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 .
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. Therefore, the module comprising a light source to conduct measurement (claim 16) and the module comprising a light source to promote photosynthetic growth (claim 17) must be shown or the feature(s) canceled from the claim(s). 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.
Specification
The abstract of the disclosure is objected to because the legal phraseology, "herein are described," was present within the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 1 is objected to because of the following informalities: “registrations features” in line 4 of the claim should read “registration features”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: it is suggested to recite “it” on line 2 of the claim as “the at least one module”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: it is suggested to recite “that module” on line 2 of the claim as “the at least one module”. Appropriate 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 1-18 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.
The term “standard” in claims 1, 2, 3, 4, and 11 is a relative term which renders the claim indefinite. The term “standard” is not defined by the claim, although the specification provides a standard for ascertaining the requisite degree (ANSI, [0024]), and one of ordinary skill in the art would likely be reasonably apprised of the scope of the invention the detail of the invention is not adequately disclosed within the claim for definiteness to be achieved. In claim 1 the use of "standard" without defining to what the term is referring when describing a The dependent claims do not resolve the 112b rejection of the independent claims, and therefore claims 2-18 are rejected by virtue of their dependency on claim 1.
The term “extreme” in claim 14 is a relative term which renders the claim indefinite. The term “extreme” is 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. The relative term "extreme" being used to describe the temperature the claimed module would be able to endure in no way gives a definite scope of what is considered extreme in order for one of ordinary skill in the art to ascertain what materials would be acceptable for use and construction of the claimed module.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bunn (US 20020127742 A1; cited in the IDS filed 01/14/2024).
Regarding claim 1, Bunn teaches:
A modular well plate system (Abstract; Fig. 1 ), comprising:
a plurality of disposable modules (multi-well slide assemblies (20); Para. [0041]; Fig. 1), each, comprising:
at least one chamber (chambers in wells (42); Para. [0045]; Fig. 1); and
one or more registrations features (slide plate (32); Para. [0044]; Fig. 1); and,
a reusable frame (frame (100); Para. [0073]; Figs. 1 and 7), comprising:
at least one horizontal reference plane (left side (102) and right side (104); Para. [0071]; Fig. 7);
at least one vertical reference plane (front end (106) and rear end (108); Para. [0071]; Fig. 7);
a plurality of receiving areas (space above each horizontal row of access apertures (162); Paras. [0071] and [0082-0083]; Figs. 1 and 7) circumscribed by the reference planes (as shown in Fig. 7), each receiving area configured to receive one of the plurality of modules (Paras. [0078-0080]; Figs. 10A-10C);
one or more registration features (channels (110) formed by lowerwall (114) and retaining portion (112a) of upper wall (112); Figs. 1, 8 and 9) corresponding to the one or more registration features on the modules (Para. [0074]);
wherein:
the modules are configured individually for experimental purposes (the assemblies (20) are capable of being configured individually);
the modules are temporarily affixed to the frame via each module's respective registration features (Para. [0074]); and
the frame is configured to mate with a standard multi well plate reader and present the temporarily affixed modules for measurement (a “standard multiwell plate reader” is not positively recited within the claims of this application) (Bunn; The dimensions (5.025 inches by 3.365 inches) of the frame are similar to the conventional microwell plate or multiwell cell culture dishes the dimension being the same as a conventional multiwell plate would allow for mating/joining with a multiwell plate reader, Para. [0072]; Para. [0103]).
Regarding claim 2, Bunn teaches all of the elements of the current invention as stated with respect to claim 1. Bunn teaches wherein the horizontal external dimensions of the frame match those of a standard multiwell plate (Para. [0072]).
Regarding claim 3, Bunn teaches all of the elements of the current invention as stated with respect to claim 1. Bunn further teaches wherein the modules are presented at horizontal locations corresponding to the horizontal locations of one or more wells of a standard multi well plate (a “standard multiwell plate” is not positively recited within the claims of this application) (The dimensions (5.025 inches by 3.365 inches) of the frame are similar to the conventional microwell plate or multiwell cell culture dishes, Para. [0072] ).
