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 .
Detailed Action
This is in response to the amendment filed 04/28/2025.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,413,427
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 recites “An introducer hub assembly, comprising: an introducer hub having a longitudinal axis defining an axial direction; a hub cap coupled to a proximal end of the introducer hub; and a hemostatic seal between the hub cap and the introducer hub, wherein the hemostatic seal includes a proximal face separated from a distal face along the longitudinal axis, wherein the hemostatic seal includes first slits intersecting along the longitudinal axis and extending distally from the proximal face to a first depth, wherein the hemostatic seal includes second slits intersecting along the longitudinal axis and extending proximally from the distal face to a second depth, and wherein the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction.” which is not patetably distinct from claim 1 of the patent which recites “An introducer hub assembly, comprising: an introducer hub having a longitudinal axis defining an axial direction; a hub cap coupled to a proximal end of the introducer hub; and a hemostatic seal between the hub cap and the introducer hub, wherein the hemostatic seal includes a seal flange having a proximal face and a first distal face, wherein the seal flange includes a tapered flange having a distal edge at an outer diameter of the first distal face and a proximal edge at a location nearer to the longitudinal axis than the distal edge, a distal section extending distally from the seal flange to a second distal face, first slits intersecting along the longitudinal axis and extending distally from the proximal face to a first depth, and second slits intersecting along the longitudinal axis and extending proximally from the second distal face to a second depth, wherein the second slits are angularly offset relative to the first slits, and wherein the first slits are in fluid communication with the second slits and the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction.”
Claim 11 recites: “A hemostatic seal, comprising: a proximal face separated from a distal face along a longitudinal axis defining an axial direction; first slits intersecting along the longitudinal axis and extending distally from the proximal face to a first depth; and second slits intersecting along the longitudinal axis and extending proximally from the distal face to a second depth, and wherein the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction.”, which is not patetably distinct from claim 11 of the patent which recites “A hemostatic seal, comprising: a seal flange having a proximal face and a first distal face, wherein the seal flange includes a tapered flange having a distal edge at an outer diameter of the first distal face and a proximal edge at a location nearer to a longitudinal axis than the distal edge; a distal section extending distally from the seal flange to a second distal face; first slits extending distally from a proximal face of the seal flange to a first depth, and intersecting along the longitudinal axis defining an axial direction; and second slits extending proximally from the second distal face of the distal section to a second depth, and intersecting along the longitudinal axis, wherein the second slits are angularly offset relative to the first slits, and wherein the first slits are in fluid communication with the second slits and the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction.”
Claim 16 recites “A leadless pacemaker system, comprising: a deflectable catheter; a guide catheter mounted on the deflectable catheter; and an introducer hub assembly mounted on the guide catheter, wherein the introducer hub assembly includes a hemostatic seal including a proximal face separated from a distal face along a longitudinal axis defining an axial direction, wherein the hemostatic seal includes first slits intersecting along the longitudinal axis and extending distally from the proximal face to a first depth, wherein the hemostatic seal includes second slits intersecting along the longitudinal axis and extending proximally from the distal face to a second depth, and wherein the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction”, which is not patentably distinct from claim 16 of the patent which recites “A leadless pacemaker system, comprising: a deflectable catheter; a guide catheter mounted on the deflectable catheter; and an introducer hub assembly mounted on the guide catheter, wherein the introducer hub assembly includes a hemostatic seal including a seal flange having a proximal face and a first distal face, wherein the seal flange includes a tapered flange having a distal edge at an outer diameter of the first distal face and a proximal edge at a location nearer to a longitudinal axis than the distal edge, a distal section extending distally from the seal flange to a second distal face, first slits extending distally from a proximal face of the hemostatic seal to a first depth, and intersecting along the longitudinal axis defining an axial direction, and second slits extending proximally from the second distal face of the distal section to a second depth, and intersecting along the longitudinal axis, wherein the second slits are angularly offset relative to the first slits, and wherein the first slits are in fluid communication with the second slits and the first depth of the first slits at least partly overlaps the second depth of the second slits in the axial direction.”
It is clear that all the elements of claims 1-20 of the application are to be found in claims 1-20 of the patent. The difference between claims 1-20 of the application and claims 1-20 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 1-20 of the patent is in effect a “species” of the “generic” invention of claims 1-20 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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 nonobviousness.
Claims 1, 2, 7, 11-12, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland)
Regarding claims 1, 2, 7, 11, 12 Matsumoto et al. discloses an introducer hub assembly, comprising: an introducer hub having a longitudinal axis defining an axial direction; a hub cap (cap 12, see 7, lines 7-19) coupled to a proximal end of the introducer hub; and a hemostatic seal (valve body 16, see 7, lines 7-19 ) between the hub cap and the introducer hub, wherein the hemostatic seal includes a proximal face separated from a distal face, the hemostatic seal comprising: first slit (second slit 18, see col. 7, lines 7-20) extending distally from the proximal face to a first depth, and second slit (first slit 17, see col. 7, lines 7-20) extending proximally from the distal face to a second depth, the first depth of the first slit at least partly overlaps the second depth of the second slit overlap the first slit in the axial direction, the second slit angularly offset relative to the first slit.
Matsumoto fails to disclose first slits intersecting along the longitudinal axis, second slits intersecting along the longitudinal axis.
Nijland, from the same field of endeavor teaches a similar introducer hub assembly as shown in Figure 2, and that it is known to configure a seal to have slits as opposed to a single slit for the purpose of permitting the introduction of an instrument with a much lower introduction force, wherein the slits are perpendicular with respect to each other. See paragraph [0047].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first slit and second slit disclosed by Matsumoto to include an additional slits in each, such that the assembly had first slits intersecting along the longitudinal axis, second slits intersecting along the longitudinal axis, wherein the first slits are perpendicular with respect to each other, and wherein the second slits are perpendicular with respect to each other, in order to permitting the introduction of an instrument with a much lower introduction force, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claims 3-6, 9, 10, and 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland) as applied to claims 1 and 11 above, and further in view of U.S. Patent Number 6,551,283 (Guo et al.)
Regrading claims 3-6 Matsumoto et al. fails to disclose wherein the hemostatic seal includes a seal flange having the proximal face, and a distal section extending distally from the seal flange to the distal face, wherein the seal flange is shaped to be retained between the hub cap and the introducer hub, wherein the seal flange includes a proximal mating feature shaped to engage the hub cap, wherein the proximal mating feature includes a groove formed in the proximal face.
Guo, from the same field of endeavor teaches a similar introducer hub assembly as show in Figure 4 with a similar seal which includes a seal flange (an outermost edge 29, see col. 7, lines 48, lines 67) having the proximal face, and a distal section extending distally from the seal flange to the distal face, wherein the seal flange is shaped to be retained between the hub cap and the introducer hub, wherein the seal flange includes a proximal mating feature (slots, see col. 6, lines 5-21) shaped to engage the hub cap, wherein the proximal mating feature includes a groove formed in the proximal face. See col. 6, lines 65-67 and col. 7, lines 1-4
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly disclosed by Matsumoto to include the seal flange taught by Guo shaped to be retained between the hub cap and the introducer hub, wherein the proximal flange includes at least one of a proximal mating feature shaped to engage the hub cap or a distal mating feature shaped to engage the introducer hub, wherein the proximal mating feature includes a groove formed in a proximal face of the proximal flange, in order to better mate the first and section sections of the seal, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claims 9, 10, 14 Matsumoto fails to disclose wherein the hemostatic seal further comprises a tapered inner surface extending distally from a proximal opening at the proximal face, wherein the tapered inner surface tapers toward the longitudinal axis from the proximal opening, and wherein the first slits extend through the tapered inner surface.
