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, see “Specification”, filed 05/25/2026, with respect to the objections to the specification have been fully considered and are persuasive. Objections to the specification have been withdrawn.
Applicant's arguments, see “Claim Rejections – 35 USC § 102”, filed 05/25/2026, have been fully considered but they are not persuasive.
In the REMARKS Applicant asserts that Ikenaka does not contain all of the limitations of claim 1. Specifically, Applicant asserts that ammonium sulfate is not explicitly described as being part of “the final kit or reaction solution”; instead, it is used to synthesize an intermediate.
In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the final kit or reaction solution”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, Examiner respectfully puts forth that Ikenaka teaches all of the limitations of claim 1; Ikenaka describes their kit as having all of the components of their described methods (see paras. 0054-0055, cited in previous office action) (The present invention provides a kit for performing the methods of the present invention as described above), which includes ammonium sulfate, which is used in “Example 1” as cited in the previous office action. Furthermore, the fact that ammonium sulfate is used for synthesizing an intermediate does not detract from Ikenaka including ammonium sulfate in a kit that is stated to encompass all of the methods of their disclosed invention.
Applicant further asserts that, because Ikenaka does not teach the limitations of claim 1, Ikenaka does not teach the limitations of claims 2-7 either.
Regarding claims 2-7, Examiner respectfully puts fourth that Ikenaka teaches the kit of claim 1 as discussed above. Furthermore, claims 4-7 are interpreted to be non-limiting for being product-by-process claims or the intended use of the kit, as Examiner described in a previous office action and restated below. See MPEP 2113 and MPEP 2173.05(p)(I) and MPEP 2114(II).
Applicant further asserts that Ikenaka discloses a different reaction scheme.
Examiner respectfully puts fourth that the reaction scheme is only positively recited in claims 6-7, which, as stated above, is being interpreted as an intended use of the claimed kit and is not granted patentable weight. See MPEP 2114(II). Applicant’s invention is directed to a kit, not the use of a kit nor the preparation of the components of the kit. Furthermore, claims 4-7 do not further limit the structural features of the claimed kit or introduce additional structural features.
Applicant further asserts that the aggregates formed in Ikenaka during the ultrasonication reaction are not disclosed by Ikenaka as being part of a kit.
Examiner respectfully puts fourth that Ikenaka does describe the aggregates (LMW-syn and/or HMW-syn) as being part of a kit (paragraph [55], as cited in previous office action) (The components of the kit other than the α-synuclein monomers may include… artificial fibrils).
Claim Interpretation
Claims 4 and 5 are product-by-process claims directed to the kit of claim 3, where the preparation process of the pre-formed fibrils (formed by self-aggregation of the alpha-synuclein monomers) follows a series of steps. Unless the process imbues special structural features to the product, the process is not granted patentable weight. In light of the specification, this process does not appear to imbue any special structural features to the pre-formed fibrils. Therefore, the process steps in claims 4 and 5 are not granted patentable weight. See MPEP 2113 and MPEP 2173.05(p)(I).
Claims 6 and 7 recite the kit of claim 1, where the “detecting steps” comprise a series of steps. These “detecting steps” represent the intended use of the kit of claim 1. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114(II). Here, the intended use is not given patentable weight since the limitations are with respect to a manner in which the claimed apparatus is intended to be used.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by IKENAKA in US 20220128576 (as cited in previous office action on 04/02/2026).
Regarding Claim 1, IKENAKA teaches the following: A kit for quiescent detecting alpha-synuclein aggregates (par. 0057, Example 1, solutions of Example 1 are a kit, additionally see paras. 0054-0055), wherein the kit comprises recombinant (par. 0057) (Escherichia coli BL21(DE3) transfected with an expression vector encoding wild-type human α-synuclein) monomeric alpha-synuclein (par. 0059) (an α-synuclein monomer conformer… termed “HMW-syn”), ammonium sulfate (par. 0057) (addition of ammonium sulfate) and thioflavine T (par. 0061) (ThT [Thioflavin T] was added to the solutions).
Regarding Claim 2, IKENAKA teaches the following: The kit for quiescent detecting alpha-synuclein aggregates according to claim 1, wherein the kit also comprises Tris buffer solution (par. 0058) (solution prepared in Tris buffered saline).
Regarding Claim 3, IKENAKA teaches the following: The kit for quiescent detecting alpha-synuclein aggregates according to claim 1, wherein kit also comprises pre-formed fibrils, and the pre-formed fibrils are aggregates formed (par. 0061) (the formed aggregates) by self-aggregation of the alpha-synuclein monomers (par. 0062) (HMW-syn [an α-synuclein monomer] produces twisted aggregates).
Claims 4 and 5 are product-by-process claims that describe the preparation of the preformed fibrils of claim 3. In light of the specification, the process described in claims 4 and 5 are not reported to give any special structural features to the preformed fibrils. As such, the processes of claims 4 and 5 are not given patentable weight. The fibrils taught by IKENAKA are structurally identical to the preformed fibrils of claim 3 because: (1) the IKENAKA fibrils are formed using recombinant alpha-synuclein monomers (par. 0059) (an α-synuclein monomer conformer… termed “HMW-syn”); and (2) the end products are aggregates of alpha-synuclein monomers (par. 0062) (HMW-syn produces twisted aggregates). See MPEP 2131.02(I).
Claims 6 is drawn to the kit of claim 1, wherein the “detecting steps” are described in two steps (S1 and S2). These detecting steps are the intended use of the kit of claim 1, and are not granted patentable weight. Therefore, the teachings of IKENAKA meet the instant claim.
Claim 7 is drawn to the kit claim 6, wherein the detecting step “S1” further comprises a certain temperature and time. The use of a particular temperature and time is the intended use of the kit, and is not granted patentable weight. Therefore, the teachings of IKENAKA meet the instant claim.
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.
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/H.D.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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