DETAILED ACTION
This is the initial Office action for application 18/515,115 filed November 20, 2023, which is a divisional of application 16/465,098 (now US Patent 11,819,437) filed May 29, 2019, which is a national stage entry of PCT/EP2016/082450 filed December 22, 2016. Claims 20-39, as presented in the preliminary amendments filed November 20, 2023, are currently pending.
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 . 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 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.
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.
Claims 34 and 37-39 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 34 recites the limitations “a plantar flexion direction” and “a dorsiflexion direction”; however, it is unclear whether or not the plantar flexion and dorsiflexion directions recited in claim 34 are referring to the same plantar flexion and dorsiflexion directions previously recited in claim 20. For examination purposes, the limitations “a plantar flexion direction” and “a dorsiflexion direction” recited in claim 34 have been interpreted as “the plantar flexion direction” and “the dorsiflexion direction”, respectively.
Claim 37 recites the limitation “a dorsiflexion direction”; however, it is unclear whether or not the dorsiflexion direction recited in claim 37 is referring to the same dorsiflexion direction previously recited in claim 35. For examination purposes, the limitation “a dorsiflexion direction” recited in claim 37 has been interpreted as “the dorsiflexion direction”.
Claim 38 recites the limitation “a dorsiflexion direction” in line 13; however, it is unclear whether or not the dorsiflexion direction recited in line 13 is referring to the same dorsiflexion direction previously recited in line 10. For examination purposes, the limitation “a dorsiflexion direction” recited in line 13 has been interpreted as “the dorsiflexion direction”.
Claim 38 recites the limitation “the ankle orthosis” in line 15; however, there is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation “the ankle orthosis” has been interpreted as “the ankle foot orthosis” as previously recited in line 1.
Claim 39 is included in the rejection under 35 U.S.C. 112(b) based on its dependance from rejected claim 38.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 20-23 and 35-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Will et al. (US 2015/0164660).
Regarding claim 20, Will discloses an ankle foot orthosis (orthotic joint device 1 designed for an ankle joint orthosis) (¶ 0019) comprising:
a lower leg element (upper part 2 when joint device 1 is designed for an ankle joint orthosis) (Fig. 1; ¶ 0019 & 0050);
a foot element (lower part 3 when joint device 1 is designed for an ankle joint orthosis) (Fig. 1; ¶ 0019 & 0050); and
a first energy storing unit (hydraulic unit 10) comprising a pressure chamber (pressure accumulator 23), the first energy storing unit (10) configured to store additional energy in the form of an increased pressure in the pressure chamber (23) (Abstract; Figs. 1-2; ¶ 0011, 0016, & 0053) in response to:
moving the foot element (3) relative to the lower leg element (2) in a plantar flexion direction (extension movement) from a first position in which the amount of energy stored in the first energy storing unit is at a minimum into a second position to increase the amount of energy stored in the first energy storing unit (¶ 0011, 0013, 0016, & 0021); and
moving the foot element (3) relative to the lower leg element (2) in a dorsiflexion direction (flexion movement) from the second position back into the first position to increase the amount of energy stored in the first energy storing unit (¶ 0011, 0013, 0016, & 0021).
Regarding claim 22, Will further discloses a cylinder (housing 11) and a cylinder piston (piston 12), the cylinder (11) in fluid communication with the pressure chamber (23) (Abstract; Fig. 2; ¶ 0052). Although Will does not expressly designate the cylinder (11) and the cylinder piston (12) as a “heel” cylinder and a “heel” cylinder piston, the term “heel” is only nominally recited and does not impart any further structural limitations regarding the cylinder and the cylinder piston. Further Will discloses that the joint device (1) may be designed for an ankle joint orthosis) (Fig. 1; ¶ 0019) such that the cylinder (11) and cylinder piston (12) will implicitly be positioned near an ankle joint and thus near a heel of the user.
Regarding claim 22, Will discloses a rod (piston rod 13) attached to the foot element (3) and the heel cylinder piston (12) (Figs. 1-2; ¶ 0001 & 0052). Although Will does not expressly teach that the rod (13) is attached to a heel part of the foot element (3), when the joint device (10) is designed for an ankle joint orthosis, the elements of the hydraulics unit (10) will be implicitly be positioned near an ankle joint and thus a heel part of the foot element (3).
Regarding claim 23, Will discloses that the heel cylinder comprises two first valves (adjustable valves 40, 50) configured to control a flow of air between the heel cylinder (11) and the pressure chamber (23) (Fig. 2; ¶ 0054-0055).
