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 Arguments
Regarding the unity of invention/restriction, applicant’s arguments are moot. As made clear in the Non-Final mailed 1/17/2024, the restriction has been made final. Any arguments directed to the restriction/unity of invention, at this stage of prosecution, should be made in a petition. The examiner maintains the position stated in the restriction and Non-final rejection. If applicant continues to disagree, then a petition is the appropriate course of action.
Regarding the 112f claim interpretation, applicant’s argument “the implantable requirement distinguishes the component from a non-implantable component. There are certain structural attributes to the implantable requirement, and the person of skill would recognize this as such” is considered persuasive. Therefore, the claimed “implantable component” will be interpreted under BRI and the 112f claim interpretation is hereby withdrawn.
Regarding the 112a written description rejection of the functional language associated with an implantable component, applicant’s arguments have been considered but are not persuasive.
Applicant argues that these are original claims in the current app and the PCT. However, as noted in the previous rejection, original claims can fail the written description requirement. MPEP 2163.03 “An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”
Applicant proceeds to copy and paste the title, abstract, some figures from the current specification as evidence that the claim is supported, but this fails to address the issue of what structure specifically performs the claimed function, i.e. the structure responsible for performing the function or HOW the function is performed. MPEP 2163 states “An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.”
Applicant argues “The specification is quite detailed. We describe all of the enumerated elements of the figures, explaining the structure that corresponds to such. No person of skill, even ordinary skill, would have any doubt that our application evidences that the inventors were in possession of ... ‘An Implantable Component of An Implantable Prosthesis’”. This is mere general/conclusory statement with no evidence to support it. Again, as made clear in the Non-Final rejection, the issue is not whether applicant sufficiently disclosed an implantable device. Instead, the issue is the lack of explanation of what/how the claimed function is performed, i.e. the structure responsible for performing the function. The specification merely/generally ties the claimed function to the implantable device (as a whole) with no indication/explanation as to how the implantable device or which particular structures perform the function. Applicant’s response simply does not address the rejection or the specific issues pointed out by the examiner.
The questions presented by the examiner were merely examples to reiterate the issues that have been previously explained, as the specification provides no indication as to how the function is performed and/or what structure provides the claimed function. If the function is performed by a computer/software, then additional issues exist. MPEP 2161.01 states “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.”. Applicant is under no obligation to answer these questions directly, they merely serve to elaborate the examiner’s issue/point.
Applicant generally alleges “the specification is clear what elements provide the function”. The examiner disagrees, as applicant has provided no evidence to support this position. It is emphasized that merely copying and pasting the original claims, the title, the abstract and some figures, provides no clarity as to what structure performs the claimed function and how that structure performs the claimed function. The examiner recommends that applicant clearly point out and explain where the specification discloses the structure responsible for performing the function and how that structure performs the function.
Regarding the 112a written description rejection related to “not magnetically coupled”, applicant’s arguments have been considered but are not persuasive. The issue here is the BRI/scope of the term “magnetically coupled”. The examiner maintains that under BRI, induction is a type of magnetic coupling (“In electrical engineering, two conductors are said to be inductively coupled or magnetically coupled when they are configured in a way such that change in current through one wire induces a voltage across the ends of the other wire through electromagnetic induction.” https://en.wikipedia.org/wiki/Inductive_coupling). Therefore, any two devices that are inductively coupled are also magnetically coupled. Furthermore, since the implantable device is within the patient, any device that is inductively coupled to the implantable device (within the patient) is magnetically coupled to the patient. Applicant does not have support for the breadth of this claim language, as the only disclosed powering of the implantable component is through induction. The examiner recommends amending the claims to make the distinction between an external device physically coupled/attached to or worn by the recipient, and magnetically coupled.
Regarding the 112a written description rejection of claim 26, applicant’s arguments have been considered but are not persuasive. Applicant’s remarks amount to a general allegation that the implantable device provides the alarm. However, as previously noted, the implantable component includes numerous structural elements. It remains unclear which of these structural elements provides the alarm and how, as this is never discussed in applicant’s specification.
Regarding the 112a written description of claims 27, 29 and 34. Applicant argues that “frequency” is not recited in the claims and therefore the rejection is not pertinent to the claims. While applicant is correct that the exact term “frequency” does not appear in the claims, the frequency, i.e. how often something is done, as is understood as the normal/ordinary definition of frequency, is recited in the claims. In this case, the claimed frequency (“always”, “at least sometimes”) refers to how often the data is streamed. Therefore, the examiner disagrees, as frequency is very much pertinent to the claims, and the rejection is therefore maintained, as applicant has provided no arguments to refute the examiner’s position.
