DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 8, 13, 18 and 20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “the slotted ball member” in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears that the limitation should be amended to recite “the slotted ball” in order to have sufficient antecedent basis for this limitation in the claim; and for the purpose of compact prosecution will be examined below under this assumption.
Claim 13 recites the limitation “one of the clips” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It appears that the limitation should be amended to recite “a clip” in order to have sufficient antecedent basis for this limitation in the claim; and for the purpose of compact prosecution will be examined below under this assumption.
Claim 18 recites the limitation "the actuator" in line 4. There is insufficient antecedent basis for this limitation in the claim. It appears that the limitation should be amended to recite “an actuator” in order to have sufficient antecedent basis for this limitation in the claim; and for the purpose of compact prosecution will be examined below under this assumption.
Claim 20 recites the limitation “the mounting mechanism actuator” in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 20 should depend from claim 19 instead of claim 17 in order to have sufficient antecedent basis for this limitation in the claim; and for the purpose of compact prosecution will be examined below under this assumption.
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.
Claim(s) 1-6, 17 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 5-8, 18-20 of U.S. Patent No. 12,004,732 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm.
2. The instrument of claim 1, wherein the joint member comprises a first joint member and a second joint member, wherein the first joint member confines movement of the proximal portion of the arm to yawing, and the second joint member confines movement of the proximal portion of the arm to pitching.
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm, wherein the surgical instrument is a stabilizer and the working end comprises a pair of contact members; wherein the joint member comprises a first joint member and a second joint member, wherein the first joint member confines movement of the proximal portion of the arm to yawing, and the second joint member confines movement of the proximal portion of the arm to pitching.
3. The instrument of claim 1, wherein the joint member pivotally mounted at the distal end portion of the mount body is a disk member.
2. The instrument of claim 1, wherein the joint member pivotally mounted at the distal end portion of the mount body is a disk member.
4. The instrument of claim 1, wherein the joint member further comprises a slotted ball.
5. The instrument of claim 1, wherein the joint member further comprises a slotted ball.
5. The instrument of claim 4, wherein the joint member is a disk member, and the slotted ball is connected to the disk member.
6. The instrument of claim 5, wherein the joint member further comprises a disk member, and the slotted ball is connected to the disk member.
6. The instrument of claim 4 , further comprising an actuator rotatably mounted to the mount body towards the proximal end of the mount body, and a cable extending from the actuator through the mount body, joint member, slotted ball and arm, the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction.
7. The instrument of claim 5, further comprising an actuator rotatably mounted to the mount body towards the proximal end of the mount body, and a cable extending from the actuator through the mount body, joint member, slotted ball and arm, the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction.
17. The instrument of claim 1, wherein the bottom portion comprises a mounting mechanism configured to reversibly clamp the instrument to a fixed object.
8. The instrument of claim 1, wherein the bottom portion comprises a mounting mechanism configured to reversibly clamp the instrument to a fixed object.
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm.
4. The instrument of claim 1, wherein the joint member further comprises a slotted ball.
18. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm, wherein the surgical instrument is a stabilizer and the working end comprises a pair of contact members; wherein the joint member comprises a slotted ball.
5. The instrument of claim 4, wherein the joint member is a disk member, and the slotted ball is connected to the disk member.
19. The instrument of claim 18, wherein the joint member further comprises a disk member, and the slotted ball is connected to the disk member.
6. The instrument of claim 4 , further comprising an actuator rotatably mounted to the mount body towards the proximal end of the mount body, and a cable extending from the actuator through the mount body, joint member, slotted ball and arm, the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction.
20. The instrument of claim 18, further comprising an actuator rotatably mounted to the mount body towards the proximal end of the mount body, and a cable extending from the actuator through the mount body, joint member, slotted ball and arm, the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction.
As is evident from the table above, the patent claims disclose all of the features of the application claims and additional limitations. The differences emphasized above in bold appear to be drawn to slight grammatical variations, not affecting the scope of the claims, for example the patent uses “comprises” instead of “is”.
Claim(s) 1-7, 10-12, 14-15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 5-6, 7-8, 24-26 of U.S. Patent No. 9,655,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm.
11. The instrument of claim 1, further comprising an actuator rotatably mounted to the mount body at the proximal end of the mount body, the actuator being configured to change a state of the arm from a flexible state to a rigid state by rotation of the actuator in a first rotational direction, and from the rigid state to the flexible state by rotation of the actuator in a counter-rotational direction.
