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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 regarding the amended limitations of “wherein the chamber is configured to remain at least at atmospheric pressure while the vibration mechanism induces vibration in the needle to draw the sample into the port and to the chamber” 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. Specifically, none of either Andino (US 2023/0363941 A1), Yan (US 2022/0249282 A1) or Tumlinson (US 2021/0353455 A1) are relied upon to disclose or teach the amended limitations of claim 1.
Applicant’s arguments, see “Remarks”, filed 12/11/2025, with respect to the rejection(s) of claim(s) 17 under Andino (US 2023/0363941 A1) in view of Yan (US 2022/0249282 A1), further in view of Tumlinson (US 2021/0353455 A1) pertaining to the limitations “maintaining a chamber of a sample container coupled to the needle and in fluid communication with the lumen at least at atmospheric pressure while inducing ultrasonic vibration in the needle to draw a sample of the vitreous into the port and to the chamber” have been fully considered and are persuasive in light of Applicant’s arguments to point out that none of either Andino, Yan or Tumlinson expressly disclose wherein the pressure within the sample container is “maintained” at “at least atmospheric pressure” while a sample of vitreous is drawn into the port and to the chamber. Rather, the sample container of Tumlinson, as incorporated into the device of Andino, would only be held at atmospheric pressure when the vacuum of Andino is turned “off”, resulting in no negative pressure applied thereto. Once the vacuum of Andino is turned on, without a seal or proper separatory structure, the sample container would be brought to a negative vacuum pressure to aspirate a sample into the sample container. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1) and a second non-final rejection is issued herewith.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 12/11/2025, with respect to the objection to claim 10 for reciting “further comprising structure”, which contained a grammatical error, have been fully considered and are persuasive in light of Applicant’s amendment to now recite “further comprising a structure”, which corrected the grammatical error. The objection of claim 10 has been withdrawn.
Claim Interpretation
Applicant's arguments filed 12/11/2025 regarding the 112(f) invocation for the phrase “a mechanism for inducing vibration in the needle” recited in claim 1 have been fully considered in light of Applicant’s amendment to have the cited limitations now recite “a vibration mechanism which is configured to induce vibration in the needle” but they are not persuasive. Applicant contends that, as the recently-amended claim language does not recite the phrase “means for”, a 112(f) invocation is improper. Further, Applicant contends that one of ordinary skill in the art would understand the term has sufficiently definite meaning of the name of the structure that performs the corresponding function. The Examiner respectfully disagrees. Regarding the lack of a “means for” recitation, the phrase “vibration mechanism configured to…” is used as a substitute for the phrase “means for” and is seen as an analogous generic placeholder for performing the claimed function of “inducing vibration in the needle”. The phrase “vibration mechanism configured to…” is further modified by functional language and is not modified by sufficient structure for performing the claimed function. The three-pronged analysis for invoking 112(f) for the cited language is understood to be met and the 112(f) invocation is maintained below.
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: “a vibration mechanism which is configured to induce vibration in the needle” in claims 1 and 21.
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 § 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.
Claim(s) 1-2, 5, 10, 14-17 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1).
Regarding claim 1, Ross discloses:
A device configured to remove vitreous from an eye (removal system 1800, see Fig. 17), comprising:
a needle defining a lumen (needle 1704, see Fig. 17 and Para. [0104]) and a port extending to the lumen (distal opening of the needle, see Fig. 17), the needle being configured for insertion into the vitreous of the eye (see Para. [0002], [0036] and [0046]; all embodiments within the figures are understood to be operable within a patient’s eye unless otherwise stated);
a sample container coupled to the needle (collection receptacle 1734, see Fig. 17 and Para. [0103]) and having a chamber in fluid communication with the lumen (see Fig. 17 and Para. [0103] and [0105]) and being at least at atmospheric pressure (collection receptable 1734 is understood to be at atmospheric pressure when the vacuum is not actively being applied to the surgical site); and
a vibration mechanism (transducer 1714, see Fig. 17 and Para. [0110] and [0111]; the transducer of Ross is equivalent under 112(f) to the structure disclosed in the specification as corresponding to the claimed means plus function limitation, which is an ultrasonic transducer (see Specification Para. [0011])) which is configured to induce vibration in the needle (see Para. [0111]) to draw a sample of the vitreous into the port and to the chamber (see Para. [0111] mentioning wherein the needle undergoes vibration to break up tissue within an eye while simultaneously aspirating said tissue to the collection receptable).