Regarding the 112b rejection of the functional language associated with the implantable component. It seems as if applicant has misconstrued the rejection. The issue is not with the term “implantable component” itself, the issue is with the functional language tied to the implantable component, as it is unclear what structure is specifically responsible/required for performing the claimed function. The examiner maintains that the metes and bounds of the claimed device, i.e. what structure element(s) is specifically encompassed by the scope, is unclear to a POSITA. MPEP 2173.05g states “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. Additionally, MPEP 2114 states “apparatus claims cover what a device is, not what a device does.”. So if it is not clear what is structurally required in order to perform the claimed function, then the examiner maintains that the claim is indefinite, per the MPEP. Applicant’s arguments fail to provide any response to the examiner’s rejection, other than generally alleging that the examiner has not met the requirements/standard for such a rejection. As pointed out above, the standards/requirements used by the examiner to reject the claims under 112b indefiniteness are detailed in the MPEP. Therefore, since applicant failed to address the specific issues pointed out by the examiner in the rejection, the examiner is maintaining the rejection.
Regarding the 112b rejection of “magnetically coupled”, applicant’s arguments have been considered but are not persuasive. As discussed above, in relation to the 112a written description rejection of this term, the examiner maintains and has provided evidence (which was previously presented in the Non-Final) as to the BRI of magnetically coupled (which encompasses inductively coupled). It is noted that the examiner did not ignore “to the recipient” and specifically explained in the rejection, how an external device inductively coupled to an implantable device is magnetically coupled to the patient, as the implantable device is within the patient; Therefore anything inductively/magnetically coupled to the implantable device is also inherently/by definition inductively/magnetically coupled to the patient (as the implantable device is located within the patient). The examiner contends that “how people talk” is not necessarily the “ordinary and customary meaning of a term”. Regardless, the examiner has provided evidence how the ordinary and customary meaning of “magnetically coupled” includes inductively coupled. Therefore, the BRI includes an interpretation that makes the claims indefinite. As pointed out above, the examiner recommends that applicant amend around this interpretation to make it clear that the claims refer to an external device that is not physically coupled/attached or worn by the patient/recipient. It seems as if applicant agrees with this interpretation, but refuses to amend the claims to make this distinction clear.
Applicant’s argument “the external device has a magnet, and that interacts with a magnet in the implant. When the external device is attached to the side of the head, it is magnetically coupled to the recipient” seems to support the examiner’s interpretation. Even applicant agrees that when an external device magnetically interacts with the implantable device (in applicant’s example, the magnet on the external device interacts with the magnet in the implantable device) it is magnetically coupled to the patient (since the implantable device resides within the patient). In applicant’s example, the patient itself is not interacting with the external magnet, but the implantable device within the patient is interacting external magnet. In the interpretation explained by the examiner the external device is interacting with the patient in the same manner, i.e. via/through the implantable device. Therefore, the examiner is maintaining the position that the BRI of the claim is indefinite/unclear and recommends a simple amendment to make the distinction clear.
Regarding the 112b indefiniteness rejection of claim 26, applicant argues “we most certainly disclose structure for this, which is the implantable component”. The examiner disagrees that this is sufficient, as it provides no indication as to what specific structural element or configuration of the implantable component is required in order operate the implantable component in the second mode, as claimed.
Regarding the 112b indefiniteness rejection of claim 27. Applicant argues that indefiniteness cannot be established by raising hypothetical questions. The examiner would disagree that these are hypothetical, but are used as a tool to make the examiner’s point clear. Stated different (not in question form)… it is unclear what always is referring to in the claim. Specifically, it is unclear if always is referring to the frequency of the streaming (as explained above, how often something is done) or if it refers to the source/direction of the streaming. As discussed above, the claim does not recite the word “frequency”, but it does recite a frequency, i.e. always or at least sometimes, in regard to how often something is streamed.
Regarding the 112b rejections of claims 27, 29 and 34 and the structure responsible for the claimed function. MPEP 2173.05g, as recited above, makes it clear that “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”.
Regarding applicant’s arguments related to the 102 rejection of claims of 24-27, 29 and 34 as anticipated by Darley, applicant’s arguments have been considered but are not persuasive. Applicant’s entire argument is “Darley does not disclose an implantable component that is configured to operate in our recited first mode. No prima facie case of anticipation has been established.” This does not meet the requirements of 37 CFR 1.111b which states:
“In order to be entitled to reconsideration or further examination, the applicant or patent owner must reply to the Office action. The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references…The applicant’s or patent owner’s reply must appear throughout to be a bona fide attempt to advance the application or the reexamination proceeding to final action. 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 does not comply with the requirements of this section.”
