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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/28/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 28 October 2025.
Claims 1 and 6-10 are pending.
Claims 2-5 and 11-20 are cancelled.
No claims are withdrawn from consideration.
No claims are newly added.
Claim 1 is amended.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a droplet sorter to allow for the separation of droplets based on the analysis of the inner content of droplets...”, as in Claim 1.
“an induction media droplet generator to release...”, as in Claim 1.
“a signal amplification media droplet generator to release...”, as in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Differential size sorting, bifurcation-induced droplet sorting, dielectrophoretic (DEP) force-based sorting, acoustic force-based sorting, pneumatic force-based sorting, magnetic force-based sorting, thermal- based droplet sorting, and combinations of the same and like as in para. [0004] of Applicant’s instant specification; and equivalents thereof.
“an entry point” as in para. [0014] of Applicant’s instant specification filed 05/16/2022...and equivalents thereof.
“an entry point” as in para. [0011] of Applicant’s instant specification filed 05/16/2022...and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 6-10 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.
Claim 1 recites the limitation "the first droplet incubator ". There is insufficient antecedent basis for this limitation in the claim.
Applicant may intend to recite “the first droplet incubation chamber”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (US 2018/0231522 A1), referred to hereinafter as “Han”.
Regarding Claim 1, Han teaches a microfluidic platform 100 (Fig. 1 and [0008]: “Embodiments of the claimed invention are directed to a microfluidic platform device 100…”) comprising:
a droplet generator 102 comprising an entry point for donor particles and target particles (Fig. 1 and [0011]: “The assay components may include a B cell encapsulation that is introduced to the microfluidic platform device 100 via the first droplet generator 102.” – Herein, while this first droplet generator 102 is taught as for encapsulating B cells, the first droplet generator 102 is fully capable of encapsulating other cell types and/or assay reagents such as antibodies, thereby comprising an entry point for any type of donor particles and target particles.);
wherein the droplet generator 102 comprises a donor particle droplet generator and a target particle droplet generator (Given Applicant’s instant Fig. 1A showing the “droplet generator for donor and target cells”, the “a donor particle droplet generator and a target particle droplet generator” are interpreted as referring to a single droplet generator for introducing donor and target particles. As the droplet generator of Han is commensurately structured as in the instant device, the droplet generator of Han is fully capable of being used to provide both donor and target particle droplets. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, whether the droplet generator is used for donor/target particle droplet generation or generation of other droplets containing other particles is immaterial, as the function of generating droplets is the same and the structures of the instant droplet generator and that of the prior art are the same. – If Applicant intends the structure of the instant drawings Fig. 1B, Applicant must specifically describe the adjacent first and second droplet generators having the merging channels as seen through Fig. 1B. – Further, the Fig. 1 of Han shows a bifurcated entry point, thereby interpreted as forming the claimed dual function droplet generator if two entry points are intended.),
a first droplet incubation chamber 104 in fluid communication with the droplet generator 102 (Fig. 1 [0011]: “The B cell encapsulation proceeds to the first droplet incubation chamber 104 for Ab accumulation.”),
wherein the first droplet incubation chamber 104 is configured to allow interaction between the donor particles and the target particles (As the first droplet incubation chamber 104 merely holds a droplet for a specified amount of time, donor and target particles contained in said droplet will interact while held in the chamber. As such, the first droplet incubation chamber 104 is configured to allow interaction between the donor particles and the target particles.);
a first droplet merging region 108 in fluid communication with the first droplet incubation chamber 104 ([0010]: “...a droplet merging region 108 to merge these two droplets (e.g. electric field based, surface tension based droplet merging)...”),
an induction media droplet generator 106 to release an induction media at a point between the first droplet incubator 104 and the first droplet merging region 108 (Fig. 1 and [0010]: “a second droplet generator 106 that encapsulates infectious agents”);
a second droplet incubation chamber 110 in fluid communication with the first droplet merging region 108, wherein the second droplet incubation chamber 110 is configured to allow for signal induction (Fig. 1 and [0010]: “a second droplet incubation chamber 110 to co-incubate the Ab-producing B cells and pathogens, reporter viral particles (RVP), or other agents to allow neutralization (or enhancement) of the agents to take place” – As the second droplet incubation chamber of Han is commensurately structured as a chamber as in the instant claims, said incubation chamber of Han is commensurately configured to allow for signal induction.);
a second droplet merging region 114 in fluid communication with the second droplet incubation chamber 110 (Fig. 1 and [0010]: “a second droplet merging region 114 that merges the two droplets”);
a signal amplification media droplet generator 112 to release signal amplification media at a point between the second droplet incubation chamber 110 and the second droplet merging region 114 (Fig. 1 and [0010]: “a third droplet generator 112 encapsulating host cells that may be engineered to express a fluorescent reporter upon infection with pathogens”);
a third droplet incubation chamber 116 in fluid communication with the second droplet merging region 114, wherein the third droplet incubation chamber 116 is configured to allow for signal amplification (Fig. 1 and [0010]: “a third droplet incubation chamber 116 that allows the neutralization (or enhancement) assay to take place” -- As the second droplet incubation chamber of Han is commensurately structured as a chamber as in the instant claims, said incubation chamber of Han is commensurately configured to allow for signal amplification.);
