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 .
Claims 1, 4, 7-15, and 17 – 26 are examined in this office action.
Claims 2, 3, 5, 6, and 16 are cancelled.
Claims 21-26 are new.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/12/2026 has been entered.
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 7-12 and 24-26 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 claim 7, the phrase “greater than or equal to .1 µm and less than or equal to 75 µm.” claims the range of “greater than or equal to” and “less than or equal to” and the range of .1 µm to 75 µm.
In claim 10, the phrase “greater than or equal to 1:500” claims the range “greater than or equal to” and the range of “1:500”. In claim 11, the phrase “less than or equal to 1:120” claims the range of “less than or equal to” and the range of “1:120”. In claim 12, the phrase “range between about 1:500 to about 1:120” claims the range of “1:500”, “1:120”, and “about”. In claim 24, the phrase “greater than or equal to 1:500 and less than or equal to 1:120” claims the range “greater than or equal to” and “less than or equal to” in addition to the ranges of “1:500” and “1:120”. It is unclear what the desired range is if there are multiple ranges claimed. Examiner recommends choosing one range, for example “greater than 1” or “1:500” or “about 500” but not multiple ranges.
All remaining claims are rejected as they depend from rejected dependent claims.
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) 1, 4, 7, 15, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fotjik (US Pub No. 2020/0093618 A1).
Regarding claim 1, Fotjik discloses a drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30), the drug elution control sleeve comprising:
a nickel-titanium alloy (“The body 12 may be formed from any of a variety of suitable materials or from a combination of materials. Examples of suitable metals include, but are not limited to … nickel chromium alloys, and the like.” – Para [0062]) tubular member (expandable section 30, Fig. 3) concentrically engaged about the drug-eluting balloon (expander 530, Fig. 30) and having a plurality of elongate slits (slits 32, Fig. 3) passing through the tubular member (“… slits 32 that extend at least partially through a wall 13 of the body 12 …” – Para [0065]) defining a plurality of elongate strut members (struts 36, Fig. 3) between adjacent pairs of elongate slits (“The solid portions of the body 12 that are located between each adjacent pair of series 34a and 34b, 34b and 34c, 34c and 34d, etc., of slits 32 comprise struts 36 of the expandable section 30.” – Para [0073]), wherein at least some of the plurality of elongate strut members are capable of at least partially rotating about their longitudinal axis (“… as the expandable section 30 expands, the struts 36 may rotate.” – Para [0080]) thereby opening at least some of the plurality of elongate slits (“… the slits 32 are opened upon expanding the expandable section 30.” – Para [0080]) with the at least some of the at least partially rotated elongated strut members projecting radially outward in an undulating manner from a central longitudinal axis of the tubular member (“As the slits rotate, they protrude outwardly (e.g., radially, etc.) from the circumference of the expandable section 30.” – Para [0074]) when the drug-eluting balloon is expanded and tubular member is in a diametrically expanded state, thereby exposing the drug-eluting balloon through the at least partially rotated elongated strut members (“As the expander 530 of an expandable instrument 510 is expanded, it expands the expandable section 30 of the exoskeleton device 10. as the expandable section 30 expands, struts 36 of the expandable section 30 may rotate, outwardly, as show in FIG. 5-7.” – Para [0111]) and then rotating about their longitudinal axis thereby closing the at least some of the elongate slits over the drug-eluting balloon (“The release of the pressure within the expander 130 may enable the expandable section 30 to collapse over the expander 130.” – Para [0117]) and returning the at least some of the plurality of elongate strut members to a substantially co-planar normal position ("… (e.g., struts 36 that rotate to a desired extent upon expansion of the expandable section 30, etc.), and the ability to return to substantially its original shape …" - Para [0078]) with the remainder of the tubular member on the drug-eluting balloon when the drug-eluting balloon is unexpanded (Fig. 29) and tubular member is in a diametrically unexpanded state (Fig. 29).
Regarding claim 4, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
the plurality of elongate slits (slits 32, Fig. 3) further comprises a first set of elongate slits (See annotated Fig. 3) and a second set of elongate slits (See annotated Fig. 3), the first set of elongate slits and the second set of elongate slits being circumferentially off-set from each other about circumferential and longitudinal axes of the sleeve ("… each slit 32 of the expandable section 30 may be staggered relative to its circumferentially adjacent slits 32." - Para [0071], Fig. 3).