Regarding claims 35-37, Will discloses an ankle foot orthosis (orthotic joint device 1 designed for an ankle joint orthosis) (¶ 0019) comprising:
a lower leg element (upper part 2 when joint device 1 is designed for an ankle joint orthosis) (Fig. 1; ¶ 0019 & 0050);
a foot element (lower part 3 when joint device 1 is designed for an ankle joint orthosis) pivotally coupled to the lower leg element (3) (Fig. 1; ¶ 0019 & 0050); and
a first energy storing unit (hydraulic unit 10) comprising a pressure chamber (pressure accumulator 23), wherein the first energy storing unit (10) is adapted such that moving the foot element (3) relative to the lower leg element (2) in a plantar flexion direction (extension movement) from a first position to a second position increases an amount of energy stored in the pressure chamber (23) in the form of a pressure increase (Abstract; Figs. 1-2; ¶ 0011, 0013, 0016, 0021, & 0053);
wherein a pressure inside the pressure chamber (23) is increased when the foot element (3) is moved relative to the lower leg element (2) in the plantar flexion direction (extension movement) from the first position to the second position, and wherein the pressure inside the pressure chamber (23) is increased when the foot element (3) is moved relative to the lower leg element (2) in the dorsiflexion direction (flexion movement) from the second position to the first position (Abstract; Figs. 1-2; ¶ 0011, 0013, 0016, 0021, & 0053).
Regarding claim 38, Will discloses a method for controlling an ankle foot orthosis (orthotic joint device 1 designed for an ankle joint orthosis) (¶ 0019) comprising:
providing the ankle foot orthosis (1) with a lower leg element (upper part 2 when joint device 1 is designed for an ankle joint orthosis), a foot element (lower part 3 when joint device 1 is designed for an ankle joint orthosis) pivotally coupled to the lower leg element (3), and a first energy storing unit (hydraulic unit 10) comprising a pressure chamber (pressure accumulator 23) (Figs. 1-2; ¶ 0011, 0019, 0050, & 0053);
moving the foot element (3) relative to the lower leg element (2) in a plantar flexion direction (extension movement) from a first position to a second position, wherein pressure insides the pressure chamber (23) is increased when the foot element (3) is moved relative to the lower leg element (2) in the plantar flexion direction (extension movement) from the first position to the second position (Abstract; Figs. 1-2; ¶ 0011, 0013, 0016, 0021, & 0053); and
moving the foot element (3) relative to the lower leg element (2) in a dorsiflexion direction (flexion movement) from the second position to the first position, wherein the pressure inside the pressure chamber (23) is increased when the foot element (3) is moved relative to the lower leg element (2) in the dorsiflexion direction (flexion movement) from the second position to the first position, wherein the pressure increase in the pressure chamber (23) comprises additional energy for the ankle foot orthosis (1) that is stored in the pressure chamber (23) in the form of a pressure increase (Abstract; Figs. 1-2; ¶ 0011, 0013, 0016, 0021, & 0053).
Regarding claim 39, Will further discloses initiating a powered plantarflexion (extension) (¶ 0085).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Will as applied to claim 20 above.
Will discloses the invention substantially as claimed, as described above, and further discloses that the pressure chamber (23) comprises a first pressure chamber (23) and may comprise a second pressure chamber (multiple pressure accumulators or an additional accumulator), wherein moving the foot element (3) relative to the lower leg element (2) in the plantar flexion direction (extension movement) increases the amount of energy stored in a first chamber (extension chamber 14) and moving the foot element (3) relative to the lower leg element (2) in the dorsiflexion direction (flexion movement) increases the amount of energy stored in a second chamber (flexion chamber 15) (¶ 0021, 0057-0058, & 0067).
Although Will fails to teach a second energy storing unit comprising the second pressure chamber, wherein moving the foot element relative to the lower leg element in a plantar flexion direction increases the amount of energy stored in the first pressure chamber and moving the foot element relative to the lower leg element in a dorsiflexion direction increases the amount of energy stored in the second pressure chamber, such a modification would require the mere duplication of the essential working parts of the device which has been held to have no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it has been held that rearranging parts of an invention that would not have modified the operation of the device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of base claim 20 and intervening claims 21-23.
Claims 25-33 are also objected to as being dependent upon a rejected base claim, but would be allowable based on their dependence from allowable claim 24.
Claim 24 is indicated as containing allowable subject matter since the two first valves (40, 50) of the ankle foot orthosis (1) taught by Will are configured to open at controlled times during use (¶ 0061, 0072, & 0074-0078) rather than to open under pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 12/15/2025