The examiner disagrees, as clearly and explicitly pointed out in the 102 rejection of claim 24 (pages 13-14 of the NF), every limitation of applicant’s claim language is mapped/explained as to how Darley teaches/anticipates the claim, including the claimed first mode. Specifically, the examiner takes the position that Darley teaches all of the necessary structural elements to operate in the claimed mode. Furthermore, applicant is reminded that:
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114).
Regarding the 103 rejections in view of Darley, applicant’s only argument is “The rejections based on Darley are based on the above misapprehensions of Darley vis-a-vis claim 24, and we thus traverse on the grounds that the section 103 rejections do not remedy the deficiencies articulated above, and thus no prima facie case of obviousness could have been established”. However, as emphasized above no specific deficiencies have been articulated above. Therefore, the examiner is maintaining the 103 rejection of Darley.
Regarding the 103 rejections of Parker in view of Kolz, applicant’s arguments have been considered, but are not persuasive. Again, applicant’s arguments have failed the requirements of 37 CFR 1.111b. Specifically, applicant has reproduced Figs. 2 and 4 of Parker and the cited paragraphs from the rejection and then generally alleges that these figures and paragraphs do no teach/suggest claim 24, without any additional explanation. It is unclear which limitations applicant believes are not taught suggested by Parker and Kolz, as applicant has not particularly pointed out the errors in the examiner’s rejection.
The examiner would emphasize that Figs. 2 and 4 show an implantable device (depicted as an oval within the patient/recipient sleeping) being inductively powered via an external device (202 or 402) in a pillow or mattress (respectively) while the patient/recipient is sleeping. Par 0041 explicitly states “An external charging coil 202 is embedded within a pillow so as to charge the cranial implant when the implant recipient is lying down or sleeping.”. As pointed out in the NF, this is the implantable device operating in the first mode, as consistent with applicant’s specification.
Furthermore, Fig. 1 shows an internal control unit (14) within the implantable component/device and Pars 0030 and 0047 discloses communication, specifically the transferring of data, between the implant and an external device. At the very least, the internal control unit (14) is structurally capable of storing data. More specifically, the discussion of transferring data from the implant to the external device inherently/implicitly requires such data to be internally stored to the implantable component (“During this synchronization where data is transferred from implant to external charging unit, information other than the status of the battery such as information which relates to the use of the device or settings may be transferred”).
Lastly, Fig. 1 of Parker, specifically the implantable pulse generator/internal controller (3) includes all of the necessary structural requirements (internal transceiver, inductive receiver, internal control unit, power source, electrode driver, electrodes) that are configured to operate in the claimed mode(s). See MPEP 2114.
Applicant fails to provide any arguments related to Kolz. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
Regarding the 103 rejection of Parker in view of Kolz in relation to claim 25, applicant’s arguments are not persuasive. As emphasized in the office action, what a user is doing (being active) while using the implantable device and for how long (at least 6 hours) is intended use. For example, it is well understood that a person is generally active and/or works for at least 6 hours a day. Again, the device taught by Parker includes all of the necessary structural components and configurations to operate in the second mode.
Regarding applicant’s argument related to In re Gianelli, applicant has not sufficiently showed how the facts of the current case align with In re Gianelli. First, the main issue in Gianelli was whether it would have been obvious to modify the device taught by the primary reference to perform the claimed function. This is not at issue in the current rejection, as Parker is not being modified to perform the function of operating in a second mode “that is a recipient-active mode of at least 6 hours in length where data is at least sometimes streamed from the implantable component to an external component”. Parker is only being modified to include an internal alarm in this second mode. Second and most importantly, in Gianelli the term “adapted to”, as made clear by Gianelli’s specification, has a narrower meaning that “capable of” or “suitable for”. Applicant’s current specification makes no such distinction that “configured to” should be interpreted as anything other than capable of. The decision of In re Gianelli makes it clear that the BRI of “configured to” includes “capable of” or “suitable for”, unless the specification of the current application defines this term to be narrower. It is emphasized that applicant’s specification provides no indication that “configured to” should be interpreted more narrowly than “capable of”. Therefore, the examiner maintains that the rejection uses the correct BRI of “configured to”, as consistent with the MPEP ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim.) and In re Gianelli.
