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 with traverse of Group II (claims 6-9) in the reply filed on Oct. 22, 2025 is acknowledged.
The traversal is on the ground(s) that restriction is proper only if the claim groups are patentably distinct and there would be a serious burden on the examiner without the restriction being imposed, citing MPEP 803. This is not found persuasive because restriction was under 35 USC 121 and 372 and the lack of unity standard was applied. Under the lack of unity analysis, there is no assessment of burden. MPEP chapter 1800 applies to national stage application under 35 USC 371; MPEP chapter 800 applies only to regular domestic applications, under 35 USC 111(a).
The traversal is additionally on the ground(s) that the restriction asserted that a special technical feature was not present without assessing the special technical feature as interpreted in light of the description. This is not found persuasive because no additional analysis has been provided to demonstrate where in the description the limitations of the claim are defined in such a way that the prior art does not teach the technical feature shared by the method and product claims, rather a blanket assertion has been made that this did not happen. As explained in the restriction dated Aug. 22, 20225 and below in the prior art rejection, the technical feature shared by the method claims and the product claims (that is the limitations of the supporting bath recited in claim 1) do not make a contribution over the prior art and are therefore a technical feature, not a special technical feature. As such, unity of invention is not present.
The traversal is additionally on the ground(s) that under 37 CFR 1.475(b), different categories of invention have unity of invention when limited to certain combinations, including (as claimed) a product and process of using that product. This is not found persuasive because multiple categories of invention are only examined when they have unity of invention – e.g. all of the claims that fit into the categories delineated in 37 CFR 1.475(b) share a special technical feature. See MPEP 1850, 13.1-13.2 As explained in the restriction dated Aug. 22, 20225 and below in the prior art rejection, the technical feature shared by the method claims and the product claims (that is the limitations of the supporting bath recited in claim 1) do not make a contribution over the prior art and are therefore a technical feature, not a special technical feature. As such unity of invention is not present and groups of inventions are not required to be considered unless and until unity of invention is present.
Lastly, the traversal is on the ground(s) that group II includes all the limitations of group I, as the method of group II includes the product of group I. As explained in the restriction dated Aug. 22, 20225 and below in the prior art rejection, the technical feature shared by the method claims and the product claims (that is the limitations of the supporting bath recited in claim 1) do not make a contribution over the prior art and are therefore a technical feature, not a special technical feature.
Applicants further request that if the restriction requirement is maintained, rejoinder of “any claim depending from, or otherwise including all of the limitations of, a claim of the elected group found allowable. See MPEP 821.04(b). This is inapplicable here because (1) MPEP chapter 800 applies only to regular domestic applications, under 35 USC 111(a), not to national entry application under (the present application) 35 USC 371; (2) the method claims recite the inclusion of the product claim as recited in claim 1 – any product claims will not include all of the limitations of an allowable method claim; rather the inverse would be true – any method claims that depend from an allowable product claim would include all the limitations of an allowable product claim. As applicants have elected to pursue the method claims, this does not apply; (3) the title of the recited MPEP cite 821.04(b) “Rejoinder of Process Requiring an Allowable Product [R-07.2022] is not applicable to the current situation. The claims being examined are method claims. Any allowable claims will be method claims. This provision addresses rejoining process claims that require an allowable product. Since process (method) claims, not product claims have not been elected, there will be no allowable product claims which would require rejoinder of process claims. Rather the inverse of the situation described in MPEP 821.04(b) is present and this MPEP section does not address the inverse situation.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 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. Applicant timely traversed the restriction (election) requirement in the reply filed on Oct. 22, 2025.
Claims 1-5 are withdrawn. Claims 6-9 are examined below.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Japanese Patent Application No. JP2020-056029 filed on March 26, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is March 26, 2020.
Information Disclosure Statement
The information disclosure statements filed Nov. 29, 2022; June 25, 2024; Feb. 20, 2025 and Sept. 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
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 6-9 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.
Claim 6 recites forming a three-dimensional tissue precursor (step (i)), dissolving the gel of the supporting bath (step (ii)) and then “culturing a three-dimensional tissue”. How is this three-dimensional tissue related to the three-dimensional tissue precursor recited in step (i)? As currently recited, there is no relationship between the three-dimensional tissue of step (iii) and the three-dimensional tissue precursor recited in step (i). Does dissolving the gel turn the tissue precursor into a non-precursor tissue? Or does step (iii) merely require that a different three-dimensional tissue is cultured, after steps (i) and (ii) are performed?
