Detailed Action
► The applicant's Preliminary Amendment filed 08 feb 2022has been entered. Following the entry of the Preliminary Amendment, Claim(s) 24-43 is/are pending.
► 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 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.
Sequence Rules
► This application complies with the sequence rules and the sequence(s) have been entered by the Scientific and Technical Information Center.
35 U.S.C. 102
► The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that may form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
35 U.S.C. 103
► 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.
► 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.
Claim Rejection(s) under 35 U.S.C. 102/103
► Claim(s) 24-43 is/are rejected under 35 U.S.C. 102(a)(2) or (a)(1) as being anticipated by or in the alternative under 35 U.S.C. 103 as obvious over Zhou et al. [US 2012/0115738 – hereinafter “Zhou
Zhou teach a kit comprising for example distilled water (i.e. i.e. a reagent), a microfluidic device and instructions for using their kit., see especially para 69.That said, Zhou does not teach producing droplets and/or capsules [i.e. Zhou does not expressly teach the method(s) of the instant application]. However, the invention is directed to a kit (i.e./ a composition) having a particular structure. It is well settled that a claimed product is defined by its structure and not how it was made or used . Something which is old does not become patentable upon the discovery of a new property. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The limitations of Claims 25-29, 34-37 and 39-43 are consider intended use limitations which fail to further limit the claimed invention..
As regards Claim 38, please consider the rejection of Claim 24 outlined directly above.
Claim Rejection(s) under 35 U.S.C. 103
► Claim(s) 24-43 is/are rejected under 35 U.S.C. 103 as obvious over Kurn [US 2009/0203531 – hereinafter “Kurn”] in view of the Perkin Elmer Cetus GeneAmp PCR reagent Kit (1988) – hereinafter “GeneAmp Kit” and/or in view of Shiffman et al.[US 2009/0132410 – hereinafter “Shiffman”].
As regards Claim 24, Kurn teaches a method ,device and compositions (e.g. kit) for practicing an Emulsion based [i.e. a droplet-based linear strand nucleic acid amplification teachnique(s) similar to EmulsionPCR] which use reagents capable of generating droplets/capsules. See for example, para 591. In some embodiments of Kurn the kits disclosed may comprise oil and/or surfactant. Kurn further teach that their droplet may comprise primers and/or enzymes [e.g. a polymerase(s)] which primers are releasably bound to droplets. In addition, Kurn teach including instructions with their kits. Finally, while Kurn teach the use of “microfluidic devices” in their method(s) , these inventors do not expressly teach including microfluidic devices in their kits. However, it was known to include all or many reagents and/or devices for practicing a given method in a kit useful for practicing said given method, consider for example the GeneAmp reagent kit for practicing PCR and/or the teachings of Shiffman who expressly teach the inclusion of a microfluidic device in a kit, see at least para 186.
The limitations of Claims 25-29, 34-37 and 39-41 are consider intended use limitations which fail to further limit the claimed invention.
Claims 30-31 comprise an embodiment of the kit wherein a microfluidic device is included in the kit. Kurn, as noted above, teach the use of microfluidic device In addition Shiffman teach including a microfluidic device in a kit
As regards Claim(s) 38, note the rejection of Claim 24 outlined above.
► Claim(s) 24-43 is/are rejected under 35 U.S.C. 103 as obvious over Hindson et al. [US 2014/378349 – hereinafter “Hindson”].
Claim 24 is drawn to a kit comprising
reagents capable of generating a capsule comprising a species,
reagents capable of generating a droplet in an emulsion,
instructions for introducing the capsule into the droplet, wherein the capsule is configured to release contents of the capsule upon application of a stimulus, wherein the stimulus is selected from a defined group which includes a reducing agent .
Hindson teaches methods, devices, reagents and kits which involve droplets and/or capsules (i.e. beads/ microcapsules) formation, which beads are to comprise a species [e.g. nucleic acid barcode molecule(s)] , see at least the abstract and paras 3-48. For example, in section VIII Hindson describes “Kits”. See especially paras 387-388. That said, Hindson does not teach including instructions in their kit(s) However the inclusion of instruction in kits so as to inform an end user of said kit how to utilize any kit component (s) in a particular method was well known as evidenced by at least para 69 in Wada. Therefore, absent a showing, it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the kit(s) of Hindson wherein instruction for using said kit(s) are included in said kit(s). The PHOSITA would have been motivated by a desire to inform an end user of said kit as to how to use said kit. Such was routine and well known in the art.
As regards the limitation which relates to how the capsules/beards are to be configured as recited on line(s) 5-7 of Claim 24, Hindson teach this limitation, see especially paras 41 and 124-145, 189 and 422. As regards the limitation of Claim 24 which relates to the instruction(s) the examiner considered this limitation to be a printed matter limitation and as such it was given little weight For a kit to be patentable, its components (like printed matter/instructions) must have a functional or structural relationship with each other or a physical product, meaning they work together to achieve a specific task, not just provide information. If instructions (printed matter) merely describe the product without performing a function with it (e.g., a measuring cup's markings), or if elements only relate conceptually (mental steps), they lack patentable weight as they are considered mere information, not part of the inventive structure or process.
As regards Claim(s) 25-26, see at least paras , 4, 35 and 245 in Hindson.
As regards Claim(s) 27, see at least the abstract, and paras 11-47.
As regards Claim(s) 28-29, see at least the abstract, and paras 11, 19 and 102.
As regards Claim(s) 30-31, see at least paras 14-22,96-100, 143-160, 179, 260-283, 320 anf 382-387 wherein Hindson describes a microfluidic device(s) for use in their method.
As regards Claim(s) 32, see at least paras 20 and 96.
As regards Claim(s) 33, see at least paras 105, 162 and 268.
As regards Claim(s) 34-35 it is noted that Hindson does not expressly teach an embodiment wherein the reagent(s) used in capsule/droplet generation comprise a fluid that is less dense (i.e. Claim 34) than the capsule and/or more dense (i.e. Claim 34) than the capsule. However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As regards Claim(s) 36-37, see at least the paras 41 - for Claim 36 - and para 5 -for Claim 37.
As to Claims 38-43, note the rejection set forth above against Claims 24-37 using Hindson. These claims appear directed to the same invention with slightly different wording.
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
07 JAN 2026 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Hindson B?/in
Emulsion$
Droplet$
Capsule$
Stimul$
Releas$
Microfluidic device$
► See the Examiner’s PE2E SEARCH notes/strategy in IFW