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 amendment and remarks filed 01/21/2026.
Claims 1, 3 and 9 are amended.
Claim 15 is canceled.
New claims 22 and 23 are added.
Claims 1-7, 9-14 and 16-23 are pending.
Priority
This application is a 371 of PCT/US2022/020382 filed 03/15/2022 and which claims benefits of 63/161,389 filed 03/15/2021.
Response to Arguments
Regarding claim 1, applicant argues that the amendment to claim 1 requiring that the bioactive borate glass (BBG) comprises at least about 60 wt% boron overcomes the rejection because SCHUHLADEN teaches BBG comprising at most 56.6% B2O3 and not the 60% now in the claim.
Response: The examiner agrees that with respect to claim 1 that SCHUHLADEN does not teach BBG comprising at least about 60% boron. Thus, the rejection of claim 1 under 35 USC 102 is withdrawn. Applicant has not presented any arguments that the claimed amount of at least about 60% for the boron provides unexpected results and the as filed specification has not shown that at least about 60% boron provides unexpected results to the wound dressing of the claims.
With respect to claim 9, applicant argues that the BBG of SCHUHLADEN does not comprise B, Ag, Ca, Mg, Sr, Cu, Zn or combinations -- SCHUHLADEN does not teach the claimed process where the hydrogel and BBG comprise one or more of the specifically claimed elements.
Response: The examiner disagrees because the BBG comprises boron, which is one of the elements. Therefore, the rejection of claim 9 will be maintained below.
For Rejections under 35 USC 103, applicant argues that for claim 1, although SCHUHLADEN teaches boron to be 56.6% of B2O3 (Table 2), SCHUHLADEN does not does not provide any indication for maximum boron. For claim 9, applicant argues the process of claim 9 as amended would not have been obvious in view of SCHUHLADEN because the BBG of SCHUHLADEN does not comprise B, Ag, Ca, Mg, Sr, Cu, Zn or combination as these elements are believed to create crosslinks between the hydrogel networks.
Response: The examiner disagrees. 56.6 is about 10% of 60% and the composition can be optimized with the goal of arriving at a wound dressing composition that would be effective. For Claim 9, BBG of SCHUHLADEN comprises boron, which is one of the elements.
For new claims 22 and 23, SCHUHLADEN contains no disclosure or direction for the artisan to arrive at the invention of claims 22 and 23.
Response: The examiner disagrees because the composition contains gelatin and alginate. A reference is considered for all that it teaches and not limited to the examples or preferred embodiments.
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.
Claim(s) 9-11, 13-14, 16 and 19 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by SCHUHLADEN, KATHARINA, “Development of multifunctional wound dressings by using newly designed ion-doped borosilicate and borate bioactive glasses,” September 2020, cited by applicant on 1449.
For claim 9, SCHUHLADEN discloses a process for preparing a bioactive borate glass (BBG) by providing MC and MH which are hydrogels (page 125) which as hydrogels broadly read on paste; MC and MH (section 4.2.1) and B3 BG (section 2.2) were used to produce the bioactive borate glass wound treatment by extrusion based 3D printing to form 3D printed constructs (first full paragraph of page 22; Figure 11; second paragraph of page 2; page 36; Table 12 at page 120; third full paragraph at page 125); the wound dressing comprises a hydrogel matrix and MC-MH solutions containing 10 wt.%, 20 wt.% and 40 wt.% of B3 BG particles with respect to the polymer content fabricated using the same parameters as described for the MC-solution fabrication which meets the limitation of up to 50 w/v % of a bioactive borate glass (BBG) with the 50% being the upper limit. “Hydrogels in general are 3D networks of crosslinked polymeric chains and can be separated into chemically and physically crosslinked materials [336]. As shown in section 4.3.1, the addition of MH into the MC hydrogel leads to the formation of covalent bonds: MH acts therefore as chemical crosslinker...at the interface between the B3 BG particles and the MC-MH hydrogel, physical crosslinks, for instance in the form of ion-bonding, can occur [336]. Since the amount of MH was not changed and therefore the degree of chemical crosslinking was kept constant, only the change of the extent of physical cross-linking due to the addition of B3 BG particles needs to be further considered.” (second full paragraph of page 136). SCHUHLADEN teaches crosslinking methods (section 2.4.2). The BBG comprises Boron (B) which is released from borosilicate and borate BGs (page 43, first full paragraph) meeting the requirement for boron (B) in the BBG.
