DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendment filed on 10/13/2025 has been entered. Claims 1-17 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the non-final Office Action mailed 7/16/2025.
Claim Rejections - 35 USC § 102
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 4 and 6-16 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by United States Application Publication No. 2003/0047688, hereinafter Faris.
Regarding claim 1, Faris teaches a method for designing a substrate with a plurality of reaction sites, the method comprising: coating a surface of the substrate and a surface of each reaction site of the plurality of reaction sites with a coating material (paragraph [0076]); determining an advancing water contact angle and a receding water contact angle of a liquid sample with the coating material (paragraph [0045]); determining a water contact angle for the liquid sample with the coating material (paragraph [0044]); and if a hysteresis is within 15 degrees (paragraph [0045]), loading the sample into the plurality of reaction sites (paragraph [0072]), wherein the hysteresis is the difference between the advancing water contact angle and the receding water contact angle (paragraph [0045]).
Regarding claim 4, Faris teaches wherein the coating material configures the surface of the substrate and the surface of each of the reaction site to have the same hydrophilicity (paragraph [0043]).
Regarding claim 6, Faris teaches wherein the surface of the substrate and the surface of each reaction site is coated by a vapor deposition process (paragraph [0076]).
Regarding claim 7, Faris teaches wherein the coating material results in a hydrophilicity to generate a sufficient surface tension force to substantially confine the liquid sample within each loaded reaction site (figure 1A).
Regarding claim 8, Faris teaches wherein a dimension of each reaction site is selected based on a volume of sample loaded into each reaction site by capillary action (figure 1A).
Regarding claim 9, Faris teaches wherein the substrate with the plurality of reaction sites is configured for undergoing an amplification reaction of the liquid sample (paragraph [0086]).
Regarding claim 10, Faris teaches wherein the advancing water contact angle and the water contact angle facilitates loading of the liquid sample into the plurality of reaction sites (paragraph [0045]).
Regarding claim 11, Faris teaches wherein the advancing water contact angle and the water contact angle minimizes pooling of the liquid sample on the substrate (paragraph [0045]).
Regarding claim 12, Faris teaches wherein the coating material minimizes adsorption of biological reaction chemicals and components (paragraph [0045]).
Regarding claim 13, Faris teaches wherein the coating material is biocompatible (paragraph [0067]).
Regarding claim 14, Faris teaches selecting a geometry of the plurality of reaction sites to provide sufficient surface tension to substantially confine the liquid sample within each loaded reaction site (figure 1A).
Regarding claim 15, Faris teaches wherein the selected geometry of the plurality of reaction sites minimizes cross-talk between the plurality of reaction sites (figure 1A).
Regarding claim 16, Faris teaches wherein the surface of the substrate and the surface of each reaction site is by a liquid coating process (paragraph [0076]).
Claim Rejections - 35 USC § 103
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 2, 3 and 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Faris in view of United States Application Publication No. 2010/0285573, hereinafter Leck.
Regarding claim 2, Faris teaches all limitations of claim 1; however, Faris fails to teach the advancing water contact angle is 70-85 degrees.
Leck teaches an apparatus for processing samples within a droplet with a hydrophobic coating which can be hexamethyldisilazane (Leek, paragraph [0097]).
Examiner further finds that the prior art contained a device/method/product (i.e., a hexamethyldisilazane coating) which differed from the claimed device by the substitution of component(s) (i.e., 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating) with other component(s) (i.e., hexamethyldisilazane), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating with hexamethyldisilazane), and the results of the substitution (i.e., hydrophobicity of the surface) would have been 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 substitute a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating of reference Faris with a hexamethyldisilazane coating of reference Leck, since the result would have been predictable.
Regarding the limitations of the advancing water contact angle, while modified Faris does not address the advancing water contact angle, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, a coating material of hexamethyldisilazane has been established and is the same coating material disclosed in the specification for providing the given water contact angles. Absent persuasive evidence that the coating composition is different, the prior art is considered to have the same properties with respect to the advancing water contact angles as that is claimed. MPEP § 2112.01 (I-IV).
