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 .
Status of Claims
In the preliminary amendment filed April 17, 2023, claims 1-20 were cancelled, and claims 21-40 were added. Claims 21-40 are pending for examination and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 17, 2023, and October 5, 2023, were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “40” has been used to designate both an absorbent pad (see, e.g., absorbent pad 40 at p. 12, l. 19 and p. 13, l. 2 of Applicant’s specification) and a membrane pad (see, e.g., membrane pad 40 at p. 19, l. 17 and p. 47, l. 22 of Applicant’s specification), and reference character “440” has been used to designate both an absorbent pad (see, e.g., absorbent pad 440 at p. 60, l. 24 and p. 61, l. 2 of Applicant’s specification) and a membrane pad (see, e.g., membrane pad 440 at p. 63, l. 5 of Applicant’s specification). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 22-27, 29, and 31-40 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 22, the limitation “wherein the solution supply device is an automatic supply part which… receives a washing solution and a reaction solution,” is recited. However, independent claim 21 recites, “a solution supply device that…receives a washing solution and a reaction solution.” It is unclear whether the washing solution and the reaction solution in claim 22 refers to the washing solution and the reaction solution in independent claim 21, or whether the washing solution and the reaction solution in claim 22 is in addition to the washing and reaction solutions recited in independent claim 21. For examination purposes, the limitation “wherein the solution supply device is an automatic supply part which… receives a washing solution and a reaction solution,” in claim 22 is interpreted as referring to the washing and reaction solutions of independent claim 21.
Regarding claim 23, the limitation “an upper part of the first housing” is recited in line 8. However, an upper part of the first housing is previously recited in line 4 of claim 23. It is unclear whether the limitation “an upper part of the first housing” in line 8 refers to the upper part of the first housing previously recited or another upper part of the first housing. For examination purposes, the limitation “an upper part of the first housing” in line 8 is interpreted as referring to the upper part of the first housing previously recited in claim 23.
Furthermore, claim 23 recites the limitation “a second receptacle… to receive the reaction solution… to introduce the washing solution into the second inlet.” It is unclear how the second receptacle receives reaction solution and dispenses washing solution. It appears that the second receptacle receives and dispenses reaction solution. The Examiner respectfully requests clarification.
Regarding claim 25, the limitation “an upper part of the first housing” is recited in line 7. However, an upper part of the first housing is previously recited in line 4 of claim 25. It is unclear whether the limitation “an upper part of the first housing” in line 8 refers to the upper part of the first housing previously recited or another upper part of the first housing. For examination purposes, the limitation “an upper part of the first housing” in line 7 is interpreted as referring to the upper part of the first housing previously recited in claim 25.
Furthermore, claim 25 recites the limitation “a second receptacle… to receive the reaction solution… to introduce the washing solution into the second inlet.” It is unclear how the second receptacle receives reaction solution and dispenses washing solution. It appears that the second receptacle receives and dispenses reaction solution. The Examiner respectfully requests clarification.
Regarding claim 29, the limitation “an inner upper surface” is recited in lines 5-6. However, an inner upper surface is previously recited in line 3 of claim 29. It is unclear whether the limitation “an inner upper surface” in lines 5-6 refers to the inner upper surface previously recited or another inner upper surface of the first housing. For examination purposes, the limitation “an inner upper surface” in lines 5-6 is interpreted as referring to the inner upper surface previously recited in claim 29.
Claim 31 recites the limitation "the sample solution" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 32, the limitation “an upper surface of the upper plate” is recited. However, claim 32 depends on claim 31 which recites an upper surface of the upper plate. It is unclear whether the limitation “an upper surface of the upper plate” in claim 32 refers to the upper surface of the upper plate in claim 31 or another upper surface of the upper plate. For examination purposes, the limitation “an upper surface of the upper plate” in claim 32 is interpreted as referring to the upper surface of the upper plate previously recited in claim 31.
