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 .
Priority
Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 63/245,467 filed 17 September 2021.
Examiner's Note
Applicant's amendments and arguments filed 6 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 6 November 2025, it is noted that claims 185, 195, and 202 have been amended and claims 205-206 newly added. Support can be found in the claims as originally filed and the specification at [0101]. No new matter has been added.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 185-193, 195-200, and 202-204 are rejected under 35 U.S.C. 103 as being unpatentable over Wyndham et al. (US 2019/0170705) in view of Devereaux (US 6,267,969).
Wyndham teaches encapsulated reagents for sample and workflow preparation and devices comprising the same [0006]. The encapsulated workflow reagent can be selected from enzymes, surfactants, labeling reagents, reactive compounds, an internal standard, or an external standard [0038] however the choice thereof by the skilled artisan can be any agent to provide a desired result in the analytical workflow [0124]. For example, in certain embodiments, and enzyme can be used and can be in solution or immobilized on a surface of a scaffolding material [0126]. The encapsulated workflow reagent can be attached to a porous solid scaffolding [0011-0013]. The scaffolding material can then provide the composition in the form of a solid or a hydrogel [0140-0141]. The workflow reagents can further be bound to chromatographic material such as activated carbon [0172, 0174]. The encapsulation shell can further encapsulate one or more additional encapsulation shells, effectively forming a core-shell structure of a microsphere [0040; 0200]. The thickness of said encapsulation shells can be varied to adjust the release rate of the reagent [0201]. Regarding the encapsulation shell, the shell can be made of polymeric materials such as water-soluble polyethylene glycol [0188-0189, 0194]. The workflow reagents in each shell can then be sequentially released [0041] wherein Wyndham teaches a method of controlling the release may be induced by a change in temperature [0051, 0207], a change in ionization [0052], or more than one means to release the reagent [0053]. The encapsulated material can further be used in a biological assay device [0044], separation device, sample preparation device, or fluidic device [0216] wherein the device can further include a housing such as a syringe, cartridge, or 96-well plate and wherein the housing can receive a flow of solution [0224-0225].
Wyndham does not teach the claimed components in one embodiment. Wyndham does not teach wherein the reagent is lyophilized.
Devereaux teaches reagents necessary for binding assays which are incorporated into a porous material and a carrier matrix (abstract). The lyophilization can be done on the reagent to avoid the need for cold storage (abstract) and also to extend reagent stability and facilitate the handling and packaging of the reagent (col 8, lns 35-38).
It would have been prima facie obvious to prepare the encapsulated composition of Wyndham wherein the product comprises multiple encapsulation shells and reagents that can be released in each shell, further wherein the release can be initiated by a change in temperature, ionization, or both. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of shell components, reagents, scaffolding, chromatographic material, activated carbon, and housing components from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting composition renders obvious the claimed shell surrounding an interior compartment (secondary shell) both of which release their contents in response to a condition. Said condition can be temperature, ionization, or both. Because the composition of Wyndham can be used as a sample preparation device, it would have been obvious to include a sample preparation reagent. The resulting composition can comprise a sample preparation reagent along with the aforementioned activated carbon, wherein the reagent can be formed as a hydrogel, thus rendering obvious instant claims 185-188, and 190-193.
Regarding claim 189, the thickness of the shell (i.e. width) is variable based on the desired release rate of the reagent. Therefore any thickness that results in a suitable release would have been obvious. That being said and in lieu of objective evidence of unexpected results, the shell thickness can be viewed as a variable which achieves the recognized result of adjusting the composition to the desired release rate. The optimum or workable range of shell thickness can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of shell thickness nonobvious.
Regarding the reagent, the limitation that the reagent be lyophilized is a product-by-process limitation that merely requires the reagent be free of water. That being said, Devereaux teaches that lyophilization of a reagent useful for assays is beneficial for providing storage stability to the reagent and avoiding the need for cold storage. Thus, it would have been obvious to include a lyophilized form of the desired workflow reagent in the porous scaffold of Wyndham.
Regarding claims 195-200, Wyndham teaches a method of controlling the release of the reagent, in the composition described above, that may be induced by a change in temperature, ionization, or more than one means. Regarding claim 200, Wyndham does not teach at what temperature the shell can be configured to release, therefore any temperature would have been obvious including those that are above room temperature, and thus above 25 ºC.
Regarding claims 202-204, Wyndham teaches providing a housing (such as a 96-well plate) for the composition along with solvent.
As such, instant claims 185-193, 195-200, and 202-204 are obvious in view of the prior art.
Response to Arguments
Applicant's arguments filed 6 November 2025 have been fully considered but they are not persuasive. The Applicant argues, on pages 11-12 of their remarks, that Wyndham does not teach a lyophilized reagent and that “solid form” does not equate “free of water.”
In response, although a solid form can be also “free of water” as required by the claims, the Applicant’s amendment has necessitated a new rejection including the teachings of Devereaux. Devereux teaches that providing the reagent in lyophilized form provides the benefit of increased stability of the composition and reduced need for cold storage.
The Applicant argues, on pages 12-13 of their remarks, that Wyndham does not disclose the reagents of claims 191 and 198. The Applicant further argues that because the present application is towards sequencing workflows that the dependent claims should be limited to sequence-related reagents.
In response, it is noted that the features upon which applicant relies are not recited in the rejected claims. 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). Therefore, there is no requirement in claims 185-193, 195-200, and 202-204 for the reagents to be sequence-related reagents. Because the composition of Wyndham can be used as a sample preparation device, it would have been obvious to include a sample preparation reagent, which reads on the limitations of claims 191 and 198.
Claims 185-193, 195-200, and 202-206 are rejected under 35 U.S.C. 103 as being unpatentable over Wyndham et al. (US 2019/0170705) in view of Devereaux (US 6,267,969) in view of Borner (US 2009/0062132) in view of Thill (US 2002/0055109).
Wyndham and Devereaux, as applied supra, are herein applied in their entirety for the teaching of encapsulated reagents for sample and workflow preparation and devices comprising the same. Wyndham teaches that in certain embodiments, the workflow reagent is an agent useful for amino acid analysis [0135].
Wyndham does not teach wherein the reagent is a sequencing reagent and wherein the method further includes sequencing a polynucleotide in a flow cell.
Borner teaches that for determining a sequence of a polynucleotide, nucleic acid sequencing reagents are necessary [0005].
Thill teaches that once a nucleic acid has been identified, it is worthwhile to clone the polynucleotide to confirm the structure [0242].
It would have been prima facie obvious to prepare the device of Wyndham for the purpose of analyzing amino acids, which can include nucleic acids. In order to analyze nucleic acids, Borner teaches that sequencing reagents would be necessary. Thus, it would have been obvious to use a sequencing agent as the reagent of Wydham, as required in instant claim 205. Furthermore, once the amino acid sequence is identified, Thill teaches that is worthwhile to close the polynucleotide to confirm it. As such, it would have been obvious to include a step of sequencing the identified polynucleotide within the same device, addressing instant claim 206.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613