DETAILED ACTION
This Office Action is in response to the communication dated 09 February 2026 concerning Application No. 18/293,104 filed on 29 January 2024.
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 .
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 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.
Status of Claims
Claims 26-36 are pending and currently under consideration for patentability; claim 32 has been amended; claims 1-25 previously were cancelled.
Response to Arguments
Applicant’s arguments filed 09 February 2026 have been fully considered, but they are not persuasive.
Applicant argues that Song does not disclose, teach, or suggest a bio-printing process but rather is limited to a manually prepared alginate-cell construct (Arguments, p. 4). The Examiner respectfully submits that the Wang reference has been used to read on the bio-printing process.
Applicant argues that “Examiner’s assertion that Song incorporates a resting period is based on a misinterpretation of the cited passage” (Arguments, p. 5). The Examiner respectfully disagrees and directs Applicant to the rationale in the text of the rejection below, in which the Examiner describes the obviousness of incorporating a rest step similar to that recited. The passage to which Applicant refers has been used to describe the use of a calcium chloride solution and crosslinking the biodressing, not specifically the use of a 5 minute rest period.
Applicant argues that the Examiner has used Official Notice when describing that calcium chloride solutions aid in solidification of the biodressing. The Examiner respectfully disagrees, as the Song reference itself describes the use of calcium chloride solutions to aid in the solidification step. The Examiner respectfully submits that no Official Notice has been taken.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 26-28 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2015/0203820 A1) in view of Wang Song et al. (Wound Dressing Model of Human Umbilical Cord Mesenchymal Stem Cells-Alginates Complex Promotes Skin Wound Healing by Paracrine Signaling. Stem Cells Int. 2016:3269267, referred to herein as “Song”).
Regarding claim 26, Wang describes a process to obtain a three-dimensional biodressing ([0223]) comprising
three-dimensionally bioprinting mesenchymal stem cells ([0221]: “matrices, hydrogels, scaffolds, and the like that comprise hES-MSC…seeded onto a natural matrix. e.g., a biomaterial…the scaffold is obtained by 3D printing”) cultured in a xenoantigen-free medium ([0109]: “the single cells are re-suspended in a medium optimized for mesenchymal stem cell growth such as alpha-MEM containing 2-20% of fetal bovine serum, human AB serum…”) in an alginate hydrogel to create the 3D biodressing ([0221]: “the hydrogel is, e.g., an organic polymer (natural or synthetic) that is cross-linked via covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice structure…hydrogel-forming materials include polysaccharides such as alginate and salts thereof”)
crosslinking the 3D biodressing after resting ([0221]: “the hydrogel is, e.g., an organic polymer (natural or synthetic) that is cross-linked via covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice structure…hydrogel-forming materials include polysaccharides such as alginate and salts thereof…which are crosslinked ionically, or block polymers such as polyethylene oxide-polypropylene glycol block copolymers which are crosslinked by temperature or pH”; [0222], the polymers may be buffered salt solutions)
Regarding claim 26, Wang does not explicitly disclose resting the 3D biodressing for at least 5 minutes after the bioprinting. Also, although Wang describes that buffered salt solutions may be used in the crosslinking step ([0221] - [0222]), Wang does not explicitly disclose crosslinking the 3D biodressing in a calcium chloride solution after the resting. However, Song also describes a process to obtain a 3D biodressing, including crosslinking the 3D biodressing in a calcium chloride solution (§2.2.3: cells-alginate compound was solidified with 3mL 150mM sterile CaCl2 solution for 2-3 min, §4: alginate can crosslink with calcium into a calcium alginate hydrogel). As Song is also directed towards obtaining a 3D biodressing and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a calcium chloride solution similar to that described by Song when using the process described by Wang, as it is known that such solutions aid in the solidification of the biodressing.
Specifically regarding the step of resting the 3D biodressing for at least 5 minutes, as both Wang and Song incorporate resting periods in their protocols, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to rest the 3D biodressing for at least 5 minutes, as recited, prior to the crosslinking step, as doing so advantageously allows sufficient time for the biodressing to form completely prior to crosslinking.
Regarding claim 27, Wang describes wherein the mesenchymal cells are selected from mesenchymal cells derived from human adipose tissue and mesenchymal cells derived from the human umbilical cord ([0004]).
Regarding claim 28, Wang describes wherein the mesenchymal cells are cultured in human AB serum ([0109]).
Regarding claim 31, Song describes wherein the bioprinting is performed at a concentration of mesenchymal cells of 0.5×105 to 1×106 cells/mL (§2.2.3).
Regarding claim 32, Wang describes a three-dimensional biodressing obtained by the process as defined in claim 26 ([0223]).
Regarding claim 33, Wang describes a process comprising using the 3D biodressing obtained by the process as defined in claim 26 to treat a burn ([0298]), and Song describes treating a wound (Abstract).
Regarding claim 34, Wang describes wherein the using comprises applying the 3D biodressing to the burn ([0298]), and Song describes applying it to a wound (Abstract).
Regarding claim 35, Wang describes wherein the 3D biodressing has a healing, anti-inflammatory, and analgesic effect ([0185] - [0186], [0298]).
Regarding claim 36, Wang describes wherein the 3D biodressing accelerates and improves the healing process ([0298]), of which one known effect is an increase in the production of TGF-b and KGF (for example, please see Peng et al., KGF-1 accelerates wound contraction through the TGF-β1/Smad signaling pathway in a double-paracrine manner. J Biol Chem. 2019 Mar 20;294(21):8361–8370, which provides evidence for the causal relationship between the healing process and an increase in the production of these growth factors).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Song, further in view of Yoo (US 2011/0212501 A1).
Regarding claim 29, Wang in view of Song suggests the process according to claim 26, including wherein the cells are arranged within the alginate hydrogel (Wang: [0221]), but neither Wang nor Song explicitly disclose wherein the bioprinting comprises a layer-by-layer deposition of a mesh with 2 to 10 layers. However, Yoo also describes a process to obtain a three-dimensional biodressing ([0005]), including a bioprinting process that comprises a layer-by-layer deposition of a mesh with 2 to 10 layers ([0006], [0011]). As Yoo is also directed towards obtaining a 3D biodressing and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a bioprinting step similar to that described by Yoo when forming the biodressing, as doing so applies the known technique of layer-by-layer deposition of a mesh in order to form a substrate that may be used in the bioprinting process described by Wang and Song.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Song, further in view of Ozbolat et al. (US 2016/0288414 A1).
Regarding claim 30, Wang in view of Song suggests the process according to claim 26, including the use of a sodium alginate hydrogel (Song: §2.2.3), but neither Wang or Song explicitly disclose wherein the alginate is at a level of 4% weight-by-volume. However, Ozbolat also describes the use of a bioprinter, including wherein 4% weight-by-volume sodium alginate is used to form the hydrogel ([0124], [0301]). As Ozbolat is also directed towards bioprinting scaffolds and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a 4% w/v sodium alginate hydrogel similar to that described by Ozbolat when using the process described by Wang and Song, as this is a known concentration of sodium alginate that can be used to make a suitable hydrogel.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792