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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 16 March 2025. As directed by the amendment: Claims 3, 4, 34, 37, 48, 49, and 50 have been amended, Claims 5-9, 14, 16-17, and 19-33 have been cancelled, and Claim 54 has been added. Thus, Claims 1-4, 10-13, 15, 18, and 34-54 are presently pending in this application.
Claim Objections
Claim 37 is objected to because of the following informalities: the claim recites “the support structure” in Line 4. It appears that this is a typographical error and is intended to be “the support body”, to match the other instances of this element in the claims. Appropriate correction is required.
Claim 48 is objected to because of the following informalities: the claim recites “the medical device” in Line 2. It appears that this is a typographical error and is intended to be “the implantable medical device”, to match the other instances of this element in the claims. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim terms are interpreted as described below:
Claim 48 recites, “means for attracting” which will be interpreted as the magnet/magnet apparatus as described in the Specification for example in Paragraphs 0034, 0036, 0037, 0073, 0078, 0080, 0090
Claim 48 recites, “means for supporting” which will be interpreted as the support body as described in the Specification for example in Paragraphs 0007, 0008, 0091, 0098, 0101
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 10-13, 15, 18, and 34-53 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.
Regarding Claim 10, the claim recites “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case”. It is indefinite as to whether this is referring to the alignment, the rotation of the magnet apparatus, or both, and the Specification does not provide explanation of the intention of this limitation. Furthermore, it is unclear as to what structure/definition is intended by “relative to that which would otherwise be the case” – since this appears to be relying on the interpretation of otherwise/alternative structures. Therefore, the claim fails to comply with the written description requirement because the Specification does not describe what exactly is defined as “relative to that which would otherwise be the case”, and therefore does not fully disclose or describe the infinite ‘alternative’ possibilities defined by the claim. Claims 11-13, 15, 18, 34-47, and 51-53 are rejected for depending on Claim 10.
Regarding Claim 48, the claim has been amended to recite “the implantable medical device further includes an inductance coil extending about the means for attracting the external component”. However, neither the Specification nor the Drawings explicitly discloses an inductance coil “extending about the means for attracting the external component”. The inductance coil is described in Paragraphs [0021], [0066], [0067], and [0072] of the instant Specification, and is referred to as element COIL 442 in Figs. 4C-4D. However, none of these sections describe or show “an inductance coil extending about the means for attracting the external component”, which appears to be referring to a coil wrapped around a magnet apparatus. Therefore this limitation is considered to be New Matter. Claims 49 and 50 are rejected for depending on Claim 48.
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 1-4, 10-13, 15, 18, and 34-54 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.
Regarding Claim 1, the claim recites, “at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis”. However, it is unclear what is intended by the limitation “[the surface] establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis”. It is unclear how a curved outer periphery can be established ‘with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis’, since it is unclear which plane is being referred to. A plane of the long axis would be normal/perpendicular to the short axis, not parallel. It is unclear where the outer periphery is intended that is curved “with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis”, since the planes appear to contradict one another. For purposes of examination, this limitation will be interpreted as, “at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane which is parallel to the short axis or long axis”. Appropriate correction or clarification is required. Claims 2-4 and 54 are rejected for depending on Claim 1.
Regarding Claim 10, the claim recites “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case”. However, due to the structure of the limitation, it is unclear as to what limitations are “enable[d by] the magnet apparatus” – either the alignment, the rotation, both, or another meaning. Furthermore, in the context of the claim, it is unclear as to what is intended by “relative to that which would otherwise be the case”. It is indefinite as to whether this is referring to the diffusion of force, the rotation of the magnet apparatus, or both, and furthermore, it is unclear as to what structure/definition is intended by “relative to that which would otherwise be the case” – since this appears to be relying on the interpretation of otherwise/alternative structures (of which are infinite). For purposes of examination, this limitation will be interpreted as “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus will substantially align with the external magnetic field
Regarding Claim 13, the claim has been amended to recite “the surface of a skin”. However, Claims 11 and 12 also recite “a patient’s skin” and “the skin”. It is unclear as to whether this limitation is Claim 13 is referring to the same or a different skin. For purposes of examination, the Examiner is interpreting these to be the same surface of the skin, and the interpretation of this limitation of Claim 13 will be “the surface of the skin” to clarify that this is the same surface/skin as recited in Claims 11 and 12 (from which Claim 13 depends).
Regarding Claim 15, the claim recites “the device is configured to enable the magnet apparatus to tumble within the support body”. However, it is unclear as to how “tumble” is distinct or different from “rotate”. The term “tumble” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite distinction/difference from “rotate”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention since this is not a common term in the art. For purposes of examination, this limitation will be interpreted as being equivalent to “rotate”. Appropriate correction or clarification is required.
Regarding Claim 18, the claim recites “a non-circular and non-flat cross section lying on a second plane”. However, it is unclear as to how a cross-section can be “non-flat”, since a ‘cross-section’ is by definition flat/planar. Wolfram Mathworld defines a ‘cross-section’ as: “A cross section of a solid is a plane figure obtained by the intersection of that solid with a plane.” (Weisstein, Eric W. "Cross Section." From MathWorld-- A Wolfram Web Resource. https://mathworld.wolfram.com /CrossSection.html, previously cited). Since a plane is inherently flat, this limitation is indefinite. For purposes of examination, this limitation will be interpreted as intending to mean that at least a portion of the perimeter of the cross section lying on a second plane is non-circular and non-flat (i.e. at least a portion of the perimeter is rounded or does not have a uniform straight shape). Appropriate correction or clarification is required.
Regarding Claim 34, the claim recites, “the support body includes elastic features that hold the magnet apparatus with a long axis so that the magnet apparatus has an orientation where the long axis relatively parallel to a surface of the skin of a recipient of the implantable medical device in the absence of the 3 T magnetic field and returns the long axis to be relatively parallel to the surface of the skin of the recipient upon the elimination of the 3 T magnetic field”. Firstly, this limitation appears to be missing the word “is”. Furthermore, it is unclear as to how the absence/elimination of the 3 T magnetic field can both be “an orientation where the long axis relatively parallel to a surface of the skin of a recipient of the implantable medical device in the absence of the 3 T magnetic field” and “returns the long axis to be relatively parallel to the surface of the skin of the recipient upon the elimination of the 3 T magnetic field”. It appears that these descriptions are missing steps (e.g. the application of the 3 T magnetic field which changes an orientation of the magnet apparatus), since “the elimination of the 3 T magnetic field” lacks antecedent basis. Therefore, these limitations are indefinite. For purposes of examination, the examiner is interpreting these limitations as “the support body includes elastic features that hold the magnet apparatus with a long axis so that the magnet apparatus has an orientation where the long axis is relatively parallel to a surface of the skin of a recipient of the implantable medical device in the absence of the 3 T magnetic field, wherein the magnet apparatus rotates during application of the 3 T magnetic field, and returns the long axis to be relatively parallel to the surface of the skin of the recipient upon the elimination of the 3 T magnetic field”. Appropriate correction or clarification is required.
Regarding Claim 36, the claim recites “the implantable medical device is configured so that a top-dead-center position of the magnet apparatus is avoided”. However, both “top-dead-center position” and “avoided” are relative terms, which renders the claim indefinite. The terms “top-dead-center position” and “avoided” are not defined by the claim (it is unclear as to where a “top-dead-center position” is relative to magnet apparatus, and it is unclear as to the scope of “avoided” – either fully, partially, and/or attempted to be in a different position) , 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.
