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 .
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).
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Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-16 of U.S. Patent No. US 12,114,875. Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding the application claim 1, the patent claim 9 recites: A fecalith treatment device configured to be received through an endoscopic device (patent claim 9, lines 1-5), comprising: an elongate hollow cylindrical body extending along a longitudinal axis of the cylindrical body and defining a first interior cavity (patent claim 9, lines 6-8); an elongate drive member configured to be rotatably mounted about a longitudinal axis of the first interior cavity of the cylindrical body, the elongate drive member defining a second interior cavity (patent claim 9, lines 9-12); and a loop configured to be selectively and rotatably articulated about a longitudinal axis of the fecalith treatment device, wherein the loop is coupled to a distal end of the elongate drive member and extends distally longitudinally away from the distal end of the elongate drive member in an operative plane that is substantially parallel to the longitudinal axis, wherein a distal portion of the loop is configured to not injure or otherwise damage diverticula tissue while the impacted fecalith is urged therefrom the formed diverticula, wherein a peripheral exposed portion of the loop is configured to yield to the diverticula tissue wall at the operative location, and wherein the distal portion of the loop defines a gentle distally oriented tip configured to dislodge an impacted fecalith without damaging the underlying diverticula tissue (patent claim 9, lines 13-30).
Therefore patent claim 9 is in essence a “species” of the generic invention of the application claim 1. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1 is anticipated by patent claim 9, it is not patentably distinct from the patent claim 9.
Regarding the application claim 2, 3, 4, 6, 7, 8 and 9, the patent claims 10, 11, 12, 13, 14, 15 and 16 recite the limitations as claimed, respectively.
Regarding the application claim 5, the patent claim 9 recites the limitations in lines 19-21.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Guglielmi (US 5,916,235) in view of Lind et al. (US 8,523,879).
Regarding claim 1, Guglielmi discloses a device (Figure 4) capable of fecalith treatment configured to be received through an endoscopic device, comprising: an elongate hollow cylindrical body (12) extending along a longitudinal axis of the cylindrical body and defining a first interior cavity; an elongate drive member (18); and a loop (e.g. outermost wires of cage 20 in Figure 1b) wherein the loop is coupled to a distal end of the elongate drive member (at 16) and extends distally longitudinally away from the distal end of the elongate drive member in an operative plane that is substantially parallel to the longitudinal axis (evident from Figure 4), wherein a distal portion of the loop is configured to not injure or otherwise damage diverticula tissue while the impacted fecalith is urged therefrom the formed diverticula, wherein a peripheral exposed portion of the loop is configured to yield to the diverticula tissue wall at the operative location (col. 6, lines 55-58; col. 8, lines 46-50; the loop will yield to a shrinking aneurysm or and/or vessel and is therefore asserted to be capable of yielding as claimed), and wherein the distal portion of the loop defines a gentle distally oriented tip (26; Figure 6b; it would be gentle enough to yield to a shrinking aneurysm wall which is notoriously well-known for being fragile) configured to dislodge an impacted fecalith without damaging the underlying diverticula tissue (all parts of the cage 20 are configured to yield to fragile tissue while being strong enough to snare and remove an embolic coil).
Guglielmi fails to disclose that the elongate drive member defines a second interior cavity. Guglielmi discloses that the loop does not require detachment and may be used to snare and retrieve objects (col. 7, lines 62-64; col. 8, lines 14-19). Guglielmi discloses that the loop wires may be joined to the drive member by crimping or any other means (col. 5, lines 5-8).
Lind et al. also disclose a snaring device (Abstract; Figures 1 and 7; Guglielmi and Lind et al. being in Applicant’s field of snaring devices for removing objects from a body) and further teach providing a drive member with a tube (73; Figure 7) having a cavity for joining loop ends to the drive member (col. 9, line 60 to col. 10, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the tube of Lind et al. to join the loop of Guglielmi to the drive member as a suitable, alternative attachment means that may provide a stronger connection than the detachable joint (16).
Guglielmi fails to disclose that the drive member is configured to be rotatably mounted about a longitudinal axis of the first interior cavity of the cylindrical body and/or that the loop is configured to be selectively and rotatably articulated about a longitudinal axis of the fecalith treatment device.
Lind et al. disclose providing rotational control of a basket in order to help with enclosing an object within the basket for removal from a body (col. 1, lines 44-48; col. 11, lines 41-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Lind et al. to have made the drive member and basket (and therefore loop) of Guglielmi rotatable as claimed in order help with enclosing an object within the basket for removal from the body.
Regarding claim 2, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the rotational control means (40) of Lind et al. to allow rotational control of the basket of Guglielmi. With this modification, a proximal end of the elongate drive member would define a transversely extending lip (at “40” - Figure 2 of Lind et al.) that extends transversely away from the longitudinal axis.
Regarding claim 3, the lip is configured for rotative movement of the elongate drive member relative to the cylindrical body (col. 11, lines 41-51 of Lind et al.).
Regarding claim 4, the respective loop ends of the loop are mounted to the distal end of the elongate drive member and are spaced in opposition about 180 degrees from each other (evident from col. 9, line 60 to col. 10, line 4 and Figure 7 of Lind et al.).
Regarding claim 5, the entirety of the loop is configured to yield to a diverticula tissue wall at the operative location (evident from col. 6, lines 55-58 and col. 8, lines 46-50 of Guglielmi and explained above).
