Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
“Bending angle” is equivalent to “flexion angle”.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A).
It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim except “applying a passive dampening of a swing phase flexion movement using a drive device”. Aulie teaches applying a passive dampening of a swing phase flexion movement using a drive device (abstract: hydraulic damper is used to reduce swing rate of knee joint). Since the damping of Aulie is applied to the entire swing phase, this will include dampening of a mid-swing phase flexion moment. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase dampening of Aulie in the knee joint because this permits a desired gait and reduces terminal impact at full extension (abstract).
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim. Bending angle is the same as flexion angle.
Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11998458B2 in view of Aulie (5171325A). It has been held that a genus anticipates a species and the prior filed patent anticipates each and every aspect of the instant filed claim.
Claim Objections
Claim(s) 32 is/are objected to because of the following informalities:
In regard to claim 32, “support moment” in line 1 of the claim should be “supporting moment” for clarity since the moment is referred to as “supporting moment” in claim 31.
Appropriate correction is required.
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.
Claims 23-42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kazerooni (2007/0233279A1).
In regard to claim 23, Kazerooni teaches a method for controlling an orthotic or prosthetic knee joint device with an upper part 103 and a lower part 105 arranged in an articulated manner thereon (fig 2; 107 is articulation),
fastening devices (straps 243, 244) to secure the knee joint device on a user, (fig 3, 6)
a drive device 213 to apply a moment to the knee joint device, and a control device 159 communicatively coupled to at least one sensor 158, 157 and configured to control the drive device [0057: single process receives knee angle signal; configured to generate command signals for various components of power unit 215; 0060: power dissipation or regeneration mode], the method comprising:
applying a supporting moment to the orthotic or prosthetic knee joint device with the drive device during operation of the orthotic or prosthetic knee joint device when mounted to the user, where the supporting moment is a supporting flexion moment or a supporting extension moment, and where the supporting flexion moment or the supporting extension moment is sufficient to support a flexion movement or an extension movement and is applied in a same direction as a flexion movement or an extension movement, respectively, of the lower part relative to the upper part; [positive power applied is a flexion moment; fig 14-16, power applied just before and during knee flexion; 0006: power applied results in torque generated]
applying a passive dampening of a swing phase flexion movement using a drive device; [0047: power regeneration/dissipation mode in swing phase in some embodiments; see negative power in early swing phase in fig 14-16]
and applying an activation moment to the knee joint device in the swing phase, wherein the applied activation moment causes flexion movement or extension movement of the lower part relative to the upper part. [0061: power utilization mode to assist swinging; figure 14; power applied during early swing phase; figure 15, positive power applied in late swing phase during level walking; fig 16 positive power applied in early swing phase]
However, Kazerooni does not teach multiple straps in the same embodiment.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use both the thigh strap 243 and the shank strap 244 simultaneously (add shank strap 244 to the embodiment of figure 3) to ensure the brace is fully attached to the leg above and below the joint in order to function as intended and provide support to the knee joint.
In regard to claim 24, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further teaches applying the support moment (interpreted as the supporting moment) to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment [see positive power applied in fig 14 during stair descent; applied at approximately 25% of the gait cycle; fig 15 applied prior to flexing in stance] the supporting flexion moment being applied prior to the knee joint device being flexed and reduced when the knee joint device begins to flex. (fig 14, power applied just prior to when flexing stairs during stair descent; fig 15 decreased at a time after flexion starts)
In regard to claim 25, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further teaches applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment (see power applied in stance phase in figs 14-16), the supporting flexion moment being provided in a varying degree in dependence on a walking situation selected from walking on level ground, walking up an incline, or walking up stairs. (fig 15 is level walking; fig 16 is stair ascent; the positive power amount applied changes during flexion based on the terrain)
In regard to claim 26, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further teaches applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment,
the supporting flexion moment including a first supporting flexion moment that is applied after activation of supporting flexion movement of the lower part relative to the upper part,
and a second supporting flexion moment that is greater than the first supporting flexion moment and is applied before activation of supporting flexion movement of the lower part relative to the upper part. (see annotated fig 15)
In regard to claims 27-28, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further teaches applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment (the supporting moment is a flexion moment, see positively power applied at approximately 50% of the gait cycle in fig 15) and further discloses the supporting flexion moment being applied during supporting flexion movement up to a predetermined, ascertained flexion angle/bending angle of the lower part relative to the upper part. (see fig 15, predetermined could be at any point before the change occurs and therefore the change in controls will be predetermined under the broadest reasonable interpretation since the signal must be sent from the controller to change the power) Further, Kazerooni teaches the use of a knee angle sensor to control the device [0056-0057].
