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
Applicant’s election of Group I, claims 1, 3-7, and 9 in the reply filed on November 3, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
While Applicant asserts section 37 CFR 1.475(b) was skipped, pages 2-4 of the Office Action dated 09/03/2025 discuss that section. Applicant does not specifically point out the supposed errors in the restriction requirement. Instead, asserts without specificity that the 09/03/2025 Office Action Restriction Requirement is not following “unity of invention” regulations. A mere broad allegation that the requirement is in error does not comply with the requirement of 37 CFR 1.111 (see MPEP 818.01(a)).
Priority
Claims 1, 3-7, and 9 are deemed to have an effective filing date of September 30, 2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “190” has been used to designate both a hose in Fig. 1B and an electrode assembly in Fig. 1E.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 12A (Fig. 1C).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 1902 (paragraph [0030]); 201 (paragraphs [0042]) and [0043]); and 4182 (paragraph [0055]).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “130” has been used to designate both an external coil in Fig. 1A and a tongue (?) in Fig. 1D.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “100” has been used to designate both a cochlear implant in Fig. 1A and a recipient in Fig. 1D.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “198” has been used to designate both leads in Fig. 1B and a processor unit (circle) in Fig. 1D.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “220” has been used to designate both a sound processor that is located behind the ear in Fig. 2C and a sound processor located within the ear canal in Figs. 1F and 26.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “118” has been used to designate both an elongate stimulating assembly in Fig. 1A and mastoid bone in Figs. 11-12.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate 1) an auricle/pinna in Fig. 1A; in Figs.; an implant unit in Fig. 1D; and an ear canal in Figs. 24-25.
The drawings are objected to under 37 CFR 1.84 (l) because "every line, number and letter must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well defined". The lead lines for 1577, 1588, 1515 in Fig.15 are not well defined and it is hard to distinguish which lead line designates the curves discussed in paragraphs [0087]-[0088] of the specification.
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. 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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0042], lines 12 and 19, the reference to Fig. 1D is confusing as Fig. 1D is directed to a wireless connection and not a bayonet connector as stated in paragraph [0042].
Paragraph [0045], line 1, the recitation of “Fig. 1F” as showing the ITE component 250 connected to the spine of the BTE is inaccurate as Fig. 2C shown that feature.
Appropriate correction is required.
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 3-4 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.
The term “miniaturized” in claim 3 is a relative term which renders the claim indefinite. The term “miniaturized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What is the apparatus miniaturized with?
In claim 4, it is unclear what location is intended by “above the electronics with respect to the direction above a surface of the mastoid bone”. Fig. 16 appears to show this feature where the coil 436 is located above the mastoid bone when the apparatus is implanted.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4 and 7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 4, Applicant recites part of a human, i.e. "the housing is implanted in a mastoid bone” (Claim 4, line 2) and "the coil is located above the electronics with respect to the direction above a surface of the mastoid bone” (Claim 4, lines 4-5). Thus, this claim includes a human within the scope and is non-statutory.
In claim 7, Applicant recites part of a human, i.e., “the apparatus is in … communication with a BTE or ITE device worn behind an ear of a human or in an ear canal of a human, respectively” (claim 7, lines 3-5) and “the signal enters the ear canal wall and passes therethrough” (claim 7, lines 7-8).
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be implanted in claim 4, line 2. It is unclear how to fix referring to the location of the coil with respect to a surface of the mastoid bone as the claim could be worded in a different fashion to avoid issues under Section 101. With respect to claim 7, the examiner suggests using the phrases “adapted to be worn” and “adapted to enter the ear canal”, respectively.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2015/0343225 to Leigh et al. (hereinafter referred to as “Leigh”) in view of US Patent No. 11,943,588 to Andersson et al. (EFD 08/31/2016, published on 03/01/2018 as US 2018/0063658 and hereinafter referred to as “Andersson”).