Applicant argues that Kolz is for when a user is sleeping, the examiner disagrees. While Kolz uses sleeping as a primary example, Par 0005 (as cited in the office action) makes it clear that there are many reasons why a person doesn’t wear or removes their externally worn portion (“However, most persons with cochlear implants or similar devices remove the externally worn portion at least part of the time… It is also typically removed while bathing, and sometimes may be removed purely for relaxation, to shut out externally distracting noise”). Kolz, as a whole, makes it clear that this internal alarm is for any situation where the user removes or is not wearing the externally worn device, and this removal is purely the decision/choice of the recipient/patient for any number of reasons (including, but not limited to sleep).
Regarding applicant’s argument that the cited figures of Parker (3, 5 and 6) are not for the cochlear implant. The examiner would disagree, as a POSITA when reading Parker as a whole, would understand that while these figures do not specifically show a cochlear implant, they encompass such an implant (See Pars 0006-8 and 0055). Par 0025-28 make it clear that any of these implantable devices can be charged in the shown/described manner. For example, Fig. 5 shows a charging coil in a ceiling. While this specific figure shows/describes charging an abdominal or spinal implant, it is clear when reading Parker, as a whole, that such an embodiment applies to the cochlear implant, as well.
Regarding the 103 rejection of Parker in view of Kolz in relation to claim 26, applicant’s arguments have been considered but are not persuasive. The examiner maintains that the only way an alarm can be applied when an externally worn device is not physically attached to the patient is internally. As made clear, in claim 25 above, the second mode is when a user is active/awake but not wearing the externally worn/physically attached component (for whatever desired reason). In any situation when a user is not wearing the physically attached external device, an internal alarm is seemingly the only possible alarm, as this is the only alarm disclosed by Kolz.
Applicant’s remarks related to analogies and hypothetically rewritten claims are moot, as they are not pertinent to the current claim language or rejection.
Applicant argues “the assertions of obviousness are based on the scenario where "a user is not wearing the body-worn external device, as explicitly taught by Kolz." (OA, page 18.) But the second mode as explicitly stated in claim 25 is a mode where data is at least sometimes streamed on the implantable component to an external device. Accordingly, the alleged rationale for obviousness contradicts the requirements of claim 26, where claim 26 depends from claim 25” The examiner disagrees, as pointed out in Par 0047 and Fig. 7 of Parker, the data is streamed/transferred when the user is not wearing the externally worn/attached device. Specifically, the tuned coil 702 is equivalent to the tuned coils 202, 302, 402, 502 and 602 in the embodiments shown in Figs. 2-6, which are explicitly not worn/attached to the user. It’s unclear how/why applicant believes this transferring/streaming of data doesn’t apply to the second mode (where a user isn’t wearing the externally worn/physically attached device).
Regarding the 103 rejection of Parker and Kolz in relations to claims 27, 29 and 34, applicant’s arguments have been considered but are not persuasive. It is noted that the synchronization and transferring of data/information (as recited in Par 0047) is the claimed streaming, i.e. the normal and ordinary meaning/definition of “stream” is to transmit data, therefore the claim language is met. Furthermore, Par 0047 makes it clear that this synchronization and transferring of data occurs “as necessary”. It is noted that “as necessary” is by definition at least sometimes. Furthermore, based on the 112b rejection, always can refer to the direction that the transfer/streaming occurs, i.e. always from implant to external device, in this case the synchronization/transfer of data disclosed in Par 0047 is always from implant to external. Therefore, the claim language is met.
Therefore, based on the reasons explained above, all of the previous rejections are maintained. In an effort to advance prosecution, the examiner highly recommends that applicant recite specific structural elements that are configured to provide the claimed function. Furthermore, if it is applicant’s position that the structural element(s) disclosed by the prior art are not capable of providing the claimed function, then evidence supporting this position is respectfully requested.
Election/Restrictions
Newly submitted claims 37 and 38 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: These new claims recite a system, the originally presented claims are directed to an apparatus. Under unity of invention, the shared technical feature of these two groups (apparatus and system) are the limitations of claim 25. Since claim 25 is rejected over the prior art (see response to arguments, above, and 102/103 rejections, below), these claims do not show unity of invention, as there is no special technical feature.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 37 and 38 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
“receiver-stimulator” is not recited in the specification.
“inducive link antenna” is not recited in the specification
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “receiver-simulator” (Claim 44) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 24-27, 29, 34-36 and 39-44 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.
