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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-14 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 1,12, the new limitation of “a homogeneous fine-meshed network” is not evident if this adjective used to describe the fibers is meant to describe the same kind of fiber, meaning a material or meant to describe a similar structure for example a diameter. Thus the independent and dependent claims are indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6,7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 6 and 7 recite first and second layers of fibers which are different. Claim 1 was amended and now requires a “homogenous” implant. Claims 6 and depend from claim 1 and it is understood that fibers are of the same type or structure which would be required for claims 6 and 7. However, now claims 6,7 contradict claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7,9,12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holzer et al. (WO 2008/062414). Holzer et al. disclose a fibrous implant for rebuilding tissue, abstract. Please note the limitations of “cardiovascular implant” and “for rebuilding elastin” are recitations of intended use. Holzer et al. further disclose (page 3, lines 26-28) the implant is comprised of fibers forming a network, wherein the fibers comprised in said network have a fiber diameter of between 1 nm and 150 µm. Holzer et al. also disclose the implant comprising a homogeneous or same type material (page 30, lines 7,8) fine-meshed network facing blood flow, page 6, lines 14-19. Since the implant of Holzer is used for permitting blood flow therethrough it is capable of being a “cardiovascular implant” and additionally since endothelial cells adhere to the fibrous mesh, it is capable of rebuilding elastin thereon. Regarding claim 2, Holzer et al. disclose (page 15, lines 14-16) the fibrous implant is at least partially bioabsorbable. Regarding claim 3, Holzer et al. further disclose (page 31, lines 23-28) the fibrous implant comprises a drug and/or adhesive component. Regarding claim 4, Holzer et al. further disclose (page 31, lines 27-30) the fibers are coated with a coating layer and wherein the coating layer comprises a drug. With respect to claim 5, Holzer et al. disclose (page 23, lines 9-13) that the fibrous implant comprises fibers and/or pores that allow cells to adhere, migrate, infiltrate, proliferate, (trans)differentiate, synthesize tissue, and combinations thereof. Regarding claims 6,7 as best understood Holzer et al. disclose (page 28, lines 9,10) there can be multiple layers. Holzer et al. further disclose (page 30, lines 9-11) the materials can be different for the layers. Regarding claim 9, Holzer et al. disclose (page 7, lines 9-12,29,30) that the fibrous implant is capable of reconstructing at least partially a vascular media and/or intima layer by additionally rebuilding a smooth muscle layer and/or endothelium layer. Regarding claim 12, Holzer et al. disclose (abstract) implanting into the host a fibrous implant comprising fibers forming a network and having a fiber diameter of between 1 nm and 150 µm (page 7, lines 9-12), wherein the fibrous implant comprises a homogeneous or same type material (page 30, lines 7,8) fine-meshed network facing blood flow, page 6, lines 14-19. Since the implant of Holzer is used for permitting blood flow it can be understood that the endothelial cells adhering to the fibrous mesh, is capable of rebuilding an ECM thereon. Holzer et al. further disclose that the method of using has the implant brought into direct contact with blood flow, page 7, lines 25,26, also since the fibrous network cover lines the implant inner surface to face blood it comes into direct contact with blood flow, page 23, lines 16-20. Regarding claim 13, Holzer discloses (page 14, lines 30-33) the fibrous implant is attached to an additional support delivery device. With respect to claim 14, Holzer et al. further disclose that the fibrous implant in assembling the structure that it is exposed to mechanical loading conditions (page 20, lines 6-11), wherein said mechanical loading conditions are either static mechanical loading conditions and/or dynamic mechanical loading conditions, and wherein said mechanical loading conditions are selected from the group consisting of shear stress, pre-stress, pre-strain, residual stress, stretch, compression and combinations thereof, see for example page 32, lines 18-25, page 36, lines 25-28.
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) 8,11 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al. (WO 2008/062414) in view of Lee et al. (2019/0127884). Holzer et al. is explained supra. Fig. 10 of Holzer shows the fibrous implant 104 having a tubular shape to define the implant body 100. However, Holzer et al. did not explicitly disclose the fibrous implant comprises: a. a valve to be used as a valvular prosthesis; b. either a membrane, embolization or swelling component to be used as a closure device, embolization device or occlusion device. Lee et al. teach (paragraph 70) that fibrous implant structures can be used for many cellular repair applications, including the incorporation of a valve to be used as a valvular prosthesis. It would have been obvious to utilize the fibrous implant in a tubular prosthesis and provide a valve as taught by Lee et al. and incorporate with the implant of Holzer such that a surgeon can treat a patient in need of a replacement cardiovascular valve. Regarding claim 11, Holzer et al. disclose (Fig. 10) that the tubular shaped fibrous implant is a stent 102 graft 104.
Claim(s) 1,8,10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2019/0127884) in view of Holzer et al. (WO 2008/062414). Lee et al. show Fig. 3C a cardiovascular (paragraph 70) fibrous implant for rebuilding (paragraph 51) elastin, wherein the implant is comprised of fibers forming a network. Lee et al. disclose (paragraphs 10,54,87) the fibers comprised in said network have a fiber diameter between 1nm and 150 µm. However, Lee et al. did not explicitly state the implant comprising a homogeneous fine-meshed network facing blood flow. Holzer et al. teach that a cardiovascular implant can be constructed with a fiber network comprising a homogeneous or same type material (page 30, lines 7,8) defining a fine-meshed network facing blood flow, page 6, lines 14-19. Since the implant of Holzer is used for permitting blood flow therethrough it is capable of being a “cardiovascular implant” and additionally the fibrous network cover lines the implant inner surface to face blood, page 23, lines 16-20. It would have been obvious to one of ordinary skill in the art to select a particular fiber based on its properties and provide a homogeneous or same type material to define a fine-meshed network facing blood flow as taught by Holzer et al. with the implant of Lee et al. such that it provides the desired properties and has predictable results. Selecting known materials and its construction, diameter only involves routine skill in the art. Regarding claims 8,10 it can be construed that Lee et al. disclose (paragraph 70) an implant that has a planar shape and can be a patch or membrane.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cox et al. (20160015396) teach a vascular implant formed of a fibrous network of fibers that can have a diameter between 1nm to 150 µm.
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 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
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