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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16 in the reply filed on January 9, 2026 is acknowledged.
Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the term “cells” (and any other term ending in “s”) only requires 2 cells.
It is not that any stream (not limited to any specific fluid) comprising 2 cells can be considered as an “ordered” stream.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
As to claims 1, 12, and 14, it is unclear what/which undulating portion is being referenced by the phrase “the undulating portion” because claim 1 previously recites a plurality of undulating portions.
Claims 2-16 are rejected via dependency upon a rejected claim.
The term “about” in claims 6-7 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as to what variations from the respective recited values are considered as being “about” the recited width and length values.
It is unclear how claim 4-5 further limits the method because as previously noted the term cells in claim 1 only requires 2 cells. The “when” clause is directed to a condition that is required to occur. It has not been established that the first and second streams comprise 50 pairs of cells. It is never required that the first and second stream streams comprise 50 pairs of cells as indicated by the “when” clause.
The term “adjacent” in claims 4-5 is a relative term which renders the claim indefinite. The term “adjacent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as what is considered, required of cells to be considered “adjacent”. The term does not provide for any definitive structural nexus, contact, distance between any cells, nor precludes anything from being present between the cells (including other cells).
Double Patenting
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.
Claims 1-3 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 18 of U.S. Patent No. US 12,391,914. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Patent include the same steps and features of the instant claims such that the scope of the claims of the Patent fully encompasses the scope of the instant claims. The claims of the patents are as follows:
1. A method for encapsulating a population of single droplets, the method comprising: flowing a first aqueous phase comprising a first ordered stream of immune cells in a first microchannel towards a junction, the first microchannel comprising between 60 to 120 undulating portions, wherein each of the 60 to 120 undulating portions comprises at least a 90 degree change in a flow vector across a length of each undulating portion of the first channel; flowing a second aqueous phase comprising a second ordered stream of antigen presenting cells (APCs) in a second microchannel towards the junction, the second microchannel comprising between 60 to 120 undulating portions, wherein each of the 60 to 120 undulating portions comprises at least a 90 degree change in a flow vector across a length of each undulating portion of the second channel; flowing an oil phase in a third microchannel towards the junction; and at the junction formed at a meeting of the first microchannel, the second microchannel, and the third microchannel, generating the population of single droplets formed from the first aqueous phase, the second aqueous phase, and the oil phase, the population of single droplets includes a total number of single droplets in the population of single droplets, wherein each single droplet of the total number of single droplets comprises only one immune cell from the first ordered stream of immune cells and an APC from the second ordered stream of APCs, and wherein the total number of single droplets in the population of single droplets exceeds a predicted number of single droplets comprising only one immune cell from the first ordered stream and an APC from the second ordered stream predicted using a Poisson distribution.
2. The method of claim 1, wherein the method generates droplets of the population of single droplets at a rate of at least 5,000 droplets per second.
3. The method of claim 1, wherein each of the 60 to 120 undulating portions of the first microchannel comprises at least a 180 degree change in a flow vector across the length of each undulation portion of the first channel.
4. The method of claim 1, wherein each of the 60 to 120 undulating portions of the second microchannel comprises at least a 180 degree change in a flow vector across the length of each undulation portion of the second channel.
18. The method of claim 1, wherein an inter-cell spacing of at least 80% of cells in the first ordered stream of immune cells or the second ordered stream of APCs is between 1 times an average cell diameter and 3.5 times an average cell diameter of the immune cells and APCs, respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bailey; Ryan et al. disclose devices comprising channels and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798