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 .
Amendment
This action is in response to the Amendment filed on 10/30/2025.
Claims 1, 2, 6-8, 10-31 and 34-39 are pending.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Claim Rejections Under 35 U.S.C. 112, first paragraph
Applicant’s arguments with respect to the rejection of claim 21 have been fully considered.
Claim 21 as recited states
21. (Currently Amended) The method of claim 1, wherein the drilling creates the blind hole in the patient's promontory, wherein the blind hole has a depth that is no more than 95.4% of the thickness of the patient’s promontory.
Claim 21 was filed on 7/30/2024 as part of the claim set during prosecution.
Upon review of the applicant’s originally filed disclosure, specifically paragraph [0057] (from the printed publication as reproduced below and the corresponding originally filed specifications) describes that a patient's promontory is patient specific and provides examples of various ranges of a thickness of a patient's promontory and a desirable blind hole depth, there is no disclosure of the limitation "the blind hole has a depth of no more than 95.4% of the thickness of the promontory.”
[0057] In most cases, the most suitable drill device 500 and/or electrode device for a particular patient can be determined in advance of the implant procedure. For example, in some cases a patient can undergo a pre-operative imaging procedure, such as a computerized tomography (CT) scan, to determine the patient's anatomical features such as, but not limited to, promontory thickness. Based on the inventor's investigations, minimal promontory thickness is about 0.4-0.5 mm and maximal promontory thickness is about 2.0-2.2 mm. Thus, a desirable hole depth (and intraosseous electrode length) can be about 0.3 mm to about 0.7 mm, or about 0.5 mm to about 0.9 mm, or about 0.7 mm to about 1.1 mm, or about 0.9 mm to about 1.3 mm, or about 1.1 mm to about 1.5 mm, or about 1.3 mm to about 1.7 mm, or about 1.5 mm to about 1.9 mm, or about 1.7 mm to about 2.1 mm, and/or anywhere within such ranges. In some cases, a set of multiple drill devices 500 will be made available in 0.2 mm depth increments, or 0.1 mm depth increments.
Therefore if the thickness of the promontory is 0.4-0.5mm, a hole depth of 0.7mm or 0.5 mm-0.9mm or more as described in [0057] reproduced above does not meet the limitation “the blind hole has a depth of no more than 95.4% of the thickness of the promontory.”
The paragraph simply provides a discussion of using a suitable drill device and the use of a preoperative imaging procedure to determine a promontory thickness and provides various ranges of a desirable hole depth. There is no support for the specific limitation of the blind hole having a depth of no more than 95.4% of a thickness of the promontory as claimed.
Therefore, the rejection is maintained.
Similarly claim 22 was filed on 7/30/2024 as part of the claim set during prosecution.
Claim 22 recites:
22. (Currently Amended) The method of claim 1, further comprising selecting the drill device having a depth limiter that equals a selected cochlear bone drilling depth, wherein the action of selecting the drill device comprises selecting from at least a first drill device that produces a hole that has a depth that is at least 0.1 mm greater than a hole produced by a second drill device that could be selected.
The originally filed disclosure, specifically [0055]-[0058] (from the printed publication as reproduced below and the corresponding originally filed specifications) discuss using a drill device for making a hole of a proper depth and determining a suitable drill device and a hole depth using imaging. But none of these paragraphs provide any support for the limitation of “selecting the drill device having a depth limiter that equals a selected cochlear bone drilling depth, wherein the action of selecting the drill device comprises selecting from at least a first drill device that produces a hole that has a depth that is at least 0.1 mm greater than a hole produced by a second drill device that could be selected.
Therefore, the rejection is maintained.
Claim Rejections Under 35 U.S.C. $112, second paragraph
Applicant’s amendment has been considered and the rejection is withdrawn.
Claim Rejections Under 35 U.S.C. 103
Applicant’s arguments have been fully considered.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Previous discussion regarding claim 14 from the office action mailed on 9/5/2024 have been provided below.
With regards to claim 14, the examiner provided two rejections. The first rejection in view of Maltan’s teachings were under the broadest reasonable interpretation since Maltan teaches a remote programming device that employs a bi-directional radio-frequency communication link to control and program the microstimulator (e.g. 54 Fig. 4, Abstract,[0008], [0010],[0032]) they also teach an external charging unit that transmits radio-frequency (RF) energy that can be picked up by the implantable microstimulator and which energy is used to charge the rechargeable battery of the microstimulator (e.g. [0032]) thus implying that Maltan’s implantable stimulator device necessarily comprises the claimed receiver that is configured to wirelessly communicate through the patient's scalp with an external device in order to provide power from the external device to the
implantable stimulator device, activate the implantable stimulator device, adjust
the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device, and program the implantable
stimulator device.
Since Maltan teaches a remote programming device that employs a bi-directional radio-frequency communication link to control and program and an external charging unit, the implantable stimulator device necessarily comprises a receiver coil for wireless communication through the scalp as claimed.
The second rejection in view of Gantz’s teachings was provided to clearly demonstrate the claimed limitations of claim 14 are well known as taught by the combination of the prior art cited (i.e. Maltan in view of Marx and Kuzma and further in view of Gantz) with respect to the rejection of claim 14.
Therefore, the rejections have been maintained.
Claim 35 recites:
35. The method of claim 1, wherein the stimulation lead with the single solid electrode attached at the end of the stimulation lead is coupled to the stimulator device, wherein the stimulator device is part of a receiver/stimulator that has a functionality akin to an implantable receiver/stimulator.
Maltan modified by the teachings of Marx and Kuzma teaches a non-permanent test stimulator (eg.56Fig.4,[0028]) that communicates with a remote (e.g. 54Fig.4). The examiner relied on Gantz’s teachings to show that it would be obvious to one of ordinary skill in the art to modify the teachings of Maltan in view of Marx and Kuzma to implant a permanent stimulator unit wherein the stimulation lead with the single solid electrode attached at the end of the stimulation lead is coupled to the stimulator device, wherein the stimulator device is part of a receiver/stimulator that has a functionality akin to an implantable receiver/stimulator as taught by Gantz in order to provide the predictable results of having a hybrid device that can be used for stimulation and treatment of multiple targets when required. This is clearly established as being within the level of ordinary skill at the time the claimed invention was made.
Applicant has not identified any specific limitation in the claim that has not been taught by the prior art cited in the rejections or how the combination of the prior art fails to meet the claimed limitations.
Similar reasoning applies for claim 34 since claims 34 and 35 were rejected in view of Gantz’s teachings.
Claim 28 recites
28. A method, comprising:
a step for forming a hole in a cochlear bone of a patient a step for implanting a stimulation lead with a single solid electrode attached at an end of the stimulation lead, wherein the stimulation lead is coupled to or coupleable to a stimulator device; and
a step for placing the single solid electrode within the hole, wherein the method is a method of treating a tinnitus condition of the patient.
Applicant states that they traverse the rejection for the pertinent reasons detailed with respect to the other claims. Applicant has not identified any specific limitation in the claim that has not been taught by the prior art cited in the rejections or how the combination of the prior art fails to meet the claimed limitations. Therefore, due to the reasons discussed above the rejections have been maintained.
Claim 21 recites:
21. (Currently Amended) The method of claim 1, wherein the drilling creates the blind hole in the patient's promontory, wherein the blind hole has a depth that is no more than 95.4% of the thickness of the patient’s promontory.
With regards to the arguments with respect to claim 21, as discussed in the response to arguments section with regards to the 112 first paragraph rejection, applicant has not provided any support for the limitation “wherein the blind hole has a depth that is no more than 95.4% of the thickness of the patient’s promontory”. Kuzma teaches drilling a blind hole depth of1.3mm (e.g. Col.3 lines22-23,30-37).
In order to advance prosecution, the examiner considers that since the blind hold depth taught by Kuzma meets the ranges in the limitations claimed in claim 5-7 and the desired blind hole depths disclosed in paragraph [0057], they teach that the drilling creates the blind hole in the patient's promontory, wherein the blind hole has a depth that is no more than 95.4% of the thickness of the patient’s promontory.
Claim 22 recites:
22. The method of claim 1, further comprising selecting the drill device having a depth limiter that equals a selected cochlear bone drilling depth, wherein the action of selecting the drill device comprises selecting from at least a first drill device that has produces a hole that has a depth that is at least 0.1 mm greater than a hole produced by a second drill device that could be selected.
With regards to the arguments with respect to claim 22, as discussed in the response to arguments section with regards to the 112 first paragraph rejection, applicant has not provided any support for the limitation “selecting the drill device having a depth limiter that equals a selected cochlear bone drilling depth, wherein the action of selecting the drill device comprises selecting from at least a first drill device that has produces a hole that has a depth that is at least 0.1 mm greater than a hole produced by a second drill device that could be selected”.
However upon further consideration of the rejection in view of Brown’s teachings, the prior art rejection under 35 U.S.C. 103 has been withdrawn.
New claims 37-39 are addressed in the current office action below.
Obviousness-Type Double Patenting
Applicant acknowledges the obviousness-type double patenting rejections.
The rejections have been maintained.
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 21 and 22 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 21 recites “… wherein the drilling creates the blind hole in the patient's promontory, wherein the blind hole has a depth that is no more than 95.4% of the thickness of the promontory.” While paragraph [0057] of originally filed specifications describes that a patient’s promontory is patient specific and provides examples of various ranges of a thickness of a patient’s promontory and a desirable blind hole depth, the originally filed specifications do not provide any disclosure of the limitation “the blind hole has a depth of no more than 95.4% of the thickness of the promontory.”
Claim 22 recites “selecting the drill device having a depth limiter that equals a selected cochlear bone drilling depth, wherein the action of selecting the drill device comprises selecting from at least a first drill device that has produces a hole that has a depth that is at least 0.1 mm greater than a hole produced by a second drill device that could be selected.” There is no disclosure of such a selection being made in the originally filed disclosure.
Claim Rejections - 35 USC § 112
9. 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.
Claim 38 is 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 38 recites the limitation "the action of anchoring the lead…" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 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 1, 6, 7, 10, 11, 13, 14, 19, 20, 21, 23-27 and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan”- APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx” - APPLICANT CITED) and further in view of Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED).
Regarding claim 1, Maltan teaches a method of treating a tinnitus condition (e.g. Abstract) of a patient, the method comprising:
a single solid electrode (e.g. 120 Fig.2) at the end of a stimulation lead (e.g. 140 Fig.2) and a microstimulator (e.g. [0022], 110 Fig. 2),
implanting under a scalp of the patient a stimulation lead with the single solid electrode attached at an end of the stimulation lead (e.g. 120 Fig.2) and coupled to the stimulator device (e.g. [0022]) in the promontory bone of a cochlea (e.g. abstract, [0026]) and
wherein the stimulator device and the single solid electrode (e.g. 120 Fig.2) is configured to deliver a pattern of electrical pulse stimuli to the cochlear bone of the patient to reduce the tinnitus condition (e.g. Fig. 2, [0008], [0010], [0028],[0031]).
Maltan does not specifically teach drilling, using a drill device, a blind hole in the cochlear bone of the patient without breaking through the cochlear bone and intraosseously placing the single solid electrode within the blind hole.
In a similar field of endeavor, Marx teaches drilling a blind hole in a bone (i.e. bone of the vestibular labyrinth [0025]) of the patient without breaking through the bone (e.g. 403 Fig. 4 shows the electrode 303 placed in a blind hole (e.g. [0025], i.e. the endosteum 403 in the hole remains intact);
implanting, under a scalp of the patient, a stimulation lead (e.g. 301 Fig 3A,B, Fig. 4) with a single solid electrode (e.g. 303 Fig 3A,B, Fig. 4) attached at an end of the stimulation lead, wherein the stimulation lead is coupled to a stimulator device (i.e. implanted stimulation module [0025]);
intraosseously placing the single solid electrode within the blind hole (e.g. 403 Fig. 4). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Maltan and place the electrode of Maltan intraosseously in a blind hole drilled using a drill device without breaking through the promontory of the cochlear bone and implanting, under a scalp of the patient, the stimulation lead with the single solid electrode attached at an end of the stimulation lead of Maltan as taught by Marx in order to provide the predictable results of ensuring a proper implantation of the electrode in the target location and minimizing damage to the surrounding structures of the ear.
While Maltan in view of Marx teach drilling as discussed above, they do not specifically teach a drill device that is used for the drilling. Kuzma teaches that it is well know to drill a blind hole using ball-tipped diamond drill (e.g. 38 Fig. 4A, col. 3 lines 15-23). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Maltan in view of Marx to drill the hole using a drill device to drill the blind hole as taught by Kuzma in order to provide the predictable results of providing the clinician with more control during implantation.
Regarding claims 6-7, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above, but do not specifically teach that the hole depth is 0.9 mm to 1.5 mm or 101.3 mm to 1.7 mm of the patient’s promontory.
Marx further teaches that the electrode is implantable in a bone of the vestibular labyrinth (e.g. [0025], Fig. 4). Marx teaches that the electrode has a diameter of 0.5mm and the distance from the mesh to the tip of the electrode is 0.7 mm (e.g. [0026] and while they teach that the electrode 303 Fig. 4 is placed in a hole.
Kuzma teaches drilling a blind hole depth of 1.3 mm (e.g. Col. 3 lines 22-23, 30-37) in a patient’s promontory bone and therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the teachings of “modified” Maltan to have the target tissue be the promontory with a hole having the claimed depth ranges including 1.3 mm as taught by Kuzma in order to provide the predictable results of making the lead easier to implant and secure.
Regarding claim 10, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches implanting a tinnitus treatment device under a post-auricular scalp of the patient (e.g. Fig. 3).
Regarding claim 11, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches the pattern of electrical pulse stimuli sourced from the stimulator device is controllable according to pulse width, amplitude, and stimulus rate (e.g. [0028], [0031], [0032]).
Regarding claim 13, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches the pattern of electrical pulse stimuli comprises a selected: (i) pulse width, (ii) amplitude, and (iii) stimulus rate (e.g. [0028], [0031], [0032]).
Regarding claim 14 and 24-27, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches a remote programming device that employs a bi-directional radio-frequency communication link to control and program the microstimulator (e.g. 54 Fig. 4, Abstract,[0008], [0010],[0032]) they also teach an external charging unit that transmits radio-frequency (RF) energy that can be picked up by the implantable microstimulator and which energy is used to charge the rechargeable battery of the microstimulator (e.g. [0032]) and therefore they teach that the implantable stimulator device comprises a receiver coil via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device in order to: (i) provide power from the external device to the implantable stimulator device, (ii) activate the implantable stimulator device, (iii) adjust the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device, and (iv) program the implantable stimulator device.
Regarding claim 19 and 20, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above, but do not specifically teach that the blind hole has a depth of 0.3 mm to 0.7 mm. Marx further teaches that the electrode is implantable in a bone of the vestibular labyrinth (e.g. [0025], Fig. 4). Marx teaches that the electrode has a diameter of 0.5mm and the distance from the mesh to the tip of the electrode is 0.7 mm (e.g. [0026] and while they teach that the electrode 303 Fig. 4 is placed in a hole.
Kuzma teaches drilling a blind hole depth of 1.3 mm (e.g. Col. 3 lines 22-23, 30-37) in a patient’s promontory bone and therefore it would have been Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the teachings of “modified” Maltan to have the target tissue be the promontory with a hole having the claimed depth ranges as taught by Kuzma in order to provide the predictable results of making the lead easier to implant and secure.
Further it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Maltan in view of Marx and Kuzma with a blind hole that has a depth of 0.3 mm to 0.7 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05)
Regarding claim 21 (as best understood), Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above, but do not specifically teach that the blind hole depth is no more than 95.4% of the thickness of the patient’s promontory.
Marx further teaches that the electrode is implantable in a bone of the vestibular labyrinth (e.g. [0025], Fig. 4). Marx teaches that the electrode has a diameter of 0.5mm and the distance from the mesh to the tip of the electrode is 0.7 mm (e.g. [0026] and while they teach that the electrode 303 Fig. 4 is placed in a hole.
Kuzma teaches drilling a blind hole depth of 1.3 mm (e.g. Col. 3 lines 22-23, 30-37 Note: 1.3 mm is considered as less than 95.4% of the patient’s promontory since it is in the range of 1.1-1.7 mm as claimed in claims 5-7) in a patient’s promontory bone and therefore it would have been Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the teachings of “modified” Maltan to have the target tissue be the promontory with a hole having the depth of the blind hole as 1.3 mm which is considered as no more than 95.4% as claimed and as taught by Kuzma in order to provide the predictable results of making the lead easier to implant and secure.
Regarding claim 23, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches the pattern of electrical pulse stimuli from the stimulator device is controlled accruing to pulse width, amplitude, and stimulus rate (e.g. [0028], [0031], [0032]).
Regarding claim 36, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but Maltan does not specifically teach anchoring the lead to the patient outside the blind hole. Marx further teaches an anchor mesh (e.g. 304 Figs. 3A-B,4) that is used to anchor a lead (e.g. 301 Fig.4) outside a blind hole (e.g. Fig.4, [0024]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the lead in the teachings of Maltan in view of Marx and Kuzma to have an anchor mesh that is used to anchor the lead to the patient outside the blind hole as taught Marx in order to provide the predictable results of ensuring that the electrode tip is fixedly and accurately secured to the blind hole in the bone.
Regarding claim 37, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but Maltan does not teach that the stimulation device and the electrode establish a bipolar stimulation assembly. Marx teaches that the electrode tip may be adapted for bipolar stimulation operation (e.g. [0023]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Maltan in view of Marx and Kuzma to be used for bipolar stimulation operation as taught by Marx in order to provide the predictable results of providing a more targeted stimulation.
Regarding claim 38, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but Maltan does not teach that the action of anchoring the lead is executed using an anchoring element including a fenestration that is attached to the lead, and an adhesive is received in the fenestration. Marx teaches that the electrode tip is anchored using an anchor mesh 304 located around the outer surface of the electrode lead 301 near the electrode tip 303 to engage the outer surface of the bony labyrinth to fixedly and accurately secure the electrode tip 303 within the fenestration opening and glued to the outer surface of the bony labyrinth (e.g. [0024]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Maltan in view of Marx and Kuzma to be anchor the lead to the opening in the bone and glue it as taught by Marx in order to provide the predictable results of providing a more secured implantation.
Regarding claim 39, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but Maltan does not teach prior to the action of implanting, placing a test electrode on the cochlea and applying a varying pattern of electrical stimulation. Marx teaches that it is well known to provide a test stimulation by using a temporary electrode and applying electrical stimulation through the electrode using a test stimulator (e.g. [0010], Fig. 4, [0028]: Stimulation parameters such as stimulus pulsewidth, stimulus amplitude and frequency of stimulus pulses may be adjusted with the remote-control device, by a clinician or a patient). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Maltan in view of Marx and Kuzma with a test stimulator and using varying patterns of electrical stimulation on the cochlea as taught by Marx in order to provide the predictable results of to improve the efficacy of the therapy by confirming that the electrode placement is good and that stimulation is effectively treating tinnitus before implanting the permanent system.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan” - APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx”- APPLICANT CITED) and Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED) and further in view of Baker et al (U.S. Patent Application Publication Number: US 2016/0324552 A1, hereinafter “Baker” - APPLICANT CITED) OR Maxson (U.S. Patent Application Publication Number: US 2014/0222002 A1, hereinafter “Maxson” - APPLICANT CITED).
Regarding claims 2 and 12, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above, but do not specifically teach the drill device comprises a depth limiter that establishes a maximum the of the blind hole in the cochlear bone or a drill device having a depth limiter that equals a selected cochlear bone drilling depth.
Baker teaches a drill guide system for drilling into the bone of the patient with a depth limiter (e.g. [0068], [0080]-[0081], claim 29. i.e. the indicia marking on the elongate shaft of the depth gauge is generally aligned with an indicia marking on either the fixed angle drill guide or the variable angle drill guide feature to indicate an appropriate length, Note: that would allow establishing a maximum the of the blind hole in the cochlear bone).