However, Ross does not expressly disclose:
wherein the chamber is configured to remain at least at atmospheric pressure while the vibration mechanism induces vibration in the needle to draw the sample into the port and to the chamber.
In the same field of endeavor, namely devices configured to aspirate material from a patient’s eye through a hollow needle to a proximal collection site, Clauson teaches:
a device for aspirating material from a patient’s eye (see Fig. 1; see also Abstract and Para. [0009]) comprising a hollow needle (shaft 51 defining lumen 6 having a suction path 4 extend therethrough; see Fig. 1 and Para. [0119]) and a sample collection chamber (disposal enclosure 40, see Fig. 1) in fluid communication with the lumen of the hollow needle (see Para. [0117] and Fig. 1);
wherein the suction path within the hollow needle comprises one or more one-way valves (valve(s) 42, see Fig. 1 and Para. [0092] and [0117]) which permit material to move along the suction path within the hollow needle to the collection chamber during aspiration, but isolates the collection chamber from the vacuum pressure during aspiration (see Para. [0092] and [0117]) such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Para. [0092] and [0117]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included one or more one-way valves along the suction path of the hollow needle to the collection receptacle of Ross as taught and suggested by Clauson to, in this case, isolate the collection receptacle from vacuum pressure (i.e., negative pressure) of the suction path such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Clauson Para. [0092] and [0117]). This “isolation” of the collection receptacle from the suction pressure is understood to allow the collection receptacle to be maintained at “at least atmospheric pressure” since no vacuum pressure is applied to or through the collection receptacle.
Regarding claim 2, the combination of Ross and Clauson disclose the invention of claim 1, Ross further discloses wherein the vibration mechanism comprises an ultrasonic transducer (see Para. [0104] mentioning wherein transducer 1714 is an ultrasonic transducer).
Regarding claim 5, the combination of Ross and Clauson disclose the invention of claim 2, Ross further discloses wherein the ultrasonic transducer energizes piezoelectric crystals to cause a solid acoustic horn to vibrate (see Para. [0104] mentioning wherein the piezoelectric ultrasonic transducer of Ross vibrates an acoustic horn. The horn is understood to be “solid” as is common in the art unless otherwise stated).
Regarding claim 10, the combination of Ross and Clauson disclose the invention of claim 1, Ross, as modified by Clauson further discloses a structure for sealing a proximal end of the chamber (proximal wall of the collection receptable, see Ross Fig. 17) and an actuator for sealing a distal end of the chamber (one-way valve of Clauson, as incorporated into the device of Ross, acts as an actuatable seal at the distal end of the collection receptacle).
Regarding claim 14, the combination of Ross and Clauson disclose the invention of claim 1, Ross further discloses wherein a distal end of the needle comprises a sharpened tip (see Fig. 17; see also Para. [0104] mentioning wherein the needle 1704 is a “needle”, understood to be sharp) configured for insertion into or through at least one of a sclera, a pars plana or a vitreous body of the eye (see Para. [0036] and [0046] mentioning wherein the device of Ross is configured to be inserted and used within an eye of a patient).
Regarding claim 15, the combination of Ross and Clauson disclose the invention of claim 1, Ross further discloses a controller configured to control the vibration mechanism for stopping and starting vibration of the needle (control console 1732, see Fig. 17 and Para. [0110]).
Regarding claim 16, the combination of Ross and Clauson disclose the invention of claim 1, Ross further discloses wherein the port, in combination with the vibrating needle, is configured to liquefy the vitreous by disrupting the integrity of the vitreous using at least one of shear force or viscous heat (see Para. [0010] and [0104]).
