DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 6, 7, 10, 11 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over United States Application Publication No. 2011/0312102, hereinafter Jo in view of WO 2012/012779, hereinafter Wilson and United States Application Publication No. 2001/0019826, hereinafter Ammann.
Regarding claim 1, Jo teaches an apparatus for performing nucleic acid amplification reactions, comprising: a thermally-conductive receptacle holder (item 1120) comprising a row of receptacle wells (the openings where item 1110 rest, figure 8), wherein an inner surface of each of the receptacle wells is defined to receive a receptacle (item 1110), and wherein each of the receptacle wells has a through-hole extending between the inner and outer surfaces thereof (item 1150 in item 1120); a plurality of optical fibers (item 1280), each of the optical fibers providing optical communication between one of the receptacle wells and at least one of an excitation signal source (item 1200) and an emission signal detector (the optical fiber could be in contact with the emission signal detector which is not positively recited), wherein a first end of each of the optical fibers is disposed outside, within, or extends through the through-hole of a corresponding one of the receptacle wells (figure 8), and wherein a second end of each optical fiber is in optical communication with the excitation signal source (item 1200) and/or the emission signal detector (optional).
Jo fails to teach one or more thermal elements for altering a temperature(s) of the receptacle holder, the one or more thermal element being in contact with a side surface of the receptacle holder.
Wilson teaches a cartridge heater with thermal elements (each of items 3027 in figure 20(b) which provides thermal energy though the lateral side surface to each of the plurality of receptacle wells and one or more force-applying bodies positioned to provide a compressive force to a second lateral side surface (paragraph [00519], the left hand heater, item 3027, and the force applying body on the right side) with the thermal element coupled to a lateral side surface of a support (item 3007(b)) extending up from a base (figure 20(a)). Wilson further teaches the one or more force-applying bodies comprise one or cross-braces (item 3007(c)) and each of the force applying bodies comprise a linker (the both within the spring as seen in figure 20(b) and a low thermal conductive body (item 3017) coupled to a second support (item 3007(a)) and the receptacle holders are in sliding engagement with the support (figures 20(a) and 20(b)). The left hand heater component and the force applying bodies allow for the heater to be opened and closed and to press the cartridge against the left hand heater component (paragraphs [00519] and [00520]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized the both of the thermal elements, with one of the thermal elements coupled to a first support in sliding arrangement with the receptacle holders and the force applying bodies comprising cross-bracing, a linker, a low thermal conductive body all coupled to a second support of Wilson in the device of Jo to apply heat to the side of the of the receptacle holder because it would allow for the heater to be opened and closed and to press the cartridge against the left hand heater component (paragraphs [00519] and [00520]).
Jo and Wilson fail to teach two or more thermistors disposed in contact with the receptacle holder; a channel disposed within the side surface and containing wires and/or electrical connections for the two or more thermistors.
Ammann teaches an automated diagnostic analyzer in which two thermistors are utilized and provided within a housing to monitor the temperature (Ammann, paragraph [0245]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have added one or more thermistors in a channel (within the housing) so that they can monitor the temperature (Ammann, paragraph [0245]).
Regarding claim 2, modified Jo teaches wherein the two or more thermistors comprise one or more thermistors disposed in contact with each of the receptacle wells (see supra).
Regarding claim 3, modified Jo teaches wherein the channel extends from an edge of the side surface to a location corresponding to a center-most receptacle well of the receptacle holder (see supra, the channel would have to connect from the outside of the housing (side surface) to the location where the thermistor is (center-most).
Regarding claim 6, modified Jo teaches wherein the two or more thermistors consist of two thermistors (Ammann, paragraph [0245]).
Regarding claim 7, modified Jo teaches further comprising a support (see supra, the support added by Wilson), the support being coupled to a lateral side surface of each of the one or more thermal elements, such that the one or more thermal elements are positioned between a portion of the support and the back surface of the receptacle holder (see supra).
Regarding claim 10, Jo teaches further comprising a controller (item 122, paragraph [0181]) electrically connected to the one or more thermal elements to cycle the temperature of each of the one or more thermal elements (paragraph [0183]).
Regarding claim 11, Jo teaches wherein the first end of each optical fiber is fixedly disposed within the through-hole of the corresponding receptacle well (paragraphs [0172]-[0173]).
Regarding claim 13, Jo teaches wherein the apparatus does not include a cover (paragraph [0167]).
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jo, Wilson and Ammann as applied to claim 1 above, and further in view of United States Application Publication No. 2005/0206895, hereinafter Salmelainen.
Regarding claim 12, Jo teaches further comprising a cover (item 1150) movable between an opened position and a closed position relative to the receptacle holder (paragraph [0188], the cover applies pressure to the tubes when they are present and therefore, the cover must be movable in order to allow for the tubes to be inserted into the device), wherein one or more receptacles disposed within one or more of the receptacle wells are seated or secured into the receptacle well by the cover when the cover is moved into the closed position (paragraph [0188]).
Modified Jo fails to disclose that the first end of the optical fiber is movable with respect to one of the through-holes. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the first end of the optical fiber movable, since it has been held that the provision of adjustability, where needed, involves only routine skill in the art. MPEP §2144.04 (V)(D). See for example, Salmelainen which is provided to show that making the optical fiber adjustable is routine in the art because it would allow the height position of the end of the optical fiber to be adjusted to a distance from the sample so that the conical light beam coming from the optical fiber produces on the bottom of the sample well a light spot exactly the size of the bottom (Salmelainen, paragraph [0079]).
Regarding that the optical fiber moves when the cover is moved when a receptacle is present in a receptacle well, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Jo, Wilson and Amma and Salmelainen and the apparatus of modifed Jo is capable of having the optical fibers move when the cover is closed when a receptacle is present in a receptacle well. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Jo (see MPEP §2114). Modifying the optical fibers as disclosed by Salmelainen would allow for the optical fibers to move when the cover is closed as the optical fibers are movable so that the light beam can be exactly the size of the bottom of a sample well.
Allowable Subject Matter
Claims 4, 5, 8 and 9 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record is Jo which teaches a receptacle holder with a front a back surface with receptacle wells which receive a receptacle with a through hole in the bottom of the receptacle well, a thermal element and a plurality of optical fibers between the wells at least on of an excitation signal source and an emission signal detector. However, the prior art does not disclose, teach or suggest the claimed combination of a pair of closed through-holes provided at the location of the channel corresponding to the center-most receptacle at an end of the channel, the closed through-holes being disposed on opposite sides of the center-most receptacle, wherein one of the two or more thermistors is provided through each of the closed through-holes (claim 4) nor does the prior art disclose the support comprises: a base portion having a plurality of through-holes, each of the through-holes being aligned with the through-hole of one of the receptacle wells; and an upright portion extending from the base portion and coupled to the lateral side surface of the thermal element.
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 and 3-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4-8 of U.S. Patent No. 11,788,128 (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.
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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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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