Maxon is another teaching that teaches that it is well known to have a drill device for drilling the bone of a patient wherein the drill device comprises a depth limiter that is set to the bone drilling depth (e.g. [0048] Note: Note: that would allow establishing a maximum the of the blind hole in the cochlear bone) so that the implant can be implanted flush or substantially flush with the surrounding bone.
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the drill device “modified” Maltan to include a depth limiter that establishes a maximum the of the blind hole in the cochlear bone as taught by Baker OR Maxon in order to provide the predictable results of having a more precise and controlled drilling method for creating the blind hole in the cochlear bone.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan” - APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx”- APPLICANT CITED) and Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED) and further in view of Kleinman (U.S. Patent Application Publication Number: US 2010/0121390 A1, hereinafter “Kleinman” - APPLICANT CITED) OR Maxson (U.S. Patent Application Publication Number: US 2014/0222002 A1, hereinafter “Maxson” - APPLICANT CITED).
Regarding claim 8, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above, but do not specifically teach that after intraosseously placing the single solid electrode within the blind hole, applying an adhesive to fixate the stimulation lead relative to the cochlear bone.
Kleinman teaches that it is well known to use an adhesive such as bone cement to fixate a prosthesis to a bone (e.g. [0065]). Maxson is another teaching of using bone cement for fixating an implant to a bone (e.g. [0060]) Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the method of “modified” Maltan to use an adhesive as taught by Kleinman OR Maxon to fixate the electrode to the bone in order to provide the predictable results of ensuring the implant is fixed and stays in place in the bone and improving safety of the device.
Claims 14, 15, 24-27, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan” - APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx”- APPLICANT CITED) and Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED) and further in view of Gantz (U.S. Patent Application Publication Number: US 2012/0185028 A1, hereinafter “Gantz” - APPLICANT CITED).
Regarding claims 14 and 15, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and while Maltan teaches a remote programming device that employs a bi-directional radio-frequency communication link to control and program the microstimulator (e.g. 54 Fig. 4, Abstract,[0008], [0010],[0032]) they also teach an external charging unit that transmits radio-frequency (RF) energy that can be picked up by the implantable microstimulator and which energy is used to charge the rechargeable battery of the microstimulator (e.g. [0032]), they do not specifically teach a receiver coil via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device in order to: (i) provide power from the external device to the implantable stimulator device, (ii) activate the implantable stimulator device, (iii) adjust the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device, and (iv) program the implantable stimulator device and wherein the implantable stimulator device further comprises a magnet for aligning the receiver coil with the external device.
Gantz teaches a hybrid cochlear implant device that comprises an implantable component and an external controller (e.g. Fig. 1) and that comprises a receiver coil (e.g. 23 Fig.1) via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device (e.g. 29 Fig 1, [0101] i.e. receiver coil 23 for receiving power and data from the transmitter coil 24) in order to:
(i) provide power from the external device to the implantable stimulator device (e.g. [0101] i.e. receiver coil 23 for receiving power and data from the transmitter coil 24.), (ii) activate the implantable stimulator device (e.g. [0121],[0122]) (iii) adjust the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device and (iv) program the implantable stimulator device (e.g.[0085]-[0087]), and
the receiver coil includes a magnet for aligning with an external device (e.g. [0088]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the implantable device of Marx to include the teachings of Gantz in order to provide the predictable results of making the device more user friendly for better transmission and reception of signals.
Regarding claims 24-27, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but does not specifically teach a receiver coil via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device to provides power from the external device to the implantable stimulator device, activate the implantable stimulator device, adjust the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device, and program the implantable stimulator device and wherein the implantable stimulator device further comprises a magnet for aligning the receiver coil with the external device.
Gantz teaches a hybrid cochlear implant device that comprises an implantable component and an external controller (e.g. Fig. 1) and that comprises a receiver coil (e.g. 23 Fig.1) via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device (e.g. 29 Fig 1, [0101] i.e. receiver coil 23 for receiving power and data from the transmitter coil 24) in order to:
provide power from the external device to the implantable stimulator device (e.g. [0101] i.e. receiver coil 23 for receiving power and data from the transmitter coil 24.), activate the implantable stimulator device (e.g. [0121],[0122]), adjust the pulse width, the amplitude, and the stimulus rate of the pattern of the electrical pulse stimuli generated by the implantable stimulator device and program the implantable stimulator device. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the implantable device of Marx to include the teachings of Gantz in order to provide the predictable results of making the device more user friendly for better transmission and reception of signals.
Regarding claims 34 and 35, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and while Maltan teaches a non-permanent test stimulator (e.g. 56 Fig. 4, [0028]) that communicates with a remote (e.g. 54 Fig. 4), they do not specifically teach implanting the stimulator device and wherein the stimulation lead with the single solid electrode attached at the end of the stimulation lead is coupled to the stimulator device and a second stimulation lead coupled to the stimulator device and an electrode array comprising a plurality of electrodes is attached to the second stimulation lead and wherein the stimulator device is part of a receiver/stimulator has a functionality akin to an implantable receiver/stimulator.
Gantz teaches a hybrid cochlear implant device that comprises an implantable component (e.g. 22 Fig.1, Fig. 6) and an external controller (e.g. 29, 24 Fig. 1) and that comprises a receiver coil (e.g. 23 Fig.1) via which the implantable stimulator device is configured to wirelessly communicate through the patient's scalp with an external device (e.g. 29 Fig 1, [0101] i.e. receiver coil 23 for receiving power and data from the transmitter coil 24) and teaches that the implantable stimulator device comprises a second lead with a plurality of electrodes (e.g. 52 Fig. 6). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Maltan in view of Marx and Kuzma to implant a permanent stimulator unit wherein the stimulation lead with the single solid electrode attached at the end of the stimulation lead is coupled to the stimulator device and a second stimulation lead coupled to the stimulator device and an electrode array comprising a plurality of electrodes is attached to the second stimulation lead and wherein the stimulator device is part of a receiver/stimulator has a functionality akin to an implantable receiver/stimulator as taught by Gantz in order to provide the predictable results of having a hybrid device that can be used for stimulation and treatment of multiple targets when required.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan” - APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx”- APPLICANT CITED) and Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED) and further in view of Della Santina et al (U.S. Patent Application Publication Number: US 2015/0039057 A1, hereinafter “Della Santina” - APPLICANT CITED).
Regarding claim 16, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above but does not specifically teach that a ground lead extending from the implantable stimulator device separately from the stimulation lead.
In a similar field of endeavor, Della Santina teaches an implantable medical device with leads that are implanted in the vestibular labyrinth and the cochlea (e.g. Figs. 2,3, [0037]-[0039], [0046]-[0047]) and a ground lead (e.g. 120 Fig.2, 224 Fig.3) extending from the implantable stimulator device separately from the stimulation leads. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the implantable device of Maltan in view of Marx and Kuzma to have a separate ground lead extending from the stimulator device as taught by Della Santina in order to provide the predictable results of improving safety of the device with proper grounding.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan” - APPLICANT CITED) in view of Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx”- APPLICANT CITED) and Kuzma (U.S. Patent Number: US 4809712, hereinafter “Kuzma” - APPLICANT CITED) and further in view of Goldsmith et al (U.S. Patent Application Publication Number: US 2002/0099421 A1, hereinafter “Goldsmith”-PREVIOUSLY CITED).
Regarding claims 17 and 18, Maltan in view of Marx and Kuzma teaches the invention as claimed as discussed above and Maltan further teaches prior to placing the single solid electrode within the blind hole, placing one or more test electrodes on the patient's cochlea region (e.g. Fig 4 [0028]: test system) and using one or more test electrodes, varying patterns of electrical stimulation to the patient's cochlea region; and identifying, by the patient, an optimum pattern of the varying patterns of electrical stimulation that provides a best tinnitus reduction (e.g. [0028], [0030], Stimulation parameters such as stimulus pulse width, stimulus amplitude and frequency of stimulus pulses may be adjusted with the remote control device by a patient, various test stimulation parameters may be tried to assess if the electrical stimulation treatment is adequately suppressing or masking the occurrence of tinnitus).