In regard to claim 29, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further teaches the supporting moment is applied in a time period before the knee joint device is flexed (As shown in figure 15, during level ground walking the supporting moment is applied during mid stance phase which is before the knee joint is flexed as indicated by the dotted lines. Further, the gait cycle is cyclical) that is between 5% and 40% of a duration of a gait cycle. (see figure 15, positively powered applied between 5 and 40% of a duration of the gait cycle)
In regard to claim 30, Kazerooni meets the claim limitations as discussed in the rejection of claim 23, and further discloses applying a passive dampening of a swing phase flexion movement using a drive device comprises applying a passive dampening of a mid-swing phase flexion movement of a swing phase flexion movement using a drive device. (see negative power in mid swing phase in figure 15; [0039: power regeneration mode)
In regard to claim 31, Kazerooni teaches a method for controlling an orthotic or prosthetic knee joint device with an upper part 103 and a lower part 105 arranged in an articulated manner thereon (fig 2, 107 is an articulation), fastening devices (straps 243, 244) to secure the knee joint device on a user (fig 3), a drive device 213 to apply a moment to the knee joint device, and a control device 159 communicatively coupled to at least one sensor 157, 158 and configured to control the drive device, [0057: single process receives knee angle signal; configured to generate command signals for various components of power unit 215; 0060], the method comprising:
applying a supporting moment to the orthotic or prosthetic knee joint device with the drive device during operation of the orthotic or prosthetic knee joint device when mounted to the user, the applied supporting moment being a supporting flexion moment or a supporting extension moment, the supporting flexion moment or the supporting extension moment being sufficient to support a flexion movement or an extension movement and that is applied in the same direction as a flexion movement or an extension movement, respectively, of the lower part relative to the upper part; (see figure 14-16, positive power applied; 0006: power causes torque generation)
wherein applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment, the supporting flexion moment being applied in a time period before a swing phase flexion movement during a gait cycle; (as shown in figure 14-16, positive power is applied in stance phase prior to swing phase or swing phase flexion occurring)
and applying an activation moment to the knee joint device in the swing phase during the gait cycle, the applied activation moment causes flexion movement or extension movement of the lower part relative to the upper part. (As shown in figure 14-16, power is applied during swing phase, causing flexion or extension movement)
However, Kazerooni does not teach multiple straps in the same embodiment.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use both the thigh strap 243 and the shank strap 244 simultaneously (add shank strap 244 to the embodiment of figure 3) to ensure the brace is fully attached to the leg above and below the joint in order to function as intended and provide support to the knee joint.
In regard to claim 32, Kazerooni discloses the method of claim 31, and further discloses applying the support moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment, the supporting flexion moment being applied prior to the knee joint device being flexed and reduced when the knee joint device begins to flex. (see fig 14, positive power applied prior to knee flexion during stance phase and reduced once flexion occurs during stair descent; fig 15, power is applied during stance phase and power is reduced during portions of swing phase)
In regard to claim 33, Kazerooni meets the claim limitations as discussed in the rejection of claim 31, and further discloses applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment (fig 15-6, positive power applied during flexion) the supporting flexion moment being provided in a varying degree in dependence on a walking situation selected from walking on level ground, walking up an incline, or walking up stairs. (fig 15 is level walking; fig 16 is stair ascent)
In regard to claim 34, Kazerooni meets the claim limitations as discussed in the rejection of claim 31, and further teaches applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment, the supporting flexion moment including a first supporting flexion moment that is applied after activation of supporting flexion movement of the lower part relative to the upper part, and a second supporting flexion moment that is greater than the first supporting flexion moment and is applied before activation of supporting flexion movement of the lower part relative to the upper part. (see annotated fig 15)
In regard to claims 35-36, Kazerooni meets the claim limitations as discussed in the rejection of claim 31, and further teaches applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment. (see fig 15, supporting moment is positively applied power at approximately 50% of the gait cycle in fig 15) the supporting flexion moment being applied during supporting flexion movement up to a predetermined, ascertained flexion/bending angle of the lower part relative to the upper part. (see fig 15, predetermined could be at any point before the change occurs and therefore the change in controls will be predetermined under the broadest reasonable interpretation since the controller will have to send a signal to change the power level) Further, Kazerooni teaches the use of a knee angle sensor to control the device [0056-0057].