Regarding claim 17, Ross discloses:
A method for removing vitreous from an eye, comprising:
inserting a needle defining a lumen (needle 1704, see Fig. 17 and Para. [0104]) and a port extending to the lumen (distal opening of the needle, see Fig. 17) into the vitreous of the eye (see Para. [0002], [0036] and [0046]); and
maintaining a chamber of a sample container (collection receptacle 1734, see Fig. 17 and Para. [0103]) coupled to the needle (see Fig. 1) and in fluid communication with the lumen (see Fig. 17 and Para. [0103] and [0105]) at least at atmospheric pressure (collection receptable 1734 is understood to be at atmospheric pressure when the vacuum is not actively being applied to the surgical site).
However, while the sample container of Ross is maintained at “at least atmospheric pressure” when the vacuum is not actively applied to the target site, Ross does not expressly disclose
Wherein the chamber of the sample container is maintained at "at least atmospheric pressure" while inducing ultrasonic vibration in the needle to draw a sample of the vitreous into the port and to the chamber.
In the same field of endeavor, namely devices configured to aspirate material from a patient’s eye through a hollow needle to a proximal collection site, Clauson (US 2019/0254872 A1) teaches a device for aspirating material from a patient’s eye (see Fig. 1; see also Abstract and Para. [0009]) comprising a hollow needle (shaft 51 defining lumen 6 having a suction path 4 extend therethrough; see Fig. 1 and Para. [0119]) and a sample collection chamber (disposal enclosure 40, see Fig. 1) in fluid communication with the lumen of the hollow needle (see Para. [0117] and Fig. 1); wherein the suction path within the hollow needle comprises one or more one-way valves (valve(s) 42, see Fig. 1 and Para. [0092] and [0117]) which permit material to move along the suction path within the hollow needle to the collection chamber during aspiration, but isolates the collection chamber from the vacuum pressure during aspiration (see Para. [0092] and [0117]) such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Para. [0092] and [0117]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included one or more one-way valves along the suction path of the hollow needle to the collection receptacle of Ross as taught and suggested by Clauson to, in this case, isolate the collection receptacle from vacuum pressure (i.e., negative pressure) of the suction path such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Clauson Para. [0092] and [0117]). This “isolation” of the collection receptacle from the suction pressure is understood to allow the collection receptacle to be maintained at “at least atmospheric pressure” since no vacuum pressure is applied to or through the collection receptacle.
Regarding claim 21, Ross discloses:
A device configured to remove vitreous from an eye (removal system 1800, see Fig. 17), comprising:
a needle defining a lumen (needle 1704, see Fig. 17 and Para. [0104]) and a port extending to the lumen (distal opening of the needle, see Fig. 17), the needle being configured for insertion into the vitreous of the eye (see Para. [0002], [0036] and [0046]; all embodiments within the figures are understood to be operable within a patient’s eye unless otherwise stated);
a sample container coupled to the needle (collection receptacle 1734, see Fig. 17 and Para. [0103]) and having a chamber in fluid communication with the lumen (see Fig. 17 and Para. [0103] and [0105]); and
a vibration mechanism (transducer 1714, see Fig. 17 and Para. [0110] and [0111]; the transducer of Ross is equivalent under 112(f) to the structure disclosed in the specification as corresponding to the claimed means plus function limitation, which is an ultrasonic transducer (see Specification Para. [0011])) which is configured to induce vibration in the needle (see Para. [0111]) to draw a sample of the vitreous into the port and to the chamber (see Para. [0111] mentioning wherein the needle undergoes vibration to break up tissue within an eye while simultaneously aspirating said tissue to the collection receptable).
However, Ross does not expressly disclose:
wherein a first pressure of the chamber is greater than or equal to a second pressure at the port while the vibration mechanism induces vibration in the needle to draw the sample into the port and to the chamber.