Regarding Claim 48, the claim has been amended to recite “the implantable medical device further includes an inductance coil extending about the means for attracting the external component”. However, neither the Specification nor the Drawings explicitly discloses an inductance coil “extending about the means for attracting the external component”. The inductance coil is described in Paragraphs [0021], [0066], [0067], and [0072] of the instant Specification, and is referred to as element COIL 442 in Figs. 4C-4D. However, none of these sections describe or show “an inductance coil extending about the means for attracting the external component”, which appears to be referring to a coil wrapped around a magnet apparatus, however the limitation is unclear as to the intended structure. Therefore, this limitation is indefinite. For purposes of examination, the Examiner is interpreting this limitation as “the implantable medical device further includes an inductance coil located proximal to the means for attracting the external component”. Appropriate correction or clarification is required. Claims 49 and 50 are rejected for depending on Claim 48.
Regarding Claims 48-50, the claims recite, “a means for supporting the means for attracting the external component and enabling the means for attracting the external component to rotate in at least two different axes”. However, it is unclear as to which element is “enabling the means for attracting”, and what that ‘enabling’ is intended to entail. Therefore these limitations are indefinite. For purposes of examination, the Examiner is interpreting these limitations as “a means for supporting the means for attracting the external component, and wherein the means for supporting the means for attracting the external component structurally enables the means for attracting the external component to rotate in at least two different axes.” Appropriate correction or clarification is required.
Regarding Claim 53, the claim recites, “wherein the housing is clad to the permanent magnet”. However, it is unclear what is intended by the limitation “clad to" in this context, since the plain meaning of “clad” is “clothed” or “covered”, which is inconsistent with the context of the claim/invention. It is unclear as to whether this was intended to mean “attached” or a specific type of attachment, therefore this limitation is indefinite. For purposes of examination, the examiner is interpreting these limitations as “wherein the housing is attached to and surrounds the permanent magnet”. Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 102
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 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 1-4, 10-13, 15, 17, 34, 35, 36, 38-40, 43-45, and 53-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimmerling et al. (US Publication No. 2011/0264172, previously cited).
Regarding Claim 1, Zimmerling et al. discloses an implantable medical device (Abstract; Paragraph 0003), comprising:
a magnet apparatus (401, Fig. 4; 402, Figs. 8-12, 15, 16; 1501, Fig. 15; 1601, Fig. 16; Paragraph 0009, 0036, 0040; Claims 3-8); and
a support body supporting the magnet apparatus (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8),
wherein the magnet apparatus has a long axis and a short axis shorter than the long axis normal to the long axis (multiple axis directions for different orientations, including a long axis longer than the short axis, Figs. 8-16, Paragraph 0027, 0030, 0031, 0043), and
at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis (see curved outer periphery of disc, cylindrical, and/or oval shaped magnets; 401, Fig. 4; 402, Figs. 8-12, 15, 16; 1501, Fig. 15; 1601, Fig. 16; it is noted that ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet; Paragraph 0009, 0036, 0040; Claims 3-8).
Regarding Claim 2, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus is magnetized in a direction of a short axis of the magnet apparatus (magnetized in direction of short axis, m ->, see Figs, 1-2, 4, 8, 11, 12, 13, Paragraph 0028, 0031, 0034).
Regarding Claims 3, 4, and 54, Zimmerling et al. discloses an implantable medical device further wherein with respect to a first axis parallel to a base of the support body (housing/structure, any section of which could be considered a “base”, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8), the implantable medical device is configured such that the magnet apparatus can rotate about the first axis parallel to the base (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1; at least one axis is parallel to a housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8), wherein the implantable medical device is configured such that the magnet apparatus can rotate about a second axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1) normal to a first axis (multiple perpendicular axis directions, Figs. 8-16) and parallel to the base (housing/structure, any section of which could be considered a “base” with a parallel axis, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8), wherein the curved outer periphery (see curved outer periphery of disc, cylindrical, and/or oval shaped magnets; 401, Fig. 4; 402, Figs. 8-12, 15, 16; 1001, Fig. 10; 1501, Fig. 15; 1601, Fig. 16) is convex relative to a center of the magnet apparatus (disc, cylindrical, and/or oval shaped magnets have convex curved outer periphery, e.g. see 401, Fig. 4; 402, Figs. 8-12, 15, 16; 1001, Fig. 10; 1501, Fig. 15; 1601, Fig. 16).
Regarding Claims 10, 15, and 38, Zimmerling et al. discloses an implantable medical device (Abstract; Paragraph 0003), comprising:
a non-spherical magnet apparatus (non-spherical shapes, Paragraph 0009, 0036, 0040; Claims 3-8);
a support body supporting the magnet apparatus (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8),
wherein the device is configured to enable the magnet apparatus to rotate relative to the support body (rotate partially or fully within the housing, Paragraph 0029-0031, 0034) and to tumble within the support body (rotate partially or fully within the housing, Paragraph 0029-0031, 0034) when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case (magnet substantially aligns with MRI/magnetic field when exposed; Paragraph 0007-0009, 0029-0034, 0040-0044),
and at least one of: the magnet apparatus is a modified sphere shape (non-spherical shapes, Paragraph 0009, 0036, 0040; Claims 3-8); or the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1).
Regarding Claim 11, Zimmerling et al. discloses an implantable medical device further wherein the medical device is configured such that in a relaxed position (outside of a magnetic field/MRI; Paragraph 0030-0031, 0034), a long axis of the magnet apparatus is relatively parallel to a surface of the skin immediately above the magnet apparatus (magnet parallel, Paragraph 0007-0009, 0027, 0029-0034, 0040-0044) when the device is implanted between bone and the surface of the skin (Paragraph 0005, 0008, 0032, 0042, Claims 9, 13). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 12, Zimmerling et al. discloses an implantable medical device further wherein the medical device is configured such that a 3 T magnetic field (magnetic field may be less than, equal to, or more than 3 Tesla, Paragraph 0031, 0041) aligned parallel to the surface of skin (inside a magnetic field/MRI, Paragraph 0030-0031, 0034) immediately above the magnet apparatus moves the long axis of the magnet apparatus relatively perpendicular (magnet moves/rotates along multiple planes, Paragraph 0007-0009, 0027, 0029-0034, 0040-0044) to the surface of the skin when the device is implanted between bone and the surface of the skin (Paragraph 0005, 0008, 0032, 0042, Claims 9, 13). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 13, Zimmerling et al. discloses an implantable medical device further wherein the medical device is configured such that upon the elimination of the 3 T magnetic field (outside of a magnetic field/MRI; Paragraph 0030-0031, 0034; magnetic field may be less than, equal to, or more than 3 Tesla, Paragraph 0031, 0041) the magnet apparatus moves the long axis of the magnet apparatus back towards the relatively parallel to the surface of the skin orientation (magnet parallel, Paragraph 0007-0009, 0027, 0029-0034, 0040-0044) when the device is implanted between bone and the surface of the skin (Paragraph 0005, 0008, 0032, 0042, Claims 9, 13). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 17, Zimmerling et al. discloses an implantable medical device further wherein a plate (401, 402, 405, 801, 802, Figs. 4, 8; Paragraph 0029, 0032) is located inside the support body between the magnet apparatus and the surface of the skin, which plate (401, 402, 405, 801, 802, Figs. 4, 8; Paragraph 0029, 0032) diffuses force throughout the body (distribution of force, Paragraph 0031-0032, 0034, 0043) upon rotation of the magnet apparatus (rotate partially or fully within the housing, Paragraph 0029-0034) relative to that which would otherwise be the case.
Regarding Claim 34, Zimmerling et al. discloses an implantable medical device further wherein the body includes elastic features (coating, 802, Fig. 8, Paragraph 0032; limited rotation angles due to encapsulation components, Paragraph 0034) that hold the magnet apparatus with a long axis so that the magnet apparatus has an orientation where the long axis is relatively parallel to the surface of the skin (magnet parallel, Paragraph 0007-0009, 0027, 0029-0034, 0040-0044) in the absence of the 3 T magnetic field (outside of magnetic field, which may be less than, equal to, or more than 3 Tesla, Paragraph 0031, 0041) and returns the long axis to be relatively parallel to the surface of the skin of the recipient upon the elimination of the 3 T magnetic field (magnet parallel, Paragraph 0007-0009, 0027, 0029-0034, 0040-0044). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 35, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus is magnetized in a direction of a short axis of the magnet apparatus (magnetized in direction of short axis, m ->, see Figs, 1-2, 4, 8, 11, 12, 13, Paragraph 0028, 0031, 0034).
Regarding Claim 36, Zimmerling et al. discloses an implantable medical device further wherein the implantable medical device is configured so that a top-dead-center position of the magnet apparatus is avoided (rotatable in multiple axis/angles, depending on particular shape, some of which ‘avoid’ particular orientations which may be interpreted as “top-dead-center”, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1. See 35 USC 112(b) rejection above.).
Regarding Claim 39, Zimmerling et al. discloses an implantable medical device further wherein the support body (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) is an elastomeric material (coating, 802, Fig. 8, Paragraph 0032; limited rotation angles due to encapsulation components, Paragraph 0034), and the support body (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) is in direct contact with a majority of a surface area of the magnet apparatus (housing/coating/structures are in direct contact with magnet in use, Paragraph 0009, 0036, 0040; Claims 3-8).
Regarding Claim 40, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1), the more than one axis including a first axis and a second axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1); and the first axis is parallel to a base of the support body (at least one axis is parallel to a housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8).
Regarding Claim 43, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations), the more than one axis including a first axis and a second axis; and the second axis is normal to the first axis (multiple perpendicular axis directions, Figs. 8-16), which first axis is parallel to a base of the support body (housing/structure, any section of which could be considered a “base” with a parallel axis, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8).
Regarding Claim 44, Zimmerling et al. discloses an implantable medical device further wherein the implantable medical device is configured to effectively prevent rotation about the second axis (housing structure to prevent rotation about a particular axis, Paragraph 0033-0034, 0040), wherein the second axis is normal to a base of the implantable medical device (cochlear implant device, any section of which may be considered a “base”, Paragraph 0003, 0005, 0029; 400, Fig. 4) and normal to the first axis (multiple perpendicular axis directions, Figs. 8-16).
Regarding Claim 45, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations), the more than one axis including a first axis and a second axis and a third axis (multiple axis directions for different orientations, Figs. 8-16); and the second axis is normal to the first axis, which first axis is parallel to a base of the support body (housing/structure, any section of which could be considered a “base” with a parallel axis, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8), and which second axis is parallel to the base of the support body (housing/structure, any section of which could be considered a “base” with a parallel axis, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8); and the third axis is normal to the second axis and normal to the first axis (rotatable in multiple axis/angles, including perpendicular axis directions, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations).
Regarding Claim 53, Zimmerling et al. discloses an implantable medical device further wherein the non-spherical magnet apparatus (non-spherical shapes, Paragraph 0009, 0036, 0040; Claims 3-8) includes a housing (housing/coating/structures is attached to and surrounds the permanent magnet, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) and a permanent magnet (Paragraph 0009, 0036, 0040; Claims 3-8), wherein the housing is clad to the permanent magnet (housing/coating/structures is attached to and surrounds the permanent magnet, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8).
Claims 1-4, 10-13, 15, 35, 38, 48-50, and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leigh et al. (US Publication No. 2016/0361537, previously cited).
Regarding Claim 1, Leigh et al. discloses an implantable medical device (Abstract), comprising: a magnet apparatus (160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151); and a support body (housing/support structure, Paragraph 0009, 0062-0064, 0070) supporting the magnet apparatus, wherein the magnet apparatus has a long axis and a short axis shorter than the long axis normal to the long axis (see short and long axis of magnet 160, Figs. 6-10, 14-19), and at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis (curved outer periphery of magnet 160, see Figs. 6-10, 14-19; disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151; it is noted that ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet)
Regarding Claims 3, 4, and 54, Leigh et al. discloses an implantable medical device further wherein with respect to a first axis parallel to a base of the support body (housing/support structure, Paragraph 0009, 0062-0064, 0070, any part which may be considered a ‘base’), the device is configured such that the magnet apparatus can rotate about the first axis parallel to the base (rotatable magnet within support body; Abstract; Paragraph 0064, 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152), and wherein the device is configured such that the magnet apparatus can rotate about a second axis normal to a first axis and parallel to the base (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152; see multiple normal/perpendicular axes in Figs. 9, 10, 15, 16, 17), wherein the curved outer periphery (curved outer periphery of magnet 160, see Figs. 6-10, 14-19; disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151) is convex relative to a center of the magnet apparatus (curved outer periphery of magnet 160, see Figs. 6-10, 14-19; disks and cylinders have convex shapes; Paragraph 0102, 0104, 0147, 0150-0151).
Regarding Claims 10, 15, and 38, Leigh et al. discloses an implantable medical device (Abstract), comprising:
a non-spherical magnet apparatus (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151);
a support body supporting the magnet apparatus (housing/support structure, Paragraph 0009, 0062-0064, 0070),
wherein the device is configured to enable the magnet apparatus to rotate relative to the support body (rotatable magnet; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152) and to tumble within the support body (rotatable magnet within support body; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152) when exposed to an external magnetic field (MRI/magnetic field; Paragraph 0106, 0107, 0111) such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case (Paragraph 0061, 0100-0101; 0135; 0186),
and at least one of: the magnet apparatus is a modified sphere shape (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151); or the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152).
Regarding Claims 2 and 35, Leigh et al. discloses an implantable medical device wherein the magnet apparatus is magnetized in a direction of the short axis of the magnet apparatus (see N/S magnetization direction in direction of short axis, Fig. 6, Paragraph 0100-0101).