If it is determined that the advancing water contact angle of 70-85 degrees is not considered to be a property of the structure as that is claimed. The courts have held that the use of optimum or workable ranges discovered by routine experimentation is ordinarily within the skill of the art. Furthermore, the MPEP states (MPEP 2144.05) that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made, to determine, through routine experimentation, the claimed optimum advancing water contact, which would allow the sample to enter the reaction sites.
Regarding claim 3, Faris teaches all limitations of claim 1; however, Faris fails to teach the water contact angle is 60-100 degrees.
Leck teaches an apparatus for processing samples within a droplet with a hydrophobic coating which can be hexamethyldisilazane (Leek, paragraph [0097]).
Examiner further finds that the prior art contained a device/method/product (i.e., a hexamethyldisilazane coating) which differed from the claimed device by the substitution of component(s) (i.e., 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating) with other component(s) (i.e., hexamethyldisilazane), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating with hexamethyldisilazane), and the results of the substitution (i.e., hydrophobicity of the surface) would have been 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 substitute a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating of reference Faris with a hexamethyldisilazane coating of reference Leck, since the result would have been predictable.
Regarding the limitations of the water contact angle, while modified Faris does not address the water contact angle, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, a coating material of hexamethyldisilazane has been established and is the same coating material disclosed in the specification for providing the given water contact angles. Absent persuasive evidence that the coating composition is different, the prior art is considered to have the same properties with respect to the water contact angles as that is claimed. MPEP § 2112.01 (I-IV).
If it is determined that the water contact angle of 60-100 degrees is not considered to be a property of the structure as that is claimed. The courts have held that the use of optimum or workable ranges discovered by routine experimentation is ordinarily within the skill of the art. Furthermore, the MPEP states (MPEP 2144.05) that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made, to determine, through routine experimentation, the claimed optimum water contact, which would allow the sample to enter the reaction sites.
Regarding claim 5, Faris teaches all limitations of claim 1; however, Faris fails to teach the coating material is hexamethyldisilazane.
Leck teaches an apparatus for processing samples within a droplet with a hydrophobic coating which can be hexamethyldisilazane (Leek, paragraph [0097]).
Examiner further finds that the prior art contained a device/method/product (i.e., a hexamethyldisilazane coating) which differed from the claimed device by the substitution of component(s) (i.e., 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating) with other component(s) (i.e., hexamethyldisilazane), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating with hexamethyldisilazane), and the results of the substitution (i.e., hydrophobicity of the surface) would have been 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 substitute a 1H, 1H, 2H, 2H-perfluorodecyltrichlorosilane coating of reference Faris with a hexamethyldisilazane coating of reference Leck, since the result would have been predictable.
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Faris in view of United States Application Publication No. 2006/0228722, hereinafter Kim
Regarding claim 17, Faris teaches all limitations of claim 15; however, Faris fails to teach the geometry is hexagonal shape.
Kim teaches a microwell array in which the reaction chambers can be round or hexagonal (Kim, paragraph [0141]).
Examiner further finds that the prior art contained a device/method/product (i.e., hexagonal geometry) which differed from the claimed device by the substitution of component(s) (i.e., round geometry) with other component(s) (i.e., hexagonal geometry), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., round with hexagonal geometry), and the results of the substitution (i.e., holding a volume of liquid) would have been 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 substitute a round geometry of reference Faris with a hexagonal geometry of reference Kim, since the result would have been predictable.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Faris fails to teach if a hysteresis is within 15 degrees, loading the sample into the plurality of reaction sites, wherein the hysteresis is the difference between the advancing water contact angle and the receding water contact angle is not found persuasive. Faris teaches in paragraph [0045] that the contact angle hysteresis is preferable less than 2 degrees on the surface of the fluid-transporting surface and in paragraph [0072] moving a droplet around on the fluid-transporting surface to any well on the substrate. This teaching is teaching that the hysteresis is less than 15 degrees and with the specified hysteresis the droplet is moved around on the fluid-transporting surface which is considered to be loading the liquid sample as claimed. Additionally, the examiner notes that this limitation is written as a contingent limitation and if the hysteresis is not met, then the claim would not require the loading of the liquid sample and therefore only require determining the specified contact angles.
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