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 without traverse of Group I in the reply filed on January 27, 2026 is acknowledged.
In response to Applicant’s traversal of the species election, the examiner notes that Applicant’s response is technically incomplete. Per 37 CFR 1.143, in requesting reconsideration the applicant must indicate a provisional election of one invention for prosecution, which invention shall be the one elected in the event the requirement becomes final. In Applicant’s response on pg. 3, it appears that Applicant is electing the “embodiment” of figs. 8-9 for Group I and 10-12 of Group II. This election encompasses all species set forth in the Restriction Requirement so that the election is improper as it does not encompass one invention set forth in the restriction requirement. Nevertheless, Applicant’s arguments are persuasive; as such, the restriction requirement between species has been withdrawn.
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.
Claim 9 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.
Regarding claim 9, the claim recites that the distal tip of the cannula extends distally beyond a distal end of the third lumen at the proximal travel limit. This claim has been amended to be dependent on claim 8 which recites that the distal tip is within the third lumen at the proximal travel limit. There is insufficient support for the distal tip of the cannula to be both beyond the distal end of the third lumen and within the third lumen at the proximal travel limit. Additionally, the claim introduces indefiniteness issues, discussed below.
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 9 and 16-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the claim recites that the distal tip of the cannula extends distally beyond a distal end of the third lumen at the proximal travel limit. This claim has been amended to be dependent on claim 8 which recites that the distal tip is within the third lumen at the proximal travel limit. It is unclear how the distal tip of the cannula can be both beyond the distal end of the third lumen and within the third lumen at the proximal travel limit.
Claim 16 recites the limitation "the lumen of the body" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 17 and 18 are also rejected by virtue of being dependent on claim 16.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-19 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ha (US 20160287851).
Regarding claim 19, Ha discloses a system (fig. 31) comprising:
a body configured to releasably couple with an endoscope (handle 650 in fig. 32);
a tube affixed to the body (guide catheter 530 in fig. 33A);
a cannula configured to be slidably disposed in a lumen of the tube (catheter 540 in fig. 33A); and
a cannula handle affixed to a proximal end of the cannula (actuator 654 in fig. 33A; the examiner notes that the proximal end is not defined so that the position where actuator 654 is attached to catheter 540 is considered the “proximal end”).
Regarding claim 16, Ha discloses the lumen of the body is a first lumen configured to slidably receive a shaft of an endoscope (lumen of cylindrical knuckle 653 in fig. 33A; paragraph 188 discloses the endoscope translating), wherein the body further comprises a second lumen (see below), and wherein the cannula handle engages with the body both at a distal travel limit (fig. 33F) and a proximal travel limit (fig. 33A-E).
PNG
media_image1.png
304
348
media_image1.png
Greyscale
Regarding claim 17, Ha discloses the cannula is slidable within the tube, distally and proximally, relative to the body (fig. 33A and 33F; paragraph 193) between: (i) the distal travel limit at which a first portion of the cannula handle abuts a first portion of the body (fig. 33F) and (ii) the proximal travel limit at which a second portion of the cannula handle abuts a second portion of the body (fig. 33A-E).
Regarding claim 18, Ha discloses the endoscope (endoscope 460 in fig. 32).
Regarding claim 24, Ha discloses the cannula handle comprises a radial projection (see below) configured to extend through a slot defined by the body when the cannula handle engages the body (channel 658 in fig. 31).
PNG
media_image2.png
282
422
media_image2.png
Greyscale
Claim(s) 16, 17, 19, 23, and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson (US 20210361477 ).
Regarding claim 19, Johnson discloses a system (fig. 1A) comprising:
a body configured to releasably couple with an endoscope (housing 110 in fig. 1A);
a tube affixed to the body (outer cannula 120 in fig. 1A);
a cannula configured to be slidably disposed in a lumen of the tube (inner catheter 115 in fig. 1A); and
a cannula handle affixed to a proximal end of the cannula (connector 105 in fig. 1A).
Regarding claim 16, Johnson discloses the lumen of the body is a first lumen configured to slidably receive a shaft of an endoscope (see below; the lumen below is functionally capable of slidably receiving a shaft of an endoscope), wherein the body further comprises a second lumen (see below), and wherein the cannula handle engages with the body both at a distal travel limit (fig. 1B) and a proximal travel limit (fig. fig. 1A).
PNG
media_image3.png
302
744
media_image3.png
Greyscale
Regarding claim 17, Johnson discloses the cannula is slidable within the tube, distally and proximally, relative to the body (fig. 1A and 1B) between: (i) the distal travel limit at which a first portion of the cannula handle abuts a first portion of the body (fig. 1Band (ii) the proximal travel limit at which a second portion of the cannula handle abuts a second portion of the body (fig. 1A).
Regarding claim 23, Johnson discloses a distal tip portion of the cannula comprises a curved portion that is curved between 70° and 110° (fig. 1B shows a curved distal tip portion; the examiner notes that the angle is not defined relative to any other structure so that the curve formed by the tip of inner catheter 115 is considered to be within the claimed angle), wherein the curved portion is compliant and resilient (paragraph 14 discloses shape memory materials) such that: (i) the curved portion straightens to conform to the lumen of the tube when the curved portion is positioned within the lumen of the tube (fig. 1A) and (ii) the curved portion is curved when the curved portion is positioned outside of the lumen of the tube (fig. 1B).