Regarding claim 4, Bunn teaches all of the elements of the current invention as stated with respect to claims 1 and 3. Bunn further teaches wherein the standard multiwell plate is a 96-well plate (Para. [0072]).
Regarding claim 5, Bunn teaches all of the elements of the current invention as stated with respect to claim 1. Bunn further teaches wherein the frame is sterilizable (Para. [0073]).
Claims 1, 8-10, 12, and 15 are under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carvalho (US20190309249A1; cited in the IDS filed 01/14/2024).
Regarding claim 1, Carvalho teaches:
A modular well plate system (Abstract; Fig. 6), comprising:
a plurality of disposable modules (hold wells (22); Para. [0031]; Fig. 4), each, comprising:
at least one chamber (unnumbered chamber in well (22) visible in Fig. 4); and
one or more registrations features (locking feature (122); Para. [0031]; Fig. 4); and,
a reusable frame (tray (10) and cell culture media reservoir (35); Para. [0020]; Fig. 6; “reusable” interpreted as intended use (MPEP 2114), while “reusable” is not explicitly stated the tray (10) and cell culture media reservoir (35) are structurally capable of being reused by a user), comprising:
at least one horizontal reference plane (left to right edge of cell culture media reservoir (35) as shown in Fig. 6 where the cell culture media reservoir (35) is a standard multi-well plate; Para. [0020]);
at least one vertical reference plane (top to bottom edge of cell culture media reservoir (35) as shown in Fig. 6 where the cell culture media reservoir (35) is a standard multi-well plate; Para. [0020]);
a plurality of receiving areas (well apertures (20) with rims (21); Figs. 1 and 6) circumscribed by the reference planes (Para. [0020], well aperture (20)), each receiving area configured to receive one of the plurality of modules (Paras. [0020] and [0022]);
one or more registration features (locking feature (121); Fig. 4) corresponding to the one or more registration features on the modules (Para. [0031]);
wherein:
the modules are configured individually for experimental purposes (Para. [0024]);
the modules are temporarily affixed to the frame via each module's respective registration features (Para. [0031]); and
the frame is configured to mate with a standard multi well plate reader and present the temporarily affixed modules for measurement (the cell culture media reservoir (35) is a standard multi-well plate, Para. [0020], and standard multi-media plates are configured to mate with a standard multi-well plate reader and present the temporarily affixed modules for measurement).
Regarding claim 8, Carvalho teaches all of the elements of the current invention as stated with respect to claim 1. Carvalho further teaches wherein at least one module is a single, flat-bottomed sample well (Para. [0024]; Fig. 4).
Regarding claim 9, Carvalho teaches all of the elements of the current invention as stated with respect to claim 1. Carvalho further teaches wherein at least one module is a single, round-bottomed sample well (Para. [0024]).
Regarding claim 10, Carvalho teaches all of the elements of the current invention as stated with respect to claim 1. Carvalho further teaches wherein at least one module is pretreated with a selective-growth substrate (cell culture material (106); Paras. [0020], [0030] and [0032]; Fig. 5).
Regarding claim 12, Carvalho teaches all of the elements of the current invention as stated with respect to claim 1. Carvalho further teaches wherein at least one module is a tissue-culture treated well designed to promote the growth of adherent cells (Paras. [0020], [0024], [0030] and [0032]; Fig. 5).
Regarding claim 15, Carvalho teaches all of the elements of the current invention as stated with respect to claim 1. Carvalho further teaches wherein at least one module is configured to nest a secondary module inside of it (the cone shape of the wells (22) would allow another cone to nest inside of it).
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.
Claim 6 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bunn as and further in view of Schober (US20110020929A1).
Regarding claim 6, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module is a well pair designed to induce contact-independent interaction between two microbial cultures.
However, Schober teaches a modular well plate system (Abstract; Fig. 8) and teaches of at least one module is a well pair (pair of wells of mold (10); Fig. 8) designed to induce contact-independent interaction between two microbial cultures (Para. [0037]). Schober further teaches motivation that the inclusion of multiwell constructs within the modular well is able to reproduce the three-dimensional in vivo situation of the cells and tissue used in the study thus improving the studies efficacy (Para. [0004-0006]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well construct of Bunn to incorporate the Schober’s teachings of making one of the variants a well pair to provide: “wherein at least one module is a well pair designed to induce contact-independent interaction between two microbial cultures.” Doing so would have a predictable result and reasonable expectation of successfully of allowing reproduction of three-dimensional in-vivo situation of cells and tissues, thus improving the efficacy of cultures as taught by Schober (Para. [0004]-[0006]).
