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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Invention II, claims 11-20 in the reply filed on 11/17/2025 is acknowledged. The traversal is on the ground(s) that Invention I and Invention II have overlapping subject matter. This is not found persuasive because applicant argues the restriction requirement between Invention I and Invention II are related as combination and sub combination. Applicant has provided a claim analysis for the argument. Invention I is directed to a thermal control module. Invention II is directed to a bio-separation system. Both applicant’s thermal control module and bio-separation system are utilized for biological and/or biochemical processing. Applicant’s bio-separation system requires a cartridge and a separation mechanism. The thermal control module can be utilized for as a separate invention for biological and/or biochemical processing (e.g., PCR). The bio-separation system can be utilized as a separate invention for biological and/or chemical analyses. Additionally, while there may be some overlap in the searches of the two inventions, there is not reason to believe that the searches would be identical.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/17/2025.
The requirement is still deemed proper and is therefore made FINAL.
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 15 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.
Claim 15 contains parenthetical words (narrowing/tapering to narrow the gap towards the bottom of the block) and it is unclear as to whether these words are meant to be claim limitations or not.
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.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Amirkhanian et al. (hereinafter Amirkhanian) US 2005/0106612.
Regarding claim 11, Amirkhanian discloses a bio-separation system (integrated system 200), comprising:
a chassis (interface mechanism 300);
a cartridge supporting a capillary column (capillaries 140) for capillary electrophoresis, wherein the cartridge body is supported by the chassis (The CE system 200 incorporates an interface mechanism 300, in accordance with one embodiment of the present invention. The interface mechanism 300 supports a multi-channel cartridge 100 in accordance with the one embodiment of the present invention…[0046]);
a thermal control module, comprising:
a thermal platform thermally coupled to the thermoelectric module (The PCR sample preparation device 250 is controlled by a PCR thermoelectric controller 68.[0046]), wherein the thermal platform comprises:
a base (transport frame 81), and
at least a thermal block (thermal interface structure 252) thermal conductively supported on the base, wherein the thermal block is structured to receive a receptacle (micro titer plate 72) comprising wells (wells 73) containing at least a sample, and wherein the thermal block comprises a body (complementary wells 255) conforming to convex conical tube shaped profile of bottom surfaces of the wells of the receptacle as shown in Fig. 5 [0050, 0052, 0057 and 0067];
a heat sink (At the bottom of the peltier thermoelectric unit 251,a heat sink is provided to remove heat from the peltier thermoelectric unit 251 during the cooling cycle of the unit and/or to remove excess heat during the heating cycle.) [0052]; and
a thermoelectric module (peltier thermoelectric unit 251) thermal conductively coupled between the base of the thermal platform and the heat sink as shown in Fig. 5, heating/cooling the thermal platform in accordance with a desired heating/cooling temperature profile [0047 and 0051];
a separation mechanism (high-voltage power supply 76) effecting bio-separation within the capillary column after loading the sample that was subject to heating/cooling from the receptacle [0049 and 0053]; and
a controller controlling the separation mechanism to effect separation (The operations of the CE system 200, including the interface mechanism 300, are controlled by a controller 32 interfacing with an external user control interface (e.g., a PC 918). [0048, 0049 and 0059]).
Amirkhanian does not explicitly disclose that the body of thermal block comprises a split longitudinal block having two longitudinal sides defining a valley, wherein the facing walls of the sides each has a scalloped concave profile.
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed thermal block body was significant, since it appears that the invention would perform equally well with the thermal block body disclosed in Amirkhanian. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent thermal block body shape and since the same expected heating would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 12, Amirkhanian does not explicitly disclose wherein the facing walls are spaced apart by a tapered gap to define the valley to accommodate a joined mid-line sections of wells, and wherein the scalloped profile of the facing walls, along with the gap between the facing walls.
However, Amirkhanian does disclose a thermal block body [255] that substantially conforms to the profile of the exterior bottom surfaces of the wells [73] of the receptacle [72] as shown in Fig. 5, so as to allow efficient thermal conduction between the thermal block and the walls of the wells, to thereby efficiently heat/cool the contents in the wells [0050, 0052, 0057 and 0067].
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed thermal block body was significant, since it appears that the invention would perform equally well with the thermal block body disclosed in Amirkhanian. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent thermal block body shape and since the same expected heating would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 13, Amirkhanian does not explicitly disclose wherein when viewed from the top of the thermal block into the valley, the scalloped profile generally resembles a series of adjoining concave surfaces each having a sectional profile of concave curve or arc along the facing walls of the thermal block.
However, Amirkhanian does disclose a thermal block body [255] that substantially conforms to the profile of the exterior bottom surfaces of the wells [73] of the receptacle [72] as shown in Fig. 5, so as to allow efficient thermal conduction between the thermal block and the walls of the wells, to thereby efficiently heat/cool the contents in the wells [0050, 0052, 0057 and 0067].
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed thermal block body was significant, since it appears that the invention would perform equally well with the thermal block body disclosed in Amirkhanian. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent thermal block body shape and since the same expected heating would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 14, Amirkhanian does not explicitly disclose wherein the facing walls of the thermal block define a row of cavities wherein adjacent cavities are joined/connected to accommodate the adjoining mid-line sections at the bottom of the receptacle.
