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 .
This action is in response to the papers filed on 07/30/2026. Claims 1-20 are
currently pending as per claims filed on 07/30/2026.
Applicant’s election of Group II, without traverse, of claims 10-12, 16, and 17 in the reply filed on 07/30/2026 is acknowledged.
Therefore, claims 1-9,13-15, and 18-20 are withdrawn from further consideration
pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no
allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 10-12, 16, and 17 are subject to examination to which the following grounds of rejection are applicable. Claim 10 and 16 are independent claims.
Priority
The instant application is a CON of PCT/JP2022/044794 filed 12/05/2022 which
claims benefit of foreign filed applications JAPAN 2021-197665 filed 12/06/2021
and JAPAN 2021-197639 filed 12/06/2021. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) JAPAN 2021-197665 filed 12/06/2021 and JAPAN 2021-197639 filed 12/06/2021.
Filing of certified untranslated copies of the applications JAPAN 2021-197639 and JAPAN 2021-197665 is acknowledged.
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.
Thus, the earliest possible priority for the instant application is 12/06/2021.
Claim Rejections - 35 USC § 112 (b)
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 10 amd12 is 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 10 recites “retaining a first solution including a multibranched polymer…”. It is unclear how the first solution is being “retained”, the meaning of “retaining” a first solution, and if the second solution is also “retained” or not. Appropriate correction is required.
Claim 12 recites wherein the first solution and the second solution are brought into contact with each other at a resolution of 500 μm or less. It is unclear if the resolution is caused by the dispersal of ink-jet method directly, if the resolution indicates the hydrogels are a size of 500 μm or less, or there is an alternative meaning to the phrase “brought into contact with each other at a resolution of 500 μm”. The specification does not disclose the meaning of the phrase. Appropriate correction is required.
Claim Interpretation
Regarding claim 12, the recitation “brought into contact with each other at a resolution of 500 μm or less”, the examiner is interpreting this to mean when the first and second solution are brought in contact with each other, the size of the contact is 500 μm or less.
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.
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.
Claim(s) 10-12, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh et al (WO2020189645A1) and further in view of Yoo et al (gels, 2021, pages 1-17), and as evidenced by Sunbright (SUNBRIGHT® PTE-100SH – NOF AMERICA CORPORATION, pages 1-4).
The applied Satoh reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1). The publication dated for Satoh is September 24, 2020. The earliest effective filing date of the instant application is December 06, 2021.
Therefore rejection under 35 U.S.C. 103 CANNOT be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(c) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Because the reference qualifies as prior art under 102(a)(1), the provisions of MPEP 717.02 do not apply.
Regarding claim 10, Satoh teaches a method for producing a cell culture carrier, comprising a first solution containing a polymer having a polyethylene glycol backbone and having one or more nucleophilic functional groups or electrophilic functional groups at its side chains and/or terminals, and a gel forming step of depositing a second solution containing a polymer having a polyethylene glycol backbone and having one or more nucleophilic functional groups or the other functional group at its side chains and/or terminals using a droplet dispensing device to bring the second solution into contact with the first solution (i.e. landing droplets of a second solution from a droplet dispensing device), thereby forming one or more hydrogels (page 12, para 5, 7, 8) and that the second solution contains cells (page 12, last paragraph). Satoh teaches that the PEG in the first solution can be a Tetra-PEG-SH (Example 1, page 19). It is noted that “-SH” indicates a thiol nucleophilic functional group at each arm terminus as evidenced by Sunbright (page 1).
Satoh does not teach that the second solution contains a linear polymer and the linear polymer is protein, peptide, or polysaccharide.
However, one of ordinary skill in the art would have considered the teachings of
Yoo as this reference is analogous prior art pertaining to hydrogels comprising thiol-functionalized PEG polymers and maleimidyl-functionalized gelatin for bioprinting, cell culture, and tissue engineering purposes.
Yoo teaches a method of making hydrogels comprising hyaluronic acid maleimide (HA-Mal) and gelatin-maleimide (Gel-Mal; i.e. a polysaccharide) which is crosslinked with PEGDSH crosslinker (i.e. a PEG polymer functionalized with -SH thiol group) also comprised within the hydrogel (page 5, 2.2. Hydrogel Preparation). Yoo teaches hydrogels comprising defined extracellular matrix material, such as Gel-Mal as described by their protocol, are advantages over fully synthetic materials such as only PEG because they provide support for cell types of many lineages, including difficult to culture cell populations, due to preservation of ECM-bound growth factors and cytokines, and are more advantageous than complex natural ECM materials since complex natural ECM materials cannot be completely defined or controlled, posing hurdles in terms of regulatory hurdles and clinical translation (page 2, para 2).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to substitute the highly branched polymer having a PEG backbone in the second solution of Satoh with a Gel-Mal linear polymer from Yoo as Yoo teaches that Gel-Mal has advantages in supporting cells compared to using synthetic material such as PEG only. One would be motivated to combine the teachings to enhance the culture of cells due to providing an optimal cell growth environment. As PEG and Gel-MA have been used in the art as hydrogel materials, one would have a reasonable expectation of success.
Regarding claim 11, the teachings of Yoo and Satoh render obvious claim 10. Moreover, Satoh teaches the first solution may be ejected using a droplet ejection method such as the inkjet method (page 12, para 5) and are dispensed to come in contact with the second solution (page 12, para 7), rendering obvious wherein when the first solution and the second solution are brought into contact with each other, at least one of the first solution and the second solution is discharged by an ink jet method.
Regarding claim 12, the teachings of Yoo and Satoh render obvious claims 10 and 11. Moreover, Yoo teaches that the droplets formed from dispersing of the second solution are at a pitch of 20 × 20 and 400 μm (Example 1, page 19).