Claim 7 rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bunn and further in view of Nelson (US4725388A; cited in IDS filed 01/14/2024).
Regarding claim 7, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn further teaches the use of the taught multiwell modular plate in the use of detecting fluorescent labeling of monoclonal antibodies (Paras. [0005-0010]). However, Bunn does not teach wherein at least one module is at least partially opaque to facilitate measurement of sample fluorescence.
Nelson teaches a well plate system (plate (20); Abstract; Fig. 1) and teaches of wherein at least one well (well (26); Fig. 1) is at least partially opaque to facilitate measurement of sample fluorescence (Col. 5, Lines 53-60 and Col. 6, Lines 4-6). Nelson further teaches that the purpose of having an opaque and nonfluorescent well for the purpose of fluorescent measurement is to avoid the fluorescing of a non-opaque well interfering with the measurements (Col. 1 lines 46-68, Col. 2 lines 1-49).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well component of Bunn by to incorporate Nelson’s teachings of the partially opaque and nonfluorescent components within the modular wells which provides: wherein at least one module is at least partially opaque to facilitate measurement of sample fluorescence. Both Bunn and Nelson are directed to modular multiwell cell culture apparatuses. Nelson teaches having an opaque and nonfluorescent well for the purpose of fluorescent measurement is to avoid the fluorescing of a non-opaque well interfering with the measurements (Col. 1 lines 46-68, Col. 2 lines 1-49). The modification of the wells in Bunn with the teachings of Nelson involves applying a known technique to a similar device to yield a predictable result (e.g. avoiding fluorescing of non-opaque well that interferes with measurements).
Claim 11 rejected under 35 U.S.C. 103 as being unpatentable over Bunn and further in view of Lund (US4245043A; cited on IDS filed 01/14/2024).
Regarding claim 11, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module is a standard-value artificial sample for the purposes of calibration or comparison.
Lund teaches a well plate system (Abstract; Fig. 1) and teaches of wherein at least one well (Negative control wells "A" and "K"; Fig. 1) is a standard-value artificial sample for the purposes of calibration or comparison and further teaches that the standard-value artificial sample provides means to detect subtle changes (Abstract; Col. 1 lines 8 -12; Negative control wells "A" and "K"; Fig. 1).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well of Bunn by including calibration standards within some of the wells as taught by Lund to provide: wherein at least one module is a standard-value artificial sample for the purposes of calibration or comparison. Both Bunn and Lund are directed to multiwell cell culture apparatuses, Lund teaches that the consistency and accuracy of the negative control wells and calibration standards are essential for eliminating the problem of false positive reactions (Abstract; Col. 1 lines 8 -12), and this involves applying a known teaching (the use of negative control and sample standards for calibration) to a similar device to yield predictable results (the sample standards and calibration wells allowing for accuracy of readings).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bunn and further in view of Simon (US20100055790A1; cited in the IDS filed 01/14/2024).
Regarding claim 13, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module is treated with extracellular matrix to promote eukaryotic cell growth.
Simon teaches a modular well plate system (Abstract; Fig. 6A) and teaches of wherein at least one module is treated with extra-cellular matrix (gelatin, Para. [0090]) to promote eukaryotic cell (hepatocytes, Para. [0090]) growth (Paras. [0089-0090]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well component of Bunn by including an extracellular matrix or cell scaffolding component within the well module as taught by Simon to provide: wherein at least one module is treated with extracellular matrix to promote eukaryotic cell growth. Bunn and Simon are considered analogous since both are directed to modular cell culture apparatuses. Simon further teaches that the inclusion of cell-interfacing surfaces, extracellular matrix, fabricated can promote cell adhesion and growth of the culture (Para. [0046]), and this involves applying a known technique to a similar device to yield predictable results.
