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.
Claim(s) 13 is/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.
Regarding claim 13, the phrase "the intermediate regions" renders the claim indefinite because it is unclear whether the limitation refers to the left intermediate regions or the right intermediate regions or both that are recited in claim 10.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 8, 10-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. (US 2008/0188928).
Regarding claim 1, Salahieh discloses
An expandable sheath (18, fig. 1A and pars. 0043-0044) comprising:
a central lumen (central lumen of 18, see figs. 1A and 6-7) and a longitudinal axis (longitudinal axis of 18, see fig. 1A) extending therethrough;
a tubular layer (36/38, fig. 1B and par. 0045) comprising an inferior longitudinal region (36) and a superior longitudinal region (38); and
a longitudinally extending reinforcement (21, fig. 5 and par. 0047. Examiner notes: see par. 0045 for one or more support members having variable axial stiffnesses are positioned between 36 and 38. Then see par. 0047 for more detail about the support member 21) coupled to the inferior longitudinal region (see par. 0045 for support member being positioned between 36 and 38) and biased to bend in an inferior direction under axial compression (see fig. 11), the reinforcement (21) comprising a central axis (central axis of 21, see fig. 5) extending parallel to the longitudinal axis of the sheath (see figs. 5-7);
wherein the sheath (18) is expandable from a collapsed configuration to a radially expanded configuration to facilitate passage of a medical device through the central lumen of the sheath (see par. 0044 for 18 exhibiting sufficient radial compliance on its distal end to allow the sheath to expand and receive the implant 600).
Regarding claim 2, Salahieh discloses
The expandable sheath of claim 1, wherein the tubular layer (36/38) further comprises a tapered proximal region (region of 36/38 near 20, see fig. 1A), a distal region (distal region of 36/38), and a central shaft (shaft of 36/38) extending distally therebetween (see fig. 1A).
Regarding claim 4, Salahieh discloses
The expandable sheath of claim 1, wherein a durometer of the reinforcement is higher than a durometer of the tubular layer (Examiner notes: see par. 0045 for 36 and 38 being polymer liners, while support members 21 are configured to provide variable axial stiffness to the sheath. Therefore, durometer of 21 is higher than durometer of 36/38).
Regarding claim 5, Salahieh discloses
The expandable sheath of claim 1, wherein the reinforcement (21) is coupled to an external surface of the inferior longitudinal region (Examiner notes: see par. 0045 for one or more support members having variable axial stiffnesses are positioned between 36 and 38. Therefore, 21 is coupled to an external surface of 36).
Regarding claim 6, Salahieh discloses
The expandable sheath of claim 5, wherein an outer jacket (12) extends over the reinforcement (21) and the tubular layer (36/38) (see fig. 1A).
Regarding claim 8, Salahieh discloses
The expandable sheath of claim 1, wherein the reinforcement (21) is arc-shaped (see fig. 22 and par. 0051 for partial rib segments 31) at a selected transverse cross section taken perpendicular to the longitudinal axis of the sheath (see fig. 22).
Regarding claim 10, Salahieh discloses
The expandable sheath of claim 1, wherein the reinforcement (21) comprises a series of longitudinally spaced ribs (see fig. 22 and par. 0051 for rib 31, or see fig. 21 and par. 0051 for another embodiment of rib 31), each rib (31) comprising left and right intermediate regions (see fig. 22 or fig. 21) extending circumferentially away the central axis of the reinforcement (see fig. 22 or fig. 21).
Regarding claim 11, Salahieh discloses
The expandable sheath of claim 10, wherein each rib of the series of longitudinally spaced ribs is coupled at a left end to a left longitudinally extending spine, and each rib of the series of longitudinally spaced ribs is coupled at a right end to a right longitudinally extending spine (see fig. 22 for left ribs 31 and right ribs 31).
Regarding claim 12, Salahieh discloses
The expandable sheath of claim 11, wherein a selected rib of the series of longitudinally spaced ribs comprises a left extension extending from the left intermediate region and a right extension extending from the right intermediate region, the left extension being coupled to the left longitudinally extending spine and the right extension being coupled to the right longitudinally extending spine (see fig. 22 for left ribs 31 and right ribs 31).
Regarding claim 13, Salahieh discloses
The expandable sheath of claim 10, wherein the intermediate regions of a selected rib widen extending away from the central axis of the reinforcement (see figs. 8 and 10 for the intermediate regions between the ribs widen extending away from the central axis of 21).
Regarding claim 14, Salahieh discloses
The expandable sheath of claim 10, wherein the series of longitudinally spaced ribs (31) define a series of longitudinally spaced gaps (see fig. 22 or fig. 21 for the gap between ribs 31), each gap comprising a left side extending circumferentially away from the central axis (see fig. 22 or fig. 21 for the left side of 31) and a right side extending circumferentially away from the central axis (see fig. 22 or fig. 21 for the right side of 31).
