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 01/14/2026 is acknowledged.
Claims 19-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/14/2026.
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 artificial tissue in the form of a tumor (claim 12), the artificial tissue in the form of a tumor micro-environment (claim 13), the artificial tissue in the form of a tumor micro-environment of pancreatic ductal adenocarcinoma (claim 14), and the artificial tissue associated with a tissue maintenance system comprising a housing unit and more or more additional housing units in fluid communication with the housing unit (claim 18) 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.
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 12-14 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 claims 12-14, it is not clear what, if any, additional structural limitations these claims set forth on the final structure of the claimed invention, i.e. the artificial tissue. Specifically, the claims seem to be reciting intended use of the artificial tissue, i.e. being different types of tumors, however there is no structure set forth in any of the claims to further limit the final structure/make-up of the claimed invention/artificial tissue to meet the recited intended use. Furthermore, the originally filed disclosure does not aid in clarifying what exact structure would be needed in order to meet the parameters recited in the claims; thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 3 and 8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 3 and 8 set forth a parameter wherein a human organism is claimed.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as currently elected claims 1-18, only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
It is further to be noted that the claimed invention of claims 7-18 is “An artificial tissue”; thus, only the claimed structure of the final device, i.e. the artificial tissue, bears patentable weight; any other structure, such as for example the tissue maintenance system, and/or housing units, and/or nutrient source, does not hold patentable weight, will only be considered to the extent that it further defines the claimed structure of the final inventive device, i.e. the artificial tissue.
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1, 2, 7 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US PG Pub. 2020/0101194), hereinafter Kim.
Regarding claim 1, Kim discloses a bioink operational to form an artificial tissue, wherein the bioink comprises at least 20% by weight of collagen ([0025] & [0026], Lines 1-8).
Regarding claim 2, Kim discloses the bioink of claim 1, wherein the bioink further comprises a plurality of cells selected from the group consisting of tissue cells, cancer cells, immune cells, fibroblasts, or combinations thereof ([0035]).
Regarding claims 7 and 16, Kim discloses an artificial tissue, illustrated in Figure 1A, wherein the artificial tissue comprises a plurality of cells, selected from the group consisting of tissue cells, cancer cells, immune cells, fibroblasts, or combinations thereof; and a bioink embedded with the cells, wherein the bioink comprises at least 20% by weight of collagen, and wherein the artificial tissue is in the form of a three-dimensional structure, illustrated in Figure 1A ([0011]; [0025]; [0026], Lines 1-8; [0035] & [0041], Last 3 Lines).
Regarding claims 17 and 18, Kim discloses the artificial tissue of claim 7, and inasmuch as only the final product/apparatus of the claimed invention, i.e. the artificial tissue, bears patentable weight, Kim discloses all the structural limitations set forth in in the claims of the final product/apparatus of the artificial tissue, and the artificial tissue would be capable of meeting the intended use of being associated with a tissue maintenance system comprising at least two housing units, in fluid communication, for housing the artificial tissue and a nutrient source/culture medium in fluid communication with the housing unit , and therefore anticipates the claims.
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.
Claims 3, 5, 6, 8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claims 1 and 7 above, and in view of Schmidt et al. (US PG Pub. 2021/0324336), hereinafter Schmidt.
Regarding claims 3 and 8, Kim discloses the bioink of claim 1 and the artificial tissue of claim 7, but does not specifically disclose at least 80% by weight of the bioink is derived from humans.
However, Schmidt teaches a bioink, in the same field of endeavor, comprising ECM material/component comprising collagen, wherein it is known for the ECM material/component to be human ([0004] & [0053], Lines 4-5).
In view of the teachings of Schmidt, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for at least 80% by weight, of the bioink of Kim, to be derived from humans, since this is a known source of ECM material/collagen used in bioinks, as taught by Schmidt.
Regarding claims 5 and 10, Kim discloses the bioink of claim 1 and the artificial tissue of claim 7, but does not specifically disclose the collagen comprises at least collagen I, collagen III, and collagen IV.
However, Schmidt teaches a bioink, in the same field of endeavor, comprising ECM material/component comprising collagen I, collagen III, and collagen IV ([0004] & [0053], Lines 1-3).
In view of the teachings of Schmidt, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the collagen, of the bioink and the artificial tissue of Kim, to comprise at least collagen I, collagen III, and collagen IV, since these are known types of collagen of ECM material used in bioinks, as taught by Schmidt; and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the collagen comprising at least collagen I, collagen III, and collagen IV, as opposed to any other type/combination of collagen.
Regarding claims 6 and 11, Kim in view of Schmidt disclose the bioink of claim 5 and the artificial tissue of claim 10, and though it is not specifically disclosed the bioink comprises at least 25% by weight of collagen I, at least 5% by weight of collagen III, and at least 1% by weight of collagen IV, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate/optimal amounts/values of the different types of collagen in the bioink/artificial tissue, including, by weight, at least 25% collagen I, at least 5% collagen III, and at least 1% collagen IV, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the bioink comprising, by weight, at least 25% collagen I, at least 5% collagen III, and at least 1% collagen IV, as opposed to any other amount/value and/or types of collagen.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claims 1 and 7 above, and in view of Bagley et al. (US PG Pub. 2020/0179563), hereinafter Bagley.
Regarding claims 4 and 9, Kim discloses the bioink of claim 1 and the artificial tissue of claim 7, but does not specifically disclose the bioink further comprising one or more components selected from the group consisting of sodium alginate, gelatin, fibronectin, laminin, or combinations thereof.
However, Bagley teaches a bioink, in the same field of endeavor, comprising collagen and one or more components selected from the group consisting of gelatin, fibronectin, or combinations thereof ([0080]); crosslinking agents, which gelatin and/or fibronectin are known to be, improve mechanical stability and decrease the degradation rate of collagen ([0078]).
In view of the teachings of Bagley, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the bioink, of Kim, to further comprise gelatin and/or fibronectin, in order to improve mechanical stability and decrease the degradation rate of collagen, as taught by Bagley.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kim.
Regarding claims 12-14, Kim discloses the artificial tissue of claim 7, and though it is not specifically disclosed the artificial tissue is in the form of a tumor, and/or a tumor micro-environment, and or a tumor micro-environment of pancreatic ductal adenocarcinoma (PDAC), these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine shape/form for the artificial tissue, of Kim, including in the shape/form of a tumor, and/or a tumor micro-environment, and or a tumor micro-environment of PDAC, based on intended use of the artificial tissue; and doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 15, Kim discloses the artificial tissue of claim 7, and though it is not specifically disclosed the artificial tissue is in the form of a blood vessel, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine shape/form for the artificial tissue, of Kim, including in the shape/form of a blood vessel, based on intended use of the artificial tissue; and doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 10/06/2026
