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 filed 6/10/2026 regarding claim 21 have been fully considered but they are not persuasive.
Regarding claim 21, Applicant contends that none of either Ross (US 2016/0058614 A1) or Clauson (US 2019/0254872 A1) disclose the limitations of “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” on the grounds that the one-way valve of Clauson, incorporated into the device of Ross to provide the benefit of isolating 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, aiding in preventing any pressure response by the collection chamber during use (see Clauson Para. [0092] and [0117]) is only configured to isolate the sample collection chamber in between suction times (see Clauson Para. [0092] and [0117]).
While the Examiner agrees that Clauson does not disclose wherein the one-way valve maintains the sample collection chamber at atmospheric pressure while the sample collection chamber is “in fluidic communication” with the suction flow channel while the vibration mechanism induces vibration in the needle to draw the sample into the port and to the chamber (as recited in amended claim 1), claim 21 does not require the sample collection chamber to be in “fluidic communication” with the suction flow channel during active aspiration . Rather, claim 21 only requires “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”. Therefore, the Examiner contends that, while the one-way valve of Clauson may restrict fluidic communication between the sample collection chamber and flow path during active aspiration, so long as the sample collection chamber is isolated from the flow path during active aspiration, Clauson provides adequate teachings pertaining to the one-way valve’s function of maintaining the sample collection chamber at a greater pressure than the aspiration flow path during active aspiration.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2016/0058614 A1) (previously of record) in view of Clauson (US 2019/0254872 A1) (previously of record).
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 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.
Allowable Subject Matter
Claims 1-17, 19-20 and 22 are allowed.
Regarding claim 1, the closest prior art of record, namely Ross (US 2016/0058614 A1) (previously of record) 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 lumen remains in fluidic communication with the chamber and 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) (previously of record) 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]).
However, Clauson does not expressly disclose wherein the chamber is configured to remain at least at atmospheric pressure while the lumen remains in fluidic communication with the chamber and while the vibration mechanism induces vibration in the needle. The one-way valve of Clauson is configured to provide a fluid barrier between the sample collection chamber and the suction flow path during active aspiration (see Para. [0092] and [0119]). The one-way valve is configured to intermittently open to allow debris collected within the suction flow path to enter the sample collection chamber in between aspiration pulses. Therefore, during active aspiration, the one-way valve of Clauson would prevent the sample collection chamber from being “in fluid communication” with the flow path lumen.
Claims 2-16 and 22 are additionally allowable due to their dependency from and further modification of claim 1.
Regarding claim 17, Applicant’s incorporation of the previously-indicated allowable limitations of claim 18 of “a drug delivery syringe in fluid communication with the lumen for delivering a therapeutic agent through the port” render claim 17 allowable over the prior art of record.
The closest prior art, namely Ross (US 2016/0058614 A1) 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]);
maintaining a chamber of a sample container (collection receptable 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 1737 is understood to be at atmospheric pressure when the vacuum is not actively applied at 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 while inducing ultrasonic vibration in the needle to draw a sample of the vitreous into the port and to the chamber; and
placing a drug delivery syringe in fluid communication with the lumen for delivering a therapeutic agent through the port.
In the same field of endeavor, namely Clauson (US 2019/0254872 A1) (previously of record) 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.
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 17.
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 11051883 B1 to Thornton and US 2014/0276713 A1 to Hoey who all teach a transducer assembly for a phacoemulsification device,
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./
Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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