Regarding Claim 11, Leigh et al. discloses an implantable medical device further wherein the medical device is configured such that in a relaxed position (outside of a magnetic field/MRI; Paragraph 0061, 0100-0101, 0106-0107, 0111, 0135, 0182, 0186), a long axis of the magnet apparatus is relatively parallel to a surface of the skin immediately above the magnet apparatus (Abstract; Paragraph 0104, 0111, 0113, 0119, 0122, 0128, 0130, 0135, 0147, 0152) when the device is implanted between bone and the surface of the skin (Paragraph 0009, 0068, 0106). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 12, Leigh et al. discloses an implantable medical device further wherein the medical device is configured such that a 3 T magnetic field (Paragraph 0112, 0182) aligned parallel to the surface of skin immediately above the magnet apparatus moves the long axis of the magnet apparatus relatively perpendicular to the surface of the skin when the device is implanted between bone and the surface of the skin (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 13, Leigh et al. discloses an implantable medical device further wherein the medical device is configured such that upon the elimination of the 3 T magnetic field (outside of a magnetic field/MRI; Paragraph 0061, 0100-0101, 0106-0107, 0111, 0135, 0182, 0186) the magnet apparatus moves the long axis of the magnet apparatus back towards the relatively parallel to the surface of the skin orientation when the device is implanted between bone and the surface of the skin (Abstract; Paragraph 0104, 0111, 0113, 0119, 0122, 0128, 0130, 0135, 0147, 0152). It is noted by the Examiner that these limitations merely recite functional language which the medical device is configured to perform. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 48, Leigh et al. discloses an implantable medical device (Abstract) comprising: a means for attracting (magnet, 160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151) an external component of the implantable medical device; and a means for supporting (housing/support structure, Paragraph 0009, 0062-0064, 0070; including plates e.g. 170 & 172, Figs. 7-10, 14-17; Paragraph 0105, 0110-0113, 0119, 0122, 0147, 0161) the means for attracting the external component and enabling the means for attracting the external component to rotate in at least two different axes (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152), the at least two different axes being normal to each other (see multiple normal/perpendicular axes of magnet 160 rotation in Figs. 9, 10, 15, 16, 17), wherein the implantable medical device further includes an inductance coil extending about the means for attracting the external component (as interpreted by the Examiner, an inductance coil located proximal to the means for attracting the external component, see 35 USC112(b) rejection above, Leigh et al. inductance coil 442, Figs. 4C-4D, Paragraph 0093, 0094, 0099, 0150).
Regarding Claim 49, Leigh et al. discloses an implantable medical device further wherein the means for supporting the means for attracting the external component (housing/support structure, Paragraph 0009, 0062-0064, 0070; including plates e.g. 170 & 172, Figs. 7-10, 14-17; Paragraph 0105, 0110-0113, 0119, 0122, 0147, 0161) and enabling the means for attracting the external component (magnet, 160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151) to rotate in at least two different axes is a means for supporting the means for attracting the external component and enabling the means for attracting the external component to rotate in three different axes (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152), each of the three different axes being respectively normal to each of the other three different axes (see multiple normal/perpendicular axes of magnet 160 rotation in Figs. 9, 10, 15, 16, 17).
Regarding Claim 50, Leigh et al. discloses an implantable medical device further wherein the means for supporting the means for attracting the external component (housing/support structure, Paragraph 0009, 0062-0064, 0070; including plates e.g. 170 & 172, Figs. 7-10, 14-17; Paragraph 0105, 0110-0113, 0119, 0122, 0147, 0161) and enabling the means for attracting the external component (magnet, 160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151) to rotate in at least two different axes is a means for supporting the means for attracting the external component and enabling the means for attracting the external component to rotate in only the two different axes (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152), the only two different axes being normal to each other (see multiple normal/perpendicular axes of magnet 160 rotation in Figs. 9, 10, 15, 16, 17), wherein both of the only two different axes lie in a plane parallel to a base of the implantable medical device (implantable device 100, Fig. 1; 200A, Fig. 2; Paragraph 0049, 0053, 0071-0072; any part which may be considered a ‘base’).
Claim Rejections - 35 USC § 102/103
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 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimmerling et al. and/or Leigh et al., or in the alternative, under 35 U.S.C. 103 as being unpatentable over Zimmerling et al. and/or Leigh et al. (US Publication No. 2016/0361537, previously cited)
Regarding Claim 18, as described above in the 35 USC 112(b) rejection section, it is unclear as to what is intended by the limitation “non-flat cross section” of the magnet apparatus, since a ‘cross-section’ is by definition flat/planar. Wolfram Mathworld defines a ‘cross-section’ as: “A cross section of a solid is a plane figure obtained by the intersection of that solid with a plane.” (Weisstein, Eric W. "Cross Section." From MathWorld-- A Wolfram Web Resource. https://mathworld.wolfram .com/CrossSection.html). As best interpreted by the Examiner, this is intended to mean that at least a portion of the perimeter is rounded or does not have a uniform straight shape.
Zimmerling et al. discloses wherein the magnet apparatus has a circular cross-section lying on a first plane normal to a north-south magnetization direction of the magnet apparatus (potential shapes include disc and/or cylindrical shapes, Paragraph 0009, 0036, 0040; Claims 3-8) and a rectangular or other-shaped cross sections lying on a second plane normal to the first plane (planar disc shape, rectangular beam shape, cylindrical beam shape, cut away disc shape, Paragraph 0009, 0036, 0040; Claims 3-8). As best interpreted by the Examiner, these shapes disclosed by Zimmerling et al. would read on “the magnet apparatus has a circular cross-section lying on a first plane normal to a north- south magnetization direction of the magnet apparatus and a non-circular and non-flat cross section lying on a second plane normal to the first plane”.
Alternatively, Leigh et al. discloses the magnet apparatus has a circular cross-section lying on a first plane normal to a north- south magnetization direction of the magnet apparatus (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0150-0151) and a non-circular/non-uniform cross section lying on a second plane normal to the first plane (see disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151). As best interpreted by the Examiner, these shapes disclosed by Leigh et al. would read on “the magnet apparatus has a circular cross-section lying on a first plane normal to a north- south magnetization direction of the magnet apparatus and a non-circular and non-flat cross section lying on a second plane normal to the first plane”.
However, in the event of any alternative intention/interpretation of the particular shape of the magnet apparatus, it would have been an obvious matter of design choice before the effective filing date of the claimed invention to configure the magnet disclosed by either Zimmerling et al. or Leigh et al. apparatus to be any particular shape, for the purpose of allowing for rotation and/or to adjust to a particular housing or size, since such a modification would have involved a mere change in the form or shape of a component (i.e. the magnet apparatus). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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.
Claims 42, 46, 51, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmerling et al. (US Publication No. 2011/0264172, previously cited).
Regarding Claims 42 and 46, Zimmerling et al. discloses an implantable medical device further wherein the implantable medical device is a receiver stimulator of a cochlear implant (Paragraph 0003, 0005, 0029; 400, Fig. 4).
Zimmerling et al. discloses where the magnet apparatus is smaller than the receiver stimulator of a cochlear implant (see receiver 400 and magnet 401, Fig. 4), and therefore the diameter of the magnet apparatus would be in the order of magnitude of millimeters. However, Zimmerling et al. does not explicitly disclose wherein the magnet apparatus has a maximum diameter of no more than 8 mm and the magnet apparatus has a minimum diameter of no less than 3 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the magnet apparatus have a maximum diameter of no more than 8 mm and to have a minimum diameter of no less than 3 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claims 51 and 52, Zimmerling et al. discloses an implantable medical device further wherein the magnet apparatus has a circular cross-section lying on a first plane normal to a north-south magnetization direction of the magnet apparatus (potential shapes include disc and/or cylindrical shapes, Paragraph 0009, 0036, 0040; Claims 3-8) and a rectangular or other-shaped cross sections lying on a second plane normal to the first plane (planar disc shape, rectangular beam shape, cylindrical beam shape, cut away disc shape, Paragraph 0009, 0036, 0040; Claims 3-8). As additionally can be seen in Figs. 8-16, multiple possibly magnet shapes/configurations are shown by Zimmerling et al.
