DETAILED ACTION
The amendment filed on 02/17/2026 has been entered and fully considered. Claims 1 and 3-22 are pending. Claims 5-8, 10-13 and 16-19 have been withdrawn from consideration. Claims 1, 3-4, 14-15 and 20-22 are considered on merits, of which claim 1 is amended, and Claim 22 is newly added.
Response to Amendment
In response to amendment, the examiner maintains rejection over the prior art established in the previous Office 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 .
Election/Restrictions
Applicant's election with traverse of group I comprising claims 1-4, 9, 14-15 and 20-21 is acknowledged. The traversal is on the ground(s) that there is not serious burden on the examiner in examining all of claims 1-21. This is not found persuasive because the restriction is based on the lack of the same or corresponding special technical features. The requirement is still deemed proper and is therefore made FINAL. Thus, claims 1 and 3-22 are pending in the application, claims 5-8, 10-13 and 16-19 are withdrawn from consideration as directed to non-elected invention, and claims 1, 3-4, 9, 14-15 and 20-22 are considered on merits.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 9, 14-15 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (WO 2017/210218).
Regarding claim 1, Anderson discloses a solid mixture comprising:
at least one internal standard protein (par [0074]);
at least one chaotropic agent or a derivative or salt thereof (par [0073][00131]); and
optionally a buffer (par [0073]);
wherein said chaotropic agent is selected from the group consisting of urea, guanidine, thiourea and derivatives and salts thereof (par [00131]).
Regarding claim 9, Anderson discloses a container comprising a solid mixture according to claim 1 (par [0073][0074][00131]).
Regarding claim 14, Anderson discloses a kit, the kit comprising:
a container according to claim 9 (par [0073][0074][00131]).
“USPTO personnel need not give patentable weight to printed matter absent a new and unobvious functional relationship between the printed matter and the substrate. See In re Lowry, 32 F.3d 1579, 1583-84,32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004)” (MPEP 2111.05).
“Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339”. (MPEP 2111.05).
Thus, “instructions for carrying out the method” is not given patentable weight.
The preamble “for carrying out the method according to claim 10” merely describes an intended use, and does not further limit the structure of the kit. Thus, caries no patentable weight.
Regarding claim 15, Anderson discloses a container comprising a solid mixture obtainable by
providing a solution comprising said at least one internal standard protein and at least one chaotropic agent selected from the group consisting of urea, guanidine and derivatives and salts thereof (par [0073][0074][00131]),
placing said solution in a container par [0074]),
removing residual liquid from said solution par [0074]),
thereby obtaining a container comprising a solid mixture comprising said at least one internal standard protein and said at least one chaotropic agent (par [0074]).
Regarding claim 20, Anderson discloses a kit, the kit comprising:
a container according to claim 15 (par [0073][0074][00131]).
“USPTO personnel need not give patentable weight to printed matter absent a new and unobvious functional relationship between the printed matter and the substrate. See In re Lowry, 32 F.3d 1579, 1583-84,32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004)” (MPEP 2111.05).
“Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339”. (MPEP 2111.05).
Thus, “instructions for carrying out the method” is not given patentable weight.
The preamble “for carrying out the method according to claim 16” merely describes an intended use and does not further limit the structure of the kit. Thus, caries no patentable weight.
Regarding claim 21, Anderson discloses that wherein the container is selected from the group consisting of a microtiter plate, a vial, a collection tube, a bottle, a pre-coated filter paper, a blood tube, a Whatman paper, a DBS collection device, a dried plasma spot device, a dried serum spot device, and a culturing plate (par [0073][0074][00167]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-4 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (WO 2017/210218).
Regarding claim 3, Anderson teaches a step of long-term storage of dried sample preceding the steps of subjecting said sample to analysis and determining the amount of said at least one target protein in said sample by comparison with said standard protein (par [0078][00158]).
Thus, it would have been obvious to one of ordinary skill in the art to let the solid mixture further comprising a sample suspected to comprise at least one target protein for long-term storage of the sample.
Regarding claim 4, Anderson discloses that wherein said internal standard protein comprises a fragment of said target protein (par [00134][00135]).
Regarding claim 22, Anderson teaches drying and stabilization of reagents and samples for later transport and use, including unrefrigerated storage for days or weeks and longer frozen storage, in a low-humidity dried format (par [00158][00167]). In view of that teaching, maintaining reagent usability over a period such as 4 weeks at room temperature would have been at least an obvious result-effective variable, especially where the reagents are intentionally dried and protected for later analytical use. Optimization of storage conditions and confirmation that dried internal standards remain suitable for later analysis would have been routine to a person of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
With respect to amended claim 1, applicant argues that Anderson fails to teach a “solid mixture comprising at least one internal standard protein” and “at least one chaotropic agent,” and further argues that Anderson merely lists possible reagents individually rather than disclosing the claimed combination. Applicant also argues that Anderson is directed to drying and stabilizing a collected biological sample, rather than to a pre-packaged solid-form quantitative standard. These arguments are not persuasive.