However they do not specifically teach placing the one or more test electrodes on the patient's cochlea region via a transcanal tympanotomy using local anesthetic with the patient awake. In a similar field of endeavor, Goldsmith teaches that it is well known to implant an electrode (e.g. 54 Fig. 3) into the cochlear region of a patient using under local anesthesia while the patient is awake (since local anesthesia just numbs the target region) in a doctor's office via transcanal tympanotomy (e.g. [0018], [0033], [0055]-[0061]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the implantable device of Maltan in view of Marx and Kuzma to perform a transcanal tympanotomy to implant a test electrode in the patient’s cochlear region as taught by Goldsmith in order to provide the predictable results of providing a minimally invasive procedure for implantation for quicker recovery.
Claims 28-31 are rejected under 35 U.S.C. 103 as being unpatentable Marx et al (U.S. Patent Application Publication Number: US 2015/0066126 A1, hereinafter “Marx” - APPLICANT CITED) in view of Maltan et al (U.S. Patent Application Publication Number: US 2007/0021804 A1, hereinafter “Maltan”- APPLICANT CITED).
Regarding claims 28-31, Maltan teaches a method of treating a tinnitus condition (e.g. Abstract) of a patient, the method comprising:
a single solid electrode (e.g. 120 Fig.2) at the end of a stimulation lead (e.g. 140 Fig.2) and a microstimulator (e.g. [0022], 110 Fig. 2),
a step for implanting a stimulation lead under the scalp (e.g. 140 Fig.2) with a single solid electrode (e.g. 120 Fig.2) in the promontory bone of a cochlea (e.g. abstract, [0026]) and the electrode being attached to an end of the stimulation lead, wherein the wherein the stimulation lead is coupled to or coupleable to a stimulator device; and
delivering, from the stimulator device and the single solid electrode (e.g. 120 Fig.2), a pattern of electrical pulse stimuli to the cochlear bone of the patient to reduce the tinnitus condition (e.g. Fig. 2, [0008], [0010], [0028],[0031]).
Maltan does not specifically teach a step for forming a blind hole and placing the electrode in the blind hole intraosseously within the blind hole.
In a similar field of endeavor, Marx teaches drilling a blind hole in a bone (i.e. bone of the vestibular labyrinth [0025]) of the patient without breaking through the bone (e.g. 403 Fig. 4 shows the electrode 303 placed in a blind hole (e.g. [0025], i.e. the endosteum 403 in the hole remains intact);
implanting a stimulation lead (e.g. 301 Fig 3A,B, Fig. 4) with a single solid electrode (e.g. 303 Fig 3A,B, Fig. 4) attached at an end of the stimulation lead, wherein the stimulation lead is coupled to or coupleable to a stimulator device (i.e. implanted stimulation module [0025]) and intraosseously placing the single solid electrode within the blind hole (e.g. 403 Fig. 4).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Maltan and place the electrode of Maltan intraosseously in a blind hole of the cochlear bone of Maltan as taught by Marx in order to provide the predictable results of ensuring a proper implantation of the electrode in the target location and minimizing damage to the surrounding structures of the ear.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 6-8, 10-31 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8, 10-31 and 34-36 of copending Application No. 16/925837. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. 16/925837 are obvious over the claims of the instant application as shown below. Claims 28-31 are also rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 16/925837. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is broader and overlaps the subject matter of copending Application No. 16/925837. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Further dependent claims of the current application recite limitations that are similar to the dependent claims (10-13 and 16-19) of copending Application No. 16/925837.
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This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 6-8, 10-31 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11253704. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11253704 are obvious over the claims of the instant application as shown below. Claims 28-31 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11253704. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is broader and overlaps the subject matter of U.S. Patent No. 11253704. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Further dependent claims of the current application recite limitations that are similar to the dependent claims (4, 6-13 and 15) of U.S. Patent No. 11253704
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Conclusion
Applicant's amendment necessitated the new grounds 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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792