[Claim 24] It is noted that the entirety of the claim is functional language associated with “an implantable component of an implantable prosthesis”. Specifically, the claims recite an implantable component configured to operate in specific first and second modes of operations, however it is unclear what specific structural elements/components provide the claimed functions, as none are claimed or disclosed. While these modes are disclosed in the specification, it is unclear what structure performs/provides these modes, i.e. what specific/corresponding structure is required in order to perform these functions. Can any implantable device having the disclosed components (a transceiver unit 208, stimulator unit 214, electronics module 213 and electrode assembly 254; as discussed above in the 112f claim interpretation section) inherently provide the claimed modes? Are all of these components required or only some of them in order to provide the function, if only some of them, which ones? Is this a processor/software specifically configured in a particular manner to provide the function? MPEP sections 2163, 2161.01 and 2818, all make it clear that when claiming functional language, it must be clear in the specification what specific structural element(s) provide(s) the function.
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function”; MPEP 2163
“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”; MPEP 2163
“For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed” MPEP 2161.01
“The principal function of claims is to provide notice of the boundaries of the right to exclude by defining the limits of the invention, and means-plus-function claims rely on the disclosure to define those limits. Accordingly, an inadequate disclosure may give rise to both an indefiniteness rejection for a means-plus-function limitation and a failure to satisfy the written description and enablement requirements of section 112(a) or pre-AIA section 112, first paragraph.” MPEP 2181.
[Claim 24] Furthermore, the limitation “where the implantable component is powered for functional operation primarily from an external device not magnetically coupled to the recipient”. As discussed in more detail below (in relation to the 112b), it is never explained how this function is achieved. From the specification, it appears as if inductive coils in both the implanted device (transceiver 208 within the patient/recipient) and the external device (coil 247 within pillow or mattress) provide this function. However, such inductive coils by definition provide magnetic coupling. So if the implantable component is within the patient, inherently the external device is magnetically coupled to the recipient, otherwise induction wouldn’t work. Based on the specification, it appears as if applicant intended to mean an external device that is not worn, i.e. physically coupled/connected/attached, to the patient, but this distinction is not clear in the claims.
[Claim 26] Similar to above, it’s unclear from the specification what structure is responsible for providing this function of an alarm only being applied internally in a second mode.
[Claims 27, 29 and 34] Similar to above, it’s unclear from the specification what structure is responsible for determining the frequency in which data is streamed in either the first or second mode.
[Claims 35 and 39] As discussed above, it’s unclear from the specification what structure is responsible for providing the claimed function and how the function is performed.
[Claims 36 and 43] Applicant appears to mixing mutually exclusive embodiments. While the disclosure, as a whole, encompasses EEG monitors or visual prosthesis, there is no discussion as to how an internal alarm (as required by independent claim 24) can be applied to recipient with either a visual prosthesis or EEG monitor. Specifically, there is no explanation as to how an internal alarm is applied in the first or second modes, as it specifically relates to an EEG monitor or a visual prosthesis.
[Claim 44] The term “receiver-stimulator” appears nowhere in applicant’s specification, which makes it unclear what structure applicant possessed. Second, there is no discussion/explanation as to how this structure (which is not disclosed) is responsible for/achieves the function of operating in the first mode.
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 24-27, 29, 34-36 and 39-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 24] As noted above, applicant has claimed “an implantable component of an implantable prosthesis” and defined it entirely by its functionality, specifically different operating modes. However, as noted above, it’s unclear what structure elements are required in order to provide these functions, which makes the scope of the claims indefinite; See MPEP 2181 and 2173.05(g). While the claimed function is provided generally by the “implantable component” as a whole, it is unclear what specifically provides the claimed function, i.e. corresponding structure. Is any implantable device with the disclosed components (a transceiver unit 208, stimulator unit 214, electronics module 213 and electrode assembly 254; as discussed above in the 112f claim interpretation section) inherently provide the claimed function? Are all of these components required or only some of them in order to provide the function, if only some of them, which ones? Is some sort of specific configuration and/or programming of a processor/computer/software required? Applicant’s claims that further define the modes are similar indefinite, as it’s unclear what is specifically required (structurally) to meet these limitations.
“The use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” MPEP 2173.05(g)
“The proper test for meeting the definiteness requirement is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function.” MPEP 2181.
