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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Claim Rejections - 35 USC § 112
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 1, 2 and 10-12 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.
Claim 1 states that the biological glass fiber forms a single bare fiber configuration “and” a hybrid construction fiber configuration. The specification states that a glass is made into a single bare fiber “or” a hybrid construction ([0011] and [0052]). It is unclear what fiber structure is necessary to be considered the claimed fiber that forms a single bare fiber configuration “and” a hybrid construction fiber configuration.
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.
Claims 1, 2 and 10-12 are rejected under 35 U.S.C. 103 as obvious over USPAP 2015/0209095 to Lu in view of USPAP 2004/0009598 to Hench, USPAP 2010/0136131 to Roberts, and/or USPAP 2019/0099515 to Bagga.
Claim 1, Lu discloses a biological (bioactive) glass fiber for regenerative medical materials, comprising a biological glass or a biologically-inert glass; wherein the biological glass fiber forms a single bare fiber configuration and a hybrid construction fiber configuration comprising a hybrid solid fiber configuration that includes an outer layer made of bioinert glass and a center made of biological glass surrounded by the outer layer, and an intermediate layer made of bioinert glass between the outer layer and the center (see entire document including [0051]). Lu explicitly discloses that the fiber comprises a core (center) layer, a middle (intermediate) layer, and a shell (outer) layer wherein at least one layer is made of bioinert glass material and at least one layer is made of bioactive (biological) glass material and wherein the core and/or middle layer is made of a bioactive (biological) glass material and the shell is made of bioinert glass [0051].
Lu does not appear to mention specific biological glass compositions but Hench discloses that it is known in the art to use a biological (bioactive) glass fiber for regenerative medical materials comprising a biological glass chemical composition comprising: 5 to 25 wt% Na2O, 45 to 67 wt% SiO2, 15 to 25 wt% CaO, and 2 to 6 wt% P2O5, based on 100 wt% of the glass chemical composition (see entire document including [0001], [0007] and [0032]-[0036]). In addition, Roberts discloses that it is known in the art to use a biological (bioactive) glass fiber for regenerative medical materials comprising a biological glass composition comprising: 5 to 25 wt% Na2O, 45 to 67 wt% SiO2, 15 to 25 wt% CaO, and 2 to 6 wt% P2O5, based on 100 wt% of the glass chemical composition (see entire document including [0012], [0034]-[0038] and [0049]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the biological (bioactive) glass of Lu from any suitable biological glass composition, such as claimed, because it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability and desired characteristics.
Claim 2, the glass chemical composition of the biological glass further comprises 1 to 8 wt% MgO and 8 to 12.5 wt% K2O ([0036] of Hench and [0038] of Roberts).
Claim 10, Lu discloses that the fiber may include bioinert glass with X-ray opacity [0051].
Claim 11, Lu does not appear to mention the fiber being made to have different regenerative material absorption times in a human or animal organism, based on either glass chemical composition modification or fiber component diameter sizing parameters, but Bagga discloses that it is known in the art to engineer components with two more materials having different regenerative material absorption times to vary the resorption rates ([0079]-[0081]). Therefore, it would have been obvious to one having ordinary skill in the art to construct the fibers of Hench as claimed to vary the resorption rates.
Claim 12, Lu does not appear to mention the fiber diameter but Bagga discloses that it is known in the art to construct fibers with a diameter of between 3 and 25µm [0078]. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the fibers with any suitable diameter, such as claimed, because it is within the general skill of a worker in the art to select a known fiber size on the basis of its suitability and desired characteristics.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been considered but are moot in view of the new ground(s) of rejection.
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 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 ANDREW T PIZIALI whose telephone number is (571)272-1541. The examiner can normally be reached Monday-Thursday 7am-5pm.
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/ANDREW T PIZIALI/Primary Examiner, Art Unit 1789