DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I in the reply filed on 26 March 2026 is acknowledged.
Claims 17-26 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 March 2026.
Claims 1-16 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 3 November 2023, 27 March 2024, 16 August 2024, 3 December 2024, 24 March 2025, 24 June 2025, 12 November 2025, and 26 March 2026 ate acknowledged and have been considered.
Specification
4. The use of trade names or marks used in commerce (including but not necessarily limited to TRUESEQ BARCODES, as found in paragraph 0407), has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A. Claims 1 (upon which claims 2-16 depend), 5, 9, 10, 12 (upon which claims 13-14 depend), 13 (upon which claim 14 depends), 15, and 16 are each indefinite in the recitation “the fluidic droplet,” which lacks antecedent basis in the previous recitation of a “first fluidic droplet.”
It is also noted that while the preamble refers to “microfluidic” droplets, the term “microfluidic” does not appear again in any of the claims.
B. Claim 2 is indefinite in the recitation “the droplet,” which lacks antecedent basis in the previous recitation of a “first fluidic droplet.”
C. Claim 13 (upon which claim 14 depends) and 15 are each indefinite in the recitation “the plate,” which lacks antecedent basis because there is no previous recitation of a “plate.”
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,772,093 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to method of manipulating microfluidic droplets, oleophobic and hydrophobic opposing first and second sheets, elongating and dividing droplets, etc. Any additional limitations of the ‘093 claims are encompassed by the open claim language “comprising” found in the instant claims.
With respect to claim 3, the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). See MPEP 2144.04 IV B.
The courts have also held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). See MPEP 2144.04, IVA.
Thus, the claimed stylet is an obvious variant of the pin of the ‘093 claims.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
9. Claims 6-10 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,772,093 B2 as applied to claim 1 above, and further in view of Griffiths et al. (U.S. Patent Application Publication No. US 2015/0258520 A1, published 17 September 2015).
Regarding claims 6-10 and 16, the method of claim 1 is discussed above.
While the ‘093 claims recite different forces and magnetic particles, the ‘093 claims do not discuss combining droplets, ferrous particles, or the droplet volume.
However, Griffiths et al. teach methods comprising mixing (i.e., coalescing) two droplets into one (i.e., claims 6-8; paragraph 0080), the use of ferrous (i.e., iron oxide) magnetic particles (i.e., claims 9-10; paragraph 0034), and picoliter droplet volumes of (i.e., claim 16; paragraph 0045). Griffiths et al. also teach the methods have the added advantage of allowing high-throughput screens and sensitive assays (paragraph 0006). Thus, Griffiths et al. teach the known techniques discussed above.
With respect to claim 10, it is noted that the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). Thus, having a “controllable” magnet encompasses automation of the process of disabling the magnet. See MPEP 2144.04 III.
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “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). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ‘093 claims with the teachings of Griffiths et al. to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in methods having the added advantage of allowing high-throughput screens and sensitive assays as explicitly taught by Griffiths et al. (paragraph 0006). In addition, it would have been obvious to the ordinary artisan that the known techniques of Griffiths et al. could have been applied to the ‘093 claims with predictable results because the known techniques of Griffiths et al. predictably result in techniques useful in droplet formation and assays.
10. Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,772,093 B2 as applied to claim 1 above, and further in view of Fair et al. (U.S. Patent Application Publication No. US 2016/008433 A1, published 21 April 2016).
Regarding claim 15, the method of claim 1 is discussed above.
The the ‘093 claims do not discuss temporary pores in cells (i.e., electroporation).
However, Fair et al. teach methods comprising performing electroporation in cells within droplets utilizing an electrode (paragraph 0039), and the methods have the added advantage of allowing improved cell transfection efficiency (paragraph 0008). Thus, Fair et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ‘093 claims with the teachings of Fair et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of allowing improved cell transfection efficiency as explicitly taught by Fair et al. (paragraph 0008). In addition, it would have been obvious to the ordinary artisan that the known techniques of Fair et al. could have been applied to the ‘093 claims with predictable results because the known techniques of Fair et al. predictably result in techniques useful in droplet formation and assays.
Allowable Subject Matter
11. The following is an examiner’s statement of reasons for allowance:
The claims are drawn to methods of microfluidically manipulating a droplet using sheets having surfaces that are hydrophobic and oleophobic. The following prior art is cited for similar methods:
A. Beer et al (U.S. Patent Application Publication No. US 2010/0015614 A1) teach methods comprising moving droplets via compression of cover layers (e.g., paragraph 0058).
B. Fogelman et al (U.S. Patent Application Publication No. US 2013/0168250 A1) teach methods comprising moving droplets via compression of layers (e.g., Figures 1A-B).
C. Cheng et al (U.S. Patent Application Publication No. US 2015/0008123 A1) teach methods comprising moving droplets using flexible substrates (e.g., paragraph 0057).
D. Prakash et al (U.S. Patent Application Publication No. US 2015/0238959 A1) teach methods comprising moving droplets via deformation of flexible substrates (e.g., paragraph 0113).
E. Lee et al (U.S. Patent No. 9,975,117 B2) teach methods comprising moving droplets using flexible substrates (Abstract).
F. Kim et al. (U.S. Patent Application Publication No. US 2013/0236377 A1, published 12 September 2013) teach droplet dispensers having hydrophobic and oleophobic coatings (paragraph 0085).
G. Sheng (U.S. Patent Application Publication No. US 2021/0047680 A1, published 18 February 2021) teaches droplet reservoirs having hydrophobic and oleophobic coatings (paragraph 0187).
However, none of the cited references teach using compressing sheets having surfaces that are hydrophobic and oleophobic
Conclusion
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights