) Disclosure of method of making the claimed invention:
The specification only discloses detecting aberrant results which result from incomplete delivery of a polyhapten reagent used in a turbidimetric immunoassay for glycated hemoglobin (HbA1c) in a biological sample that is contained in a reaction cuvette and reacted with an anti-HbA1c antibody to form a soluble HbA1c-antibody complex in a mixture (A); which the excess of anti-HbA1c antibody reacts to the polyhapten reagent to form insoluble polyhapten/ anti-HbA1c antibody complexes through agglutination in a mixture (B); the reaction cuvette is irradiated with light to allow turbidimetric detection of the insoluble polyhapten/anti-HbA1c antibody complexes, detecting polyhapten that is polypeptide at 293nm and the polyhapten at 700 nm as the blank and determining an absorbance value of the initial polyhapten reagent added to the reaction by obtaining a regression of specific wavelengths with respect to time (reaction cycles) and reads are obtained immediately thereafter at cycles 69-71 (see Examples 1-2 and Figures 1-3) and wherein the polyhapten reagent good reads at 293nm and 700nm are at cycles 69 – 71.
As stated above, the specification only provides detecting polyhapten reagent at measured wavelength of 293 nm and blank measured at 700 nm, fails to provide a representative number of species for extrapolating an absorbance value to correlate with the concentration value of the target analyte. There is no description that other polyhaptens and blanks (i.e., wavelengths) are known to correlate with the concentration of the target analytes.
As stated above, MPEP has stated that written description for a genus can be achieved by a representative number of species within a broad generic limitation. However, it is unquestionable that the claims 1-5, 7-14 and 16-20 are broad and generic to the polyhaptens and blanks. The possible structural variations are limitless to the combination of molecules that would produce an absorbance value correlating with target analyte. The claims lack written description because there is no disclosure of a correlation between function and structure of these generic molecules beyond Examples 1-2. In particular, Voutsinas teaches that in turbidimetric assay the source that is being measured is dependent on wavelength and affected by the protein that is associated with the source. Importantly, the instant disclosure has stated that “Because the agglutination starts at the time of polyhapten delivery in the reaction mixture, and because there is no photometric read taken right after delivery, its delivery cannot be directly measured using mAU (293nm – 700 nm)” (see Example 1, paras. [0077] –[0079], as filed on 10/18/2021). Therefore, the person would not be able to envision performing a turbidimetric assay to extrapolate absorbance values for the polyhapten reagent at the time of delivery and flagging unacceptable concentration values for the target analyte based from absorbance values measured at the second and third wavelengths because the instant specification discloses that there is no confirmation that the flagging is in fact unacceptable concentration values, as no photometric read can be taken right after delivery.
In light of the teachings, the person skilled in the art would face an undue burden of examination in extrapolating from the myriad of combinations of polyhapten and blank that do not associate correlate with concentration of target analyte. The person cannot envision the detailed chemical structures until reduction to practice has occurred, regardless of the simplicity of the method to produce/structure, as it is understood in art that immunoassay produces interferences and the specification has disclosed that no photometric read can be taken right after delivery for confirmation.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed invention and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of polyhaptens and blanks in using turbidimetric assay to extrapolate an absorbance value to correlate with target analyte.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19047709 (CON of Patent 12247987).
Claims 1 and 18-20, although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 19047709 recites a method of detecting aberrant results caused by incomplete dispersion of a reagent used in a turbidimetric immunoassay, the method comprising the steps of:(A) reacting, within a reaction cuvette, a biological sample suspected of containing a target analyte with an antibody against the target analyte, thereby forming a soluble analyte/antibody complex; (B) adding a polyhapten reagent to the reaction cuvette, wherein the polyhapten reagent reacts with excess antibody to form an insoluble polyhapten/antibody complex; (C) irradiating the reaction cuvette with light at a first wavelength and a second wavelength; (D) turbidimetrically detecting the insoluble polyhapten/antibody complex and undispersed polyhapten reagent in the reaction mixture by measuring an absorbance value at the first wavelength and an absorbance value at the second wavelength; (E) comparing the measured first and second wavelength absorbance values to predicted values of an established regression obtained from first and second wavelength absorbances at different analyte concentrations during assay calibration; and (F) flagging, as unacceptable, a concentration value for the target analyte obtained by a separate algorithm if the measured second wavelength absorbance value exceeds the predicted value by an established flag constant. Copending Application claim 7 recites measuring a third wavelength. Copending Application claim 8 recites the third wavelength is in a range of from about 600nm to about 850 nm. Note that the instant claim 5 recites that the third wavelength (i.e., blank) is in a range of from about 650 nm to about 850 nm.