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion wherein the bottom portion comprises a mounting mechanism configured to reversibly clamp the surgical instrument to a retractor system; an actuator mounted to the mount body at a proximal end region of the mount body; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member from a left distal region of the mount body to a right distal region of the mount body and vice versa without causing movement of the actuator, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane, wherein a proximal link of the arm immediately adjacent to the joint member is pivotable to a substantially perpendicular position with respect to the mount body; and a working end mounted to a distal end portion of the arm, wherein the actuator is rotatably mounted to the mount body at the proximal end of the mount body, wherein the actuator is configured to change a state of the arm from a flexible state to a rigid state by rotation of the actuator in a first rotational direction, and from the rigid state to the flexible state by rotation of the actuator in a counter-rotational direction.
3. The instrument of claim 1, wherein the joint member pivotally mounted at the distal end portion of the mount body is a disk member.
2. The instrument of claim 1, wherein the joint member comprises a disk member that is received within a cavity of the mount body, and a slotted ball connected to the disk member.
4. The instrument of claim 1, wherein the joint member further comprises a slotted ball.
2. The instrument of claim 1, wherein the joint member comprises a disk member that is received within a cavity of the mount body, and a slotted ball connected to the disk member.
5. The instrument of claim 4, wherein the joint member is a disk member, and the slotted ball is connected to the disk member.
2. The instrument of claim 1, wherein the joint member comprises a disk member that is received within a cavity of the mount body, and a slotted ball connected to the disk member.
10. The instrument of claim 1, further comprising a vacuum tube in fluid communication with the working end, and the working end is configured to reversibly attach to the exterior surface of a human's heart.
5. The instrument of claim 1, further comprising a vacuum tube in fluid communication with the working end, and the working end is configured to reversibly attach to the exterior surface of a human's heart.
12. The instrument of claim 11, further comprising a suction tube in fluid communication with the working end, and a clip configured to receive and temporarily hold the suction tube to maintain the suction tube in a low profile with the instrument, wherein the clip is formed with or connected to the mount body, the actuator, or both the mount body and the actuator.
6. The instrument of claim 1, further comprising a suction tube in fluid communication with the working end, and a clip configured to receive and temporarily hold the suction tube to maintain the suction tube in a low profile with the instrument, wherein the clip is formed with or connected to the mount body, the actuator, or both the mount body and the actuator.
14. The instrument of claim 1, wherein the instrument is an organ stabilizer and the working end comprises at least one contact member configured to be exerted against a tissue surface to stabilize the tissue surface.
7. The instrument of claim 1, wherein the instrument is an organ stabilizer and the working end comprises at least one contact member configured to be exerted against a tissue surface to stabilize the tissue surface.
15. The instrument of claim 1, wherein the instrument is an organ positioner and the working end comprises a suction member defining a vacuum space therein, wherein the suction member is configured to receive the apex of a human heart.
8. The instrument of claim 1, wherein the instrument is an organ positioner and the working end comprises a suction member defining a vacuum space therein, wherein the suction member is configured to receive the apex of a human heart.
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm.
4. The instrument of claim 1, wherein the joint member further comprises a slotted ball.
5. The instrument of claim 4, wherein the joint member is a disk member, and the slotted ball is connected to the disk member.
6. The instrument of claim 4 , further comprising an actuator rotatably mounted to the mount body towards the proximal end of the mount body, and a cable extending from the actuator through the mount body, joint member, slotted ball and arm, the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction.
24. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion wherein the bottom portion comprises a mounting mechanism configured to reversibly clamp the surgical instrument to a retractor system; an actuator mounted to the mount body at a proximal end region of the mount body; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member from a left distal region of the mount body to a right distal region of the mount body and vice versa without causing movement of the actuator, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane, wherein a proximal link of the arm immediately adjacent to the joint member is pivotable to a substantially perpendicular position with respect to the mount body; a working end mounted to a distal end portion of the arm, wherein the joint member comprises a disk member that is received within a cavity of the mount body, and a slotted ball connected to the disk member, and wherein the actuator is rotatably mounted to the mount body; and a cable extending from the actuator through the mount body, the slotted ball and the arm, wherein the actuator and the cable are configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction, and from the rigid state to the flexible state by movement of the actuator in a second direction opposite the first direction.
7. The instrument of claim 6, wherein movement of the actuator involves rotation, the first direction is a first rotational direction, and the second direction is a counter-rotational direction.