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Regarding claim 7, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
the tubular member (expandable section 30, Fig. 3) has a substantially uniform wall thickness (expandable section 30, Fig. 29) between greater than or equal to .1 µm and less than or equal to 75µm ("… the struts defined from a .0025 inch thick outer wall will have cutting profiles of .0025 inch when the expandable section of the exoskeleton device is in its expanded state." - Para [0009]).
Regarding claim 15, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
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each elongate slit of elongate slits (slits 32, Fig. 3) further comprises a circumferentially offset section intermediate opposing terminal ends of each slit of the plurality of slits (See annotated Fig. 3).
Regarding claim 17, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
at least some of the elongate strut members that project radially outward in an undulating manner (struts 36, Fig. 7) forming arcuate projections from a normal plane of the tubular member ("As the expandable section or a portion thereof expands each arcuate strut may rotate…" - Para [0006]) and are configured to return to a substantially co-planar position in the normal plane of the tubular member ("… (e.g., struts 36 that rotate to a desired extent upon expansion of the expandable section 30, etc.), and the ability to return to substantially its original shape …" - Para [0078]) when the tubular member is in a diametrically non-expanded state (Fig. 3).
Regarding claim 18, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
the tubular member is radiopaque (“… a radiopaque marker 44 may be provided at the distal end 40 of the exoskeleton 10.” – Para [0103]).
Regarding claim 19, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
the tubular member comprises a shape memory, superleastic, or pseudometallic material ("The body 12 may be formed from any of a variety of suitable materials or from a combination of suitable materials. Examples of suitable metals … memory metals …" - Para [0062]).
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) 8, 20-23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Fotjik (US Pub No. 2020/0093618 A1) in view of Ferrera et al. (US Patent No. 10,120,803 B2).
Regarding claim 8, Fotjik in view of Ferrera discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
each elongate slit of the plurality of elongate slits (Fotjik, slits 32, Fig. 3) passes through the wall thickness of the tubular member (Fotjik, “… slits 32 that extend at least partially through wall 13 of body 12 …” – Para [0065]) when the sleeve is in an unexpanded state (Fotjik, Fig. 3).
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has a width less than or equal to 25µm.
Ferrera teaches that each elongate slit of the plurality of elongate slits has a width less than or equal to 25µm ("strut width of an expandable scaffold may be from about 10 to 100 microns..." – Col. 48, Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a width less than or equal to 25µm as taught by Ferrera to aide in the performance of the structure (Ferrera, Col. 48, Line 34).
Examiner interprets setting the width of each elongate slit of the plurality of elongate slits to be less than or equal to 25µm would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, Fotjik in view of Ferrera discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
Fotjik does not expressly disclose a plurality of terminal extension member projecting from the tubular member at a proximal and/or distal end thereof.
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Ferrera teaches a plurality of terminal extension members (See annotated Fig. 6D) projecting from the tubular member (expandable scaffold 610, Fig. 6A) at a proximal and/or distal end thereof (See annotated Fig. 6D).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a plurality of terminal extension member projecting from the tubular member at a proximal and/or distal end thereof as taught by Ferrera to aide in the performance of the structure (Ferrera, Col. 48, Line 34).
Regarding claim 21, Fotjik in view of Ferrera discloses a drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) concentrically coupled to a drug-eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30), the drug elution control sleeve comprising:
a nickel-titanium alloy (“The body 12 may be formed from any of a variety of suitable materials or from a combination of materials. Examples of suitable metals include, but are not limited to … nickel chromium alloys, and the like.” – Para [0062]) tubular member (expandable section 30, Fig. 3) having a plurality of elongate strut members (struts 36, Fig. 3) separated by elongated slots (slits 32, Fig. 3), each of the elongated slots having a width between about 1micron and 5 microns when the drug-eluting balloon and the tubular member are in an unexpanded state (Fig. 3); at least some of the plurality of the elongate strut members being capable of at least partially rotating about their longitudinal axis (“… as the expandable section 30 expands, the struts 36 may rotate.” – Para [0080]) thereby opening at least some of the elongate slits (“… the slits 32 are opened upon expanding the expandable section 30.” – Para [0080]), the rotated elongated strut members projecting radially toward from a central longitudinal axis of the tubular member in an undulating manner (“… as the expandable section 30 expands, the struts 36 may rotate … As the slits rotate they protrude outwardly (e.g., radially, etc.) from the circumference of the expandable section 30.” – Para [0074]) when the drug-eluting balloon is in an expanded state thereby exposing the drug-eluting balloon through the open elongate slits (“As the expander 530 of an expandable instrument 510 is expanded, it expands the expandable section 30 of the exoskeleton device 10. as the expandable section 30 expands, struts 36 of the expandable section 30 may rotate, outwardly, as show in FIG. 5-7.” – Para [0111]) , wherein upon the drug-eluting balloon being deflated to the unexpanded state the rotated elongate strut members return to a substantially co-planar normal position (“The release of the pressure within the expander 130 may enable the expandable section 30 to collapse over the expander 130.” – Para [0117]) thereby substantially closing the elongated slots thereby preventing release of a drug from the drug-eluting balloon ("… (e.g., struts 36 that rotate to a desired extent upon expansion of the expandable section 30, etc.), and the ability to return to substantially its original shape …" - Para [0078]).
