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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 17 is 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. The claim twice recites “a product collection device” which is unclear. It is unclear whether the first and second product collection devices are the same or different devices.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 6517234 to Kopf-Sill.
Regarding Claim 1, Kopf-Sill discloses a micro-sampling mixer (Figs. 1 and 5, microfluidic device 100; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52), comprising: a sample injection channel, a diluent injection channel, a mixing channel, and a connecting portion (Figs. 1 and 5, microfluidic device 100 with channels 106 connected to sample/diluent ports 110-116 and to mixing channel 104/118/518 at junction 108, and lower channel adjacent optical detection window 120; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52); wherein one end of the sample injection channel is in communication with the mixing channel, and another end of the sample injection channel is a sample input end (Figs. 1 and 5, sample introduction channel 106 connected to sample port 110-116 and to mixing channel 104/118/518 at junction 108; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52); wherein one end of the diluent injection channel is in communication with the mixing channel, and another end of the diluent injection channel is a diluent input end (Figs. 1 and 5, diluent introduction channel 106 connected to diluent port 110-116 and to mixing channel 104/118/518 at junction 108; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52); and wherein the connecting portion is arranged on the mixing channel (Figs. 1 and 5, lower portion of mixing channel 104/118/518 adjacent optical detection window 120; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52), and the connecting portion is connected to an external optical inspection device (Figs. 1 and 5, lower portion of mixing channel 104/118/518 adjacent optical detection window 120; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52).
Regarding Claim 16, Kopf-Sill discloses a material of the mixing channel is transparent silicon-based material or borosilicate glass (Figs. 1 and 5, mixing channel 104/118/518 with silica based substrates, such as glass, quartz, silicon or polysilicon and transparent optical detection window 120; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52).
Claim(s) 2-5 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopf-Sill as applied to claim 1 above, and further in view of US 20080254541 to Kang.
Regarding Claim 2, Kopf-Sill discloses micro-sampling mixer according to claim 1, and further discloses the mixing channel is silicon-based material or borosilicate glass (Figs. 1 and 5, mixing channel 104/118/518 with silica based substrates, such as glass, quartz, silicon or polysilicon; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52). However, Kopf-Sill does not explicitly disclose the micro-sampling mixer is a micro-sampling chip. Kang discloses the micro-sampling mixer is a micro-sampling chip (Figs. 1-3, microchannel chip for continuously diluting a sample; ¶¶ [0029]-[0038]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing the micro-sampling mixer is a micro-sampling chip as in Kang in order to provide for a well-known alternative substrate for a microfluidic device. See, e.g., "substitution of art-recognized equivalents" as discussed in MPEP 2144.06II "An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
Regarding Claim 3, Kopf-Sill discloses micro-sampling mixer according to claim 1, but does not disclose a buffer chamber provided at one end of the mixing channel, wherein the buffer chamber is in communication with the sample injection channel and the diluent injection channel. Kang discloses a buffer chamber provided at one end of the mixing channel, wherein the buffer chamber is in communication with the sample injection channel and the diluent injection channel (Fig. 3G, diluent inlet (or buffer inlet) with first channel 1 and sample inlet with second channel 2 connected to folded channel unit 2a with buffer chambers; ¶¶ [0047]-[0059], [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing a buffer chamber provided at one end of the mixing channel, wherein the buffer chamber is in communication with the sample injection channel and the diluent injection channel as in Kang in order to provide more efficient mixing.
Regarding Claim 4, Kang discloses a shape of the buffer chamber is spherical, hemispherical, heart-shaped, or gourd-shaped (Fig. 3G, folded channel unit, 2a with buffer chambers; ¶¶ [0047]-[0059], [0067]).
Regarding Claim 5, Kang discloses one end of the mixing channel away from the buffer chamber is a serpentine channel, and the serpentine channel is in communication with the buffer chamber (Fig. 3G, folded channel unit, 2a with buffer chambers and serpentine channel; ¶¶ [0047]-[0059], [0067]). Kopf-Sill also discloses a serpentine channel (Fig. 1, serpentine mixing channel 104/118; Col. 4, line 18 – Col. 5, line 26, Col. 12, line 12 – Col. 14, line 52).
Regarding Claim 8, Kopf-Sill discloses micro-sampling mixer according to claim 1, but does not disclose the mixing channel is formed by connecting a plurality of heart-shaped mixing chambers, each of the heart-shaped mixing chambers at one end of the mixing channel close to the sample injection channel serves as the buffer chamber, and the buffer chamber is in communication with the sample injection channel and the diluent injection channel. Kang discloses the mixing channel is formed by connecting a plurality of heart-shaped mixing chambers, each of the heart-shaped mixing chambers at one end of the mixing channel close to the sample injection channel serves as the buffer chamber, and the buffer chamber is in communication with the sample injection channel and the diluent injection channel (Fig. 3G, diluent inlet (or buffer inlet) with first channel 1 and sample inlet with second channel 2 connected to folded channel unit 2a with buffer chambers; ¶¶ [0047]-[0059], [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing the mixing channel is formed by connecting a plurality of heart-shaped mixing chambers, each of the heart-shaped mixing chambers at one end of the mixing channel close to the sample injection channel serves as the buffer chamber, and the buffer chamber is in communication with the sample injection channel and the diluent injection channel. as in Kang in order to provide more efficient mixing.
Regarding Claim 9, Kopf-Sill discloses the micro-sampling mixer according to claim 1, but is silent regarding an inner diameter of the diluent injection channel is greater than an inner diameter of the sample injection channel. Kang discloses an inner diameter of the diluent injection channel is greater than an inner diameter of the sample injection channel (Fig. 3G, diluent inlet (or buffer inlet) with first channel 1 with branch channel 3 larger than sample inlet with second channel 2; ¶¶ [0032]-[0039], [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing an inner diameter of the diluent injection channel is greater than an inner diameter of the sample injection channel as in Kang in order to provide greater control of the dilution/flow rate.
Regarding Claim 10, Kang discloses the inner diameter of the diluent injection channel is 3 to 5 times the inner diameter of the sample injection channel (Fig. 3G, diluent inlet (or buffer inlet) with first channel 1 with branch channel 3 larger than sample inlet with second channel 2; ¶¶ [0032]-[0039], [0067]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopf-Sill in view of Kang as applied to claim 3 above, and further in view of US 20070137314 to Watson
Regarding Claim 6, Kopf-Sill in view of Kang discloses the micro-sampling mixer according to claim 3, and Kang further discloses the mixer has a serpentine channel (Fig. 3G, folded channel unit 2a; ¶¶ [0047]-[0059], [0067]). However, Kopf-Sill in view of Kang do not disclose an inner diameter of the mixing channel is greater than an inner diameter of the sample injection channel. Watson discloses an inner diameter of the mixing channel is greater than an inner diameter of the sample injection channel (Figs. 1-3, sample inlet tube 2 of a smaller diameter than the narrowest diameter of the mixing conduit 5; ¶¶ [0051], [0087], [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill in view of Kang by providing an inner diameter of the mixing channel is greater than an inner diameter of the sample injection channel as in Watson in order to provide greater control of the dilution/flow rate.
Regarding Claim 7, Watson discloses the inner diameter of the serpentine channel is 3 to 5 times the inner diameter of the sample injection channel (Figs. 1-3, sample inlet tube 2 of a smaller diameter than the narrowest diameter of the mixing conduit 5; ¶¶ [0051], [0087], [0098]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopf-Sill as applied to claim 1 above, and further in view of US 20230085052 to Klein.
Regarding Claim 11, Kopf-Sill discloses the micro-sampling mixer according to claim 1, and further discloses “structural elements or features of a device which have at least one fabricated dimension in the range of from about 0.1 .mu.m to about 500 .mu.m “. However, Kopf-Sill does not explicitly disclose an inner diameter of the sample injection channel is 500-750 μm. Klein discloses an inner diameter of the sample injection channel is 500-750 μm (¶¶ [0501], [0566]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing an inner diameter of the sample injection channel is 500-750 μm as in Klein in order to provide greater control of the dilution/flow rate.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopf-Sill as applied to claim 1 above, and further in view of US 20200147548 to van Dam.
Regarding Claim 12, Kopf-Sill discloses the micro-sampling mixer according to claim 1, but does not disclose the connecting portion comprises a first sub-connecting portion and a second sub-connecting portion arranged oppositely, the first sub-connecting portion is connected to an incident excitation light fiber, and the second sub-connecting portion is connected to a luminescent optical fiber configured to receive light emitted by a product. van Dam discloses the connecting portion comprises a first sub-connecting portion and a second sub-connecting portion arranged oppositely, the first sub-connecting portion is connected to an incident excitation light fiber, and the second sub-connecting portion is connected to a luminescent optical fiber configured to receive light emitted by a product (Fig. 1, waveguides 52, 54 for optical fibers of the microfluidic detector chip 40; ¶ [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Kopf-Sill by providing the connecting portion comprises a first sub-connecting portion and a second sub-connecting portion arranged oppositely, the first sub-connecting portion is connected to an incident excitation light fiber, and the second sub-connecting portion is connected to a luminescent optical fiber configured to receive light emitted by a product as in van Dam in order to provide a well-known alternative to an out-of-plane detector. See, e.g., "substitution of art-recognized equivalents" as discussed in MPEP 2144.06II "An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
Allowable Subject Matter
Claims 13-15 are 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.
Claims 17-20 would be allowable if rewritten or amended 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J BOLDUC whose telephone number is (571)270-1602. The examiner can normally be reached M-F, 10am-6pm.
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/DAVID J BOLDUC/Primary Examiner, Art Unit 2852
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