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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the venting sub-system must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Venting sub-system in claims 1 and 10 will be interpreted as any system capable of venting.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-13, 16, and 20 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 limitation “venting sub-system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, the disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-8, 10-13, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boukhny et al. (US 2011/0015563 A1—previously cited) in view of Wells et al. (US 20140364885 A1).
Regarding claim 1, Boukhny discloses a smart auto phaco phacoemulsification system (paras. [0045]-[0110]), comprising: a surgical console 114 (para. [0046]) having at least one computing processor 116 capable of accessing at least one computing memory (para. [0049]-[0052]) associated with the at least one computing processor (para. [0049]-[0052]), wherein the surgical console is configured to receive one or more configuration variables (para. [0049]-[0052] ); and a surgical instrument 112 comprising a surgical tip 113, wherein the processor is configured to: track time duration during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure, initiate a reset of ultrasound power in response to the time duration reaching a threshold value, and cause the surgical instrument to release or dispense the at least one or more particles from the at least one surgical tip in accordance with the one or more configuration variables (i.e., para. [0069] discloses the temperature of the eye (i.e., threshold value) is determined by performing calculations at specific time intervals, para. [0070] discloses that the amount of power is reduced based on decreasing the duty cycle of the ultrasound signal if the estimated temperature exceeds the threshold value; see also (para. [0076]-[0084] such that power may be pulsed or reset, therefore, the amount of time that the power is “on” is tracked and can be pulsed or shut “off” for a period of time depending on the temperature reaching or exceeding a threshold value, as such the surgical instrument would release the particles of tissue from the distal end that were being treated during the burst (see paras. [0084]-[0086]) and additionally discloses aspiration vacuum and irrigation pressure (paras. [0050]-[0060]); note: see also paras. [0088]-[0089] which discloses not only duration of both cutting intervals and sense intervals, but also that during the interval a maximum amount of power (i.e., all of the power by the surgeon’s request as disclosed by para. [0089]), and the next cutting interval have no power)).
Boukhny doesn’t directly disclose a venting sub-system.
In the same field of endeavor, namely ocular lens cutting devices, Wells discloses a venting sub-system (see paras. [0032]-[0034] in which power can be controlled and in response, the venting sub-system can also be controlled (see paras. [0032]-[0034]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny and Kuebler to have a venting sub-system in which aspiration and/or irrigation can be controlled based on the power change for purposes of performing the aspiration and irrigation during the surgical procedure through one system (para. [0034]).
Regarding claim 2, Boukhny and Wells disclose the system of claim 1. Boukhny also discloses wherein the one or more configuration variables include one or more of: auto phaco on/off (para. [0077]), max power (para. [0077]), max VAC (para. [0050]), threshold (para. [0068]), and total active time (para. [0069], [0073], [0077]-[0080]).
Regarding claim 3, Boukhny and Wells disclose the system of claim 2. Boukhny also discloses the one or more configuration variables are entered into the system by a user (para. [0072]).
Regarding claim 4, Boukhny and Wells disclose the system of claim 2. Boukhny also discloses the one or more configuration variables are based on historical data gathered over time with respect to a specific surgeon (para. [0051]).
Regarding claim 5, Boukhny and Wells disclose the system of claim 2. Boukhny also discloses the one or more configuration variables are based at least in part on user-entered variables and historical (para. [0049]-[0051]).
Regarding claim 6, Boukhny and Wells disclose the system of claim 2. Boukhny also discloses additional variables are determined in response to the one or more configuration variables being related, sharing same functionalities, or depending on each other (para. [0049]-[0052]).
Regarding claim 7, Boukhny and Wells disclose the system of claim 6. Boukhny also discloses the additional variables are extracted and calculated from the inputted one or more configuration variables (i.e., see para. [0049]-[0052], [0073]-[0077]).
Regarding claim 8, Boukhny and Wells disclose the system of claim 6. Boukhny also discloses the at least one computer processor is configured to cause an ultrasound power reset based at least in part on an ultrasound power condition meeting at least one of the additional variables (paras. [0072]-[0080]).
