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 .
The examiner acknowledges receipt of response to restriction requirement filed 03/25/2026, IDS filed 02/06/2024 and 04/30/2026.
Claims 1-18 are pending.
Election/Restrictions
Applicant's election with traverse of Groups I in the reply filed on 03/25/2026 is acknowledged. The traversal is on the ground(s) that the office action failed to establish serious search and examination burden. This is not found persuasive because the office action clearly stated that the inventions may require different field of search searching different electronic resources, employing different search queries, which is search and examination burden.
Applicant has also elected porous structure, fibroblast. Applicant then stated that claims 1-12 and 15-18 read on the elected species. The examiner disagrees with that characterization because, of the Porous structure, Cultured cell, Method for producing porous structure, Method for culturing cell, Method for producing a cultured cell, applicant elected porous structure. By electing porous structure, claims directed to Cultured cell, Method for producing porous structure, Method for culturing cell, Method for producing a cultured cell do not read on the elected porous structure.
The requirement should have been made final except that the claims are rejectable over the prior art applied against the claims.
Therefore, pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I, II and III, as set forth in the Office action mailed on 01/28/2026, is hereby withdrawn and claims 13 and 14 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
This application claims benefit of Japan applications 2023-018664 filed 02/09/2023 and 2023-21964 filed 12/15/2023.
Information Disclosure Statement
The IDS filed 04/20/2026 and 02/06/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of laminin, fibronectin, thrombin, vimentin, heparin and vitronectin is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: heparin is not a polypeptide.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jeong (US 20200254142 A1).
For claims 9 and 14, Jeong teaches preparation of injectable porous hydrogel by mixing gelatin microgels with a cross-linking enzyme transglutaminase/microbial transglutaminase in phosphate-buffered saline (PBS) (paragraph [0005]). The gelatin microgels comprises gelatin and methacrylated gelatin (GelMA) in an embodiment (paragraph [0005]) which meets the limitation of first and second polypeptides. Aqueous gelatin solution comprises plurality of microgels referred to as microgel particles and these particles have average size of from 130 micron to 250 micron (paragraph [0048]). Microbial transglutaminase meets the limitation of claim 10. Claim 9 does not contain distinction between first and second polypeptide of claim 9. Hydrogel is a gel. Jeong teaches that the gelatins are cross-linked by creating amide bonds between glutamine (Glu) and lysine (Lys) residues of gelatin that comprises the microgels; contacting the microgel with enzyme microbial transglutaminase results in cross-linking forming isopeptide bond (paragraphs [0056], [0057]).
Thus, Jeong teaches claims 9, 10 and 14.
Claim(s) 1-3, 5-8, 11-13 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jeong (US 20200254142 A1).
Claim 1 talks of first and second polypeptide without describing distinct polypeptides.
For claims 1-3, 5 and 13, Jeong teaches injectable porous hydrogel, which meets the limitation of porous comprising gelatin microgels with a cross-linking enzyme transglutaminase/microbial transglutaminase in phosphate-buffered saline (PBS) (paragraph [0005]) with microbial transglutaminase being a specific transglutaminase. The gelatin microgels comprises gelatin and methacrylated gelatin (GelMA) in an embodiment (paragraph [0005]) which meets the limitation of first and second polypeptides. Aqueous gelatin solution comprises plurality of microgels referred to as microgel particles and these particles have average size of from 130 micron to 250 micron (paragraph [0048]) with this range being a species of the claimed range in claim 5. Claims 1 and 13 do not contain distinction between first and second polypeptide of claim 1. Hydrogel is a gel. Jeong teaches that the gelatins are cross-linked by creating amide bonds between glutamine (Glu) and lysine (Lys) residues of gelatin that comprises the microgels; contacting the microgel with enzyme microbial transglutaminase results in cross-linking forming isopeptide bond (paragraphs [0056], [0057]) with the isopeptide meeting the isopeptide bond in claims 1 and 13, the glutamine and lysine residues meet claim 2, gelatin meets claim 3.
For claim 6, Jeong’s porous hydrogel contains growth factor (example 7, paragraphs [0022], [0048] and [0095]).
For claims 11 and 12, Jeong cultures cell be seeding the hydrogel with cells (paragraphs [0016], [0085], [0086], [0097], [0125]).
For claims 7 and 8 and 15 and 16 and 17, the porous hydrogel of Jeong is seeded with one or more live cells that includes endothelial cells, epithelial cells, vascular cell, vascular cells, neuronal cells, corneal epithelial cells, huma dermal fibroblast (see the whole document with emphasis on at least paragraph [0003], [0005], [0006], [0008], [0009], [0054], [0070]-[0072], [0091], [0016[, [0046]).
For claim 18, the Jeong’s gel comprises adipose cells, muscle cells, neuronal cells (paragraphs [0054], [0072]).
Therefore, Jeong teaches claims 1-3, 5-8, 11-13 and 15-18.
Prior art of Interest: Attar (US 20180256641 A1) discloses porous scaffold where the size of the pores is 2 to 500 micron, the porous scaffold comprises collagen or gelatin, cross-linker which induces cross-linking of cross-linkable protein, a liquid (paragraphs [0004]-[0031]). Cells such as pancreatic stem cells, epithelial cells, endothelial cells, mesenchymal stem cells are seeded into the injectable porous scaffold (paragraphs [0027]-0050]). The cross-linking enzyme is transglutaminase (paragraph [0120]) and the bond is lysine isopeptide bonds (paragraph [0121]).
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights