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 request for continued examination under 37 CFR 1.114, IDS, amendment and remarks filed 05/22/2026.
Claims 1-3, 9 and 18 are amended.
Claims 4 and 11 are canceled.
New claims 24 and 25 are added.
Claims 1-3, 5-7, 9-10, 12-14 and 16-25 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/22/2026 has been entered.
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 Rejection under 35 USC 102: Applicant argues that independent claim 9 has been amended to select the one or more biologically active element from the group consisting of Ag, Ca, Mg, Sr, and combinations thereof. That the removal of Boron from the list of biologically active elements overcomes Schuhladen.
Response: The examiner agrees that the exclusion of boron from the biologically active metals from the bioactive borate glass (BBG) of SCHUHLADEN overcomes the rejection of claim 9 and the claims dependent thereon over SCHUHLADEN. However, excluding boron from borate material raises different issues under 112 that will be addressed later.
For the rejection under 35 USC 103 of claims 1-7, 9, 12, and 17-23: applicant argues that the rejection should be withdrawn because SCHUHLADEN does not teach wound dressing hydrogel composition comprising bioactive borate glass (BBG) comprising at least 60 wt% of boron and that the artisan cannot get to at least 60% by routinely optimizing the BBG of SCHUHLADEN from 31% or 17.55 boron to at least 60%. Applicant also argues that for the reason presented previously above that in the current amended claim 9, the exclusion of boron from the BBG overcomes SCHUHLADEN.
Response: The examiner agrees that with respect to claim 1 that SCHUHLADEN does not teach BBG comprising at least about 60% boron. However, the boron of the bioactive borate glass (BBG) is released. For example, SCHUHLADEN teaches BBG that comprises Boron (B) which is released from borosilicate and borate BGs (page 43, first full paragraph) and Table 2 of SCHUHLADEN teaches that about 30% of B is released from borosilicate and borate BGs (page 43, first full paragraph). It is also known in the art that boron is an effective element in the wound healing process and can be applied in a topical gel formulation for the purpose of wound healing (see section 6.1 on page 5409 of Mehrabi et al, “Bioactive Glasses: A promising Therapeutic Ion Release Strategy for Enhancing Wound Healing” in ACS Biomaterials Science & Engineering, 2020, 6, 5399-5430). Therefore, before the effective date of the invention, the ordinary skilled artisan would be motivated to include borate ions in the bioactive glass that would be expected to release amount of the boron that would be expected to predictably treat/heal wound. The rejection will be maintained below. Applicant has not provided factual showing and the as filed specification has not provided data showing that BBG containing at least 60% boron provides unexpected results.
The rejection of claim 9 over SCHUHLADEN is withdrawn in light of the exclusion of Boron Cu and Zn.
Regarding applicant’s argument about Young’s modulus and crosslinking and claim 9, SCHUHLADEN teaches 3D printing as chosen method (section 2.3; first full paragraph of pages 22 and 23; section 6), furthermore, the wound dressing of SCHUHLADEN 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. Further also, the BBG of SCHUHLADEN releases bioactive metals. While SCHUHLADEN is silent as to the Young’s modulus, borate bioactive glass (BBG) and/or bioactive glass (BG) in general have Young’s modulus or elastic modulus (see sections 3, 3.2 of Qiang et al., “Bioactive glass Scaffolds for bone tissue engineering: state of the art and future perspectives: Mater Sci Eng C Bio Appl 2011 Oct 10 1245-1256 and the abstract of XIN Liu et al., “Mechanical properties of bioactive glass (13-93) scaffolds fabricated by robotic deposition for structural bone repair” in Acta Biomater, 2013 June. Therefore, the borate bioactive glass SCHUHLADEN would be expected to inherently have elastic modulus or Young’s modulus. The claims have not recited any Young’s modulus. SCHUHLADEN teaches achieving crosslinking effect and networks of crosslinked polymeric chains (page 136, line 5, 6; section 6.4.2, second paragraph; page 141, line 6; Table 13 on page 143).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 9-10, 12-14, 16-18 and 23-25 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is new matter rejection.
The amendment to claim 9 excludes boron from bioactive borate glass (BBG). Borate is derived from boron such as boron trioxide B2O3. The as filed specification teaches bioactive borate glass (BBG) and claim 9 is directed to BBG. The specification does not envision a BBG that would not have boron. Paragraph [0023] of the specification as filed teaches that biological active elements such as B, Ag, Ca, Mag, Sr, Cu and Zn can be incorporated into the glass network. Paragraph [0024] then teaches that bioactive borate glass (BBG) is a type of bioactive glass comprising borate (B2O3) as the glass network matrix. At least paragraph [0039] of the specification as filed teaches wt% amounts of boron in BBG. Therefore, the specification as filed does not envision a BBG that does not have boron. Specifically, the fact that the bioactive borate glass (BBG) has borate moiety, the BBG must have boron in the structure.
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 9-10, 12-14, 16-18, 23-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claim 9 teaches that the bioactive borate glass (BBG) does not contain boron. The BBG has a borate moiety (B2O3) Borate is (B2O3). It is unclear how bioactive borate glass (BBG) which contains boron in the borate moiety would also have boron excluded from the BBG. The issue is not resolved using the specification as a guide as the specification in paragraph [0039] teaches that BBG has boron in the amounts listed in the paragraph.
Correction is respectfully requested.
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) 1-3, 5-7 and 19-22 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, in combination with Mehrabi et al, “Bioactive Glasses: A promising Therapeutic Ion Release Strategy for Enhancing Wound Healing” in ACS Biomaterials Science & Engineering, 2020, 6, 5399-5430).
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. 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).
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 60%. However, SCHUHLADEN teaches BBG that comprises Boron (B) which is released from borosilicate and borate BGs (page 43, first full paragraph) and Table 2 of SCHUHLADEN teaches that about 30% of B is released from borosilicate and borate BGs (page 43, first full paragraph). It is also known in the art that boron is an effective element in the wound healing process and can be applied in a topical gel formulation for the purpose of wound healing (see section 6.1 on page 5409 of Mehrabi et al, “Bioactive Glasses: A promising Therapeutic Ion Release Strategy for Enhancing Wound Healing” in ACS Biomaterials Science & Engineering, 2020, 6, 5399-5430). Therefore, before the effective date of the invention, the ordinary skilled artisan would be motivated to include borate ions in the bioactive glass that would be expected to release amount of the boron that would be expected to predictably treat/heal wound. The rejection will be maintained below. Applicant has not provided factual showing and the as filed specification has not provided data showing that BBG containing at least 60% boron provides unexpected results. There is no factual showing that at least 60% boron in the BBG 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.
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 claim 5, 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 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."
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).
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, SCHUHLADEN teaches alginate and gelatin (sections 2.4.2, 4.2, 5.4.2, 5.4.3, 6.4.1).
Therefore, SCHUHLADEN in combination with Mehrabi renders claims 1-3, 5-7 and 19-22. 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.
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).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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