In regard to claim 37, Kazerooni meets the claim limitations as discussed in the rejection of claim 31, and further teaches the supporting moment is applied in a time period before the knee joint device is flexed that is between 5% and 40% of the duration of a gait cycle. (see figure 15, positively powered applied between 5 and 40% of a duration of the gait cycle)
In regard to claim 38, Kazerooni teaches a method for controlling an orthotic or prosthetic knee joint device with an upper part 103 and a lower part 105 arranged in an articulated manner thereon (fig 2, 107 is an articulation), fastening devices (straps 243, 244) to secure the knee joint device on a user (fig 3), a drive device 213 to apply a moment to the knee joint device, and a control device 159 communicatively coupled to at least one sensor 157, 158 and configured to control the drive device, [0057: single process receives knee angle signal; configured to generate command signals for various components of power unit 215; 0060], the method comprising:
applying a supporting moment to the orthotic or prosthetic knee joint device with the drive device during operation of the orthotic or prosthetic knee joint device when mounted to the user, the applied supporting moment being a supporting flexion moment or a supporting extension moment, the supporting flexion moment or the supporting extension moment being sufficient to support a flexion movement or an extension movement and that is applied in the same direction as a flexion movement or an extension movement, respectively, of the lower part relative to the upper part; (Fig 14=-16, see positively power applied during stance)
wherein a supporting flexion moment or a supporting extension moment of a varying degree is provided in dependence on a walking situation; (fig 14-16; the amount of power applied and therefore moments varies depending on level walking, stair ascent or stair descent)
and applying an activation moment to the knee joint device in a swing phase during a gait cycle, the applied activation moment causes flexion movement or extension movement of the lower part relative to the upper part. (see positive power in swing phase as shown in figures 14-16 during the flexion or extension movements)
However, Kazerooni does not teach multiple straps in the same embodiment.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use both the thigh strap 243 and the shank strap 244 simultaneously (add shank strap 244 to the embodiment of figure 3) to ensure the brace is fully attached to the leg above and below the joint in order to function as intended and provide support to the knee joint.
In regard to claim 39, Kazerooni discloses the method of claim 38, and further discloses applying the support moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment (fig 14),
the supporting flexion moment being applied prior to the knee joint device being flexed and reduced when the knee joint device begins to flex. (fig 14, power applied just prior to when flexing stairs during stair descent and then reduced)
In regard to claim 40, Kazerooni discloses the method of claim 38, and further discloses applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment, (see positive power applied during stance phase in figures 14-16 during the flexing time period)
the supporting flexion moment being provided in a varying degree in dependence on a walking situation, the walking situation including walking on level ground, walking up an incline, or walking up stairs. (see figs 15-16 the power varies resulting in a different amount of moment based on level ground, or stair ascent)
In regard to claim 41, Kazerooni discloses the method of claim 38, wherein applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment (see positive power applied in fig 15 during level walking),
the supporting flexion moment including a first supporting flexion moment that is applied after activation of supporting flexion movement of the lower part relative to the upper part, and a second supporting flexion moment that is greater than the first supporting flexion moment and is applied before activation of supporting flexion movement of the lower part relative to the upper part. (see annotated fig 15)
In regard to claim 42, Kazerooni discloses the method of claim 38, and further discloses applying the supporting moment to the orthotic or prosthetic knee joint device includes applying the supporting flexion moment, (see positive power in fig 15 applied during stance phase and flexion between 40-60% of the gait cycle) the supporting flexion moment being applied during supporting flexion movement up to a predetermined, ascertained flexion angle of the lower part relative to the upper part. (see fig 15, predetermined could be at any point before the change occurs and therefore the change in controls will be predetermined under the broadest reasonable interpretation since the controller will have to send a signal to the knee joint to change the power applied) Further, Kazerooni teaches the use of a knee angle sensor to control the device [0056-0057].
PNG
media_image1.png
624
842
media_image1.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
Prosecution Insights