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 Objections
Claims 6, 7, 10, 20, 24 and 27 are objected to because of the following informalities:
Claim 6, line 4, “fist” should read “first”.
Claim 7, line 4, “sate” should read “state”.
Claim 10, line 5, both “sate” should read “state”.
Claim 20, line 1, “fist” should read “first”.
Claim 24, lines 3, “fist” should read “first”.
Claim 27, line 1, “pace” should read “space”
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 6-9, 11-19, 23 and 27 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 6 recites "wherein the controlling element is automatically opened or closed under the change of a liquid pressure or an air pressure between in a first space [...] and in a second space...'. It is unclear what "between in" means in this context, whether this is a comparison of pressure values or whether this refers to a physical location located between the two spaces. For the purposes of examination, the examiner interprets claim 6 to mean "wherein the controlling element is automatically opened or closed under the change of a liquid pressure or an air pressure in a first space [...] and in a second space..." Claims 7-9 and 16-19 are rejected by virtue of their dependence on a rejected base claim.
Claim 7 recites the limitation "the pressure" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 9 and 16-19 are rejected by virtue of their dependence on a rejected base claim.
Claim 7 recites the limitation "the increased pressure" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 9 and 16-19 are rejected by virtue of their dependence on a rejected base claim.
Claim 8 recites the limitation "the pressure" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the liquid" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the pressure" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 12-15 are rejected by virtue of their dependence on a rejected base claim.
Claim 11 recites the limitation "the increased pressure" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 12-15 are rejected by virtue of their dependence on a rejected base claim.
Claim 12 recites the limitation "the increase of the pressure" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 13-15 are rejected by virtue of their dependence on a rejected base claim.
Claim 15 recites the limitation "the air" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the liquid" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the rebound force" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 24-28 are rejected by virtue of their dependence on a rejected base claim.
Claim 27 recites the limitation "the air" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 28 is rejected by virtue of their dependence on a rejected base claim.
Claim 27 recites the limitation "the liquid" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 28 is rejected by virtue of their dependence on a rejected base claim.
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.
Claim(s) 1-4 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2019/0336972, hereinafter Gutsell.
Regarding claim 1, Gutsell teaches a device for detecting an analyte in a fluid sample (paragraph [0001]), comprising: an absorbing element (item 70) configured for absorbing a fluid sample (paragraph [0277]) and a testing element (item 270) configured for testing an analyte in the fluid sample (paragraph [0277]); wherein a fluid communication between the testing element and the absorbing element is controlled by a controlling element (item 305).
Regarding claim 2, Gutsell teaches whether the fluid communication between the testing element and the absorbing element is blocked or not is controlled by the controlling element (paragraph [0213]).
Regarding claim 3, Gutsell teaches when the controlling element is in a first state, the absorbing element is not in fluid communication with the testing element (paragraph [0213]); and when the controlling element is in a second state, the absorbing element is in fluid communication with the testing element (paragraph [0213]).
Regarding claim 4, Gutsell teaches when the controlling element has an opened state and closed state (paragraph [0213]); wherein when the controlling element is in a closed state, the absorbing element is not in fluid communication with the testing element (paragraph [0213]); and when the controlling element is in an open state, the testing element is in fluidic communication with the absorbing element (paragraph [0213]).
Regarding claim 20, Gutsell teaches a first space including the absorbing element therein is connected to a second space including the testing element therein via a channel (item 520, paragraph [0213]) such that the fluidic communication between the first space and the second space is achieved by the channel (paragraph [0213]), and wherein the controlling element is located in the channel (paragraph [0213]).
Claim Rejections - 35 USC § 103
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(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutsell.
Regarding claim 5, Gutsell teaches all limitations of claim 4; however, Gutsell fails to specifically teach the opened state or the closed state of the controlling element is automatically opened or automatically closed.
Gutsell discloses the claimed invention except for opened state or the closed state of the controlling element is automatically opened or automatically closed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automatically control the opened or closed state, since it has been held broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP § 2114.04 (III)).
Regarding claim 6, Gutsell teaches the controlling element is automatically opened or closed under the change of a liquid pressure or an air pressure between in a fist space including the absorbing element therein and in a second space including the test element therein (functional limitation (MPEP § 2114) and is taught in paragraph [0213]).
Claim(s) 7-16 and 21-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutsell in view of United States Application Publication No. 2019/0293196, hereinafter Weintraub.
Regarding claim 7, Gutsell teaches all limitations of claim 6; however, Gutsell fails to teach the controlling element is automatically opened or closed under the change of a liquid pressure or an air pressure between in a fist space including the absorbing element therein and in a second space including the test element therein.
Weintraub teaches a microfluidic valve in which has a pressure regulating valve with the sealing elements sealing the valve inlet from the valve outlet to selectively allow or prevent passage of fluid from the inlet to the outlet of the valve (Weintraub, paragraph [0018]) which allows the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have replaced the actuated valve of Gutsell with the pressure-activated valve of Weintraub because it would allow for the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]) and eliminate an external valve actuator. Further the pressure of the liquid or the pressure of the air being increased is considered to be functional limitations (MPEP § 2114).
Regarding claim 8, Gutsell teaches all limitations of claim 6; however, Gutsell fails to teach the pressure is an air pressure; when the controlling element is forced by the air pressure, the controlling element is opened to exchange a gas between the first space and the second space.
Weintraub teaches a microfluidic valve in which has a pressure regulating valve with the sealing elements sealing the valve inlet from the valve outlet to selectively allow or prevent passage of fluid from the inlet to the outlet of the valve (Weintraub, paragraph [0018]) which allows the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have replaced the actuated valve of Gutsell with the pressure-activated valve of Weintraub because it would allow for the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]) and eliminate an external valve actuator. Further the pressure of the air being increased is considered to be functional limitations (MPEP § 2114).
Regarding claim 9, modified Gutsell teaches the pressure is liquid pressure; when the controlling element is forced by the liquid pressure, the controlling element is opened to exchange the liquid between the first space and the second space (functional limitation (MPEP § 2114) and is taught above).
Regarding claim 10, Gutsell teaches the device further comprises a chamber (item 67) configured to accommodate the absorbing element (paragraph [0277]); when the absorbing element is located in the chamber, there is a pressure change between the chamber and a space where the testing element is located (functional limitation (MPEP § 2114) and is taught in paragraph [0278]).
Gutsell fails to teach the pressure change enables the controlling element to be opened sate or closed state automatically.
Weintraub teaches a microfluidic valve in which has a pressure regulating valve with the sealing elements sealing the valve inlet from the valve outlet to selectively allow or prevent passage of fluid from the inlet to the outlet of the valve (Weintraub, paragraph [0018]) which allows the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have replaced the actuated valve of Gutsell with the pressure-activated valve of Weintraub because it would allow for the valve to be controlled from the pressure within the device (Weintraub, paragraph [0040]) and eliminate an external valve actuator. Further the pressure changes is considered to be functional limitations (MPEP § 2114).
Regarding claim 11, modified Gutsell teaches when the pressure in the chamber is higher than the pressure in the space, the increased pressure in the chamber enables the controlling element to be opened (functional limitation (MPEP § 2114) and is taught above); or, when the pressure in the chamber is substantively equal to the pressure in the space, the controlling element is closed automatically (functional limitation (MPEP § 2114) and is taught above).
Regarding claim 12, Gutsell teaches the increase of the pressure in the chamber for accommodating the absorbing element is achieved by compressing a gas or a liquid in the chamber such that the pressure in the chamber is higher than the pressure of the space where the testing element is located (functional limitation (MPEP § 2114) and is taught in paragraph [0278]).
Regarding claim 13, Gutsell teaches the chamber is a sealed chamber (paragraph [0277]).
Regarding claim 14, Gutsell teaches the chamber is sealed by inserting the absorbing element into the chamber (paragraph [0277]).
