DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/25/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-11 and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,178,416 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, US 12,178,416 B2 discloses a tissue removal device for acquiring one or more samples of intrauterine tissue (claim 1), the tissue removal device comprising: a housing (claim 1); an outer tube coupled to the housing and having an outer tube lumen (claim 1); an inner tube slidably disposed within the outer tube lumen (claim 1); an inner tube holder disposed around and coupled to a portion of the inner tube, the inner tube holder defining a helical groove on an outer surface thereof (claim 1); a cam follower formed on an inner surface of the housing, wherein the cam follower is disposed in the helical groove on the outer surface of the inner tube holder, such that longitudinal movement of the inner tube relative to the housing causes rotational movement of the inner tube relative to the housing (claim 1); and a manual actuator moveably coupled to the housing and operatively coupled to the inner tube such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing, thereby moving the helical groove on the outer surface of the inner tube holder over the cam follower causing rotation of the inner tube holder and the inner tube relative to the housing (claim 1).
Regarding claim 2, US 12,178,416 B2 discloses the outer tube also has a tissue in-take window (claim 1), wherein the inner tube has an inner tube lumen extending from an open inner tube distal end to an inner tube proximal end, and wherein the open inner tube distal end severs intrauterine tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window-open position to a window-closed position (claim 1).
Regarding claim 3, US 12,178,416 B2 discloses that the open inner tube distal end comprises an annular cutting edge (claim 2).
Regarding claim 4, US 12,178,416 B2 discloses the housing defines a cylindrical portion configured to support the inner tube (claim 3).
Regarding claim 5, US 12,178,416 B2 discloses the helical groove and the cam follower are configured such that translating the inner tube holder from a proximal most position to a distal most position relative to the housing rotates the inner tube approximately twice around a longitudinal axis of the inner tube (claim 4).
Regarding claim 6, US 12,178,416 B2 discloses a spring operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring (claim 5).
Regarding claim 7, US 12,178,416 B2 discloses an external connector configured to pneumatically couple the device to an external vacuum source (claim 6).
Regarding claim 8, US 12,178,416 B2 discloses a specimen collection chamber in communication with the inner tube lumen (claim 7).
Regarding claim 9, US 12,178,416 B2 discloses a body disposed around and coupled to the inner tube proximal of the inner tube holder, wherein the manual actuator is operatively coupled to the body such that moving the manual actuator toward the housing moves the body longitudinally relative to the housing, thereby moving the respective inner tube and inner tube holder longitudinally relative to the housing (claim 8).
Regarding claim 10, US 12,178,416 B2 discloses a tissue removal device for acquiring one or more samples of intrauterine tissue (claim 9), the tissue removal device comprising: a housing (claim 9); an outer tube coupled to the housing and having an outer tube lumen (claim 9); an inner tube slidably disposed within the outer tube lumen (claim 9); a spring operatively coupled to the inner tube (claim 9); an inner tube holder disposed around and coupled to a portion of the inner tube (claim 9), the inner tube holder defining a helical groove on an outer surface thereof (claim 9); a body disposed around and coupled to the inner tube proximal of the inner tube holder (claim 9); a cam follower formed on an inner surface of the housing, wherein the cam follower is disposed in the helical groove on the outer surface of the inner tube holder, such that longitudinal movement of the inner tube relative to the housing causes rotational movement of the inner tube relative to the housing (claim 9); and a manual actuator moveably coupled to the housing and operatively coupled to the body such that moving the manual actuator toward the housing moves the respective body, inner tube, and inner tube holder longitudinally relative to the housing, thereby moving the helical groove over the cam follower on the inner surface of the housing causing rotation of the inner tube holder and the inner tube relative to the housing (claim 9).
Regarding claim 11, US 12,178,416 B2 discloses the outer tube also has a tissue in-take window, wherein the inner tube has an inner tube lumen extending from an open inner tube distal end to an inner tube proximal end, and wherein the open inner tube distal end severs intrauterine tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window-open position to a window-closed position (claim 9).
Regarding claim 13, US 12,178,416 B2 discloses the housing defines a cylindrical portion configured to support the inner tube (claim 10).