Claim 34 recites the limitation "the lower side" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 35, the limitation “a plurality of diagnostic lines” is recited in lines 6-7. However, a plurality of diagnostic lines is previously recited in lines 4-5 of claim 35. It is unclear whether the limitation “a plurality of diagnostic lines” in lines 6-7 refers to the plurality of diagnostic lines previously recited or a second plurality of diagnostic lines. For examination purposes, the limitation “a plurality of diagnostic lines” in lines 6-7 of claim 35 is interpreted as referring to the plurality of diagnostic lines previously recited.
Regarding claim 36, the limitation “a plurality of diagnostic lines” is recited in line 4. However, claim 36 depends on claim 35 which previously recites a plurality of diagnostic lines. It is unclear whether the limitation “a plurality of diagnostic lines” in line 4 in claim 36 refers to the plurality of diagnostic lines previously recited in claim 35 or a second plurality of diagnostic lines. For examination purposes, the limitation “a plurality of diagnostic lines” in line 4 of claim 36 is interpreted as referring to the plurality of diagnostic lines previously recited in claim 35.
Claim 38 recites the limitation "the diagnostic lines" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the diagnosis line" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the diagnostic line" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 24, 26-27, 33, and 37 are also rejected for being dependent upon a claim rejected under 35 U.S.C. 112(b).
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.
Claims 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bird et al. (U.S. Pat. Pub. No. 2011/0236960; hereinafter “Bird”) in view of Dafforn et al. (U.S. Pat. No. 4,981,786; hereinafter “Dafforn”).
Regarding claim 21, Bird teaches a diagnostic cartridge (cartridge 2001; ¶¶ [0114] and [0117]; Fig. 3), comprising:
a housing (first module 2110; ¶ [0114]; Fig. 3) that has formed therein a receiving space (first module 2110 defines a first chamber 2114 and a second chamber 2190 which are collectively interpreted as the receiving space; ¶ [0114]; Fig. 3), and has formed, on the upper surface thereof, a first inlet (the opening above first chamber 2114 that receives second module 2160; ¶ [0115]; Fig. 3) and a second inlet (the opening above second chamber 2190 that receives third module 2200; ¶ [0116]; Fig. 3) that are spaced apart from each other in communication with the receiving space and an outer space (wherein the openings above first chamber 2114 and second chamber 2190 are spaced apart and in communication with the receiving space, e.g., first chamber 2114 and second chamber 2190, and the outer space, e.g., first volume 2163, reaction chamber 2262, and second volume 2213; ¶¶ [0115]-[0116]; Fig. 3); and
a solution supply device (third module 2200; ¶ [0116]; Fig. 3) that is integrally or detachably mounted in the second inlet (wherein third module 2200 is coupled to the opening above second chamber 2190 of first module 2110; ¶ [0116]; Fig. 3), receives a washing solution and a reaction solution (wherein third module 2200 receives one or more biological or chemical substances such as a mineral oil, wash buffer, one or more PCR reagents, a reagent, or the like that participates in or otherwise supports a reaction; ¶ [0116]; Fig. 3), and sequentially introduces at intervals the washing solution and the reaction solution through the second inlet (substances and/or samples can be transferred between the second chamber 2190 and the reaction chamber 2262 and/or the second volume 2213 using any suitable fluid transfer mechanism, such as actuators that sequentially actuate wash buffer modules and reagent modules; ¶¶ [0116], [0282], and [0300]; Fig. 3).
However, Bird does not explicitly teach a membrane pad on which the washing solution and the reaction solution are introduced through the second inlet. Dafforn, in the analogous art of devices for conducting assays, teaches a housing (housing 12; col. 12, ll. 12-13; Figs. 1 and 1A) comprising a membrane pad (bibulous strip 14 having one or more immunosorbing zones; col. 11, ll. 58-60; Fig. 1A) on which a liquid reagent and sample are introduced (see col. 12, ll. 9-11) through a second inlet (second means 22 for introducing a liquid reagent and sample; col. 12, ll. 9-11; Figs. 1A and 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Bird to incorporate a membrane pad within the housing as taught by Dafforn, whereby the washing solution and the reaction solution of Bird would be introduced, for the benefit of transporting fluids within the housing through capillary action to a predetermined site (Dafforn, col. 1, ll. 22-27 and col. 7, ll. 44-52).
