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
Claims 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/23/2026.
Drawings
The drawings are objected to because there are areas of dark shading and/or black background and/or appear to be photographs that obscure the images. The drawings should be black and white line drawings. 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.
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 1-10 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 “…wherein a portion of the hydrogel and a portion of the hydrogel which constitute the first module and the second module…” It is unclear if Applicant intended to recite a portion of the hydrogel separate from the modules, or whether applicant intended to recite “…wherein a portion of the hydrogel which constitutes the first module and a portion of the hydrogel which constitutes the second module...” Claims 2-10 depend from claim 1 and are indefinite for the same reason.
Claim 6 recites “…wherein a portion of the hydrogel and a portion of the hydrogel which constitute the first module and the third module.” It is unclear if Applicant intended to recite a portion of the hydrogel separate from the modules, or whether applicant intended to recite “wherein a portion of the hydrogel which constitutes the first module and a portion of the hydrogel which constitutes the third 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.
Claim(s) 1, 2, and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Ariyasinghe” (Extracellular Matrix in Cardiovascular Pathophysiology) cited by Applicant in IDS filed 11/1/2023).
In regards to claim 1, Ariyasinghe discloses a multiaxial artificial muscle tissue that is contractible or stretchable about a plurality of axes, comprising:
a first module which is formed by gelling a hydrogel including muscle cells and extends in a first axis direction so as to be contractible or stretchable in the first axis direction;
and a second module which is formed by gelling the hydrogel and extends in a second axis direction to be contractible or stretchable in the second axis direction (see description of 3D tissue constructs on page H780, right column, lines 1 to page H781),
wherein a portion of the hydrogel which constitute the first module and the second module, respectively, are integrated with each other such that a portion of the first module and a portion of the second module are connected to each other (see “microtissue formation” in Figure 5A wherein a “module” is connected to one of four pillars in a mold).
In regards to claim 2, the muscle cells include cardio myocytes (page H780, second column).
Regarding claim 4, the X-shaped structure in Figure 5A is interpreted to have four modules, wherein each leg of the X shape is a “module.” Therefore, the axes of two adjacent modules cross each other (see Fig. 5A).
Regarding claim 5, the X-shaped structure in Figure 5A is interpreted to have four modules, wherein each leg of the X shape is a “module.” The X-shape as two modules that are directly opposite to one another, wherein the axes of these modules are parallel to one another.
In regards to claim 6, the X-shaped structure in Figures 5A can be described as having a third module extending along a third axis (wherein the X-shape can be described as having four modules, or legs, extending outwardly from the center), so as to be contractible or stretchable in the third axis direction, wherein a portion of the hydrogel and a portion of the hydrogel which constitute the first module and the third module, respectively, are integrated with each other such that a portion of the first module and a portion of the third module are connected to each other.
Claim 7 has been treated as a product-by-process claim, as the language “…integrally formed by using a single frame in a multi-axis structure including the first axis and the second axis” is directed towards a method of manufacture and not given patentable weight. As set forth in MPEP 2113, “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 in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Therefore, the prior art is not required to disclose the frame. The connection of the modules to form a single piece meets the requirement of “integral.”
Claim 8 has been treated as a product-by-process claim, as the steps of cross-linking, moved and connected are directed towards a method of manufacture and not given patentable weight. As set forth in MPEP 2113, “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 in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985).
In regards to claim 9, the term “above” is given its broadest reasonable interpretation since the claim does not clearly set forth a direction of “above” relative to a component of the device. Therefore, the a portion of the first module is considered to be “above” the second module in at least one axis in 3D space.
Regarding claim 10, the first module and the second module are contacting one another, wherein this contact is on a plane that intersects an area wherein the two modules cross one another.
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ariyasinghe in view of USPAP 2006/0233850 (Michal).
Ariyasinghe fails to disclose that the muscle cells include skeletal muscle cells. Michal is directed towards a bioscaffold for cardiac repair having a gel combined with cells (abstract). Michal teaches that it is known in the art to use skeletal myoblasts instead of cardiomyocytes (see [0075] and [0080]). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute or combine skeletal muscle cells with the hydrogel material of Ariyasinghe, as taught by Michal, as the modification merely involves a substitution of one type of cells suitable for forming a hydrogel bioscaffold for the purpose of repairing a patient’s cardiac function that obtains predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USPAP 2019/0367733 discloses 3D artificial tissue scaffolds comprising various types of cells [0067].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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