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 Office Action is in response to the amendments dated August 4, 2026.
Claims 1-2, 7-12, 17-19, and 24 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over respective Claims 1 and 10 of U.S. Patent No. 12,022,998 in view of Aristizabal (US PGPUB 2018/0296378 – “Aristizabal”). Claims 1 and 11 claim all features found in respective Claims 1 and 10 of U.S. Patent No. 12,022,998 except for the features of “wherein the elongated rod is configured to move between a retracted position and an extended position, wherein when the elongated rod is in the extended position, the sleeve plug is disposed distal to the distal end of the hollow tube and when the elongated rod is in the retracted position, at least a portion of the sleeve plug is disposed within the central lumen of the hollow tube”. (See comparison table below showing underlined differences.)
Aristizabal teaches wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the elongated rod is configured to be moved proximally to the retracted position to clamp the distal end of the elongated flexible tubular sleeve inside of the distal end of the hollow tube (Aristizabal FIG. 32, showing nosecone 62 pressing against distal end 198 of tubular everting sheath 172 to press against catheter 12), and (ii) the elongated rod is configured to be moved distally to the extended position to release the distal end of the elongated flexible tubular sleeve from within the distal end of the hollow tube (Aristizabal FIG. 47, showing everting sheath 172 released from catheter 12 when chassis 16 is moved distally). It would have been obvious to combine Aristizabal’s everting sheath 172 and nosecone 62 with the invention claimed in Claims 1 and 10 of U.S. Patent No. 12,022,998 in order to yield the predictable result of an apparatus that has a selectively-imposed protective sheath over an insertion tube (see Aristizabal paragraphs [0110]) that include optional retraction tethers 188 (see Aristizabal FIG. 40) for additional connectors to the everting sheath 172. As such, this is an obviousness-type double rejection.
Dependent Claims 2, 7-10, 17-19, and 24 are rejected according to this obviousness-type double rejection based on their respective dependence on independent Claims 1 or 11.
Current application 18/761,646
Parent Patent 12,022,998
Claim 1
Claim 1
Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug, wherein the elongated rod is configured to move between a retracted position and an extended position, wherein when the elongated rod is in the extended position, the sleeve plug is disposed distal to the distal end of the hollow tube and when the elongated rod is in the retracted position, at least a portion of the sleeve plug is disposed within the central lumen of the hollow tube;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; and
at least one flexible mandrel configured to be passed through at least one support tube formed on an exterior surface of the elongated flexible tubular sleeve;
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the elongated rod is configured to be moved proximally to the retracted position to clamp the distal end of the elongated flexible tubular sleeve inside of the distal end of the hollow tube, and (ii) the elongated rod is configured to be moved distally to the extended position to release the distal end of the elongated flexible tubular sleeve from within the distal end of the hollow tube; and
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube; and
further wherein when the distal end of the elongated flexible tubular sleeve is clamped within the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.
further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.
Claim 11
Claim 10
A method for inverting an elongated, flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising:
A method for inverting an elongated, flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising:
providing an apparatus comprising:
providing an apparatus comprising:
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug, wherein the elongated rod is configured to move between a retracted position and an extended position, wherein when the elongated rod is in the extended position, the sleeve lug is disposed distal to the distal end of the hollow tube and when the elongated rod is in the retracted position, at least a portion of the sleeve plug is disposed within the central lumen of the hollow tube;
an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube;
disposing the elongated flexible tubular sleeve over the hollow tube;
disposing the elongated flexible tubular sleeve over the hollow tube;
moving the elongated rod proximally to the retracted position, whereby to clamp the distal end of the elongated flexible tubular sleeve inside of the distal end of the hollow tube; and
moving the elongated rod proximally, whereby to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube;
pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve.
pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve; and
applying a hydrophilic coating to the inverted flexible tubular sleeve.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 7, 10-11, 17, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aristizabal (US PGPUB 2018/0296378 – “Aristizabal”).
