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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 17-18 of U.S. Patent No. 12,268,362 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations in the application claims can be found in the patented claims. Except for a minor difference in terminology, it is clear that all elements of claims 1-20 are found in claims 1-9 and 17-18 of the patent. The difference between claims of the application and claims of the patent lies in the fact that the patent claims includes more elements and is, thus, more specific. Thus, the invention of claims 1-9 and 17-18 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). Since claims 1-20 are anticipated by claims 1-9 and 17-18 of the patent, they are not patentably distinct from the patented claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 12 each recite, in pertinent part, “wherein the articulation joint has a straight configuration and at least four different bent configurations”. However, the specification, as originally filed, only discloses four different bent configurations. The specification does not disclose more than four different bent configurations to provide support for the “at least four” recitation. Accordingly, the claims fail to comply with the written description requirement. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-6, 12-14 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goto (JP H11-155806 A) in view of Moriyama (US 2005/0065404 A1).
Regarding claim 1, Goto discloses an articulation joint (12; Fig. 1) for a medical device (1; Fig. 1), the articulation joint including: a proximal portion comprised of proximal links (15b and proximal links of 15d; Fig. 2); a distal portion comprised of distal links (15a and distal links of 15c; Fig. 2); and an intermediate portion comprised of intermediate links (proximal-most link of 15c and distal-most links of 15d; Fig. 2), wherein the intermediate portion is disposed between the proximal portion and the distal portion (Fig. 2), wherein the articulation joint has a straight configuration along a longitudinal axis (Fig. 2) and two different bent configurations when the articulation joint bends towards a first side (upward bending; Figs. 2 and 5; side where adjacent proximal links have a gap therebetween), a second side opposite the first side (downward bending; Figs. 2 and 5; side where adjacent proximal links do not have a gap therebetween), wherein the proximal portion is bendable towards only the first side (Fig. 5; downward bending), and wherein the distal portion is bendable towards each of the first, second (Fig. 5; upward and downward bending).
Although Goto teaches that its invention can be applied to an endoscope having a four-way curve (see page 7, paragraph), it does not specifically disclose the articulation joint having four different bent configurations, wherein the articulation joint bends toward a third side, and a fourth side opposite the third side of the articulation joint and away from the longitudinal axis, and wherein the distal portion is bendable towards each of the first, second, third and fourth sides. Moriyama teaches an analogous articulation joint (12) that has a distal section (12a) that is bendable in four directions (par. [0039]) and a proximal section (12b) that is bendable in two directions (par. [0040]). Moriyama teaches two bent configurations wherein the distal portion (12a) bends toward a third and fourth side, and the proximal portion (12b) does not bend (Fig. 4). Moriyama teaches the desirability of the distal end of an articulation joint being able to navigate torturous pathways and achieve different bending radii for improved viewing of target areas and navigation (par. [0009] and [0052]; Figs. 4 and 5). It would have been obvious to one having ordinary skill in the art to modify the distal portion of the articulation joint of Goto to bend in four directions as taught by Moriyama, and contemplated by Goto, such that the operator may view easily view target areas by manipulating the articulation joint to achieve various bending radii, as taught by Moriyama, and to navigate tortuous pathways easier. Such modification provides a configuration wherein the distal portion can bend in four directions thereby providing an articulation joint with four different bent configurations.
Regarding claim 2, Goto in view of Moriyama disclose the articulation joint of claim 1, wherein, in the straight configuration: (1) a first plurality of gaps is defined between adjacent links of the proximal links, the intermediate links, and the distal links on the first side (Fig. 2; upward bending), and (2) a second plurality of gaps is defined between adjacent links of only the distal links on the second, opposite side (Fig. 2; downward bending).
Regarding claim 3, Goto in view of Moriyama disclose the articulation joint of claim 2, wherein, in the straight configuration: (3) a third plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the third side (Moriyama: Fig. 3; 12 has gaps on all four sides), and (4) a fourth plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the fourth, opposite side (Moriyama: Fig. 3; 12 has gaps on all four sides).
