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 limitations are:
“light emission unit” in claims 1, 8; as noted in specification at para [0033] by reference number 66 and includes either a light emitting material of such as a fluorescent material or phosphorescent material (paras [0039]-[0040]).
“movement restriction mechanism” in claim 2; as noted in the specification at para [0028] and [0030] by reference number 54, which includes one or more protrusions 62 which restriction movement of the piston 70.
“Irradiation unit” in claim 6; as noted in specification at para [0042] by reference number 74 and includes a light source 80.
“light reception unit” in claim 6; as noted in the specification at paras [0044] and [0047] by reference number 76, Figs. 1, 4, 6, 8, which includes a camera (imaging unit).
“image display unit” in claim 6; as noted in the specification at para [0047], which includes a display 78.
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
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.
Claims 1-4, 6, 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Aharoni et al, WO 2015/056257.
Regarding claim 1, Aharoni discloses a catheter assembly (10, 12, see Figs. 1-6, page 7, ll. 8-30) comprising: a catheter member (2) comprising a hollow catheter shaft (catheter 2 is hollow and has a lumen, Fig. 2D, col. 9, lines 25-35); a needle member (1) comprising a hollow needle body (internal bore, Figs. 2A-D, col. 7, ll. 15-30) located in a lumen of the catheter shaft; and a guide wire (optical fiber 15) located in a lumen of the needle body (Figs. 2A-D, col. 7, ll. 8-30); wherein: a distal end opening (distal end of 1, Figs. 2A-D) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (col. 8, ll. 5-25, Figs. 2A-D); a light emission unit (optics 18 and illumination source 14, col. 8, ll. 1-5) configured to emit near-infrared light is located on a distal end of the guide wire (col. 8, ll. 1-5); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would overlap with distal opening).
Regarding claim 2, Aharoni discloses the catheter assembly according to claim 1, wherein: the needle member (1) comprises a needle hub (25, Fig. 1A-D, col. 7, ll. 30-35) located at a proximal end of the needle body; and the catheter assembly comprises a movement restriction unit (27, Fig. 1A-D, col. 10, ll. 20-30) configured to restrict movement of the guide wire in a proximal end direction with respect to the needle body in the initial state (col. 14, ll. 5-25; coupler 27 attaches to proximal end of fiber 15 and therefore prevents movement of the fiber 15 in a proximal direction upon attachment to needle body coupler 25).
Regarding claim 3, Aharoni discloses the catheter assembly according to claim 1, wherein: the distal end opening includes an opening center portion located at a center portion in an axial direction of the needle body; and the light emission unit is located proximal of the opening center portion in the initial state (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would be located proximal with distal opening center portion).
Regarding claim 4, Aharoni discloses the catheter assembly according to claim 3, wherein: the distal end opening includes an opening proximal end located on a proximal end in the axial direction of the needle body; and in the plan view in the initial state, the light emission unit overlaps the opening proximal end (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would overlap with distal opening).
Regarding claim 6, Aharoni discloses a blood vessel puncture system comprising: the catheter assembly according to claim 1 (see rejection for claim 1 above); an irradiation unit (illumination source 14, col. 8, ll. 1-5) configured to irradiate a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (col. 8, ll. 1-25); a light reception unit (cameras, 46, Figs. 4A-D) configured to receive reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit to create a light reception image (col. 17, ll. 5-35); and an image display unit (screen or display, col. 18, ll. 3-30) configured to display the light reception image (col. 18, ll. 3-30).
Regarding claim 8, Aharoni discloses a method for determining whether a blade surface of a needle body is inserted in a blood vessel (Figs. 1-6, pages 6-8, 12-15), the method comprising:
providing a catheter assembly (10, 12, see Figs. 1-6, page 7, ll. 8-30) comprising: a catheter member (2) comprising a hollow catheter shaft (catheter 2 is hollow and has a lumen, Fig. 2D, col. 9, lines 25-35); a needle member (1) comprising a hollow needle body (internal bore, Figs. 2A-D, col. 7, ll. 15-30) located in a lumen of the catheter shaft; and a guide wire (optical fiber 15) located in a lumen of the needle body (Figs. 2A-D, col. 7, ll. 8-30); wherein: a distal end opening (distal end of 1, Figs. 2A-D) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (col. 8, ll. 5-25, Figs. 2A-D); a light emission unit (optics 18 and illumination source 14, col. 8, ll. 1-5) configured to emit near-infrared light is located on a distal end of the guide wire (col. 8, ll. 1-5); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would overlap with distal opening);
using an irradiation unit (illumination source 14, col. 8, ll. 1-5), irradiating a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (col. 8, ll. 1-25);
using a light reception unit (cameras, 46, Figs. 4A-D), receiving reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit, and creating a light reception image (col. 17, ll. 5-35); and
using a display unit (screen or display, col. 18, ll. 3-30), displaying the light reception image (col. 18, ll. 3-30).
