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 .
Status of Claims
As directed by the amendment filed on 16 January 2025: claim(s) 1-8 have been cancelled. Thus, claims 9-21 are presently pending.
Claim Objections
Claims 17 and 19 are objected to for improperly depending on cancelled claim 8. They are presumed to be dependent upon claim 9 for present examination. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims do not further limit the flow rate of Claim 14. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bandhauer et al. (US 20080114301 A1).
Regarding Claim 9, Bandhauer discloses a system for identifying a surgical cassette in a phacoemulsification surgery ([0017]), the system comprising:
a cassette ("cassette 16" [0040]; FIG. 1) comprising one or more fluid channels ("cassette may include a surgical fluid network" [0039]), at least one pressure sensor ("pressure sensor" [0039]), and aspiration tubing ("resiliently deformable tubing" [0039]); wherein the at least one pressure sensor is in fluid communication with the one or more fluid channels and the aspiration tubing ("fluid network of the cassette may include resiliently deformable tubing, a pressure sensor, a holding tank or chamber, and the like" [0039]); and
a surgical console ("console 14" [0040]; FIG. 1) comprising a controller ("controller 40" [0043]) and a cassette receiving area for engaging the cassette ("cassette receptacle" [0017]);
wherein the controller is configured to record a plurality of pressure measurements from the at least one pressure sensor during an unoccluded vacuum applied to the cassette and compare the plurality of pressure measurements to a predetermined value indicative of an identifiable cassette type ("level of vacuum within the aspiration flow network may be identified in part with reference to a vacuum sensor 64 disposed along the aspiration flow network 50 between peristaltic pump 54 and handpiece 12" [0046-0047]); and
wherein the predetermined value is a function of flow rate and restriction to flow caused by an inner diameter of the aspiration tubing, the one or more fluid channels, or both ("To determine the appropriate flow rate, the level of vacuum within the aspiration flow network may be identified in part with reference to a vacuum sensor 64 disposed along the aspiration flow network 50 between peristaltic pump 54 and handpiece 12" [0048]).
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.
Claim(s) 10-13, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandhauer in view of Muser et al. (US 20170165405 A1).
Regarding Claims 10-13, 15, and 17, Bandhauer fails to specify the controller is configured to record the plurality of pressure measurements and the value of the unoccluded vacuum. However, Muser teaches “a pressure sensor configured to measure pressure in a fluid flow path” ([0007]) wherein the controller is configured to record the plurality of pressure measurements ("suitable number of latest pressure sensor readings" [0106]) when the measurable flow rate is greater than 10 mil/min ([0104]); the controller is configured to record the plurality of pressure measurements ("suitable number of latest pressure sensor readings" [0106]) when the measurable flow rate is less than 80 mil/min ([0104]); the controller is configured to record the plurality of pressure measurements within a ten minute interval ("2 minutes" [0109]); the unoccluded vacuum is between about 80mmHg and 0mmHg ("above 0 mmHg" [0040]); the unoccluded vacuum is between about 0mmHg and -320mmHg ("−80 mmHg, or between about −20 mmHg and −200 mmHg" [0039]); the unoccluded vacuum is between about -80mmHg and -440mmHg ("−80 mmHg, or between about −20 mmHg and −200 mmHg" [0039]). NOTE: since Muser device is structurally able to perform the function measuring pressure during the claimed environments, Muser meets the claim even though Muser does not specify the claimed flow rate range. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bandhauer to incorporate the teachings of Muser to “determine a rate of flow in the fluid flow path”, “detect presence of one or more leaks in the fluid flow path based at least in part on the pressure in the fluid flow path and the rate of flow in the fluid flow path, and provide indication of presence of one or more leaks.” ([0007])
Claim(s) 14, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandhauer/Muser in view of Plahey et al. (US 20200397969 A1).
Regarding Claims 14, 16, and 18, Bandhauer fails to specify the flow rate is about 10 ml/min, 40 ml/min, or 60 ml/min. However, Plahey teaches “a pressure sensor or other sensing means can be used to detect that the flow rate of fluid … is lower than a threshold value” ([0024]) wherein the flow rate is about 10 ml/min, 40 ml/min, or 60 ml/min ("fluid flow rate to be greater or less than 30 mL/min" [0090]), ("approximately 30 milliliters per minute" [0090]), ("50 mL/min" [0095]). Therefore, it would have been obvious to modify Bandhauer/Muser to suitably define a cassette type ([0085]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandhauer in view of Kishimoto (US 20170042731 A1).
Regarding Claims 19-20, Bandhauer fails to specify the inner diameter of the aspiration tubing is less than or greater than 0.10 inch. However, Kishimoto teaches an “intraocular surgery system” comprising pressure sensors ([0048]) and aspiration tubes ([0007]) wherein the inner diameter of the aspiration tubing is less than or greater than 0.10 inch ("inner diameter of the first aspiration tube 31 is preferably within the range of 0.9 mm to 3.0 mm" [0032]; NOTE: 0.1 inch ≈ 2.54 mm). Therefore, it would have been obvious to modify Bandhauer “to reduce the aspiration flow rate without lowering the aspiration pressure” ([0005]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandhauer in view of Look et al. (US 20150327875 A1).
Regarding Claim 21, Bandhauer fails to specify the outer diameter of the aspiration tubing is less than 0.20 inch. However, Look teaches “a system for aspirating thrombus includes an aspiration catheter” ([0009]) wherein the outer diameter of the aspiration tubing is less than 0.20 inch ("aspiration catheter 118 outer diameter of about seven French or less" [0088]). Therefore, it would have been obvious to modify Bandhauer to suitably customize the device for desired target area ([0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781