Regarding claim 14, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn teaches wherein the frame of the modular well assembly is autoclavable (Para. [0073]), however, Bunn does not teach wherein at least one module is constructed of a material resistant to the effects of extreme temperature.
Simon teaches of wherein at least one well is constructed of a material resistant to the effects of extreme temperature and further teaches that the autoclave sterilizes the item (autoclave temperatures; Paras. [0090] and [0092-0093]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well component of Bunn by making the modular well out of a material that is resistant to high temperatures as taught by Simon to provide: wherein at least one module is constructed of a material resistant to the effects of extreme temperature. Bunn and Simon are considered analogous since both are directed to modular cell culture apparatuses. Simon further teaches that a high temperature resistance will allow the modular well component to be autoclaved following non sterile experiment preparations (Para. [0090]). This combination involves applying a known teaching (the use of temperature resistant material in the construction of a cell culture vessel) to a similar device to yield predictable results (a cell culture vessel which has temperature resistance).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bunn and further in view of Chung (US20170362561).
Regarding claim 16, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module, further comprises: a light source to conduct measurement.
Chung teaches a high throughput photobioreactor (Abstract; Fig. 1) that can house a 96 well plate and has a plurality of the light sources (Paras. [0014-0015]). The light sources can be a one to one with well number due to the customizability of the invention (Paras. [0033] and [0109]). Chung further teaches that the lights can be used for measurement (Para. [0077]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the customizability of the light sources of Chung and the modular wells of Bunn by including a single light source dedicated to a single module capable of measurement as taught by Chung to provide: wherein at least one module, further comprises: a light source to conduct measurement. Bunn and Chung are analogous since both are directed to multiwell cell culture plates. Chung teaches that the customizability of changing the light amount dedicated to each well allows for optimization of the cellular growth (Para. [0033]). This combination involves applying a known technique/teaching (the customizability of light sources and including light sources with the ability to take part in measurements) to a similar device to yield predictable results (a configuration with one light source per module with measurement capabilities).
Regarding claim 17, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module, further comprises: a light source to promote photosynthetic growth.
Chung further teaches that the lights contained in the invention can also include lights that allow for photosynthetic growth (Paras. [0001-0008], [0015], [0033]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the customizability of the light sources (which includes lights of photosynthetic wavelengths) of Chung and the modular wells of Bunn by including a single light source at a photosynthetic wavelength dedicated to a single module as taught by Chung to provide: wherein at least one module, further comprises a light source to promote photosynthetic growth. Bunn and Chung are analogous since both are directed to multiwell cell culture plates. Chung teaches that the customizability of changing the light amount dedicated to each well allows for optimization of the cellular growth (Para. [0033]). This combination involves applying a known technique/teaching (the customizability of light sources and including light sources at photosynthetic wavelengths) to a similar device to yield predictable results (a configuration with one light source at a photosynthetic wavelength per module).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bunn as and further in view Forschung (DE102009039868; cited on IDS filed 01/14/2024).
Regarding claim 18, Bunn teaches all of the elements of the current invention as stated with respect to claim 1.
Bunn does not teach wherein at least one module, further comprises: an element designed to positively control the temperature inside that module.
Forschung teaches a well plate system (Abstract; Fig. 1) and teaches of wherein at least one well (culture vessel (32); Para. [0094]), further comprises: an element (electrical heating device (20)) designed to positively control the temperature inside that well (Para. [0092]) and further teaches that the heating control can also regulate the evaporation rate of the maintenance medium to prevent the biological test system from drying out and thus from dying (Para. [0076]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modular well component of Bunn by adding a heating control element to the modular well component as taught by Forschung to provide: wherein at least one module, further comprises an element designed to positively control the temperature inside that module. Bunn and Forschung are analogous since both are directed to multiwell cell culturing. Forschung teaches the temperature control element will have the benefit of allowing for the control of evaporative factors on the culture media (Para. [0076]). This combination involves applying a known teaching (a heating element top control the temperature condition of a cell culture plate) to a similar device to yield predictable results (a modular cell culture plate where each well module has a temperature controlling element to provide more precise control of culture conditions).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONAVAN L BRIDGES whose telephone number is (571)272-9636. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.L.B./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights