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 .
Claims 21-40, of record 9/11/2024, are pending and subject to prosecution.
Priority
The instant application is a CON of application 17/446563 (US patent 11981933, filed 8/31/2021). Acknowledgement is made of the applicant’s claim for benefit to provisional application 63/072659 (filed 8/31/2020)
Specification
The use of the terms LIVE/DEAD, Mach-1, and EVOS, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 recites “wherein a length of each pre-aligned microtissue the plurality of pre-aligned microtissues”, which appears to be missing one or more words.
Appropriate correction is required.
Claim Interpretation
Claims 21 recites a bioink comprising a suspension medium and a plurality of pre-aligned microtissues comprising a plurality of cells aligned in a single direction. The bioink is defined using product-by-process limitations. Product-by-process limitations are considered only in so far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant application, the bioink comprises, essentially, a suspension medium and a plurality of cells aligned in a single direction. The limitation “pre-aligned microtissues” does not appear to distinguish the bioink structurally from bioink generated by other methods. That is, “microtissue” does not appear to provide any physical structure that limits the bioink in any way apart from an effect on cell alignment. The bioink is therefore interpreted as reading on any bioink comprising a suspension medium and a plurality of cells aligned in a single direction.
The limitations “pre-aligned” and “aligned in a single direction” are not defined by the instant specification. The broadest reasonable interpretation is therefore considered to encompass the orientation of more than one cell along the same axis or plane.
The limitation “configured to be dispensed from a nozzle to form a tissue construct” is interpreted as requiring the bioink to have a viscosity such that it can flow or be extruded through a nozzle of unknown size to form a tissue construct.
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 35 and 39 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 35 recites the limitation “the exposed core” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the length to width ratio" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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)(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 21-24 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (ACS Applied Materials & Interfaces, 2019).
Chen et al. teach strategies for improving extrusion bioprinting (See Abstract).
Regarding claims 21-24 and 28: Chen et al. teach a multilayered low-viscosity GelMA (which reads on “suspension medium”, “liquid”, and “hydrogel”) bioink comprising silk fibroin particles and 3T3 fibroblasts, human umbilical vein endothelial cells, or human umbilical artery smooth muscle cells (See page 30586, col. 1, full ¶2 and col. 2, full ¶2-3 and page 30587, col. 2, ¶2). Volumes of the cell-laden bioinks were sequentially loaded into a cooled reservoir to promote gelling into discrete layers (See page 30587, col. 1, full ¶2 and fig. 1). Within each layer, the cells settled and remained at the bottom due to interfacial tension (See page 30591, col. 1, ¶1 and fig. 1 and 4-5). The settling of cells in each layer along one plane reads on “a plurality of cells aligned in a single direction”. The bioinks were extruded through a syringe fitted with a straight nozzle (which reads on “the bioink is configured to be dispensed from a nozzle”) and crosslinked under UV light after printing (See page 30587, col. 2, ¶3 and fig. 1).
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.
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 21-25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (ACS Applied Materials & Interfaces, 2019) in view of Xu et al. (Biomedical Materials, 2020).
The teachings of Chen et al. are set forth in the 102 rejection above and are incorporated herein in their entirety.
Regarding claim 25: Following the discussion of claims 21-24 and 28, Chen et al. teach a bioink comprising a photoinitiator, Irgacure 2959 (See page 30586, col. 2, full ¶3), but do not teach the use of LAP as a photoinitiator.
Xu et al. compare the effects of Irgacure 2959 and LAP for 3D bioprinting GelMA-based cellular constructs (See Abstract). Xu et al. teach that LAP is less cytotoxic during the duration of printing but with a roughly similar pore size, degradation rate, and swelling ratio versus Irgacure 2959 (See fig. 3-4 and 7-8).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the bioink of Chen et al. to comprise LAP in place of Irgacure 2959. One would be motivated to make this modification because Xu et al. teach that LAP better preserves cell viability prior to crosslinking compared to Irgacure 2959 while having similar physical properties (See fig. 3-4 and 7-8), which suggests that LAP could be readily used in its place.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-22, 26, 28, 31, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, and 12 of U.S. Patent No. 11981933. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 21-22: Patented claim 1 recites a method of printing a tissue construct wherein pre-aligned microtissues (which read on “a plurality”) are suspended in a liquid (which reads on “a suspension medium”) to create a bioink and dispensed out of a nozzle (which reads on “. The patented claim renders obvious the instant claims.
Regarding claim 26: Following the discussion of claims 21-22, patented claim 12 recites the method of patented claim 1, wherein the pre-aligned microtissues have a length to width ratio of at least 3:1. The patented claim renders obvious the instant claim.
Regarding claim 28: Following the discussion of claims 21-22, patented claim 6 recites the method of patented claim 1 wherein the cells comprise muscle cells. Patented claim 7 recites the method of patented claim 6 wherein the muscle cells are gut smooth muscle cells. The patented claims render obvious the instant claim.
Regarding claim 31: Patented claim 1 recites a method of printing a tissue construct, the method comprising: aligning cells in a single direction to create pre-aligned microtissues with the cells aligned in the single direction; suspending the pre-aligned microtissues in a liquid to create a bioink comprising the pre-aligned microtissues; and dispensing the bioink out of a nozzle such that the pre-aligned microtissues exit the nozzle in a flow direction parallel with the single direction of cell alignment to create the tissue construct. Patented claim 2 recites, in part, method of patented claim 1, wherein aligning the cells in the single direction comprises: suspending, within one or more wells located on a substrate between a first attachment structure and a second attachment structure, the cells within a hydrogel; inducing, via compaction of the hydrogel, a strain on the cells to cause the cells to align in the single direction between the first attachment structure and the second attachment structure (which reads on “aligning cells under tension in a single direction to create pre-aligned microtissues”). The patented claims render obvious the instant claim.
Regarding claim 40: Following the discussion of claims 21-22 and 31, patented claim 6 recites the method of patented claim 1 wherein the cells comprise muscle cells. Patented claim 7 recites the method of patented claim 6 wherein the muscle cells are gut smooth muscle cells. The patented claims render obvious the instant claim.
Allowable Subject Matter
Claims 27, 29-30, 32-34, and 36-38 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633