Regarding claim 1, Leigh discloses an apparatus, comprising: an implantable housing (e.g., paragraph [0040]: main implant comprises a hermetically sealed housing 276; and Fig. 2B, housing 276); implantable electronics hermetically sealed within at least a portion of the implantable housing (e.g., paragraphs [0039]-[0040]: main implant comprises a hermetically sealed housing 276; and Fig. 2B, housing 276; power supply 270; simulator unit 272 and an internal receiver/transmitter unit 274); and an implantable inductance coil (e.g., paragraphs [0007]: implantable hearing system includes an implantable coil forming a radio-frequency link with an external coil where the coil is implanted in the recipient at a location distal to at least one implant module; [0028]: implantable coils positioned at the skull exterior 127 are co-located with a stimulator/receiver unit; and [0034]: implantable coil 254 is sized and shaped to be positioned in the recipient’s middle ear cavity and is inductively coupled to an external coil across the tympanic membrane), wherein an outer diameter of the inductance coil is less than 17.5 mm (e.g., paragraph [0038]: coils in the trans-tympanic membrane RF link may each have a diameter of approximately 6 mm), and wherein the apparatus is fully implantable within a human (see Fig. 2A). Leigh differs from the claimed invention in that it does not expressly disclose that the outer diameter of the inductance coil when implanted/positioned to be inductively coupled across the tympanic membrane is within 5 mm of a portion of the implantable housing. However, Andersson teaches, in a related art: intracutaneous implantation techniques of a housing within which electronics are hermetically sealed and an implantable inductance coil, that teachings detailed herein are applicable to a cochlear implant and/or middle ear implant (e.g., column 3, lines 1-7 of Andersson); that the inductance coil may be placed above the housing so that a thin layer of skin is between the outer diameter of the inductance coil 558 and the housing 454 (as shown in Fig. 16), or that the inductance coil may be part of the stimulator housing (e.g., column 13, lines 14-27). That is, Andersson teaches that the inductance coil may be above the stimulator housing or may be within the stimulator housing in an implantable cochlear implant and middle ear apparatus. Accordingly, one of ordinary skill in the art would have recognized the benefits of an inductive coil placed above/outside an implantable electronics housing, or, within the implantable electronics housing in view of the teachings of Andersson. Consequently, one of ordinary skill in the art would have modified the apparatus of Leigh so that an outer diameter of the inductance coil is located in its entirety within 5 mm of a portion of the housing (which the inductance coil would be if inside the implantable electronics housing). It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the apparatus as taught by Leigh so that the inductance coil has an outer diameter of less than 17.5 mm and is located/positioned within 5 mm with the stimulation housing when implanted, because Leigh teaches that the diameter of the trans-tympanic inductance coil can be as small as 6 mm as the location of the implanted coil is closer to the in-ear external coil, and thus, Leigh provides a teaching of the advantage of being able to provide smaller inductive coils. Applicant does not appear to provide criticality for the coil being close to the stimulator unit, just that the coil can be smaller than which is traditionally utilized (paragraph [0053], lines 5-6, of the originally-filed specification (OFS)) and that the outer diameter of the coil can be located within its entirety within 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm of a portion of the housing (e.g., paragraph [0072], lines 5-7, of the OFS). One of ordinary skill in the art, furthermore, would have expected Applicant' s invention to perform equally well with the outer diameter of the inductance coil being between 0.0 mm and 10 mm apart as taught by Leigh in view of Andersson, because it provides an inductive coil with a diameter (about 3 times smaller than the claimed amount) and there is no evidence of criticality of the distance (e.g., 0 mm to 5 mm).
Alternatively, with respect to the coil being within 5 mm from a portion of the housing, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus as taught by Leigh in view of Andersson so that an outer diameter of the inductance coil in its entirety is located within 5 mm of a portion of the housing, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
With respect to claim 4, Leigh in view of Andersson teaches the apparatus of claim 1, wherein: the at least a portion of the housing is implanted in a mastoid bone of a human recipient (e.g., paragraph [0008] of Leigh: The cochlear implant comprises a stimulator unit configured to be implanted within a recipient’s mastoid and an implantable tympanic membrane coil electrically connected to the stimulator unit); and the coil is located above the electronics with respect to the direction above a surface of the mastoid bone and the coil extends outboard of outer walls of the housing (e.g., column 12, lines 27-37, of Andersson: inductance coil assembly 558 is placed above the housing 454 as shown in Fig. 16 with respect to the direction above a surface of the mastoid bone 136 where the coil in 558 extends outboard of the outer walls of housing 454). Accordingly, one of ordinary skill in the art would have modified the apparatus of Leigh in view of Andersson so that the coil is located above the electronics with the coil extending outboard of the outer walls of the housing when implanted with the stimulation unit in view of the teachings of Andersson. Consequently, one of ordinary skill in the art would have modified the apparatus of Leigh in view of Andersson so that the coil is located above the electronics and extends past the outer walls of the electronics housing as taught by Andersson, and because the combination would have yielded a predictable result.
As to claim 5, Leigh in view of Andersson teaches the apparatus of claim 1, wherein: the apparatus is capable of being configured for functional implantation in a recipient with the housing implanted in a mastoid of a human skull and the coil implanted in the recipient so that the coil is adjacent an ear canal side wall of the recipient (e.g., Leigh paragraphs [0008]: coil is implanted in a recipient’s middle ear cavity adjacent to the recipient’s tympanic membrane; [0034]: implantable coil 254 is adjacent the tympanic membrane and Figs. 3A, 4A, 5A of Leigh).
With respect to claim 6, Leigh in view of Andersson teaches the apparatus of claim 1, wherein: the apparatus is capable of being configured for functional implantation in a recipient with the at least a portion of the housing implanted in the mastoid of a human skull (Leigh paragraph [0008]), and the coil implanted in the recipient so that the coil is shadowed by a pinna of the recipient when viewed directly from the side of the human skull (e.g., Figs. 3A, 4A, 5A of Leigh when the sun is positioned to cast a shadow of the pinna/auricle onto the tympanic membrane).
