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 .
Election Acknowledged
Applicant's election with traverse of the invention of Group I encompassing claims 1-5 and 14 in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground(s) that Groups I do not pose a serious burden on the examiner as both Groups overlap. This argument is not found persuasive because the claims of Groups I and II are considered distinct as the claimed product could be made by a materially different process in addition to being differently classified. Further, prior art which may anticipate or render obvious one method would neither anticipate nor render obvious the other. It is noted that upon finding the product allowable the method will be considered for rejoinder per MPEP 821.04.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/18/2024 was considered by the examiner.
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) in view of Klee et al. (Biomaterials, 2003, 24, 21, 3663-3670) and Zaarour et al. (J Applied Polymer Science, 2019, 136, 47049-47057).
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.
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.
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.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3, dependent from claim 1, recites, “…wherein the randomly-distributed configuration… facilitates the calcium influx.” Claim 1 does not contemplate ‘a calcium influx’ and so a limitation to ‘the’ calcium influx lacks proper antecedent support.
Potentially Relevant Prior Art
Ribeiro et al., RSC Advances, 2012, 2, 11504-11509
Fu, CN 116650725
Conclusion
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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