25. The instrument of claim 24, wherein movement of the actuator involves rotation, the first direction is a first rotational direction, and the second direction is a counter-rotational direction.
1. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane; and a working end mounted to a distal end portion of the arm.
2. The instrument of claim 1, wherein the joint member comprises a first joint member and a second joint member, wherein the first joint member confines movement of the proximal portion of the arm to yawing, and the second joint member confines movement of the proximal portion of the arm to pitching.
26. A surgical instrument comprising: a mount body having a top portion, a distal end, a proximal end and a bottom portion wherein the bottom portion comprises a mounting mechanism configured to reversibly clamp the surgical instrument to a retractor system; an actuator mounted to the mount body at a proximal end region of the mount body; a joint member pivotally mounted at a distal end portion of the mount body to allow positioning of a proximal portion of an arm extending distally from the joint member from a left distal region of the mount body to a right distal region of the mount body and vice versa without causing movement of the actuator, the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane, wherein a proximal link of the arm immediately adjacent to the joint member is pivotable to a substantially perpendicular position with respect to the mount body; and a working end mounted to a distal end portion of the arm, wherein the joint member comprises a first member and a second member, wherein the first member confines movement of the proximal portion of the arm to yawing, and the second member confines movement of the proximal portion of the arm to pitching.
As is evident from the table above, the patent claims disclose all of the features of the application claims and additional limitations. The differences emphasized above in bold appear to be drawn to slight grammatical variations, not affecting the scope of the claims, for example the patent uses “comprises” instead of “is”. With regard to application claim 6, it is clear that the limitation “an actuator … mounted to the mount body toward the proximal end of the mount body” is anticipated by the limitation of patent claim 24 “an actuator mounted to the mount body at a proximal end region of the mount body”, since “mounted at” is more specific and means the actuator would be “mounted towards”. And with regard to the application claim 6, it is clear that the limitation “a cable extending from the actuator through the mount body, joint member, slotted ball and arm” is anticipated by the limitation of patent claim 24 “a cable extending from the actuator through the mount body, the slotted ball and the arm”, since patent claim 24 recites that the joint member comprises … a slotted ball”, therefore the cable would be extending through the joint member / slotted ball. In addition, application claim 4 from which application claim 6 depends from recites that the joint member comprises a slotted ball without any other structure differentiating the joint member from the slotted ball.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-5, 8-9, 17 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Philips et al. (U.S. Pub. No. 2007/0142712 A1, hereinafter “Philips”).
Philips discloses, regarding claim 1, a surgical instrument (see Fig. 1) comprising: a mount body (16 and 20) having a top portion (e.g. top portion of 16 and 20), a distal end (20), a proximal end (16) and a bottom portion (e.g. bottom portion of 16 and 20); a joint member (24 and 32, see Fig. 4) pivotally mounted at a distal end portion of the mount body (see Fig. 1) to allow positioning of a proximal portion (see annotated Fig. 1 below) of an arm (14) extending distally from the joint member (see annotated Fig. 1 below), the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane (via slot 50 and pin 26, see Fig. 1, see also paras. [0021] and [0030]); and a working end (76) mounted to (via 74) a distal end portion of the arm (see annotated Fig. 1 below).
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Regarding claim 2, wherein the joint member comprises a first joint member (24) and a second joint member (32), wherein the first joint member confines movement of the proximal portion of the arm to yawing (via slot 50 and pin 26, see Fig. 1, see also paras. [0021] and [0030]), and the second joint member confines movement of the proximal portion of the arm to pitching (via slots 66 and pin 68, see Fig. 1, see also para. [0026]).
Regarding claim 3, wherein the joint member pivotally mounted (via pin 26) at the distal end portion of the mount body is a disk member (56).
Regarding claim 4, wherein the joint member further comprises a slotted ball (see annotated Fig. 5 below, note the end of 32 is spherical similar to a ball and separated by a slot 72).
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Regarding claim 5, wherein the joint member is a disk member (56, see Fig. 4), and the slotted ball is connected to the disk member (via pin 68, see Fig. 1).
Regarding claim 8, wherein the slotted ball member forms a joint (via pin 68 and slots 66, see Fig. 1) with a proximal end of the arm portion (e.g. portion of 14 near 74, see Fig. 1, see para. [0026]).
Regarding claim 9, wherein upper and lower surfaces of the disk member extend substantially parallel with the top portion of the mount body (see annotated Fig. 1), and wherein the slotted ball is capable of pivoting to an angularly downward position from a plane parallel to the upper and lower surfaces of the disk member (via slots 66 and pin 68, see Fig. 1, see para. [0026], see also annotated Fig. 1 above).
Regarding claim 17, wherein the bottom portion comprises a mounting mechanism (48, see Fig. 6) configured to reversibly clamp the instrument to a fixed object (46, see para. [0028] “clamp”).
Claim(s) 1, 3-11, 13-15, 17, 19-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Goodman et al. (U.S. Patent 6,866,628 B2, hereinafter “Goodman”).
Goodman discloses, regarding claim 1, a surgical instrument (see Fig. 1A and 2C) comprising: a mount body (24) having a top portion, a distal end, a proximal end and a bottom portion (see annotated Fig. 2C below); a joint member (see annotated Fig. 2C below) pivotally mounted (via 242) at a distal end portion of the mount body to allow positioning of a proximal portion of an arm (20) extending distally from the joint member (see Fig. 2C), the joint member configured to at least partially constrain movement of the proximal portion of the arm to a plane (see lines 30-37 of column 5); and a working end (21) mounted to a distal end portion of the arm (see Fig. 1A).
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Regarding claim 3, wherein the joint member pivotally mounted at the distal end portion of the mount body is a disk member (242, see Fig. 2C, see also lines 31-33 of column 5 “disk topping”).
Regarding claim 4, wherein the joint member further comprises a slotted ball (204, see Fig. 2A and 2C, note that 204 is spherical shaped and has a long narrow aperture 250, e.g. slot and ball).
Regarding claim 5, wherein the joint member is a disk member (242), and the slotted ball (204) is connected to the disk member (204, see Fig. 2C).
Regarding claim 6, further comprising an actuator (23) rotatably mounted to the mount body towards the proximal end of the mount body (see annotated Fig. 2C below), and a cable (40) extending from the actuator through the mount body, joint member, slotted ball and arm (see Fig. 2C), the actuator and the cable being configured to change a state of the arm from a flexible state to a rigid state by movement of the actuator in a first direction (see lines 64-67 of column 5 and lines 1-4 of column 6), and from the rigid state to the flexible state by movement of the actuator is a second direction opposite the first direction (see lines 5-15 of column 8 and lines 31-66 of column 9).
Regarding claim 7, wherein movement of the actuator involves rotation, the first direction is a first rotational direction, and the second direction is a counter-rotational direction (see lines 5-15 of column 8 and lines 31-66 of column 9).
Regarding claim 8, wherein the slotted ball member forms a joint with a proximal end of the arm (see Fig. 1A).
Regarding claim 10, further comprising a vacuum tube in fluid communication with the working end (see lines 13-20 of column 4, note vacuum line attached at connection 25), and the working end is configured to reversibly attach to the exterior surface of a human's heart (see lines 25-30 of column 9).
Regarding claim 11, further comprising an actuator (23) rotatably mounted to the mount body at the proximal end of the mount body (see Fig. 2C), the actuator being configured to change a state of the arm from a flexible state to a rigid state by rotation of the actuator in a first rotational direction (see lines 64-67 of column 5 and lines 1-4 of column 6), and from the rigid state to the flexible state by rotation of the actuator in a counter-rotational direction (see lines 5-15 of column 8 and lines 31-66 of column 9).
Regarding claim 13, wherein the actuator (23) comprises a plurality of fins (see annotated Fig. 2E below) with a clip (see annotated Fig. 2E below) formed in one or more of the fins (see annotated Fig. 2E below, note that when the clips 223 are received in portion 211 of the fins they are being considered to be formed in, since they retain their fully formed expanded shape once received in 211).
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Regarding claim 14, wherein the instrument is an organ stabilizer (see Fig. 1A, see ABSTRACT) and the working end comprises at least one contact member (22) configured to be exerted against a tissue surface to stabilize the tissue surface (see lines 25-30 of column 9).
Regarding claim 15, wherein the instrument is an organ positioner (see Fig. 1A, see ABSTRACT) and the working end comprises a suction member (22, see Fig. 3B) defining a vacuum space therein (304), wherein the suction member is configured to receive the apex of a human heart (see lines 25-30 of column 9).
Regarding claim 17, wherein the bottom portion comprises a mounting mechanism (see annotated Fig. 2C above) configured to reversibly clamp the instrument to a fixed object (see lines 14-18 of column 5).
