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 .
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 1 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. US 17/635658 in view of Li et al. (Hydroxyethyl Cellulose As a Rheological Additive for Tuning the Extrusion Printability and Scaffold Properties, 2021). Claim 1 of González recites the following:
“A method for the preparation of a perfusable scaffold for cell culture , the method comprising : providing a bioink composition and a fugitive ink com position ; chaotic printing the bioink composition and the fugitive ink composition to generate a microstructured precursor comprising a plurality of lamellar structures formed from the bioink composition ; curing the bioink composition to form a cured scaffold precursor ; and removing the fugitive ink from the cured scaffold precursor , thereby forming the perfusable scaffold”
This reads verbatim on claim 1 of the claimed invention up until the last line wherein the requirement for HEC is incorporated. Additionally, regarding claim 27, González teaches use of a housing element which encloses the plurality of perfusable scaffolds. (0127) However, Li et al. teaches use of HEC as an additive to bioink compositions for the purpose of improved scaffold swelling to cause better cell adhesion, molecular permeability, and can also tune scaffold degradation, giving one skilled in the art motivation to incorporate it into the bioink taught by González. (Pg 96, Conclusion) As such, it would be obvious to a person of ordinary skill in the art to incorporate HEC into the composition and method as taught by González to arrive at the method step of claim 1 of the present invention.
Furthermore, claims 2, 3, 5-13, 15-17, and 24-25 of the claimed invention appear to match nearly verbatim to claims 2, 3, 5-13, 15-17, and 24-25 of González (outside of the improper dependency of the claims in González) and claims 57-58 of the claimed invention appear to match claims 27 and 28 of González, barring dependency.
This is a provisional nonstatutory double patenting rejection.
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.
Claim(s) 1-3, 513, 15-17, 24-25, 27, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over González et al. (WO 2021/062411 A1) in view of Li et al. (Hydroxyethyl Cellulose As a Rheological Additive for Tuning the Extrusion Printability and Scaffold Properties, 2021).
Regarding claims 1 and 27: González et al. teaches in claim 1 on page 68 of the reference the following: “A method for the preparation of a perfusable scaffold for cell culture, the method comprising: providing a bioink composition and a fugitive ink composition; chaotic printing the bioink composition and the fugitive ink composition to generate a microstructured precursor comprising a plurality of lamellar structures formed from the bioink composition;
curing the bioink composition to form a cured scaffold precursor; and removing the fugitive ink from the cured scaffold precursor, thereby forming the perfusable scaffold.” This reads on the entirety of claim 1 except for the addition of hydroxyethyl cellulose. Regarding claim 27, González further teaches that a housing may enclose the plurality of perfusable scaffolds. (Pg 29, ln 20-26) As such, this would lead to the perfusable scaffold being disposed within the housing after removal from the cured scaffold precursor.
Li et al. teaches a method in which different concentrations of hydroxyethyl cellulose (hereafter HEC) were added to printed bioink based structures. It was found that the addition of HEC improves the printability of the bioink without reducing the biocompatibility of said bioink. (Pg 88, Abstract) Li further teaches that HEC can increase rheological properties of said bioink printed constructs up to 100 times in order to stabilize complex structures and improve printing fidelity. (Pg 88, Abstract) Lastly, Li teaches that HEC is able to convert nonviscous inks into directly printable inks, improve scaffold swelling, aid cell adhesion, improve molecular permeability, and tune scaffold degradation. (Pg 96, Conclusion)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li of incorporation of HEC into the printable bioink composition taught by González. One skilled in the art would have had motivation and a reasonable expectation of success based on the teachings of Li, who state that incorporation of HEC into a bioink composition leads to improved permeability, scaffold swelling, cell adhesion, molecular permeability, and allow for the tunability of scaffold degradation.
Regarding claim 2: Claim 2 of González recites “The method of claim 1, wherein the method further comprises dispersing a population of cells in the bioink composition prior to the chaotic printing”, reading fully on claim 2 of the claimed invention
Regarding claim 3: Claim 3 of González recites “The method of claim 1, wherein the method further comprises seeding the perfusable scaffold with a population of cells”, fully reading on claim 3 of the claimed invention.