“The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.” MPEP 2173
[Claim 24] Furthermore, the term “magnetically coupled” is indefinite, as it appears that it is being used contrary to it’s normal/ordinary meaning. Specifically, any inductive charging/coupling is by definition two components that are magnetically coupled (“In electrical engineering, two conductors are said to be inductively coupled or magnetically coupled when they are configured in a way such that change in current through one wire induces a voltage across the ends of the other wire through electromagnetic induction.” https://en.wikipedia.org/wiki/Inductive_coupling). It is clear from the specification that the recipient-passive mode occurs when an inductive coil (247 in pillow or mattress) is used to power and transfer data to the internal/implanted inductive coil within the patient (transceiver 208; Pars 0042 and 0058 of applicant’s specification). Therefore, by definition any inductive coupling between an external device and internal device within a patient, is an external device magnetically coupled to the recipient, i.e. patient, otherwise induction wouldn’t work. Based on the specification, it appears as if applicant intended to mean an external device that is not worn, i.e. physically coupled/connected/attached, to the patient (which is how the examiner will be interpreting this claim limitation). However, this distinction is not clear in the claims.
[Claim 26] Similar to above, because it is unclear what structure is responsible for providing this function of an alarm only being applied internally in a second mode, the scope/boundaries of the claim is indefinite.
[Claim 27] The limitation “the second mode is such that the data is always streamed from the implantable component to the external component” is indefinite, is it is unclear what “always” is referring to in this context. Does “always” refer to the frequency of the streaming, i.e. constantly/continuously streamed, or does it refer to the source/direction of the streaming?
[Claims 27, 29 and 34] Similar to above, because it’s unclear what structure is responsible for determining the frequency in which data is streamed in either the first or second mode, the scope/boundaries of these claims is indefinite.
Furthermore, the terms “always” and “at least sometimes” in the context of these claims are indefinite, as it is unclear what they are referring to. Specifically, it’s unclear if they refer to the frequency of the streaming, e.g. always meaning constantly or continuously (at all times) streamed, or does it refer to the source/direction of the streaming, e.g. when transferring data, it always occurs from the implantable component to the external component.
Applicant is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim” MPEP 2114.
For examination purposes, the examiner contends that in order to provide the claimed function, all that is required is an internal inductive coil and an internal alarm system located within an implantable device, the rest is intended use which these structures are inherently capable of providing. Specifically, applicant has not positively claimed the external device or a processor/computer/software specifically configure in any manner. Applicant’s claims only recite an internal/implantable component that is capable/configured to be powered by and receive data from an external device (if/when such a hypothetical/imaginary external device is provided), as well as an internal alarm system. The examiner contends that any inductive coil is capable of receiving power/data from another inductive coil, if/when such a coil is provided.
[Claims 35 and 39] Similar to above, because it’s unclear what structure element/component and/or specific configuration of the implantable component is required/necessary in order to perform the claimed function, the scope, i.e. metes and bounds, of the claims cannot be determined.
Furthermore, claim 39 is additionally indefinite, as it’s unclear if applicant’s claims are attempting to positively require/recite an external device (that applies an external alarm). Claims 24-25 make it clear that the claims relate solely to an implantable component/device (that is configured to cooperate with an external device), i.e. an external device is not actually required. However, claim 39 appears to require such an external device, which creates confusion in terms of the scope and what is structurally required by this claim. In addition, if no external device is required, it’s unclear how this recited functional limitation serves to further limit the structure of the implantable device.
[Claim 44] It’s unclear what a receiver-stimulator structurally encompasses, as the specification provides no guidance on this term is or what it covers, in terms of structure. For examination purposes, any receiver or transceiver within an implantable device is considered to read on the claimed receiver-stimulator and inherently capable of operating in the first mode.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 24-27, 29, 34, 35, 39-42 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0106344 to Darley et al.
[Claim 24] Darley discloses an apparatus, comprising:
an implantable component of an implantable prosthesis, the implantable component configured to operate in at least one operation mode, including a first mode is a recipient-passive mode of at least 4 hours length where the recipient sleeps, where the implantable component is powered for functional operation primarily from an external device not magnetically coupled to the recipient, where data is at least sometimes stored internally to the implantable component (“Internal coil 124 receives power and data from external coil 108.”’ Pars 0027-28. Furthermore, Par 0026 discloses that the external device can be “indirectly attached” to the recipient, the examiner contends that when the external component is indirectly attached, the implantable component is in the claimed first mode), and an alarm is applyable to the recipient via an internal alarm system of the implantable component (internal alarms 526; Par 0079).
The examiner contends that such an internal coil is inherently capable of providing the claimed function, i.e. operating in claimed mode, specifically if/when such an external device, i.e. pillow or mattress with an inductive coil, is used while the user is sleeping the inductive coil is configured to receive power/data from such an external device, which is considered a first recipient-passive mode; see explanation above. It is emphasized that what the user is doing during this time or how long they are doing it for is intended use, as long as the device is capable of performing the function should the situation occur, the claim language is met.