Regarding claim 10, Boukhny discloses an auto phaco system (paras. [0045]-[0110]) including a surgical console 114 (para. [0046]) and a surgical instrument 112, the system having at least one processor 116 coupled to a memory (para. [0049]), the processor being configured to: receive one or more data inputs as initial data settings (variables; para. [0049]-[0052]); extract one or more further data inputs from the received one or more data inputs (paras. [0061], [0068]-[0070]), track time duration during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure, initiate a reset of ultrasound power in response to the time duration reaching a threshold value, and cause the surgical instrument to release or dispense the at least one or more particles from the at least one surgical tip in accordance with the one or more configuration variables (i.e., para. [0069] discloses the temperature of the eye (i.e., threshold value) is determined by performing calculations at specific time intervals, para. [0070] discloses that the amount of power is reduced based on decreasing the duty cycle of the ultrasound signal if the estimated temperature exceeds the threshold value; see also (para. [0076]-[0084] such that power may be pulsed or reset, therefore, the amount of time that the power is “on” is tracked and can be pulsed or shut “off” for a period of time depending on the temperature reaching or exceeding a threshold value, as such the surgical instrument would release the particles of tissue from the distal end that were being treated during the burst (see paras. [0084]-[0086]) and additionally discloses aspiration vacuum and irrigation pressure (paras. [0050]-[0060])).
Boukhny doesn’t directly disclose a venting sub-system.
In the same field of endeavor, namely ocular lens cutting devices, Wells discloses a venting sub-system (see paras. [0032]-[0034] in which power can be controlled and in response, the venting sub-system can also be controlled (see paras. [0032]-[0034]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny and Kuebler to have a venting sub-system in which aspiration and/or irrigation can be controlled based on the power change for purposes of performing the aspiration and irrigation during the surgical procedure through one system (para. [0034]).
Regarding claim 11, Boukhny and Wells disclose the system of claim 10. Boukhny also discloses the received one or more data inputs are received from a user interface (para. [0072]).
Regarding claim 12, Boukhny and Wells disclose the system of claim 10. Boukhny also discloses the received one or more data inputs are based on historical data (para. [0051]).
Regarding claim 13, Boukhny and Wells disclose the system of claim 10. Boukhny also discloses the received one or more data inputs are received from a user interface and based on historical data (para. [0049]-[0051]).
Regarding claim 20, Boukhny and Wells disclose the system of claim 1. Boukhny further discloses a fluid line 130, 132, 134 operatively coupled to the surgical instrument (para. [0049]); and a sensor 122 operatively coupled to the fluid line (para. [0049]), wherein the sensor is configured measure a pressure in the fluid line (para. [0049]), wherein the at least one computing processor is configured to detect an occlusion at the at least one surgical tip based on a pressure measurement (para. [0050]-[0053]), and wherein the at least one computer processor is further configured to cause an ultrasound power reset and to active the venting system based on detection of the occlusion for a period of time (para. [0067]-[0080]).
The combination of Koukhny and Wells would also disclose activating the venting sub-system (see above).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Boukhny and Wells and further in view of Kuebler (US 2011/0092896 A1—previously cited).
Regarding claim 9, Boukhny and Wells discloses the system of claim 6. Boukhny doesn’t directly disclose discloses the system is configured to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables.
In the same field of endevaor, namely surgical systems, Kuebler discloses (paras. [0022]-[0032] a similar device including a handpiece 4 of a phaco-emulsification system that includes vibrating tip 5, an irrigation line 3, an irrigation valve 40, and a venting valve 17. Kuebler also discloses the venting system is configured to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables (para. [0029]-[0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables for purposes of forcing the particle causing an occlusion away from the needle tip such that the occlusion is no longer present in the system (para. [0029]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Boukhny in view of Wells.
Regarding claim 16, Boukhny and Wells disclose the system of claim 10. Boukhny and Wells dont expressly disclose the threshold value is 3 seconds as required by the claim.
Instead, Boukhny discloses recording over a period of time, temperature calculations (para. [0069]), and that the temperature needs to be optimized such that it doesn’t reach a temperature threshold to cause tissue damage. As such, the device has “on” and “off” times to reduce the temperature of the tip. Therefore, the time that the power is on (and off) is disclosed to be a result effective variable in that changing the time would change the temperature of the tip during the treatment (para. [0080]). Additionally, the Applicant’s disclosure does not teach any criticality or importance to the value being 3 seconds (para. [0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny and Wells by having the time to 3 seconds (i.e., to keep the device cool) as a matter of routine optimization since a person of ordinary skill in the art would have a reasonable expectation of success and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm 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 on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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