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 .
Response to Amendment
The Amendment filed on 9/11/2025 has been entered. Claims 1, 3-5 and 9-18 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(a) and 112(b) rejection previously set forth in the non-final Office Action mailed 6/18/2025.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1, last line “substrates” should read “substrate”
Claim 5, line 3 “an” should read “a”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 9, 10, 17 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation regarding the first substrate includes a side surface having a non-90 degree gradient does not have support in the specification as filed. Figures 2A, 4A and 5 do provide support for the limitation that it is a non-90 degree gradient. It can be seen from these figures that it appears that the side surface is at some angle, however, the figures do not provide support for having the angle as a non-90 degree angle as the scope of this limitation is broader than what is shown in the figures. The written specification only refers to this side as having a gradient, and that the angle is between 1 and 5 degrees. A 90 degree angle is interpreted to be an infinite slope/incline angle and as such this infinite slope is considered to be a gradient. With a 90 degree angle being interpreted as being a gradient, the specification doesn’t provide support for the angle not to be 90 degrees as claimed.
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.
Claim(s) 1, 5, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2003/0157503, hereinafter McGarry in view of United States Application Publication No. 2009/0266421, hereinafter Linder
Regarding claim 1, McGarry teaches a microchip (item 10) comprising: a bonded substrate (paragraph [0115]) that includes a plurality of substrates (items 11 and 16), each of the substrates having a main surface (the surfaces of items 11 and 16 which face each and have item 15 on) and a side surface (the sides of items 11 and 16), the main surfaces being at least partially bonded with each other (paragraph [0115] and figure 1); and a microchannel located inside the bonded substrate (paragraph [0107]), wherein the bonded substrate is composed of a first substrate (item 11) with a large thickness and a second substrate (item 16) with a smaller thickness than the first substrate (figure 1), and at least the first substrate includes a side surface having a gradient and extending to an outermost side of the bonded substrate when one end of the bonded substrate is viewed from a direction parallel to the main surface (figure 1), the second substrate has a side surface, wherein when the longitudinal side surface and/or the transverse side surface of the bonded substrate is viewed from a direction parallel to the main surfaces, the first substrate includes non-bonded regions at ends of the main surface, the non-bonded regions are areas where the first substrate is not bonded to the second substrates (figure 1, there is a portion of item 11 not bonded to item 16 on the sides).
McGarry fails to teach the first substrate includes side surface having a non-90 degree gradient.
Linder teaches a microfluidic system in which some or all of the features to be replicated in plastic have a non-zero draft angle (specifically 1 to 10 degrees (paragraph [0129])) to allow demolding of the replica from the molding tool (Linder, paragraph [0126]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the side surface of the first substrate to have a non-90 degree gradient (1 to 10 degrees) because it would allow for the demolding of the replica from the molding tool (Linder, paragraph [0126]).
Regarding claim 5, McGarry teaches wherein the main surface of the first substrate is bonded to the second substrate (figure 1), a first outermost portion of one side surface of the first substrate is located on the main surface and extending over the second substrate when one end of the bonded substrate is viewed from a direction parallel to the main surface (figure 1); and the second substrate is bonded to the first substrate and includes a second outermost portion of one side surface of the second substrate, the second outermost portion is located on the main surface when one end of the bonded substrate is viewed from a direction parallel to the main surface (figure 1).
Regarding claim 17, modified McGarry teaches wherein the non-90 degree gradient angle between a direction along the side surface and a thickness direction (figure 1).
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of non-90 degree gradient angle in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 18, McGarry and Linder teaches all limitations of claim 1; however, McGarry is silent at to the width of the non-bonded region in the transvers direction.
McGarry further teaches that the reaction volume is defined the by the substrate, the adhesive layer and the flexible layer (paragraph [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum width of the non-bonded region in the transverse direction to a range of 0.05 to 0.5 mm which would allow for the desired amount of reaction volume between the substrate, adhesive layer and flexible layer (MPEP § 2144.05 (II)).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGarry and Linder as applied to claim 1 above, and further in view of United States Application Publication No. 2007/0243603, hereinafter Einsle.
Regarding claims 9 and 10, McGarry and Linder teach all limitations of claim 1; however, they fail to teach wherein when one of corners of the bonded substrate is viewed from a direction orthogonal to the main surface of the bonded substrate, the corner of the remaining substrate exhibits a chamfered shape and the corner of the first substrate is located from the center of gravity of the bonded substrate farther than the corner of the remaining substrate and wherein at least the one corner of the first substrate exhibits an arc-shaped chamfered shape and the corner of at least one substrate constituting the remaining substrate exhibits a line shape or a polyline shape when one of the corners of the bonded substrate is viewed from a direction orthogonal to the main surface of the bonded substrate.
Einsle teaches a device with channels (Einsle, paragraph [0076]) in which the base is rectangular in design and has rounded corners (Einsle, paragraph [0053]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., rounded corners), and that in combination, each element merely would have performed the same function as it did separately (i.e., being the structure of the device), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine corners of reference McGarry with the rounded corners of reference Einsle, since the result would have been predictable.
Response to Arguments
Applicant's arguments filed 9/11/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the non-90 degree gradient is supported by the original disclosure is not found persuasive. Figures 2A, 4A and 5 do provide support for the limitation that it is a non-90 degree gradient. It can be seen from these figures that it appears that the side surface is at some angle, however, the figures do not provide support for having the angle as a non-90 degree angle as the scope of this limitation is broader than what is shown in the figures. The written specification only refers to this side as having a gradient, and that the angle is between 1 and 5 degrees. A 90 degree angle is interpreted to be an infinite slope/incline angle and as such this infinite slope is considered to be a gradient. With a 90 degree angle being interpreted as being a gradient, the specification doesn’t provide support for the angle not to be 90 degrees as claimed.
Applicant’s arguments, see page 12, filed 9/11/2025, with respect to the rejection(s) of claim(s) 1 and 5 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McGarry and Linder.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796