Regarding claim 14, US 12,178,416 B2 discloses that the helical groove and the cam follower are configured such that translating the inner tube holder from a proximal most position to a distal most position relative to the housing rotates the inner tube approximately twice around a longitudinal axis of the inner tube (claim 11).
Regarding claim 15, US 12,178,416 B2 discloses movement of the manual actuator relative to the housing compresses the spring (claim 12).
Regarding claim 16, US 12,178,416 B2 discloses the manual actuator is operatively coupled to the body such that moving the manual actuator toward the housing moves the body longitudinally relative to the housing, thereby moving the respective inner tube and inner tube holder longitudinally relative to the housing (claim 13).
Claims 12, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,178,416 B2 in view of Clement (US 5,505,210).
Regarding claim 12, US 12,178,416 B2 discloses the invention substantially as claimed. However, US 12,178,416 B2 fails to disclose the open inner tube distal end comprises an annular cutting edge.
In the same field of endeavor, Clement teaches (Figure 1) a tissue removal device comprising a housing (10); and outer tube (20) coupled to the housing; an inner tube (50) slidably disposed within the outer tube lumen (22); a manual actuator (64) moveably coupled to the housing and operatively coupled to the inner tube (50) such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing. Clement teaches that the outer tube also has a tissue in-take window (30), wherein the inner tube has an inner tube lumen (54) extending from an open inner tube distal end (52) to an inner tube proximal end, and wherein the open inner tube distal end severs tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window-open position (Figure 1) to a window-closed position (Figure 4). Clement teaches that the open inner tube distal end comprises an annular cutting edge (Column 5, lines 50-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the open inner tube distal end disclosed by US 12,178,416 B2 to comprise an annular cutting edge, as taught by Clement. This modification would provide a cutter with enhanced efficiency and a cutter passageway to allow severed, dissected tissue to be drawn by surgical instruments, or by suction pressure out of the device to a storage or disposal site (Column 5, line 62 – column 6, line 12).
Regarding claim 17, US 12,178,416 B2 discloses the invention substantially as claimed. However, US 12,178,416 B2 fails to disclose an external connector configured to pneumatically couple the device to an external vacuum source.
Clement teaches (Figure 5) an external connector (48/49) configured to pneumatically couple the device to an external vacuum source (90/92).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue removal device disclosed by US 12,178,416 B2 to comprise an external connector configured to pneumatically couple the device to an external vacuum source, as taught by Clement. This modification would allow dissected tissue or fumes from vaporized tissue to be removed from the device by suction (Column 6, lines 66-67).
Regarding claim 18, US 12,178,416 B2 discloses the invention substantially as claimed. However, US 12,178,416 B2 fails to disclose a specimen collection chamber in communication with the inner tube lumen.
Clement teaches (Figure 5) a specimen collection chamber (86) in communication with the inner tube lumen. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue removal device disclosed by US 12,178,416 B2 to comprise a specimen collection chamber in communication with the inner tube lumen, as taught by Clement. This modification would allow tissue samples to be collected for analysis (Column 7, lines 26-38).
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 1, 4, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2006/0116605 A1) in view of Goldenberg (US 2008/0281223 A1).
Regarding claim 1, Nakao discloses (Figures 8-11 and 14) a tissue removal device capable of acquiring one or more samples of intrauterine tissue, the tissue removal device comprising: a housing (74); an outer tube coupled to the housing and having an outer tube lumen (tubular sheath, paragraph 0061); an inner tube (80) slidably disposed within the outer tube lumen; an inner tube holder (84) disposed around and coupled to a portion of the inner tube, the inner tube holder defining a cam follower (86/87) on an outer surface thereof; a helical groove (92) formed on an inner surface of the housing, wherein the cam follower (86/87) on the inner tube holder (84) is disposed in the helical groove (92) on the inner surface of the housing, such that longitudinal movement of the inner tube relative to the housing causes rotational movement of the inner tube relative to the housing (paragraph 0064); and a manual actuator (72) moveably coupled to the housing and operatively coupled to the inner tube such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing, thereby moving the cam follower on the outer surface of the inner tube holder within the helical groove on the inner surface of housing causing rotation of the inner tube holder and the inner tube relative to the housing (paragraph 0064).
The claim requires that the cam follower is formed on an inner surface of the housing and the helical groove is defined on an outer surface of the inner tube holder. Nakao discloses the opposite configuration.
Goldenberg teaches (Figures 1-8) that it is well known in the art that a cam follower (311) can be formed on an inner surface of a housing (320) and a helical groove can be formed on a tubular member.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cam follower disclosed by Nakao to be formed on an inner surface of the housing and the helical groove to be defined on an outer surface of the inner tube holder, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 4, Nakao in view of Goldenberg teaches (Nakao, Figure 9) that the housing (74) defines a cylindrical portion configured to support the inner tube (Nakao, paragraph 0062).
Regarding claim 5, Nakao in view of Goldenberg teaches (Nakao, Figure 10) the helical groove (92) and the cam follower (86/87) are configured such that translating the inner tube holder (84) from a proximal most position to a distal most position relative to the housing rotates the inner tube approximately twice around a longitudinal axis of the inner tube (Nakao, paragraph 0064).
Regarding claim 7, Nakao in view of Goldenberg teaches (Nakao, Figure 9) an external connector (76) configured to pneumatically couple the device to an external vacuum source (paragraphs 0061 and 0070).
Regarding claim 8, Nakao in view of Goldenberg teaches (Nakao, Figure 14) a specimen collection chamber (syringe barrel) in communication with the inner tube lumen (paragraph 0061). NOTE: a syringe barrel would be capable of collecting a specimen.
Regarding claim 9, Nakao in view of Goldenberg teaches (Nakao, Figure 9) a body (76) disposed around and coupled to the inner tube (80) proximal of the inner tube holder (84), wherein the manual actuator (72) is operatively coupled to the body such that moving the manual actuator toward the housing (74) moves the body (76) longitudinally relative to the housing, thereby moving the respective inner tube and inner tube holder longitudinally relative to the housing (paragraph 0064).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2006/0116605 A1) in view of Goldenberg (US 2008/0281223 A1) as applied to claim 1 above, and further in view of Clement (US 5,505,210).
Regarding claim 6, Nakao in view of Goldenberg teaches the invention substantially as claimed. However, the combined teaching fails to teach a spring operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring.
In the same field of endeavor, Clement teaches (Figure 1) a tissue removal device comprising a housing (10); and outer tube (20) coupled to the housing; an inner tube (50) slidably disposed within the outer tube lumen (22); a manual actuator (64) moveably coupled to the housing and operatively coupled to the inner tube (50) such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing; and a spring (72) operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring and a manual actuator moveably coupled to the housing and operatively coupled to the inner tube such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing (Column 6, lines 21-34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue removal device taught by Nakao in view of Goldenberg to further comprise a spring operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring, as taught by Clement. This modification would provide a manually operated reciprocating motion with a return force provided by the spring that would allow the device to be actuated multiple times to collect multiple samples (Clement, Column 6, lines 21-34).
Claims 10 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2006/0116605 A1) in view of Goldenberg (US 2008/0281223 A1) and Clement (US 5,505,210).
Regarding claims 10 and 15, Nakao discloses (Figures 8-11 and 14) a tissue removal device capable of acquiring one or more samples of intrauterine tissue, the tissue removal device comprising: a housing (74); an outer tube coupled to the housing and having an outer tube lumen (tubular sheath, paragraph 0061); an inner tube (80) slidably disposed within the outer tube lumen; an inner tube holder (84) disposed around and coupled to a portion of the inner tube, the inner tube holder defining a cam follower (86/87) on an outer surface thereof; a body (76) disposed around and coupled to the inner tube proximal of the inner tube holder (Figure 9); a helical groove (92) formed on an inner surface of the housing, wherein the cam follower is disposed in the helical groove on the inner surface of the housing, such that longitudinal movement of the inner tube relative to the housing causes rotational movement of the inner tube relative to the housing (paragraph 0064); and a manual actuator (72) moveably coupled to the housing (74) and operatively coupled to the body such that moving the manual actuator toward the housing moves the respective body (76), inner tube (80), and inner tube holder (84) longitudinally relative to the housing (74), thereby moving the helical groove over the cam follower on the outer surface of the inner tube holder causing rotation of the inner tube holder and the inner tube relative to the housing.
