DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on Jun 16, 2023 and May 16, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 9 and 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.
The term “substantially” in claim 9 is a relative term which renders the claim indefinite. The term “substantially longer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what would be sufficient to meet the limitation “substantially longer”. For the purposes of examination, this limitation is being interpreted as “longer”.
Claim 14 recites the limitation "the compacted delivery diameter" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 8, upon which claim 14 depends does not recite “a compacted delivery diameter” but instead uses the term “first diameter”. It is clear from applicant’s disclosure that the first diameter is the compacted delivery diameter. For the purposes of examination, claim 14 is being interpreted as referring back to the “first diameter” as recited in claim 8. Appropriate action is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 8, and 10-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edoga (US PG Pub 5,591,228) in view of Purdy et al (US PG Pub 2008/0288042).
Regarding claim 1, Edoga teaches a medical apparatus, comprising: a catheter (10) having a proximal end portion and a distal end portion (See, for example, Fig. 6); a stent member (50) having a trunk and a leg portion (See Figs. 10-14) and arranged on the proximal end portion of the catheter, wherein the stent member has an inner surface and an outer surface (note the stent is tubular to allow for blood to flow therethrough and thus has inner and outer surfaces); a first sheath material (81) covering the trunk portion of the stent member, (See Col. 9, lines 30-41) wherein the first sheath material is configured to maintain the stent member at a first diameter suitable for endoluminal delivery (See Col. 9, lines 30-41).
Edoga also teaches a second sheath material (82) covering the stent member, and a third sheath material (82’) covering at least a portion of the leg portion, wherein the
third sheath material is configured to maintain the leg portion of the stent member at the
first diameter. (See Col. 9, lines 30-41.)
Edoga does not explicitly teach wherein the second sheath material is configured to maintain the stent member at a second diameter, wherein the second diameter is greater than the first diameter and less than a fully expanded deployed diameter.
Purdy teaches an analogous stent delivery system featuring a catheter (100) featuring two overlapping sheaths (105 and 215) where the first sheath (215) maintains the stent in the smallest delivery configuration and the second sheath (105 with flaps 110) which maintains the stent at a second diameter (See Fig. 11A – partially deployed configuration) which is greater than the first diameter (Fig. 10A). Purdy teaches since one or more longitudinal portions of the stent remain restrained by the delivery system during retraction of the sheath 215, axial stretching or other deformation of the stent is minimized or avoided as the stent partially deploys (See paragraph [0066]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the delivery system as taught by Edoga to incorporate the teachings of Purdy such that the second sheath material is configured to maintain the stent member at a second diameter, wherein the second diameter is greater than the first diameter and less than a fully expanded deployed diameter since allowing for partial deployment (an intermediate diameter) reduces or eliminates undesirable axial stretching. Additionally, having the stent partially expanded allows the operator to readjust the stent in the proper position before full expansion and deployment which leads to better patient outcomes.
Regarding claim 2, modified Edoga teaches the medial apparatus required by claim 1 as set forth above and further teaches the first sheath material extends over both the stent member and the second sheath material. (See Purdy Figs. 10-12; paragraphs [0057]-[0066])
Regarding claim 3, modified Edoga teaches the medial apparatus required by claim 2 as set forth above and further teaches wherein the second sheath material is disposed between the stent member and the first sheath material, wherein the stent member is configured to expand to the second diameter upon a release of the first sheath material, the second sheath material configured to maintain the stent member at the second diameter. (See Purdy Figs. 10-12; paragraphs [0057]-[0066]).
Regarding claim 4, modified Edoga teaches the medial apparatus required by claim 3 as set forth above and further teaches the stent member is configured such that the trunk expands upon the release of the first sheath material. (See Purdy Figs. 10-12; paragraphs [0057]-[0066]. Note Edoga as modified to include the teachings of Purdy as set forth above would result in the trunk portion of the stent being partially released and held in the second, intermediate diameter).
Regarding claim 8, Edoga teaches a medical apparatus, comprising: a catheter (10) having a proximal end portion and a distal end portion (See, for example, Fig. 6); a stent member (50) arranged on the proximal end portion of the catheter, wherein the stent member has an inner surface and an outer surface (note the stent is tubular to allow for blood to flow therethrough and thus has inner and outer surfaces); a first sheath material (81) covering the trunk portion of the stent member, (See Col. 9, lines 30-41) wherein the first sheath material is configured to maintain the stent member at a first diameter suitable for endoluminal delivery (See Col. 9, lines 30-41).
Edoga also teaches a second sheath material (82) covering the stent member. (See Col. 9, lines 30-41.)
Edoga does not explicitly teach wherein the second sheath material is configured to maintain the stent member at a second diameter, wherein the second diameter is greater than the first diameter and less than a fully expanded deployed diameter.
Purdy teaches an analogous stent delivery system featuring a catheter (100) featuring two overlapping sheaths (105 and 215) where the first sheath (215) maintains the stent in the smallest delivery configuration and the second sheath (105 with flaps 110) which maintains the stent at a second diameter (See Fig. 11A – partially deployed configuration) which is greater than the first diameter (Fig. 10A). Purdy teaches since one or more longitudinal portions of the stent remain restrained by the delivery system during retraction of the sheath 215, axial stretching or other deformation of the stent is minimized or avoided as the stent partially deploys (See paragraph [0066]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the delivery system as taught by Edoga to incorporate the teachings of Purdy such that the second sheath material is configured to maintain the stent member at a second diameter, wherein the second diameter is greater than the first diameter and less than a fully expanded deployed diameter since allowing for partial deployment (an intermediate diameter) reduces or eliminates undesirable axial stretching. Additionally, having the stent partially expanded allows the operator to readjust the stent in the proper position before full expansion and deployment which leads to better patient outcomes.
Regarding claim 10, modified Edoga teaches the medial apparatus required by claim 8 as set forth above and further teaches the stent member is self-expandable. (See Edoga Col. 5, lines 45-50; Col. 14, lines 1-5; and Purdy paragraphs [0055] and [0057]).
Regarding claim 11, modified Edoga teaches the medial apparatus required by claim 8 as set forth above and further teaches one or more of the first and second sheath materials are configured1 for removal from an implantation site. (See Edoga Col. 11, lines 4-16).
Regarding claim 12, modified Edoga teaches the medial apparatus required by claim 8 as set forth above and further teaches a length of the first sheath material is substantially equal to a length of the second sheath material. (See Purdy Figs. 10-12; paragraphs [0057]-[0066]. Note Edoga as modified to include the teachings of Purdy as set forth above would result in the first and second sheaths having substantially equal lengths).
Regarding claim 13, modified Edoga teaches the medial apparatus required by claim 8 as set forth above and further teaches the first and second portions are the same portion. (See Purdy Figs. 10-12; paragraphs [0057]-[0066]. Note Edoga as modified to include the teachings of Purdy as set forth above would result in the first and second portions being the same)
Regarding claim 14, modified Edoga teaches the medial apparatus required by claim 8 as set forth above and further teaches a third sheath material (82’) covering at least a portion of the leg portion, wherein the third sheath material is configured to maintain the leg portion of the stent member at the first (compacted delivery) diameter (See Edoga Col. 9, lines 30-41) while the second sheath material is configured to simultaneously maintain the stent member at the second diameter. (It is noted that the three sheaths as taught by Edoga are independently removable. It is further noted that Edoga as modified to include the teachings of Purdy as set forth above would result in the third sheath constraining the leg portion of the stent in the compact first diameter while the trunk is partially expanded)
Regarding claim 15, modified Edoga teaches the medial apparatus required by claim 14 as set forth above and further teaches one or more of the first and second and third sheath materials are removable from an implantation site (See Edoga Col. 11, lines 4-16; note sheaths 81, 92, and 82’ are described as “removable”).
Claims 5 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edoga (US PG Pub 5,591,228) in view of Purdy et al (US PG Pub 2008/0288042), as applied to claim 1 above, and further in view of Pierce (US Pat. No. 6,152,956).
Regarding claim 5, modified Edoga teaches the medical apparatus as required by claim 1 above but does not explicitly teach wherein the stent member includes anchors along the distal end thereof for engaging a vessel.
Pierce teaches an analogous medical assembly for delivering a bifurcated stent to an abdominal aorta where the stent includes anchors (barbs 92) along the distal end thereof for engaging a vessel (See Figs. 5, 6, and 8; Col. 8, lines 21-30). Pierce teaches the barbs assist in holding the stent in place and prevent downstream migration.
It would have been obvious to one of ordinary skill in the art at the time of invention to further modify Edoga to include the anchors (barbs) as taught by Pierce since the barbs help the stent to be securely attached to the vessel and prevent migration. Furthermore, stents with barbs/anchors are widely known and used in the art.
Regarding claim 6, modified Edoga teaches the medical apparatus as required by claim 5 above but does not explicitly teach the second sheath material is configured to constrain the anchors after the release of the first sheath material and prior to the stent member expanding to the fully expanded deployed diameter.
Pierce teaches an analogous medical assembly for delivering a bifurcated stent to an abdominal aorta where the stent includes anchors (barbs 92) along the distal end thereof for engaging a vessel (See Figs. 5, 6, and 8; Col. 8, lines 21-30) and further teaches the sheath constrains the anchors (barbs) before the stent is expanded to the fully deployed diameter (Col. 8, lines 30-37).
It would have been obvious to one of ordinary skill in the art at the time of invention to further modify Edoga to have the anchors (barbs) be constrained by the second sheath prior to the stent fully expanding as taught by Pierce since having the barbs covered during delivery up until final placement prevents accidental or unintentional damage to surrounding tissue and ensures the barbs only contact the desired deployment location. This is known to be safer for the patient.
Claims 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edoga (US PG Pub 5,591,228) in view of Purdy et al (US PG Pub 2008/0288042) as applied to claim 1 above and further in view of Cully et al (US PG Pub 2007/0198077).
Regarding claim 7, modified Edoga teaches the medical apparatus as required by claim 1 above but is silent as to the material from which the first and second sheaths are formed. Edoga does not explicitly teach the sheaths are made from ePTFE film.
Cully teaches an analogous medical assembly for delivering a stent where the constraining sheath is made of ePTFE film (See paragraphs [0097]). Cully teaches ePTFE film is a known suitable material for delivery sheaths.
It would have been obvious to one of ordinary skill in the art at the time of invention to form the sheaths as taught by modified Edoga from ePTFE film as taught by Cully since ePTFE is a known suitable material for delivery sheaths. It is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 It is noted the functional limitation "configured to" is not given full patentable weight. As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Edoga meets all the structural requirements and is capable of performing the intended function. Edoga specifically states the sheaths are “removable”.
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