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 .
This action is responsive to papers filed 07/22/2026.
Claims 1, 4-9, 21, and 25 have been amended.
No claims have been newly added or newly canceled.
Claims 1-10 and 21-30 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claim 1 recites a molar composition of 16Na2O-24CaO-xB2O3-(60-x)P205 (mol%), wherein x is an integer from 20 to 40. Claim 4 recites where x is from 20 to 30.
Applicant has calculated in their response filed 07/21/2026 that these molar concentrations correspond to weight concentrations of 10.5-12.5 wt% Na2O, 14.3-16.9 wt% CaO, 14.8-35 wt% B2O3 and 35.7-60.4 wt% P205 for claim 1 in their response filed 07/22/2026. For claim 4 this conversion is calculated to be 14.8-24 wt% for B2O3 and 49-60.4 wt% P205.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-7-10 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kolan et al (International Journal of Bioprinting 2019-from IDS filed 03/18/2024) in view of Nazhat et al (US 2017/0274118 A1), Abokefar, Nada (Masters Theses 7972, 2021, https://scholarsmine.mst.edu/masters_theses/7972), and Kolesnikova (RU 2323252-C1-using a machine translation).
Regarding claims 1-2, 5, 21-24, Kolan disclose a bio-ink composition for use in tissue engineering and regenerative medicine (Title, abstract, page 3 Introduction). The bio-ink contains alginate, gelatin and a bioactive glass, specifically 13-93B3 glass particles, and 2 x 106 adipose derived mesenchymal stem cells per mL (ASCs)(which are adult stem cells) (page 4, column 2, page 5, column 1, section 2.3). The 13-93B3 glass was approved by the FDA for treating skin burns and chronic wounds and known to contain Na2O, CaO, B2O3 and P2O5 (borophosphate glass particles)(page 4 column 2, Table 1). The 13-93B3 glass is added at 10wt% (page 5, section 2.3) which is deemed to be a nominal amount. The glass is directly mixed with Alg-Gel hydrogel to create bioactive inks. The concentration of the bioactive glass is deemed important to achieve viable cell cultures and using lower concentrations (less than what was used which was 2.5 mg/ml and 10 wt% of the hydrogel material) is indicated as preferable (pages 11-13).
Kolan do not disclose wherein the borophosphate glass particles have the molar composition of 16Na2O-24CaO-xB2O3-(60-x)P2O5 (mol%) wherein x is an integer from 20 to 40 or 20-30.
Nazhat disclose borate-glass biomaterials as an alternative or improved bioactive glass biomaterial to be used for the repair, replacement, construction or augmentation of hard and soft tissue in response to disease, trauma and cosmetic enhancement as well as drug delivery (page 1 para 2, para 6). Nazhat detail a bioactive glass material that is aNa2O, bCaO, cP2O5, dB2O3, wherein a is from about 1-40 wt%, b is from about 10-40 wt%, c is from about 1-40 wt%, and d is from about 35-80 wt% (page 6 para 88). The bioactive glass may be formed into particles (pages 6-7 Example 1, para 104-106, page 12 claims 54-55). Suitable carrier materials include gelatin, alginate, water and hydrogels (page 3 para 26-29). Suitable bioactive agents to include with the biomaterials are cells, specifically mesenchymal stem cells (page 3 para 31-32). Suitable diameters for the bioactive glass particles are 5-100 µm or 25-75 µm (page 12 claim 55).
In converting the claimed molar values to wt%, in order to compare them to what is commonly used in the art, the claimed molar composition of borophosphate glass corresponds to about:
Na2O at 10.5-12.5 wt%
CaO at 14.3-16.9 wt%
B2O3 at 14.8-35 wt% for claim 1 and 14.8-24 wt% for claim 4.
P2O5 at 35.7-60.4 wt% for claim 1 and 49-60.4 wt% for claim 4.
The Nazhat reference has Na2O, CaO, B2O3 and P2O5 with wt% ranges that overlap the ranges of claim 1 thus renders obvious borophosphate glass particles that meet the requirements of the claimed borophosphate glass particle of claim 1 (MPEP 2144.05 I).