Regarding claim 24, Johnson discloses the cannula handle comprises a radial projection configured to extend through a slot defined by the body when the cannula handle engages the body (see below).
PNG
media_image4.png
294
553
media_image4.png
Greyscale
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha, as applied to claim 19 above, and in view of Sudhoff (US 20200406014).
Regarding claim 20, Ha discloses all of the claimed limitations set forth in claim 19, as discussed above, and further discloses that the system is configured to deliver an otic treatment fluid (paragraph 147) and is used to treat an ear disorder (paragraph 2). However, Ha does not explicitly teach or disclose a source of an otic treatment fluid in communication with the cannula so as to deliver from the cannula an otic treatment fluid to treat at least one of: hearing loss, tinnitus, balance disorders, vertigo, Meniere's disease, vestibular neuronitis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain.
Sudhoff is directed towards a system (fig. 1) which further comprises a source of an otic treatment fluid in communication with the cannula so as to deliver from the cannula an otic treatment fluid to treat hearing loss (paragraph 24 discloses a syringe comprising cortisone to treat acute hearing loss; paragraph 20 discloses the catheter 2 comprises a luer lock 4 which can receive a syringe). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of Ha to include the source of an otic treatment fluid in communication with the cannula so as to deliver from the cannula an otic treatment fluid to treat hearing loss, as taught by Sudhoff, in order to treat hearing loss using the system of Ha, thus rendering it operable for its intended purpose.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, as applied to claim 19 above, and in view of Kaji (US 6126633).
Regarding claim 21, Johnson discloses all of the claimed limitations set forth in claim 19, as discussed above, but does not teach or disclose the body comprises a ring, and wherein the cannula handle is slidably disposed within the ring while the cannula is disposed within the lumen of the tube.
Kaji is directed towards a similar system comprising a cannula (tube 42b in fig. 12) slidably disposed within a lumen of a tube (tube 2b in fig. 12) which is affixed to a body (mount 43 in fig. 12). Kaji further teaches the cannula comprises a cannula handle (slider 44 in fig. 12) which is slidably received within the body (mount 43 in fig. 12). Kaji teaches the body comprises a ring (grooves 49 form recessed rings which receive O-ring 51), and wherein the cannula handle is slidably disposed within the ring while the cannula is disposed within the lumen of the tube (9:24-35).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the body and the cannula handle of Johnson to comprise the rings on the inside of the body and to have an O-ring on the outside of the cannula handle, as taught by Kaji. This modification would enable the handle to be retained in a variety of positions to adjust the extension of the cannula.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha.
Regarding claim 22, Ha discloses all of the claimed limitations set forth in claim 19, as discussed above. However, in this embodiment, Ha does not explicitly teach or disclose the tube comprises a surface treatment.
In a different embodiment (fig. 7A), Ha teaches a tube (guide catheter 100 in fig. 7A) which comprises a surface treatment (paragraph 129 discloses the guide catheter 100 can comprise a “PTFE liner”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the tube of the first embodiment of Ha (fig. 33A) to comprise a surface treatment in the form of a PTFE liner in order to ease insertion of the balloon catheter through the guide catheter.
Allowable Subject Matter
Claims 1-8, 10, and 11 are allowed over the prior art of record.
The following is an examiner’s statement of reasons for allowance: The claims in this application are allowed because the prior art of record fails to disclose either singly or in combination the claimed system.
The closest prior art of record is Ha.
Regarding independent claim 1, Ha fails to teach among all the limitations or render obvious a cannula handle defining a fifth lumen that is continuous with the fourth lumen of the cannula, in combination with the total structure and function as claimed.
Ha discloses a system for delivering a therapeutic formulation to treat an ear condition of a patient (fig. 31), the system comprising:
a body configured to releasably couple with an endoscope (handle 650 in fig. 32), the body defining: (i) a first lumen configured to slidably receive a shaft of the endoscope (lumen formed by cylindrical knuckle 653 in fig. 33a) and (ii) a second lumen (see below);
PNG
media_image1.png
304
348
media_image1.png
Greyscale
a tube affixed to the body (guide catheter 530 in fig. 33a) and defining a third lumen that is continuous with the second lumen of the body (fig. 33a shows the lumen of the guide catheter 530 receiving catheter 540);
a cannula configured to be slidably disposed in the third lumen of the tube and defining a fourth lumen (catheter 540 in fig. 33a; paragraph 193 discloses the catheter 540 sliding); and
a cannula handle affixed to a proximal end of the cannula (actuator 654 in fig. 33a is attached to a proximal end of the cannula; the examiner notes that the proximal end is not further defined so that the end of the cannula where the actuator is attached is considered to encompass the proximal end) and defining a fifth lumen (bore 668 in fig. 33A),
wherein, while the cannula is disposed within the third lumen of the tube, the cannula and the cannula handle are slidable, distally and proximally, relative to the body between: (i) a distal travel limit at which a first portion of the cannula handle abuts a first portion of the body (fig. 33F) and (ii) a proximal travel limit at which a second portion of the cannula handle abuts a second portion of the body (fig. 33A-E).
However, as seen in fig. 33A, the fifth lumen of the cannula handle (bore 668 in fig. 33A) is configured to receive the cannula (catheter 540 in fig. 33A) so that the fifth lumen is not continuous with the fourth lumen of the cannula, as required by the claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. 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.
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights