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 .
This action is in response to the amendment filed on 01/21/2026. Claims 2-31 are pending. Claims 2, 12, 17, and 21 are independent. Claims 12-20 are withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites the limitation “the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to withdrawal of the stent.” The disclosure of the pending application is completely silent on that the cover portion of the sleeve is configured to block blood flow through the portion of the stent in response to withdrawal of the stent. Therefore, the limitation is considered as new matter.
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 21-30 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.
Claim 21 recites the limitation “the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to withdrawal of the stent.” It is unclear how the cover portion of the sleeve is configured to block blood flow through the portion of the stent in response to withdrawal of the stent (if the stent is withdrawn). For the purpose of examination, the limitation is interpreted to be “the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent.”
The art rejection(s) on claims 21-30 are made as best understood by the examiner because of the 35 U.S.C. 112 issue(s) stated above.
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.
Claim(s) 2, 3, 7, 8, 11, 21, 22, 26, 27, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abrams (US Pub No.: 2005/0121043).
Regarding claims 2, 3, 7, 8, and 11, Abrams discloses [claim 2] a deformable sleeve (20, Fig. 2) having a proximal end (proximal end at 25, Fig. 2) to couple to a distal end outside wall of a catheter (10, Fig. 2), the sleeve including a hole (a hole/slot of holes/slots through the sheath 20, Para. [0019]) extending radially through a cover portion (a solid cover/wall portion of sheath 20 surrounding/around a hole/slot of holes/slots through the sheath 20, Paras. [0019] and [0018]) of the sleeve proximal to a distal end of the sleeve (distal end at 27, Para. [0019] and Fig. 2), the sleeve having a sleeve lumen (central lumen of the 20, Fig. 2) between the proximal end and the distal end of the sleeve; wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole is fully capable to engage a strut of a stent as the stent is advanced through a lumen of the catheter and depending on the structure of the stent. It should be noted that the stent is not positively recited in the claim.), and a tethered portion (portion at 30 / the circumferential tearable perforation, Fig. 4 and Para. [0020]) positioned between the proximal end of the sleeve and the distal end of the sleeve, and wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole/slot of holes/slots through the sheath 20 is a solid material. The materials, such as latex and Pebax, listed in Para. [0018] are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve); [claim 3] wherein the tethered portion comprises an annular set of perforations closer to the proximal end of the sleeve (Para. [0020], circumferential perforation); [claim 7] wherein the sleeve comprises a polymer (Para. [0018], e.g. Pebax); [claim 8] wherein the polymer comprises two or more polymers with different properties (Para. [0018], Pebax is a combination of two polymers, a rigid polyamide block and a soft polyether block, with different properties); and [claim 11] wherein the sleeve is tapered from the proximal end to the distal end of the sleeve (Fig. 2).
Regarding claims 21, 22, 26, 27, and 30, Abrams discloses [claim 21] deformable sleeve (20, Fig. 2) comprising: a sleeve proximal end (proximal end at 25, Fig. 2) to couple to a distal end of a catheter (10, Fig. 2); a sleeve distal end (distal end at/near 27, Figs. 2 and 3); a cover portion (a solid cover/wall portion of sheath 20 surrounding/around a hole/slot of holes/slots through the sheath 20, Paras. [0019] and [0018]) having a lumen (central lumen of the 20, Fig. 2) extending between the sleeve proximal end and the sleeve distal end; a hole (a hole/slot of holes/slots through the sheath 20 surrounded by the solid cover portion, Para. [0019]) extending radially through the cover portion, wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole is fully capable to engage a strut of a stent as the stent is advanced through a lumen of the catheter and depending on the structure of the stent. It should be noted that the stent is not positively recited in the claim.); and a tethered portion (portion at 30 / the circumferential tearable perforation is between the proximal end of the sleeve at 25 and hole defined in the figure above, Fig. 4 and Para. [0020]; alternatively, portion at 30 / the circumferential tearable perforation is between the proximal end of the sleeve at 25 and the hole as described in Para. [0019] because portion 30 is the detachable portion, Fig. 4 and the holes/slots described in Para. [0019] is for enhancing flexibility, and therefore the holes/slots would be located distal of 30) positioned between the sleeve proximal end and the hole, wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole/slot of holes/slots through the sheath 20 is a solid material. The materials, such as latex and Pebax, listed in Para. [0018] are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve); [claim 22] wherein the tethered portion comprises an annular set of perforations closer to the proximal end of the sleeve (Para. [0020], circumferential perforation); [claim 26] wherein the sleeve comprises a polymer (Para. [0018], e.g. Pebax); [claim 27] wherein the polymer comprises two or more polymers with different properties (Para. [0018], Pebax is a combination of two polymers, a rigid polyamide block and a soft polyether block, with different properties); and [claim 30] wherein the sleeve is tapered from the proximal end to the distal end (Fig. 2).