Zimmerman et al. does not explicitly disclose wherein the non-spherical magnet apparatus includes a permanent magnet that has an elliptical cross-section lying on a first plane and a circular cross section lying on a second plane normal to the first plane, wherein the permanent magnet has an elliptical cross-section lying on a third plane that is normal to the first plane and normal to the second plane. However, it would have been an obvious matter of design choice to configure the magnet disclosed by either Zimmerling et al. apparatus to be any particular shape, for the purpose of allowing for rotation and/or to adjust to a particular housing or size, since such a modification would have involved a mere change in the form or shape of a component (i.e. the magnet apparatus). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). In particular, the Applicant has noted no criticality in the explicit shape of the magnet/magnet apparatus with respect to the rotation of the magnet/magnetic structure and functionality of the implantable medical device.
Claims 42, 46, 51, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Leigh et al. (US Publication No. 2016/0361537, previously cited).
Regarding Claims 42 and 46, Leigh et al. discloses an implantable medical device further wherein the implantable medical device is a receiver stimulator of a cochlear implant (100, Fig. 1A-1B; Paragraph 0049, 0051, 0053).
Leigh et al. discloses where the magnet apparatus is smaller than the receiver stimulator of a cochlear implant (e.g., magnet 160 [Figs. 7-10, 15, 16, 17] is smaller than and located within receiver stimulator of a cochlear implant; Paragraph 0100, 0103, 0106, 0108, 0135), and therefore the diameter of the magnet apparatus would be in the order of magnitude of millimeters. However, Leigh et al. does not explicitly disclose wherein the magnet apparatus has a maximum diameter of no more than 8 mm and the magnet apparatus has a minimum diameter of no less than 3 mm. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the magnet apparatus have a maximum diameter of no more than 8 mm and to have a minimum diameter of no less than 3 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claims 51 and 52, Leigh et al. discloses an implantable medical device further wherein the magnet apparatus has a circular cross-section lying on a first plane normal to a north- south magnetization direction of the magnet apparatus (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0150-0151) and a non-circular/non-uniform cross section lying on a second plane normal to the first plane (see disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151).
However, Leigh et al. does not explicitly disclose wherein the non-spherical magnet apparatus includes a permanent magnet that has an elliptical cross-section lying on a first plane and a circular cross section lying on a second plane normal to the first plane, wherein the permanent magnet has an elliptical cross-section lying on a third plane that is normal to the first plane and normal to the second plane. However, it would have been an obvious matter of design choice to configure the magnet disclosed by Leigh et al. apparatus to be any particular shape, for the purpose of allowing for rotation and/or to adjust to a particular housing or size, since such a modification would have involved a mere change in the form or shape of a component (i.e. the magnet apparatus). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). In particular, the Applicant has noted no criticality in the explicit shape of the magnet/magnet apparatus with respect to the rotation of the magnet/magnetic structure and functionality of the implantable medical device.
Claims 37, 41, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmerling et al. (US Publication No. 2011/0264172, previously cited) in view of Smith et al. (US Publication No. 2018/0133486, previously cited).
Regarding Claim 37, Zimmerling et al. discloses wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (Zimmerling et al.: rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1). However, Zimmerling et al. does not disclose wherein the implantable medical device is configured so that the support body deforms to enable the magnet apparatus to rotate about a first axis of the more than one axis and so that the support body deforms to rotate about a second axis of the more than one axis; and the first axis is normal to the second axis.
Smith et al. teaches an implantable medical device comprising a non-spherical magnet apparatus (partial disk/frustoconical shape magnets, and/or parallelogram/trapezoid shapes, Paragraph 0041, 0047), wherein the implantable medical device is configured so that the support structure is an elastomeric body (flexible housing, Abstract; silicone elastomer, Paragraph 0040) and includes a monolithic portion made of elastomeric material (102, Figs. 5-9; silicone elastomer housing, Paragraph 0040, 0042) that at least partially envelops the magnet apparatus (magnets embedded in silicone elastomer housing, Paragraph 0040, 0042, 0045; 102, Figs. 5-9), which elastically deforms (distorts/deforms flexible housing, Paragraph 0007, 0045) to enable the magnet apparatus to rotate about a first axis of the more than one axis (rotates with respect to multiple axis directions, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6) and so that the support structure deforms to rotate about a second axis of the more than one axis (deformation/distortion to allow for rotation with respect to multiple axis directions, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6); and the first axis is normal to the second axis (multiple axis directions, some of which are normal/perpendicular to one another, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6; see magnet 126/226/424 in Figs. 10-23).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the support structure to deform in order to enable the magnet apparatus to rotate about a first axis of the more than one axis and so that the support structure deforms to rotate about a second axis of the more than one axis; and the first axis is normal to the second axis, as taught by Smith et al., in the implantable medical device disclosed by Zimmerling et al. as described above, since this configuration would significantly reduce the associated stress on the dermis and pain to the patient during an MRI procedures, and eliminate the need for surgical removal/replacement of the cochlear implant for an MRI procedure, as also taught by Smith et al. (Paragraph 0012, 0045).
Regarding Claim 41, Zimmerling et al. discloses wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (Zimmerling et al.: rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1). However, Zimmerling et al. does not disclose wherein the support body includes a monolithic portion made of elastomeric material that at least partially envelops the magnet apparatus and elastically deforms to enable the magnet apparatus to rotate in a plane normal to a base of the implantable medical device at least 70 degrees from a relaxed orientation when subjected to a magnetic field of at least 1 T.
Smith et al. teaches an implantable medical device comprising a non-spherical magnet apparatus (partial disk/frustoconical shape magnets, and/or parallelogram/trapezoid shapes, Paragraph 0041, 0047), wherein the implantable medical device is configured so that the support body is an elastomeric body (flexible housing, Abstract; silicone elastomer, Paragraph 0040) and includes a monolithic portion made of elastomeric material (102, Figs. 5-9; silicone elastomer housing, Paragraph 0040, 0042) that at least partially envelops the magnet apparatus (magnets embedded in silicone elastomer housing, Paragraph 0040, 0042, 0045; 102, Figs. 5-9), and elastically deforms (deformation/distortion to allow for rotation with respect to multiple axis directions, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6) to enable the magnet apparatus to rotate in a plane normal to a base of the implantable medical device at least 70 degrees from a relaxed orientation (at least 75 degrees, or 135 degrees, Paragraph 0046, 0049) when subjected to a magnetic field of at least 1 T (distorts in MRI magnetic field of at least 1.5 T, Paragraph 0007, 0046, 0047, 0049, 0052; Claim 6, 16).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the support body to include a monolithic portion made of elastomeric material that at least partially envelops the magnet apparatus and elastically deforms to enable the magnet apparatus to rotate in a plane normal to a base of the implantable medical device at least 70 degrees from a relaxed orientation when subjected to a magnetic field of at least 1 T, as taught by Smith et al., in the implantable medical device disclosed by Zimmerling et al. as described above, since this configuration would significantly reduce the associated stress on the dermis and pain to the patient during an MRI procedures, and eliminate the need for surgical removal/replacement of the cochlear implant for an MRI procedure, as also taught by Smith et al. (Paragraph 0012, 0045).
Regarding Claim 47, Zimmerling et al. discloses wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (Zimmerling et al.: rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1). However, Zimmerling et al. does not disclose wherein the support body is an elastomeric body; and the magnet apparatus is in direct contact with the elastomeric body when the magnet apparatus rotates about the first axis; the magnet apparatus is in direct contact with the elastomeric body when the magnet apparatus rotates about the second axis; and the magnet apparatus is in direct contact with the elastomeric body when the magnet apparatus rotates about the third axis.
Smith et al. teaches an implantable medical device comprising a non-spherical magnet apparatus (partial disk/frustoconical shape magnets, and/or parallelogram/trapezoid shapes, Paragraph 0041, 0047), wherein the implantable medical device is configured so that the support body is an elastomeric body (flexible housing, Abstract; silicone elastomer, Paragraph 0040) and includes a monolithic portion made of elastomeric material (102, Figs. 5-9; silicone elastomer housing, Paragraph 0040, 0042) that at least partially envelops the magnet apparatus (magnets embedded in silicone elastomer housing, Paragraph 0040, 0042, 0045; 102, Figs. 5-9), and elastically deforms (deformation/distortion to allow for rotation with respect to multiple axis directions, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6), and the magnet apparatus (magnets embedded in silicone elastomer housing, Paragraph 0040, 0042, 0045; 102, Figs. 5-9) is in direct contact with the elastomeric body when the magnet apparatus rotates about the first, second, and third axis (deformation/distortion to allow for rotation with respect to multiple axis directions, Paragraph 0007, 0042, 0044-0045, 0048-0049, 0052; Claim 1, 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the support body as an elastomeric body; and the magnet apparatus to be in direct contact with the elastomeric body when the magnet apparatus rotates about the first axis; the magnet apparatus is in direct contact with the elastomeric body when the magnet apparatus rotates about the second axis; and the magnet apparatus is in direct contact with the elastomeric body when the magnet apparatus rotates about the third axis, as taught by Smith et al., in the implantable medical device disclosed by Zimmerling et al. as described above, since this configuration would significantly reduce the associated stress on the dermis and pain to the patient during an MRI procedures, and eliminate the need for surgical removal/replacement of the cochlear implant for an MRI procedure, as also taught by Smith et al. (Paragraph 0012, 0045).
Claims 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmerling et al. (US Publication No. 2011/0264172, previously cited) in view of Leigh et al. (US Publication No. 2016/0361537, previously cited).
Regarding Claim 48, Zimmerling et al. discloses an implantable medical device (Abstract; Paragraph 0003) comprising a means for attracting (magnet, 401, Fig. 4; 402, Figs. 8-12, 15, 16; 1501, Fig. 15; 1601, Fig. 16; Paragraph 0009, 0036, 0040; Claims 3-8) an external component of the implantable medical device (magnet substantially aligns with MRI/magnetic field when exposed; Paragraph 0007-0009, 0029-0034, 0040-0044; magnet attracts other magnets of devices, Paragraph 0027, 0032, 0034, 0037-0042; Claims 1-7); and a means for supporting the means for attracting the external component (support housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) and enabling the means for attracting the external component to rotate in at least two different axes (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 0040; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations), the at least two different axes being normal to each other (multiple perpendicular axis directions, Figs. 8-16). Zimmerling et al. further discloses coils extending about the means for attracting the external component (see coil e.g. 402, proximate magnets e.g. 401, Figs. 4, 8-11; Paragraph 0028-0029, 0031, 0032, 0035; Claims 1, 9, 13). However, Zimmerling et al. does not explicitly disclose wherein the implantable medical device further includes an inductance coil extending about the means for attracting the external component.
Leigh et al. teaches an implantable medical device (Abstract) comprising: a means for attracting (magnet, 160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151) an external component of the implantable medical device; and a means for supporting (housing/support structure, Paragraph 0009, 0062-0064, 0070; including plates e.g. 170 & 172, Figs. 7-10, 14-17; Paragraph 0105, 0110-0113, 0119, 0122, 0147, 0161) the means for attracting the external component and enabling the means for attracting the external component to rotate in at least two different axes (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152), the at least two different axes being normal to each other (see multiple normal/perpendicular axes of magnet 160 rotation in Figs. 9, 10, 15, 16, 17), wherein the implantable medical device further includes an inductance coil extending about the means for attracting the external component (as interpreted by the Examiner, an inductance coil located proximal to the means for attracting the external component, see 35 USC112(b) rejection above, Leigh et al. inductance coil 442, Figs. 4C-4D, Paragraph 0093, 0094, 0099, 0150).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include specifically an inductance coil extending about the means for attracting the external component, as taught by Leigh et al., in the implantable medical device disclosed by Zimmerling et al., in order to allow for inductively transmitted data and power from other components, as also taught by Leigh et al. (Paragraph 0093, 0094, 0099, 0150).
Regarding Claim 49, Zimmerling et al. discloses an implantable medical device further, wherein the means for supporting the magnets apparatus (support housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) and enabling the means for attracting the external component to rotate in at least two different axes (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 0040; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations) is a means for supporting the magnets apparatus and enabling the means for attracting the external component to rotate in three different axes (multiple axis directions for different orientations, Figs. 8-16), each of the three different axes being respectively normal to each of the other three different axes (rotatable in multiple axis/angles, including perpendicular axis directions, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations).
Regarding Claim 50, Zimmerling et al. discloses an implantable medical device, wherein the means for supporting the magnets apparatus (support housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) and enabling the means for attracting the external component to rotate in at least two different axes (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 0040; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations) is a means for supporting the magnets apparatus (support housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8) and enabling the means for attracting the external component to rotate in only the two different axes (rotatable in multiple axis/angles depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations), the only two different axes being normal to each other (rotatable in multiple axis/angles, including perpendicular/normal axis directions, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1, 3-8, see magnet shapes of Figs. 8-16 with different rotations), wherein both of the only two different axes lie in a plane parallel to a base of the implantable medical device (Abstract; Paragraph 0003; implant 400, Fig. 4; any part of which may be considered a ‘base’).
Response to Arguments
It is noted that throughout the arguments presented in the Remarks/Amendment filed 16 April 2025, the Applicant has requested yes or no answers or blanket statements as to what is taught in the prior art references (e.g. Pages 9, 10, 23, 25), how examination has been or is carried out by TC 3700 (e.g. Pages 9, 10, 15, 17-20, 21, 23-25), or how the Office would examine claims if rewritten pursuant to the Applicant’s understanding of how the Examiner is construing them (e.g. Pages 24-28). Responses to such generalized statements will not be made since the examination of each patent application and each claim within an application turns on its own facts and any arguments with regards to rewritten claims construction will not be addressed as the rewritten claims are not part of the pending application. Additionally, the Applicant has presented numerous broad analogies, remarks or arguments in amendments or other papers submitted for entry into the application which have been reviewed and considered, furthermore, it is believed that all of the Applicant’s remarks and arguments that pertain to the current application and prior art as interpreted in accordance with the current claims are addressed in the remarks below.
For each ground of rejection, the Applicant argues the Examiner fails to make a prima facie case, the Examiner respectfully disagrees. The Applicant imposes a heightened requirement for a prima facie case. “The prima facie case is merely a procedural device that enables an appropriate shift of the burden of production.” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (citations omitted) (quoting Hyatt v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007)). A prima facie case is established when a rejection satisfies 35 U.S.C. § 132, in notifying the application by stating reasons for its rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of the application. Section 132 does not require an Examiner to make a formal claim construction of every term in a rejected claim to make out a prima facie case or to explicitly preempt every possible response to a rejection; rather, all that is required of the Office is to set forth the statutory basis of the rejection in a sufficiently articulate and informative manner. Section 132 is violated when a rejection is so uninformative that it prevents the Applicant from recognizing and seeking to counter the grounds for rejection. Even if the Examiner failed to make a prima facie case, the Applicant is required to identify alleged error in the rejection. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011); 37 C.F.R. § 41.37(c)((iv). As outlined in the rejection of the claims under 35 USC 112, 102(a)(1) and 103 the Examiner clearly conveys the reasons for the rejection.
