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 .
Detailed Action
This is the Final Action for application 18/168705 response filed 02/04/2026.
Claims 1-14 are pending.
Claims 1-11 were elected and have been fully examined.
Claims 12-14 are withdrawn.
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 1-11 are rejected under 35 U.S.C. 103 as being obvious over STANLEY in US 20100086990 in view of ROBOLE in US 20110117656.
With respect to Claim 1, STANLEY teaches of an apparatus for conducting sequential nucleic acid amplification reactions. The apparatus (1) comprises a platform (2), which reads on the claimed “planar main body,” having a sample compartment (5) and a plurality of reaction compartments (10)., which reads on the claim “substate with a cannel-and-chamber structure.”
STANLEY specifically teaches that the reaction compartments (10) and sample compartments (5), are the claimed “chambers,” and the channels are all the channels shown on Figure 1 connecting the 2 (paragraphs 0024, 0026, 0037-0038, 0053, 0069, 0079-0080).
The sample compartment (5) is adapted to receive a fluid sample for conducting a first amplification reaction and the platform (2) is adapted to substantially evenly distribute the fluid sample into the plurality of reaction compartments (10) for conducting second amplification reactions (See Figure 2).
STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075).
STANELY also teaches of using wax valves which seals off the channels preventing flow there-though and then when it is heated up and melts thereby permitting flow through the channels. Also, melting the wax creates a surface seal/seal layer on the fluid since the wax is of typically lower density than the fluid (paragraph 0037, 0069).
As claimed, what is required is “a sealing layer sealing off said channel and chamber structure from a heat input side.” Since when the wax is not melted, in the device of STANLEY, it functions to “seal off,” the channels from compartments it reads on this sealing layer through broadest reasonable interpretation. Also, when the layer of wax melts and it forms the surface seal and then is surface sealing the fluid wherever it moves through the device it also reads on “a sealing layer sealing off said channel and chamber structure,” through broadest reasonable interpretation.
Further, with respect to the “heat input side,” the examiner notes that no heater is claimed, so “heat input side,” can be broadly interpreted. Though broadest reasonable interpretation (BRI), the side where the wax seal in STANELY sits can be considered the “heat input side,” since the sample and reaction compartments, having the claimed channel and chamber structure in STANLEY is “adapted for thermal communication with a heat exchanger,” so it is receiving “heat input,” a the side the wax seal is on and further the heating means, again which is not claimed, can be a variety of elements such as infrared illumination, or activation of heating elements (paragraph 0043, 0053).
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STANELY does not teach of the claimed positioning or fastening elements, to a support plate.
ROBOLE is used to remedy this and teaches of a system and method for processing sample processing devices (see the overall device on Figures 1-3).
The system includes a cartridge (See Figure 1, with cartridge parts 110, 150, and 160).
The cartridge has a planarly extended main body (the body (150) in Figures 1-2) in which a microfluidic channel and chamber structure is formed (see the non-thermal process chambers (154) which are connected to the thermal process chambers (152) by channels in Figures 1-2), wherein a plurality of process chambers interconnected by means of multiple process channels (paragraph 0028).
ROBOLE further teaches of a number of positioning and/or fastening elements including the central opening (166) formed in the main body for positioning and/or fastening the main body to a support plate (the support plate (110) having heating elements/thermal structures (130) in Figures 1-2) on the analysis device for carrying out the analysis method.
ROBLE teaches that the device from Figure 1 is inserted into analyzer in Figure 3 (See paragraphs 0057-0061), and it connects to the analyzer through the rotation axis, 111, which can be considered a fastener of the base to the analyzer through broadest reasonable interpretation.
ROBOLE also teach of magnetic elements and projections which can be considered “fastening,” elements as they operate to force the cover and base plate/support plate together (abstract, paragraphs 0120-0122 & 0048-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the positioning and fastening elements of ROBOLE in the device of STANELY due to the advantage they offer in forcing the device parts together (ROBOLE abstract, paragraphs 0120-0122 & 0048-0052) and due to the advantage the axis/122 offers for rotating the device (paragraph 0060).
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With respect to Claim 2, STANELY teaches of one chamber being an amplification chamber (abstract).
ROBOLE teaches of the cartridge having a microfluidic channel and chamber structure is formed (see the chambers (154) which are connected to the thermal chambers (152) by means of multiple process channels (paragraph 0028), which also has a covering body (the annular covering body, 160 in figures 1-2 that covers and surrounds all the thermal chamber 152), wherein the process chambers are amplification chambers (paragraph 0020, and “”for,” rotating sample processing devices to, “amplify genetic materials,” as claimed, paragraph 0001).
With respect to Claim 3, STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075). This reads on the claimed “substantially completely,” through broadest reasonable interpretation.
ROBOLE further teaches of a covering body (the annular covering body, 160 in figures 1-2 that covers and surrounds all the thermal chamber 152), which is fastened to the main body, is located on one side on a main body upper face facing away from a heat-input side, and covers all the thermal chambers (152) (See item 160 on Figures 1-2). This can be considered to cover the top side of the main body “substantially completely,” through broadest reasonable interpretation. Also, ROBOLE teaches of a lid on a housing of the overall device (104 on Figure 4), which can also be considered to “substantially completely,” cover the top side of the main body 150 (See Figure 4).
With respect to Claim 4, STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075). This reads on the claimed “frame web” through broadest reasonable interpretation.
ROBOLE teaches of the cover body, 100 having a frame “web,” (the 4 sides of the cover 160) which projects in a direction of said top side of the main body 150 and forms a frame around at least one chamber cover by the cover body 100. See on Figure 2, where 100 covers chambers 152 (See figure 1 & 2). Though the frame itself is not specifically around each individual chamber, this can be considered a “frame,” “web,” though broadest reasonable interpretation and the frame encompasses within it an array of interconnected microchannels which resembles a web.
With respect to Claim 5, STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075). This reads on the claimed “frame web” “at a slight spacing distance,” through broadest reasonable interpretation.
ROBOLE teaches of the cover body, 100 having a frame “web,” which projects in a direction of said top side of the main body 150 and forms a frame around at least one chamber cover by the cover body 100. See on Figure 2, where 100 covers all of the chambers 152 (See figure 1 & 2). Though the frame itself is not specifically around each individual chamber, this can be considered a “frame,” “web,” though broadest reasonable interpretation and the frame encompasses within it an array of interconnected microchannels which resembles a web. As shown in Figures 1 & 2—the frame (160), in an “operational,” orientation as shown in Figures 1-4, the frame (the 4 sides of cover 160,) lie on the main body (See figure 2, 160 and its 4 sides is directly on top of 150).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the positioning and fastening elements to force small distance as is done in ROBOLE in the device of STANELY due to the advantage they offer in forcing the device parts together (ROBOLE abstract, paragraphs 0120-0122 & 0048-0052).
With respect to Claim 6, STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075). This reads on the claimed “frame web” through broadest reasonable interpretation. STANELY does not call out the exact distance claimed though.
ROBOLE teaches that the cover plate 160 and base plate 110 are brought together with the main plate body 150 in between and that they are brought together in a way in which plate 150 is compressed or deformed (paragraph 0032). This means that there is 0 mm distance between the cover 160 and main plate body 150, which reads on “spacing distance is less than .5 millimeter,” as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the positioning and fastening elements to force small distance as is done in ROBOLE in the device of STANELY due to the advantage they offer in forcing the device parts together (ROBOLE abstract, paragraphs 0120-0122 & 0048-0052).
With respect to Claim 7, STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075). This reads on the claimed “frame web” through broadest reasonable interpretation. STANELY does not call out the exact distance claimed though.
ROBOLE teaches that the cover plate 160 and base plate 110 are brought together with the main plate body 150 in between and that they are brought together in a way in which plate 150 is compressed or deformed (paragraph 0032). This means that there is 0 mm distance between the cover 160 and main plate body 150, which reads on “spacing distance is smaller than or equal to 0.1 millimeter,” as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the positioning and fastening elements to force small distance as is done in ROBOLE in the device of STANELY due to the advantage they offer in forcing the device parts together (ROBOLE abstract, paragraphs 0120-0122 & 0048-0052).