With regard to Claim 1, Aristizabal discloses:
Apparatus for inverting an elongated flexible tubular sleeve (Aristizabal FIG. 32, everting sheath 172) having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:
a hollow tube (Aristizabal FIG. 32, prosthesis tube 12) comprising a proximal end, a distal end and a central lumen (Aristizabal FIG. 32, interior push-pull rod 45 can include a mechanism for adjusting the size of a portion of its diameter, such as an inflatable and deflatable head 48 of tube 12) extending between the proximal end and the distal end; and
an elongated rod (Aristizabal FIG. 32, chassis 16) movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug (Aristizabal FIG. 32, nosecone 62),
wherein the elongated rod (Aristizabal FIG. 32, chassis 16) is configured to move between a retracted position (Aristizabal FIG. 32) and an extended position (Aristizabal FIG. 28), wherein when the elongated rod is in the extended position, the sleeve plug (Aristizabal FIG. 25, nosecone 62) is disposed distal to the distal end of the hollow tube (Aristizabal FIG. 25, showing nosecone 62 distal to the distal end of device/catheter 12) and when the elongated rod is in the retracted position, at least a portion of the sleeve plug is disposed within the central lumen of the hollow tube (Aristizabal FIG. 32, showing nosecone 62 within the central lumen of catheter 12);
wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the elongated rod is configured to be moved proximally to the retracted position to clamp the distal end of the elongated flexible tubular sleeve inside of the distal end of the hollow tube (Aristizabal FIG. 32, showing nosecone 62 pressing against distal end 198 of tubular everting sheath 172 to press against catheter 12), and (ii) the elongated rod is configured to be moved distally to the extended position to release the distal end of the elongated flexible tubular sleeve from within the distal end of the hollow tube (Aristizabal FIG. 47, showing everting sheath 172 released from catheter 12 when chassis 16 is moved distally); and
further wherein when the distal end of the elongated flexible tubular sleeve is clamped within the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve (Aristizabal FIG. 32, showing everting sheath 172 clamped within catheter 12 and inverted as caused by chassis 16 pulling everting sheath 172 toward catheter 12).
With regard to Claim 7, Aristizabal discloses the features of Claim 1, as described above.
Aristizabal further discloses wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit (Aristizabal FIG. 32, showing everting sheath 172 clamped within catheter 12 caused by chassis 16 pulling everting sheath 172 toward catheter 12).
With regard to Claim 10, Aristizabal discloses the features of Claim 1, as described above.
Aristizabal further discloses a handle (Aristizabal FIG. 31, handle 186), wherein the handle is configured to be mounted over the proximal end of the elongated flexible tubular sleeve for pulling the elongated flexible tubular sleeve distally (Aristizabal FIG. 31, retraction end 182; Aristizabal FIG. 32, outer section 180 and inner section 174 of everting sheath 172; Aristizabal paragraph [0110], “retraction end 182 is secured to a retraction handle 186 that may be used to apply proximal axial tension to the outer section 180 relative to the chassis 16 and inner section 174 in order to pull the outer section 180 back over the inner section 174 to evert the everting sheath 172”).
With regard to Claim 11, Aristizabal discloses:
A method for inverting an elongated, flexible tubular sleeve (Aristizabal FIG. 32, everting sheath 172) having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising providing an apparatus comprising:
a hollow tube (Aristizabal FIG. 32, prosthesis tube 12) comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and
an elongated rod (Aristizabal FIG. 32, chassis 16)) movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug (Aristizabal FIG. 32, nosecone 62)).