a droplet detector 118 to allow for analysis of the inner content of droplets (Fig. 1 and [0012]: “Upon exiting the third droplet incubation chamber 116, light from a light source 124 is directed towards a conduit 117 where the merged droplet within which the assay (e.g., neutralization, enhancement, or no effect) occurs is passing through. Light that passes through the assayed Ab composition is analyzed by the droplet fluorescence detector 118.”),
wherein the droplet detector 118 is at least one of optically coupled with or incorporated on the microfluidic platform 100 (As shown in Fig. 1 and discussed in para. [0010], the fluorescence detector 118 is a component of the platform 100, and is thereby paired with and incorporated on the platform 100.);
and a droplet sorter 120 to allow for the separation of droplets based on the analysis of droplet content (Fig. 1 and [0013]: “After passing through the light from the light source 124, the droplet containing assayed Ab composition passes through a conduit 117 to the droplet sorter 120. The droplet sorter 120 sorts between neutralized and uninfected “hits” that exit the outlet 122 and enhanced and highly infected “hits” that exit the outlet 123 so that they may be later sent off chip to allow for B cell recovery and further analysis.”),
wherein the droplet sorter 120 is at least one of communicatively coupled with or incorporated on the microfluidic platform 100 (As shown in Fig. 1 and discussed in para. [0010], the droplet sorter 120 is a component of the platform 100, and is thereby paired with and incorporated on the platform 100.), and
as in Claim 1.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Han teaches the microfluidic platform discussed above further comprising:
a first outlet 121, wherein the first outlet 121 is configured to release waste particles displaying no transfer (Fig. 1 and [0010]: “Droplets with no effect will continue to flow out of outlet 121.”);
and a second outlet 123, wherein the second outlet 123 is configured to recover particles displaying successful transfer (Fig. 1 and [0010]: “…enhanced and highly infected “hits” that exit an outlet 123 so that they may be later sent off chip to allow for B cell recovery and further analysis.”),
wherein the first outlet and second outlet are in fluid communication with the droplet sorter (Fig. 1 shows the outlets 121/123 in fluid communication with the droplet sorter 120.),
as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Han teaches the microfluidic platform discussed above wherein the donor particles and target particles comprise at least one of DNA, RNA, cells, small molecules, or combinations thereof ([0018]: “…the microfluidic platform device 100 may also be used in conjunction with cells that produce and/or secrete non-antibody based capture reagents (including but not limited to) aptamers comprised of DNA, RNA, or synthetic nucleic acids and capture reagents comprised of natural or synthetic proteins.”), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Han teaches the microfluidic platform discussed above wherein the donor particles and target particles comprise cells comprising DNA ([0018]: “…the microfluidic platform device 100 may also be used in conjunction with cells that produce and/or secrete…DNA…”), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Han teaches the microfluidic platform discussed above further comprising:
a first outlet 121, wherein the first outlet 121 is configured to release waste cells displaying no DNA transfer (Fig. 1 and [0010]: “Droplets with no effect will continue to flow out of outlet 121.”);
wherein the first outlet and second outlet are in fluid communication with the droplet sorter (Fig. 1 shows the outlets 121/123 in fluid communication with the droplet sorter 120.),
and a second outlet 123, wherein the second outlet 123 is configured to recover cells displaying successful DNA transfer (Fig. 1 and [0010]: “…enhanced and highly infected “hits” that exit an outlet 123 so that they may be later sent off chip to allow for B cell recovery and further analysis.”), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Han teaches the microfluidic platform discussed above further comprising:
one or more microfluidic channels 105/111/117 that connect each chamber 104/116 of the microfluidic platform 100 (Fig. 1 and para. [0012]), as in Claim 10.
Response to Arguments
35 USC 112
Applicant’s amendments herein sufficiently overcome the rejection of Claims 1-3 and 6-10 as indefinite under 35 USC 112(b) and as introducing new matter under 35 USC 112(a). As such, those rejections under 35 USC 112(b) and 112(a) are withdrawn.
Note that a new grounds of rejection under 35 USC 112(b) is provided above as necessitated by Applicant’s amendment.
35 USC 102
Applicant’s arguments are on the grounds that Han allegedly fails to teach the induction media droplet generator to release an induction media at a point between the first droplet incubator and the first droplet merging region and a signal amplification media droplet generator to release signal amplification media at a point between the second droplet incubation chamber and the second droplet merging region, as in the amended Claim 1.
Applicant’s arguments are not persuasive because Han teaches the “induction media droplet generator to release an induction media at a point between the first droplet incubator” in para. [0010] (“a second droplet generator 106 that encapsulates infectious agents”); and Han further discusses “the first droplet merging region and a signal amplification media droplet generator to release signal amplification media at a point between the second droplet incubation chamber and the second droplet merging region” in para. [0010] (“a third droplet generator 112 encapsulating host cells that may be engineered to express a fluorescent reporter upon infection with pathogens”) and as shown through Han Fig. 1. While these elements in Han are taken as providing the recited induction and amplification media, even if the “induction media droplet generator” is not taught by Han as being for introducing induction media, and/or if the “amplification media droplet generator” is not taught by Han as being for introducing amplification media, limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, the droplet generators of Han are commensurately structured as in the instant claims and are thus fully capable of providing the recited induction/amplification media.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798