Regarding claim 4, Goto in view of Moriyama disclose the articulation joint of claim 3, wherein, as the articulation joint transitions from the straight configuration to the first bent configuration (upward bending; Fig. 5), (i) a size of the first plurality of gaps defined along the first side is reduced (Fig. 5), (ii) a size the second plurality of gaps defined along the second side is increased (Fig. 5), (iii) a size of the third plurality of gaps and a size of the fourth plurality of gaps remains the same (Fig. 5; the third and fourth sides are not bent).
Regarding claim 5, Goto in view of Moriyama disclose the articulation joint of claim 1, wherein a maximum bend angle towards the first side (Fig. 5; upward bending) is greater than a maximum bend angle towards each of the second, third, and fourth sides (Fig. 5; the proximal portion does not bend toward the second, third and fourth sides).
Regarding claim 6, Goto in view of Moriyama disclose the articulation joint of claim 1, wherein a maximum bend angle towards the third side is equal to a maximum bend angle towards the fourth side (Moriyama: Fig. 3; third and fourth gaps are equal).
Regarding claim 12, Goto discloses an articulation joint (12; Fig. 1) for a medical device (1; Fig. 1), the articulation joint including: a proximal portion comprised of proximal links (15b and proximal links of 15d; Fig. 2); a distal portion comprised of distal links (15a and 15c; Fig. 2); and an intermediate portion comprised of intermediate links (distal-most links of 15d; Fig. 2), wherein the intermediate portion is disposed between the proximal portion and the distal portion (Fig. 2), wherein the articulation joint has a straight configuration along a longitudinal axis (Fig. 2) and two different bent configurations when the articulation joint bends towards a first side (upward bending; Figs. 2 and 5; side where adjacent proximal links have a gap therebetween), a second side opposite the first side (downward bending; Figs. 2 and 5; side where adjacent proximal links do not have a gap therebetween), and wherein the intermediate portion is bendable towards the first side (Fig. 5; upward bending), and wherein a maximum bend angle towards the first side (Fig. 5; upward bending) is greater than a maximum bend angle toward the second side (Fig. 5; downward bending).
Although Goto teaches that its invention can be applied to an endoscope having a four-way curve (see page 7, paragraph), it does not specifically disclose the articulation joint having four different bent configurations, wherein the articulation joint bends toward a third side, and a fourth side opposite the third side of the articulation joint and away from the longitudinal axis, wherein the distal portion is bendable towards each of the first, second, third and fourth sides, and wherein the intermediate portion is bendable toward the third side and the fourth side, wherein the maximum bend angle towards the first side is greater than a maximum bend angle towards each of the third side and the fourth side, and wherein a maximum bend angle towards the third side is equal to the maximum bend angle towards the fourth side. Moriyama teaches an analogous articulation joint (12) that has a distal section (12a) that is bendable in four directions (par. [0039]) and a proximal section (12b) that is bendable in two directions (par. [0040]). Moriyama teaches two bent configurations wherein the distal portion (12a) bends toward a third and fourth side, and the proximal portion (12b) does not bend (Fig. 4). Moriyama teaches the desirability of the distal end of an articulation joint being able to navigate torturous pathways and achieve different bending radii for improved viewing of target areas and navigation (par. [0009] and [0052]; Figs. 4 and 5). It would have been obvious to one having ordinary skill in the art to modify the distal portion of the articulation joint of Goto to bend in four directions as taught by Moriyama, and contemplated by Goto, such that the operator may view easily view target areas by manipulating the articulation joint to achieve various bending radii, as taught by Moriyama, and to navigate tortuous pathways easier. Such modification provides a configuration wherein the distal portion can bend in four directions thereby providing an articulation joint with four different bent configurations, wherein the intermediate portion is bendable toward the third side and the fourth side, wherein a maximum bend angle towards the first side (Fig. 5; upward bending) is greater than a maximum bend angle towards each of the third and fourth sides (Fig. 5; the proximal portion does not bend toward the second, third and fourth sides), and wherein a maximum bend angle towards the third side is equal to a maximum bend angle towards the fourth side (Moriyama: Fig. 3; third and fourth gaps are equal).
Regarding claim 13, Goto in view of Moriyama disclose the articulation joint of claim 12, wherein, in the straight configuration: (1) a first plurality of gaps is defined between adjacent links of the proximal links, the intermediate links, and the distal links on the first side (Fig. 2; upward bending), and (2) a second plurality of gaps is defined between adjacent links of only the distal links on the second, opposite side (Fig. 2; downward bending), (3) a third plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the third side (Moriyama: Fig. 3; 12 has gaps on all four sides), and (4) a fourth plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the fourth, opposite side (Moriyama: Fig. 3; 12 has gaps on all four sides).