Regarding claim 22, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 21 as discussed above. Bird further teaches wherein the solution supply device is an automatic supply part (wherein substances and/or samples can be transferred from third module 2200 using any suitable fluid transfer mechanism, such as an instrument for manipulating and/or actuating a cartridge, and therefore third module 2200 is considered as an automatic supply part; ¶¶ [0091], [0116], and [0130]) which is mounted integrally or detachably to the second inlet (wherein third module 2200 is coupled to the opening above second chamber 2190 of first module 2110; ¶ [0116]; Fig. 3), receives a washing solution and a reaction solution (wherein third module 2200 receives one or more biological or chemical substances such as a mineral oil, wash buffer, one or more PCR reagents, a reagent, or the like that participates in or otherwise supports a reaction; ¶ [0116]; Fig. 3) and introduces the washing solution into the membrane pad when a sliding member moves (third module 2200, via a fluid transfer mechanism, is capable of introducing the washing solution into the membrane pad when a sliding member moves; ¶¶ [0116], [0280]-[0282], and [0300]) (Examiner’s Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art), and after a predetermined time has elapsed after the washing solution is introduced, the reaction solution is introduced into the second inlet (third module 2200, via a fluid transfer mechanism, is capable of introducing the reaction solution into the second inlet after a predetermined time has elapsed after the washing solution is introduced; ¶¶ [0116], [0282], and [0300]) (Examiner’s Note -"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art).
Regarding claim 23, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 22 as discussed above. Bird further teaches wherein the automatic supply part comprises:
a first housing (the housing of third module 2200; ¶ [0114]; Fig. 3) which is coupled to the second inlet (wherein third module 2200 is coupled to the opening above 2190 of first module 2110; ¶ [0116]; Fig. 3);
a first receptacle (second volume 2213; ¶ [0116]; Fig. 3) which is located at an upper part of the first housing (which is located at an upper part of third module 2200, e.g., the portion of third module 2200 above the opening of second chamber 2190; ¶ [0116]; Fig. 3) and receives the washing solution (second volume 2213 contains wash buffer; ¶ [0116]; Fig. 3), and comprises a breaking line (second volume 2213 is fluidically isolated from second chamber 2190 by a breaking line, e.g., puncturable membrane; ¶ [0116]); and
a second receptacle (reaction chamber 2262; ¶ [0116]; Fig. 3) which is located at an upper part of the first housing and a side surface of the first receptacle (which is located at an upper part of third module 2200, e.g., the portion of third module 2200 above the opening of second chamber 2190, and a side surface of second volume 2213; ¶ [0116]; Fig. 3) to receive the reaction solution (reaction chamber 2262 contains one or more biological or chemical substances such as a mineral oil, wash buffer, one or more PCR reagents, a reagent, or the like that participates in or otherwise supports a reaction; ¶ [0116]; Fig. 3), and is broken by the action of a breaking part to introduce the washing solution into the second inlet (reaction chamber 2262 is fluidically isolated from second chamber 2190 by a puncturable membrane which is capable of being broken by the action of a breaking part, e.g., an actuator with a piercing portion, to introduce the washing solution into the second inlet; ¶¶ [0116] and [0151]) (Examiner’s 1st Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge).
Bird, in a different embodiment, teaches a receptacle having a breaking line as the bottom surface (the receptacle is collectively interpreted as top wall and side walls of second housing 1160 and a breaking line, e.g., puncturable member 1170, as a bottom surface that encloses substance R1; ¶ [0100]; Fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first receptacle of Bird in view of Dafforn to position the breaking line as the bottom surface as taught by Bird for the benefit of readily dispensing substances into a chamber for additional processing.
