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 Invention 1 [claims 1-12] made with traverse in the reply filed on 09/19/2025, has been acknowledged. Applicants argue that the prior restriction requirement is, allegedly, improper. In particular, the applicants, on the one hand, admit that “Wheeler may depict all the geometric elements the Office lists: array, first/second inlets and chambers, an island structure in the second chamber, and a third inlet above it” [the applicants’ admission having been noted by the examiner], on the other hand, applicants state that the functionality intended by the instant claims, “is not disclosed in Wheeler” because “Wheeler’s “island” is not used for storing or releasing an antibiotic, nor does Wheeler disclose …controlled diffusion into a gelled first fluid”.
The examiner disagrees and notes that, first, the same structure [as admitted by the applicants] is clearly capable to function as intended by the instant claims. Second, intended functionality does not have patentable moments in the claims to apparatus.
Clearly, Wheeler does disclose the same structure as the technical feature shared by the instant inventions as recited. Therefore, the unity of invention is lacking.
Accordingly, the method claims 13-14 have been withdrawn from further consideration under 37 CFR 1.142(b), as being drawn to the non-elected inventions.
Claim Objections
. Claims 1-12 are objected to as being in improper format. In particular, while the claims recite many structural elements, no line indentations are provided in the text, which creates additional difficulties for proper understanding of the claimed invention. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate sub-combinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p). Correction is required.
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 1-12 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 how the plurality of the ‘well units’ can be arranged as recited, in the absence of any supporting base [disclosed in the specification as ‘commercial multi-well plate]. It is further unclear
what structural features must configure the ‘accommodation spaces’ and the ‘island / island-connecting’ structures for the intended functionality as recited.
In claim 2, it is unclear what is meant by the ‘center’ of the ‘accommodation space’ of unspecified shape.
In claim 3, ‘the lower end of the island structure’, as well as ‘the bottom surface of the second accommodation space’, lack antecedent basis.
In claim 4, it is unclear how the intended functionality as recited, can further limit the structure of the preceding claim.
Referring to claim 5, it is unclear how the dimensions of the accommodation space can be defined relative to unspecified volume of unspecified fluid. Note that capillary forces depend on many factors [including the nature of solid and fluid materials involved, temperature, pressure, geometry, et cetera] not defined by the claim language
In claim 7, it is not clear what is meant by the ‘side surface’ of the second accommodation space.
In claim 11, ‘the rear surface’ lacks antecedent basis.
. Note that it is applicants’ responsibility to locate and correct all in stances of the raised issues in other claims as well.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wheeler et al., [US 20100234674].
With respect to claims 1, 4 and 8-12, Wheeler discloses a cell culture test device comprising, as shown in Figures 3-4, a multi-well format test plate accommodating an array of aligned well units each having first inlet portion 36; a second inlet portion 38; first and second fluid accommodation spaces 32, 34 with open surfaces
; where the second accommodation space accommodates ‘island structure’ 48 [ with its’ center coinciding with the center of the accommodation space 34]; and a third inlet portion 50. It is further noted that the features not positively recited as part of the claimed invention [such as the ‘fluids’, the ‘antibiotic’, the ‘island’ / ‘island-connecting’ structures, or the ‘capillary valve, including all associated details], are not accorded patentable weight when evaluated for patentability. Further note that functional features recited within the context of intended use, are given patentable weight only to the extent they effect the structure of the invention. Additionally, the inclusion of the material or article worked upon by a structure [i.e., in this case, the fluids, or antibiotic] being claimed does not impart patentability to the claims.
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 center of the island structure that coincides with the center of the first accommodation space; the island structure that is spaced as recited; the distance as recited; the lower end of the island structure; the bottom surface of the second accommodation space; the rear surface; thickness and width of the first accommodation space; the capillary valve and the side surface of the second accommodation space is in communication with the inner surface of the first accommodation spaces, must be clearly shown and properly referenced as such, or the feature(s) canceled from the claim(s). Additionally, the drawings include two figures marked as ‘Figure 1-b’. Many drawings[i.e., figures 1-c, 3, 4 a-b, 5 a-d, 6, 7, 8 a-b, 9-11] do not include any reference characters whatsoever. Moreover, many drawings fail to clearly and distinctly show the boundaries of the claimed components Formal drawings are requested. Correction is required. No new matter should be entered.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIA LEVKOVICH/Primary Examiner, Art Unit 1798
Prosecution Insights