Regarding claim 14, Goto in view of Moriyama disclose the articulation joint of claim 13, wherein, as the articulation joint transitions from the straight configuration to the first bent configuration (upward bending; Fig. 5), (i) a size of the first plurality of gaps defined along the first side is reduced (Fig. 5), (ii) a size the second plurality of gaps defined along the second side is increased (Fig. 5), (iii) a size of the third plurality of gaps and a size of the fourth plurality of gaps remains the same (Fig. 5; the third and fourth sides are not bent).
Regarding claim 18, Goto discloses an articulation joint (12; Fig. 1) for a medical device (1; Fig. 1), the articulation joint comprising: a plurality of links (15a-15d; Fig. 2), wherein the plurality of links define: a proximal portion (15a and 15c; Fig. 2); a distal portion (15b and proximal links of 15d; Fig. 2); and an intermediate portion (distal-most links of 15d; Fig. 2), wherein the intermediate portion is disposed between the proximal portion and the distal portion (Fig. 2), wherein the articulation joint has a straight configuration along a longitudinal axis (Fig. 2) and two bent configurations bending the articulation joint towards two sides of the articulation joint (Fig. 5 – upward and downward bending), and away from the longitudinal axis, wherein, in a first bent configuration, the proximal portion bends only towards a first side of the articulation joint (upward bending; Figs. 2 and 5; side where adjacent proximal links have a gap therebetween), wherein, in a second bent configuration the proximal portion is coaxial with the longitudinal axis (downward bending; Figs. 2 and 5; side where adjacent proximal links do not have a gap therebetween), and wherein, in the first bent configuration, the intermediate portion respectively bends towards the first side of the articulation joint (upward bending; Figs. 2 and 5; side where adjacent proximal links have a gap therebetween).
Regarding claim 19, Goto in view of Moriyama disclose the wherein a maximum bend angle in the first bent configuration is greater than a maximum bend angle in the second bent configuration, the third bent configuration, and the fourth bent configuration, wherein a maximum bend angle in the second bent configuration is less than a maximum bend angle in the third bent configuration and the fourth bent configuration, and wherein a maximum bend angle in the third bent configuration is equal to a maximum bend angle in the fourth bent configuration.
Regarding claim 20, Goto in view of Moriyama disclose the articulation joint of claim 18, wherein, in the straight configuration: (1) a first plurality of gaps is defined between adjacent links of the proximal links, the intermediate links, and the distal links on the first side, and (2) a second plurality of gaps is defined between adjacent links of only the distal links on the second, opposite side, (3) a third plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the third side, and (4) a fourth plurality of gaps is defined between adjacent links of the intermediate links and the distal links on the fourth, opposite side
Claim(s) 7-11 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goto in view of Moriyama as applied to claims 1 and 12 above, and further in view of Dirusso et al. (US 2006/004118 A1) in view of Banik et al. (US 2005/0075538 A1).
Regarding claim 7, Goto in view of Moriyama disclose the articulation joint of claim 1, but does not specifically disclose the wherein the adjacent links are attached to a respective adjacent link by a first spring and a second spring. Dirusso teaches an analogous articulation joint wherein the links can be comprised slots formed in a tubular shaped member (par. [0070]-[0071] and [0075]-[0076]; Fig. 11) or comprised of metal rings hinged to each other to provide pivotal movement (par. [0078]). It would have been obvious to one having ordinary skill in the art to substituted the hinged metal rings for the slotted tube, being a simple substitution of one known configuration for another having predictable results, as taught by Dirusso. Various mechanisms for providing a hinged attachment between links are generally known in the art. Banik teaches an analogous articulation joint wherein links are hinged to each other to provide pivotal movement by a first spring and a second spring (1010; Fig. 23B; par. [0153]). Banik also teaches that the springs prevent adjacent segments from rotating with respect to each other or otherwise becoming misaligned (par. [0165]). It would have been obvious to
one having ordinary skill in the art to use first and second springs to provide the hinged connections between links, as taught by Banik, as a simple substitution of one known mechanism for providing a hinged connection for another, having a predictable result, and to prevent adjacent segments from rotating with respect to each other or otherwise becoming misaligned, as taught by Banik.