One of ordinary skill in the art would have been motivated to substitute the bioactive glass used in the bio-ink of Kolan with the bioactive glass particles with diameters of 5-100 µm or 25-75 µm of Nazhat because Nazhat indicate that their bioactive glass is a suitable alternative and can be an improvement over other bioactive glasses used in the art of borate glass biomaterials (page 1 para 6-7, page 12 claim 55). It is prima facie obvious to substitute equivalents known for the same purpose and in the current case the bioactive glass of Kolan and the bioactive glass of Nazhat are both known to be used in hydrogel carriers for use in regenerative medicine. An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious (MPEP 2144.06 II). One of ordinary skill in the art would have had a reasonable expectation of success because both Kolam and Nazhat include alginate, gelatin, water and hydrogels as carrier materials for their bioactive glass compositions and are both used with mesenchymal stem cells.
Regarding claims 1, 4, 6, the combined teachings of Kolan and Nazhat render obvious the claimed bio-ink as described above, but do not disclose the claimed concentrations of borophosphate glass wherein x is 20-30 or the claimed pH range.
Abokefa teach in vitro and in vivo response to a borophosphate bioactive glass tested on adipose stem cells (Title, abstract). Abokefa teach that increasing the phosphate content in a bioactive glass (BBG) can balance the basic borate ions and reduce the local pH without the need of pretreating the glass prior to use (page 8 first paragraph). Abokefa disclose wherein the borophosphate bioglass has x at 0, 40 and 60 (page 9 Table 1) which encompasses the claimed ranges for the value of x and thus renders them obvious. Abokefa teach that it has been proven that combining borate with phosphate can counter the acidic and basic effects and create a neutral pH environment which showed higher levels of cell viability, specifically ASCs (adipose stem cells) (page 26).
Kolan disclose that the use of the bioactive glass at higher concentrations could have affected the viability of the ASCs (adipose-derived mesenchymal stem cells) due to the drastic change in pH and that lower concentrations of the bioactive glass and dynamic culture conditions would be used in the future to control the pH (page 12 column 2).
Nazhat disclose that a pH adjusting agent can be used to adjust the pH of the solution after mixing the precursors (page 4 para 52).
Kolesnikova teaches methods for cultivating mesenchymal stem cells ex vivo for therapeutic use (page 1 abstract, pages 2-3 of 14). Fresh culture medium is used in a pH range of 6-8 (page 1 abstract, page 3 of 14 and page 5 of 14).
One of ordinary skill in the art would have been motivated to optimize the pH of the bio-ink of Kolan to arrive at a pH of about 6-7 because Kolesnikova teaches that this is a suitable pH for culturing MSCs. One of ordinary skill in the art would have been motivated to adjust the concentrations of borate and phosphate in the bioglass to arrive at a pH of about 6-7 because Abokefar teach and suggest that this provides a more neutral pH that is more favorable to cell viability, such as adipose stem cells. One of ordinary skill in the art would have had a reasonable expectation of success because Kolan suggest adjusting the pH of their bio-ink, Nazhat also suggests adjusting pH and Abokefar teaches how modifying the concentrations of borate and phosphate can provide a more neutral and preferable pH for cell viability.
Regarding claims 3 and 28, Kolan disclose wherein their bio-ink further comprises a crosslinker such as CaCl2 (pages 6-7), but also includes a complete culture media (CCM) which consisted of 10% fetal bovine serum (FBS, also a crosslinker according to claim 28) (page 4, column 2-page 5 column 1).
Regarding claims 7-9, Kolan disclose concentrations of gelatin, alginate, and borophosphate glass particles (page 5 section 2.3) that either fall within the claimed ranges or are reasonably close such that the claimed ranges would be obtainable through routine optimization and experimentation. Kolan also specifically suggests that the borophosphate glass particles should be used at a lower concentration (nominal) (page 12 column 2).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells would have been affected by these concentrations.
Regarding claims 10 and 29, Kolan disclose wherein water is included as a solvent to dissolve the gelatin (page 5 section 2.3).
Regarding claims 10, 26-27 and 30, Kolan disclose wherein the bio-ink includes a culture medium, specifically CCM, which includes minimal essential medium Eagle-alpha modification (α-MEM) (which also qualifies as a solvent according to claim 30)(page 4 section 2,2-page 5 section 2.3).
Regarding claim 25, Kolan disclose wherein the adipose derived stem cells (ASCs) (mammalian cells) remain viable for at least 7 days (pages 11-12, Figure 7). Nazhat discloses that cells in contact with their bioactive glass remain largely viable for at least about 1 day (24 hours) and that the viability of the cells was related to composition and ionic concentration and was controllable (page 12, Example 13 para 146).
