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 .
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 1-5, 7-10, 12-15 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.
In claims 1,7 the recitation of “predetermined time” is indefinite as one does not know whether it implies seconds, minutes, hours, weeks, months or years for the degradation of the polymer microstructures which is critical to give some understanding as to what material is intended by the broad scope of the claim reciting generic, unspecific materials: synthetic tube and polymer microstructures. Thus it is impossible to discern with any certainty how long something could take to degrade. Further it is noted Applicant recites a time frame in dependent claims 12-15 to refer to months. However, without any specific materials specified, it is impossible to discern the boundaries of the claim(s) even with the time frame when the environment (in vivo is unlimited as it can be any lumen or vessel of the living organism which can be different conditions) is not recited with any specificity, thus will all synthetic and/or or hydrogel materials and polymer microstructures degrade in any in vivo environment lumen or channel in the time frame? This environment includes all the physiological, biochemical, and cellular processes that occur naturally in that organism and since one does not know the living organism nor its location of placement, it is impossible to discern all the potential dissolving conditions for the substrate materials intended to degrade over time.
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.
Claim(s) 1-4,7-9 are rejected under 35 U.S.C. 103 as being unpatentable over DeJuan et al. (WO 2007/087061) in view of Hu et al. (WO 03/022910) and An et al. (CN 105149888). DeJuan et al. disclose (page 15, lines 18-26) a shunt prosthesis, comprising: a synthetic tube having an inner wall defining a fixed inner diameter of said synthetic tube. DeJuan et al. also disclose (page 16, lines 4,5, 15-18) there can be a layer of hydrogel of a thickness coating said inner wall of said synthetic tube such that said layer of hydrogel is affixed to said inner wall of said synthetic tube and such that the thickness of said layer of hydrogel defines a diameter of a lumen extending through and defined by the shunt prosthesis. It is also noted that DeJuan et al. disclose (page 37, lines 21-28, page 38, lines 11-14) the gradual degradation will autonomously increase the diameter of said lumen over the predetermined period of time such that the thickness of said layer of hydrogel is reducable in vivo over the predetermined period of time. However, DeJuan et al. did not explicitly disclose polymer microstructures embedded, dispersed and immobilized within said layer of hydrogel, said polymer microstructures containing a crosslinking agent; wherein said polymer microstructures are configured to degrade over a predetermined period of time to gradually release said crosslinking agent within said layer of hydrogel to gradually decrease said thickness of said layer of hydrogel, which remains affixed to said inner wall of said synthetic tube during said predetermined period of time by control of crosslinking density of said layer of hydrogel via the gradual release of said crosslinking agent. Hu et al. teach (page 3, lines 9-11) there is polymer microstructures embedded, dispersed and immobilized within the layer of hydrogel, release chemical agents (abstract). Additionally Hu et al. further teach (page 4, lines 22- 24) that the microstructures are configured to degrade over a predetermined period of time to gradually release the crosslinking agent to reduce in thickness (page 6, lines 5- 7) of the layer of hydrogel and thus the diameter of the lumen of the device increases. It would have been obvious to one of ordinary skill in the art to alternatively incorporate or embed within the hydrogel microstructures that degrade to release crosslinking agents to react with the hydrogel as taught by Hu et al. with the stent device of DeJuan et al. to establish the self-reactive control of the lumen dimensions. However, DeJuan et al. as modified with Hu et al. do not detail the specifics of the degradation effects to provide the diameter of the lumen of the shunt prosthesis is configured to autonomously increase by 15-18% over the predetennined period of time. An et al. teach (page 4 of translation) that a degradable polymer can be provided to be about 15% change in its structure such that it can still have sufficient supporting function. An et al. also stated that the finding of the optimal amount permitted to degrade with particular polymers is such that is has improved strength upon the degradation, see page 3 of translation. Please note since the prior art is suggesting a value for a change in the material amount resulting in a size change of 14.5% that is very close to the low value of the claimed range at 15% it can be said to be obvious to select due to the teachings being in the same field of endeavor. Further MPEP 2144.05 states a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Therefore, it would have been obvious to one of ordinary skill in the art to select 15% as a target diameter change permitted by the polymer chosen per the teaching of An et al. with the shunt prosthesis of DeJuan et al. as modified by Hu et al. such that the desired volume flow is established based on the known parameters of the patient and predicted future time potential, since such a modification only involves routine skill in the art. Further the prior art discloses the materials at the same level of scope of the claim (claim 1 recites arbitrary materials, synthetic tube and a hydrogel, both are generic and non-specific) and