Bird in view of Dafforn further teaches the first receptacle in which the bottom surface is removed by a strip line having one end connected to the bottom surface and the other end connected to the sliding member so as to introduce the washing solution into the second inlet (wherein second volume 2213 comprising a puncturable member as its bottom surface is capable of having the bottom surface removed by a strip line having one end connected to the bottom surface and the other end connected to the sliding member so as to introduce the washing solution into the second inlet) (Examiner’s 1st Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the strip line has not been positively recited and therefore the recitation of the strip line and on how it is operated does not further limit the structure of the diagnostic cartridge).
Regarding claim 24, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 23 as discussed above. Bird further teaches wherein the breaking part is operated after the sliding member slides and a set time has elapsed, and breaks by puncturing or pressing the second receptacle (wherein the puncturable member is capable of being broken by puncturing using a breaking part, e.g., an actuator with a piercing portion, operated after a sliding member slides and a set time has elapsed; ¶¶ [0116] and [0151]) (Examiner’s 1st Note -"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge).
Regarding claim 25, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 21 as discussed above. Bird further teaches wherein the solution supply device comprises:
a first housing (the housing of third module 2200; ¶ [0114]; Fig. 3) which is coupled to the second inlet (wherein third module 2200 is coupled to the opening above 2190 of first module 2110; ¶ [0116]; Fig. 3);
a first receptacle (second volume 2213; ¶ [0116]; Fig. 3) which is located at an upper part of the first housing (which is located at an upper part of third module 2200, e.g., the portion of third module 2200 above the opening of second chamber 2190; ¶ [0116]; Fig. 3), receives the washing solution (second volume 2213 contains wash buffer; ¶ [0116]; Fig. 3), and is broken by the action of a breaking part so as to introduce the washing solution into the second inlet (second volume 2213 and reaction chamber 2262 are fluidically isolated from second chamber 2190 by a puncturable membrane which is capable of being broken by the action of a breaking part, e.g., an actuator with a piercing portion, to introduce the washing solution into the second inlet; ¶¶ [0116] and [0151]) (Examiner’s 1st Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge); and
a second receptacle (reaction chamber 2262; ¶ [0116]; Fig. 3) which is located at an upper part of the first housing and a side surface of the first receptacle (which is located at an upper part of third module 2200, e.g., the portion of third module 2200 above the opening of second chamber 2190, and a side surface of second volume 2213; ¶ [0116]; Fig. 3) to receive the reaction solution (reaction chamber 2262 contains one or more biological or chemical substances such as a mineral oil, wash buffer, one or more PCR reagents, a reagent, or the like that participates in or otherwise supports a reaction; ¶ [0116]; Fig. 3), and is broken by the action of the breaking part to introduce the washing solution into the second inlet (second volume 2213 and reaction chamber 2262 are fluidically isolated from second chamber 2190 by a puncturable membrane which is capable of being broken by the action of a breaking part, e.g., an actuator with a piercing portion, to introduce a washing or reaction solution into the second inlet; ¶¶ [0116] and [0151]) (Examiner’s 1st Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge).
Regarding claim 26, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 25 as discussed above. Bird further teaches wherein the breaking part breaks by sequentially puncturing or pressing the first receptacle and the second receptacle (wherein the puncturable member of second volume 2213 and reaction chamber 2262 is capable of being sequentially punctured; ¶¶ [0116], [0282], and [0300]) (Examiner’s 1st Note -"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge).
Regarding claim 27, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 24 as discussed above. Bird, in a different embodiment, teaches a receptacle having a breaking line on the bottom surface (the receptacle is collectively interpreted as top wall and side walls of second housing 1160 and a breaking line, e.g., puncturable member 1170, on a bottom surface that encloses substance R1; ¶ [0100]; Fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second receptacles of Bird in view of Dafforn to position the breaking line on the bottom surfaces as taught by Bird for the for the benefit of readily dispensing substances into a chamber for additional processing.
