DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of the apparatus claims 1-9, made with traverse in the reply filed on 10/01/2025, has been acknowledged. Applicant declares, without providing any evidence, that, allegedly, the Office has failed to show the undue burden, as required.
Examiner strongly disagrees. First, the prior Office action clearly demonstrated that the inventions recited in the apparatus claims 1-9 are classified in class and subclasses that are different from those in which the inventions recited in the method claims
10-14 are classified. Second, the action additionally explained that there would be a serious search and examination burden if the election was not required, since the examination of each of the inventions at issue would require a respective separate, extensive and non-overlapping search involving a different search strategy and reasoning, which would undoubtedly present a significant and undue search and examination burden. Thus, the action properly and sufficiently established the undue burden, in accordance with the traditional practice of the Office. Therefore, claims 10-14 have been withdrawn from further consideration under 37 CFR 1.142(b), as being drawn to the non-elected inventions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
With respect to claim 1, it is unclear from the claim language what structural features must provide for positioning the cover member and the substrate with the array of wells in the manner recited [that is, such as to form the space which further ‘forms a flow path’]. It is further unclear how the ‘space’ must be structurally inter-related with the ‘flow path’. Moreover, it is not clear how the ‘wells including a well A and a well B closest to the well A’ must be structurally inter-related to the ‘plurality of regularly arranged wells’ as recited in the preceding lines. Furthermore, it is not clear from the instant claim language whether or not, in the recited formula condition, the ‘Da/Dab’ ratio refers only to the selected pair of wells [A and B], or to all pairs of the closest wells in the ‘plurality’ of wells. Additionally, the recitations directed to the ‘openings’ of the wells, as well as to the associated ‘centroids’, are indefinite because, while the instant claim language covers various sizes of the ‘same’ unspecified well shape, a well opening's centroid can be represented by a line if the opening has a curved or complex shape, and, therefore, there can be an infinite number of various distances between the same centroids of the respective opening in the wells A and B, as recited. Moreover, it is not clear whether or not the recitation, of the ‘circle having a same area as the opening of the well A’ means that the opening must be two-dimensional rather than three-dimensional.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) 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 of this title, 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.
. Claims 1-9 are rejected under 35 U.S.C. 103 (a) as being unpatentable over
MAHER, US 20150045252, in view of PFOST et al., US 6485690.
With respect to claims 1, 3 and 7, MAHER, discloses a fluidic device comprising, as shown in Figure 3, substrate 102, 100 having a well array that includes a plurality of regularly arranged wells 104 that have the same shape and are open to at least two surfaces of the substrate, where the diameters of the well openings and spacing between the wells appear to satisfy the ratio condition as recited in the formula.
While MAHER does not teach the cover member configured as recited, such covers are routinely employed in the art, see, for example, Figure 23 of PFOST et al., showing cover member 62 and substrate 66 with a well array, arranged to have a flow/path / space 64, 68, in-between. It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of MAHER by having employed such cover member, to have additional capabilities to load or unload the wells, if needed, depending on particular goals of testing and to diversify the tests to be performed. It would have been also obvious to have varied the well diameters and spacings between the wells within a wide range of values and proportions, including those recited, in order to optimize distribution of liquid reagents or solutions used for testing, depending on particular goals and to diversify the tests to be conducted, in view of the MAHER’s considerations in [0040], where MACHER explains that the reaction site [i.e., well] density, associated with the ratio condition, may be optimized, for example, by ‘reducing ratio of the value of the spacing between adjacent well to the value of the well diameter’, to optimize the amount of solution so that ‘an initial solution or sample containing biological components of interest is located inside reaction sites 104’.
Regarding claim 2, MAHER further explains in [0046] that the diameters of wells 104 is ‘less than or equal to 20 micrometers, less than or equal to 10 micrometers, less than or equal to 1 micrometer, or less than or equal to 100 nanometers. The pitch between reaction sites [‘wells’-Ex.] may be less than 125 micrometers, for example, less than or equal to 100 micrometers, less than or equal to 30 micrometers, less than or equal to 10 micrometers, or less than or equal to 1 micrometer.’
Regarding claims 4-6, MAHER further discloses in paragraph [0047] the volumes of the wells that ‘may be less than 1.3 nanoliters, for example, by decreasing the diameter of reaction sites 104 and/or the thickness of substrate 102. For example, each reaction site 104 may have a volume that is less than or equal to 1 nanoliter, less than or equal to 100 pico-liters, less than or equal to 30 pico-liters, or less than or equal to 10 pico-liters. In other embodiments, the volume some or all of the reaction site 104 is in a range from 1 nanoliter to 20 nanoliters’., which can provide for the total volume as intended in the instant claims.
Additionally, regarding claim 7, MAHER further explains in paragraph [0047] that the substrate can have a thickness [and, therefore, a well depth] of ‘ about 300 micrometer, so that each reaction site 104 has a volume of about 1.3 nanoliters’, which can satisfy the ratio as recited.
As to claims 8-9, MAHER also explains in [0039], [0041], that the substrate assembly can be made of hydrophobic materials Therefore, the water contact angles of the surfaces in question must meet the requirement of the instant claims.
It is further noted that the features not positively recited as part of the claimed invention such as the flow path / space, including all associated details, are not accorded patentable weight when evaluated for patentability.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims, as well as any structural detail that is essential for a proper understanding of the disclosed invention. Therefore, the circle having the same area but different from the opening of the well A, as recited, must be clearly illustrated and properly referenced as such, or the feature(s) canceled from the claim(s).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Natalia Levkovich whose telephone number is (571)272-2462. The examiner can normally be reached on Monday-Friday, 2.00 pm-10:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill A Warden can be reached on 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIA LEVKOVICH/Primary Examiner, Art Unit 1798