In the same field of endeavor, namely devices configured to aspirate material from a patient’s eye through a hollow needle to a proximal collection site, Clauson (US 2019/0254872 A1) teaches a device for aspirating material from a patient’s eye (see Fig. 1; see also Abstract and Para. [0009]) comprising a hollow needle (shaft 51 defining lumen 6 having a suction path 4 extend therethrough; see Fig. 1 and Para. [0119]) and a sample collection chamber (disposal enclosure 40, see Fig. 1) in fluid communication with the lumen of the hollow needle (see Para. [0117] and Fig. 1); wherein the suction path within the hollow needle comprises one or more one-way valves (valve(s) 42, see Fig. 1 and Para. [0092] and [0117]) which permit material to move along the suction path within the hollow needle to the collection chamber during aspiration, but isolates the collection chamber from the vacuum pressure applied at the distal end of the needle during aspiration (see Para. [0092] and [0117]) such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Para. [0092] and [0117]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included one or more one-way valves along the suction path of the hollow needle to the collection receptacle of Ross as taught and suggested by Clauson to, in this case, isolate the collection receptacle from vacuum pressure (i.e., negative pressure) of the suction path such that compressibility of the material does not affect the responsiveness of the system. This aids in preventing any pressure response by the collection chamber during use (see Clauson Para. [0092] and [0117]). This “isolation” of the collection receptacle from the suction pressure applied at the distal end of the needle is understood to allow the collection receptacle to be maintained at “at least atmospheric pressure” since no vacuum pressure is applied to or through the collection receptacle. This atmospheric pressure is greater than the vacuum pressure (i.e., negative pressure) applied at the distal end of the needle during aspiration.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1), further in view of Allen (US 2010/0056986 A1)(previously of record).
Regarding claim 3, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 2.
However, none of either Ross of Clauson expressly discloses wherein the ultrasonic transducer is a Langevin transducer.
In the same field of endeavor, namely phacoemulsification device for treatment of a patient’s eye, Allen discloses wherein an ultrasonic phacoemulsification device (see Fig. 1 and Para. [0034]) comprises a Langevin transducer arrangement (see Para. [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element/arrangement for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained the predictable result of having the ultrasonic transducer arrangement of Ross be in the form of a Langevin-style transducer arrangement as disclosed by Allen, since Ross only discloses a piezoelectric stack-style transducer as a “non-limiting example” (see Para. [0104]), the type of transducer of Ross is not seen to be a critical component so long as ultrasonic waveforms are maintained. Therefore, one of ordinary skill in the art would have been able to substitute one known type of ultrasonic transducer for another without affecting or impacting the overall functionality of the device of Ross. Therefore, one of ordinary skill in the art would have been able to substitute the piezoelectric transducer of Ross with a Langevin-style transducer of Allen with a reasonable expectation of success that the functionality of the device of Ross would be maintained.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1), further in view of Parham (US 2016/0331397 A1)(previously of record).
Regarding claim 4, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 2.
However, Ross is silent regarding any disclosed frequency range for the ultrasonic transducer and thus does not expressly disclose wherein the ultrasonic transducer operates at a frequency of about 20 kHz to about 50 kHz.
In the same field of endeavor, namely ultrasonic phacoemulsification devices, Parham teaches wherein a desirable ultrasonic vibration frequency may include a range of between 20kHz to about 40kHz, though broader or narrower frequency ranges are also contemplated based on tissue or material to which ultrasonic energy is to be delivered and in what context (see Para. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the operating ultrasonic vibration frequency range of the transducer of Ross to be within a range from between 20kHz to about 50kHz as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0014] and [0043] indicating the range “can” be within the claimed range without disclosing any express benefit corresponding thereto to distinguish from other contemplated ultrasonic frequency ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1), further in view of Gu (US 2012/0017759 A1)(previously of record).
Regarding claim 6, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 2.
However, none of the combination expressly discloses wherein the ultrasonic transducer energizes piezoelectric crystals to cause a fluid acoustic horn to vibrate.
