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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 31 July 2025 is acknowledged.
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 1-7 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.
Claim 1 recites the limitation “wherein the lid is configured to provide the at least one hole over a corresponding well of the multi-well cell culture plate which contains the porous membrane insert” (emphasis added by examiner). It is not clear from the structure of this limitation whether the porous membrane insert is contained in the corresponding well, or if it is contained in the at least one hole. This ambiguity amounts to a failure to particularly point out and distinctly claim the structure of the device, rendering claim 1 indefinite. For the purposes of examination, the examiner interprets claim 1 to mean “wherein the lid is configured to provide the at least one hole over a corresponding well of the multi-well cell culture plate, and wherein the at least one hole contains the porous membrane insert.”
Claims 2-7 are rejected under 35 U.S.C. 112(b) as being indefinite due to their dependence on claim 1.
The terms “effective” and “reduce” in claim 7 are relative terms which renders the claim indefinite. The terms “effective” and “reduce” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear at what point the lid would be considered “effective” at stabilizing instrumentation, nor the amount of reduction in variability that is required for a determination of effectiveness.
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 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, 3-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al (US 5780294 A, cited on the IDS submitted 06 December 2023).
With regards to claim 1, Stevens et al teaches;
The claimed “a lid for stabilizing a porous membrane insert in a multi-well cell culture plate” has been read on the taught (Column 2, line 9, “Preferably, the lid comprises means for allowing gas diffusion into and out of the wells of the plate. Most desirably, the means for allowing the gas diffusion into and out of the wells of the plate is at least one port and associated with the port is a gas permeable membrane.”);
The claimed “a body which is planar and configured to span a top surface of the multi-well cell culture plate” has been read on the taught (Column 4, line 30, “Lid 50 includes a substantially planar cover 52 large enough to extend over all of the wells of the plate.”; Planar cover 52 reads on a body);
The claimed “sidewalls positioned along an outer perimeter of the body and configured to be seated on a shoulder of the multi-well cell culture plate” has been read on the taught (Column 4, line 39, “Extending around cover 52 is a downwardly depending skirt 58 which forms a border around lid 50.”; Column 4, line 48, “…when lid 50 is positioned over plate 20, skirt 58 extends towards annular shoulder 44 of the plate…”; Skirt 58 reads on sidewalls. Annular shoulder 44 reads on a shoulder of the multi-well cell culture plate.);
The claimed “at least one hole through the body and/or at least one knockout configured to be removed to provide the at least one hole through the body” has been read on the taught (Column 4, line 54, “Located on cover 52 is a number of orifices 72…”; Orifices 72 read on at least one hole through the body);
The claimed “wherein the lid is configured to provide the at least one hole over a corresponding well of the multi-well cell culture plate which contains the porous membrane insert” has been read on the taught (Column 4, line 55, “A gas permeable, liquid impermeable membrane 74 is associated with each orifice as shown in FIGS. 1-3. The orifices and associated membranes are arranged on the cover so that when the cover is positioned over the plate, an orifice and membrane is associated with each individual well in the plate.”
Stevens et al does not explicitly disclose wherein the at least one hole has a diameter greater than an outer diameter of the corresponding well and less than a diameter of a rim of the porous membrane insert such that the lid retains the porous membrane insert in the corresponding well while permitting unobstructed access to contents of the porous membrane insert.
However, MPEP 2144.04(IV)(A) states that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” See In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Likewise, MPEP 2144.04(IV)(B) holds that the configuration of a device may be “a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
In the case of the instant invention, the device of Stevens et al still permits unobstructed access to the contents of the porous membrane insert—see figures 3 and 4. The specification of the instant invention does not disclose any unexpected results occurring from the at least one hole having a diameter greater than an outer diameter of the corresponding well. As the device of Stevens would not perform differently than the claimed invention, and as the specification does not include any persuasive evidence that the configuration of a hole with a diameter greater than an outer diameter of the corresponding well is significant, the claimed device is obvious over the teachings of Stevens et al.
With regards to claim 3, the lid of claim 1 is obvious over Stevens et al.
Stevens et al additionally teaches;
The claimed “wherein the lid comprises a plastic” has been read on the taught (Claim 7, “…wherein said plate and said lid are made of transparent plastic.”).
With regards to claim 4, the lid of claim 1 is obvious over Stevens et al.
Stevens et al additionally teaches;
The claimed “wherein the lid has rounded or straight corners to accommodate various multi-well cell culture plate designs” has been read on the taught (Column 4, line 4, “Surrounding the wells and forming the outside border of plate 20 is sidewall 40... Well known tissue culture plates are rectangle or quadrilaterally shaped…”; The sidewall forming the outside border of a rectangular plate reads on the lid having straight corners. Figure 2 also illustrates the lid having straight corners).
With regards to claim 5, the lid of claim 1 is obvious over Stevens et al.