Claim(s) 2, 3, 7, 8, 21, 22, 26, 27, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sgro (US Pat. No.: 6,063,112).
Regarding claims 2, 3, 7, and 8, Sgro discloses [claim 2] a deformable sleeve (6 with 11, Figs. 10 and 11) having a proximal end (proximal end of 6 near 4b, Fig. 10) to couple to a distal end outer wall of a catheter (3, Figs. 1 and 10), the sleeve including a hole (a hole in a cover portion of the sleeve at a distal end of the sleeve since the sleeve is formed of a permeable continuous wall, Col. 5, lines 2-9) extending radially through in a cover portion of the sleeve (a solid cover portion / part of the wall of sleeve at the distal end of the sleeve surrounding/around a hole of holes through the sleeve 6, Figs. 10 and 11) proximal to a distal end of the sleeve; the sleeve having a sleeve lumen between the proximal end and the distal end of the sleeve (Fig. 10); wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole/holes in the permeable continuous wall is/are fully capable to directly/indirectly engage a strut of a stent advanced through a lumen of the catheter. It should be noted that the stent is not positively recited in the claim.), and a tethered portion (9b, Fig. 10) positioned between the proximal end of the sleeve and the distal end of the sleeve, wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole of holes through the sleeve 6 is a solid material. The materials, such as polyurethane or polyester, listed in Col. 5, lines 2-9 are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve); [claim 3] wherein the tethered portion comprises an annular set of perforations closer to the proximal end of the sleeve (Fig. 10); [claim 7] wherein the sleeve comprises a polymer (Col. 5, lines 2-9, e.g. PTFE or polyamide); and [claim 8] wherein the polymer comprises two or more polymers with different properties (Col. 5, lines 2-9 and Col. 6, lines 2-6, e.g. PTFE and polyester).
Regarding claims 21, 22, 26, and 27, Sgro discloses [claim 21] a deformable sleeve (6 with 11, Figs. 10 and 11) comprising: a sleeve proximal end (proximal end of 6 near 4b, Fig. 10) to couple to a distal end of a catheter (3, Figs. 1 and 10); a sleeve distal end (distal end near 4a, Fig. 10 and 11); a cover portion (a solid cover portion / part of the wall of sleeve extending between the proximal end and the distal end and surrounding/around a hole of holes through the sleeve 6, Figs. 10 and 11cover portion / part of 6) having a lumen (central lumen of 6, Fig. 10) extending between the proximal end and the distal end; a hole (the hole/holes in the permeable continuous wall near the distal end of the sleeve, Col. 5, lines 2-9) extending radially through the cover portion, wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole is fully capable to directly/indirectly engage a strut of a stent advanced through a lumen of the catheter, Fig. 11. It should be noted that the stent is not positively recited in the claim.); and a tethered portion (9b, Fig. 10) positioned between the proximal end of the sleeve and the hole, wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole of holes through the sleeve 6 is a solid material. The materials, such as polyurethane or polyester, listed in Col. 5, lines 2-9 are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve); [claim 22] wherein the tethered portion comprises an annular set of perforations closer to the proximal end of the sleeve (Fig. 10); [claim 26] wherein the sleeve comprises a polymer (Col. 5, lines 2-9, e.g. PTFE or polyamide); and [claim 27] wherein the polymer comprises two or more polymers with different properties (Col. 5, lines 2-9 and Col. 6, lines 2-6, e.g. PTFE and polyester).
