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 .
Election/Restrictions
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
Applicant’s election without traverse of Group I in the reply filed on May 26, 2026 is acknowledged.
Drawings
The drawings are objected to because the reference numbers in Fig. 1 are illegible, many of the digits are indistinguishable. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the actuator must be shown or the feature(s) canceled from the claim(s). The specification recites transducers 340 may comprises a plurality of actuators but actuators as distinguished from the transducers are not shown. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 18-35 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 18 recites “wherein a peristaltic pump configured to be implanted on or within a recipient, the peristaltic pump comprising;” does not appear to be an appropriate wherein clause. It appears claim 18 should be drawn to the apparatus further comprising a peristaltic pump. Claim 18 recites “a recipient” however “a recipient” is previously recited in claim 1. Claim 18 recites “a peristaltic pump…comprising the cannula is configured to…” the language is unclear. Similarly, the recitation to “a peristaltic pump comprising the plurality of flow controllers comprises…” is unclear. Additionally, as claim 1 already recites the cannula and the plurality of flow controllers it is not clear if the peristaltic pump is a separate component from these or if the peristaltic pump is simply these two features. For purposes of the claim, separate structure to a pump is not considered as required. Claims 24 and 25 recite a heat conduit and a heat generator, it is not clear if this is the same or different than the at least one heat source recited in claim 1. For purposes of the rejection, it is taken to be the same. Claim 26 recites “a recipients’ body” however a recipient is already present in claim 1. It is not clear if these are the same or different. For purposes of the rejection, it is taken to be the same.
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.
Coil
Claim(s) 1-8, 10, 18-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dueck et al. (WO 2020/144534 A1) in view of Ishikawa et al. (US 6,464,687 B1).
With regard to claims 1, 5-7, 10, 18, and 22-25, Dueck et al. teaches an apparatus comprising: a housing configured to be implanted on or within a recipient (Fig. 3A including at least walls of 214 surrounding area 310); a cannula at least partially within the housing (Fig. 3A member 260); and a plurality of flow controllers on or within the housing and in mechanical communication with corresponding portions of the cannula, the plurality of flow controllers configured to control flow of a material through the portions of the cannula (Fig. 3A and 3B members 250 function as pistons to peristaltically pump fluid, [0047]), each flow controller of the plurality of flow controllers comprising: a phase-change material configured to, in response to heat, change from a first phase to a second phase ([0039], exemplary Fig. 3B material 252); and at least one heat source in thermal communication with the phase-change material, to transmit heat to the phase-change material (Fig. 3A members 240, also considered as a heat conduit and het generator, including at least conductive material/actuator 422 and thermal conduits 424 Fig. 5C). Dueck et al. do not disclose the heat source receives energy from a device external to the recipient. However, Ishikawa et al. teach controls which transmit electromagnetic energy to a heater for heating a phase change material may be external or implanted (Col. 7 lines 7-9 and 22-24, Fig. 1, electromagnetic energy is received by the power coil 128 and transmitted to the heater 136). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use external controls to supply electromagnetic energy to the heat source in Dueck et al. as Ishikawa et al. teach such is an art effective equivalent and would yield the same predictable result. Further this would allow easier access to the electronics for replacement.
With regard to claims 2-4 and 19-21, medicament may be provided from 340 (Fig. 3 A) or the device may be used for sampling ([0028]).
With regard to claim 8, Dueck et al. includes a resistor 244/422 (Fig. 5C, [0051]) and as combined with Ishikawa et al. a coil (Fig. 1 128) is used to receive energy which is transmitted to the heater.
With regard to claims 26-29, 31-32, and 34, the first portion of the conduit is taken as members 424 and the second portion is taken as 422/244 (Fig. 5C).
With regard to claim 30, the first surface is the upper surface of 424 connected to 234 that is flat and parallel to the tissue (Fig. 5C).
With regard to claim 33, see shapes of 250/252 in Fig. 3B.
With regard to claim 35, see [0052] 244 may be insulated.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dueck et al. (WO 2020/144534 A1) and Ishikawa et al. (US 6,464,687 B1) as applied to claim 1 above, and further in view of Traverso et al. (US 2023/0001083 A1) and Boyden et al. (US 2009/0163894 A1)
With regard to claim 9, Ducek et al. as combined do not disclose how the components are held in place. However, Traverso et al. teach using magnets to align an external control with an implanted pump (abstract). Further, Boyden et al. teach using ferromagnetic elements to retain external and internal components in place ([0037]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use ferromagnetic elements to algin the internal and external components in Ducek et al. as combined as Traverso et al. teach it is beneficial for alignment ensuring components communicate correctly and Boyden et al. teach ferromagnetic members are suitable for such use with external and internal components and would yield the same predictable result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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