Therefore, it would have been obvious to have used a third wavelength for the method of detecting aberrant results caused by incomplete dispersion of a reagent used in a turbidimetric immunoassay as recited in the copending Application.
With respect to claims 2-4, the copending Application claim 2 recites the target analyte is selected from the group consisting of albumin, human chorionic gonadotropin (hCG), ferritin, growth hormone, prolactin, thyroglobulin (Tg), C-reactive protein (CRP), and Rheumatoid Factor (RF).
With respect to claims 5-6, 10-11 and 15, the copending Application claims 5-8 recite wherein the first wavelength is in a range of from about 190 nm to about 300 nm, and the second wavelength is in a range of from about 300 nm to about 650 nm, and wherein the first wavelength is different from the second wavelength; wherein the first wavelength is about 293 nm, and the second wavelength is about 340 nm; and wherein the third wavelength is in a range of from about 600 nm to about 850 nm.
With respect to claims 7, 12 and 16, the copending Application recites the addition of polyhapten but does not recite the two time points wherein the first time point is about 7.2 seconds following addition of the polyhapten and the second is about 7.2 seconds after the first time point.
However, it has been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum ratio for a result-effective variable in maximizing the readings of absorbance values for polyhapten at the time of addition. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Absent of unexpected results, it would have been obvious to the person of ordinary skill to discover the optimum reading time for in a turbidimetric assay reaction after the addition of polyhapten reagent.
With respect to claims 8, 13, and 17, the copending Application does not explicit recite the biological is whole blood or any portion thereof. Hamwi teaches blood samples from 179 patients that were consecutively sent for HbA1c determination were assayed (see pg. 90, left col., para. 1). It would have been obvious to have used blood samples or any portion thereof because HbA1c analyte is in the blood system and routinely tested.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive under the written description. The written description under 35 U.S.C. 112(a) has been modified in view of Applicant’s amendments.
Applicant argues on page 15 that in step (C) that the step is now reciting “polyhapten reagent”. Applicant argues on page 16 that the person would have reasonably conclude that Applicant’s disclosure more than adequately described the claimed invention at the time of filing. Applicant argues on page 17 that inhibition immunoassay format and data collection and data processing/analysis (regression and extrapolation) technology are well developed and mature. Applicant further argues on pages 17-18 that Applicant possessed polyhapten reagents and blanks in using turbidimetric assays.
The arguments are not found persuasive for the following reasons. The claim recites in step (F) that the absorbance value for the polyhapten reagent and blank at the time of delivery can be correlated with the target analyte concentration. Although turbidimetric assays for inhibition immunoassay have been established in the art but using absorbance values of polyhapten to correlate the target analyte concentration through a measurement that cannot be verified requires a representative number of species. In particular, the instant specific discloses that “Because the agglutination starts at the time of polyhapten delivery in the reaction mixture, and because there is no photometric read taken right after delivery, its delivery cannot be directly measured using mAU (293nm – 700 nm)” (see Example 1, paras. [0077] –[0079], as filed on 10/18/2021). The specification has indicated that delivery cannot be directly measured between 293-700 nm. Therefore, the person would not be able to conclude that, for example, polyhapten at 303 nm would perform in the same manner as polyhapten at 293 nm (as disclosed in Examples 1-2) or a blank at 650 nm would perform in the same manner as a blank 700 nm (as disclosed in Examples 1-2). Meanwhile, the specification through Examples 1-2 only provided one polyhapten at 293 nm and one blank at 700 nm to be extrapolated to flag certain analyte concentration as unacceptable. Based from the claims of detecting aberrant results caused by incomplete delivery of a polyhapten reagent, the person of ordinary skill in the art would recognize that there is unpredictability related to inhibition immunoassay. Because delivery cannot be directly measured between 293-700 nm (as disclosed by Applicant) and the method is based on prediction of the outcome of the target analyte in a reaction, a representative number of species is required. In other words, the specification has not disclosed extrapolating another polyhaptens and blanks at different wavelengths to provide the correlation as recited in the claims.
With respect to the provisional nonstatutory double patenting rejection, it is newly rejected in view that the copending Application 19047709 is a CON of Patent 12247987, which has an earlier effective filing date.
Conclusion
No claim is allowed.
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/N.P.N/
Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678