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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19, Species depicted in Figs. 61A-63B encompassing claims 1-19 in the reply filed on 2/25/26 is acknowledged.
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.
Claim 4 is 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 pre-AIA the applicant regards as the invention.
Claim 4 recites “RMS value”. The term is unclear, since the acronym is not stated in the disclosure. For examination purposes the term is interpreted as a surface value of the liner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 7, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US2019/0029823).
Regarding claim 1, Nguyen discloses a sheath (100) for delivering a medical device ([0135]), wherein the sheath has a proximal and a distal end ([0133]) and comprises:
an expandable inner liner (108) having an inner surface and an outer surface (see Fig. 37), wherein the inner surface of the expandable inner liner defines a lumen (see Fig. 37, [0134]) and wherein the inner liner comprises at least one folded portion (118) having an inner portion and outer portion (see annotated Fig. 37);
an outer layer having an inner surface and an outer surface (see Fig. 37) and extending at least partially around the inner liner such that a first portion of the outer surface of the outer layer is positioned adjacent to the inner portion of the at least one folded portion of the inner liner (see annotated Fig. 37), while a first portion of the inner surface of the outer layer is positioned adjacent to the outer portion of the at least one folded portion of the inner liner (see annotated Fig. 37); and
wherein the inner liner comprises at least one first portion (inner layer 108 excluding 112; alternatively the portion defined by marker 112 that can be blended within inner layer 108, [0131]) and at least one second portion (portion defined by marker 112 that can be blended within inner layer 108, [0131]; alternatively, the inner layer 108 excluding 112), wherein an outer surface of the at least one first portion comprises a composition and/or morphology that is substantially different from an outer surface of the at least one second portion ([0132]) (the phrase “substantially different is given its broadest reasonable interpretation – see rejection of claim 3); and
wherein an outwardly directed radial force from a prosthetic device moving through the inner lumen unfolds the at least one folded portion to allow expansion of the sheath ([0136]).
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Regarding claim 3, Nguyen discloses the sheath of claim 1, wherein the inner liner comprises a fluorocarbon-based polymer ([0011]), and wherein the outer surface of the at least one first portion comprises a fluorine-to-carbon ratio that is lower than a fluorine-to-carbon ratio present on the outer surface of the at least one second portion of the inner liner (the inner layer comprises a fluorine-to-carbon and the other portion of the inner layer that comprises the band 112 does not comprise fluorine-to-carbon ratio).
Regarding claim 4, Nguyen discloses the sheath claim 1, wherein the outer surface of the at least one first portion of the inner liner exhibits an RMS value lower than an RMS value of the outer surface of the at least one second portion of the inner liner (where RMS is interpreted as a surface value, where the surface values are different between the inner layer 108 and the marker 112).
Regarding claim 6, Nguyen discloses the sheath of claim 1, wherein the inner liner comprises two or more second portions ([0132]), and each of the two or more second portions, if present, comprises the same or different composition and/or morphology ([0132]).
Regarding claim 7, Nguyen discloses the sheath of claim 1, wherein a length of the at least one first portion is greater than a length of the at least one second portion (marker 112 is mark that extends around the sheath 100, but does not extend the majority of the length; the first portion of remainder of layer 108 extends the length of the sheath 108, [0132]).
Regarding claim 9, Nguyen discloses the sheath of claim 1, wherein the at least one second portion of the inner liner extends along the inner portion of the at least one folded portion of the inner liner (second portion in the alternative is the inner layer 108 excluding 112, which would contact the inner portion of the at least one folded portion, see Fig. 37).
Regarding claim 10, Nguyen discloses the sheath of claim 1, wherein the outer layer comprises high-density polyethylene polymer (HDPE), nylon, or polypropylene ([0128]).
Regarding claim 11, Nguyen discloses the sheath of claim 1, wherein the outer surface of the at least one second portion exhibits a contact angle from greater than about 65 degrees to about 140 degrees (contact angle of the second portion 112 with another component as shown in Fig. 37 encompasses this range).
Regarding claim 12, Nguyen discloses the sheath of claim 1, wherein the inner liner comprises the at least one second portion at the proximal end of the sheath (the second portion in the alternative is interpreted as the inner layer 108 that would be at the proximal end of the sheath).
Regarding claim 13, Nguyen discloses the sheath of claim 1, wherein the at least one second portion of the inner liner (112) is separated from the proximal end of the sheath by the at least one first portion of the inner liner (inner layer 108) such that the length of the at least one first portion is substantially similar or shorter than the length of the at least one second portion (where the length of the inner layer 108 that defines the claimed first portion could be taken at a proximal end of the sheath as less than the length of the marker 112 that defines the second portion).
Regarding claim 14, Nguyen discloses the sheath of claim 13, wherein the at least one second portion of the inner liner is followed by an additional first portion (an additional portion of the inner layer 108 taken a different portion of the length) of the inner liner, and wherein the length of the at least one second portion of the inner liner is shorter than a length of the additional first portion of the inner liner (portion taken for additional first portion can be taken to be longer than a length of the marker 112 that defines the second portion.
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 2, 5, 8, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823).
Regarding claim 2, Nguyen discloses the sheath of claim 1; yet, does not explicitly disclose the at least one second portion is etched and subsequently surface-modified such that a composition of the outer surface of the at least one second portion is substantially different from a composition of the outer surface of the at least one first portion.
Nguyen, in the alternative, discloses the second portion is interpreted as the inner layer 108. Nguyen according to other embodiments teaches the inner layer can be surface treated by etching ([0105]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the second portion of the inner liner to include an etched surface in order to provide better adhesion at areas between the inner liner and the outer layer ([0105]).
Regarding claim 5, Nguyen makes obvious the sheath of claim 2, wherein the at least one second portion is surface-modified and comprises a gradient morphology (the etching of the surface of the inner layer 108 is interpreted as surface modified and having a gradient morphology by being a pattern).
Regarding claim 8, Nguyen discloses the sheath of claim 1; yet, does not explicitly disclose wherein a wall thickness of the at least one second portion is up to about 2% larger than a wall thickness of the at least one first portion. Nguyen teaches the wall thickness of the layers is a result effective variable, that can be varied dependent on the particular application of the sheath ([0079]). It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to modify the wall thickness of the second portion to be 2% larger than a wall thickness of the first portion, since wall thickness of the different layers of the sheath is a result effective variable, that can varied dependent on the application of the sheath, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 15, Nguyen discloses the sheath of claim 1; yet, is silent regarding wherein the sheath further comprises an outer jacket comprising an inner surface and outer surface and a proximal end and a distal end and extending at least partially around the outer layer, such that the inner surface of the outer jacket overlies the outer surface of the outer layer and wherein the outer jacket has a first predetermined length.
Nguyen according to the embodiment of sheath 22 teaches an additional outer covering 50 (outer jacket) that covers the outer layer 26 of the sheath ([0092]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the sheath to include an outer jacket that covers the outer layer in order to protect the sheath prior to insertion of the sheath into the patient’s body ([0092]). Where the covering 50 (jacket) would have some predetermined length that extends over the outer layer.
Regarding claim 16, Nguyen makes obvious the sheath of claim 15, wherein the at least one second portion (in the alternative the second portion is the inner layer 108 that would extend from the proximal end of the sheath) extends from the proximal end of the sheath:
the length of the at least one second portion is substantially similar to the first predetermined length of the outer jacket (the length of the inner layer 108 and the length of the covering 50 would be similar since the covering 50 is intended to cover the entirety of the sheath),
Regarding claim 17, Nguyen makes obvious the sheath of claim 16, wherein the distal end of the outer jacket is substantially sealed with the outer layer of the sheath (where the seal is formed by the covering of the outer covering 50 over the outer layer 110).
Regarding claim 18, Nguyen makes obvious the sheath of claim 15, wherein the outer jacket extends from the proximal end of the sheath to the distal end of the sheath (the modified outer cover would extend along the distal end of the sheath 100 until removed, [0092]).
Regarding claim 19, Nguyen makes obvious the sheath of claim 18, the at least one second portion of the inner liner extends along portions of the inner liner that contact the outer surface of the outer layer (see Fig. 37, [0131]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774