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
Newly submitted claim amendments to claims 4 and 7 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (claims 2-3, 6, 11-13, and 20-21) and II (claims 4-5 and 26) are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention II requires a blister pack containing liquid constituents of the amplification process and dried constituents of the amplification process provided within the test well which is not included in Invention I. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I (claims 2-3, 6, 11-13, and 20-21) and III (claims 7-10 and 22-25) are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention III requires a circuit board adhered to a base and a base comprising a unitary piece of liquid impermeable material which is not included in Invention I. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II (claims 4-5 and 26) and III (claims 7-10 and 22-25) are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention II requires a blister pack containing liquid constituents of the amplification process and dried constituents of the amplification process provided within the test well which is not included in Invention III, and Invention III requires a circuit board adhered to a base and a base comprising a unitary piece of liquid impermeable material which is not included in Invention II. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 4-5, 7-10, and 22-26 are withdrawn from consideration as being directed to non-elected inventions. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 is objected to because of the following informalities: it is recommended that "when the device is positioned in the reader device" in line 7 read "when the cartridge device is positioned in the reader device" so that it is clear that "the device" is referring to the cartridge device. Appropriate correction is required.
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 20-21 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.
Regarding claim 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 2 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nisch et al. (US 6,315,940).
Regarding claim 2, Nisch et al. discloses a device for testing a sample for a target agent, the device (abstract “detecting the presence of a nucleic acid in one or more samples”) comprising:
a sample introduction area configured to receive a sample comprising the target agent (microcuvette 60);
a test well (microcuvette 60) containing an excitation electrode and a sensing electrode (annular electrodes 61; electrodes 66, 67; Col. 4, lines 62-64), the excitation electrode and the sensing electrode configured to be in electrical communication with a reader device comprising a processor when the device is positioned in the reader device (Col. 4, line 52 “signal processing plate”), wherein, when the cartridge device is placed within the reader device, the test well is configured to:
contain the sample during an amplification process (abstract),
apply a current to the sample during the amplification process using the excitation electrode (Col. 7, line 53 “a voltage… is applied”), and
sense a signal using the sensing electrode, the signal representing the current after attenuation by at least the sample within the test well (Col. 4, line 62 “sensing electrodes”);
and a fluid path fluidically coupling the sample introduction area to the test well (Fig. 3 common channel 63).
Regarding claim 20, Nisch et al. discloses a device wherein liquid constituents of the amplification process comprise a component selected from the group consisting of an antibody or an antigen-binding fragment thereof, a protein receptor, a nucleic acid such as a primer, a buffer (Col. 7, line 7 “buffer solution”), and an enzyme such as a polymerase.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Pais et al. (US 2019/0001325 A1).
Regarding claim 3, Nisch et al. discloses a device comprising a channel for fluid flow (Fig. 3 common channel 63), but does not disclose a blister pack containing liquid constituents of the amplification process, the blister pack positioned in a region of the device having an aperture leading into the fluid path, wherein the sample introduction area is positioned between the aperture and the test well along the fluid path; and dried constituents of the amplification process provided within the test well. However, Pais et al. teaches that a reagent-filled blister pouch is known in the art and enable simple, miniaturized, and low-power automation of fluid handling (para. 0003). Though Nisch et al. does not explicitly teach a blister pouch, it would have been obvious to a person of ordinary skill in the art to use a blister pouch because the substitution of one known element for another would have predictably resulted in a device that enables simple, miniaturized, and low-power automation of fluid handling, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Nisch et al. with the teachings of Pais et al. to obtain the invention as specified in claim 3.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Rajaraman et al. (US 2015/0027885 A1).
Regarding claim 6, Nisch et al. discloses a device comprising electrodes (Col. 4, lines 62-64), but does not disclose a first electrode interface including a first contact pad in electrical communication with the excitation electrode and a second contact pad in electrical communication with the sensing electrode. However, Rajaraman et al. teaches that electrode contact pads allow flexible well and electrode configurations without requiring hardware or connectivity changes (para. 0091). It would have been obvious to a person of ordinary skill in the art to use the Rajaraman et al. configuration of electrode contact pads in Nisch et al.’s device with a reasonable expectation that it would allow flexible well and electrode configurations without requiring hardware or connectivity changes. This method for improving Nisch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Rajaraman et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nisch et al. and Rajaraman et al. to obtain the invention as specified in claim 6.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Hong et al. (US 2016/0250632 A1).