Guo, from the same field of endeavor teaches a similar introducer hub assembly as show in Figure 4 with a similar seal which includes a tapered inner surface (tapered surface of conical receive area 22, see col. 6, lines 41-64) extending distally from a proximal opening at the proximal face, wherein the tapered inner surface tapers toward the longitudinal axis from the proximal opening, and wherein the first slits extend through the tapered inner surface, for the purpose of helping guide a medical devices to the center of seal. See col. 6, lines 65-67 and col. 7, lines 1-4.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly disclosed by Matsumoto to include the tapered inner surface of conical receive area 22 in a proximal opening of disk 22 in order to help guide a medical devices to the center of seal, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regrading claims 15 Matsumoto et al. fails to disclose wherein the proximal mating feature includes a groove formed in the proximal face.
Guo, from the same field of endeavor teaches a similar introducer hub assembly as show in Figure 4 with a similar seal which includes a seal flange (an outermost edge 29, see col. 7, lines 48, lines 67) having the proximal face, and a distal section extending distally from the seal flange to the distal face, wherein the seal flange is shaped to be retained between the hub cap and the introducer hub, wherein the seal flange includes a proximal mating feature (slots, see col. 6, lines 5-21) shaped to engage the hub cap, wherein the proximal mating feature includes a groove formed in the proximal face. See col. 6, lines 65-67 and col. 7, lines 1-4
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly disclosed by Matsumoto to include the seal flange taught by Guo shaped to be retained between the hub cap and the introducer hub, wherein the proximal flange includes at least one of a proximal mating feature shaped to engage the hub cap or a distal mating feature shaped to engage the introducer hub, wherein the proximal mating feature includes a groove formed in a proximal face of the proximal flange, in order to better mate the first and section sections of the seal, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claims 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland) as applied to claims 1 and 11 above, and further in view of U.S. Patent Publication Number 2011/0082344 (Barnes)
Regarding claim 8 Matsumoto fails to disclose wherein the first slits are angularly offset from the second slits by an angle in a range of forty to fifty degrees.
Barnes, from the same field of endeavor teaches a similar introducer hub assembly as shown in Figure 2 with a similar seal with first slits (114) angularly offset from the second slits (134), where the angle the slits are offset by is a result effective variable recognized for the purpose of minimizing leakage between the sections of the seal. See paragraph [0030].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly such that the first slits are angularly offset from the second slits by an angle in a range of forty to fifty degrees in order to optimally minimize leakage between the sections of the seal because it would only require the optimization of the general conditions in the art and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2008/0021532 (Kveen) in view of U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland)
Regarding claims 16, 17 Kveen discloses as shown in Figure 1, a leadless pacemaker system, comprising: a deflectable catheter (delivery catheter 130, see paragraph [0029]) ; a guide catheter (guide sheath 110, see paragraph [0030]) mounted on the deflectable catheter.
Kveen fails to disclose an introducer hub assembly mounted on the guide catheter, wherein the introducer hub assembly includes a hemostatic seal including a first section having first slits extending distally from a proximal face of the hemostatic seal and intersecting along a longitudinal axis, and a second section having second slits extending proximally from a distal face of the hemostatic seal and intersecting along the longitudinal axis, wherein the second slits are angularly offset relative to the first slits.
Matsumoto et al. discloses an introducer hub assembly, comprising: an introducer hub having a longitudinal axis defining an axial direction; a hub cap (cap 12, see 7, lines 7-19) coupled to a proximal end of the introducer hub; and a hemostatic seal (valve body 16, see 7, lines 7-19 ) between the hub cap and the introducer hub, wherein the hemostatic seal includes a proximal face separated from a distal face, the hemostatic seal comprising: first slit (second slit 18, see col. 7, lines 7-20) extending distally from the proximal face to a first depth, and second slit (first slit 17, see col. 7, lines 7-20) extending proximally from the distal face to a second depth, the first depth of the first slit at least partly overlaps the second depth of the second slit overlap the first slit in the axial direction, the second slit angularly offset relative to the first slit.