Fotjik does not expressly disclose that each of the elongated slots has a width between about 1 µm and 5 µm.
Ferrera teaches that each of the elongated slots has a width between about 1 µm and 5 µm (“… strut width may be from …. less than 10 microns …” – Col. 48, Lines 11-20).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include that each of the elongated slots has a width between about 1 µm and 5 µm as taught by Ferrera to aide in the performance of the structure (Ferrera, Col. 48, Line 34).
Examiner interprets setting the width of each elongate slit of the plurality of elongate slits to be between 1 µm and 5 µm would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 22, Fotjik in view of Ferrera discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) as recited above, wherein
the plurality of elongate slits (Fotjik, slits 32, Fig. 3) further comprises a first set of elongate slits (Fotjik, See annotated Fig. 3)and a second set of elongate slits (Fotjik, See annotated Fig. 3), the first set of elongate slits and the second set of elongate slits being circumferentially off-set from each other about circumferential and longitudinal axes of the sleeve (Fotjik, “… each slit 32 of the expandable section 30 may be staggered relative to its circumferentially adjacent slits 32.” – Para [0071], Fig. 3).
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Regarding claim 23, Fotjik in view of Ferrera discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) as recited above, wherein
each elongate slit of the plurality of elongate slits (Fotjik, slits 32, Fig. 3) passes through the wall thickness of the tubular member (Fotjik, “… slits 32 that extend at least partially through wall 13 of body 12 …” – Para [0065]) when the sleeve is in an unexpanded state (Fig. 3).
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has a width less than or equal to 25 µm when the sleeve is in an unexpanded state.
Ferrera teaches that each elongate slit of the plurality of elongate slits has a width less than or equal to 25 µm when the sleeve is in an unexpanded state ("strut width of an expandable scaffold may be from about 10 to 100 microns..." – Col. 48 Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include that each elongate slit of the plurality of elongate slits has a width less than or equal to 25 µm when the sleeve is in an unexpanded state as taught by Ferrera to aide in the performance of the structure (Ferrera, Col. 48, Line 34).
Examiner interprets setting the width of each elongate slit of the plurality of elongate slits to be less than or equal to 25µm would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, Fotjik in view of Ferrera discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) as recited above, wherein
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each elongate slit of the plurality of elongate slits (slits 32, Fig. 3) further comprises a circumferentially offset section intermediate opposing terminal ends of each slit of the plurality of slits (See annotated Fig. 3).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fotjik (US Pub No. 2020/0093618 A1) in view of Kumoyama et al. (US Pub No. 2005/0216047 A1, herein Kumoyama).
Regarding claim 9, Fotjik in view of Kumoyama discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has a length greater than 1mm.
Kumoyama teaches that each elongate slit of the plurality of elongate slits (slits 41, Fig. 1) has a length greater than 1mm ("… the length L1 (see FIG. 1) of each slit 41 is preferably in the range of about .5 to 5 mm…" - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include that each elongate slit of the plurality of elongate slits has a length greater than 1mm as taught by Kumoyama so the outer sleeve 4 can be expanded uniformly (Kumoyama, Para [0078]).
Examiner interprets setting the length of each elongate slit of the plurality of elongate slits to be greater than or equal to 1mm would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 10-12 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fotjik (US Pub No. 2020/0093618 A1) in view of Ferrera et al. (US Patent No. 10,120,803 B2) and Kumoyama et al. (US Pub No. 2005/0216047 A1, herein Kumoyama).
Regarding claim 10, Fotjik in view of Ferrera and Kumoyama discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
each elongate slits of the plurality of elongate slits (Fotjik, slits 32, Fig. 3).
Fotjik does not expressly a width to length aspect ratio greater than or equal to 1:500.