wherein the elongated rod (Aristizabal FIG. 32, chassis 16) is configured to move between a retracted position (Aristizabal FIG. 32) and an extended position (Aristizabal FIG. 28), wherein when the elongated rod is in the extended position, the sleeve plug (Aristizabal FIG. 25, nosecone 62) is disposed distal to the distal end of the hollow tube (Aristizabal FIG. 25, showing nosecone 62 distal to the distal end of device/catheter 12) and when the elongated rod is in the retracted position, at least a portion of the sleeve plug is disposed within the central lumen of the hollow tube (Aristizabal FIG. 32, showing nosecone 62 within the central lumen of catheter 12);
disposing the elongated flexible tubular sleeve (Aristizabal FIG. 32, everting sheath 172) over the hollow tube (Aristizabal FIG. 32, catheter 12);
moving the elongated rod proximally to the retracted position (Aristizabal FIG. 32), whereby to clamp the distal end of the elongated flexible tubular sleeve inside of the distal end of the hollow tube (Aristizabal FIG. 32, showing nosecone 62 pressing against distal end 198 of tubular everting sheath 172 to press against catheter 12); and
pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve (Aristizabal FIG. 31, handle 186; (Aristizabal FIG. 31, retraction end 182; Aristizabal FIG. 32, outer section 180 and inner section 174 of everting sheath 172; Aristizabal paragraph [0110], “retraction end 182 is secured to a retraction handle 186 that may be used to apply proximal axial tension to the outer section 180 relative to the chassis 16 and inner section 174 in order to pull the outer section 180 back over the inner section 174 to evert the everting sheath 172”).
With regard to Claim 17, Aristizabal discloses the features of Claim 11, as described above.
Aristizabal further discloses wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit (Aristizabal FIG. 32, showing everting sheath 172 clamped within catheter 12 caused by chassis 16 pulling everting sheath 172 toward catheter 12).
With regard to Claim 24, Aristizabal discloses the features of Claim 11, as described above.
Aristizabal further discloses moving the elongated rod distally to release the distal end of the elongated flexible tubular sleeve from the hollow tube (Aristizabal FIG. 47, showing everting sheath 172 released from catheter 12 when chassis 16 is moved distally).
Claim Rejections - 35 USC § 103
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.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Aristizabal (US PGPUB 2018/0296378 – “Aristizabal”) in view of Ortiz (US PGPUB 2007/0106302 – “Ortiz”).
With regard to Claim 2, Aristizabal discloses the features of Claim 1, as described above.
Aristizabal does not explicitly disclose a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.
Ortiz teaches a lever (Ortiz FIG. 5, lever arms 70a/70b) for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod (Ortiz paragraph [0045], “FIG. 5 illustrates an alternative embodiment of device 10' that includes control elements 20a', 20b' connected to tubing elements 18a', 18b'. Each control element 20a', 20b' includes first and second lever arms 70a, 70b, 71a, 71b. Moving the lever arms together or apart controls rods 40 and thus tubing elements 18a', 18b'.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ortiz’s levers with Aristizabal’s chassis 16 in the apparatus disclosed by Aristizabal. A person having ordinary skill in the art would be motivated to make this combination in order to control axial movement of the elongated rod (see Ortiz paragraph [0045]).
As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the ability to combine Ortiz’s lever arms 70a/70b Lichtenstein with Aristizabal’s apparatus. As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
With regard to Claim 12, Aristizabal discloses the features of Claim 11, as described above.
Aristizabal does not explicitly teach a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.
Ortiz teaches a lever (Ortiz FIG. 5, lever arms 70a/70b) for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod (Ortiz paragraph [0045], “FIG. 5 illustrates an alternative embodiment of device 10' that includes control elements 20a', 20b' connected to tubing elements 18a', 18b'. Each control element 20a', 20b' includes first and second lever arms 70a, 70b, 71a, 71b. Moving the lever arms together or apart controls rods 40 and thus tubing elements 18a', 18b'.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ortiz’s levers with Aristizabal’s chassis 16 when performing the method disclosed by Aristizabal. A person having ordinary skill in the art would be motivated to make this combination in order to control axial control of the elongated rod (see Ortiz paragraph [0045]).
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Aristizabal (US PGPUB 2018/0296378 – “Aristizabal” in view of Lichtenstein (US PGPUB 2017/0265724 – “Lichtenstein”).