[Claim 25] Darley teaches that implantable component is configured to operate in at least two different operation modes, including the first mode and a second mode that is a recipient-active mode of at least 6 hours in length where data is at least sometimes streamed from the implantable component to an external component (Pars 0027-28), and an alarm is applyable to the recipient via an internal alarm system of the implantable component (internal alarms 526; Par 0079). Specifically, if/when the implantable component uses an inductive coil within a pillow or mattress to receive power/data, e.g. external component indirectly attached to the recipient, the implantable device is in the first mode (as explained in relation to claim 24, above), if/when the implantable component uses an inductive coil within the ear-worn external device (142), e.g. directly attached to the recipient, the implantable device is in the second mode.
[Claim 26] Darley teaches “In accordance with one embodiment, operational mode controller 500 comprises an alarm selector 520 that selects whether alarm conditions are to be broadcast using internal alarms 526 or external alarms 524 based on the selected operational mode 501”. In the instance where the internal alarms are selected, seemingly these are the only alarms applied. If applicant disagrees, see alternative 103 below.
[Claims 27, 29 and 34] Darley teaches that the internal coil receives data from the external coil (Par 0027). Seemingly, this transfer/streaming always happens in either the first mode or second, otherwise operation of the device would not be as effective (and would be potentially dangerous). It is noted that “always” streamed reads on “at least sometimes” streamed. Furthermore, based on the 112, 2nd (discussed above), the examiner contends that the disclosure of Darley reads on the claimed limitations. If applicant disagrees with the examiner’s position, see alternative 103 below.
[Claim 35] Darley teaches all of the necessary structure to operate in the claimed second mode such that data is stored at least sometimes internally. Darley discloses the transfer of data from the implant to external device (Pars 0009; 0026-27), in order to transfer this data from the implant, it must be internally stored on the implant at least sometimes. Furthermore, Darley teaches the exact same components of the implantable device (internal receiver unit, stimulator unit, and electrodes) as applicant’s device; see MPEP 2114.
[Claim 39] Darley disclose external alarms (Par 0079); these alarms are applicable in any/all modes.
[Claim 40] Darley discloses an internal alignment magnet (140; Par 0037)
[Claim 41] Darley discloses an inductive link antenna (internal transcutaneous transfer coil 124) that receives power from any external device that is inductively coupled to it, i.e. directly or indirectly (Pars 0008-9 and 0026-28).
[Claim 42] Darley disclose a cochlear implant (Pars 0025-26; Fig. 1A)
[Claim 44] Darley disclose an internal receiver unit (112)
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 26, 27, 29 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0106344 to Darley et al.
[Claim 26] As discussed above, Darley discloses that a selection is made between internal and external alarms. In the case that the internal alarm is selected, it will only be internal. If applicant disagrees, then the examiner contends that it would be obvious to try, specifically in the first mode, either option internal or external alarms, as these are the only two options for the alarms.
[Claims 27, 29 and 34] As discussed above, Darley is silent on the frequency in which data is streamed. While the examiner takes the position that this data is constantly/continuously/always transferred/streamed, it not clear from the reference alone. Therefore, the examiner contends that it would be obvious to always stream data, in either mode, as this would provide the most effective treatment in any circumstance.
Claims 36 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Darley as applied to claims 24 or 25 above, and further in view of US 2010/0016922 to Daly.
Darley is discussed, including teaching implantable device (in general) that require transcutaneous transfer of power and/or information (Pars 0005-6), but is silent regarding specific implants other than cochlear implants. However, in the same field of endeavor, Daly teaches “In some devices, the external and implanted components are communicably linked by a communication link, such as an RF or inductive link, to provide the required functionality. Although the following will often refer to a particular category of implantable medical devices, namely implantable prosthetic hearing devices known as cochlear implants, it is to be understood that the following is applicable to other types of implantable medical devices such as spinal, visual or other neural stimulators, and medical devices developed for other applications, including those medical implant applications which help to diagnose, monitor, regulate or treat conditions within a recipient's body in which components of the medical device is implanted”. The examiner takes official notice that EEG is a common and known type of implantable device that monitors a patient’s brain. Therefore, it would have been obvious to modify Darley to include other implantable devices, specifically an EEG monitor or visual stimulation device, as these are known/common implantable device where transcutaneous transfer of power/data is necessary.
Claims 24-27, 29, 34-36 and 39-44 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0053657 to Parker et al. and in view of US 2008/0111677 to Kolz et al.