Further, claim 6, in step (iii), recites “a step of culturing a three-dimensional tissue in an obtained solution. (emphasis added). The recitation of the “obtained solution” is unclear and indefinite. Is this solution intended to be a specific solution? Any solution that can be used for culturing cells? Any solution for culturing could be described as “obtained,” as in one obtains a solution for culturing cells and then cultures the cells in the obtained solution. If this is the case for this claim, it would be less confusing to recite that the cells are cultured in a solution. If the intention of reciting “an obtained solution” is to indicate that the solution is that produced by/resulting from the dissolution of the gel of the supporting bath, then the step of dissolution should recite that a solution is formed, thereby clarifying that “the obtained solution” would be a solution formed during step (ii).
With respect to both of the issues identified in claim 6, provision of additional limitations in the claims explaining how these elements relate to later structures would resolve this indefiniteness.
Claims 7-9 do not provide additional clarification with respect to the problematic limitations of claim 6 and are rejected on the same basis as claim 6.
For the purposes of examination, the claim elements at issue in claim 6 and their relationships are interpreted broadly, that is, the elements need not be related to previously recited potentially related elements. However, art is applied that would cover the narrowest interpretation of the claim, as it will cover both the broad and the narrow interpretations of the 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) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Matsusaki (WO 2017/141691 A1, cited in IDS filed on Nov. 29, 2022, citing to US Patent App. 2019/0093070, its English counterpart, as noted on the IDS) in view of Huang (WO 2018/191244 A1, cited in IDS filed on Nov. 29, 2022, citing to US Patent App. No. 2020/0239824 A1, as noted on the IDS).
The claims are directed to methods of making a cultured three-dimensional tissue including the steps of (1) forming a three-dimensional tissue precursor in a supporting bath (the bath including a container for 3D culturing and a thixotrophic gel including a polymer and water that is capable of dissolving in a solvent) using three-dimensional printing; (2) dissolving the gel and (3) culturing a three-dimensional tissue in an obtained solution.
Matsusaki teaches a method of producing a three-dimensional tissue with a vascular structure by producing a template of a vascular system structure, forming a three-dimensional tissue adjacent to the template, then dissolving the template with a cationic solution and seeding blood vessel endothelial cells in the void left after the dissolution. (paras. [0013]-[0017], [0046], [0057Fig. 4). The template can also have blood vessel endothelial cells or smooth muscle cells seeded on it. (paras. [ 0018], [0020]-[0023]). Matsusaki further teaches that the template and three-dimensional tissue are formed on an appropriate substrate, including cell culture containers, such as plates, bottles, flasks, tubes, etc. (para. [0077]). Matsusaki teaches selective patterning of the 3D precursor tissue (in this case creating a void to then form a vascular structure in its place) by dissolving the gel. (Fig. 3, paras. [0013]-[0017]. Matsusaki teaches a dissolvable gel that is gellan gel (GG), which includes a polymer and water, is thixotrophic, and dissolves in cationic solution. (paras. [0069] –[0071]).
Matsusaki does not teach three-dimensional printing of the tissue precursor into a culture container that includes the gellan gel. Matsusaki teaches that the template could be made using an ink jet printer, in addition to other common production methods. (para. [0074]).
Huang teaches methods of using soft polysaccharide hydrogels for organoid culture that include 3D cell culture. (Abstract). Huang teach three-dimensional printing of the cell containing hydrogels (para. [0036]), which include gellan gum. (para. [0072]). Huang teaches gellan gum is made into a hydrogel (gellan gel) by directly mixing the polymer with water-based solvents and that such hydrogels are useful for 3D cell culture and bioprinting. (para. [0072]).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Matsusaki to incorporate 3D printing a tissue precursor (as taught by Huang) into a culture container that contained gellan gel already because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating these modifications would have led to predictable results with a reasonable expectation of success because both Matsusaki and Huang teach that gellan gel can be used to print or form 3D tissue precursors and Matsusaki teaches dissolution of the gel to pattern a tissue precursor so that the tissue/organoid can be finished (e.g. a vascular structure can be created by seeding vascular endothelial cells in the void created by the dissolution).
With respect to dependent claims 7-9, Matsusaki teaches that the gel is dissolved in the solvent (“cationic solution”), a solution that is added for dissolution (claim 8). (para. [0078]). The cationic solution can be an aqueous tris solution (claim 9). (para. [0071]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634