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 1-12 and 20-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over United States Application Publication No. 2005/0221358, hereinafter Carrillo in view of United States Application Publication No. 2002/0164820, hereinafter Brown and United States Application Publication No. 2010/0285573, hereinafter Leck.
Regarding claim 1, Carrillo teaches a system (figure 160) for performing biological reactions, the system comprising: a chip (item 408) including a plurality of reaction sites (item 26), wherein the plurality of reaction sites are each configured to include a liquid sample (intended use MPEP § 2114 (II)), a loading system (item 1800) to load the liquid sample into the plurality of reaction sites (paragraph [0472]); a control system (item 982) configured to initiate biological reactions in the liquid samples (paragraph [0198]); and a detection system configured to detect biological reactions on the chip (paragraph [0198]).
Carrillo further teaches wherein the multi-well plate comprise more than 30,000 reactions (Table 1) and further performing an assay within the reaction sites and detecting with an optical system (paragraphs [0748]-[0749]) along with the chip being made from one material (figure 160)
Carrillo fails to teach the reaction sites are each configured to include a liquid sample of at most one nanoliter.
Brown teaches a multi-well reaction plate comprising 100,000 chambers of 100 pl volumes to provide multiplex assays at high density (Brown, paragraphs [0076]-[0081]).
Examiner further finds that the prior art contained a device/method/product (i.e., reactions sites which hold 1 pl) which differed from the claimed device by the substitution of component(s) (i.e., reaction sites that hold more than 1 nanoliter) with other component(s) (i.e., reaction sites which hold 100 pl), 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., reaction sites which hold more than 1 nanoliter with reaction sites which hold 1 pl), and the results of the substitution (i.e., holding the sample) 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 reaction sites with volumes greater than 1 nanoliter of reference Carrillo with reaction sites of 100 pl of reference Brown, since the result would have been predictable.
Carrillo and Brown fail to teach wherein the chip is coated with a coating material, and wherein the coating material is configured to have a water contact angle and advancing contact angle to facilitate loading the liquid sample into the plurality of reaction sites.
Leck teaches an apparatus in which a coating of hexamethyldisilazane is applied to the surface so that a hydrophobic surface can be rendered for hydrophilic (paragraph [0097]) so that the surface can have the desired surface energy (Leck, paragraph [0087]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have coated all of the surface of the chip in hexamethyldisilazane because it would render the surface hydrophilic so that the surface can have the desired surface energy (Leck, paragraph [0087]).
Regarding claim 2, Carrillo teaches wherein the chip includes at least 20000 reaction sites (Table 1).
Regarding claim 3, Carrillo teaches wherein the chip includes at least 30000 reaction sites (Table 1).
Regarding claim 4, Carrillo teaches wherein each reaction site of the plurality of reaction sites is a through-hole (paragraphs [0220]-[0222]).
Regarding claim 5, Carrillo teaches wherein each reaction site of the plurality of reaction sites is a well (figure 160).
Regarding claim 6, Carrillo teaches wherein he control system is configured to calculate a polymerase chain reaction (PCR) result (paragraph [0657]).
Regarding claim 7, Carrillo teaches wherein the control system is configured to calculate a digital PCR result (paragraphs [0702]-[0723]).
Regarding claim 8, Carrillo teaches wherein the detection system includes an optical system, wherein the optical system includes an excitation source and an optical sensor configured to detect fluorescent signals emitted from a plurality of liquid samples within the plurality of reaction sites (paragraphs [0748]-[0749]).
Regarding claim 9, modified Carrillo teaches wherein a surface of the reaction sites are hydrophilic (see supra).
Regarding claim 10, modified Carrillo teaches wherein a surface of the substrate is hydrophilic (see supra).
Regarding claim 11, 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 Carrillo and Brown and the apparatus of modified Carrillo is capable of having the chip be enclosed in a carrier. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Carrillo (see MPEP §2114).
Regarding claim 12, Carrillo teaches wherein the plurality of reaction sites include a range of volumes to increase dynamic range (paragraphs [0705], [0736] and [0737]).
Regarding claim 20, while Carrillo, Brown and Leck does not address the water contact angle being 60-100 degrees and the advancing contact angle being 70-85 degrees, 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, the same coating material is utilized. Absent persuasive evidence that the coating materials are different, the prior art is considered to have the same properties with respect to the water contact angle and advancing contact angle as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 21, Carrillo teaches wherein the biological reactions is a polymerase chain reaction (PCR) (paragraph [0657]).
Regarding claim 22, Carrillo teaches wherein the loading system comprises a loader (item 1800) comprising a tip (items 1840 and 1844) including a first blade (item 1844) and a second blade (item 1840), wherein a reservoir is formed between the first blade and the second blade (figure 160), wherein the tip is in fluid communication with the reservoir (figure 160).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carrillo, Brown and Leck as applied to claim 1 above, and further in view of United States Application Publication No. 2007/0081163, hereinafter Liang.
Regarding claim 14, Carrillo, Brown and Leck teach all limitations of claim 1; however, they fail to teach the optical system has a focal length of 15 mm.
Liang teaches a device with collection optics which may be varied to keep the system in focus (Liang, paragraph [0043]).
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 focal length to a range of 15 mm which would allow for the device to remain in focus (Liang, paragraph [0043]) (MPEP § 2144.05 (II)).
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that implementing the Examiner’s combination would have required undue experimentation and fundamental redesign of features of Carrillo is not found persuasive. The physical size of the reaction sites of Carrillo would not have to be modified in order for the amount of fluid to be contained in the reaction sites to be smaller. The claim is currently written that the plurality of reaction sites are each configured to include a liquid sample of at most one nanoliter. The prior art of Carrillo modified by Brown would be capable of holding a liquid sample which is at most one nanoliter as long as the reaction site has a volume which is larger. In this case, the reaction site volume of Carrillo modified by Brown would have a reaction site volume which is in the order of 100 nl and this volume of reaction site would be able to hold a liquid sample which is at most 1 nl.
Conclusion
THIS ACTION IS MADE FINAL. 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