Bird in view of Dafforn further teaches that the breaking lines are broken by the pressure of the breaking part (the puncturable membranes of second volume 2213 and reaction chamber 2262 are capable of being broken by the pressure of the breaking part, e.g., an actuator with a piercing portion; ¶¶ [0116] and [0151]) (Examiner’s 1st Note - "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); See MPEP 2114 (II) Manner Of Operating The Device Does Not Differentiate Apparatus Claim From The Prior Art) (Examiner’s 2nd Note – the breaking part has not been positively recited and therefore the recitation of the breaking part and how it is operated does not further limit the structure of the diagnostic cartridge).
Regarding claim 28, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 21 as discussed above. Bird in view of Dafforn further teaches wherein the membrane pad is pre-treated with a capture antibody that specifically binds to a predetermined antigen on one side surface (Dafforn’s bibulous strip 14 comprises one or more immunosorbing zones, such as a membrane or a filter to which is bound an antibody, that contacts a sample containing an antigenic analyte; Dafforn, col. 6, ll. 35-43, col. 10, ll. 59-63, col. 11, ll. 58-61, and col. 20, ll. 43-46 and 51-54).
Regarding claim 29, the combination of Bird and Dafforn teaches the diagnostic cartridge of claim 21 as discussed above. Dafforn further teaches an absorbent pad which is disposed in a receiving space (liquid absorbent material 16 within housing 12; col. 11, ll. 62-65; Figs. 1 and 1A) and has an other side surface spaced apart from the membrane pad (wherein liquid absorbent material 16 comprises an other side, e.g., the right side in Fig. 15 that is the other side of the left side in Fig. 15, spaced apart from bibulous strip 14; Fig. 5), wherein the absorbent pad comprises an absorbent member (liquid absorbent material 16 absorbs a volume of liquid and therefore it is interpreted as comprising the absorbent member; col. 16, l. 65 – col. 17, l. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the housing of Bird and Dafforn to incorporate an absorbent pad as taught by Dafforn for the benefit of transporting liquid away from a zone by capillary action (Dafforn, col. 11, ll. 62-68).
However, Bird in view of Dafforn does not explicitly teach wherein the absorbent pad (i) is disposed between the first inlet and the second inlet and has one side surface in contact with the inner upper surface of the housing, and (ii) comprises an elastic member which is in contact with an inner upper surface of the housing and that the absorbent member is disposed below the elastic member.
Dafforn further teaches that the absorbing member can be repositioned to introducing a sample (see col. 12, ll. 8-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the absorbent pad of Bird in view of Dafforn to be disposed between first and second inlets and having one side surface in contact with an inner upper surface of the housing as an obvious matter of engineering design choice in a rearrangement of parts. See MPEP 2144.04(VI)(C) – Rearrangement of Parts; see also In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Furthermore, Dafforn teaches an elastic member as a support for an absorbent pad so that the capillary action remains essentially unchanged when in contact with the inner walls of a housing (see col. 7, ll. 55-60, col. 12, ll. 12-22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the absorbent pad of Bird in view of Dafforn to incorporate an elastic member as taught by Dafforn, in contact with an inner upper surface of the housing and above the absorbent member, for the benefit of reducing changes to the capillary action due to the contact of the absorbent pad with the inner walls of the housing (Dafforn, col. 7, ll. 55-60, col. 12, ll. 12-22).
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Bird in view of Dafforn as applied to claim 21 above, and further in view of Anderson et al. (U.S. Pat. Pub. No. 2011/0201099; hereinafter “Anderson”).
Regarding claim 35, the combination of Bird and Dafforn teaches a diagnostic cartridge, comprising:
the housing of claim 21 (see above rejection of claim 21);
a membrane pad which is disposed in the receiving space (see Bird as modified by Dafforn in the above rejection of claim 21) such that both ends of the housing are exposed to a first inlet and a second inlet (first module 2110 comprises two ends that are exposed, e.g., in fluid communication, with the openings above first chamber 2114 and second chamber 2190; Bird, ¶¶ [0114]-[0116]; Bird, Fig. 3); and
a cutting part (a valve that can selectively place the first chamber 2114 in fluid communication with the second chamber 2190 and therefore cut, e.g., reduce in amount, fluid transfer between first chamber 2114 and second chamber 2190; Bird, ¶ [0114]) which is installed in the housing (the valve is installed within first module 2110; Bird, ¶ [0114]).
