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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11 and 17-19) in the reply filed on April 20, 2026 is acknowledged.
Claims 12-16 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 20, 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement filed October 31, 2023 fails to comply with the provisions of 37 CFR 1.98 and MPEP § 609 because the copy of the non-patent literature document titled "Flow and magnetic field induced collagen alignment" was illegible due to is poor image quality. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 extracellular matrix chamber of claim 2 line 2 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 there is legalese present in the abstract: “disclosed herein” is recited on lines 1, 2, 3, and 5 of the provided 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 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 6, 7, and 10 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.
Regarding claim 6, it is recited that the extracellular matrix fibers “are radially aligned and extend from a center portion of the observation chamber towards and outer periphery of the observation chamber.” However, in claim 2 of which claim 6 is dependent via claim 3, it is recited that “an extracellular matrix is positioned within an extracellular matrix chamber and separating the first reservoir from the second reservoir.” While this does place the extracellular matrix chamber and thus the extracellular matrix within the cell culture container it does not clearly or positively place the extracellular matrix within the observation chamber thus the claim language relating the extracellular matrix’s position and alignment to the orientation of the observational chamber is made unclear.
It is suggested to positively recite in claim 2 that the extracellular matrix chamber is either equitable to the observation chamber, deposited within the observation chamber, or replace the recitation of “extracellular matrix chamber” of claim 2 line 2 with the “observation chamber”.
With respect to interpretation during examination the examiner is interpreting the “extracellular matrix chamber” of claim 2 line 2 as the observation chamber disclosed wherein an extracellular matrix is present within.
Similarly, with regards to claim 7, it is recited the that the extracellular matrix fibers “are circumferentially aligned and extend circumferentially within the observation chamber.” However, as stated above, claim 2 discloses that the extracellular matrix is within the extracellular matrix chamber not the observation chamber.
It is suggested to positively recite in claim 2 that the extracellular matrix chamber is either equitable to the observation chamber, deposited within the observation chamber, or replace the recitation of “extracellular matrix chamber” of claim 2 line 2 with the “observation chamber”.
With respect to interpretation during examination the examiner is interpreting the “extracellular matrix chamber” of claim 2 line 2 as the observation chamber disclosed wherein an extracellular matrix is present within.
Regarding claim 10, it is recited:
“a channel extending from the aperture to the second reservoir, and the channel, the aperture,
wherein the observation chamber defines a fluid pathway from the first reservoir to the second reservoir”
Clarification of what was intended was found in the specification, “The observation chamber, the aperture, and the channel together form a fluid pathway between the first reservoir and the second reservoir.” (Para. [0013] lines 9-11). The examiner will interpret the claim as such.
It is suggested to recite:
“a channel extending from the aperture to the second reservoir, and the channel, the aperture,
wherein the observation chamber defines a fluid pathway from the first reservoir to the second reservoir”
instead as:
“a channel extending from the aperture to the second reservoir,
wherein;
the channel, the aperture, and the observation chamber define a fluid pathway from the first reservoir to the second reservoir”
The above suggested correction will be how claim 10 lines 6-9 are to be interpreted for examination.
Claim Rejections - 35 USC § 102
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 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)(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 1-4 and 8-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Paves (US20240182831A1).