Therefore, the combined teachings of Kolan et al, Nazhat et al, Abokefar and Kolesnikova render obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 14-17, 19-20, 22-23, and 25 of copending Application No. 18/688413 in view of Kolan et al (International Journal of Bioprinting 2019-from IDS filed 03/18/2024), Nazhat et al (US 2017/0274118 A1) Abokefar, Nada (Masters Theses 7972, 2021, https://scholarsmine.mst.edu/masters_theses/7972), and Kolesnikova (RU 2323252-C1-using a machine translation).
The claims of the copending application ‘413 are drawn to a bioactive glass composition derived from calcining a reactant composition comprising about 10 wt% to about 40 wt% B2O3; about 15 wt% to about 40 wt% P2O5; about 10 wt% to about 25 wt% CaO; about 5 wt% to about 20 wt% Na2O and other optional elements and methods of using in therapeutic applications of treating damaged or diseased tissue.
In converting the claimed molar values to wt%, in order to compare them to what is commonly used in the art, the claimed molar composition of borophosphate glass corresponds to about:
Na2O at 10-16 wt%
CaO at 12-20 wt%
B2O3 at 14.8-35 wt% for claim 1 and 14.8-24 wt% for claim 4.
P2O5 at 35.7-60.4 wt% for claim 1 and 49-60.4 wt% for claim 4.
The copending claims of ‘413 do not include limitations regarding the molar composition of the bioactive glass, however when the claimed bioactive glass is converted to wt% the reference values fall within or overlap with those claimed in the current application, and thus render obvious the claimed bioactive glass portion of bio-ink.
The copending claims of ‘413 do not include formulating the bioactive glass as a bio-ink with alginate and gelatin, but Kolan indicate that this is a desirable and beneficial use and formulation to use bioactive glass, especially one that contains Na2O, CaCO, B2O3, and P2O5, thus providing motivation for the addition of alginate and gelatin and rendering the claimed bio-ink an obvious modification with a reasonable expectation of success. Kolan also render obvious the addition of a crosslinker, such as CaCl2 and FBS, the starting concentrations for the optimization for the ingredients of the bio-ink, the further use of a solvent, the concentrations and types of the cells to be added, the expected viability of the cells, and the inclusion of cell culture medium as described above.
Nazhat suggest the addition of alginate, gelatin, and hydrogels as carriers to bioactive glass for use in regenerative medicine as described above.
Kolesnikova teaches methods for cultivating mesenchymal stem cells ex vivo for therapeutic use (page 1 abstract, pages 2-3 of 14). Fresh culture medium is used in a pH range of 6-8 (page 1 abstract, page 3 of 14 and page 5 of 14).
Abokefa teach in vitro and in vivo response to a borophosphate bioactive glass tested on adipose stem cells (Title, abstract). Abokefa teach that increasing the phosphate content in a bioactive glass (BBG) can balance the basic borate ions and reduce the local pH without the need of pretreating the glass prior to use (page 8 first paragraph). Abokefa disclose wherein the borophosphate bioglass has x at 0, 40 and 60 (page 9 Table 1) which encompasses the claimed ranges for the value of x and thus renders them obvious. Abokefa teach that it has been proven that combining borate with phosphate can counter the acidic and basic effects and create a neutral pH environment which showed higher levels of cell viability, specifically ASCs (adipose stem cells) (page 26).
One of ordinary skill in the art would have been motivated to optimize the pH of the bio-ink of Kolan to arrive a pH of about 6-7 because Kolesnikova teaches that this is a suitable pH for culturing MSCs. One of ordinary skill in the art would have been motivated to adjust the concentrations of borate and phosphate in the bioglass to arrive at a pH of about 6-7 because Abokefar teach and suggest that this provides a more neutral pH that is more favorable to cell viability, such as adipose stem cells. One of ordinary skill in the art would have had a reasonable expectation of success because Kolan suggest adjusting the pH of their bio-ink, Nazhat also suggests adjusting pH and Abokefar teaches how modifying the concentrations of borate and phosphate can provide a more neutral and preferable pH for cell viability.
The combined teachings of the copending claims of “413, Kolan et al, Nazhat et al, Abokafer and Kolesnikova render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive. Applicant’s arguments have been addressed in so far as they relate to the new rejections above.