Regarding claim 5: Claim 5 of González recites “The method of any of claim 1-4, wherein chaotic printing of the bioink composition and the fugitive ink composition comprises inducing laminar flow of the bioink composition and the fugitive ink composition through a mixer that chaotically mixes the bioink composition and the fugitive ink composition to form lamellar interfaces between the bioink composition and the fugitive ink composition.”, fully reading on claim 5 of the claimed invention.
Regarding claim 6: Claim 6 of González recites “The method of any of claims 1-5, wherein chaotic printing of the bioink composition and the fugitive ink composition comprises coextruding the bioink composition and the fugitive ink composition through a mixer that chaotically mixes the bioink composition and the fugitive ink composition to form lamellar interfaces between the bioink composition and the fugitive ink composition.”, reading fully on claim 6 of the claimed invention.
Regarding claim 7: Claim 7 of González recites “The method of any of claims 5-6, wherein the mixer comprises a static mixer, such as a Kenics static mixer”, reading fully on claim 7 of the claimed invention.
Regarding claim 8: Claim 8 of González recites “The method of any of claims 1-7, wherein the perfusable scaffold an average striation thickness of from 10 nm to 500 µm.”, reading fully on claim 8 of the claimed invention.
Regarding claim 9: Claim 9 of González recites “The method of any of claims 1-8, wherein the perfusable scaffold exhibits a surface-area-to-volume (SAV) of from 400 m-1 to 5000 m-1.”, fully reading on claim 9 of the claimed invention.
Regarding claim 10: Claim 10 of González recites “The method of any of claims 1-9, wherein the perfusable scaffold exhibits a surface density of at least 0.05 m2 cm-3.”, reading fully on claim 10 of the claimed invention.
Regarding claim 11: Claim 11 of González recites “The method of any of claims 1-10, wherein the perfusable scaffold is produced in the form of a fiber.”, reading fully on claim 11 of the claimed invention.
Regarding claim 12: Claim 12 of González recites “The method of any of claims 1-11, further chaotic printing the bioink composition and the fugitive ink composition comprises 3D printing, electrospinning, extrusion, or any combination thereof.”, reading fully on claim 12 of the claimed invention.
Regarding claim 13: Claim 13 of González recites “The method of any of claims 1-12, wherein the bioink composition comprises a polymer.”, reading fully on claim 13 of the claimed invention.
Regarding claim 15: Claim 15 of González recites “The method of any of claims 13-14, wherein the polymer comprises a polysaccharide, such as alginate, hyaluronic acid, agarose, or any combination thereof.”, reading fully on claim 15 of the claimed invention.
Regarding claim 16: Claim 16 of González recites “The method of any of claims 13-15, wherein the polymer comprises a protein or peptide, such as gelatin, collagen, or any combination thereof.”, fully reading on claim 16 of the claimed invention.
Regarding claim 17: Claim 17 of González recites “The method of any of claims 13-16, wherein the polymer comprises a synthetic polymer, such as a polyester (e.g., poly(propylene fumarate) (PPF), polycaprolactone, poly(lactic-co-glycolic acid), polylactic acid, polyglycolic acid, or any combination thereof).”, fully reading on claim 17 of the claimed invention.
Regarding claim 24: Claim 24 of González recites “The method of any of claims 1-23, wherein the fugitive ink composition comprises a polymer.”, reading fully on claim 24 of the claimed invention.
Regarding claim 25: Claim 25 of González recites “The method of claim 24, wherein the polymer comprises a poly(alkylene oxide) block copolymer, such as a polyoxyethylene-polyoxypropylene (PEO-PPO) block copolymers (e.g., a poloxamer).”, fully reading on claim 25 of the claimed invention.
Regarding claim 57: Claim 27 of González recites “A perfusable scaffold for cell culture prepared by the method of any of claims 1-26.”, fully reading on claim 57 of the claimed invention.
Regarding claim 58: Claim 28 of González recites “A bioreactor comprising
a plurality of perfusable scaffolds, each prepared by the method of any of claims 1-26.”, reading fully on claim 58 of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA MARIE THUESON whose telephone number is (571)272-3680. The examiner can normally be reached Monday-Friday 8:30-5.
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/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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