With respect to Claim 8, ROBOLE teaches of the cover body, 100 having a frame “web,” which projects in a direction of said top side of the main body 150 and forms a frame around at least one chamber cover by the cover body 100 (it forms a frame around all of the chambers, 152) (See Figures 2 & 1). The chambers 152 projects upwardly in a raised manner from the top of the main body 150(See figure 1), since the word “chamber,” indicates a closed space having walls, and the walls need to be upward or raised from a surface. Though the frame itself is not specifically around each individual chamber, this can be considered a “frame,” “web,” though broadest reasonable interpretation and the frame encompasses within it an array of interconnected microchannels which resembles a web and “overlaps,” all of the chambers 152. As shown in Figures 1 & 2—the frame (160), the frame (the 4 sides of cover 160,) lie on the main body (See figure 2, 160 and its 4 sides is directly on top of 150).
With respect to Claim 9, STANLEY is used to remedy this and teaches of a cover sheet (which functions as the cover body in STANLEY) (paragraph 0040). STANLEY further teaches of the cover body being a transparent thermally fusible plastic (paragraph 0040).
With respect to Claim 10, STANLEY is used to remedy this and teaches of a cover sheet (which functions as the cover body in STANLEY) (paragraph 0040). STANLEY further teaches of the cover body being a transparent thermally fusible plastic (thermoplastic) (paragraph 0040).
With respect to Claim 11, STANLEY is used to remedy this and teaches of the rotatable platform being made of thermoplastic (which functions as the main body & substrate in STANLEY) (paragraph 0040).
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive.
The prior claim objections have bee overcome due to amendments made 02/04/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references as used in the order applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically with respect to the prior art and amendments made 02/04/2026, applicant argues the ROBOLE reference does not teach of the seal being on the “heat input side,” nor does ROBOLE teach of the “cover body…fastened to the cartridge at a planar main body,” as required by the instant claims. Further applicant argues that the instant device functions to “improve heat transfer.” With respect to this last point, the examiner notes, that improving heat transfer is a function of the device, and therefore is not limiting in the claims.
Further, the examiner notes that the “heat input side,” as claimed can be broadly interpreted, and can be any side where heat is shown to travel to. As shown above, in STANELY, heat melts the wax seal, so this can be consider the “heat input side,” as not heater positioning itself is actually claimed.
Specifically, STANELY teaches of using wax valves which seals off the channels preventing flow there-though and then when it is heated up and melts thereby permitting flow through the channels. Also, melting the wax creates a surface seal/seal layer on the fluid since the wax is of typically lower density than the fluid (paragraph 0037, 0069).
Further, with respect to the claimed “cover body fastened to said planar main body,” as instantly claimed:
STANLEY teaches that the device in which the compartments/ chambers are in contains a raised upper edge for sealing, “fastening,” engagement with a cover sheet (which reads on the instantly claimed, “cover body,” – which is one-sidedly arranged at a top side of a planar main body, and which again since all objects have two sides can be considered to “face away,” from a “heat input side,” through broadest reasonable interpretation (paragraph 0040, 0075).
More specific to the base being connected through a support and fastening elements to an analyzer (the analyzer is not positively recited), ROBLE teaches that the device from Figure 1 is inserted into analyzer in Figure 3 (See paragraphs 0057-0061), and it connects to the analyzer through the rotation axis, 111, which can be considered a fastener of the base to the analyzer through broadest reasonable interpretation.
Therefore, the combination of STANELY in view of ROBOLE read on the instant claims. All claims remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
PEYTAVI in US 20130344496. PEYTAVI teaches of a fluidic centripetal apparatus for testing components of a biological material in a fluid is presented. A bottom-fillable chamber is coupled to an entry channel for receiving the fluid, the chamber inlet being provided at an outer side of the bottom-fillable chamber. A container is wholly provided in a retention chamber and contains a liquid diluent, until it releases it upon application of an external force, restoring the fluidic connection between the liquid diluent and the fluid in the retention chamber. The retention chamber can have a flow decoupling receptacle for receiving the fluid, located at the outer side of the retention chamber and interrupting a fluidic connection between the entry and exit of the retention chamber. A test apparatus and a testing method using a fluidic centripetal device for testing components of a biological material in a fluid are also provided (abstract).
PEYTAVI further teaches of the system being rotatable (paragraph 0010, 0023), the device using a chamber and channel structure (paragraph 0015), attaching a resistive heater to one side of the substrate in the device (paragraph 0013, Claim 12), of the device being made of thermoplastic (paragraph 0057), and of having a lid/cover (paragraph 0109, 0112, 0227), of being used for PCR (paragraph 0207, 0208, 0296).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel, can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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