Regarding claim 6, the tip is configured to yield to the diverticula tissue wall at the operative location (evident from col. 6, lines 55-58 and col. 8, lines 46-50 of Guglielmi and explained above).
Regarding claim 7, as modified above in view of Lind et al., the elongate drive member is rotatable and would therefore be configured to be rotated relative to the cylindrical body to aid in inserting the distal portion of the loop into a luminal opening of the diverticulum (noting that the device of Guglielmi is small enough to enter an aneurysm - Figure 2a).
Regarding claim 8, the loop has a selectable width, transverse to the longitudinal axis of the elongate drive member (col. 5, lines 8-13 of Guglielmi).
Regarding claim 9, the elongate drive member is configured to move axially relative to a distal end of the cylindrical body to effect the selection of the width of the loop (col. 5, lines 8-13 of Guglielmi).
Regarding claim 10, Guglielmi discloses providing distal ends of the basket with a curved shape in order to avoid damaging tissue (col. 8, lines 43-45; Figure 8). It would have therefore been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the tip (26) of the distal portion with a smooth, continuously curved shape in order to avoid damaging tissue.
Regarding claim 11, Guglielmi discloses a system capable of fecalith treatment and removal of an impacted fecalith from a formed diverticula without damaging the underlying diverticula tissue, comprising: a device (Figure 4) capable of fecalith treatment and configured to be received through an endoscopic device comprising: an elongate hollow cylindrical body (12) extending along a longitudinal axis of the cylindrical body and defining a first interior cavity; an elongate drive member (18); and a loop (e.g. outermost wires of cage 20 in Figure 1b) wherein the loop is coupled to a distal end of the elongate drive member (at 16) and extends distally longitudinally away from the distal end of the elongate drive member in an operative plane that is substantially parallel to the longitudinal axis (evident from Figure 4), wherein a distal portion of the loop is configured to not injure or otherwise damage diverticula tissue while the impacted fecalith is urged therefrom the formed diverticula, wherein a peripheral exposed portion of the loop is configured to yield to the diverticula tissue wall at the operative location (col. 6, lines 55-58; col. 8, lines 46-50; the loop will yield to a shrinking aneurysm or and/or vessel and is therefore asserted to be capable of yielding as claimed), and wherein the distal portion of the loop defines a gentle distally oriented tip (26; Figure 6b; it would be gentle enough to yield to a shrinking aneurysm wall which is notoriously well-known for being fragile) configured to dislodge an impacted fecalith without damaging the underlying diverticula tissue (all parts of the cage 20 are configured to yield to fragile tissue while being strong enough to snare and remove an embolic coil).
Guglielmi fails to disclose an endoscopic device through which the fecalith treatment device is receivable as claimed. Guglielmi discloses imaging the device during a procedure (col. 4, lines 65-67).
Lind et al. also disclose a snaring device (Abstract; Figures 1 and 7; Guglielmi and Lind et al. being in Applicant’s field of snaring devices for removing objects from a body) usable for removing a variety of objects (col. 21, lines 12-15) and effectively teach passing the device through an endoscope to improve procedural visibility when removing an object (col. 12, lines 34-37; col. 20, lines 20-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Lind et al. to have passed the device of Guglielmi through an endoscopic device in order to improve procedural visibility when removing an object.
Regarding claims 12, 13 and 16, Guglielmi fails to disclose that the drive member is configured to be rotatably mounted about a longitudinal axis of the first interior cavity of the cylindrical body and/or that the loop is configured to be selectively and rotatably articulated about a longitudinal axis of the fecalith treatment device and/or that a proximal end of the drive member defines a lip as claimed.
Lind et al. disclose providing rotational control of a basket in order to help with enclosing an object within the basket for removal from a body (col. 1, lines 44-48; col. 11, lines 41-51) and further disclose rotational control means (40) defining a transversely extending lip (at “40” - Figure 2 of Lind et al.) extending transversely away from a longitudinal axis for rotating a drive member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the drive member and basket (and therefore loop) of Guglielmi rotatable using the control means of Lind et al. as claimed in order help with enclosing an object within the basket for removal from the body.
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the rotational control means (40) of Lind et al. to allow rotational control of the basket of Guglielmi. With this modification, a proximal end of the elongate drive member would define a transversely extending lip (at “40” - Figure 2 of Lind et al.) that extends transversely away from the longitudinal axis.
Regarding claims 14 and 15, Guglielmi fails to disclose that the elongate drive member defines a second interior cavity and/or loop ends of the loop being mounted to the drive member 180 degrees apart as claimed. Guglielmi discloses that the loop does not require detachment and may be used to snare and retrieve objects (col. 7, lines 62-64; col. 8, lines 14-19). Guglielmi discloses that the loop wires may be joined to the drive member by crimping or any other means (col. 5, lines 5-8).
Lind et al. also disclose teach providing a drive member with a tube (73; Figure 7) having a cavity for joining loop ends 180 degrees apart to the drive member (col. 9, line 60 to col. 10, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the tube of Lind et al. to join the loop of Guglielmi to the drive member as claimed as a suitable, alternative attachment means that may provide a stronger connection than the detachable joint (16).
Regarding claim 17, the loop has a selectable width, transverse to the longitudinal axis of the elongate drive member (col. 5, lines 8-13 of Guglielmi).
Regarding claim 18, the elongate drive member is configured to move axially relative to a distal end of the cylindrical body to effect the selection of the width of the loop (col. 5, lines 8-13 of Guglielmi).
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771