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 .
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 3-10, 12-23, and 38-46 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.
The subject matter which was not described is the decoupling structure oriented at a predetermined angle relative to an axis “of a straight portion of a distal section of the elongate stimulation assembly” within a body chamber of the recipient, in combination with the other element(s) in the claims. The applicant(s) had a general idea of having a structure with this feature by filing the original claim(s) and using similar language in the disclosure, but did not possess the specific details of how this specific structure is carried out when they filed the application.
The disclosure shows a cochlear stimulation assembly have a curved distal section (e.g. figure 3A, element 179; figure 4A, element 479, etc.) and a proximal straight section (e.g. figure 3A, element 168; figure 4A, element 417, etc.), but did not explain how there is a straight portion of a distal section of the elongate stimulation assembly. In addition, the disclosure does not provide a standard for determining what constitutes the proximal section from the distal section.
Similarly, for claim 38, the subject matter which was not described is the angular discontinuity that is non-parallel to an axis “of a straight portion of a distal section of the elongate stimulation assembly” within a body chamber of the recipient, in combination with the other element(s) in the claims. The applicant(s) had a general idea of having a structure with this feature by filing the original claim, but did not possess the specific details of how this specific structure is carried out when they filed the application. The disclosure shows a cochlear stimulation assembly have a curved distal section (e.g. figure 3A, element 179; figure 4A, element 479, etc.) and a proximal straight section (e.g. figure 3A, element 168; figure 4A, element 417, etc.), but did not explain how there is a straight portion of a distal section of the elongate stimulation assembly. In addition, the disclosure does not provide a standard for determining what constitutes the proximal section from the distal section.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-10, 12-23, and 38-46 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.
In claim 3, “a straight portion of a distal section of the elongate stimulation assembly” is vague and inferentially including the straight portion. It is suggested to first state the elongate assembly has a straight section before it is further used in the claim. It is also unclear if the straight portion is pre-formed/molded to be straight, or if the lead is just flexible and a user can just place the lead in a straight orientation. In addition, “straight” means there are no bends or deviations from linear. The use of “a distal section” is vague as the figures in the disclosure show a cochlear stimulation assembly have a curved distal section (e.g. figure 3A, element 179; figure 4A, element 479, etc.) and a proximal straight section (e.g. figure 3A, element 168; figure 4A, element 417, etc.). In the last line, “within a body chamber” is vague and sounds as if there is a connection to the body. Apparatus claims cannot claim a connection to the body and it is suggested to use functional language, such as “when the distal section is within a body chamber…”.
Similarly, claim 38 has these problems.
In claims 4, 6-8, and 14, “a straight portion of a distal section” and “within a body chamber” are vague as claim 3 also uses these terms and it is unclear if they are the same elements or not. If they are the same, then “the straight portion of the distal section” and “within the body chamber” should be used.
In claim 5, “a straight section…within a basal turn” is vague as shouldn’t that portion be curved if it’s within a turn?
In claim 39, “an implantable stimulator unit” is inferentially included and it is unclear if it is being positively recited/claimed or is meant as an intended/functional use. If it is meant to be positively recited, it is suggested to first state the system further comprises the stimulator unit.
Claim 44 is vague and appears to be broadening, instead of narrowing, claim 38. Claim 38 has 3 separate elements—an assembly, a lead, and an angular discontinuity that has an extension region. However claim 44 states the extension comprises an entire length of the lead, and it is unclear if claim 44 is now saying the extension is the lead, and therefore not a separate element.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12-16, 19-23, 38-43 and 45-46 are rejected under 35 U.S.C. 102a1 as being anticipated by Dhanasingh et al (9522268). Dhanasingh meets the claimed limitations as follows:
--a stimulator unit (e.g. abstract, elements 108/701, etc.)
--an elongate stimulation cochlear assembly with electrodes and a distal straight portion (e.g. figure 5, element 501; figure 7, element 703, etc.)
--a flexible lead with a wire connecting the electrode to the stimulator (e.g. abstract, figures 5B and 5C, straight bottom section next to element 509; figure 7, element 702, etc.)
--decoupling structure connecting distal end of lead to proximal end of stimulation assembly (e.g. figure 5B, elements 504-509; figure 5C, element 510, or element 509-506; figure 7, elements 704, 705, and/or 706, etc.) that mechanically decouples torsional, linear, and angular forces (e.g. abstract, col. 3, lines 5-12, etc.). The decoupling structure has a pre-formed bend (e.g. where the decoupling structure meets the elongate stimulation assembly-- e.g. figure 5B, near where element 504 meets 501; figure 5C, element 510; figure 7, elements 704, 705, or 706, meet 703, etc.) and a proximal extension that is oriented at an angle to a straight portion of a distal section of the stimulation assembly and is also non-parallel (e.g. proximal length of the decoupling structure before the pre-formed bend meets the elongate stimulation assembly).
For claims 3-8, Dhanasingh shows the bend at approximately 90 degrees to the straight section (e.g. figure 5b, near numeral 504; figure 7, where element 704 or 706 meets stimulation assembly 703, etc.). For claim 9, the bend is malleable and moldable during insertion (e.g. col. 3, lines 5-6, etc.). For claim 10, the material may be pre-molded into the angle (e.g. nitinol, col. 3, lines 10-12, figure 6, col. 6, lines 40-59, etc.). For claims 12 and 13, the pre-formed bend is a pre-biased shape element that can be straightened or configured to adopt the predetermined angle after implantation, as the system can be straightened and or molded after insertion (e.g. figure 6, col. 6, lines 48-49; col. 3, lines 5-6, etc.). For claims 15, 16, 45, and 46, Dhanasingh shows in the figures, such as figure 5b, the length of the extension (e.g. from element 505 to element 509) being at least 10 times the diameter of the stimulation assembly (in the alternative, see the 103 rejection below). For claim 19, the proximal section does has a linear shape (e.g. figure 5b, straight/linear section from area 503 toward numeral 507, etc.). For claims 20-23, the shape can be non-linear, a coil, undulating or serpentine (e.g. figure 5b for non-linear, undulating or serpentine; figure 6b for coil or non-linear, etc.).
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.
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 17 and 18, and in the alternative claims 15, 16, 45, and 46, are rejected under 35 U.S.C. 103 as being unpatentable over Dhanasingh et al. Dhanasingh discloses the claimed invention except for the predetermined length being at least 2.5 or 5 mm, and in the alternative, the first length being at least 5/10 times the diameter of the elongate assembly. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Dhanasingh, with the predetermined length being at least 2.5 or 5 mm, and in the alternative, the first length being at least 5/10 times the diameter of the elongate assembly, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of providing enough slack/length for the structure to effectively decouple any forces from the lead onto the assembly.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/George R Evanisko/Primary Examiner, Art Unit 3792 2/25/26