Regarding claim 15, Salahieh discloses
The expandable sheath of claim 14, wherein the series of longitudinally spaced gaps (gaps between 31, see fig. 22) is bounded on a left end by a left longitudinally extending spine (see fig. 22 for left 31), and the series of longitudinally spaced gaps (gaps between 31, see fig. 22) is bounded on a right end by a right longitudinally extending spine (see fig. 22 for right 31).
Regarding claim 16, Salahieh discloses
The expandable sheath of claim 14, wherein the left side of a selected gap comprises a left taper that narrows approaching a left end of the selected gap (see fig. 21 for the gap), and the right side of the selected gap comprises a right taper that narrows approaching a right end of the selected gap (see fig. 21 for the gap).
Regarding claim 17, Salahieh discloses
The expandable sheath of claim 16, wherein the left side of a selected gap comprises a widening strain relief portion between the left taper and the left end of the selected gap, and the right side of the selected gap comprises a widening strain relief portion between the right taper and the right end of the selected gap (see annotated fig. 21 below).
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Regarding claim 20, Salahieh discloses
The expandable sheath of claim 1, wherein the sheath (18, fig. 1A) is bendable from a straight configuration to a bent configuration (see fig. 1A for the bent configuration of 18), both the straight configuration and the bent configuration facilitating unobstructed passage of the medical device through the central lumen of the sheath (see fig. 1A and par. 0044 for implant 600).
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) 3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928).
Regarding claim 3, Salahieh discloses the expandable sheath of claim 1, as set forth above, except for wherein a length of the sheath is from 4 inches to 10 inches.
There is no evidence of record that establishes that changing the length of the sheath would result in a difference in function of Salahieh device. Further, a person having ordinary skill in the art, being faced with modifying the length of the sheath would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the length of Salahieh sheath to be from 4 inches to 10 inches as an obvious matter of design choice within the skill of the art.
Regarding claim 9, Salahieh discloses the expandable sheath of claim 8, as set forth above, except for wherein at the selected transverse cross section, the reinforcement extends around from 25% of a circumference of the tubular layer to 60% of the circumference of the tubular layer.
There is no evidence of record that establishes that changing the length of the reinforcement would result in a difference in function of Salahieh device. Further, a person having ordinary skill in the art, being faced with modifying the length of the reinforcement would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the length of Salahieh reinforcement to be from 25% to 60% of the circumference of the tubular layer as an obvious matter of design choice within the skill of the art.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928) in view of Quiachon et al. (US 5,256,150).
Regarding claim 7, Salahieh discloses the expandable sheath of claim 5, as set forth above, except for wherein the superior longitudinal region of the tubular layer further comprises at least one longitudinally extending fold.
Salahieh only discloses the distal end of the sheath is configured to expand to allow the passage of the implant (par. 0044).
However, Quiachon teaches wherein the superior longitudinal region of the tubular layer (layer of 12) further comprises at least one longitudinally extending fold (17, see fig. 4) wherein the fold is configured to expand to allow the passage of a device or fluid.
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the distal end of the sheath to have longitudinally extending folds, as taught by Quiachon, for the purpose of allowing the sheath to reduce its diameter to facilitate introduction of the sheath to make it less traumatic for the vessel into which it is introduced and to provide a kink resistance sheath (col. 3 lines 20-38 of Quiachon).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2008/0188928) in view of Fojtik et al. (US 2019/0126011).
Regarding claim 18, Salahieh discloses the expandable sheath of claim 1, wherein the tubular layer further comprises a distal region (distal region of 18, fig. 1A and par. 0044),
Salahieh only discloses the distal end of the sheath configured to expand but is silent about the distal region comprising a plurality of longitudinally extending struts, the plurality of longitudinally extending struts at least partially defining a plurality of elongated slits extending through a wall thickness of the distal region.
However, Fojtik teaches a device with an expandable distal portion wherein the expandable portion comprises a plurality of longitudinally extending struts (36, fig. 2 and pars. 0046-0049), the plurality of longitudinally extending struts (36) at least partially defining a plurality of elongated slits (32) extending through a wall thickness of the distal region (see figs. 2-8).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Salahieh by adding a plurality of longitudinally extending struts and a plurality of elongated slits, as taught by Fojtik, for the purpose of allowing the distal end of the sheath to expand (pars. 0046-0049 of Fojtik).
Regarding claim 19, Salahieh in view of Fojtik discloses the expandable sheath of claim 18,
Fojtik further teaches wherein upon axial compression the distal region transforms to a bowed configuration (expanding configuration of 30) wherein each elongated slit widens circumferentially and each strut bows radially away from the longitudinal axis, thereby shortening the distal region (see figs. 1-8 and pars. 0046-0049).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783