Ferrera teaches a width ("strut width of an expandable scaffold may be from about 10 to 100 microns..." - Col. 48, Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a width as taught by Ferrera to aides in the performance of the structure (Ferrera, Col. 48, Line 34).
Ferrera does not expressly disclose a to length aspect ratio greater than or equal to 1:500.
Kumoyama teaches a length ("… the length L1 (see FIG. 1) of each slit 41 is preferably in the range of about .5 to 5 mm…" - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a length as taught by Kumoyama so the outer sleeve 4 can be expanded uniformly (Kumoyama, Para [0078]).
Examiner interprets that it would be obvious that the combination of the width as taught by Ferrera (.01mm) and the length as taught by Kumoyama (5mm) would produce the same ratio (.01:5 = 1:500) since it has been held that 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 11, Fotjik in view of Ferrera and Kumoyama discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
each elongate slit of the plurality of elongate slits (Fotjik, slits 32, Fig. 3).
Fotjik does not expressly disclose that has a width to length ratio less than or equal to 1:120.
Ferrera teaches a width ("strut width of an expandable scaffold may be from about 10 to 100 microns ..." - Col. 48, Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a width as taught by Ferrera to aides in the performance of the structure (Ferrera, Col. 48, Line 34).
Ferrera does not expressly disclose a to length ratio less than or equal to 1:120.
Kumoyama teaches a length ("… the length L1 (see FIG. 1) of each slit 41 is preferably in the range of about .5 to 5 mm…" - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a length as taught by Kumoyama so the outer sleeve 4 can be expanded uniformly (Kumoyama, Para [0078]).
Examiner interprets that it would be obvious that the combination of the width as taught by Ferrera (.01mm) and the length as taught by Kumoyama (5mm) would produce the same ratio (.01:5 = 1:500 < 1:120) since it has been held that 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 12, Fotjik in view of Ferrera and Kumoyama discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
each of the plurality of elongate slits (Fotjik, slits 32, Fig. 3).
Fotjik does not expressly disclose a width to length aspect ratio greater than or equal to 1:500 to about 1:120.
Ferrera teaches a width ("strut width of an expandable scaffold may be from about 10 to 100 microns ..." - Col. 48, Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a width as taught by Ferrera to aide in the performance of the structure (Ferrera, Col. 48, Line 34).
Ferrera does not expressly disclose a width to length aspect ratio greater than or equal to 1:500 to about 1:120.
Kumoyama teaches a length ("… the length L1 (see FIG. 1) of each slit 41 is preferably in the range of about .5 to 5 mm…" - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a length as taught by Kumoyama so the outer sleeve 4 can be expanded uniformly (Kumoyama, Para [0078]).
Examiner interprets that it would be obvious that the combination of the width as taught by Ferrera (.01mm) and the length as taught by Kumoyama (5mm) would produce the same ratio (.01:5 = 1:500 < 1:120) since it has been held that 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 24, Fotjik in view of Ferrera and Kumoyama discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) as recited above, wherein
each of the plurality of elongate slits (Fotjik, slits 32, Fig. 3).
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has a length greater than 1mm and has a width to length ratio greater than or equal to 1:500 and less than or equal to 1:120.
Ferrera teaches a width ("strut width of an expandable scaffold may be from about 10 to 100 microns..." - Col. 48, Lines 11-12).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a width as taught by Ferrera to aides in the performance of the structure (Ferrera, Col. 48, Line 34).
Ferrera does not expressly disclose a to length aspect ratio greater than or equal to 1:500 and less than or equal to 1:120.
Kumoyama teaches that each elongate slit of the plurality of elongate slits has a length greater than 1mm ("… the length L1 (see FIG. 1) of each slit 41 is preferably in the range of about .5 to 5 mm…" - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include a length as taught by Kumoyama so the outer sleeve 4 can be expanded uniformly (Kumoyama, Para [0078]).
Examiner interprets that it would be obvious that the combination of the width as taught by Ferrera (.01mm) and the length as taught by Kumoyama (5mm) would produce the same ratio (.01:5 = 1:500 < 1:120) since it has been held that 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).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fotjik (US Pub No. 2020/0093618 A1) in view of Shanley (US Pub No. 2002/0013619 A1).
Regarding claim 13, Fotjik in view of Shanley discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has terminal strain relief sections at opposing ends thereof.
