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, Species A, claims 1-7 and 9-10 in the reply filed on December 16, 2025 is acknowledged.
Claims 8 and 11-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 16, 2025.
Claim Rejections - 35 USC § 112
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 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Claim 9 depends on claim 8, which is directed to a withdrawn species, however, the limitations of claim 9 are mutually exclusive to the species in figures 10-13 and 23-34B. Claim 8 recites the limitation “wherein the distal end effector is self-expanding and transitions toward the expanded state upon exposure from the outer sheath”, whereas claim 9 recites the limitation “the device further comprises a core wire extending through a lumen of the treatment probe, and wherein the core wire is configure to transition the distal end effector from the unexpanded state to the expanded state” in the claim. The specification only describes the core wire transitioning the distal end effector in by active expansion as an alternative to self-expansion as shown in figures 22A-22B and claimed in claim 8. Therefore, it is unclear how the distal end effector both is self-expanding as well as transitions from the unexpanded state to the expanded state via a core wire as required by claim 9. The examiner interprets claim 9 to be dependent on claim 7 for examination purposes.
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 1-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clauson et al (US 20180318132).
Regarding claim 1, Clauson et al (hereafter Clauson) discloses an intraocular device for treating glaucoma, the device comprising: a treatment probe (660; 800) comprising a distal end region (670, 682, 676; 820, 808, 824) and a proximal end region (672, 691, 692, 674; 804), the distal end region including a distal end effector (670, 676, figure 8B; 808, figure 18B) sized to penetrate the trabecular meshwork (paragraph 0136, sized for introduction of a distal end of the shaft into an eye and sizes disclosed in paragraph 0137 would be capable of penetrating the trabecular meshwork); an outer sheath (662; 802) surrounding at least the proximal end region of the treatment probe (figure 8A); and a drive mechanism (paragraph 0019) operatively coupled to a proximal end of the treatment probe and configured to cause oscillatory movement of the proximal end of the treatment probe to vibrate the distal end effector and agitate intraocular tissue in contact with the distal end effector (paragraph 0090, 0009, 0010, 0216)
Regarding claim 2, Clauson discloses all of the limitations set forth in claim 1, wherein the drive mechanism further comprises a piezoelectric crystal stack (paragraph 0013).
Regarding claim 3, Clauson discloses all of the limitations set forth in claim 2, wherein the piezoelectric crystal stack is driven at a frequency of 50 Hz – 40 kHz to vibrate the distal end effector (paragraph 0019).
Regarding claim 4. , Clauson discloses all of the limitations set forth in claim 3, wherein the distal end effector vibrates at a frequency that does not emulsify intraocular tissue (paragraph 0023, below threshold speed for cavitation bubbles to be formed).
Regarding claim 5, Clauson discloses all of the limitations set forth in claim 1, wherein the device further comprises an input (control processor) configured to control the drive mechanism (paragraph 0012)
Regarding claim 6, Clauson discloses all of the limitations set forth in claim 1, wherein the distal end effector is configured to transition from an unexpanded state (figure 8A) having a first outer diameter to an expanded state (figure 8B, 8C, 11) having a second outer diameter that is larger than the first outer diameter (paragraph 0145).
Regarding claim 7, Clauson discloses all of the limitations set forth in claim 6, wherein the first outer diameter of the distal end effector in the unexpanded state is sized to be surrounded by the outer sheath (figure 8A).
Regarding claim 9, Clauson discloses all of the limitations set forth in claim 7, wherein the device further comprises a core wire (672, 674; 820) extending through a lumen of the treatment probe (figure 18A), and wherein the core wire is configured to transition the distal end effector from the unexpanded state to the expanded state (paragraph 0145; 0152-0153).
Regarding claim 10, Clauson discloses all of the limitations set forth in claim 1, wherein the device further comprises an irrigation channel (123) for supplying irrigation fluid (paragraph 0016, 0123) and a vacuum source for applying a vacuum through the device (suction path and source, paragraph 0092-0094).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm 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, Darwin Erezo can be reached at (571) 272-4695. 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.
/ANH T DANG/Primary Examiner, Art Unit 3771