For claim 10, SCHUHLADEN discloses further sterilizing the 3D printed constructs (last paragraph of page 146, 3rd line).
For claim 11, SCHUHLADEN discloses that methylcellulose (MC) is a biopolymer of BG (second full paragraph of page 3) and specifically SCHUHLADEN teaches B3 BG particles are comprised of MC-MH comprising 10 wt.%, 20 wt.% and 40 wt.% of B3 BG particles with respect to the polymer content (Table 12) and the methylcellulose if cellulose meeting the requirement of claim 11.
For claim 13, SCHUHLADEN discloses that different pore sizes can be obtained (last paragraph of page 20, first full paragraph of page 22 under 3D printing; section 4.3.3 at page 74).
For claim 14, the SCHUHLADEN’s 3D constructs are formed in situ (under 3D printing on page 22) ---“deposited by extrusion to build cell laden tissue construct [109].”
For claim 16, SCHUHLADEN teaches layer-by-layer processing to form 3D structures, each newly formed layer adhering to the previous layer during the printing process (paragraph under 3D printing at page 22).
For claim 19, the method of treating wound comprises applying the wound dressing of claim 1 to a wound. In SCHUHLADEN, the wound dressing is applied to a wound (first full paragraph of page 115) and SCHUHLADEN discloses treating wound (abstract at pages III-V, sections 2.1.3).
Therefore, SCHUHLADEN teaches all the elements of claims 9-11, 13-14, 16 and 19.
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) 1-7, 9, 12, 17-18, 19 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over SCHUHLADEN, KATHARINA, “Development of multifunctional wound dressings by using newly designed ion-doped borosilicate and borate bioactive glasses,” September 2020, cited by applicant on 1449, as applied to claim 9.
Claims 20 and 21 depend on claim 19.
Claims 12 and 17-18 depend from claim 9.
Claim 23 depends on claim 9.
Claims 9 and 19 have been described above to be anticipated by SCHUHLADEN.
For claim 1, SCHUHLADEN teaches wound dressing obtained by freeze drying, electrospinning and 3D printing; the wound dressing is comprised of methylcellulose (MC) and Manuka honey (MH) doped with bioactive glasses (BG) particles were made (see at least the abstract on page III and second paragraph of page III and first full paragraph on page IV). The wound dressing comprises a hydrogel matrix and up to 50 w/v % of a bioactive borate glass (BBG) comprising boron MC-MH (MC and MH are hydrogels, page 125) solutions containing 10 wt.%, 20 wt.% and 40 wt.% of B3 BG (borate BG when borate is commonly known as boron-oxygen compound, page 36) particles in respect to the polymer content were fabricated using the same parameters as described for the MC-solution fabrication (page 125, first full paragraph; page 129, first full paragraph) with the 10, 20 and 40% meeting the limitation of up to 50% as the 50% is the upper limit. Scaffolds with desired dimensions, the printing pressure and speed of the four MC-MH solutions containing 0, 10, 20 and 40 wt.% of B3 BG particles inclusions were separately optimized, as summarized in Table 12. Further, scaffolds fabricated using these parameters (Figure 78) were used for further experiments (page 125, first full paragraph as shown in Fig. 78 on page 125). SCHUHLADEN teaches boron to be 56.6% of B2O3 (Table 2) and about 30% of B which is released from borosilicate and borate BGs (page 43, first full paragraph). SCHUHLADEN differs from claim 1 by not teaching at least about 60%. However, 56.6% is about 10% of 60% which renders the at least about 60% p[rima facie obvious. There is no factual showing that at least about 60% provides unexpected results.
For claim 2, SCHUHLADEN discloses the wound dressing having at least a portion of the boron is doped with Cu, Zn (pages 144, 145) meeting the requirement of claim 2.
For Claim 3, SCHUHLADEN discloses the wound dressing wherein the BBG comprises around/about 56.6% or 30% of B which is released from borosilicate and borate BGs (page 43, first full paragraph). SCHUHLADEN differs from claim 3 by not teaching at least about 65%. The artisan guided by the teaching of SCHUHLADEN would use BBG that would have at least about 65% and with about 65% being 58.5 which at least about 65% prima facie obvious. There is no factual showing that at least about 65% provides unexpected results.
