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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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: “control element” in claims 2-4.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11, 14-17 and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panotopoulos et al (U.S. Pub. 2020/0237977 A1, hereinafter “Panotopoulos”).
Regarding claim 1, Panotopoulos discloses a microsurgical device comprising:
a handle 26 see Fig 4 and para [0121]);
a shaft 44 (see Fig 21) having a distal portion (distal tip 108; see para [0167]) that is insertable into an opening of an operating site of an eye (see para [0166] disclosing that “the tip of a catheter 44 that is inserted in biological material, e.g. the patient's body, is called the distal tip”; the catheter 44 includes microsurgical instruments (see para [0171]), wherein the shaft comprises an outer tube 104 (the outer body of shaft 44; para [0167]) and an inner tube 106 disposed therein (see paras [0167] and [0173], disclosing that lumina 104 and 106 are telescopically arranged such that 106 is disposed within 104) wherein the inner tube extends through a lumen of the outer tube and a distal portion of the inner tube extends out and beyond a distal end of the outer tube (see para [0173]; inner tube 106 extends beyond outer tube 104);
a distal member, e.g., 110 on a distal end of the shaft (see Fig. 21 and para [0168]); and
a fluidics control 4 (see Fig 2) configured to enable bi-directional flow and fluid separation or mixing (see para [0118], disclosing that the control unit 4 enables bi-directional flow to direct fluid to a patient or drain fluid from a patient; and see paras [0149]-[0150] disclosing that the control unit 4 enables mixing of a drug combination);
wherein the fluidics control comprises a housing (combination of housing 8 and tube set 36; see Fig. 2) and an end piece (the piece with ports on the left side of the housing 8, Fig 2);
wherein the housing comprises a mixing chamber (tube set 36) configured to mix multiple fluids or drugs or dilute a concentrated drug to provide varying drug concentration (tube set 36 that connects to the shaft 44 provides a mixture of at least two drugs to shaft 44; accordingly, the tube set is a mixing chamber that where the drugs mix before being simultaneously delivered to the shaft 44; see also para [0149]-[0150]); and
wherein the end piece comprises one or more ports (ports on the left side of the housing 8 that connect to tubing; see Fig. 5A) that are connected to an aspiration pump and/or one or more substance chambers (see para [0116] disclosing that the ports connect to a substance chamber/fluid source 10; and see para [0118] disclosing that a pump 66 directs fluid through a port of 8 and generates a negative pressure to drain fluid into the lower drainage receptacle during aspiration).
Regarding claim 2, Panotopoulos discloses the device of claim 1, further comprising a control element (pinch valve 64; see para [0118]) configured to enable selective control of fluids (see para [0118], disclosing that the pinch valve 64 controls the flow of fluid through the housing 8).
Regarding claim 3, Panotopoulos discloses the device of claim 2, wherein the control element is configured to allow for bolus or continuous delivery (see para [0118], disclosing that the pinch valve 64 controls the flow of fluid through the housing 8 and para [0140] disclosing that the control is configured for bolus delivery).
Regarding claim 4, Panotopoulos discloses the device of claim 2, wherein the control element is configured to enable a measured delivery of drug at independent rates (see para [0118], disclosing that the pinch valve 64 controls the flow of fluid through the housing 8 and para [0141] disclosing that the control is configured for adjustable bolus delivery).
Regarding claim 5, Panotopoulos discloses the device of claim 2, wherein the control element comprises a user interface 18 (see Fig 2 and para [0119]) mounted on the handle (see Fig. 2 showing user interface 17 mounted on handle 26).
Regarding claim 6, Panotopoulos discloses the device of claim 5, wherein the user interface comprises one or more tactile and intuitive switches (see para [0119], disclosing that the user interface 18 includes touchscreen intuitive switches to operate the control unit).
Regarding claim 7, Panotopoulos discloses the device of claim 6, wherein the switch activates a flow control valve (see para [0118], disclosing that the pinch valve 64 controls the flow of fluid through the housing 8) situated within the handle (see Fig. 2 and para [0118] showing that valve 64 is situated within portion 14 of the handle).
Regarding claim 8, Panotopoulos discloses the device of claim 7, wherein the switch provides a fully open position (see para [0118] disclosing that the pinch valve 64 has a fully open position when not pinching the tube), a fully closed position (see para [0118] disclosing that the pinch valve 64 has a fully closed position when pinching and closing the tube) and one or more intermediate positions for enabling variable control over a fluid flow (see para [0131] disclosing that the flow rate is selectable and adjustable so includes multiple intermediate positions between fully open and fully closed).
Regarding claim 9, Panotopoulos discloses the device of claim 1, wherein the handle comprises a body 14 (see Fig. 4) and a lumen formed in the body (see para [0118] disclosing that the pump 66 and pinch valve 64 are within a lumen of the handle housing 14).
Regarding claim 10, Panotopoulos discloses the device of claim 1, wherein the handle is in fluid communication with one or more substance chambers (see para [0116] and [0118] disclosing that the pump 66 and pinch valve 64 are within portion 14 of the handle; thus, the handle is in fluid communication with the fluid source 10).