The claim requires that the cam follower is formed on an inner surface of the housing and the helical groove is defined on an outer surface of the inner tube holder. Nakao discloses the opposite configuration. Further, Nakao fails to disclose a spring operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring.
Goldenberg teaches (Figures 1-8) that it is well known in the art that a cam follower (311) can be formed on an inner surface of a housing (320) and a helical groove can be formed on a tubular member.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cam follower disclosed by Nakao to be formed on an inner surface of the housing and the helical groove to be defined on an outer surface of the inner tube holder, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
In the same field of endeavor, Clement teaches (Figure 1) a tissue removal device comprising a housing (10); and outer tube (20) coupled to the housing; an inner tube (50) slidably disposed within the outer tube lumen (22); a manual actuator (64) moveably coupled to the housing and operatively coupled to the inner tube (50) such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing; and a spring (72) operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring and a manual actuator moveably coupled to the housing and operatively coupled to the inner tube such that moving the manual actuator toward the housing moves the inner tube and the inner tube holder longitudinally relative to the housing (Column 6, lines 21-34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue removal device taught by Nakao in view of Goldenberg to further comprise a spring operatively coupled to the inner tube, wherein movement of the manual actuator relative to the housing compresses the spring, as taught by Clement. This modification would provide a manually operated reciprocating motion with a return force provided by the spring that would allow the device to be actuated multiple times to collect multiple samples (Clement, Column 6, lines 21-34).
Regarding claim 13, Nakao in view of Goldenberg and Clement teaches (Nakao, Figure 9) that the housing (74) defines a cylindrical portion configured to support the inner tube (Nakao, paragraph 0062).
Regarding claim 14, Nakao in view of Goldenberg and Clement teaches (Nakao, Figure 10) the helical groove (92) and the cam follower (86/87) are configured such that translating the inner tube holder (84) from a proximal most position to a distal most position relative to the housing rotates the inner tube approximately twice around a longitudinal axis of the inner tube (Nakao, paragraph 0064).
Regarding claim 16, Nakao in view of Goldenberg and Clement teaches (Nakao Figures 8-11) the manual actuator (72) is operatively coupled to the body (76) such that moving the manual actuator toward the housing (74) moves the body longitudinally relative to the housing, thereby moving the respective inner tube (80) and inner tube holder (84) longitudinally relative to the housing (Nakao, paragraph 0064).
Regarding claim 17, Nakao in view of Goldenberg and Clement teaches (Nakao, Figure 9) an external connector (76) configured to pneumatically couple the device to an external vacuum source (paragraphs 0061 and 0070).
Regarding claim 18, Nakao in view of Goldenberg and Clement teaches (Nakao, Figure 14) a specimen collection chamber (syringe barrel) in communication with the inner tube lumen (paragraph 0061). NOTE: a syringe barrel would be capable of collecting a specimen.
Allowable Subject Matter
Claims 2, 3, 11, and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 2 recites that the outer tube also has a tissue in-take window, wherein the inner tube has an inner tube lumen extending from an open inner tube distal end to an inner tube proximal end, and wherein the open inner tube distal end severs intrauterine tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window-open position to a window-closed position. These limitations, in combination with the limitations of claim 1, are not disclosed or suggested by the prior art of record. Claim 3 is dependent on claim 2, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11 recites that the outer tube also has a tissue in-take window, wherein the inner tube has an inner tube lumen extending from an open inner tube distal end to an inner tube proximal end, and wherein the open inner tube distal end severs intrauterine tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window-open position to a window-closed position. These limitations, in combination with the limitations of claim 10, are not disclosed or suggested by the prior art of record. Claim 12 is dependent on claim 11, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/C.D.K/Examiner, Art Unit 3771 /DIANE D YABUT/Primary Examiner, Art Unit 3771
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