thus is fully capable of being optimized based on the needs of the patient and site parameters. Regarding claims 2,8 DeJuan et al. did not explicitly disclose the layer of hydrogel has a mesh structure provided by a three-dimensional array of polymer chains and crosslinks in which the greater a length of the polymer chains between crosslinks, the larger a mesh size of the hydrogel. Hu et al. teach (page 4, lines 3-12, page 18, lines 13-24) that polymer chains in a hydrogel define a mesh structure and the mesh size can be larger with greater length chains. It would have been obvious to one of ordinary skill in the art to use crosslink chain polymer hydrogels as taught by Hu et al. such that it can be controlled to effectively deliver therapeutics to a site of use, page 5, lines 19-24, page 6, lines 1-7. Thus it would be an obvious expedient to select crosslinking capability to provide larger chains between crosslinks when the desired coverage is needed to be greater for the mesh size of the hydrogel disposed on the inner surface of the prosthetic device. Regarding claims 3,9 DeJuan et al. discloses (page 39) that the crosslinking can be done to polymers/hydrogels and chemically accomplished (page 35, lines 24-26). Hu et al. also teach (page 12, lines 15-17) that the hydrogel can be chemically crosslinked and can thus provide the mesh structure of the hydrogel to reduce in thickness (page 6, lines 5-7) of the layer of hydrogel and thus the diameter of the lumen of the device increases. Thus it would be an obvious expedient to select the optimal crosslinking capability such as chemically induced crosslinks to establish the desired coverage needed on the prosthetic device and sufficiently enabling chemical reaction to decrease the mesh size of the hydrogel disposed on the inner surface of the prosthetic device and thus increase lumen size and use chemical agents as taught by Hu with the hydrogel in the prosthetic of DeJuan in order to provide a self-responding prosthetic not needing a surgical treatment to apply the reagent. Regarding claim 4, it is noted that DeJuan et al. disclose (page 16, lines 15-18) there can be coating the inner lumen with the layer of hydrogel to establish a plurality of concentric layers of hydrogel. With respect to claim 7, the same explanation is applied here with DeJuan as modified by Hu and An as the claim scope is the same other than the recitation of stating the use of the shunt prosthesis. However, it is noted that the method is vague and broad for any specific application (meaning intended recipient or its exact implantation site not recited) such that as already stated the references still apply, especially since DeJuan states (page 3 of document, under the summary) the shunt prosthesis is implanted such that it controls flow therethrough. In addition DeJuan also discloses (see Figs. 25A,B) the thickness of the hydrogel material disposed within the shunt prosthesis degrades and thereby gradually increase the diameter of the lumen of the shunt over the predetermined period of time. The same obviousness rejection applies here for claim 7 as detailed above for claim 1.
Claim(s) 5,10 are rejected under 35 U.S.C. 103 as being unpatentable over DeJuan et al. (WO 2007/087061) in view of Hu et al. (WO 03/022910) and An et al. (CN 105149888) as applied to claims 4,7 above, and further in view of Messersmith et al. (8796394). DeJuan et al. in view of Hu et al. and An et al. is explained as before. However, DeJuan as modified by Hu and An et al. did not suggest the concentric layers of hydrogel are separated by a peelable or dissolvable hydrophobic polymer layer. Messersmith et al. teach (col. 13, lines 60-66) that layers of hydrogel are applied to substrate surfaces of medical devices such that a primer hydrogel layer enhances attachment to the surface. It would have been obvious to one of ordinary skill in the art to use layers of hydrogel to coat the substrate as taught by Messersmith et al. on the prosthetic tube of DeJuan et al. as modified with Hu et al. and An et al. such that it improves the biocompatibility and reduce inflammatory response, see Messersmith (col. 13, lines 15- 22, col. 18, lines 60-67). Further regarding claim 5, it is noted that Messersmith teaches that the multiple layers of hydrogel applied on the substrate surface can include multiple primer hydrogel, col. 14, lines 1-5. Messersmith further teaches (col. 1, lines 44-49) that the hydrophobic polymers are immobilized on the surface to enhance the hydrogel attachment.
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over DeJuan et al. (WO 2007/087061) in view of Hu et al. (WO 03/022910) and An et al. (CN 105149888) as applied to claims 1,7 above, and further in view of Rapoza et al. (2015/0073536). DeJuan et al. in view of Hu et al. and An et al. is explained as before. However, DeJuan as modified by Hu and An et al. did not suggest the predetermined time for degradation be within four to six months or at six months. Rapoza et al. teach (paragraph 69) a degradable prosthesis can remain for a period of time during of delayed degradation to allow for remodeling and is six months. Additionally Rapoza et al. teach (paragraph 85) a polymer layer can degrade within four to six months. It would have been obvious to one of ordinary skill in the art to select the appropriate polymer for the hydrogel layer and/or polymer microstructures to degrade within four to six months or at six months as taught by Rapoza et al. in the shunt prosthesis of DeJuan et al. as modified by Hu et al. and An et al. such that it is able to provide the necessary support and stability at the site of implantation see Rapoza paragraph 67.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