However, Amirkhanian does disclose a thermal block [252] that substantially conforms to the profile of the exterior bottom surfaces of the wells [73] of the receptacle [72] as shown in Fig. 5, so as to allow efficient thermal conduction between the thermal block and the walls of the wells, to thereby efficiently heat/cool the contents in the wells [0050, 0052, 0057 and 0067].
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed thermal block was significant, since it appears that the invention would perform equally well with the thermal block disclosed in Amirkhanian. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent thermal block shape and since the same expected heating would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 15, Amirkhanian does not explicitly disclose wherein the facing walls of the thermal block define a row of cavities wherein adjacent cavities are joined/connected to accommodate the adjoining mid-line sections at the bottom of the receptacle, and wherein the adjoining cavities resembles a row of adjoining conical spaces along the tapered gap (narrowing/tapering to narrow the gap towards the bottom of the block) for receiving the conical exterior bottom surfaces of the wells in the receptacle.
However, Amirkhanian does disclose a thermal block [252] and body [255] that substantially conforms to the profile of the exterior bottom surfaces of the wells [73] of the receptacle [72] as shown in Fig. 5, so as to allow efficient thermal conduction between the thermal block and the walls of the wells, to thereby efficiently heat/cool the contents in the wells [0050, 0052, 0057 and 0067].
However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed thermal block was significant, since it appears that the invention would perform equally well with the thermal block disclosed in Amirkhanian. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent thermal block shape and since the same expected heating would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 16, the thermal block [252] and body [255] of Amirkhanian discloses wherein the thermal block receives the body of the receptacle [72] with the bottom external walls of the wells [73] in contact with or closely adjacent to the facing walls of the thermal block to facilitate thermal conduction between the sides of the thermal block and the wells as shown in Fig. 5.
Regarding claim 17, Amirkhanian does not explicitly disclose wherein the thermal platform comprises two thermal blocks, each thermal conductively supported at a different section of the base of the thermal platform, wherein the thermoelectric module comprises separate heating/cooling submodules that heat/cool the different sections of the base of the thermal platform in accordance with different heating/cooling temperature profiles thereby heating/cooling the thermal blocks in accordance with the different heating/cooling temperature profiles, and wherein the submodules are subject to separate controls to achieve the different heating/cooling temperature profiles of the corresponding thermal blocks to thereby subject samples to different temperature profiles.
Absent unexpected results, it would have been prima facie obvious to provide two thermal blocks, each thermal conductively supported at a different section of the base of the thermal platform, wherein the thermoelectric module comprises separate heating/cooling submodules, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
As to heat/cool the different sections of the base of the thermal platform in accordance with different heating/cooling temperature profiles thereby heating/cooling the thermal blocks in accordance with the different heating/cooling temperature profiles, and wherein the submodules are subject to separate controls to achieve the different heating/cooling temperature profiles of the corresponding thermal blocks to thereby subject samples to different temperature profiles, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. 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. See MPEP § 2114.
Regarding claim 18, Amirkhanian does not explicitly disclose wherein the receptacle comprises: exterior bottom surfaces of adjacent wells that are joined at mid-line sections of the wells; flap handles in the form of flaps depending from the edges of the top surface of the receptacle; and key slots provided at the end walls at the longitudinal ends of the receptacle, and wherein the thermal block further comprises: cutouts provided on the outside wall of the sides of the thermal block; and end posts each having a vertical key provided outside each end of the gap of the thermal block, wherein the cutouts receive the flap handles of the receptacle to resiliently grip the sidewalls of the thermal block, and the keys on the end posts engage corresponding key slots at end walls of the receptacle.
However, it would have been an obvious matter of design choice to provide a receptacle comprising an exterior bottom surface of adjacent wells that are joined at mid-line sections of the wells; flap handles in the form of flaps depending from the edges of the top surface of the receptacle; and key slots provided at the end walls at the longitudinal ends of the receptacle, and wherein the thermal block further comprises: cutouts provided on the outside wall of the sides of the thermal block; and end posts each having a vertical key provided outside each end of the gap of the thermal block, wherein the cutouts receive the flap handles of the receptacle to resiliently grip the sidewalls of the thermal block, and the keys on the end posts engage corresponding key slots at end walls of the receptacle, since applicant has not disclosed that the receptacle design solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the receptacle and thermal block of Amirkhanian.
Regarding claim 19, Amirkhanian discloses wherein the thermal block [252] and the base [81] are separate structures thermally conductively coupled together or in an integral, monolithic structure, and wherein the thermoelectric module [251] is thermal conductively sandwiched between the thermal platform [252] above and the heat sink [253] below as shown in Fig. 5. Also see [0047].
Regarding claim 20, the thermal block [252] and body [255] of Amirkhanian is structured to support a plurality of receptacles comprising wells in a receptacle tray or a plurality of receptacle tubes for heating/cooling as shown in Figs. 2, 4 and 5. Also see [0072 and 0077].
Conclusion
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796