However, Bird in view of Dafforn does not explicitly teach a plurality of diagnostic lines and wherein the cutting part cuts such that the plurality of the diagnostic lines are divided. Anderson, in the analogous art of assay cartridges, teaches a cartridge-based device (cartridge-based device 150; ¶ [0100]; Fig. 1b) comprising detection chambers (two detection chambers 155, 156; ¶ [0100]; Fig. 1b) and a plurality of diagnostic lines fluidly coupled to the detection chambers (two fluid input lines 160, 161 for introducing sample, reagents and/or wash solutions into the detection chambers; ¶ [0100]; Fig. 1b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the diagnostic cartridge of Bird in view of Dafforn to incorporate diagnostic lines as taught by Anderson for the benefit of introducing different fluids to different parts of the housing. Bird in view of Dafforn and Anderson further teaches wherein the cutting part cuts such that the plurality of the diagnostic lines are divided (wherein Bird’s valve would cut, e.g., reduce in amount, the diagnostic lines, such that diagnostic lines feeding Bird’s first chamber 2114 and second chamber 2190 would be divided).
Regarding claim 36, the combination of Bird, Dafforn, and Anderson teaches the diagnostic cartridge of claim 35 as discussed above. Bird in view of Dafforn and Anderson further teaches wherein the membrane pad (the membrane pad of Bird in view of Dafforn and Anderson as modified in the above rejection of claim 35) comprises:
a first pad which is exposed to the outside through the first inlet (a first portion of Dafforn’s bibulous strip 14 having one or more immunosorbing zones that would be exposed to the outside of the first inlet of Bird in view of Dafforn and Anderson; Dafforn, col. 11, ll. 58-60; Fig. 1A);
a second pad which is exposed to the outside through the second inlet (a second portion of Dafforn’s bibulous strip 14 having one or more immunosorbing zones that would be exposed to the outside of the second inlet of Bird in view of Dafforn and Anderson; Dafforn, col. 11, ll. 58-60; Dafforn, Fig. 1A);
a plurality of diagnostic lines for connecting the first pad and the second pad (Anderson’s two fluid input lines 160, 161 for introducing sample, reagents and/or wash solutions that would be fluidically coupled to the first and second pads of Bird in view of Dafforn and Anderson; Anderson, ¶ [0100]; Anderson, Fig. 1b); and
reaction parts that are located in each of the diagnostic lines (Anderson’s two fluid input lines 160, 161 for introducing reaction parts, e.g., sample, reagents and/or wash solutions; Anderson, ¶ [0100]; Anderson, Fig. 1b).
Regarding claim 37, the combination of Bird, Dafforn, and Anderson teaches the diagnostic cartridge of claim 36 as discussed above. Bird in view of Dafforn and Anderson further teaches wherein the second pad is provided in plurality (additional portions of Dafforn’s bibulous strip 14 having one or more immunosorbing zones are interpreted as the second pad is provided in plurality; Dafforn, col. 11, ll. 58-60; Dafforn, Fig. 1A), and wherein the second pad is connected to the first pad by the same number of diagnostic lines as the second pad (wherein the first and second pads of Bird in view of Dafforn and Anderson are fluidly connected by Anderson’s two fluid input lines 160, 161 for introducing sample, reagents and/or wash solutions, which remain numerically unchanged, and therefore is interpreted as being by the same number of diagnostic lines as the second pad; Anderson, ¶ [0100]; Anderson, Fig. 1b).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Bird in view of Dafforn and Anderson as applied to claim 36 above, and further in view of Stakenborg et al. (U.S. Pat. Pub. No. 2019/0309346; hereinafter “Stakenborg”).
Regarding claim 38, the combination of Bird, Dafforn, and Anderson teaches the diagnostic cartridge of claim 36 as discussed above. However, Bird in view of Dafforn and Anderson does not explicitly teach a first space forming part and a second space forming part for forming a microcavity between the diagnostic lines at the upper part and the side surface of the diagnostic lines that are adjacent to the first pad and the second pad.
Stakenborg, in the analogous art of systems for analyzing fluid samples, teaches a first space forming part and a second space forming part for forming a microcavity (a cavity that can obtain a fluid sample, buffers and/or reagents, whereby the cavity comprises a first space forming part and a second space forming part, e.g., at least first and second walls/surfaces, to contain the fluid sample, buffers and/or reagents; ¶ [0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the diagnostic cartridge of Bird in view of Dafforn and Anderson to incorporate a microcavity as taught by Stakenborg for the benefit of performing various functions in one space and therefore providing a more compact operation (Stakenborg, ¶ [0079]).
Bird in view of Dafforn, Anderson, and Stakenborg does not explicitly teach wherein the microcavity is between the diagnostic lines at the upper part and the side surface of the diagnostic lines that are adjacent to the first pad and the second pad. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the diagnostic cartridge of Bird in view of Dafforn, Anderson, and Stakenborg to position the microcavity between the diagnostic lines at the upper part and the side surface of the diagnostic lines that are adjacent to the first pad and the second pad as an obvious matter of engineering design choice in a rearrangement of parts. See MPEP 2144.04(VI)(C) – Rearrangement of Parts; see also In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Bird in view of Dafforn, Anderson, and Stakenborg as applied to claim 38 above, and further in view of Sandell (U.S. Pat. Pub. No. 2004/0171170).
Regarding claim 39, the combination of Bird, Dafforn, Anderson, and Stakenborg teaches the diagnostic cartridge of claim 38 as discussed above. However, Bird in view of Dafforn, Anderson, and Stakenborg does not explicitly teach wherein each of the first space forming part and the second space forming part has a hydrophilic coating layer formed on a surface facing the diagnosis line.
Sandell, in the analogous art of sample substrates, teaches a chamber having surfaces that are coated with a hydrophilic coating to minimizes friction between the surfaces and fluid introduced into the chamber (see ¶¶ [0033] and [0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surfaces of the first space forming part and the second space forming part, which would face the diagnosis line, of Bird in view of Dafforn, Anderson, and Stakenborg to incorporate a hydrophilic coating layer as taught by Sandell for the benefit of minimizing friction (Sandell, ¶¶ [0033] and [0037]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Bird in view of Dafforn, Anderson, and Stakenborg as applied to claim 38 above, and further in view of Bishop (U.S. Pat. Pub. No. 2015/0361487; hereinafter “Bishop”).
Regarding claim 40, the combination of Bird, Dafforn, Anderson, and Stakenborg teaches the diagnostic cartridge of claim 38 as discussed above. However, Bird in view of Dafforn, Anderson, and Stakenborg does not explicitly teach a liquid impermeable sheet which covers part or all of the diagnostic line.
Bishop, in the analogous art of capillarity-based devices for performing chemical processes, teaches a liquid impermeable sheet (an impermeable barrier that separates fluids to create distinct pathways; ¶ [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microcavity of Bird in view of Dafforn, Anderson, and Stakenborg to incorporate a liquid impermeable sheet as taught by Bishop, thereby covering at least part of the diagnostic line, for the benefit of creating distinct pathways for fluids to be processed (Bishop, ¶ [0075]).
Allowable Subject Matter
Claim 30 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. However, none of the prior art of record nor any other references found (alone or in combination) teaches or fairly suggests a diagnostic cartridge comprising an absorbent pad formed by being folded multiple times in different and opposite directions, and wherein the area of each layer, the number of folds and the volume of the absorbent pad are adjusted according to the amounts of the washing solution and the reaction solution introduced into the second inlet.
Claims 31-34 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/STEVEN RAY CASTANEDA/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797