DETAILED CORRESPONDENCE
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 .
Response to Amendment
As to the amended claims filed on 6/24/26, the previous rejections have been modified to address the claim amendments (see below).
Claim Status
Claims 1-15 are pending with claims 1-8 being examined and claims 9-15 deemed withdrawn.
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 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 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)(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.
Claims 1-8 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Shkolvikov et al (WO 2020222763 which is already of record and where US 20220072535 is used as the corresponding document; hereinafter “Shkolvikov”; already of record).
As to claim 1, Shkolvikov teaches a microfluidic device (Shkolvikov; Title), comprising: a reaction chamber, wherein the reaction chamber comprises at least one reaction reagent disposed on at least one inner surface of the reaction chamber; a heater; a thermally dissolvable or degradable film applied to the at least one inner surface of the reaction chamber on which the reaction reagent is disposed and completely separating the at least one reaction reagent from a remainder of the reaction chamber; and a controller configured by machine-readable instructions to activate the heater to cause the heater to dissolve the thermally dissolvable or degradable film and release the at least one reaction reagent into the remainder of the reaction chamber (Shkolvikov teaches a chamber 130 with a heater 170 and a reagent 202 surrounded by a thermally degradable film 212; Fig. 2, [28, 35, 36, 39, 40, 53]. See also Fig. 14 of Shkolvikov; [36, 45]. Shkolvikov teaches the degradable film can be polyvinyl alcohol; [41]. Shkolvikov teaches that the reagent is a nucleic acid primer, which is a single stranded oligonucleotide, and also that there are mixtures of various reagents; [39]. Shkolvikov teaches a PCR master mix which would contain DNA polymerase, which is a cleaving agent/enzyme; [39]. The examiner notes that any of the materials that satisfy the materials listed by applicants in [58-61] of the instant specification will be interpreted as being thermally dissolvable or degradable).
Note: The instant claims contain functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Shkolvikov teaches the microfluidic device according to claim 1, wherein the at least one inner surface of the reaction chamber comprises multiple reaction reagents and wherein each of the reaction reagents is disposed at a different location on the at least one inner surface of the reaction chamber (Shkolvikov teaches that the reagent is a nucleic acid primer, which is a single stranded oligonucleotide, and also that there are mixtures of various reagents; [39]).
As to claim 3, Shkolvikov teaches the microfluidic device according to claim 2, wherein each reaction reagent is a different reaction reagent (Shkolvikov teaches that the reagent is a nucleic acid primer, which is a single stranded oligonucleotide, and also that there are mixtures of various reagents; [39]).
As to claim 4, Shkolvikov teaches the microfluidic device according to claim 1, wherein the at least one reaction reagent is a single stranded oligonucleotide (Shkolvikov teaches that the reagent is a nucleic acid primer, which is a single stranded oligonucleotide, and also that there are mixtures of various reagents; [39]).
As to claim 5, Shkolvikov teaches the microfluidic device according to claim 1, wherein the thermally dissolvable or degradable film comprises polyvinyl alcohol, polyvinyl acetate, cellulose, polyester, polyethylene terephthalate, polyurethane or combinations thereof (Shkolvikov teaches a chamber 130 with a heater 170 and a reagent 202 surrounded by a thermally degradable film 212; Fig. 2, [28, 35, 36, 39, 40, 53]. Shkolvikov teaches the degradable film can be polyvinyl alcohol; [41]).
As to claim 6, Shkolvikov teaches the microfluidic device according to claim 1, wherein the thermally dissolvable or degradable film isolates the remainder of the reaction reagent from the reaction chamber (Shkolvikov teaches a chamber 130 with a heater 170 and a reagent 202 surrounded by a thermally degradable film 212; Fig. 2, [28, 35, 36, 39, 40, 53]. See also Fig. 14 of Shkolvikov; [36, 45]).
As to claim 7, Shkolvikov teaches the microfluidic device according to claim 1, wherein one or both of a cleaving reagent and a degrading enzyme is disposed with the reaction reagent (Shkolvikov teaches a PCR master mix which would contain DNA polymerase, which is a cleaving agent/enzyme; [39]).
As to claim 8, Shkolvikov teaches the microfluidic device according to claim 1, wherein the heater comprises a flat panel heater or one or more thermally conductive printed electrical traces (Shkolvikov teaches a flat heater 170; Fig. 2, [28, 35, 40]).
Claims 1-8 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Thomas et al (US 20180304260; hereinafter “Thomas”; already of record).
