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 in the reply filed on 3/27/2026 is acknowledged. Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
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 7 and 9 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.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 9 is rejected by virtue of their dependence on a rejected base claim.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2014/0220555, hereinafter Chen in view of United States Application Publication No. 2007/0212775, hereinafter Cohen.
Regarding claim 1, Chen teaches a device made of elastomeric material (paragraph [0051]) for culturing in vitro muscle tissue (intended use MPEP § 2114 (II)), the device comprising: a base section (the bottom of item 240); two pillars (items 260a and 260b) each protruding from the base section (figure 2); and a wall section (the walls of item 240) with an inner wall surface surrounding the pillars (figure 2), and an outer wall surface (figure 2).
Chen fails to teach the wall section comprises at least two rib elements extending outwardly from the outer wall surface to an outer periphery of the device.
Cohen teaches a microtiter plate which has four ribs (Cohen, items 12 and 14) on each of the middle wells of the device (Cohen, figure 2) so that the plate can be reinforced while also a considerable portion of the well to contact a sample holder (Cohen, paragraph [0017]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added four ribs which extend outwardly from the outer wall surface to an outer periphery of the device because it would allow for the device to be reinforced while also a considerable portion of the well to contact a sample holder (Cohen, paragraph [0017]).
Regarding claim 2, modified Chen teaches the wall section comprises at least three rib elements extending in at least two non-parallel directions within a virtual plane comprising the base section (see supra).
Regarding claim 3, Chen teaches the inner wall surface has a non- unity aspect ratio (paragraph [0056]).
Regarding claim 4, Chen teaches the height of the rib elements is less than or equal to the height of the wall section (paragraph [0056]) and wherein the height of the wall section is less than or equal to 2000µm (paragraph [0056]).
Regarding claim 5, Chen teaches the height of the pillar is less than 2 mm tall (paragraph [0057]).
Chen fails to specifically teach the height of the pillars is greater than or equal to 500µm and less than or equal to 2000µm.
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the height of the pillars in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 6, Chen teaches the Young's Modulus of the material used to manufacture the pillars is 1-10 MPa.
Chen fails to specifically teach the Young's Modulus of the material used to manufacture the pillars is greater than or equal to 0.5 MPa and less than or equal to 5 MPa.
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the Young’s Modulus of the material in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 7, the method of injection molding, injection compression, transfer molding or embossing is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Chen and Cohen (MPEP § 2113). The burden is on applicants to show product differences in product by process claims. Here, the limitations as to the method of forming the device by one of the specific methods is given minimal patentable weight. Further these methods are taught in paragraphs [0059]-[0060].
Regarding claim 8, Chen teaches the device or pillars, and the base wall section and ribs comprise a silicone rubber (paragraph [0051]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Cohen as applied to claim 7 above, and further in view of United States Application Publication No. 2019/0316068, hereinafter Chen2019.
Regarding claim 9, Chen and Cohen teach all limitations of claim 7; however, they fail to teach the pillars are tapered towards the distal end with respect to the base section, and the distal end of the pillars are rounded or partly rounded at the interface between one or more sides walls of the pillar and the distal end of the pillar.
Chen2019 teaches a device which have pillars that have a spherically shaped head that which permit even distribution of stress on the tissue, thus decreasing concentrations of stress at specific points of the tissue which could compromise the tissue's structural integrity (Chen2019, paragraph [0139]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the distal end of the pillars rounded (and therefore tapered) because it would permit even distribution of stress on the tissue, thus decreasing concentrations of stress at specific points of the tissue which could compromise the tissue's structural integrity (Chen2019, paragraph [0139]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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