As to claim 7, Leigh in view of Andersson teaches the apparatus of claim 1, wherein: the apparatus is in receptive wireless signal communication with a behind-the-ear (BTE) device or an in-the-ear (ITE) device worn behind an ear of a human or in an ear canal of a human, respectively; and the wireless signal communication emanates directly from a respective body of the BTE or ITE device, and in the case of the ITE device, the signal enters the ear canal wall and passes therethrough to reach the apparatus (e.g., Figs. 3A, 4A, 5A, of Leigh: in-the-ear device 258 emanates a wireless signal in the ear canal that passes through the tympanic membrane of the ear canal to reach the apparatus of Leigh in view of Andersson).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Leigh in view of Andersson as applied to claim 1 above, and further in view of US Patent Application Publication No. 2020/015843 to Yeh et al. (hereinafter referred to as “Yeh”).
Leigh in view of Andersson teaches the apparatus of claim 1, but does not expressly state that the apparatus is a miniaturized implantable portion of a cochlear implant. However, Leigh discloses that the apparatus can be a cochlear implant (e.g., paragraph [0008] of Leigh); making the inductive coil substantially smaller (e.g., paragraph [0038] of Leigh) from coils having a diameter of 30 mm (e.g., paragraph [0037] of Leigh) to coils having a diameter of 6 mm (e.g., paragraph [0038] of Leigh). Yeh further teaches that there is an ongoing desire to reduce a displacement of implantable sensor and/or stimulation devices because additional miniaturization can allow for an easier less invasive implant procedure which can reduce a probability of post-implant infection (e.g., paragraph [0137] of Yeh). Thus, Yeh expressly teaches that implantable apparatus should be miniaturized. Consequently, one of ordinary skill in the art would have modified the apparatus of Leigh in view of Andersson so that the apparatus is a miniaturized implantable portion of a cochlear implant in view of the teachings of Yeh that miniaturizing implantable device allows for an easier invasive implant procedure and can reduce a probability of post-implant infection, and because the combination would have yielded a predictable result: a cochlear implant with smaller implantable components.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leigh in view of Andersson as applied to claim 1 above, and further in view of US Patent Application Publication No. 2018/0303602 to Leigh. (hereinafter referred to as “Leigh ‘602”).
Leigh in view of Andersson teaches the apparatus of claim 1, wherein, the at least a portion of the housing has a length, a width and a height, wherein the height is at least half as that of a maximum diameter of the coil, wherein the height is measured in a direction parallel to a longitudinal axis of the coil. Leigh discloses an inductive coil with a 6 mm outer diameter (e.g., paragraph [0038] of Leigh). Thus, the housing of the electronics, as per the claim, would be at least 3 mm, where the height is measured in a direction parallel to a longitudinal axis of the coil. Leigh ‘602, in a related art: implantable prosthesis with an implantable component, teaches that the magnet 160 is completely encased in silicone so that its casing is 3.5, 4, 4.5, 5, 5.5, or 6 mm thick or a height that is parallel to a longitudinal axis of the coil (e.g., paragraph [0109] of Leigh ‘602 discussing Fig. 1C of Leigh ‘602) and that, in another exemplary embodiment, the magnet can be fully inside the housing 122 (e.g., paragraph [0137] of Leigh ‘602: magnet 1160 is located within the boundaries of the housing 122)) and thus, the housing would be at least 3.5, 4, 4.5, 5, 5.5, or 6 mm thick or a height that is parallel to a longitudinal axis of the coil in order to accommodate the magnet. Accordingly, one of ordinary skill in the art would have recognized that the thickness or height that is parallel to a longitudinal axis of the coil of Leigh in view of Andersson can be at least 3.5 mm or greater in view of the teachings of Leigh ‘602 that the magnet has those dimensions and is located within the stimulator housing. Consequently, one of ordinary skill in the art would have modified the apparatus of Leigh in view of Andersson so that stimulator housing can have a thickness of at least 3 mm in the absence of criticality because such sizing was known to those skilled in the cochlear implant art.
Alternatively, with respect to thickness/height of the stimulator housing being at least half as that of the maximum diameter of the coil, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by Leigh in view of Andersson so that thickness/height of the stimulation housing is at least half of the outer diameter of the inductive coil, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for thickness/height of the stimulator housing being at least half as that of the maximum diameter of the coil.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 5,991,664 to Seligman is directed to a compact inductive arrangement for medical implant data and power transfer where the arrangement is a stimulator unit of a cochlear implant and is suited for behind the ear and in-the ear multi-channel cochlear implants (e.g., abstract) and the implantable inductive elements 32 are located in the mastoid cavity so that the distance between the external coils 53 in the ear canal is reduced to increase coupling efficiency and reduce power consumption as shown in Fig. 2 of Seligman (e.g., column 3, lines 44-54 of Seligman).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792