As to claim 1, Thomas teaches a microfluidic device, comprising: a reaction chamber, wherein the reaction chamber comprises at least one reaction reagent disposed on at least one inner surface of the reaction chamber; a heater; a thermally dissolvable or degradable film applied to the at least one inner surface of the reaction chamber on which the reaction reagent is disposed and completely separating the at least one reaction reagent from a remainder of the reaction chamber; and a controller configured by machine-readable instructions to activate the heater to cause the heater to dissolve the thermally dissolvable or degradable film and release the at least one reaction reagent into the remainder of the reaction chamber (Thomas teaches a thermally degradable film 80 with heater 70 which heats the film to degrade the film and open the chamber space encompassing regions including spaces shown as 55/50/54; [90-92, 102, 126, 128], Fig. 2B-2C. The chamber of Thomas is the region of space that includes the entire left or right half of Figure 2, whereby the film is on the inner surface. Thomas teaches a printed circuit heater or a flat panel; Fig. 2B-2C, [128]. Thomas teaches a polyolefin or polystyrene; [128]. Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]. Thomas also teaches that the film vents control the flow to the chambers that include the reagents, whereby the chamber is the region of space encompassing the vent and chamber or recess; Fig. 2A, [126]. The examiner notes that any of the materials that satisfy the materials listed by applicants in [58-61] of the instant specification will be interpreted as being thermally dissolvable or degradable. Thomas teaches that the process is controlled by a controller; [119, 124, 128, 132]).
Note: The instant claims contain functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Thomas teaches the microfluidic device according to claim 1, wherein the at least one inner surface of the reaction chamber comprises multiple reaction reagents and wherein each of the reaction reagents is disposed at a different location on the at least one inner surface of the reaction chamber (Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]).
As to claim 3, Thomas teaches the microfluidic device according to claim 2, wherein each reaction reagent is a different reaction reagent (Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]).
As to claim 4, Thomas teaches the microfluidic device according to claim 1, wherein the at least one reaction reagent is a single stranded oligonucleotide (Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]).
As to claim 5, Thomas teaches the microfluidic device according to claim 1, wherein the thermally dissolvable or degradable film comprises polyvinyl alcohol, polyvinyl acetate, cellulose, polyester, polyethylene terephthalate, polyurethane or combinations thereof (Thomas teaches a polyolefin or polystyrene; [128]).
As to claim 6, Thomas teaches the microfluidic device according to claim 1, wherein the thermally dissolvable or degradable film isolates the remainder of the reaction reagent from the reaction chamber (Thomas; [90-92, 102, 126, 128], Fig 2B-2C).
As to claim 7, Thomas teaches the microfluidic device according to claim 1, wherein one or both of a cleaving reagent and a degrading enzyme is disposed with the reaction reagent (Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]).
As to claim 8, Thomas teaches the microfluidic device according to claim 1, wherein the heater comprises a flat panel heater or one or more thermally conductive printed electrical traces (Thomas teaches a printed circuit heater or a flat panel; Fig. 2B-2C, [128]).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 20240084408; hereinafter “Liu”; already of record) in view of Thomas et al (US 20180304260; hereinafter “Thomas”; already of record).
As to claim 1, Liu teaches a microfluidic device (Liu teaches a microfluidic device; Title), comprising: a reaction chamber, wherein the reaction chamber comprises at least one reaction reagent disposed on at least one inner surface of the reaction chamber; a heater; a thermally dissolvable or degradable film applied to the at least one inner surface of the reaction chamber on which the reaction reagent is disposed and completely separating the at least one reaction reagent from a remainder of the reaction chamber, and where the reagent is released into the remainder of the reaction chamber (Liu teaches a chamber with reagents and a dissolvable film formed from PVA or cellulose, polyurethane, or polyester; [48]. Liu teaches a heating plate; [97]. The examiner notes that any of the materials that satisfy the materials listed by applicants in [58-61] of the instant specification will be interpreted as being thermally dissolvable or degradable).
Note: The instant claims contain functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Liu does not specifically teach a controller configured by machine-readable instructions to activate the heater to cause the heater to dissolve the thermally dissolvable or degradable film and release the at least one reaction reagent into the remainder of the reaction chamber. However, Thomas teaches the analogous art of a microfluidic device with a degradable film, and a controller configured by machine-readable instructions to activate the heater to cause the heater to dissolve the thermally dissolvable or degradable film and release the at least one reaction reagent into the remainder of the reaction chamber (Thomas teaches a thermally degradable film 80 with heater 70 which heats the film to degrade the film and open the chamber space encompassing regions including spaces shown as 55/50/54; [90-92, 102, 126, 128], Fig. 2B-2C. Thomas teaches a printed circuit heater or a flat panel; Fig. 2B-2C, [128]. Thomas teaches a polyolefin or polystyrene; [128]. Thomas teaches oligonucleotide primers, and DNA polymerase enzymes; [102]. Thomas also teaches that the film vents control the flow to the chambers that include the reagents, whereby the chamber is the region of space encompassing the vent and chamber; Fig. 2A, [126]. The examiner notes that any of the materials that satisfy the materials listed by applicants in [58-61] of the instant specification will be interpreted as being thermally dissolvable or degradable. Thomas teaches that the process is controlled by a controller; [119, 124, 128, 132]). It would have been obvious to one of ordinary skill in the art to have modified the dissolvable film that allows access to the reagents of Liu to have thermally degraded via a heater as in Thomas because Thomas teaches that thermal degradation of the film is a known technique to control access to the reagents (Thomas; [90-92, 102, 128]) and because Thomas teaches that heating to degrade the film to provide access is an obvious variant to dissolving the film (Thomas; [128]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Hauser et al (US 20220081662; hereinafter “Hauser”; already of record) teaches a PVA or cellulose film valve 218/220/222 that is dissolvable; Fig. 1C-1D, [109]. Hauser teaches that there are various parameters that affect the dissolving time and that temperature is one of the parameters affecting PVA; [152].