Applicant argues that the amendment to claim 1 wherein x is an integer from 20 to 40 has now provided borophosphate glass particles with weight concentrations of B2O3 at 14.8-35 wt% and P2O5 at 35.7-60.4 wt% and that this overcomes the obviousness rejection.
This is not found persuasive. The Nazhat reference has Na2O, CaO, B2O3 and P2O5 with wt% ranges that overlap the ranges of claim 1 thus renders obvious borophosphate glass particles that meet the requirements of the claimed borophosphate glass particle of claim 1 (MPEP 2144.05 I).
Applicant argues that the amendment to claim 4 wherein x is an integer from 20 to 30 has now provided borophosphate glass particles with weight concentrations of B2O3 at 14.8-24 wt% and P2O5 at 49 to 60.4% both of which are wholly outside the values outside of the values of Nazhat and that this overcomes the obviousness rejection. Applicant argues that the presently claimed glass particles comprise B2O3 and P2O5 on the opposite end of the concentration spectrum as taught by Nazhat.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which renders obvious wherein x is an integer from 20 to 30 as described above.
Applicant argues that nothing within the disclosure of Nazhat would have directed one skilled in the art to the claimed glass particles because Nazhat makes clear that the biomaterials disclosed therein are meant to distinguish borophosphate glasses, specifically from glasses containing boron.
This is not found persuasive. Nazhat indicates that their bioglass can be modified for pH and the teaching of Abokefa also provides teachings that motivate the person of ordinary skill in the art to modify the concentrations of borate and phosphate to achieve a more favorable pH for cell viability as described above.
Applicant argues that the inventors have discovered that bio-ink as claimed is surprisingly amenable for the printing of three-dimensional scaffolds for delivery of target therapeutics such as stem cells for tissue regeneration.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which teaches and suggests the modification of a borophosphate bioactive glass for delivery of target therapeutics such as stem cells for tissue regeneration.
Applicant argues that conventional borate and silicon containing glasses, such as Nazhat, create pH shock to the system /solution. Applicant argues that this is particularly observed to be detrimental under static in vitro conditions.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which teaches and suggests the modification of a borophosphate bioactive glass for a more neutral pH that is not detrimental to cells as described above.
Applicant argues that glasses taught by Kolan are discussed by the current inventors as contributing to reduced cell viability as compared to bio-inks that lack these glass particles. Applicant argues that samples having too low or too high of an X value experience undesirable pH extremes. Applicant asserts that unlike the cited prior art that the claimed glass particles are particularly suited for producing alginate-gelatin bio-inks that do not experience a pH shock and are useful for biomedical applications. Applicant asserts that the claimed bio-ink is surprisingly useful for fabrication of human tissue scaffolds and has potential to repair and replace damaged or diseased tissue. Applicant argues that because the claimed glass particles avoid pH shock the bio-ink can be loaded with substantially higher concentrations of cells than conventional bioactive glasses, without a corresponding loss of cell viability.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which teaches and suggests the modification of a borophosphate bioactive glass for a more neutral pH that is not detrimental to cells as described above.
Applicant argues that neither Kolan nor Nazhat provide any direction as to the surprising results of the claimed invention that would have led one of ordinary skill in the art to select the specifically claimed glass particles in a bio-ink with the claimed pH range.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which teaches and suggests the modification of a borophosphate bioactive glass for a more neutral pH that is not detrimental to cells as described above.
Applicant argues that Kolesnikova fails to overcome the deficiencies of Kolan and Nazhat with respect to the identity of the borophosphate glass particles.
This is not found persuasive. The obviousness rejection has been modified to include the teachings of Abokefa which teaches and suggests the modification of a borophosphate bioactive glass for a more neutral pH that is not detrimental to cells as described above.
Applicant argues that, with regard to the double patenting rejection, the combined teachings of the co-pending claims of the ‘413 application, Kolan, Nazhat and Kolesnikova do not render obvious the currently pending claims for the same reasons as described above.
This is not found persuasive for the same reasons as described above.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dhinasekaran et al., “Fabrication of Bioactive Structures from Sol-Gel Derived Bioactive Glass”, Bioactive Glasses and Glass-Ceramics: Fundamentals and Applications, First Edition, 2022, Chapter 6, pp. 87-117.
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 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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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