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 12 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 12, the phrase “greater than or equal to about 1:500 to about 1:120” claims a range of 1:500 to 1:120 that is modified by a range “about” that is further modified by a range “greater than or equal to”. It is unclear what the desired range is if there are multiple ranges claimed.
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) 1-7, 15, 17-19 is/are rejected under 35 U.S.C. 102(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), comprising:
a tubular member (expandable section 30, Fig. 3) 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]) which project radially outward in an undulating manner form 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 tubular member is in a diametrically expanded state (“… upon expanding the expandable section 30.” – Para [0080])
Regarding claim 2, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
the tubular member (expandable section 30, Fig. 3) is coupled to a catheter at proximal and distal ends of the sleeve ("… the exoskeleton device may also include a collar around a distal end of the expandable section, as well as a tubular element (e.g., a catheter, an extension of the expandable section, etc.) coextensive with a proximal end of the expandable section." - Para [0016]), Fig. 1)
Regarding claim 3, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
the catheter (expandable instrument 510, Fig. 29) further comprises a balloon catheter ("… the expander may be expanded in a suitable manner to expand the expandable section 30 (e.g., a balloon of a balloon catheter may be inflated …" - Para [0110]) and the tubular member is coupled to a balloon ("… securing the exoskeleton device 10 to the expandable instrument 510." - Para [0107]) at a distal end of the ballon catheter (Fig. 29)
Regarding claim 4, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) 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 5, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
the at least some of the elongate strut members (struts 36, Fig. 3) configured to at least partially rotate about their respective longitudinal axes and project radially outward relative to the central axis of the catheter when the tubular member is in the diametrically expanded state (“… 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]).
Regarding claim 6, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
at least some of the elongate strut members (struts 36, Fig. 3) configured to at least partially rotate about their respective longitudinal axes and project radially outward relative to the central axis of the catheter ("… 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]) ]) are additionally configured to return to a substantially co-planar position when the tubular member is in a diametrically unexpanded state ("… (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], Fig. 3)
Regarding claim 7, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) 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) as recited above, wherein
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)
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Regarding claim 17, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
at least some of the elongate strut members that project radially outward in an undulating manner (struts 36, Fig. 7) from 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) 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) 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 and 20 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).
Regarding claim 8, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
each elongate slit of the plurality of elongate slits (slits 32, Fig. 3) passes through the wall thickness of the tubular member (“… 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 has a width less than or equal to 25µm
Ferrera teaches a width less than or equal to 25µm ("strut width of an expandable scaffold may be from about 10 to 100 microns..." - Para [240])
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 aides in the performance of the structure (Ferrera, Para [242]).
Regarding claim 20, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) 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.
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).
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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 discloses the drug elution control sleeve (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 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]).
Claim(s) 10-12 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 discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
each elongate slits of the plurality of elongate slits (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..." - Para [240])
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, Para [242])
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 discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
each elongate slit of the plurality of elongate slits
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 ..." - Para [240])
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, Para [242])
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 discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) as recited above, wherein
each of the plurality of elongate slits (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 ..." - Para [240])
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, Para [242])
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).
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 discloses the drug elution control sleeve (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])
Regarding claim 14, Fotjik discloses the drug elution control sleeve (exoskeleton device 10, Fig. 3) 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
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 6/26/2025, with respect to the rejection(s) of claim(s) 1-19 under 35 USC 112, 102, and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of different interpretation of the previously applied reference.
Examiner relies upon the new interpretation of Fotjik to teach the limitations in claims 1-20, including the newly amended limitation which project radially outward in an undulating manner form a central longitudinal axis of the tubular member. This scope of the amended limitation of the previous allowable subject matter of claim 16 because the replacement of “catheter” with “tubular member” which has a broader scope. Furthermore, examiner further relies on additional reference Ferrera to reject claims 8, 10-12, and 20. The rejection as recited above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 ESHA P KASHYAP whose telephone number is (571)-272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783