Regarding claim 11, Panotopoulos discloses the device of claim 1, wherein the handle is in communication with an aspiration pump (see para [0118] disclosing that the pump 66 is within portion 14 of the handle; thus, the handle is in fluid communication with the aspiration pump).
Regarding claim 14, Panotopoulos discloses the device of claim 1, wherein the housing and the end piece are in one piece (see para [0124] disclosing that the housing 8 is a tube set attachment and, therefore, it contains integral ports so that tubes may be enabled to connect to it).
Regarding claim 15, Panotopoulos discloses the device of claim 9, wherein the fluidics control is disposed partially within the body of the handle (see para [0118], disclosing that the pinch valve member 64 of the fluidics control system is disposed within the body 14 of the handle).
Regarding claim 16, Panotopoulos discloses the device of claim 15, wherein the housing of the fluidics control is rotationally or frictionally affixed to the body of the handle (see Fig. 5A and para [0124], disclosing that the housing 8 comprises a cassette 40 that frictionally attaches to a connection port 16 on the body of the handle 26).
Regarding claim 17, Panotopoulos discloses the device of claim 1, wherein the inner tube of the shaft has a fluid connection with the housing (see para [0167] disclosing aspiration lumen 106 and para [0124] disclosing that the tube set 36 of the housing is fluidly connected with the inner tube of shaft 44 for aspiration).
Regarding claim 19, Panotopoulos discloses the device of claim 1, wherein the outer tube of the shaft has a fluid connection with the housing (see para [0167] disclosing aspiration lumen 106 and para [0124] disclosing that the tube set 36 of the housing is fluidly connected with the outer tube of shaft 44 for aspiration).
Regarding claim 20, Panotopoulos discloses the device of claim 1, further comprising a sleeve 112 (see para [0177]).
Regarding claim 21, Panotopoulos discloses the device of claim 20, wherein a port in the end piece is fluidically communicated with the sleeve (see para [0177], disclosing that the sleeve 112 is fluidly connected with the infusion port and aspiration port of the end piece of the fluidics control).
Claims 1, 12, 13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nico (U.S. Pub. 2015/0031126 A1, hereinafter “Nico”).
Regarding claim 1, Nico discloses a microsurgical device comprising:
a handle 42 (see Fig. 1);
a shaft 44 (see Fig. 1) having a distal portion 47 (see Fig 3) that is insertable into an opening of an operating site of an eye (see para [0063], disclosing that the tissue cutting end is suitable for neurosurgical applications, meaning it would be of a size suitable for insertion into an operating site of an eye), wherein the shaft comprises an outer tube 44 (see Fig. 2 and para [0065]) and an inner tube 76 disposed therein (see Fig. 2 and para [0066]), wherein the inner tube extends through a lumen of the outer tube (inner cannula 76 is disposed in an outer cannula lumen 110, para [0066]) and a distal portion of the inner tube extends out of and beyond a distal end of the outer tube (see distal portion 79 that extends beyond distal end opening 49 of outer tube 44, Fig 3, para [0066]);
a distal member 79 (see para [0066]) on a distal end of the shaft; and
a fluidics control (combination of 302, 306, 308 and 58; see Fig. 1) configured to enable bi-directional flow and fluid separation or mixing (see para [0154], disclosing that portion 306 is connected to a fluid supply line to enable fluid to flow to the tissue; and see para [0166] disclosing that the portion 302 is configured for fluid mixing; and see para [0084] disclosing that the portion 58 is configured for aspiration with a vacuum source);
wherein the fluidics control comprises a housing (combination of portions 302 and 306; see Fig. 1) and an end piece (combination of 308 and 59; see Fig. 1);
wherein the housing comprises a mixing chamber (single channel mixing zone of housing portion 302; see para [0166]) configured to mix multiple fluids or drugs or dilute a concentrated drug to provide varying drug concentration (see para [0166], disclosing that the mixing zone is configured to mix multiple fluids); and
wherein the end piece comprises one or more ports (end piece 308 has port 310 and the second end piece has port 59; see Fig. 1) that are connected to an aspiration pump and/or one or more substance chambers (see para [0154], disclosing that port 310 is a fluid source connector which connects to a substance chamber; see para [0084], disclosing that pump hose fitting 59 is an aspiration pump).
Regarding claim 12, Nico discloses the device of claim 1, wherein the housing and the end piece are separable (see para [0154], disclosing that housing 306 and end piece 308 are separate but connected pieces).
Regarding claim 13, Nico discloses the device of claim 12, wherein the end piece is rotationally or frictionally connected to the housing (end piece 308 is a tube that is rotationally connected to housing 306; see Fig. 1 and para [0154]) and partially enclosed by the housing (end piece tube 308 extends into and is partially enclosed by housing 306; see Fig 1).
Regarding claim 18, Nico discloses the device of claim 1, wherein the inner tube of the shaft bypasses the housing and is fluidically connected to a port that is coupled to the aspiration pump (see para [0067], disclosing that housing 302 attaches to outer tube 44 but not the inner tube; and the inner tube lumen 78 is coupled to an aspiration pump hose fitting 59, as shown in Fig. 5 and disclosed in para [0084]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited, attached.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/22/2025