Anderson teaches a sample collection product in which reagents are pre-positioned on or within a sample absorber before sample introduction, and further teaches that such reagents may be dried in the absorber. As previously set forth in the Office Action, Anderson teaches internal standard molecules, including peptide or protein internal standards, as well as protein denaturants/chaotropes, including urea, guanidine hydrochloride, and related denaturing materials, as reagents suitable for preloading into the device. Anderson therefore teaches the very combination now recited in claim 1, namely a solid mixture including at least one internal standard protein and at least one chaotropic agent. The fact that Anderson describes these materials in the context of a sample collection device does not detract from the disclosure of the claimed composition itself. A composition claim is anticipated when the prior art describes the same composition, even if disclosed in a device or method context.
Applicant’s contention that Anderson only provides a “general list” of possible reagents is also unpersuasive. Anderson does not merely disclose unrelated alternatives in isolation. Rather, Anderson teaches that reagents useful for downstream proteomic analysis may be preloaded and dried in the absorber prior to sample application, including internal standards and denaturants. Thus, Anderson teaches that these reagents may coexist in the dried state in the same device. The presently claimed “solid mixture” does not require any more specific physical arrangement, preparation step, or concentration than what Anderson teaches. Amended claim 1 broadly recites a solid mixture “comprising” an internal standard protein and a chaotropic agent selected from urea, guanidine, thiourea, and derivatives and salts thereof, optionally with buffer. Applicant has not pointed to any structural limitation in claim 1 that would distinguish the claimed solid mixture from the dried reagent combination taught by Anderson. Applicant’s remarks that an 8 M urea solution would allegedly take days or weeks to dry are attorney argument unsupported by objective evidence and, in any event, do not negate Anderson’s express teaching of dried reagents.
Applicant further argues that Anderson has a different purpose, namely stabilization of collected biological samples for transport, whereas the present application is allegedly directed to a stable, solid-form quantitative standard before sample introduction. This argument is likewise not persuasive. Patentability is based on what the reference teaches, not on whether the reference emphasizes the same primary objective as applicant. Anderson teaches dried internal standards and dried denaturants in a sample-collection format intended for later analytical use. That teaching would have conveyed to one of ordinary skill in the art the claimed solid mixture regardless of whether Anderson’s broader discussion emphasizes sample stabilization. A reference is not avoided merely because it is directed to more than one benefit or because applicant characterizes its own benefit differently.
Regarding claims 3 and 4, applicant argues these claims are allowable at least by virtue of their dependence from claim 1. This argument is not persuasive because claim 1 remains unpatentable. Further, Anderson teaches embodiments in which the dried reagent composition is combined with a biological sample introduced into the device. Thus, the limitation of claim 3 that the solid mixture further comprises a sample suspected to comprise at least one target protein is met when the preloaded dried reagents are combined with the introduced sample. As to claim 4, Anderson’s disclosure of internal standard molecules including peptide standards encompasses fragments of target proteins used as internal standards in proteomic quantitation. Therefore, claims 3 and 4 remain unpatentable for the reasons previously stated.
Applicant’s arguments concerning alleged unexpected results are also not persuasive. Applicant relies on statements in the present specification asserting that drying a protein together with a chaotropic agent yields improved stability and redissolution, including stability after storage for 1 and 4 weeks at room temperature. However, these assertions do not overcome the rejection of amended claim 1 for at least two reasons.
First, amended claim 1 does not recite any stability threshold, redissolution performance, coefficient of variation, or quantitative accuracy requirement. The claim is broad and reads on any solid mixture comprising at least one internal standard protein and at least one recited chaotropic agent, optionally with buffer. Evidence of an allegedly superior property is not commensurate in scope with such a broad claim where the claim does not require that property and where the evidence appears limited to particular embodiments. Accordingly, the proffered evidence is insufficient to rebut the rejection of claim 1.
Second, even if applicant’s data are accepted as showing some degree of stability for applicant’s disclosed embodiments, that does not demonstrate that the prior art composition is structurally different from the claimed composition. Where the prior art teaches the same composition, unclaimed advantages or newly discovered properties of that same composition do not render the composition patentable.
New claim 22 recites that the internal standard protein “remains stable upon storage for at least 4 weeks at room temperature.” Applicant argues Anderson does not expressly disclose this functional stability characteristic and that a skilled artisan would have expected a chaotrope to harm protein integrity. These arguments are not persuasive.
Anderson teaches drying and stabilization of reagents and samples for later transport and use, including unrefrigerated storage for days or weeks and longer frozen storage, in a low-humidity dried format (par [00158][00167]). In view of that teaching, maintaining reagent usability over a period such as 4 weeks at room temperature would have been at least an obvious result-effective variable, especially where the reagents are intentionally dried and protected for later analytical use. Optimization of storage conditions and confirmation that dried internal standards remain suitable for later analysis would have been routine to a person of ordinary skill in the art. Applicant has not provided evidence sufficient to show that the full scope of claim 22 exhibits a truly unexpected result relative to the closest prior art, or that the asserted stability is anything more than an inherent or reasonably expected property of the dried reagent systems taught by Anderson.
Accordingly, the rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797