Regarding claim 8, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 7, wherein the first spring and the second spring (Banik: 1010; Fig. 23B) attaching a first pair of adjacent links, including a first link and a second link, are respectively on the first side of the articulation joint and the second side of the articulation joint (Banik: par. [0153] - a pair of spring segments located on opposite sides of the ring), and the first spring and wherein the second spring (Banik: 1010; Fig. 23B) attaching a second pair of adjacent links, including the second link and a third link, are respectively on a third side of the articulation joint, intermediate to the first side and the second side, and a fourth side opposite the third side of the articulation joint (Banik: par. [0153] - a pair of spring segments located on opposite sides of the ring; Fig. 23B).
Regarding claim 9, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 7, wherein the first spring and the second spring (Banik: 1010; Fig. 23B) are attached on an inner surface of each of the proximal links and distal links by one or more of laser welding or an adhesive (Banik: par. [0153]).
Regarding claim 10, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 7, wherein adjacent coils of each of the first spring and the second spring (Banik: 1010; Fig. 23B) contact each other when the first spring and the second spring are in a straight configuration (Banik: Fig. 23B; par. [0153]-[0154]).
Regarding claim 11, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 7, wherein each of the first spring and the second spring (Banik: 1010; Fig. 23B) defines a lumen for containing an articulation element (Banik: par. [0153]).
Regarding claim 15, Goto in view of Moriyama disclose the the articulation joint of claim 12, but does not specifically disclose the wherein the adjacent links are attached to a respective adjacent link by a first spring and a second spring, wherein the first spring and the second spring attaching a first pair of adjacent links, including a first link and a second link, are respectively on the first side of the articulation joint and the second side of the articulation joint, and wherein the first spring and the second spring attaching a second pair of adjacent links, including the second link and a third link, are respectively on the third side of the articulation joint, intermediate to the first side and the second side, and the fourth side opposite the third side of the articulation joint. Dirusso teaches an analogous articulation joint wherein the links can be comprised slots formed in a tubular shaped member (par. [0070]-[0071] and [0075]-[0076]; Fig. 11) or comprised of metal rings hinged to each other to provide pivotal movement (par. [0078]). It would have been obvious to one having ordinary skill in the art to substituted the hinged metal rings for the slotted tube, being a simple substitution of one known configuration for another having predictable results, as taught by Dirusso. Various mechanisms for providing a hinged attachment between links are generally known in the art. Banik teaches an analogous articulation joint wherein links are hinged to each other to provide pivotal movement by a first spring and a second spring (1010; Fig. 23B; par. [0153]). Banik also teaches that the springs prevent adjacent segments from rotating with respect to each other or otherwise becoming misaligned (par. [0165]). It would have been obvious to one having ordinary skill in the art to use first and second springs to provide the hinged connections between links, as taught by Banik, as a simple substitution of one known mechanism for providing a hinged connection for another, having a predictable result, and to prevent adjacent segments from rotating with respect to each other or otherwise becoming misaligned, as taught by Banik. Such modification provides a configuration wherein the first spring and the second spring (Banik: 1010; Fig. 23B) attaching a first pair of adjacent links, including a first link and a second link, are respectively on the first side of the articulation joint and the second side of the articulation joint (Banik: par. [0153] - a pair of spring segments located on opposite sides of the ring), and the first spring and wherein the second spring (Banik: 1010; Fig. 23B) attaching a second pair of adjacent links, including the second link and a third link, are respectively on a third side of the articulation joint, intermediate to the first side and the second side, and a fourth side opposite the third side of the articulation joint (Banik: par. [0153] - a pair of spring segments located on opposite sides of the ring; Fig. 23B).
Regarding claim 16, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 15, wherein the first spring and the second spring (Banik: 1010; Fig. 23B) are attached on an inner surface of each of the proximal links and distal links by one or more of laser welding or an adhesive (Banik: par. [0153]).
Regarding claim 17, Goto in view of Moriyama in view of Dirusso in view of Banik disclose the articulation joint of claim 15, wherein each of the first spring and the second spring (Banik: 1010; Fig. 23B) defines a lumen for containing an articulation element (Banik: par. [0153]).
Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/11/26
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