[Claim 24] Parker discloses an apparatus, comprising:
an implantable component (3, Fig. 1 with “implanted coil”; Pars 0004-7) of an implantable prosthesis, the implantable component configured to operate in at least one operation mode, including a first mode is a recipient-passive mode of at least 4 hours length where the recipient sleeps, where the implantable component is powered for functional operation primarily from an external device not magnetically coupled to the recipient (external charging coil 202 within pillow, Fig. 2 or 402 in mattress Fig. 4), where data is at least sometimes stored internally to the implantable component (Abstract; Pars 0030, 0041 and 0047).
Parker fails to explicitly teach an internal alarm. However, in the same field of endeavor, Kolz discloses during a first mode, i.e. when a user is sleeping and has taken off the wearable external device, an alarm is applyable to the recipient via an internal alarm system of the implantable component (Abstract, Pars 0005-7 and 0016-18). Therefore, it would have been obvious to one of ordinary skill in the art to modify Parker with the internal alarm system taught by Kolz, in order to alert the user of a cochlear implant of an emergency/danger while they are sleeping and have taken their external body-worn portion off for the night.
[Claim 25] When the external device (1) is in a car seat while the recipient is driving (Fig. 3), in the ceiling of an office while a person is working (Fig. 5) or in an office chair while the user is working (Fig. 6), the implantable component would be in the second mode. It is emphasized that what the user is doing during this time or how long they are doing it for is intended use, as long as the device is capable of performing the function should the situation occur, the claim language is met.
It is clear from Kolz that the alarm is intended to be internally applied to the recipient anytime they are not wearing their body-worn external device (abstract), so in these instances where the recipient is driving and/or working without their body-worn external device, it would be obvious to apply the alarm internally, as taught by Kolz.
[Claim 26] Kolz only discloses/discusses an internal alarm, and therefore the examiner interprets this as an “only” an internal alarm. However, if applicant disagrees, there are only two options, internally or externally applied alarm, it would obvious to choose an internal alarm only, especially when a user is not wearing their body-worn external device, as explicitly taught by Kolz.
[Claims 27, 29 and 34] Parker discloses “The implant and external controller synchronise information as necessary to understand the state of charge of the implanted battery. During this synchronization where data is transferred from implant to external charging unit, information other than the status of the battery such as information which relates to the use of the device or settings may be transferred” Par 0047. Furthermore, based on the 112, 2nd (discussed above), the examiner contends that the disclosure of Parker reads on the claimed limitations.
[Claim 35] As discussed above, Parker explicitly discloses transferring data to/from the implant (Pars 0007 and 0047), as necessary. The examiner contends that in order for this information to be transferred to/from the implant, it must be internally stored in the device. It’s clear that the internal storage occurs in any mode (first or second), i.e. while the user is asleep or active.
[Claims 36 and 43] Parker is discussed above, but fails to explicitly teach an EEG monitor or a visual prosthesis. However, when considering Parker, as a whole, it’s clear that the disclosed charging can apply to any implantable devices (Abstract). While neuro-stimulator implantable devices are used as the primary example, it’s clear that any implantable device that requires charging is envisioned/encompassed. Therefore, it would have been obvious to one of ordinary skill in the art to try/choose different known implantable devices (other than the three specific examples of a spinal cord implant, cochlear implant and deep brain stimulators), including known EEG monitors or visual prosthesis, in order to charge, i.e. transcutaneously transfer power/data to, any implantable medical device.
[Claim 39] Parker discloses an external alarm (“The recharging module 401 may be equipped with a user interface which alerts the recipient of the status of the charging system or implant. Such user interface may consist of any or all of audible or visual means”; Par 0047). It’s clear that this external alarm relates to any embodiment/mode, i.e. when the user is sleeping (e.g. pillow, Fig. 2) or active (e.g. ceiling, Fig. 5).
[Claim 40] Parker discloses a magnet to align the implantable device to the external device (Par 0008).
[Claim 41] Parker discloses an inductive link antenna (inductive receiver/receiver coil 23; Fig. 1; Par 0007. See also “implanted coil” throughout the specification) configured to receive power from any inductively/magnetically coupled external device. It’s clear that these inductive coils receive power/data from any external device that is inductively coupled to it, whether it be directly attached to the patient or further away.
[Claim 42] Parker specifically teaches a cochlear implant (Par 0006)
[Claim 44] Parker discloses an internal transceiver (13) and electrodes (8) to stimulate tissue; see Pars 0004-5. The examiner contends that the transceiver includes all of the necessary structure to operate in the first mode.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached on 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNSEY C Eiseman/ Primary Examiner, Art Unit 3796
Prosecution Insights