Accordingly, each of the Examiner’s rejections made above satisfies the notice requirement of § 132 and sets forth a prima facie case, thereby shifting the burden of production to the Applicant to show otherwise.
I - 35 USC 112(a)/pre-AIA first paragraph
The Applicant argues (Pages 9-15 of Remarks/Amendment filed 16 April 2025) that the limitation of Claim 10, which recites “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case” is sufficiently clear and cites Paragraph 00107 and Figs. 9, 11, 13, 18, and 25. However, the Examiner disagrees with these arguments.
The issue of the limitation “aligns more with the external magnetic field relative to that which would otherwise be the case” is not that it is New Matter, since as the Applicant points out, rotation of the magnet relative to the support body when exposed to an external magnetic field is described by the Specification and Drawings as originally filed. HOWEVER, this limitation is not definite in as to whether “that which would otherwise be the case” is referring to the alignment, the rotation of the magnet apparatus, or both, and the Specification does not provide explanation of the intention of this limitation. Furthermore, it is unclear as to what structure/definition is intended by “relative to that which would otherwise be the case” – since this appears to be relying on the interpretation of otherwise/alternative structures, which is not explicitly described in the Specification (i.e. what is encompassed by “otherwise”). Therefore, the claim fails to comply with the written description requirement because the Specification does not describe what exactly is defined as “relative to that which would otherwise be the case”, and therefore does not fully disclose or describe the infinite ‘alternative’ possibilities defined by the claim. Claims 11-13, 15, 18, 34-47, and 51-54 are rejected for depending on Claim 10.
It is noted that Claim 48 has been amended in the Amendment filed 16 April 2025, and contains new 35 USC 112(a)/New Matter issues as described in detail above.
II - 35 USC 112(b)/pre-AIA second paragraph
The Applicant argues (Pages 16-17 of Remarks/Amendment), that with respect to Claim 13, “the surface of a skin” does not lack antecedent basis, since this limitation is referring to the orientation. However, the Examiner disagrees with this argument, because the limitation in full recites, “back towards the relatively parallel to the surface of a skin orientation”. Therefore, the “a” appears to be referring to the skin as described above, and therefore should be “back towards the relatively parallel to the surface of the skin orientation”, since the claim is referring to “the relatively parallel…orientation”. Appropriate correction or clarification is required.
With respect to Claim 15, the Applicant argues (Pages 17-18 of Remarks/Amendment) that the limitation “tumble” is not indefinite. However, the Examiner disagrees with these arguments. The claim recites “the device is configured to enable the magnet apparatus to tumble within the support body”. However, it is unclear as to how “tumble” is distinct or different from “rotate”. The term “tumble” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite distinction/difference from “rotate”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention since this is not a common term in the art. For purposes of examination, this limitation will be interpreted as being equivalent to “rotate”. It is noted that the Applicant has not provided any additional explanation of “tumble” nor pointed out clarifications within the Specification. Appropriate correction or clarification is required.
With respect to Claim 18, the Applicant argues (Pages 18-19 of Remarks/Amendment) that the limitations are sufficiently clear. However, the Examiner disagrees with these arguments. As described above, Claim 18 recites “a non-circular and non-flat cross section lying on a second plane”. However, it is unclear as to how a cross-section can be “non-flat”, since a ‘cross-section’ is by definition flat/planar. Wolfram Mathworld defines a ‘cross-section’ as: “A cross section of a solid is a plane figure obtained by the intersection of that solid with a plane.” (Weisstein, Eric W. "Cross Section." From MathWorld-- A Wolfram Web Resource. https://mathworld.wolfram.com /CrossSection.html, previously cited). Since a plane is inherently flat, this limitation is indefinite. For purposes of examination, this limitation will be interpreted as intending to mean that at least a portion of the perimeter of the cross section lying on a second plane is non-circular and non-flat (i.e. at least a portion of the perimeter is rounded or does not have a uniform straight shape). Appropriate correction or clarification is required.
The Applicant argues (Pages 19-22 of Remarks/Amendment) that the limitation of Claim 10, which recites “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case”, is sufficiently clear and adequately defined. However, the Examiner disagrees with these arguments.
Due to the structure of the limitation, it is unclear as to what limitations are “enable[d by] the magnet apparatus” – either the alignment, the rotation, both, or another meaning. Furthermore, in the context of the claim, it is unclear as to what is intended by “relative to that which would otherwise be the case”. It is indefinite as to whether this is referring to the diffusion of force, the rotation of the magnet apparatus, or both, and furthermore, it is unclear as to what structure/definition is intended by “relative to that which would otherwise be the case” – since this appears to be relying on the interpretation of otherwise/alternative structures (of which are infinite). For purposes of examination, this limitation will be interpreted as “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus will substantially align with the external magnetic field
By analogy, a car configured to enable a wheel to rotate relative to the body of the car when provided with gasoline is definite. Same here.
…
With respect to the "relative to that which would otherwise be the case," we recite "more," and we want a comparison to what is "more," and that is the "relative to that which would otherwise be the case." The otherwise be the case is if the magnet apparatus could not rotate. Simple.
However, this explanation does not clearly and distinctly describe or attempt to point out what is meant by the specific claim language of Claim 10 at issue, “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case”. Since the Applicant has failed to provide additional sufficient explanation, for purposes of examination, this limitation will be interpreted as “wherein the device is configured to enable the magnet apparatus to rotate relative to the support body when exposed to an external magnetic field such that a magnetic field of the magnet apparatus will substantially align with the external magnetic field
Claims 11-13, 15, 18, 34-47, and 51-54 are rejected for depending on Claim 10. Appropriate correction or clarification is required.
III - 35 USC 102(a)(1)
The Applicant argues (Pages 22-24 of Amendment/Remarks) that Zimmerling et al. fails to disclose all of the claimed elements of Claim 1. However, the Examiner disagrees with these arguments.
As described above, regarding Claim 1, Zimmerling et al. discloses an implantable medical device (Abstract; Paragraph 0003), comprising: a magnet apparatus (401, Fig. 4; 402, Figs. 8-12, 15, 16; 1501, Fig. 15; 1601, Fig. 16; Paragraph 0009, 0036, 0040; Claims 3-8); and
a support body supporting the magnet apparatus (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8),
wherein the magnet apparatus has a long axis and a short axis shorter than the long axis normal to the long axis (multiple axis directions for different orientations, including a long axis longer than the short axis, Figs. 8-16, Paragraph 0027, 0030, 0031, 0043), and at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis (see curved outer periphery of disc, cylindrical, and/or oval shaped magnets; 401, Fig. 4; 402, Figs. 8-12, 15, 16; 1501, Fig. 15; 1601, Fig. 16; it is noted that ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet; Paragraph 0009, 0036, 0040; Claims 3-8). In particular, the Applicant argues that Zimmerling et al. does not disclose specific interpretations of particular directions/orientations (Pages 23-24 of Arguments/Remarks). It is noted that Claim 1 has been interpreted as described in the 35 USC 112(b) rejection section above. Furthermore, as described above, ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet, since the implantable device and/or structures may be implanted or oriented in any direction during use, particular since the magnets are configured to rotate. Therefore Claim 1 remains rejected as described above.