Regarding claim 31, Sgro discloses [claim 31] a deformable sleeve (6 with 11, Figs. 10 and 11) having a proximal end (proximal end of 6 near 4b, Fig. 10) to couple to a distal end of a catheter (3, Figs. 1 and 10), the sleeve including a hole (the hole/holes in the permeable continuous wall at the distal end of the sleeve, Col. 5, lines 2-9) extending radially through a cover portion of the sleeve (a solid cover portion / part of the wall of sleeve extending between the proximal end and the distal end of the sleeve and surrounding/around a hole of holes through the sleeve 6, Figs. 10 and 11) at a distal end of the sleeve having a lumen (central lumen of 6, Fig. 10), wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole is fully capable to directly/indirectly engage a strut of a stent advanced through a lumen of the catheter. It should be noted that the stent is not positively recited in the claim.), and a tethered portion (9b, Fig. 10) positioned between the proximal end of the sleeve and the distal end of the sleeve, wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole of holes through the sleeve 6 is a solid material. The materials, such as polyurethane or polyester, listed in Col. 5, lines 2-9 are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve) and the tethered portion fully capable to disengage the lumen upon withdrawal of the catheter permitting fluid flow through the lumen of the stent (Fig. 11)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-6 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams (US Pub No.: 2005/0121043) as applied to claims 2 and 21 above, and further in view of Sandhu et al. (US Pub. No.: 2009/0118817).
Regarding claims 4-6 and 23-25, Abrams discloses all the limitations of claims 2 and 21 as taught above but fails to disclose that the sleeve comprises [claims 4 and 23] a therapeutic coating on the sleeve, wherein the therapeutic coating comprises a drug; [claims 5 and 24] wherein the therapeutic coating comprises multiple drugs coating different portions of the outside of the sleeve; [claims 6 and 25] wherein the therapeutic coating comprises cells.
Sandhu teaches, in the same field of endeavor (vascular sleeve, e.g. graft), a sleeve (vascular graft, Paras. [0110] and [0118]-[0120]) comprises a therapeutic coating (836, Fig. 11) on the sleeve, wherein the therapeutic coating comprises a drug (Para. [0119]); wherein the therapeutic coating comprises multiple drugs coating different portions of the outside of the sleeve (Paras. [0119] and [0126]-[0130], drug in layer 838 and biological magnetic cells in layer 837); wherein the therapeutic coating comprises cells (Paras. [0119] and [0126]-[0130]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the sleeve of Abrams to include a therapeutic coating on the sleeve; wherein the therapeutic coating comprises a drug; wherein the therapeutic coating comprises multiple drugs coating different portions of the outside of the sleeve; wherein the therapeutic coating comprises cells as taught by Sandhu in order to obtain the advantage of localize cells and therapeutic agent with different functions for treating malignancies (Sandhu, at least Paras. [0076] and [0118]-[0119]).
Claim(s) 9 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams (US Pub No.: 2005/0121043) as applied to claims 2 and 21 above, and further in view of Cully et al. (US Pub. No.: 2007/0250153).
Regarding claims 9 and 28, Abrams discloses all the limitations of claims 2 and 21 as taught above but fails to disclose that the sleeve has a wall thickness of between 0.00635 mm and 0.127 mm.
Cully teaches, in the same field of endeavor (stent graft/sleeve), a sleeve having a wall thickness of between 0.00635 mm and 0.127 mm (Para. [0050]-[0051], e.g. 0.1 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the wall thickness of sleeve of Abrams to be between 0.00635 mm and 0.127 mm, such as 0.1 mm, as taught by Cully, since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Claim(s) 10 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams (US Pub No.: 2005/0121043) as applied to claims 2 and 29 above, and further in view of Holloway et al. (US Pub. No.: 2003/0114917).