For Claim 4, SCHUHLADEN discloses that methylcellulose (MC) is a biopolymer of BG (second full paragraph of page 3) and specifically SCHUHLADEN teaches B3 BG particles are comprised of MC-MH comprising 10 wt.%, 20 wt.% and 40 wt.% of B3 BG particles with respect to the polymer content (Table 12) and the methylcellulose if cellulose meeting the requirement of claim 4.
For claim 6, the wound dressing of SCHUHLADEN is not adherent (page 20, first full paragraph) meeting the requirement that the sound dressing is non- adhesive.
For claim 7, the wound dressing of SCHUHLADEN would also be capable of autolytic debridement because it has been settled in In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) that "Products of identical chemical composition cannot have mutually exclusive properties."
Claim 12 says that the hydrogel and the BBG is 3D printed in combination with one or more living cells of epidermal keratinocytes, dermal fibroblasts and mesenchymal stem cells. Claim 5 selects living cells from epidermal keratinocytes, dermal fibroblasts and mesenchymal stem cells. SCHUHLADEN teaches wound dressings “should be ideally able to keep a moist environment, allow the migration and proliferation of relevant skin cells and be antibacterial (paragraph bridging pages 2 and 3). In SCHUHLADEN, it is noted that human skin is divided into three different layers, the epidermis, dermis and subcutaneous tissue layer and that the epidermis is composed mainly of keratinocyte, melanocytes and Langerhans; that the majority of cells in the skin layer are fibroblasts; and the second layer, the dermis contains mesenchymal stem cells (paragraph bridging pages 5 and 6). SCHUHLADEN further teaches that in an embodiment of 3D printing, the bioprinting or biofabrication, living cells, ECM components and other biomaterials are incorporated in the polymer based bioink and deposited by extrusion in order to build cell laden tissue constructs; that in bioprinting high cell densities are incorporated inside the 3D printed construct (paragraph under 3D printing at page 22, Figure 11). SCHUHLADEN does not specifically say that the living cells incorporated in the polymer based bioink is one or more of epidermal keratinocytes, dermal fibroblast or mesenchymal stem cells. But, SCHUHLADEN teaches that living cells are incorporated in the polymer based bioink and deposited to build cell laden tissue construct.
Thus, for claims 5 and 12, before the effective date of the invention, the ordinary skilled artisan would reasonably expect that incorporation into the polymer based bioink of mesenchymal stem cells or fibroblasts, which are components of the dermis, and keratinocytes, which are components of the epidermis (paragraph bridging pages 5 and 6) would predictably build cell laden tissue contract when deposited.
For claim 17, the fibroblasts or keratinocytes incorporated in the polymer based bioink would also be capable of migration and survival within the 3D printed constructs --- it has been settled in In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) that "Products of identical chemical composition cannot have mutually exclusive properties."
For claim 18, the fibroblasts or keratinocytes incorporated in the polymer based bioink would also be capable of migration or proliferation to the top and/or bottom of the 3D printed constructs --- it has been settled in In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) that "Products of identical chemical composition cannot have mutually exclusive properties."
For claim 20, the wound dressing of SCHUHLADEN would also be capable of retaining moisture for up to 7 days after application to the wound. SCHUHLADEN teaches the wound dressing of claim 1. It has been settled in In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) that "Products of identical chemical composition cannot have mutually exclusive properties."
For claim 21, the wound dressing of SCHUHLADEN comprising borate bioglass has antibacterial activity (abstract) and would also exhibit antibacterial activity for up to 7 days after application. SCHUHLADEN teaches the wound dressing of claim 1. It has been settled in In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) that "Products of identical chemical composition cannot have mutually exclusive properties."
For claim 22 and 23, SCHUHLADEN teaches alginate and gelatin (sections 2.4.2, 4.2, 5.4.2, 5.4.3, 6.4.1).
Therefore, SCHUHLADEN renders claims 1-7, 12, 15, 17-18 and 20-23 prima facie obvious.
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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). The modification is necessitated by the amendment.
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.
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