Regarding claim 1, Paves teaches:
A device, comprising:
A cell culture container (Paves; Fig. 1, Para. [0029], cell culture well insert (130); Figs. 2A-H shows different perspective views of cell culture insert (130)) comprising a container body (Paves; Para. [0034], Figs. 2A-H, outer wall (230)) having a first end portion (Paves; Para. [0034], Figs. 2A-H, the top planar portion of the insert open to atmosphere is the first end portion of the container body), a second end portion (Paves; Para. [0034], Figs. 2A-H, base (234), the bottom planar portion of the insert abutted against bottom of well it is inserted into), and a coverslip (Paves; the coverslip is the bottom of the well that the cell culture insert is within, Para. [0054], Figs. 5A-E show the cell culture insert within a well, multi-well cell culture plate (504), cell culture well insert (502)) attached to the first end portion of the container body,
the container body defining a first reservoir (Paves; Para. [0034], Figs. 2D, 2F, 2G, , reservoir/void (238)), a second reservoir (Paves; Para. [0034], Figs. 2D, 2F, 2G, , reservoir/void (238)), and an observation chamber (observation chamber of the immediate application is being interpreted as the same as the extracellular matrix chamber) (Paves; Paras. [0034, 0037], Figs. 2E-G, sample region (245), the sample region paired with the channels allow for fluid communication between the reservoirs while being visible through the well bottom which satisfies the function of observation chamber claimed in the immediate application) positioned between the first reservoir and the coverslip (Paves; Paras. [0034, 0037], Figs. Figs. 2E-G, sample region (245), hydrogel (250), channel (266); the sample region (245) along with the two channels (266) satisfies the function of the observation chamber claimed in the immediate application by being abutted against the bottom of well plate allowing for visibility, allowing fluid communication between the reservoirs, and housing an extracellular matrix) and extending between and open to the first reservoir and the second reservoir (Paves; Paras. [0034, 0037], Figs. Figs. 2E-G, sample region (245), hydrogel (250), channel (266); the combination of the sample region (245) with the channels (266) reads upon the observation chamber of the immediate application).
Regarding claim 2, Paves teaches all of the elements of the current invention as stated with respect to claim 1. Paves teaches the device of claim 1, further comprising an extracellular matrix (Paves; Para. [0034], hydrogel (250)) positioned within an extracellular matrix chamber (the extracellular matrix chamber is being interpreted as the same as the observational chamber) (Paves; Para. [0034], Figs. 2F-H, sample region (245)) and separating the first reservoir from the second reservoir (Paves; Paras. [0037, 0038], Figs. 2F-H, sample region (245), hydrogel (250), reservoir (238), cell culture media (264)).
Regarding claim 3, Paves teaches all of the elements of the current invention as stated with respect to claim 2. Paves teaches the device of claim 2, wherein the extracellular matrix comprises a matrix of interconnected biopolymer fibers (Paves; Para. [0056], "a liver organoid cultured in a collagen hydrogel in a cell culture well insert").
Regarding claim 4, Paves teaches all of the elements of the current invention with respect to claim 3. Paves teaches the device of claim 3, wherein the extracellular matrix comprises collagen, fibronectin, elastin, laminin, vitronectin, poly (ethylene glycol), alginate, gelatin, silk fibroin, polyethylene glycol diacrylate, hyaluronic acid, or any combination thereof (Paves; Para. [0056], "a liver organoid cultured in a collagen hydrogel in a cell culture well insert").
Regarding claim 8, Paves teaches all of the elements of the current invention as stated with respect to claim 2. Paves teaches the device of claim 2, further comprising a cell culture disposed in the extracellular matrix, wherein the cell culture comprises at least one of cancer cells, endothelial cells, stem cells, or immune cells (Paves; Para [0049, 0051], cancer cells and endothelial cells).
Regarding claim 9, Paves teaches all of the elements of the current invention as stated with respect to claim 2. Paves teaches the device of claim 2, further comprising a multicellular structure incorporated in the extracellular matrix, wherein the multicellular structure is one of a tumor spheroid, tissue, organoid, or other multicellular construct (Paves; Para. [0056], "a liver organoid cultured in a collagen hydrogel in a cell culture well insert").
Regarding claim 10, Paves teaches all of the elements of the current invention as stated with respect to claim 1. Paves teaches the device of claim 1, wherein the cell culture container further comprises: an aperture extending from the observation chamber to the second end portion of the cell culture container (Paves; Para. [0037], Fig. 2H, central chamber (270)) and configured to receive a portion of an agitation device and admit a rotatable agitator into the observation chamber (The use of "configured to" recites the limitation of an agitation device being used on or within the cell culture container an intended use/function claim and thus makes the limitation not positively or structurally recited. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of claim 10 without the inclusion of an agitation device. (see MPEP §2114).); and
a channel extending from the aperture to the second reservoir (Paves; Para. [0037], Figs. 2G-H, , channel (266); Prior art for the channel as recited in the immediate application is formed in Paves with the fluid pathway of the central chamber (270) to the sample region (245) to the channel (266) and finally into the reservoir (238)), (portion of claim below within brackets [ ] is to signal that for examination purposes the suggested correction mentioned previously was used and inserted into the claim)
wherein,
the observation chamber, the channel, and the aperture,] define a fluid pathway from the first reservoir to the second reservoir (Paves; Para. [0037], Figs. 2G-H, reservoir (238), channel (266), sample region (245), cell culture media (264), arrows (268); the fluid pathway is listed in order of the connection of the components reservoir (238), channel (266), sample region (245), channel (266), reservoir (238)).
Regarding claim 11, Paves teaches all of the elements of the current invention as stated with respect to claim 1. Paves teaches the device of claim 1, wherein the first reservoir includes a first solution and the second reservoir includes a second solution having a different concentration than the first solution (Paves; Para. [0040], "skilled artisans will realize that one can adjust the concentration gradient and use pure diffusion mechanism between chambers"), thereby establishing a chemical gradient (Paves; Para. [0039], "Chemical gradients and fluid flow can then be generated in accordance with the present embodiments from left to right, right to left or from top to side.") is formed between the first reservoir and the second reservoir.
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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Paves (US20240182831A1) in view of Knoblich (US20190017016A1).
Regarding claim 5, Paves teaches all of the elements of the current invention as stated with respect to claim 4. Paves teaches an extracellular matrix (Paves; Para. [0056]) in use with a cell culture device. Paves does not teach the device of claim 4, wherein the extracellular matrix further comprises perlecan, and one or more growth factors.
Knoblich teaches wherein the extracellular matrix further comprises perlecan (Knoblich; Para. [0015], “three-dimensional matrix is preferably a gel and/or an extracellular matrix or any component thereof selected … heparin-sulfated proteoglycan”, where the perlecan equivalent is heparin-sulfated proteoglycan), and one or more growth factors (Knoblich; Para. [0062], “three dimensional matrix may further comprise growth factors”).
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 hydrogel/extracellular matrix of Paves by including perlecan and growth factors within the extracellular matrix as taught by Knoblich. Both Paves and Knoblich are directed towards the use of an extracellular matrix in cell culture. Knoblich teaches that the rigidity of the gel allows for the expansion of growing a cell culture and the inclusion of growth factors allows for the differentiation of stem cells being cultured within the extracellular matrix (Knoblich; Para. [0062]). This modification includes applying a known technique (Knoblich; the formation of an extracellular matrix with the use of both perlecan and an additional growth factor) to a similar device (Paves; cell culture insert which uses a hydrogel extracellular matrix) to yield predictable results (an extracellular matrix of Knoblich within the cell culture insert of Paves which allows for rigidity and differentiation of the desired cell types).
Regarding claim 6, Paves teaches all of the elements of the current invention as stated with respect to claim 3. Paves teaches an extracellular matrix (Paves; Para. [0056]) in use with a cell culture device. Paves does not teach the device of claim 3, wherein the interconnected biopolymer fibers are radially aligned and extend from a center portion of the observation chamber towards an outer periphery of the observation chamber.
Knoblich teaches a support/scaffold in which the cells or extracellular matrix would be able to attach and thus orient itself with the support (Knoblich; Para. [0036]). This support would allow for the orientation of the extracellular matrix to be radial or circumferentially aligned around the observation chamber (Knoblich; Para. [0039], it is disclosed that there can be either a circular or grid lattice of the scaffold (Para. [0039]), this would allow for the claimed radial or circumferential alignments).
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 hydrogel/extracellular matrix of Paves by including a scaffold to allow for the desired orientation of the matrix as taught by Knoblich. Both Paves and Knoblich are directed towards the use of an extracellular matrix in cell culture. Knoblich teaches that this scaffold will aid in patterning the extracellular matrix and the cells to be cultured within (Knoblich; Para. [0036]). This modification includes applying a known technique (Knoblich; the use of a scaffold for the orientation of the extracellular matrix formation) to a similar device (Paves; cell culture insert which uses a hydrogel extracellular matrix) to yield predictable results (an extracellular matrix of Knoblich within the cell culture insert of Paves which is aligned as chosen by the predetermined scaffold orientation).
Regarding claim 7, Paves teaches all of the elements of the current invention as stated with respect to claim 3. Paves teaches an extracellular matrix (Paves; Para. [0056]) in use with a cell culture device. Paves does not teach the device of claim 3, wherein the interconnected biopolymer fibers are circumferentially aligned and extend circumferentially within the observation chamber.
However, Knoblich teaches a support/scaffold in which the cells or extracellular matrix would be able to attach and thus orient itself with the support (Knoblich; Para. [0036]). This support would allow for the orientation of the extracellular matrix to be radial or circumferentially aligned around the observation chamber (Knoblich; Para. [0039], it is disclosed that there can be either a circular or grid lattice of the scaffold (Para. [0039]), this would allow for the claimed radial or circumferential alignments).
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 hydrogel/extracellular matrix of Paves by including a scaffold to allow for the desired orientation of the matrix as taught by Knoblich. Both Paves and Knoblich are directed towards the use of an extracellular matrix in cell culture. Knoblich teaches that this scaffold will aid in patterning the extracellular matrix and the cells to be cultured within (Knoblich; Para. [0036]). This modification includes applying a known technique (Knoblich; the use of a scaffold for the orientation of the extracellular matrix formation) to a similar device (Paves; cell culture insert which uses a hydrogel extracellular matrix) to yield predictable results (an extracellular matrix of Knoblich within the cell culture insert of Paves which is aligned as chosen by the predetermined scaffold orientation).
Allowable Subject Matter
Claims 17-19 are allowed.
Regarding claim 17, the limitations that are neither taught nor rendered obvious by the prior art are as follows:
“a first observation chamber positioned between the first end reservoir and the coverslip, and open to the first end reservoir;”
“a second observation chamber positioned between the second end reservoir and the coverslip, and open to the second end reservoir;”
“an inner wall having a first end portion and a second end portion and disposed within the container body;”
“an inner reservoir defined by the inner wall;”
“a first aperture extending through the inner wall and opening into the first observation chamber;”
“a second aperture extending through the inner wall and opening into the second observation chamber;”
“a first channel extending from the first aperture to the inner reservoir;”
“and a second channel extending from the second aperture to the inner reservoir;”
“wherein the first observation chamber, the first aperture, and the first channel define a fluid pathway between the first end reservoir and the inner reservoir,”
“and the second observation chamber, the second aperture, the second channel define a fluid pathway between the second end reservoir and the inner reservoir.”
The closest prior art to the claimed invention are those which refer to lab-on-a-chip/ microfluidic chips for use in cell culture. The prior art found closet to read on the claim was Zhang (US20230174909A1).
Zhang teaches a multiwell apparatus with three wells in which cells and media have been deposited (Zhang; Figs. 1 and 2, Abstract). In Zhang the reservoirs are the inlet, tissue, and outlet wells (Zhang; Fig. 1b) corresponding respectively to the first end, inner, and second end reservoirs of the immediate application. Zhang is a multiwell apparatus with the goal of imaging the cells being cultured, therefore the bottom of the plate is translucent in nature to allow for imaging (Zhang; Figs. 2-6, examples of images taken in the wells of the apparatus), which can reasonably be read to be equivalent to the function and purpose of the coverslip claimed in the immediate application. The construction of the multiwell in Zhang reads weakly in the inclusion of the inner wall and inner reservoir of the immediate application, which would be the central well, where the inner wall would be the walls of the central well in Zhang and the inner reservoir being the central well itself. Zhang does include the mention of a fluid pathway between the reservoirs (Zhang; connecting channel, Fig.1) and the inner reservoir.
Zhang was unable to teach an observation chamber or any sort of inclusion of a separate area between the bottom of the plate in Zhang (coverslip of immediate application) and either of the inlet or outlet wells (first end and second end reservoirs of immediate application). As a result of the lack of an observation chamber or an equivalent, Zhang is unable to read on:
the first and second apertures of the immediate application which create a fluid pathway between the inner reservoir and the observation chambers
the first and second channels which extend from the apertures to the reservoirs
wherein the observation chamber, aperture, and channel form a fluid pathway between the reservoir and the inner reservoir (applying to both the first and second of each of the components)
Regarding claims 18 and 19, both claims 18 and 18 are dependent on claim 17 and are thus allowable as a result of the allowance of claim 17.
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.
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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.
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/DONAVAN L. BRIDGES/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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