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Gasparyan et al, US 2015/0314105 A1.
Regarding claim 1, Gasparyan discloses a catheter assembly (201, Figs. 2A-E through Fig. 17, paras [0138]-[0139]) comprising: a catheter member (203) comprising a hollow catheter shaft (Figs. 2C, 5A, para [0143]); a needle member (202) comprising a hollow needle body (Fig. 2C, para [0139]) located in a lumen of the catheter shaft; and a guide wire (210) located in a lumen of the needle body; wherein: a distal end opening (204) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (Fig. 2C, 8A-D, see para [0138]); a light emission unit (optical fiber, para [0162]) configured to emit near-infrared light is located on a distal end of the guide wire (para [0162]); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 8B or Fig. 15B, paras [0174]-[0176] and [0195]).
Regarding claim 2, Gasparyan discloses the catheter assembly according to claim 1, wherein: the needle member comprises a needle hub (206, Fig. 2B) located at a proximal end of the needle body (Fig. 2B); and the catheter assembly comprises a movement restriction unit (209) configured to restrict movement of the guide wire in a proximal end direction with respect to the needle body in the initial state (para [0142]; 210 is fixed to adapter 209 and therefore adapter 209 prevents proximal movement when attached to hub 206).
Regarding claim 3, Gasparyan discloses the catheter assembly according to claim 1, wherein: the distal end opening includes an opening center portion located at a center portion in an axial direction of the needle body; and the light emission unit is located proximal of the opening center portion in the initial state (Figs. 8A-8B, paras [0174]-[0176]).
Regarding claim 4, Gasparyan discloses the catheter assembly according to claim 3, wherein: the distal end opening includes an opening proximal end located on a proximal end in the axial direction of the needle body; and in the plan view in the initial state, the light emission unit overlaps the opening proximal end (Figs. 8A-8B, paras [0174]-[0176]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Aharoni in view of Sipple et al, US 2022/0015635 A1.
Regarding claim 5, Aharoni discloses the catheter assembly according to claim 1, but is silent as to wherein: the light emission unit comprises a fluorescent material that emits the near-infrared light when irradiated with light.
However, Sipple, in the same field of art, namely a catheter assembly for locating a position inside a vein or blood vessel, teaches a catheter member (108, Fig. 1) with a needle member (102, Fig. 1) disposed within a lumen of the catheter, and a guide wire (114, Fig. 1, paras [0043]-[0044]) located within a lumen of the needle body, a distal end opening (106) communicating with the lumen of the needle body (para [0044]), and a light emission unit (116) configured to emit near-infrared light is located on the distal end of the guide wire, where the light emission unit comprises a fluorescent material (116 or 110, biomarker luminescent material includes fluorescent material, para [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fluorescent material of Sipple in the light emission unit of Aharoni since both are known as functional equivalents to emit light inside the human body and it would involve the simple substitution of one known light element of another and lead to predictable results of allowing for visualization of a needle inside a vein or blood vessel (Sipple, para [0040]).
Regarding claim 7, Aharoni discloses a catheter assembly (10, 12, see Figs. 1-6, page 7, ll. 8-30) comprising: a catheter member (2) comprising a hollow catheter shaft (catheter 2 is hollow and has a lumen, Fig. 2D, col. 9, lines 25-35); a needle member (1) comprising a hollow needle body (internal bore, Figs. 2A-D, col. 7, ll. 15-30) located in a lumen of the catheter shaft; and a guide wire (optical fiber 15) located in a lumen of the needle body (Figs. 2A-D, col. 7, ll. 8-30); wherein: a distal end opening (distal end of 1, Figs. 2A-D) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (col. 8, ll. 5-25, Figs. 2A-D); a light emitting material (optics 18 and illumination source 14, col. 8, ll. 1-5) located on a distal end of the guide wire (col. 8, ll. 1-5); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emitting material overlaps the distal end opening (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would overlap with distal opening).
Aharoni teaches that the guide wire has a light emitting material but is silent as to a phosphorescent material applied to a distal end of the guide wire.
However, Sipple, in the same field of art, namely a catheter assembly for locating a position inside a vein or blood vessel, teaches a catheter member (108, Fig. 1) with a needle member (102, Fig. 1) disposed within a lumen of the catheter, and a guide wire (114, Fig. 1, paras [0043]-[0044]) located within a lumen of the needle body, a distal end opening (106) communicating with the lumen of the needle body (para [0044]), and a light emission unit (116) configured to emit near-infrared light is located on the distal end of the guide wire, where the light emission unit comprises a phosphorescent material applied to a distal end of the guide wire (116 or 110, biomarker luminescent material includes phosphorescent material, para [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the phosphorescent material of Sipple in the light emission unit of Aharoni since both are known as functional equivalents to emit light inside the human body and it would involve the simple substitution of one known light emission element for another and lead to predictable results of allowing for visualization of a needle inside a vein or blood vessel (Sipple, para [0040]).
Claims 6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gasparyan in view of Aharoni.
Regarding claim 6, Gasparyan discloses a blood vessel puncture system comprising: the catheter assembly according to claim 1 (see rejection for claim 1 above); an irradiation unit (light source 312, para [0162], Fig. 5B) configured to irradiate a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (para [0162), but is silent as to a light reception unit configured to receive reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit to create a light reception image; and an image display unit configured to display the light reception image.
However, Aharoni in the same field of art, teaches a blood vessel puncture system comprising: the catheter assembly according to claim 1 (see rejection for claim 1 above); an irradiation unit (illumination source 14, col. 8, ll. 1-5) configured to irradiate a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (col. 8, ll. 1-25); a light reception unit (cameras, 46, Figs. 4A-D) configured to receive reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit to create a light reception image (col. 17, ll. 5-35); and an image display unit (screen or display, col. 18, ll. 3-30) configured to display the light reception image (col. 18, ll. 3-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the system of Gasparyan with the light reception unit (camera) and display of Aharoni in order to provide the stated advantages of capturing the image with a computer and allowing the physician to better visualize the insertion of the needle on a display screen using contrast images and a hands free option (Aharoni, page 17, ll. 5-30).
Regarding claim 8, Gasparyan discloses a method for determining whether a blade surface of a needle body is inserted in a blood vessel, the method comprising:
providing a catheter assembly (201, Figs. 2A-E through Fig. 17, paras [0138]-[0139]) comprising: a catheter member (203) comprising a hollow catheter shaft (Figs. 2C, 5A, para [0143]); a needle member (202) comprising a hollow needle body (Fig. 2C, para [0139]) located in a lumen of the catheter shaft; and a guide wire (210) located in a lumen of the needle body; wherein: a distal end opening (204) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (Fig. 2C, 8A-D, see para [0138]); a light emission unit (optical fiber, para [0162]) configured to emit near-infrared light is located on a distal end of the guide wire (para [0162]); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 8B or Fig. 15B, paras [0174]-[0176] and [0195]);
using an irradiation unit (312), irradiating a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (light source 312, para [0162], Fig. 5B);
Gasparyan is silent as to using a light reception unit, receiving reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit, and creating a light reception image; and using a display unit, displaying the light reception image.
However, Aharoni in the same field of art teaches a method for determining whether a blade surface of a needle body is inserted in a blood vessel (Figs. 1-6, pages 6-8, 12-15), the method comprising: providing a catheter assembly (10, 12, see Figs. 1-6, page 7, ll. 8-30) comprising: a catheter member (2) comprising a hollow catheter shaft (catheter 2 is hollow and has a lumen, Fig. 2D, col. 9, lines 25-35); a needle member (1) comprising a hollow needle body (internal bore, Figs. 2A-D, col. 7, ll. 15-30) located in a lumen of the catheter shaft; and a guide wire (optical fiber 15) located in a lumen of the needle body (Figs. 2A-D, col. 7, ll. 8-30); wherein: a distal end opening (distal end of 1, Figs. 2A-D) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (col. 8, ll. 5-25, Figs. 2A-D); a light emission unit (optics 18 and illumination source 14, col. 8, ll. 1-5) configured to emit near-infrared light is located on a distal end of the guide wire (col. 8, ll. 1-5); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 3A, col. 11, ll. 14-20; fiber 15 reaches to tip of needle 1, or col. 12, ll. 17-30; fiber extends along entire length of needle, which includes distal tip and would overlap with distal opening); using an irradiation unit (illumination source 14, col. 8, ll. 1-5), irradiating a distal end of the catheter assembly with which a living body site is punctured with light in a near-infrared region (col. 8, ll. 1-25); using a light reception unit (cameras, 46, Figs. 4A-D), receiving reflected light reflected by the living body site and the catheter assembly out of the light and the near-infrared light emitted by the light emission unit, and creating a light reception image (col. 17, ll. 5-35); and using a display unit (screen or display, col. 18, ll. 3-30), displaying the light reception image (col. 18, ll. 3-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the system of Gasparyan with the light reception unit (camera) and display of Aharoni in order to provide the stated advantages of capturing the image with a computer and allowing the physician to better visualize the insertion of the needle on a display screen using contrast images and a hands free option (Aharoni, page 17, ll. 5-30).
Claims 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gasparyan in view of Sipple et al, US 2022/0015635 A1.
Regarding claim 5, Gasparyan the catheter assembly according to claim 1, but is silent as to wherein: the light emission unit comprises a fluorescent material that emits the near-infrared light when irradiated with light.
However, Sipple, in the same field of art, namely a catheter assembly for locating a position inside a vein or blood vessel, teaches a catheter member (108, Fig. 1) with a needle member (102, Fig. 1) disposed within a lumen of the catheter, and a guide wire (114, Fig. 1, paras [0043]-[0044]) located within a lumen of the needle body, a distal end opening (106) communicating with the lumen of the needle body (para [0044]), and a light emission unit (116) configured to emit near-infrared light is located on the distal end of the guide wire, where the light emission unit comprises a fluorescent material (116 or 110, biomarker luminescent material includes fluorescent material, para [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fluorescent material of Sipple in the light emission unit of Gasparyan since both are known as functional equivalents to emit light inside the human body and it would involve the simple substitution of one known light element of another and lead to predictable results of allowing for visualization of a needle inside a vein or blood vessel (Sipple, para [0040]).
Regarding claim 7, Gasparyan discloses a catheter assembly (201, Figs. 2A-E through Fig. 17, paras [0138]-[0139]) comprising: a catheter member (203) comprising a hollow catheter shaft (Figs. 2C, 5A, para [0143]); a needle member (202) comprising a hollow needle body (Fig. 2C, para [0139]) located in a lumen of the catheter shaft; and a guide wire (210) located in a lumen of the needle body; wherein: a distal end opening (204) communicating with the lumen of the needle body is formed on a blade surface of a distal end of the needle body (Fig. 2C, 8A-D, see para [0138]); a light emission unit (optical fiber, para [0162]) configured to emit near-infrared light is located on a distal end of the guide wire (para [0162]); and in a plan view in which the blade surface is viewed in a direction orthogonal to an axis of the needle body in an initial state, the light emission unit overlaps the distal end opening (Fig. 8B or Fig. 15B, paras [0174]-[0176] and [0195]), but is silent as to the a phosphoscent material applied to a distal end of the guide wire.
However, Sipple, in the same field of art, namely a catheter assembly for locating a position inside a vein or blood vessel, teaches a catheter member (108, Fig. 1) with a needle member (102, Fig. 1) disposed within a lumen of the catheter, and a guide wire (114, Fig. 1, paras [0043]-[0044]) located within a lumen of the needle body, a distal end opening (106) communicating with the lumen of the needle body (para [0044]), and a light emission unit (116) configured to emit near-infrared light is located on the distal end of the guide wire, where the light emission unit comprises a phosphorescent material applied to a distal end of the guide wire (116 or 110, biomarker luminescent material includes phosphorescent material, para [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the phosphorescent material of Sipple in the light emission unit of Gasparyan since both are known as functional equivalents to emit light inside the human body and it would involve the simple substitution of one known light emission element for another and lead to predictable results of allowing for visualization of a needle inside a vein or blood vessel (Sipple, para [0040]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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