Stevens et al additionally teaches;
The claimed lid “which comprises 4, 6, 12, 24, 48 or 96 holes through the body” has been read on the taught (Column 3, line 58, “There may be any number of wells 26 in plate 20, although six, twelve, twenty-four, forty-eight and ninety-six well plates are commonly known and available.”; Column 4, line 57, “The orifices and associated membranes are arranged on the cover so that when the cover is positioned over the plate, an orifice and membrane is associated with each individual well in the plate.”).
With regards to claim 7, the lid of claim 1 is obvious over Stevens et al.
The limitation of a lid “which is effective to stabilize analytical instrumentation to reduce technical variability in experimental measurements” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Stevens et al teaches all of the structural limitations of the apparatus as defined in claim 7, this additional limitation does not define the instant application over the prior art.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al (US 5780294 A, cited on the IDS submitted 06 December 2023) in view of Sawyer et al (US 20200354668 A1, cited on the IDS submitted 06 December 2023).
With regards to claim 2, the lid of claim 1 is obvious over Stevens et al.
Stevens et al additionally teaches;
Wherein the lid can be manufactured from a variety of materials, as read on the taught (Column 5, line 51, “As practitioners-in-the-art will understand, the culture vessel assembly of the present invention may be comprised of simple moldable parts which may be mass produced from a variety of materials, including, for example, polyethylene, polystyrene, polyethylene terephthalate and polypropylene. As will be understood further by practitioners in the art, materials should be selected which provide a small degree of resiliency for the purpose of providing ease of use for subsequent examination of the developed cultured cells.”).
However, Stevens et al does not explicitly disclose wherein the lid comprises a metal.
In the analogous art of well devices, Sawyer et al teaches;
The claimed “wherein the lid comprises a metal” has been read on the taught ([0236], “The cassette or cassette lid can be constructed of a plastic or other material, such as metal.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lid as taught by Stevens et al with the metal lid as taught by Sawyer et al. According to MPEP 2143(I)(B), the simple substitution of one known element for another to obtain predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Stevens et al contains a lid which differs from the claimed device only by substitution of a metal element with a plastic element. The substituted metal element and its function was known in the art, as evidenced by Sawyer et al. One of ordinary skill in the art could have substituted the known metal element for the plastic element, with the predictable result of creating a resilient lid made from a moldable material.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al (US 5780294 A, cited on the IDS submitted 06 December 2023) in view of Millman (US 20200370266 A1).
With regards to claim 6, the lid of claim 1 is obvious over Stevens et al.
Stevens et al additionally teaches;
Wherein the lid comprises 4, 6, 12, 24, 48, or 96 holes through the body, as read on the taught (Column 3, line 58, “There may be any number of wells 26 in plate 20, although six, twelve, twenty-four, forty-eight and ninety-six well plates are commonly known and available.”).
However, Stevens et al does not explicitly disclose wherein the lid comprises knockouts, wherein each of the knockouts comprises a circular portion of the body defined by perforations which enable removal of the circular portion of the body to selectively provide the at least one hole through the body.
In the analogous art of lids and cover devices, Millman teaches;
The claimed “A lid” has been read on the taught ([0001], “The present device generally relates to a cover device for covering open apertures…”)
The claimed “at least one knockout configured to be removed to provide the at least one hole through the body” has been read on the taught ([0073], “In the embodiment shown in FIG. 23, the cover plate 12 of the cover device 10 includes a punch-out member 140 disposed through the body portion 14 of the cover plate 12… In this way, the punch-out member 140 is a feature that provides an on-demand aperture 150 through the cover plate 12...”
The claimed “wherein each of the knockouts comprises a circular portion of the body defined by perforations which enable removal of the circular portion of the body to selectively provide the at least one hole through the body” has been read on the taught ([0073], “Together, the attachment tabs 148A-148H and the relief portions 146A-146H define a perforated portion 144A surrounding the outer perimeter 144 of the body portion 142 of the punch-out member 140… the punch-out member 140 can be easily removed. In this way, the punch-out member 140 is a feature that provides an on-demand aperture 150 through the cover plate 12...”
According to MPEP 2143(I)(D), applying a known technique to a known device read for improvement to yield predictable results may support a case of prima facie obviousness. In the case of the instant invention, the prior art of Stevens et al contains a “base” device of a lid with holes, upon which the knockouts of the claimed invention can be seen as an “improvement.” The prior art of Millman contains a known technique of a perforated knockout region which can be used to generate an on-demand aperture. This technique is applicable to the base device, as both address the question of apertures for access to regions underneath lids. One of ordinary skill in the art would have recognized that applying the known technique of perforated knockouts to the holes to the device of Stevens et al would have yielded the predictable result of a lid with a configurable number of openings, resulting in an improved system that does not expose unused wells or membranes to the environment. In addition, MPEP 2144(V)(C) teaches that making a structure separable may alone be obvious—see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Taken together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Stevens et al including 4, 6, 12, 24, 48, or 96 holes with the perforated knockouts as taught by Millman, for the benefit of creating an improved device with removable knockouts for selectively exposing apertures within the lid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797
/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797