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 .
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: “controller module”; “communication module”; in claims 28, 33, 37, 39, 42, and 43.
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.
The structure for “controller module” and “communication module” are taught in figs. 1a and 1b; and para 0136, 0138, 0150, and 0151.
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
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 28-47 is/are rejected under 35 U.S.C. 102a1/a2 being anticipated by U. S. Publication No. 2019/0160231 to Dobie et al.
Regarding Claim 28, Dobie teaches a method for confirming tube insertion into a target insertion area, comprising: inserting a distal end of a tube into a target insertion area, wherein a proximal end of the tube is removably coupled to a pressure sensing apparatus, and wherein the pressure sensing apparatus comprises: a controller module, a pressure sensing element, wherein the pressure sensing element is coupled to the distal end of the tube, and wherein the pressure sensing element is coupled to the controller module, and an indicator coupled to the controller module, wherein the controller module outputs a signal to the indicator based at least in part on a measured pressure of the pressure sensing element (figs. 1, 2, 15 and 16; and para 035 and 048); and confirming tube insertion into the target insertion area based at least in part on the signal outputted to the indicator (figs. 1, 2, 15 and 16; and para 11, 40-42 teaches indicator).
Regarding Claim 29, Dobie teaches that the target insertion area comprises a blood vessel, an artery, a vein, a tissue to be biopsied, a nerve, a joint, a cavity, muscle tissue, fat tissue, skeletal tissue, an airway, or a combination thereof (para 038-043 teaches an artery).
Regarding Claim 30, Dobie teaches identifying the tube inserted into a second target insertion area proximal to the target insertion area (figs. 2 and 15).
Regarding Claim 31, Dobie teaches that the measured pressure of the pressure sensing element comprises a fluctuating pressure measurement (figs. 15 and 16).
Regarding Claim 32, Dobie teaches that the measured pressure of the pressure sensing element comprises a real-time measurement of pressure at the distal end of the tube (fig. 15-16 teaches real-time pressure measurement).
Regarding Claim 33, Dobie teaches that the pressure sensing apparatus comprises a base coupled to the controller module, the indicator, or a combination thereof (para 040-043 teaches an indicator for pressure sensing).
Regarding Claim 34, Dobie teaches the measured pressure of the pressure sensing element is a local pressure in the target insertion area (para 038 and figs. 15-16).
Regarding Claim 35, Dobie teaches that the indicator comprises a light-based indicator, a haptic indicator, an audio indicator, a visual display indicator, or any combination thereof (para 011 teaches a visual indicator).
Regarding Claim 36, Dobie teaches performing a procedural action upon confirming tube insertion in the target insertion region, wherein the procedural action comprises injecting a substance into the target insertion region, aspiration of a substance from the target insertion region, or a combination thereof (figs. 1 and 2 teaches injection).
Regarding Claim 37, Dobie teaches a device for confirming tube insertion into a target insertion area, comprising: a tube, and a pressure sensing apparatus removably coupled to a proximal end of the tube, wherein the pressure sensing apparatus comprises: a controller module, a pressure sensing element, wherein the pressure sensing element is coupled to a distal end of the tube, and wherein the pressure sensing element is coupled to the controller module (figs. 1, 2, 15 and 16; and para 035 and 048), and an indicator coupled to the controller module, wherein the controller module outputs a signal to the indicator based at least in part on a measured pressure of the pressure sensing element, and wherein the signal outputted to the indicator confirms when the tube is inserted into the target insertion area (figs. 1, 2, 15 and 16; and para 11, 40-42 teaches indicator). .
Regarding Claim 38, Dobie teaches that the tube is a needle, a catheter, cannula, or a combination thereof (figs. 1 and 2 teaches a needle).
Regarding Claim 39, Dobie teaches a base coupled to the controller module, the indicator, or a combination thereof (para 011 teaches a visual indicator).
Regarding Claim 40, Dobie teaches that the indicator comprises a light-based indicator, a haptic indicator, an audio indicator, a visual display indicator, or any combination thereof (para 011 teaches a visual indicator).
Regarding Claim 41, Dobie teaches that the pressure sensing apparatus is coupled to a flexible medical apparatus (para 051).
Regarding Claim 42, Dobie teaches that the pressure sensing apparatus comprises a communication module coupled to the controller module (para 051 teaches a communication module).
Regarding Claim 43, Dobie teaches that the signal of the controller module outputted to the indicator identifies the tube inserted into a second target insertion area proximal to the target insertion area (para 011 teaches a visual indicator, identifies tube insertion).
Regarding Claim 44, Dobie teaches that the target insertion area comprises a blood vessel, an airway, or a combination thereof (para 038-043 teaches an artery).
Regarding Claim 45, Dobie teaches that the measured pressure of the pressure sensing element comprises a fluctuating pressure measurement (para 038 and figs. 15-16).
Regarding Claim 46, Dobie teaches that the measured pressure of the pressure sensing element is a local pressure in the target insertion area (para 038 and figs. 15-16).
Regarding Claim 47, Dobie teaches that the pressure sensing apparatus comprises a cap, a seal, or a combination thereof, coupled to the pressure sensing apparatus to prevent fluid, debris, blood, particles, or a combination thereof, from contacting the pressure sensing element (fig. 3 teaches a cap/seal mechanism).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANJAY CATTUNGAL whose telephone number is (571)272-1306. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANJAY CATTUNGAL/Primary Examiner, Art Unit 3798
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