Shanley teaches that each elongate slit of the plurality of elongate slits (slots 22, Fig. 2) has terminal strain relief sections (circumferential slot 26, Fig. 2) at opposing ends thereof (“At each interior end of each of the axial slots 22 a circumferential slot 26 if formed.” – Para [0048]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include that each elongate slit of the plurality of elongate slits has terminal strain relief sections at opposing ends thereof as taught by Shanley to concentrate expansion stresses and strains in small, well-defined areas (Shanley, Para [0026]).
Regarding claim 14, Fotjik in view of Shanley discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) in combination with a drug eluting balloon (Fotjik, expander 530, “… an expander, such as a balloon catheter …” – Abstract, Fig. 30) as recited above, wherein
Fotjik does not expressly disclose that each of the terminal strain relief sections further comprises an enlarged rounded section having a diameter greater than a width of an elongated slit of the plurality of slits within which it is associated
Shanley teaches that each of the terminal strain relief sections (circumferential sots 26, Fig. 2) further comprises an enlarged rounded section ("… the circumferential slot 26 has semicircular ends 38 …" - Para [0055]) having a diameter greater than a width of an elongated slit of the plurality of slits within which it is associated (Fig. 2)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to that each of the terminal strain relief sections further comprises an enlarged rounded section having a diameter greater than a width of an elongated slit of the plurality of slits within which it is associated as taught by Shanley to concentrate expansion stresses and strains in small, well-defined areas (Shanley, Para [0026])..
Regarding claim 25, Fotjik in view of Shanley discloses the drug elution control sleeve (Fotjik, exoskeleton device 10, Fig. 3) as recited above, wherein
Fotjik does not expressly disclose that each elongate slit of the plurality of elongate slits has terminal strain relief sections at opposing ends thereof.
Shanley teaches that each elongate slit of the plurality of elongate slits (slots 22, Fig. 2) has terminal strain relief sections (circumferential slot 26, Fig. 2) at opposing ends thereof (“At each interior end of each of the axial slots 22 a circumferential slot 26 if formed.” – Para [0048]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug elution control sleeve of Fotjik to include that each elongate slit of the plurality of elongate slits has terminal strain relief sections at opposing ends thereof as taught by Shanley to concentrate expansion stresses and strains in small, well-defined areas (Shanley, Para [0026]).
Response to Arguments
Applicant's arguments filed 5/12/2026 have been fully considered but they are not persuasive.
Applicant argues that Fotjik fails to teach the exoskeleton device 10 coupled to a drug-eluting balloon or that the opening of the slits in some fashion exposes an underlying drug-eluting balloon to release the drug through the slits. In fact, the presently amended claims, as well as the originally filed claims, claim a drug elution sleeve. By plain English definition, as confirmed by Mirianm-Webster Dictionary, a sleeve is defined as “a tubular part (such as hollow axle or a bushing) designed to fit over another part” and/or “an open-ended flat or tubular packaging cover.” The exoskeleton device 10 of Fotjik meets neither definition. While Fotjik does teach that the exoskeleton device 10 may be expanded using a balloon catheter, it is also abundantly clear that the balloon catheter is not a drug-eluting balloon catheter, but rather that the drug is coated on or associated with the exoskeleton device itself.
Examiner interprets the exoskeleton device 10 to be a tubular part designed to fit over the expandable section 30 (which fits over the expander 530 or balloon catheter) as shown in Fig. 26, thus allowing the exoskeleton device 10 of Fotjik to meet the definition of sleeve and be coupled to the balloon catheter. Additionally, in certain embodiments disclosed Fotjik, the medicament is carried by the surface of the expander 530 which is released when the struts are opened (“The medicament or other substance may be delivered by infusion through the exoskeleton device 10, from the expandable element 30 (e.g., by elution, etc.) (see, e.g., FIGS. 17-24 and associated disclosure), or by infusing a fluid (e.g., a gas, saline, etc.) over a medicament carried by the surface of the expander 530 of the expandable instrument 510.” – Para [0114]).
Applicant argues that claim 8 pertains to the width of the elongate slit not the width of the strut as taught by Ferrera.
Examiner interprets the measurements disclosed for strut width in Ferrera to be applicable to the slit width measurements as well and that finding a slit width of 25 microns would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In response to applicant’s argument for claims 9-12 and 20 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the measurements disclosed in Ferrera and Kumoyama can be applied to the exoskeleton device of Fotjik as discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect the applicant’s arguments the rejection above teaches the claimed limitations and the rejection above is maintained.
Conclusion
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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