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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 May 2026 has been entered.
Examiner's Note
Applicant's amendments and arguments filed 6 May 2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 May 2026, it is noted that claims 190-191 have been amended. Support can be found in the specification at [0221-0222; 0235]. No new claims or 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]. Notably, Wyndham teaches example 21 wherein the encapsulated active-containing particle (of Example 18) are provided with a secondary encapsulating shell wherein the secondary shell has a different release trigger than the primary encapsulating shell [0294-0297]. Wyndham further teaches a third possible shell with a different release trigger than both the first and second shell [0298]. 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. Each encapsulation shell can be released by different triggers, as taught in the examples. 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 different trigger/condition. Said trigger/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.
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.
Response to Arguments
Applicant's arguments filed 6 May 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 10-12 of their remarks, that neither Wyndham nor Devereaux teach that the first release condition must be different from the second release condition.
In response, Wyndham actually teaches examples wherein it is specifically taught that the first, second, and third encapsulation layers are all triggered to release by different triggers, which can be interpreted as changes in temperature, ionization, or both.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
Prosecution Insights