In the field of endeavor of ultrasonic waveform generation devices, Gu teaches wherein a fluid horn may be utilized to propagate piezoelectric-induced ultrasonic vibrations to a distal tip of a device (see Para. [0032]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained the predictable result of having the ultrasonic horn of Ross (see Ross Para. [0104]) be in the form of a fluid-acoustic horn, since Ross does not disclose an express type of horn to be utilized. Therefore, one of ordinary skill in the art would have looked to the available prior art to utilize any of the readily-available types of ultrasonic horn elements to perform the function of transferring vibrational energy to the distal tip of the device. One of ordinary skill in the art would have expected the ultrasonic horn of Ross to operate equally well with either a solid-type horn or fluid-type horn since both are disclosed to be capable of transferring vibrational energy to a distal tip of an ultrasonic instrument to cause vibration therein. Further, Applicant appears to have placed to criticality on the type of horn used, indicating that both horn are capable of being used to achieve the result of transmitting vibrational energy, with neither having an express benefit over the other (see Specification Para. [0016] and [0043]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1), further in view of Mallough (US 2016/0220751 A1)(previously of record).
Regarding claim 11, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 1.
However, none of either Ross of Clauson expressly disclose an optical sensor coupled to the sample container for measuring an optical absorption of the sample therein to determine a volume of the sample collected.
In the same field of endeavor, namely phacoemulsification devices comprising an irrigation fluid system, Mallough teaches wherein optical sensors may be utilized at any or all points in an irrigation fluid path (see Para. [0062]-[0063]) to monitor fluidic volume levels within the system, including within a waste collection bag (see Para. [0063]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Ross to include optical sensors along an entirety of a fluid vacuum path, including the collection receptacle, as taught and suggested by Mallough to, in this case, monitor fluid/debris volume levels along the fluid/aspiration path (see Mallough Para. [0062]-[0063]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) in view of Clauson (US 2019/0254872 A1), further in view of Miller (US 2023/0080971 A1)(previously of record).
Regarding claim 12, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 1.
However, none of the combination expressly disclose a temperature sensor coupled to the sample container for measuring a temperature change therein to determine a volume of the sample collected.
In the field of endeavor of treatment of ocular conditions and surgical instruments provided therefore, Miller teaches wherein, within a treatment system (3100), may comprise any suitable number and location of sensors (i.e., temperature sensors) configured to sense a desired parameter such as temperature within a designated portion of the surgical system and to transmit said sensed data to a controller or human-machine interface (see Para. [0313]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Ross to have included a temperature sensor in communication with the collection receptacle as taught and suggested by Miller to, in this case, determine the temperature of the sample collection chamber at any given time to prevent damage thereto. Upon incorporation of said sensor, one of ordinary skill in the art would be fully capable of utilizing the temperature sensor to determine a volume of vitreous sample collected. As this limitation is recited as functional language, the temperature sensor need only be capable of performing the recited function (see MPEP 2114).
Regarding claim 13, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 1.
However, none of the combination expressly disclose a pressure sensor coupled to the sample container for measuring a pressure change therein to determine a volume of the sample collected.
In the field of endeavor of treatment of ocular conditions and surgical instruments provided therefore, Miller teaches wherein, within a treatment system (3100), may comprise any suitable number and location of sensors (i.e., pressure sensors) configured to sense a desired parameter such as pressure within a designated portion of the surgical system and to transmit said sensed data to a controller or human-machine interface (see Para. [0313]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Ross to have included a pressure sensor in communication with the collection receptacle as taught and suggested by Miller to, in this case, determine the internal pressure of the sample collection chamber at any given time to prevent damage thereto. Upon incorporation of said sensor, one of ordinary skill in the art would be fully capable of utilizing the pressure sensor to determine a volume of vitreous sample collected. As this limitation is recited as functional language, the pressure sensor need only be capable of performing the recited function (see MPEP 2114).
Allowable Subject Matter
Claims 7-9 and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 7, the combination of Ross and Clauson disclose all of the limitations of the invention of claim 1.