Green et al (US 20200386750; hereinafter “Green”; already of record) teaches a chamber as the depth of the device shown in figure 1B [29], where there are degradable films such as PVA or cellulose [32-34] separating various reagents.
Lizzi et al (US 20050287682; hereinafter “Lizzi”; already of record) teaches a chamber with a regent 30 and a film 40 where the film can be cellulose or any material so long as it achieves the function of dissolving to allow passage of sample to the reagents, where the reagents can include various combinations of reagents; Fig. 1-2, 1F, 1G, [27, 34-36, 39, 40, 43, 85].
Bharadwaj et al (US 20150292988; hereinafter “Bharadwaj”; already of record) teaches a chamber 708 with a barrier film that can undergo thermal degradation to release reagent 704; [50, 109], Fig. 7.
Simmons, G (US 20230213544; hereinafter “Simmons”; already of record) teaches the cartridge can include a dissolvable film with reagent; [48].
Meathrel et al (US 7727466; hereinafter “Meathrel”; already of record) teaches various degradable films.
Hindson et al (US 20140155295; hereinafter “Hindson”; already of record) teaches a reaction chamber that includes a film that when heat is applied that the film bursts; [13, 49, 50], Fig. 4.
Jung et al (US 20140154688; hereinafter “Jung”; already of record) teaches various embodiments with films and reagents in chambers to treat samples with primers/oligonucleotides; Fig. 6, [10, 108].
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, 15 of copending Application No. 18557860 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a microfluidic device (see claims 1, 9 of application 18557860), comprising: a reaction chamber (see claims 1, 9 of application 18557860), wherein the reaction chamber comprises at least one reaction reagent disposed on at least one inner surface of the reaction chamber (see “reagent” in claims 1, 9 of application 18557860); a heater; and a thermally dissolvable or degradable film applied to the at least one inner surface of the reaction chamber on which the reaction reagent is disposed, and the heater is activated by a controller to dissolve or degrade the film (Claims 7 and 15 of application 18557860 state that the film is thermally dissolvable and heated, whereby this film would require some type of heating structure that heated via a controller in order to accomplish the function of heating the film). Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of application No. 18557860.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 6/24/26 have been considered, but are moot because the arguments are towards the claim amendments and not the current grounds of rejection.
Applicants argue on page 7 of their remarks that Shkolvikov does not teach a thermally dissolvable or degradable film that separates the reagent, and states that Shkolvikov teaches a film that degrades when fluid contacts the film. The examiner respectfully disagrees and notes that applicants did not take into account all of the citations provided in the rejection. Therefore, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Further, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Shkolvikov teaches a chamber 130 with a heater 170 and a reagent 202 surrounded by a thermally degradable film 212; Fig. 2, [28, 35, 36, 39, 40, 53]. See also Fig. 14 of Shkolvikov; [36, 45]. Shkolvikov teaches the degradable film can be polyvinyl alcohol; [41]. Shkolvikov teaches that the reagent is a nucleic acid primer, which is a single stranded oligonucleotide, and also that there are mixtures of various reagents; [39]. Shkolvikov teaches a PCR master mix which would contain DNA polymerase, which is a cleaving agent/enzyme; [39].
Applicants argue on pages 7-8 of their remarks that Thomas does not teach a thermally dissolvable/degradable film on the surface on which a reaction reagent is disposed. The examiner respectfully disagrees. The region of space defining the chamber has not been further defined than that of a chamber. The examiner notes that a chamber is just a region of space internal to the microfluidic device. Thomas teaches a thermally degradable film 80 with heater 70 which heats the film to degrade the film and open the chamber space encompassing regions including spaces shown as 55/50/54; [90-92, 102, 126, 128], Fig. 2B-2C. The chamber of Thomas is the region of space that includes the entire left or right half of Figure 2, whereby the film is on the inner surface. Thomas also teaches that the film vents control the flow to the chambers that include the reagents, whereby the chamber is the region of space encompassing the vent and chamber or recess; Fig. 2A, [126]). If applicants intend to further define the chamber of the microfluidic device, then perhaps applicants should consider further defining features of the microfluidic device such as channels and chambers in order to preclude the interpretation that the chamber is the internal structure of the microfluidic device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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