With regard to Claim 8, Aristizabal discloses the features of Claim 1, as described above.
Aristizabal does not explicitly disclose wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod.
Lichtenstein teaches wherein the sleeve plug comprises an expandable plug and a holding collar (Lichtenstein FIG. 9, inflatable head 49 at distal end of push-pull rod 46), the expandable plug being mounted to the distal end of the elongated rod.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Lichtenstein’s head for Aristizabal’s nosecone 62 apparatus disclosed by Aristizabal. A person having ordinary skill in the art would be motivated to make this substitution in order to releasably connect a rod to a sleeve (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
With regard to Claim 9, Aristizabal in view of Lichtenstein teaches the features of Claim 8, as described above.
Lichtenstein further teaches wherein the expandable plug (Lichtenstein FIG. 9, inflatable head 48) comprises a first portion (Lichtenstein FIG. 9, surface of inflatable head 48/49) and a second portion (Lichtenstein FIG. 9, push-pull rod 58), wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug (Lichtenstein paragraph [0067], “Push-pull rod 45 can include a mechanism for adjusting the size of a portion of its diameter, such as an inflatable and deflatable head 48”).
With regard to Claim 18, Aristizabal discloses the features of Claim 11, as described above.
Aristizabal does not explicitly disclose wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod, and further wherein the method further comprises:
positioning the expansion plug within the distal end of the elongated flexible tubular sleeve;
positioning the holding collar over the distal end of the elongated flexible tubular sleeve and the expandable plug; and
expanding the expandable plug to secure the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube.
Lichtenstein teaches wherein the sleeve plug comprises an expandable plug and a holding collar (Lichtenstein FIG. 9, inflatable head 49 at distal end of push-pull rod 46), the expandable plug being mounted to the distal end of the elongated rod, and further wherein the method further comprises:
positioning the expansion plug within the distal end of the elongated flexible tubular sleeve (Lichtenstein FIG. 1, sleeve 30 within sheath 20; Lichtenstein paragraph [0068], “push-pull rod 46 includes inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20”);
positioning the holding collar over the distal end of the elongated flexible tubular sleeve and the expandable plug (Lichtenstein FIG. 9, exterior of inflatable head 49 at distal end of push-pull rod 46); and
expanding the expandable plug to secure the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use Lichtenstein’s head when performing the method disclosed by Aristizabal. A person having ordinary skill in the art would be motivated to make this substitution in order to releasably connect a rod to a sleeve (Lichtenstein paragraph [0068], “inflatable head 49 that help facilitate the pushing and pulling of sleeve 30 inside sheath 20. Pushing and pulling of push-pull rod 45 or 46 can be synchronized with the inflation and deflation of inflatable head 48”).
As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the ability to utilize Lichtenstein FIG. 9, inflatable head 48/49 when Aristizabal’s everting sheath 172 and nosecone 62 when are being positioned). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
With regard to Claim 19, Aristizabal in view of Lichtenstein teaches the features of Claim 18, as described above.
Lichtenstein further teaches wherein the expandable plug (Lichtenstein FIG. 9, inflatable head 48) comprises a first portion (Lichtenstein FIG. 9, surface of inflatable head 48/49) and a second portion (Lichtenstein FIG. 9, push-pull rod 58), wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug (Lichtenstein paragraph [0067], “Push-pull rod 45 can include a mechanism for adjusting the size of a portion of its diameter, such as an inflatable and deflatable head 48”).
Response to Arguments
Applicant’s arguments, see pages 7-13, filed , with respect to the rejection(s) of Claims 1-2, 7-12, 17-19, and 24 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the present amendments. Therefore, the rejection under 35 U.S.C. 103 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 102/103 in view of Aristizabal (US PGPUB 2018/0296378 – “Aristizabal”). Furthermore, Applicant’s arguments are moot since they address the previous rejections based on Johnson et al. (US Patent 6,039,721 – “Johnson”), which is no longer cited in the rejection of the pending claims.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/8/26