Regarding claim 16 and 17, Satoh teaches a method for producing a cell culture carrier, comprising a first solution containing a polymer having a polyethylene glycol backbone and having one or more nucleophilic functional groups or electrophilic functional groups at its side chains and/or terminals, and a gel forming step of depositing a second solution containing a polymer having a polyethylene glycol backbone and having one or more nucleophilic functional groups or the other functional group at its side chains and/or terminals using a droplet dispensing device to bring the second solution into contact with the first solution, thereby forming one or more hydrogels (page 12, para 5, 7, 8) and that the second solution contains cells (page 12, last paragraph). Satoh teaches that the PEG in the first solution can be a Tetra-PEG-SH (Example 1, page 19). It is noted that “-SH” indicates a thiol nucleophilic functional group at each arm terminus as evidenced by Sunbright (page 1). Satoh teaches that the first and second solutions used in this process may or may not contain cells (page 3, para 2 and 4).
Satoh does not teach that the second solution contains a linear polymer and the linear polymer is protein, peptide, or polysaccharide (claim 16) and wherein the linear polymer is gelatin (claim 17).
However, one of ordinary skill in the art would have considered the teachings of
Yoo as this reference is analogous prior art pertaining to hydrogels comprising thiol-functionalized PEG polymers and maleimidyl-functionalized gelatin for bioprinting, cell culture, and tissue engineering purposes.
Yoo teaches a method of making hydrogels comprising hyaluronic acid maleimide (HA-Mal) and gelatin-maleimide (Gel-Mal; i.e. a polysaccharide) which is crosslinked with PEGDSH crosslinker (i.e. a PEG polymer functionalized with -SH thiol group) also comprised within the hydrogel (page 5, 2.2. Hydrogel Preparation). Yoo teaches hydrogels comprising defined extracellular matrix material, such as Gel-Mal as described by their protocol, are advantages over fully synthetic materials such as only PEG because they provide support for cell types of many lineages, including difficult to culture cell populations, due to preservation of ECM-bound growth factors and cytokines, and are more advantageous than complex natural ECM materials since complex natural ECM materials cannot be completely defined or controlled, posing hurdles in terms of regulatory hurdles and clinical translation (page 2, para 2).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to substitute the highly branched polymer having a PEG backbone in the second solution of Satoh with a Gel-Mal linear polymer from Yoo as Yoo teaches that Gel-Mal has advantages in supporting cells compared to using synthetic material such as PEG and is a defined composition that has controllable properties. One would be motivated to combine the teachings to enhance the culture of cells due to providing an optimal cell growth environment and have a defined composition that is controllable. As PEG and Gel-Mal have been used in the art as hydrogel materials, one would have a reasonable expectation of success.
Provisional Rejection, Obviousness Type 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 10 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17479037 as per claims filed on 12/18/2025, in view of Yoo et al (gels, 2021, pages 1-17). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the cited claims of Application No. 17479037. It is noted that copending application has received a notice of allowance, but has not yet issued. Upon issuance as a US Patent, this rejection will become non-provisional.
The claims of co-pending application 17479037 are drawn to a method for producing a cell culture carrier comprising:
retaining a first solution containing a multiple branching polymer with one or more nucleophilic functional groups or electrophilic functional groups at a side chain(s) and/or a terminal(s), comprising polyethylene glycol as a backbone, and
forming one or more hydrogels by landing a droplet of a second solution discharged into air from a droplet discharge device in the first solution so that the droplet contacts with the retained first solution and stacking a cell acting gel containing a cell acting additive on the one or more hydrogels, wherein the second solution contains a multiple branching polymer with one or more other nucleophilic functional groups or other electrophilic functional groups at a side chain(s) and/or a terminal(s), comprising polyethylene glycol as a backbone, and
at least one or more of the first solution, the second solution, and the cell acting gel contains a dispersion medium, and at least one or more of the first solution, the second solution, and the cell acting gel contains cells.
The instant application differs from claim 1 by requiring the second solution to include a linear polymer and the linear polymer is a protein, peptide, or polysaccharide.
However, at the time the invention was made, Yoo teaches a method of making hydrogels comprising hyaluronic acid maleimide (HA-Mal) and gelatin-maleimide (Gel-Mal; i.e. a polysaccharide) which is crosslinked with PEGDSH crosslinker (i.e. a PEG polymer functionalized with -SH thiol group) also comprised within the hydrogel (page 5, 2.2. Hydrogel Preparation). Yoo teaches hydrogels comprising defined extracellular matrix material, such as gelatin-maleimide (Gel-Mal) as described by their protocol, are advantages over fully synthetic materials such as only PEG because they provide support for cell types of many lineages, including difficult to culture cell populations, due to preservation of ECM-bound growth factors and cytokines, and are more advantageous than complex natural ECM materials since complex natural ECM materials cannot be completely defined or controlled, posing hurdles in terms of regulatory hurdles and clinical translation (page 2, para 2).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to substitute the highly branched polymer having a PEG backbone in the second solution of Sato with a Gel-Mal linear polymer from Yoo as Yoo. One would be motivated to combine the teachings to enhance the culture of cells due to providing an optimal cell growth environment and Gel-Mal is a defined composition with controllable properties. As PEG and Gel-Mal have been used in the art as hydrogel materials, one would have a reasonable expectation of success.
Therefore, in view of the Yoo teaching Gel-MA having advantages in supporting cells compared to using only synthetic material such as PEG for the hydrogel composition, it would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to modify the instantly claimed method to Gel-Mal as taught by Yoo to generate a hydrogel that comprises both gelatin and PEG such that is tunable and defined for controlled cell culture.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliana Candelaria whose telephone number is (571)272-5488. The examiner can normally be reached Monday - Friday 8am - 5pm.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Prosecution Insights