Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-10 in the reply filed on 6/18/2026 is acknowledged. The traversal is on the ground(s) that Claims 1-10 are no longer pending. This is not found persuasive because the traversal is drawn to the claims as amended, not to the claims as originally filed when the restriction requirement was made.
The requirement is still deemed proper and is therefore made FINAL. However, the Examiner will examine newly added claims 61-78, as the claims that required restriction are no longer pending.
Claim Status
Claims 61-78 are pending and examined. Claims 1-60 are canceled.
Information Disclosure Statement
The information disclosure statements (IDS) received on 9/9/2024 and 6/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(c) he has abandoned the invention.
(d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
(f) he did not himself invent the subject matter sought to be patented.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
Claims 61 and 74-75 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Clarke et al. (US Pub. No. 2010/0238232; hereinafter Clarke; already of record on the IDS received 9/9/2024).
Regarding claim 61, Clarke discloses a method ([0021]). The method comprises:
(a) providing a microfluidic device comprising a main microfluidic channel, at least one side microfluidic channel, and an emulsion generation section fluidly connected to the main microfluidic channel ([0021], [0050], see Fig. 3A, where the channel containing fluid 18 and the channel holding the combined fluids can be considered a main microfluidic channel, the channel introducing fluid 17 can be considered a side microfluidic channel, and the channel after all fluids have been combined can be considered an emulsion generation section).
(b) providing a first fluid in the main microfluidic channel ([0021], [0050], see Fig. 3A).
(c) flowing the first fluid to a first junction of the main microfluidic channel and the at least one side microfluidic channel comprising a second fluid, wherein the first fluid contacts the second fluid in the main microfluidic channel without causing the first fluid or the second fluid to form separate droplets ([0021], [0050], see Fig. 3A, after fluids 17 and 18 have been combined, separate droplets are still not formed).
(d) generating an emulsion comprising a plurality of droplets in the emulsion generation section, wherein the generating comprises flowing the first fluid and the second fluid in the main microfluidic channel to a second junction of the main microfluidic channel and the emulsion generation section comprising a carrying fluid to cause portions of first fluid and the second fluid to become surrounded by the carrying fluid, wherein the carrying fluid comprises oil ([0021], [0050], see Fig. 3A, where combined fluids 17 and 18 are mixed with fluid from flow focusing junction 20, where the combined fluids 17 and 18 form droplets in this section. See also [0069], which states that the invention can be used for oil based carrier flow).
Regarding claim 74, Clarke discloses the method of claim 61, wherein the first fluid or the second fluid comprises an aqueous solution ([0069]).
Regarding claim 75, Clarke discloses the method of claim 61, wherein the emulsion comprises a surfactant ([0069]).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 62-70, 72, and 76-77 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke as applied to claims 61 and 74-75 above, and further in view of Link et al. (US Pub. No. 2006/0163385; hereinafter Link; already of record on the IDS received 9/9/2024).
Regarding claim 62, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose that the first fluid and the second fluid comprise a plurality of species, and wherein, in (d), each droplet of the plurality of droplets comprises two or more species of the plurality of species, wherein the two or more species comprises a cell.
Link is in the analogous field of methods for the formation and/or control of fluidic species (Link [0002]). Link teaches a first and second fluid that comprise a plurality of species, where droplets that are formed comprise two or more species of the plurality of species, where the two or more species comprises a cell (Link; [0007], [0086]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Link so that the fluid and the second fluid comprise a plurality of species, and wherein, in (d), each droplet of the plurality of droplets comprises two or more species of the plurality of species, wherein the two or more species comprises a cell, in order to allow for the species within the fluids to react or otherwise interact with each other (Link; [0087], [0086]).
Regarding claim 63, modified Clarke discloses the method of claim 62.
Modified Clarke fails to explicitly disclose (e) performing a chemical reaction using the two or more species, whereby the emulsion serves as a reaction vessel for the chemical reaction.
Link further teaches performing a chemical reaction using the two or more species, whereby the emulsion serves as a reaction vessel for the chemical reaction (Link; [0020], [0086], [0097]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the further teachings of Link to further comprise (e) performing a chemical reaction using the two or more species, whereby the emulsion serves as a reaction vessel for the chemical reaction, in order to produce a desired product such as a quantum dot, or a hybridoma cell (Link [0086]).
Regarding claim 64, modified Clarke discloses the method of claim 63.
Modified Clarke fails to explicitly disclose that a species of the two or more species is a nucleic acid, and (e) comprises performing the chemical reaction on the nucleic acid.
Link further teaches that a species of the two or more species is a nucleic acid, and performing a chemical reaction on the nucleic acid, where the nucleic acid is ribonucleic acid (Link [0086]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the further teachings of Link so that a species of the two or more species is a nucleic acid, and (e) comprises performing the chemical reaction on the nucleic acid, where the nucleic acid is ribonucleic acid, in order to perform gene therapy on a cell (Link [0086]).
Regarding claim 65, modified Clarke discloses the method of claim 64, wherein the nucleic acid is ribonucleic acid (see Claim 64 above at Link teaching RNA in [0086]).
Regarding claim 66, modified Clarke discloses the method of claim 63.
Modified Clarke fails to explicitly disclose that a species of the two or more species is an enzyme and (e) comprises performing the chemical reaction using the enzyme.
Link further teaches that a species of the two or more species is an enzyme and performing the chemical reaction using the enzyme (Link [0086]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the further teachings of Link so that a species of the two or more species is an enzyme and (e) comprises performing the chemical reaction using the enzyme, in order to deliver the enzyme to a cell (Link [0086]).
Regarding claim 67, modified Clarke discloses the method of claim 63.
Modified Clarke fails to explicitly disclose that (e) comprises performing the chemical reaction on a cellular component of the cell.
Link further teaches performing a chemical reaction on a cellular component of a cell, where the cellular component comprises a nucleic acid, where the nucleic acid comprises ribonucleic acid (Link [0086]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the further teachings of Link to comprise performing the chemical reaction on a cellular component of the cell, where the cellular component comprises a nucleic acid, where the nucleic acid comprises ribonucleic acid in order to perform gene therapy (Link [0086]).
Regarding claim 68, modified Clarke discloses the method of claim 67, wherein the cellular component comprises a nucleic acid (see Claim 67 above at Link teaching RNA in [0086]).
Regarding claim 69, modified Clarke discloses the method of claim 68, wherein the nucleic acid comprises ribonucleic acid (see Claim 67 above at Link teaching RNA in [0086]).
Regarding claim 70, modified Clarke discloses the method of claim 62.
Modified Clarke fails to explicitly disclose (e) detecting a species of the two or more species.
Link further teaches detecting a species of two or more species (Link [0087]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the further teachings of Link to further comprise (e) detecting a species of the two or more species, in order to determine whether a reaction has occurred (Link [0087]).
Regarding claim 72, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose that an interaction exists between two species within a droplet of the plurality of droplets, and wherein the method further comprises (e) detecting the interaction between the two species.
Link teaches that an interaction exists between two species within a droplet of a plurality of droplets, and detecting the interaction between the two species (Link [0087]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Link so that an interaction exists between two species within a droplet of the plurality of droplets, and wherein the method further comprises (e) detecting the interaction between the two species, in order to determine whether a reaction has occurred (Link [0087]).
Regarding claim 76, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose performing a polymerization reaction using components provided in the first fluid, the second fluid, or the carrying fluid.
Link teaches performing a polymerization reaction using components provided in an emulsion (Link; [0036], [0096]-[0097]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Link to include performing a polymerization reaction using components provided in the first fluid, the second fluid, or the carrying fluid, in order to harden the droplets (Link; [0036], [0096]-[0097]), which would increase their durability.
Regarding claim 77, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose that droplets of the plurality of droplets have an average diameter of less than 200 micrometers.
Link teaches droplets that have an average diameter of less than 200 micrometers (Link [0008]). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Link so that the droplets of the plurality of droplets have an average diameter of less than 200 micrometers, in order to provide droplets of a suitable size for therapeutic applications (Link; [0008], [0101]).
Claim 71 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke in view of Link as applied to claims 62-70, 72, and 76-77 above, and further in view of Weitz et al. (WO Pub. No. 2006/096571; hereinafter Weitz; already of record on the IDS received 9/9/2024).
Regarding claim 71, modified Clarke discloses the method of claim 62.
Modified Clarke fails to explicitly disclose controlling a ratio of the two or more species in each droplet of the plurality of droplets.
Weitz is in the analogous field of emulsion generation (Weitz Abstract). Weitz teaches controlling a ratio of two or more species in each droplet of a plurality of droplets (Weitz Pg. 7 Lns. 4-15). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of modified Clarke with the teachings of Weitz to comprise controlling a ratio of the two or more species in each droplet of the plurality of droplets, in order to allow for a predictable and consistent ration of two or more species in the droplets, which is important in, for instance, drug administration (Weitz Pg. 7 Lns. 4-15).