The Applicant further argues (Pages 22-24, 26-27) that Leigh et al. fails to disclose all of the claimed elements of Claim 1. However, the Examiner disagrees with these arguments. As described above, Leigh et al. discloses an implantable medical device (Abstract), comprising: a magnet apparatus (160, Figs. 6-10, 14-19; Paragraph 0061-0064, 0100, 0102, 0104, 0147, 0150-0151); and a support body (housing/support structure, Paragraph 0009, 0062-0064, 0070) supporting the magnet apparatus, wherein the magnet apparatus has a long axis and a short axis shorter than the long axis normal to the long axis (see short and long axis of magnet 160, Figs. 6-10, 14-19), and at least one of the top surface or the bottom surface of the magnet apparatus establishes a curved outer periphery with respect to a cross-section lying on a plane on which the long axis lies and which is parallel to the short axis (curved outer periphery of magnet 160, see Figs. 6-10, 14-19; disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151; it is noted that ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet). In particular, the Applicant argues that Leigh et al. does not disclose specific interpretations of particular directions/orientations (Pages 23-24, 26-27 of Arguments/Remarks). It is noted that Claim 1 has been interpreted as described in the 35 USC 112(b) rejection section above. Furthermore, as described above, ‘top’ and ‘bottom’ are relative terms which may be interpreted as any direction of the magnet, since the implantable device and/or structures may be implanted or oriented in any direction during use, particular since the magnets are configured to rotate. Therefore Claim 1 remains rejected as described above.
The Applicant argues (Pages 24-26 of Arguments/Remarks) that Zimmerling et al. fails to disclose all of the claimed elements of Claim 10. However, the Examiner disagrees with these arguments.
Zimmerling et al. discloses an implantable medical device (Abstract; Paragraph 0003), comprising: a non-spherical magnet apparatus (non-spherical shapes, Paragraph 0009, 0036, 0040; Claims 3-8); a support body supporting the magnet apparatus (housing/structure, Paragraph 0008-0009; 0027-0029, 0032; see 402, 405, 401; Fig. 4; 8), wherein the device is configured to enable the magnet apparatus to rotate relative to the support body (rotate partially or fully within the housing, Paragraph 0029-0031, 0034) and to tumble within the support body (rotate partially or fully within the housing, Paragraph 0029-0031, 0034) when exposed to an external magnetic field such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case (magnet substantially aligns with MRI/magnetic field when exposed; Paragraph 0007-0009, 0029-0034, 0040-0044), and at least one of: the magnet apparatus is a modified sphere shape (non-spherical shapes, Paragraph 0009, 0036, 0040; Claims 3-8); or the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1).
In particular, the Applicant argues (Pages 24-28 of Arguments/Remarks) that Zimmerling et al. fails to disclose “the magnet apparatus is a modified sphere shape” and “the magnet apparatus is configured to rotate relative to the support boy about more than one axis”. However, the Examiner disagree with this argument. In particular, any 3D shape may be considered “a modified sphere shape”, since a sphere can be ‘modified’ to be molded/distorted into any shape. Furthermore, Zimmerling et al. discloses potential shapes of the magnet apparatus include disc and/or cylindrical shapes (Paragraph 0009, 0036, 0040; Claims 3-8) and/or planar disc shape, rectangular beam shape, cylindrical beam shape, cut away disc shape (Paragraph 0009, 0036, 0040; Claims 3-8). As additionally can be seen in Figs. 8-16, multiple possibly magnet shapes/configurations are shown by Zimmerling et al. Therefore, the Examiner maintains that Zimmerling et al. discloses “the magnet apparatus is a modified sphere shape”. Applicant has not defined or explained what specifically is distinct with respect to “a modified sphere shape” as claimed, and therefore broadest reasonable interpretation applies.
Furthermore, the Examiner maintains that Zimmerling et al. discloses wherein the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1), the more than one axis including at least a first axis and a second axis (rotatable in multiple axis/angles, depending on particular shape, Paragraph 0009, 0031, 0034, 0036, 40; Claim 1). Therefore, these limitations of Claim 10 are met by Zimmerling et al.
The Applicant further argues (Pages 24-28 of Arguments/Remarks) that Leigh et al. fails to disclose all of the claimed elements of Claim 10. However, the Examiner disagrees with these arguments. Leigh et al. discloses an implantable medical device (Abstract), comprising: a non-spherical magnet apparatus (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151); a support body supporting the magnet apparatus (housing/support structure, Paragraph 0009, 0062-0064, 0070), wherein the device is configured to enable the magnet apparatus to rotate relative to the support body (rotatable magnet; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152) and to tumble within the support body (rotatable magnet within support body; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152) when exposed to an external magnetic field (MRI/magnetic field; Paragraph 0106, 0107, 0111) such that a magnetic field of the magnet apparatus aligns more with the external magnetic field relative to that which would otherwise be the case (Paragraph 0061, 0100-0101; 0135; 0186), and at least one of: the magnet apparatus is a modified sphere shape (disk, cylinder, bar, or nonuniform shapes; Paragraph 0102, 0104, 0147, 0150-0151); or the magnet apparatus is configured to rotate relative to the support body about more than one axis (rotatable magnet within support body in multiple planes; Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152).
In particular, the Applicant argues (Pages 24-28 of Arguments/Remarks) that Leigh et al. fails to disclose “the magnet apparatus is a modified sphere shape” and “the magnet apparatus is configured to rotate relative to the support boy about more than one axis”. However, the Examiner disagree with this argument. In particular, any 3D shape may be considered “a modified sphere shape”, since a sphere can be ‘modified’ to be molded/distorted into any shape. Furthermore, Leigh et al. discloses disk, cylinder, bar, or nonuniform shapes of the magnets (Paragraph 0102, 0104, 0150-0151), which may be considered “modified sphere shapes”. Furthermore, Leigh et al. explicitly describes that the magnet apparatus is rotatable in multiple planes (Abstract; Paragraph 0111, 0113, 0122, 0128, 0130, 0135, 0147, 0152). Applicant has not defined or explained what specifically is distinct with respect to “a modified sphere shape” as claimed, and therefore broadest reasonable interpretation applies.
Therefore, Claim 10 remains rejected as anticipated by both Zimmerling et al. and Leigh et al.
It is noted that no specific arguments were presented with respect to independent Claim 48 as amended. Claims 48-50 are rejected under 35 USC 102(a)(1) and 35 USC 103 above.
IV- 35 USC 103
The Applicant argues (Page 29 of Arguments/Remarks) that Zimmerling et al. and Leigh et al. fail to disclose or teach the claimed elements of Claim 18 based on its dependency on Claim 10. However, the Applicant did not argue an alternative interpretation of Claim 18, nor did the Applicant address the specific 35 USC 112(b) nor the specific 35 USC 103 rejections. Therefore the Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
No additional specific arguments were presented with respect to dependent Claims 2-4, 11-13, 15, 18, 34-47, and 49-54, nor with respect to the previously cited Smith et al. reference (US Publication No. 2018/0133486). Therefore, Claims 1-4, 10-13, 15, 18, and 34-54 are rejected as described in detail above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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