However, none of either Ross or Clauson expressly disclose a drug delivery syringe for delivering a therapeutic agent through the port.
The prior are is replete with nested needle devices for delivering medication to a patient’s eye. For example, in the same field of endeavor, namely devices for removing vitreous from an eye, Andino teaches:
A device for removing vitreous from an eye (apparatus 800, see Fig. 12A) comprising:
a needle (outer conduit 870, see Figs. 12B) defining a lumen (see Para. [0189]) and a port extending to the lumen (opening at the distal end of the outer conduit), the needle being configured for insertion into the vitreous of the eye (see Para. [0189] mentioning wherein the device is configured to be inserted into a patient’s eye, understood to be capable of being inserted into the vitreous of an eye); and
a drug delivery syringe (medicament container/syringe 850, see Fig. 12B) for delivering a therapeutic agent through the needle and out from the port thereof (see Para. [0193] mentioning wherein medicament is introducer via hollow conduit 820 through the distal opening of the outer conduit 870) to delivery therapeutic fluid from the hollow needle (see Para. [0193]).
However, it would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Ross to include a conduit extending through the proximal handle and into the lumen of the needle configured to receive the drug-delivery syringe of Andino therethrough since neither reference discloses an express benefit or motivation to combine a drug delivery syringe with a phacoemulsification probe. Further, the system of Ross utilizes a vacuum system coupled to the needle and it would not be readily apparent without undue experimentation how the syringe of Andino would be included into the system of Ross without impacting the performance of Ross. As it cannot be easily determined what the resulting combination would look like, or how the syringe of Andino would be incorporated into the device of Ross while maintaining all internal structures and functional elements, one of ordinary skill in the art would not have made the proposed combination without some express teaching or motivation provided by the prior art.
Claims 8-9 are also seen to be allowable due to their dependency from and further modification of claim 7.
Similarly, regarding claim 18, the combination of Ross and Clauson disclose all of the limitations of the method of claim 17.
However, none of either Ross or Clauson expressly disclose placing a drug delivery syringe in fluid communication with the lumen for delivering a therapeutic agent through the port.
The prior are is replete with nested needle devices for delivering medication to a patient’s eye. For example, in the same field of endeavor, namely devices for removing vitreous from an eye, Andino teaches:
A device for removing vitreous from an eye (apparatus 800, see Fig. 12A) comprising:
a needle (outer conduit 870, see Figs. 12B) defining a lumen (see Para. [0189]) and a port extending to the lumen (opening at the distal end of the outer conduit), the needle being configured for insertion into the vitreous of the eye (see Para. [0189] mentioning wherein the device is configured to be inserted into a patient’s eye, understood to be capable of being inserted into the vitreous of an eye); and
a drug delivery syringe (medicament container/syringe 850, see Fig. 12B) for delivering a therapeutic agent through the needle and out from the port thereof (see Para. [0193] mentioning wherein medicament is introducer via hollow conduit 820 through the distal opening of the outer conduit 870) to delivery therapeutic fluid from the hollow needle (see Para. [0193]).
However, it would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Ross to include a conduit extending through the proximal handle and into the lumen of the needle configured to receive the drug-delivery syringe of Andino therethrough since neither reference discloses an express benefit or motivation to combine a drug delivery syringe with a phacoemulsification probe. Further, the system of Ross utilizes a vacuum system coupled to the needle and it would not be readily apparent without undue experimentation how the syringe of Andino would be included into the system of Ross without impacting the performance of Ross. As it cannot be easily determined what the resulting combination would look like, or how the syringe of Andino would be incorporated into the device of Ross while maintaining all internal structures and functional elements, one of ordinary skill in the art would not have made the proposed combination without some express teaching or motivation provided by the prior art.
Claims 19-20 are also seen to be allowable due to their dependency from and further modification of claim 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 11801163 B2 to Schaller, US 11730625 B2 to Carter, US 11638660 B2 to Balkenbush and US 11622888 B2 to Chamness
who all teach a transducer assembly for a phacoemulsification device,
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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