Regarding claims 10 and 29, Abrams discloses all the limitations of claim 2 and 21as taught above but fails to disclose that the sleeve has a length between the tethered portion and the distal end of between 1 mm- 100 mm. However, Abrams discloses that length of the sleeve between the tethered portion and the distal end is the length of the sleeve configured to be deployed.
Holloway teaches, in the same field of endeavor (stent graft/sleeve), a sleeve/graft of a stent graft configured to be deployed is between 1 mm- 100 mm, such as 1 cm or 10 mm.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the length of the sleeve configured to be deployed (which would be equivalent to the length between the tethered portion and the distal end) of Abrams to be between 1 mm- 100 mm, such as 10 mm as taught by Holloway, since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-11 and 21-31 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on the art rejections on pages 7-10 of the remarks, Abrams discloses a deformable sleeve (20, Fig. 2) having a proximal end (proximal end at 25, Fig. 2) to couple to a distal end outside wall of a catheter (10, Fig. 2), the sleeve including a hole (a hole/slot of holes/slots through the sheath 20, Para. [0019]) extending radially through a cover portion (a solid cover/wall portion of sheath 20 surrounding/around a hole/slot of holes/slots through the sheath 20, Paras. [0019] and [0018]) of the sleeve proximal to a distal end of the sleeve (distal end at 27, Para. [0019] and Fig. 2), the sleeve having a sleeve lumen (central lumen of the 20, Fig. 2) between the proximal end and the distal end of the sleeve; wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole is fully capable to engage a strut of a stent as the stent is advanced through a lumen of the catheter and depending on the structure of the stent. It should be noted that the stent is not positively recited in the claim.), and a tethered portion (portion at 30 / the circumferential tearable perforation, Fig. 4 and Para. [0020]) positioned between the proximal end of the sleeve and the distal end of the sleeve, and wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole/slot of holes/slots through the sheath 20 is a solid material. The materials, such as latex and Pebax, listed in Para. [0018] are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve).
In response to the argument(s) on the art rejections on pages 8-9 of the remarks, Sgro discloses a deformable sleeve (6 with 11, Figs. 10 and 11) having a proximal end (proximal end of 6 near 4b, Fig. 10) to couple to a distal end outer wall of a catheter (3, Figs. 1 and 10), the sleeve including a hole (a hole in a cover portion of the sleeve at a distal end of the sleeve since the sleeve is formed of a permeable continuous wall, Col. 5, lines 2-9) extending radially through in a cover portion of the sleeve (a solid cover portion / part of the wall of sleeve at the distal end of the sleeve surrounding/around a hole of holes through the sleeve 6, Figs. 10 and 11) proximal to a distal end of the sleeve; the sleeve having a sleeve lumen between the proximal end and the distal end of the sleeve (Fig. 10); wherein the hole is fully capable to engage a strut of a stent advanced through a lumen of the catheter (the hole/holes in the permeable continuous wall is/are fully capable to directly/indirectly engage a strut of a stent advanced through a lumen of the catheter. It should be noted that the stent is not positively recited in the claim.), and a tethered portion (9b, Fig. 10) positioned between the proximal end of the sleeve and the distal end of the sleeve, wherein the cover portion of the sleeve is configured to cover a portion of the stent and block blood flow through the portion of the stent in response to deployment of the stent (the cover portion of the sleeve is fully capable to cover a portion of the stent, such as a small portion of the stent pressing against the sleeve and block blood flow through the portion of the stent in response to deployment of the stent because the cover portion surrounding/around the hole of holes through the sleeve 6 is a solid material. The materials, such as polyurethane or polyester, listed in Col. 5, lines 2-9 are not blood permeable. Therefore, the solid cover material portion of the sleeve is fully capable to block blood flow through the portion of the stent in response to deployment of the stent once the portion of the stent pressed against the solid cover material portion of the sleeve).
Conclusion
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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