Regarding claim 19, wherein the mounting mechanism comprises a fixed jaw and a movable jaw (see annotated Fig. 2C above); and wherein a mounting mechanism actuator (200) is pivotally mounted within the bottom portion and at least partially above the movable jaw (via 202 and 256), the mounting mechanism actuator being configured to move the movable jaw from an unlocked position to a locked position and vice versa (see lines 12-27 of column 5).
Regarding claim 20, wherein the mounting mechanism actuator is configured to move the movable jaw toward the locked position when the mounting mechanism actuator is pulled in a proximal direction (see lines 20-49 of column 7).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goodman, as applied to claims 1 and 11 above, and in view of Valerio et al. (U.S. Patent 6,364,833 B1, hereinafter “Valerio”).
Goodman discloses all of the features of the claimed invention, as previously set forth above. Goodman further discloses, regarding claim 12, further comprising a suction tube in fluid communication with the working end (see lines 13-20 of column 4, note vacuum line attached at connection 25). However fails to disclose regarding claim 12, a clip configured to receive and temporarily hold the suction tube to maintain the suction tube in a low profile with the instrument, wherein the clip is formed with or connected to the mount body, the actuator, or both the mount body and the actuator.
Valerio discloses an irrigation system for use with surgical retractors (see Figs. 1-2), with an irrigation tube (32), a stabilization arm (104), a mount body (140) and an actuator (184), with clips (38 and 39) that are connected to the mount body and actuator via the stabilization arm (see Figs. 1-2) and configured to receive and temporarily hold the irrigation tube to maintain the suction tube in a low profile with the instrument (see Figs. 1-2, see lines 43-52 of column 7) in order to ensure the tube is retained out of the operating area of the surgeon and adjacent to the handle (see lines 17-34 of column 8).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify surgical instrument in Goodman to include clips connected to the mount body or actuator via the arm in view of Valerio in order to ensure the suction tube is retained out of the operating area of the surgeon and adjacent to the mount body / actuator.
Claim(s) 16 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goodman, as applied to claims 1 and 15 above, and in view of Knight et al. (U.S. Pub. No. 2002/0115911 A1, hereinafter “Knight”).
Goodman discloses all of the features of the claimed invention, as previously set forth above. Goodman further discloses, regarding claim 18, wherein the arm is capable of being oriented downwardly to make contact with an inner surface of a sternal retractor blade without requiring the movement of an actuator (200) with respect to the mounting body (via 120, see Fig. 1A, see lines 28-30 of column 4 and lines 51-55 of column 4, note that loosening / movement of arm is controlled by handle 23 and not by actuator 200 of the mounting body). Goodman fails to disclose, regarding claim 16, wherein the instrument is further configured to exert sufficient suction force on the heart to move the heart when the suction member is placed against the heart, a negative pressure of 250 millimeters of Mercury is applied within the vacuum space to engage the suction member with the heart, and the suction member is moved; and regarding claim 18, wherein the mounting mechanism is fixed to a surface of a sternal retractor, the sternal retractor comprising a sternal retractor blade mounted to or integral with the sternal retractor, wherein the arm is capable of being oriented downwardly to make contact with an inner surface of a sternal retractor blade without requiring the movement of the actuator with respect to the mounting body.
Knight discloses a cardiac stabilizer (see Fig. 1) with a suction member placed against the heart (60) that is configured to exert a negative pressure of 250 millimeters of Mercury is applied within the vacuum space to engage the suction member with the heart (see para. [0043] “typically range from about 100 mmHg to about 400, more typically about 200 to about 350 and preferably about 250 to about 300”) in order to provide effective tissue capture by the tissue stabilizer while minimizing damage to the cardiac tissue (see para. [0043]). Knight further discloses wherein the cardiac stabilizer comprises a mounting mechanism (160) fixed to a surface of a sternal retractor (5, see para. [0030]), the sternal retractor comprising a sternal retractor blade mounted to or integral with the sternal retractor (see para. [0047] “conventional rib retractor”) in order to spread apart the ribs and expose the patient's beating heart to perform the surgery (see para. [0047]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the suction member in Goodman to be configured to exert a negative pressure of 250 millimeters of Mercury is applied within the vacuum space to engage the suction member with the heart in view of Knight in order to provide effective tissue capture by the tissue stabilizer while minimizing damage to the cardiac tissue. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the mounting mechanism in Goodman to be fixed to a surface of a sternal retractor with a sternal retractor blade in view of Knight in order to provide a device to spread apart the ribs and expose the patient's beating heart to perform the surgery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/M.C.G/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