Matsumoto fails to disclose first slits intersecting along the longitudinal axis, second slits intersecting along the longitudinal axis.
Nijland, from the same field of endeavor teaches a similar introducer hub assembly as shown in Figure 2, and that it is known to configure a seal to have slits as opposed to a single slit for the purpose of permitting the introduction of an instrument with a much lower introduction force, wherein the slits are perpendicular with respect to each other. See paragraph [0047].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first slit and second slit disclosed by Matsumoto to include an additional slits in each, such that the assembly had first slits intersecting along the longitudinal axis, second slits intersecting along the longitudinal axis, wherein the first slits are perpendicular with respect to each other, and wherein the second slits are perpendicular with respect to each other, in order to permitting the introduction of an instrument with a much lower introduction force, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claims 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland) as applied to claim 16 above, and further in view of U.S. Patent Publication Number 2011/0082344 (Barnes)
Regarding claim 18 Matsumoto fails to disclose wherein the first slits are angularly offset from the second slits by an angle in a range of forty to fifty degrees.
Barnes, from the same field of endeavor teaches a similar introducer hub assembly as shown in Figure 2 with a similar seal with first slits (114) angularly offset from the second slits (134), where the angle the slits are offset by is a result effective variable recognized for the purpose of minimizing leakage between the sections of the seal. See paragraph [0030].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly such that the first slits are angularly offset from the second slits by an angle in a range of forty to fifty degrees in order to optimally minimize leakage between the sections of the seal because it would only require the optimization of the general conditions in the art and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,610,665 (Matsumoto et al.) in view of U.S. Patent Publication Number 2010/0280456 (Nijland) as applied to claims 1 and 11 above, and further in view of U.S. Patent Number 6,551,283 (Guo et al.)
Regarding claim 19 Matsumoto fails to disclose wherein the hemostatic seal further comprises a tapered inner surface extending distally from a proximal opening at the proximal face of the hemostatic seal.
Guo, from the same field of endeavor teaches a similar introducer hub assembly as show in Figure 4 with a similar seal which includes a tapered inner surface (tapered surface of conical receive area 22, see col. 6, lines 41-64) extending distally from a proximal opening at the proximal face of the hemostatic seal, wherein the tapered inner surface tapers toward the longitudinal axis from the proximal opening, and wherein the first slits extend through the tapered inner surface, for the purpose of helping guide a medical devices to the center of seal. See col. 6, lines 65-67 and col. 7, lines 1-4.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly disclosed by Matsumoto to include the tapered inner surface of conical receive area 22 in a proximal opening of disk 22 in order to help guide a medical devices to the center of seal, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regrading claim 20 Matsumoto et al. fails to disclose wherein the proximal mating feature includes a groove formed in the proximal face.
Guo, from the same field of endeavor teaches a similar introducer hub assembly as show in Figure 4 with a similar seal which includes a seal flange (an outermost edge 29, see col. 7, lines 48, lines 67) having the proximal face, and a distal section extending distally from the seal flange to the distal face, wherein the seal flange is shaped to be retained between the hub cap and the introducer hub, wherein the seal flange includes a proximal mating feature (slots, see col. 6, lines 5-21) shaped to engage the hub cap, wherein the proximal mating feature includes a groove formed in the proximal face. See col. 6, lines 65-67 and col. 7, lines 1-4
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the introducer hub assembly disclosed by Matsumoto to include the seal flange taught by Guo shaped to be retained between the hub cap and the introducer hub, wherein the proximal flange includes at least one of a proximal mating feature shaped to engage the hub cap or a distal mating feature shaped to engage the introducer hub, wherein the proximal mating feature includes a groove formed in a proximal face of the proximal flange, in order to better mate the first and section sections of the seal, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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