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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/29/2026 has been entered.
Withdrawn Objections/Rejections
The objection to claim 11 is withdrawn in response to the amendments.
The rejection of the claims under 103 is withdrawn in response to the amendments.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2021/051577, filed 01/25/2021. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. DE10 2020 102 038.4, filed on 01/28/2020 in Germany.
Status of the Claims
Claims 1-2, 4-5 and 8-16 are pending; claims 1 and 11 are amended, claims 3 and 6-7 are canceled; claims 8-10 are withdrawn; and claims 12-16 are newly recited. Claims 1-2, 4-5 and 11-16 are examined below.
New Rejections
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 1-2, 4-5 and 11-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not reasonably provide enablement for a diagnostic reagent for quantitative determination of procalcitonin in a sample.
The specification does not provide sufficient evidence that the claimed reagent is effective for quantitative determination of procalcitonin in a sample. The only evidence regarding the quantitative determination of procalcitonin in a sample using the polymer particles in storage buffer provided is shown in Figure 7 (“Figure 7 shows that a comparison of 50 g/L vs. 75 g/L vs. 125 g/L sucrose in the storage buffer yields similar calibration curves. However, the precision (measured as CV % of 20-fold determination of a sample containing 0.5 ng/ml PCT) becomes significantly better (CV% lower) the higher the sucrose concentration (see Table 3 below)” page 11 lines 10-13). Figure 7 shows three 5-point calibration curves of the diagnostic reagent, using three different sugar concentrations. However, these data demonstrate that the quantitative determination of calcitonin varies depending on the amount of sugar. Therefore, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied.
In re Wands, 858F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The nature of the invention is a biological/chemical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the claimed method(s), with a reasonable expectation of success, because it would not have been predictable from the disclosure that the claimed reagent would function as claimed with respect to its quantitative determination of procalcitonin in a sample (see MPEP § 2164.03).
In regard to Wands factors (C), (D) and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a).
Accordingly, Precision Antibody, “How to Ensure Antibody Stability During Long-Term Storage” (retrieved online https://precisionantibody.com/how-to-ensure-antibody-stability-during-long-term-storage/ on 6/29/2026) teaches that “[a]ntibodies are complex proteins influenced by temperature, pH, light and movement…The pH of the formulation buffer can influence antibody solubility, charge interactions and chemical stability. An unsuitable pH may accelerate deamidation or promote aggregation especially near the antibody’s isoelectric point (pI).
Most antibodies are stable at slightly acidic to neutral pH (5.0–7.0)” (page 3 para. 4).
See also Scenczi et al. Biologicals 34 (2006) 5-14, Received 5 February 2004; revised 19 May 2005; accepted 23 June 2005, doi:10.1016/j.biologicals.2005.06.007 (“Scenczi”). Scenczi teaches “[t]he effect of solvent environment on the conformation and stability of human polyclonal IgG in solution” (Title). Scenczi further teaches that “[i]t was observed that the conformational stability decreases with decreasing pH, while the resistance against aggregation improves. The optimum pH range for storage is 5.0-6.0, as a compromise between conformational stability and the tendency for oligomerization… Both pH and storage temperature are decisive factors for the long-term stability of IgG solutions” (Abstract).
Given the cited teachings of the prior art that polyclonal antibodies are sensitive to pH, and require a pH between 5-7, the cited references demonstrate that the use of the diagnostic reagent in storage buffer in the range from 9.0 to 10.0 is unpredictable.
While the level of skill in the art is high, the amount of guidance provided regarding how to use the claimed reagent is scant. Accordingly, the amount of experimentation required to determine how to use the recited diagnostic reagent for quantitative determination of procalcitonin in a sample is quite extensive.
Due to the large quantity of experimentation necessary to determine how to use the recited diagnostic reagent for quantitative determination of procalcitonin in a sample, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the limited state of the prior art, the unpredictability of the effects of complex biological molecules on diseased physiological systems, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. §112 first paragraph.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-5 and 11-16 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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