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 . Claims 1-7 are pending and examined below.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 20140207248 A1) "Wang".
Regarding Claim 1, the first embodiment of Wang discloses a micro-nano medical stent for directional, quantitative and timed release of drug (par. [0042]), comprising a drug-loadable micron ordered electrospun fiber structure as a skeleton layer (Claim 2) and a drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM (extracellular matrix) layer (pars. [0027] and [0028]), but does not disclose the skeleton layer and ECM layer staggered stacked. However, another embodiment of Wang teaches at least one layer of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer and at least one layer of the drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM layer are staggered stacked to form a multi-layer composite electrospun micro-nano medical stent (pars. [0006] and [0039], Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Wang to include the skeleton layer and ECM layer staggered stacked, as taught by another embodiment of Wang, in order to promote cellular infiltration and structural support for tissues grown on scaffolds or stents (Wang, par. [0005]).
Regarding Claim 2, the first embodiment of Wang further discloses the micro-nano medical stent for directional, quantitative and timed release of drug according to claim 1, wherein the drug-loadable micron ordered electrospun fiber structure as a skeleton layer is able to construct a three-dimensional bionic tissue structure according to specific applications or construct a specific structure according to required bionic indicators, including, but not limited to, an array square ordered electrospun fiber structure or an equally spaced sinusoidal ordered electrospun fiber structure (pars. [0005] and [0042], Figs. 3 and 4).
Regarding Claim 3, the first embodiment of Wang does not disclose a skeleton layer and ECM layer staggered stacked in various patterns. However, another embodiment of Wang teaches the micro-nano medical stent for directional, quantitative and timed release of drug according to claim 1, wherein the multi-layer composite electrospun micro-nano medical stent comprises one layer of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer and one layer of the drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM layer, which are staggered stacked to form a multi-layer composite electrospun micro-nano medical stent (pars. [0006] and [0039], Fig. 6);
or one layer of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer and two layers of the drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM layer, which are staggered stacked to form a composite electrospun micro-nano medical stent (pars. [0039] and [0042]);
or two layers of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer and one layer of the drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM layer, which are staggered stacked to form a composite electrospun micro-nano medical stent (par. [0041]);
or two layers of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer and two layers of the drug-loadable core-shell nano-disordered electrospun fiber structure as an ECM layer, which are staggered stacked to form a composite electrospun micro-nano medical stent (par. [0039]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Wang to include the skeleton layer and ECM layer staggered stacked in various patterns, as taught by another embodiment of Wang, in order to promote cellular infiltration and structural support for tissues grown on scaffolds or stents (Wang, par. [0005]).
Regarding Claim 4, the first embodiment of Wang further discloses the micro-nano medical stent for directional, quantitative and timed release of drug according to claim 3, wherein, the stacking form of the drug-loadable micron ordered electrospun fiber structure as a skeleton layer includes aligned staggered stacking or non-aligned staggered stacking (par. [0006]), wherein the skeleton layer constructs a three-dimensional bionic tissue structure according to needs by printing the same structure or different structures layer by layer, and connected structures can be established between the layers (pars. [0005] and [0042]).
Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 20140207248 A1) "Wang" in view of He et al (CN 113265770 A) “He”.
Regarding Claim 5, Wang does not disclose steps to prepare a micro-nano medical stent by heating a drug-containing solid, near-field electrospinning, followed by far-field electrospinning of the shell layer and core layer, and repeating said steps. However, He, in the same field of art, teaches a preparation method of a multiscale fiber with a core shell structure through electrospinning (par. [n0001]), comprising steps of: step A: heating and melting a drug-containing polycaprolactone solid, connecting the same to the syringe of a near-field direct writing electrospinning system, and performing ordered near-field direct writing electrospinning to obtain a drug-loaded micron ordered electrospun fiber structure (Abstract, pars. [0015] and [0037]);
step B: connecting a polylactic acid spinning solution containing a shell layer drug and a polyvinyl alcohol spinning solution containing a core layer drug to the shell layer syringe and core layer syringe of a far-field electrospinning system (pars. [0018] and [n0027]), respectively, performing disordered far-field electrospinning at a temperature, humidity and gas environment required for maintaining activity of loaded drug, and collecting on the surface of the drug-loaded ordered micron fiber structure to obtain a drug-loaded micron ordered electrospun fiber structure as a skeleton layer and a drug-loaded core-shell nano disordered electrospun fiber structure, which are stacked (par. [0037]);
step C: alternately repeating step A and B at least 1 time (pars. [n0015] and par. [0037], steps may be repeated to reach the desired number of stacked layers). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Wang to include steps to prepare a micro-nano medical stent by heating a drug-containing solid, near-field electrospinning, followed by far-field electrospinning of the shell layer and core layer, and repeating said steps, as taught by He, in order to ensure biocompatibility and mechanical strength of materials and proper loading of effective ingredients on the device (He, par. [n0027]).
Regarding Claim 6, Wang further discloses the method of preparing the micro-nano medical stent for directional, quantitative and timed release of drug according to claim 5, wherein, performing ordered near-field direct writing electrospinning to obtain a drug-loaded micron ordered electrospun fiber structure in step A specifically comprises: step A1: drawing an ordered fiber trajectory path through CAD drawing software, and then importing the path into an ordered near-field direct writing electrospinning system (par. [0030]);
step A2: performing ordered near-field direct writing electrospinning to obtain a drug-loaded micron ordered electrospun fiber structure (par. [0030]);
wherein, the ordered fiber trajectory path includes, but is not limited to, an array square fiber trajectory path and an equally spaced sinusoidal fiber trajectory path (pars. [0005] and [0042], Figs. 2-4).
Regarding Claim 7, Wang does not disclose the shell layer drug doped with a hydrophilic material. However, He, in the same field of art, teaches a preparation method of a multiscale fiber with a core shell structure through electrospinning (par. [n0001]), wherein, in step B, the polylactic acid spinning solution containing a shell layer drug is doped with a hydrophilic material such that the control of degradation rate is realized, and the ECM layer with a specific number of layers can have the same or different degradation rates, thus realizing controllable release sequence of loaded drug at different layers (pars. [n0026] and [n0028]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Wang to include the shell layer drug doped with a hydrophilic material, as taught by He, in order to ensure the device membrane remains intact and to enhance the release capacity of the drug’s capacity (He, par. [n0026]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE N THOMAS/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights