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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 April 2026 has been entered.
Response to Amendment
Claims 1-2, 5-6, and 10 have been amended as requested in the amendment filed on 27 April 2026. Following the amendment, claims 1-20 are pending in the instant application.
Claims 5-11 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-4 and 12 are under examination in the instant office action.
Withdrawn Objections:
The status identifiers have been corrected, therefore, the objection set forth in the previous action is withdrawn.
Withdrawn Rejections:
As currently amended, the rejections of Claims 1-4 and 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, both written description requirement and enablement requirements, have been withdrawn. Applicant has provided evidence that the antibodies of the claims were known before filing. It should be noted that on page 11 of Remarks Applicant provides sequences of a well-characterized single domain antibody encompassed by the claims, however, there exists no such antibody with that CDR-H3 sequence.
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.
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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over CN102721813 A (2012, cited on the ISR filed 6 APRIL 2022; hereafter “the ‘813 application”); in view of CN105622755 A (2016; hereafter the ‘755 application); and, CN102621296 A (2012, cited on the ISR filed 6 APRIL 2022; hereafter “the ‘296 application”).
Regarding claims 1-4, the ‘813 application teaches a detection kit for free prostate-specific antigen, comprising a reagent comprising a first nano-microsphere coated with a first antibody and a buffer and a second microsphere coated with a second antibody. This is depicted in Figure 1 of the reference wherein (1) is a biotin-labeled secondary antibody attached to a microsphere; (4) is the human prostate specific antigen, and (3) is a microsphere coated with an anti-prostate specific antigen). The reference states recites the anti-prostate specific antigen antibody receptor microsphere solution is prepared by taking 0.1 M of phosphate buffer silane solution having a pH of 8, which fulfils the “phosphate buffer” and the pH of “6 to 8,” as claimed. The 0.1 M buffer of the reference is equivalent to 100mM, which falls squarely within the range of the instant claim (“first reagent and in the second reagent is independently 10 mM to 500mM”). The reference further teaches washing the complex of Figure 1 with phosphate buffered saline solution with 0.6 to 0.625 weight volume percentage of 10% Tween 20 solution (see paragraph [0012] of English translation), which teaches the first reagent comprising a surfactant (Tween 20) and a buffer. This teaches the concentration of the surfactant within the claimed range of 0.01 and 3%, as required by instant claim 3. Further, Tween 20 is the tradename of the functionally identical Polysorbate 20 of instant claim 3.
While the ‘813 application teaches the general dual microsphere schematic of the claimed PSA detection kit, it does not specifically disclose a “murine anti-human fPSA monoclonal antibody” or a single domain anti-human antibody, however, these deficiencies are remedied by the ‘755 publication. The ‘755 reference teaches mouse raised monoclonal antibodies that bind human-fPSA were known in the art, and discloses engineering of these to produce a single chain antibody that is specific for prostate specific membrane antigen, PSMA, but not PSA. The ‘755 prior art further teaches coupling the single chain antibody to a carrier comprising beads or microspheres (Technology background, paragraph 16, section before term definitions).
Lastly, the previous references each fail to disclose coupling antibody to microspheres by an arm spacer but the ‘296 application remedies this deficiency. The ‘296 prior art teaches a carboxylation of polystyrene microsphere to couple a protein (antibody or antigen) to the surface, which improves the utilization rate of the antibody, so as to reduce the production cost (abstract). Specifically, the method uses 1-(3 amino propyl)-3 carbodiimide hydrochloride and N-hydroxy succinimide to produce an activated carboxylic polystyrene microsphere, after activating the introduced sulfonic group; the arm is coupled to an inert protein (see paragraphs [0006] through [0017] of the English equivalent). The ‘296 reference discloses this inert protein can be human serum albumin (see paragraph [0033]), which teaches the “serum albumin” of instant claim 2. Thus the prior art teaches the spacer arm molecule and the coupled protein of instant claim 2.
The ‘296 prior art teaches polystyrene microspheres as required by instant claim 4. It should be noted that Claim 4 is a product-by-process claim. Section 2113 of the MPEP states that Product-by-Process Claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. The courts have stated, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, the claim is taught by the identical structure, polystyrene microsphere, that is recited by the prior art.
Regarding claim 12, the current claims recite the calibrator is optional (claim 1, line 4). Therefore, the elements of claim 12 do not have to be taught within the prior art. However, claim 12 states: “wherein the calibrator comprises one or more selected from the group consisting of a buffer, a stabilizer and a preservative.” As stated above the ‘813 prior art teaches a buffer, specifically a phosphate buffer, which is one of the “calibrators” recited by instant claim 12.
In KSR International Co. v. Teleflex, Inc., the Supreme Court has stated that combining prior art elements according to known method to yield predictable results is prima facie obvious if the following rationale can be applied:
(1) the prior art includes each element claimed though not necessarily in the same reference.
(2) it was within the technical grasp of one of ordinary skill in the art to combine the elements as claimed by known methods, and that in combination, each element merely would have performed the same function as it did separately.
(3) one of ordinary skill in the art would have recognized that the results of such combination were predictable.
(KSR International Co. v. Teleflex, Inc. 127 S. Ct. 1727, 82 USPQ2d 1385, Supreme Court, April 30, 2007).
It would have been well-within the technical grasp of a person having ordinary skill in the art of PSA detection to combine the known features according to known methods since each of the elements are merely performing the same function that they do in the separate references. Specifically, a person having ordinary skill would have been able to use the mouse anti-fPSA and/or the single chain antibody disclosed in the ‘755 reference in the method of the ‘813 application and recognize that this substitution would predictably result in PSA antigen, since that is the same result in the ‘755 reference. Further a person having ordinary skill in the art would have been able to use the coupling method of the ‘293 reference to attach the antibody(ies) to the microspheres of the ‘813 method. Motivation to do so is explicit in the prior art wherein it states the coupling via spacer arms “improves the utilization rate of the antibody, so as to reduce the production cost” (abstract).
Therefore the invention of the claims is obvious in view of the combined teachings of the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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