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 .
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.
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-13, in the reply filed on 11/20/2025 is acknowledged. The traversal is on the ground(s) that the reference of Nelson (US 5089413) does not disclose the special technical feature required of claim 1 (pages 6-7 of Applicants’ response dated 11/20/2025). This is not found persuasive because, as evidenced by the prior art rejection below of claim 1, the invention of claim 1 is not considered to be a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/20/2025.
Information Disclosure Statement
The references cited in the PCT international search report by the EPO have been considered, but will not be listed on any patent resulting from this application because they were not provided on a separate list in compliance with 37 CFR 1.98(a)(1). In order to have the references printed on such resulting patent, a separate listing, preferably on a PTO/SB/08 form, must be filed within the set period for reply to this Office action.
Claim Objections
Claims 1, 2 and 6-8 are objected to because of the following informalities:
In claim 1, at line 6, it appears that “coversheet” should be “cover sheet” in view of the previous cited claim language in claim 1. The same holds true for claims 6-8.
In claim 2, bridging lines 7 and 8, it appears that “a substantially dry, gelling agent; and” should be changed to “and a substantially dry, gelling agent and” in view of the language employed in claim 1.
Appropriate correction is required.
Applicant is advised that should claim 7 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 7 and 8 appear to be identical in scope. Clarification and/or correction is requested.
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 1-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, at line 9, recitation of “the microstructured film” lacks antecedent basis. It appears that the claim should recite “the microstructured cover sheet”. Clarification and/or correction is requested.
In claim 2, bridging lines 9 and 10, recitation of “the microstructured surface of the microstructured film” lacks antecedent basis. It appears that the claim should recite “the microstructured surface of the substrate” since the alternative recited in the claim recites “on a portion of the inner-facing surface of the cover sheet”. Clarification and/or correction is requested.
In claim 5, the term “aspect ratio” is considered indefinite because it is not clear what dimensions are part of the ratio. Examination of the specification recites that the aspect ratio “can be defined as a ratio between an average longitudinal dimension (e.g., along the direction generally perpendicular to the film 310) and an average lateral dimension (e.g., along a lateral, in plane direction generally parallel to the film 310). The microstructures 314 have an aspect ratio that can be defined by H/((W1+W2)/2)”. While this is a definition of the ratio, use of the language “can be” does not limit that claim language to this specific definition. As a result, the metes and bounds of the claim cannot be clearly determined. Clarification and/or correction is requested.
Claims 6-8 are considered indefinite because they employ the alternative limitations that the microstructured surface is positioned on the cover sheet or substrate; however, claim 1 only recites that the microstructured surface is positioned on the cover sheet. It appears from the language of claims 6-8 that the microstructures could be optionally on the cover sheet. As a result, the metes and bounds of the claims cannot be clearly determined. Clarification and/or correction is requested.
Claims 3, 4 and 9-13 are indefinite because they depend from indefinite claim 1 and do not sure the deficiencies of the claim from which they depend.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al.(US 5,494,823) in view of Yasushi et al. (JP H0975063 and corresponding English language machine translation).
With respect to claims 1 and 2, the reference of Takemoto et al. discloses:
A device for growing microorganisms (Figs. 1-4), comprising:
a self-supporting, water-proof substrate (2, 32, 42) having an inner-facing surface and an outer-facing surface;
a cover sheet (35, 45) having an inner-facing surface and an outer-facing surface, the cover sheet adhered to at least a portion of the substrate;
an absorbent fibrous sheet (4) on the inner-facing surface of the substrate,; and
a substantially dry, gelling agent and a substantially dry, microbial growth nutrient composition (3, 33, 43, 43’) disposed on a portion the inner-facing surface of the coversheet or on a portion of the inner-facing surface of the substrate.
Claims 1 and 2 differ by reciting that the cover sheet or substrate include a microstructured surface, wherein the microstructured surface comprises a plurality of microstructures.
The reference of Takemoto et al. discloses that the absorbent fibrous sheet (4) provides a uniform distribution of test solution when added to the device (col. 3, line 50, to col. 4, line 16).
The reference of Yasushi et al. discloses that it is known in the art to provide a test device, which is similar to that of the reference of Takemoto et al., with a microstructured surface (5a, 5b) on the inner-facing surface of the coversheet (Fig. 3(C)) or on the inner-facing surface of the substrate (Fig. 3(B), 1(D)), wherein the microstructured surface comprises a plurality of microstructures. The reference of Yashushi et al. discloses that the microstructured surface is a water retaining layer (pages 6-8 of the translation) and functions in a similar manner as the absorbent sheet of the reference of Takemoto et al.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ the microstructured surface of the reference of Yasushi et al. in plate of the absorbent sheet of the reference of Takemoto et al. for the known and expected result of providing an alternative means recognized in the art to achieve the same result, provide uniform application of a test solution to the surface of the test device in a desired area of the surface of the deivce.
With respect to claim 3, the reference of Yasushi et al. discloses that the microstructures (5a, 5b) can be arranged in an orderly pattern on the surface of the test device (Fig. 4).
With respect to claim 4, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal pattern for the microstructured surface using routine experimentation while maintaining an area for the sample to be contained within the test device.
With respect to claim 5, while the reference of Yasushi et al. is silent with respect to the specific dimensions of the microstructures, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal dimensions through routine experimentation while maintaining the efficiency of the test device.
With respect to claim 6, the reference of Yasushi et al. discloses that the microstructured surface covers part of the inner facing surface of the cover sheet or substrate (Figs. 3(A)-1(D)).
With respect to claims 7 and 8, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal coverage of the microstructure surface through routine experimentation while maintaining the efficiency of the test device.
With respect to claim 9, the reference of Yasushi et al. discloses that the microstructured surface has a circular cross-section (Figs. 1 and 4).
With respect to claims 10 and 11, both the references of Takemoto et al. and Yasushi et al. disclose the use of a transparent cover sheet of the materials required of claim 11 (col. 4, lines 35-40, and col, 5, lines 10-12, of Takemoto et al. and page 5 of the translation of Yasushi et al.).
With respect to claim 13, in the absence of further positively recited claim language, the microstructure surface as disclosed in Fig. 3(C) of the reference of Yasushi et al. is considered to be “part” of the cover sheet or film (2).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al.(US 5,494,823) in view of Yasushi et al. (JP H0975063 and corresponding English language machine translation) taken further in view of Wickert (US 2002/0072114).
The combination of the references of Takemoto et al. and Yasushi et al. has been discussed above with respect to claim 1.
Claim 12 differs by reciting that the device includes an adhesive layer.
The reference of Wickert discloses that it is known in the art to employ an adhesive when adhering the test media to a device, which is similar to that of the reference of Takemoto et al. (¶[0032]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ an adhesive when applying the test media to the surfaces of the test device, as is evidenced by the reference of Wickert.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Kayoko (JP H08280377 and corresponding English language machine translation) is cited as prior art which pertains to a test device with an absorbent element (6).
The reference of Zook et al. (US 2012/0028297) is cited as prior art which pertains to a test device with a sampling surface that includes a textured surface (¶[0044]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB