DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 6/29/2026 wherein claims 1 and 3 have been amended.
Claims 1-5 and 14 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 6/29/2026 overcome the rejection of claims 1-5 and 14 made by the Examiner under 35 USC 103 over Zhou et al. (CN 108434526; translation provided) in view of Klee et al. (Biomaterials, 2003, 24, 21, 3663-3670) and Zaarour et al. (J Applied Polymer Science, 2019, 136, 47049-47057). This rejection has been withdrawn as the references fail to teach the annealing process occurring at a temperature of between 70-120oC for between 4-6 hours.
Applicant’s amendments filed 6/29/2026 render moot the rejection of claim 3 made by the Examiner under 35 USC 112(b). This rejection has been withdrawn.
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 1-5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (CN 108434526; translation provided; of record) in view of Klee et al. (Biomaterials, 2003, 24, 21, 3663-3670; of record), Zaarour et al. (J Applied Polymer Science, 2019, 136, 47049-47057; of record) and Wilson et al. (US 5192470).
Zhou is directed to an electroactive double-layer bone-like material that is made from polyvinylidene fluoride (PVDF) fibers, the fibers having a diameter of between 150-300 nm (see claim page 4) (see instant claim 1). Th electroactive PVDF fibers are be prepared from the β form (i.e. β-PVDF) (see Example 2, page 8). As the electroactive PVDF material is described as being ‘β’ it is presumed that the beta-phase is present in about 100% of the PVDF (i.e. β-PVDF) (see instant claim 1). Zhou teaches that the electroactive β-PVDF fiber is to be plasma treated so as to produce a hydrophilic surface (see page 3) (see instant claim 1) so as to generate a surface with good biocompatibility and piezoelectric properties, capable of generating an electrical signal in response to external mechanical stimuli (see page 3). The hydrophilic β-PVDF fibers of Zhou are described as possessing the ability to promote adhesion (‘cell attachment’) of bone marrow-derived mesenchymal stem cells (BMSCs) (see Example 4) (see instant claim 1). Zhou’s β-PVDF implant having adhered BMSCs thereon overlaps with the implant of instant claim 14 (implant of claim 1 having autologous BMSCs grafter onto). Moreover, upon placing the implant into/onto the bone of a patient would also result in implant of instant claim 14 as BMSCs attach to the treatment area to promote healing. The nanofibrous electroactive β-PVDF is taught as facilitating cell differentiation by way of electrical signal conduction (see page 2) (see Example 1).
Zhou fails to teach the PVDF nanofiber as including one or more bioactive agents to benefit the growth and survival of BMSCs and/or osteoblasts.
Klee teaches that PVDF is a biomaterial used in bone repair. It is taught that functionalization of the PVDF surface so as to possess fibronectin results in material that significantly enhances osteoblast attachment and proliferation (see Figure 6). Thus, it would have been obvious to modify the surface of Zhou’s β-PVDF fibers to include fibronectin (a bioactive agent) so as to improve the materials ability to adhere and grow desired cells such as osteoblasts. The use of a known technique to improve similar products/materials in the same way is supportive of obviousness. See MPEP 2143(I)(C).
Zhou (and Klee) fails to teach the PVDF fibers as being in an aligned configuration or in a randomly-distributed configuration.
Zaarour is directed to the enhanced piezoelectric properties of randomly oriented and aligned PVDF fibers by regulating surface morphology. It is taught that structures having aligned PVDF fibers exhibit greater piezoelectric properties than randomly oriented PVDF fibers (see Figure 7) (see instant claim 2). It would have been obvious to modify Zhou’s PVDF fiber material such that the fibers of the material are either aligned or randomly-distributed. The selection of either would have been well within the purview of an ordinarily skilled person with a reasonable expectation for success in producing a material suitable for use in bone repair.
Zhou (and Klee and Zaarour) fails to teach the PVDF as having undergone an annealing polzarization process that is conducted at a temperature of 70-120oC for a duration of 4-6 hours.
Wilson is directed to process of polarizing polymeric materials such as PVDF. It is taught that PVDF may be subject to annealing polarization so as to stabilize the piezoelectric properties of the material as well as maintenance of the hydrostatic charge sensitivity up to 90oC (see Figure 7 and column 9, lines 55-67; see instant claim 1). Thus, as Zhou’s PVDF device is to also exhibit electrostatic and piezoelectric properties, it would have been obvious to utilize the annealing process of Wilson so as to ensure these properties are stable and maintained over a wide range of temperatures. See MPEP 2143(I)(C) which states that the use of a known technique to improve similar materials/methods in the same way is supportive of obviousness.
Regarding instant claims 3-5, these claims are directed to intended use limitations (e.g. ‘the artificial bone implant yields piezoelectric voltages to the BMSCs; see instant claim 5) or results associated with intended use limitations (e.g. ‘the artificial bone implant dynamically adjusts the calcium ion transmission of the BMSCs to provide a microenvironment suitable for cell growth; see instant claim 4). Regarding instant claim 3, the property of the randomly-distributed PVDF fiber providing an increased cell contact area to BSMCs and facilitating calcium influx is a property implicit to the structure. That is, the obvious material resulting from the combination of references whereby the PVDF fibers are randomly-oriented would necessarily achieve this outcome. Moreover, as noted before, the outcome of providing an increased cell contact area to BSMCs and facilitating calcium influx are outcomes associated with a method of using the material. However, the claims are to a composition rather than method and so such a limitation is deemed an intended use and/or outcomes associated to. See MPEP 2111.02(II) regarding intended use limitations.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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