Claim 73 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke as applied to claims 61 and 74-75 above, and further in view of Weitz.
Regarding claim 73, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose that the plurality of droplets further comprises a gel.
Weitz is in the analogous field of emulsion generation (Weitz Abstract). Weitz teaches a plurality of droplets that comprise a gel (Weitz Pg. 16 Lns. 19-29). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Weitz so that the plurality of droplets further comprises a gel, in order to produce consistently and repeatedly sized inner droplets and outer shells (Weitz Pg. 16 Lns. 19-29).
Claim 78 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke as applied to claims 61 and 74-75 above, and further in view of Ismagilov (WO Pub. No. 2004/038363; already of record on the IDS received 9/9/2024).
Regarding claim 78, Clarke discloses the method of claim 61.
Clarke fails to explicitly disclose that the oil comprises a fluorocarbon oil.
Ismagilov is in the analogous field of fluidic interactions (Ismagilov Pg. 3 Lns. 13-26). Ismagilov teaches fluorocarbon oil (Ismagilov Pg. 53 Lns. 25-32). It would have been obvious to one having ordinary skill in the art before the time of the invention to modify the method of Clarke with the teachings of Ismagilov so that the oil comprises a fluorocarbon oil, as fluorocarbon oils are biocompatible (Ismagilov Pg. 53 Lns. 25-32).
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 61-78 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 10,874,997 (hereinafter the reference patent; already of record on the IDS received 9/9/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 61, claims 1 and 5 of the reference patent teach a method (Claim 1). The method comprises:
(a) providing a microfluidic device comprising a main microfluidic channel, at least one side microfluidic channel, and an emulsion generation section fluidly connected to the main microfluidic channel (Claim 1, (a) providing a microfluidic device comprising a main microfluidic channel, at least one first side microfluidic channel, and at least one second side microfluidic channel…(e) generating a monodisperse double emulsion in the main microfluidic channel, wherein the monodisperse double emulsion is generated downstream of the second intersection, wherein the monodisperse double emulsion comprises the carrying fluid surrounding an outer fluidic droplet of the second fluid, wherein the outer fluidic droplet contains an inner fluidic droplet of the first fluid. The section of the main microfluidic channel downstream of the second intersection is the emulsion generation section).
(b) providing a first fluid in the main microfluidic channel (Claim 1, (b) providing a first fluid in the main microfluidic channel…).
(c) flowing the first fluid to a first junction of the main microfluidic channel and the at least one side microfluidic channel comprising a second fluid, wherein the first fluid contacts the second fluid in the main microfluidic channel without causing the first fluid or the second fluid to form separate droplets (Claim 1, (c) flowing the first fluid to a first intersection of the main microfluidic channel and the at least one first side microfluidic channel comprising a second fluid to cause the first fluid to become surrounded by the second fluid in the main microfluidic channel without causing the first fluid or the second fluid to form separate droplets…),
(d) generating an emulsion comprising a plurality of droplets in the emulsion generation section, wherein the generating comprises flowing the first fluid and the second fluid in the main microfluidic channel to a second junction of the main microfluidic channel and the emulsion generation section comprising a carrying fluid to cause portions of first fluid and the second fluid to become surrounded by the carrying fluid, wherein the carrying fluid comprises oil (Claim 1, (d) flowing the first fluid and the second fluid in the main microfluidic channel to a second intersection of the main microfluidic channel and the at least one second side microfluidic channel comprising a carrying fluid to cause the second fluid to become surrounded by the carrying fluid without causing the first fluid or the second fluid to form separate droplets; and (e) generating a monodisperse double emulsion in the main microfluidic channel, wherein the monodisperse double emulsion is generated downstream of the second intersection, wherein the monodisperse double emulsion comprises the carrying fluid surrounding an outer fluidic droplet of the second fluid, wherein the outer fluidic droplet contains an inner fluidic droplet of the first fluid…, Claim 5, …the first fluid is a first oil, the second fluid is an aqueous fluid, and the carrying fluid is a second oil, and wherein the monodisperse double emulsion is an oil-in-water-in-oil (o/w/o) emulsion).
Dependent claims 62-78 stand rejected as being dependent on independent claim 61.
Conclusion
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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