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 .
Claim Rejections - 35 USC § 112
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.
Claims 1-3 & 5-8 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 is not clear with respect to what applicant is claiming. The claim does not clearly set forth the metes and bounds of the patent protection desired. The claim is unclear reciting “each” in L3, because it is unclear what applicant is attempting to claim. The claim is further unclear reciting “a capillary pressure barrier formed at a junction between the reaction chamber and the vent channel by a change in depth between the reaction chamber and the vent channel, the capillary pressure barrier defining a boundary between the vent channel and the first and second regions of the reaction chamber” because it is unclear whether the capillary pressure barrier is a structural element, or process or intended use limitations, thereby rendering the scope of the claim unascertainable.
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 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.
Claim(s) 1-3 & 5-8 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Battrell et al. (US 2016/0193603 A1).
Regarding claim 1, Battrell et al. teach:
1. A microfluidic device, comprising:
a flow channel (e.g., 800; 1200); and
at least one reaction chamber (e.g., 802, 804, 805, 806; 1202, 1207, 1208, 1210), the at least one reaction chamber comprising:
a chamber inlet (e.g., 801; 1201) connecting the at least one reaction chamber to the flow channel (see Figs. 8A, 14A for example);
a first region (i.e., regions of 802; 1202) adjacent the chamber inlet (see Figs. 8A, 14A for example);
a second region (i.e., regions of 804, 805; 1205, 1207, 1208) spaced from the chamber inlet by the first region (see Figs. 8A, 14A for example);
a vent channel (e.g., 803, 807; 1203, 1211); and
a reaction reagent (e.g., 822, 1222) disposed on at least one inner surface of the second region (see Figs. 8B, 14C); and.
a pressure barrier (e.g., 812; 1033; 1209) between the reaction chamber and the vent channel (see Figs. 8A, 10A, 14A for example), the pressure barrier capable of defining a boundary between the vent channel and the first and second regions of the reaction chamber (see Figs. 8A, 10A, 14A for example).
With regard to limitations in claims 1, 6, 7, 8 (e.g., a capillary pressure barrier formed at a junction between the reaction chamber and the vent channel by a change in depth between the reaction chamber and the vent channel, the capillary pressure barrier defining a boundary between the vent channel and the first and second regions of the reaction chamber; thermally dissolvable or degradable; cleaving reagent and a degrading enzyme, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 3, 5-8, Battrell et al. teach:
2. The microfluidic device according to claim 1, wherein the reaction chamber comprises a plurality of reaction reagents (see i.e., Multiple separate spots may be printed using a roll-type or sheet-type process in each chamber ¶ 0141) disposed on the at least one inner surface of the second region (see Figs. 8B, 14C).
3. The microfluidic device according to claim 1, wherein the microfluidic device comprises a plurality of reaction chambers (e.g., 802, 804, 805, 806; 1202, 1207, 1208, 1210), with a reaction reagent (e.g., 822, 1222) disposed on at least one inner surface of a second region of each reaction chamber (see Figs. 8B, 14C).
5. The microfluidic device according to claim 1, wherein the reaction reagent is a single stranded oligonucleotide (¶ 0097).
6. The microfluidic device according to claim 1, wherein the device further comprises a film applied to the at least one inner surface of the second region (e.g., foil coated layers ¶ 0111).
7. The microfluidic device according to claim 6, wherein the film comprises polyvinyl alcohol, polyvinyl acetate, cellulose, polyester, polyester, polyethylene terephthalate, polyurethane or combinations thereof (see ¶ 0111, 0119 for example).
8. The microfluidic device according to claim 1, wherein one or both of a reagent and an enzyme is disposed with the reaction reagent (see i.e., A variety of dried reagents, such as a fluorescent probe, enzyme, buffer or control analyte, may be placed within chambers of a microfluidic device ¶ 0009).
Response to Arguments
Applicant's arguments filed 08/08/2026 have been fully considered but they are not persuasive.
In response to the Applicant's arguments to the process or intended use limitations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is encouraged to amend the claims to include additional structural elements of the device.
Applicant is thanked for their thoughtful amendments to the claims.
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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
Prosecution Insights