Regarding claim 15, Gutsell teaches the air or the liquid in the sealed chamber is compressed by the absorbing element (functional limitation (MPEP § 2114) and is taught in paragraphs [0277]-[0278]).
Regarding claim 16, Gutsell teaches after or when the absorbing element is inserted into the first space, the space is sealed, and a gas or a liquid is compressed in the sealed first space as to increase the air pressure or liquid pressure (functional limitation (MPEP § 2114) and is taught in paragraphs [0277]-[0278]).
Regarding claim 21, Gutsell teaches all limitations of claim 20; however, Gutsell fails to teach the controlling element comprises a piston and a spring.
Weintraub teaches a microfluidic valve with a first piston (Weintraub, item 116) and a first spring (Weintraub, item 124) as this would allow for no gaps where particulates can lodge and maintain the valve in an open condition (Weintraub, paragraph [0040]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the automatic valve of Weintraub with a piston and spring because it would allow for no gaps where particulates can lodge and maintain the valve in an open condition (Weintraub, paragraph [0040]).
Regarding claim 22, modified Gutsell teaches the piston has a first position and a second position in the channel; when the piston is in the first position, the channel is closed by the piston; when the piston is in the second position, the channel is opened by the piston (see supra).
Regarding claim 23, modified Gutsell teaches when the spring is in a first state, the piston is in the first position by the rebound face applied by the spring; when the spring is in a second state, the piston is in the second position (see supra).
Regarding claim 24, modified Gutsell teaches switching of the piston between the first position and the second position is achieved automatically by a change of a liquid pressure or an air pressure between the fist space and the second space applied on the piston (functional limitation (MPEP § 2114) and is taught above).
Regarding claim 25, modified Gutsell teaches when the pressure on the piston is increased and is higher than the rebound force of the spring, the piston is located in the second position; and when the pressure on the piston is reduced and is less than or is equal to the rebound force of the spring applied on the piston, the piston is located in the first position (functional limitation (MPEP § 2114) and is taught above).
Regarding claim 26, modified Gutsell teaches when the piston is located in the second position, the channel is opened by the piston, thus gas or liquid is exchange between the first space and the second space (see supra).
Regarding claim 27, Gutsell teaches the liquid or the air in the first space is forced by the increased pressure in the first space to flows into the second space via the channel (functional limitation (MPEP § 2114) and is taught in paragraphs [0277]-[0278]).
Regarding claim 28, the liquid is not positively claimed and therefore any limitation on the liquid has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Gutsell. Further Gutsell teaches the liquid comprises a liquid sample or a liquid sample mixed with a treatment liquid (paragraph [0026]).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutsell and Weintraub as applied to claim 16 above, and further in view of United States Application Publication No. 2003/0021736, hereinafter Kang.
Regarding claim 17, Gutsell and Weintraub teach all limitations of claim 16; however, they fail to teach the first space is located in a first receiving chamber, the first receiving chamber is located in a second receiving chamber, and the first receiving chamber is capable of moving in the second receiving chamber.
Kang teaches a first receiving chamber (Kang, item 8), a second receiving chamber (Kang, item 1) and the first receiving chamber is capable of moving in the second receiving chamber (Kang, paragraph [0040] and [0042]) so that sample transfer to a separate vessel for testing is not required and the integrity of the collected fluid is maintained (Kang, paragraph [0010]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the first and second receiving chambers of Kang because it would allow for sample transfer to a separate vessel for testing is not quired and the integrity of the collected fluid is maintained (Kang, paragraph [0010]).
Regarding claim 18, modified Gutsell teaches the air pressure or the liquid pressure in the first space is increased by the moving of the first receiving chamber in the second receiving chamber (functional limitation (MPEP § 2114) and is taught in see supra).
Regarding claim 19, Gutsell teaches the second receiving chamber comprises a third receiving chamber (item 215)); the third receiving chamber comprises a reagent for treating the liquid sample (paragraph [0211]).
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 1-4 and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-38 of copending Application No. 17/970001 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim anticipates or renders obvious the examined claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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