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 .
Remarks
The amendments and remarks filed on 03/25/2026 have been entered and considered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action. The rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 1 and 3-21 are pending; Claim 2 is cancelled; Claim 1 is amended; Claims 10-21 are withdrawn; and Claims 1 and 3-9 are under examination.
Withdrawal of Objections
The objection to the abstract of the specification is withdrawn due to the amendment of the abstract submitted on 03/25/2026.
The objection to the claim 5 is withdrawn due to the amendment to the claim filed on 03/25/2026.
Withdrawal of Rejections
The rejection of Claims 1, 4-5, and 7-8 under 35 U.S.C. 103 as being unpatentable over Steinberg et al. is withdrawn due to the amendment to the claims filed on 03/25/2026.
The rejections of Claims 1 and/or 3-9 under 35 U.S.C. 103 over Steinberg et al. in view of Morinaga et al., Yoshida et al., and/or Porrello et al. are withdrawn due to the amendment to the claims filed on 03/25/2026.
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
Claims 1 and 3-9 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 pre-AIA the applicant regards as the invention. This rejection is maintained.
Claim 1 is indefinite due to the limitation of “the gelatin film is configured to be in contact with a culture vessel … culture vessel”, newly added to the claim. It is noted that the claim previously defines the gelatin film is a part of the scaffold. It is unclear whether the culture vessel in direct contact with the gelatin film is also a part of the scaffold. According to the disclosure of the specification (examples 1-4), the claimed limitation is interpreted as: “the scaffold is placed in a culture vessel for producing the multicellular construct, wherein the gelatin film is configured to be in direct contact with the culture vessel … culture vessel”.
The remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 112, First Paragraph
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 is directed to a multicellular construct comprising: cells and a scaffold comprising a gelatin nonwoven and a gelatin film layered on a surface of the gelatin nonwoven. The amended claim 1, submitted on 03/25/2026, is added with the new limitation “the gelatin film is configured to be in contact with a culture vessel while the cells are not in direct contact with the culture vessel”. This new limitation requires that cells are absolutely not in direct contact with surfaces of a culture vessel, which holds the scaffold and contacts with the gelatin film of the scaffold. In another word, all the cells in the culture vessel are only in direct contact with the gelatin nonwoven and gelatin film of the scaffold, not in direct contact with the vessel. It is noted that the cells recited in the claim 1 comprises both viable cells and dead cells.
Support for the limitation “the cells are not in direct contact with the culture vessel” is not found in the instant specification. Applicant points to the paragraph 0011 and examples of the specification in the 03/25/2026 response (page 7) for a written description of this limitation, but such support is not found. It is noted that the paragraph 0011 and examples only disclose that a seeding efficiency on the layered gelatin scaffold can be improved by suppressing cell desorption through placing the scaffold on an un-treated and non-adhesive multi-well plate (i.e. culture vessel). However, there is no disclosure to support completely blocking the cell desorption from the scaffold (i.e. 100% seeding efficiency, letting no cells run off to directly contact the culture vessel). The most relevant disclosure is in the examples 1-4 of the specification, the results of which show the improved seeding efficiency of viable cells on the scaffold is in a range from 31.7% to 98.8% (see Tables 2-3). These results indicate that not all viable cells are seeded on the scaffold, and specifically at least 1% of the viable cells are not seeded on or attached to the scaffold and they run off and are in direct contact with the culture vessel, without mentioning that dead cells are not seeded on the scaffold either and they are in direct contact with the culture vessel too.
Therefore, claims 1 and 3-9 are directed to new matter.
Response to Arguments
Applicant's arguments about the objection to abstract and claim 5 in the response filed on 03/25/2026 (page 7) have been fully considered but they are moot because the objection has been withdrawn, as indicated above.
Applicant's arguments about the rejections of claims 1 and/or 3-9 under 35 USC 103 over Steinberg et al. either alone or in view of Morinaga et al., Yoshida et al., and/or Porrello et al. in the 03/25/2026 response (pages 7-9) have been fully considered but they are moot, because the 103 rejections have been withdrawn as indicated above.
In response to Applicant’s arguments based on separating multicellular construct from culture vessel as well as the biodegradable cross-linked polymer/support layer of Steinberg et al. in pages 7-8 of the response, Examiner notes that the gelatin nonwoven and gelatin film in the scaffold of instant claims are also cross-linked (as evidenced by the instant claim 6 and para 0013/lines 4-5 of the specification). As such, the claimed gelatin film may also act as binder or support for the claimed gelatin nonwoven since they all are cross-linked together (just like the gelatin film of Steinberg et al. does). In addition, Steinberg et al. expressively teach the scaffold has a layered structure comprising at least one biodegradable support layer (e.g. gelatin film) and at least one biodegradable cross-linked polymer layer (e.g. a gelatin nonwoven), see Claim 1; and there is no evidence in Fig. 1 of Steinberg et al. to support Applicant’s argument that the support layer is within the biodegradable cross-linked polymer layer. With regard to separating multicellular construct from a culture vessel, Steinberg et al. teach separating the multicellular construct for applications, such as engineering tissue and organs, preparing tissue scaffold, and dressing wound. The scaffold of Steinberg et al. has a strong strength and cells are seeded on and within the scaffold, which allows the multicellular construct of Steinberg et al. to be easily separated from a culture vessel, regardless of whether there are free-moving cells in direct contact with the vessel, or not. As such, the scaffold of the instant claims is not superior to the scaffold of Steinberg et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PMR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
Prosecution Insights