DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group II (claims 45-62) in the reply filed on July 13, 2026 is acknowledged. The traversal is on the grounds that “the Restriction does not assert that the different modes are material. Only that they are different” (page 7 of Remarks). This is not found persuasive because the Applicant has not explicitly presented grounds as to why they traverse the determination that the mode recited in Invention I is materially different than the mode recited in Invention II.
“The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect”. See MPEP § 806.05(j).
As previously made of record and repeated in the Applicant’s Remarks on Page 7, “Invention I does not require determining if trauma has occurred based on the difference between measured electrical properties at different locations. Therefore, the inventions have different modes of operation”.
As such, for the reasons stated above and previously made of record, the Applicant’s argument that the restriction does not assert that “the different modes are material” is not persuasive.
Additionally, the applicant traverses “the assertion that there is serious search and/or examination burden” (page 8 of Remarks). However, the Applicant fails to provide any grounds for asserting that there is no serious search and/or examination burden. As such, in absence of any explicit arguments, the contention that there is no serious search and/or examination burden is found to be unpersuasive.
Therefore, for the reasons stated above, the requirement is still deemed proper and is therefore made FINAL.
Claims 37-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 13, 2026.
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 45, 51 and 60-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,590,343. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,590,343 has been found to anticipate each and every element of the present invention, for instance both provide:
18/114,662 (claim 45)
11,590,343 (claim 1)
A method, comprising: energizing one or more electrodes of a cochlear electrode array to induce a current flow in the cochlea at a plurality of locations;
A method, comprising: energizing one or more electrodes of a cochlear electrode array to induce a current flow in the cochlea at a plurality of temporal locations;
measuring one or more electrical properties at at least two different locations resulting from the induced current flow at the plurality of different locations;
measuring one or more electrical properties at one or more locations in the cochlea resulting from the induced current flow at the plurality of different temporal locations;
and determining whether or not trauma has occurred based on a difference between the measured electrical properties at the respective different locations.
determining whether or not trauma has occurred based on a change between the measured one or more electrical properties from a first temporal location to a second temporal location of the plurality of different temporal locations;
As to claim 51, since “a diffusion technique” is not discloses, “a diffusion technique is not used to determine whether or not trauma has occurred”.
As to claim 60, the at least two different locations are different temporal locations (see Claims 1 and 20 of US 11,590,343); a change between the one or more electrical properties has occurred between the different temporal locations (see Claims 1 and 20 of US 11,590,343); the change is a change that is indicative of fibrous tissue growth (clot; see Claims 1 and 20 of US 11,590,343) within the cochlea if the temporal period was longer than a day; and the method includes determining that insertion trauma has occurred because the determined time period is less than a day.
As to claim 61, The action of determining whether or not trauma has occurred includes determining that there is blood in the cochlea; and the method further includes monitoring spread of the blood in the cochlea based on impedance measurements between electrodes inside the cochlea, the impedance measurements corresponding to the measured one or more electrical properties (see Claims 1, 20 and 23 of US 11,590,343).
As to claim 62, the electrical properties are voltages; the action of determining whether or not trauma has occurred includes determining that trauma has not occurred; and trauma has not occurred (see Claim 10 of US 11,590,343).
As set forth above, the present invention is not viewed to be patentably distinct from US 11,590,343.
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 46-49, 52-53 and 57-59 is 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.
The specification discloses “In accordance with an exemplary embodiment, there is a method, comprising energizing one or more electrodes of a cochlear electrode array to induce a current flow in the cochlea at a plurality of temporal locations, measuring one or more electrical properties at one or more locations in the cochlea resulting from the induced current flow at the plurality of different temporal locations, and determining whether or not trauma has occurred based on a change between the measured electrical properties from the first temporal location to the second temporal location”([0008]).
However, there is no specification support for “the at least two different locations are spatial locations” as recited in claims 46 and 57-58 or “the different locations are spatial locations” in claim 52.
It is noted that “spatial locations” is mentioned in the specification, “in an exemplary embodiment, there is a method of evaluating the temporal locations of increases in impedance measurements at different spatial locations along the electrode array and comparing the spatial locations and the temporal locations to each other to determine the location of the trauma” ([0085]). However, this describes the supports for the limitation of “measuring one of more electrical properties [impedance] at at least two different [temporal] locations resulting from the induced current flow at the plurality of different locations” not “two different spatial locations” as recited by 46, 52 and 57-58.
Claim 50 is 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. The specification discloses “Note also that in an exemplary embodiment, it is possible that diffusion techniques are not utilized per se. In this regard, by way of example, putting cold water into a pool where the body of water has a higher temperature than the cold water will result in the temperature near the introduction of the cold water being lower than it locations elsewhere from the pool, even though the cold water is constantly being diffused throughout the pool. Indeed, plot B of FIG. 12 can represent this phenomenon, or, in another scenario, the impedances can be elevated at many if not all locations along the array, but the most pronounced impedance increase could be at the location proximate the trauma” ([0088]). Thus while the specification does mention “diffusion technique” in paragraph 88, it is to that a diffusion technique “are not utilized per se”. Therefore, there is no support for the limitation of “a diffusion technique is used to determine whether or not trauma has occurred”.
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 45, 52-53 and 58-59 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 45 recites: “to induce a current flow in the cochlea at a plurality of locations” in lines 2-3; “measuring one or more electrical properties at at least two different locations resulting from the induced current flow at the plurality of different locations” in lines 4-5; “at the respective different locations” in line 7. It is unclear if the “at least two different locations” from lines 4-5 are considered part of the “plurality of locations” from lines 2-3 or are they different elements of the claimed invention. Additional are the “respective different locations” a separate element or is it referring to the “at least two different locations” from lines 4-5 or the “plurality of locations” from lines 2-3. Further clarification is requested.
Claim 52 recites the limitation "different measurements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
NOTE: Claim 45, from which claim 52 depends, recites “measuring electrical properties” and “determining whether or not trauma has occurred based on the difference between the measured electrical properties”. If the “different measurements” are supposed to represent the “measured electrical properties”, the examiner recommends amending claim 52 from “and the different measurements are taken in a single given temporal period” to --and the measured electrical properties are taken in a single given temporal period--.
As to claim 53, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 53 recites the broad recitation “at least ten different spatial locations”, and the claim also recites of the at least two different spatial locations” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
NOTE: if the applicant considers the “at least two” to comprise “at least 10” the examiner recommends amending the claim language for clarity to -- the at least two different spatial locations are at least ten different special locations--.
Claim 58 recites the limitation “the action of measuring an electrical property(s) at a location in the cochlea” in line 3. There is insufficient antecedent basis for the limitation for the action of measuring electrical property(s) “at a location in the cochlea”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 45-49, 51-52, 54, 57, 60 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Downing et al. (US 2015/0320550 A1).
As to claim 45, as best understood in light of the rejection under 35 U.S.C. 112 above, Downing et al. discloses energizing one or more electrodes (tip elements, depicted as 745, 750 in Figure 7A; [0024, 0040]) of a cochlear electrode array ([0024, 0040]; the cochlear electrode array is comprised of the tip electrode elements and the linear array of electrodes) to induce a current flow in the cochlea at a plurality of locations ([0040]; Figure 7A); measuring one or more electrical properties at at least two different locations ([0040-0041, 0043-0045]; Figures 7A-7B) resulting from the induced current flow at the plurality of different locations ([0040-0041, 0043-0044, 0049, 0052]); and determining whether or not trauma has occurred based on a difference between the measured electrical properties at the respective different locations ([0043, 0050]).
As to claim 46, Downing et al. discloses the at least two different locations are spatial locations (tip elements, depicted as 745, 750 in Figure 7A, are located at two different spatial locations. Additionally, tip electrode elements and linear array electrodes are located at two different spatial locations).
As to claim 47, Downing et al. discloses at least two different locations are at different spatial locations along the electrode array (Figure 7A; tip elements, depicted as 745, 750 in Figure 7A, are located at two different spatial locations along the electrode array. Additionally, tip electrode elements and linear array electrodes are located at two different spatial locations along the electrode array).
As to claim 48, Downing et al. discloses the least two different spatial locations are at a same location within the cochlea (Figure 5A and 7A-7B; the two tip elements are located at two different spatial location in the same location with the cochlea as compared to the linear array electrodes in 5A and 7A; [0021, 0049]).
As to claim 49, Downing et al. discloses the measured one or more electrical properties at a first location of the two different locations is significantly different from that at a second location of the two different locations ([0055]); and the determination of whether or not the trauma has occurred includes determining that trauma has occurred based on the significant difference ([0044, 0050, 0058-0059]).
As to claim 51, as best understood in light of the rejection under 35 U.S.C. 112 above, Downing et al. does not disclose a diffusion technique. Thus, “a diffusion technique is not used to determine whether or not trauma has occurred”.
As to claim 52, Downing et al. discloses the different locations are spatial locations (tip elements, depicted as 745, 750 in Figure 7A, are located at two different spatial locations. Additionally, tip electrode elements and linear array electrodes are located at two different spatial locations); and the different measurements are taken in a single given temporal period (since the measurements are taken within a time period, the different measurements are considered to be taken in a “single given temporal period”).
As to claim 54, Downing et al. discloses determining that trauma has occurred ([0043]); and therapeutically treating the cochlea upon the determination that trauma has occurred ([0043-0044]; mitigating and minimizing trauma, under the broadest reasonable interpretation, is “therapeutically treating” the cochlea” upon the determination that trauma has occurred).
As to claim 57, Downing et al. discloses the two different locations are spatial locations (tip elements, depicted as 745, 750 in Figure 7A, are located at two different spatial locations. Additionally, tip electrode elements and linear array electrodes are located at two different spatial locations); and the method further comprises: determining that trauma has occurred ([0043-0044]; Figure 7A); analyzing the change in the measured electrical property(s) to identify a location along the electrode array of the measured electrical property(s) ([0043-0044]); and determining the location of the trauma within the cochlea based on location along the electrode array ([0043-0045, 0047-0050]).
As to claim 60, Downing et al. discloses the at least two different locations are different temporal locations ([0043-0045]; monitoring long term health of the regions of the cochlea and auditory nerve [0045] there would be different measurements at different time periods and thus at different temporal locations); a change between the one or more electrical properties has occurred between the different temporal locations ([0043-0045]; trauma unit detects change [0043] and monitoring long term health of the regions of the cochlea and auditory nerve [0045] would also determine if a change had occurred); the change is a change that is indicative of fibrous tissue growth within the cochlea if the temporal period was longer than a day ([0058-0059]); and the method includes determining that insertion trauma has occurred because the determined time period is less than a day ([0043-0044]; detecting trauma resulting from surgical implant of the electrode array would be “determined that insertion trauma has occurred” during the insertion procedure for the electrode array. The insertion procedure would have occurred within a day (24 hours), and thus within a time period that “is less than a day.
As to claim 62, the functional language and introductory statement of intended use of claim 62 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Downing et al. utilizes the electrical properties are voltages ([0040]) and the action of determining whether or not trauma has occurred includes determining that trauma has not occurred ([0041, 0043]) as claimed by the Applicant, Downing et al. is therefore capable of doing so when “air bubbles are present in the cochlea at the time that the one or more electrical properties are measured”. In addition, nothing prevents Downing et al. from measuring electrical properties when air bubbles are present in the cochlea. Therefore, Downing et al. is capable of measuring “one or more electrical properties” when air bubbles are present in the cochlea.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Downing et al. (US 2015/0320550 A1).
As to claim 55, Downing et al. discloses the invention substantially as claimed by determining if trauma has occurred ([0043]) but does not explicitly disclose the action of therapeutically treating the cochlea includes at least one of flushing the cochlea or applying a medicament to the cochlea. Cleansing or flushing an injury site or wound and applying medicament to tissue injuries are extremely well-known treatment processes for facilitating healing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the therapeutic actions of from mitigating trauma in Downing et al. to include flushing the cochlea or applying medicament in order to optimize treatment and healing procedures to meet specific patient therapeutic needs and requirements.
As to claim 56, Downing et al. discloses the invention substantially as claimed by determining if trauma has occurred ([0043]) but does not explicitly disclose the trauma is a tear in a wall of the cochlea. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the means of determining if trauma has occurred to include determining if there is a tear in the wall of the cochlea in order to provide the predictable results of determining the specific type of trauma sustained by the patient in order to customize treatment and facilitate healing of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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 E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