Regarding claim 11, Nisch et al. discloses a device comprising a test well (microcuvette 60), but does not disclose a vent configured to release gas from the test well, wherein the vent is covered by a liquid impermeable, gas permeable filter. However, Hong et al. teaches a well plate lid having apertures which each have a gas permeable membrane (abstract) to create a conduit for gas exchange and reduce evaporation of liquid contents in the wells (para. 0010). It would have been obvious to a person of ordinary skill in the art to use the Hong et al. configuration of a well plate lid having apertures which each have a gas permeable membrane in Nisch et al.’s device with a reasonable expectation that it would create a conduit for gas exchange and reduce evaporation of liquid contents in the wells. This method for improving Nisch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Hong et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nisch et al. and Hong et al. to obtain the invention as specified in claim 11.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Xu et al. (US 2005/0112544 A1).
Regarding claim 12, Nisch et al. discloses a device comprising concentrically positioned electrodes (Col. 8, line 8), but does not disclose that the electrodes are circular. However, Xu et al. teaches that a circular electrode is known in the art which bonds the electrodes to the circular container (para. 0178). Though Nisch et al. does not explicitly teach a circular electrode, it would have been obvious to a person of ordinary skill in the art to use a circular electrode because the substitution of one known element for another would have predictably resulted in concentric electrodes that align with the circular container/well, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Nisch et al. with the teachings of Xu et al. to obtain the invention as specified in claim 12.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Mizuno et al. (US 2015/0368604 A1).
Regarding claim 13, Nisch et al. discloses a device comprising electrodes (Col. 4, lines 62-64), but does not disclose wherein the excitation electrode comprises a first semicircular electrode and wherein the sensing electrode comprises a second semicircular electrode separated by a gap from the first semicircular electrode, wherein straight portions of the first and second semicircular electrodes face each other across the gap. However, Mizuno et al. teaches that a gap between electrodes within a well (Figs. 1-4) generates an electric field within the well (para. 0021). It would have been obvious to a person of ordinary skill in the art to use the Mizuno et al. configuration of a gap between electrodes in Nisch et al.’s device with a reasonable expectation that it would generate an electric field within the well. This method for improving Nisch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mizuno et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nisch et al. and Mizuno et al. to obtain the invention as specified in claim 13.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nisch et al. (US 6,315,940) in view of Huang (US 2008/0081372 A1).
Regarding claim 21, Nisch et al. discloses a device comprising liquid buffer solution (Col. 7, line 7), but does not disclose dried constituents of the amplification process comprising a component selected from the group consisting of an antibody or an antigen-binding fragment thereof, a protein receptor, a nucleic acid such as a primer, a buffer (Col. 7, line 7 “buffer solution”), and an enzyme such as a polymerase. However, Huang teaches that dried nucleic acid molecules on electrodes allows a plate to be stored for extended time for later use (para. 0041). Though Nisch et al. does not explicitly teach dried nucleic acid, it would have been obvious to a person of ordinary skill in the art to use dried nucleic acid because the substitution of one known element for another would have predictably resulted in a test device that is able to be stored for extended time for later use, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Nisch et al. with the teachings of Huang to obtain the invention as specified in claim 21.
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 2-3 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 and 6 of U.S. Patent No. 11,465,141 to Pierson et al. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, claim 2 of Pierson et al. recites the same subject matter.
Regarding claim 3, claim 3 of Pierson et al. recites the same subject matter except for the blister pack. However, Pierson et al. discloses that a blister pack forms a sealed chamber containing liquids (Col. 22, lines 21-22). It would have been obvious to one of ordinary skill in the art to modify claim 3 of Pierson et al. to obtain the invention as specified in claim 3 of the instant application and recite a blister pack as Pierson et al. discloses that a blister pack forms a sealed chamber.
Regarding claim 6, claim 6 of Pierson et al. recites the same subject matter except for the sample introduction area configured to receive the sample and the fluid path fluidically coupling the sample introduction area to the test well. However, claim 2 of Pierson et al. recites the features of a sample introduction area configured to receive a sample and a fluid path fluidically coupling the sample introduction area to a test well. It would have been obvious to one of ordinary skill in the art to combine claims 2 and 6 of Pierson et al. to comprise the sample introduction area configured to receive the sample and the fluid path fluidically coupling the sample introduction area to the test well to obtain the invention as specified in claim 6 of the instant application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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