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 .
Election/Restrictions
Applicant’s election without traverse of Species G in the reply filed on 02/11/2026 is acknowledged.
Claims 9, 11, and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Status of claims
Examiner notes that claims 42-44 are missing from the claim set provided on 02/11/2026, however, these claims should be grouped with claims 38-41 as “previously cancelled” as set forth in the claim set provided on 07/05/2024. For these reasons, it is noted that claims 42-44 are cancelled.
Claim Objections
Claims 1 and 42-44 are objected to because of the following informalities:
Claim 1 recites “the set display mode”, however, no set display mode is recited previously. The limitation should read –a set display mode— for purposes of proper antecedent basis.
Claims 42-44 are omitted from the current claim set as noted above. “38-41. (previously cancelled)” should read “38-44. (previously cancelled)” to be consistent with the previously presented claims.
Appropriate correction is required.
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.
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:
The limitation “electromagnetic positioning module” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “module” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “module”) is modified by functional language (“to obtain position and direction of the ultrasonic image and position and direction of the puncture instrument”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that at least an electromagnetic coil, sender 21 or magnetic field processor ([00121]-[00122]) appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “ navigation processing module” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “module” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “module”) is modified by functional language (“to generate a puncture path” and “to orthographically project”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a computer ([00155]) configured to perform functions as disclosed in at least [00139]-[00140] appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “ navigation output module” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “module” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “module”) is modified by functional language (“to output the navigation image”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a computer ([00155]) configured to perform functions as disclosed in at least [00141] appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6, 8, 12, 30, 33, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “a tubular cavity”. It is unclear if this is the same as the internal cavity recited previously or if this is a different cavity. For examination purposes, it has been interpreted to mean the same or different cavity, however, clarification is required.
Claim 6 recites the limitation “the tubular cavity of the needle rod”. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that while claim 2 recites a tubular cavity of the puncture needle, there is no explicit recitation that the tubular cavity is of the needle rod specifically, therefore it is unclear if this is the same tubular cavity and the claim is intending to further define that the tubular cavity is of the needle rod or if this is a different tubular cavity. For examination purposes, it has been interpreted to mean any tubular cavity of the needle rod, however, clarification is required.
Claims 8 and 12 recite the limitation “the needle rod”. There is insufficient antecedent basis for this limitation in the claim. In this case, claims 8 and 12 depend from claim 2 which merely sets forth a puncture needle comprising a sensor mounting portion, and recites an internal cavity of the puncture needle and a concave portion of a body surface of the puncture needle. Therefore, it is unclear what the needle rod refers to and if it is intending to refer to one of the previously recited elements of the puncture needle, the puncture needle itself, or if this is a different/distinct element. For examination purposes, it has been interpreted to mean any needle rod, however, clarification is required.
Claim 30 recites the limitation “an inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube of .05 mm to 1 mm”. It is unclear what is meant by smaller than the outer diameter of the guide tube of .05 mm to 1 mm in that it is unclear if the diameter of the guide tube is .05 mm to 1 mm or if the inner diameter is smaller than the outer diameter by .05 mm to 1 mm. Examiner notes that it appears to be the latter and is interpreted as such for examination purposes,
Claim 33 recites the limitation “a thickness specification of the guide tube comprises: 13 G, 14 G, 15 G, and 16 G”. It is unclear what is meant by the thickness specification comprising each of the values 13, 14, 15, and 16 G. In other words, it is unclear if the claim is attempting to define that each of these gauges exist along a length of the guide tube or if the claim is attempting to set forth that the thickness is one of the recited specifications (i.e. is one of 13 G, 14 G, 15 G, and 16 G). For examination purposes, it has been interpreted to mean the latter, however, clarification is required.
Claim 33 recites the limitation “the inner diameter of the flexible sleeve is greater than the outer diameter of the guide tube of .1 mm to 2 mm”. It is unclear what is meant by great than the outer diameter of the guide tube of .1 mm to 2 mm. In this case, it is not clear if the claim is attempting to define that the inner diameter is greater by .1 mm to 2 mm or if the claim is attempting to define that the diameter of the guide tube is .1 mm to 2 mm in which case it is unclear how the diameter of .1 mm to 2 mm corresponds with the thickness specification in gauge units above. For examination purposes, it has been interpreted that the inner diameter is greater than the outer diameter of the guide tube by .1 mm to 2 mm, however, clarification is required.
Claim 37 recites the limitation “when the puncture instrument and the ultrasonic image are in a coplanar state and non-coplanar state” in two instances. It is unclear how these elements can be in both the coplanar and non-coplanar state. In other words, the claim appears to be reciting that the instrument and image are in two different states simultaneously in its broadest reasonable interpretation, however, it is not clear how this is possible. For examination purposes, it has been interpreted to mean that the navigation image and/or projection of the instrument/path is displayed differently depending on whether or not the puncture instrument and the ultrasonic image are in a coplanar state or a non-coplanar state, however, clarification is required.
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.
(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 1-2, 8, 37, and 45-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schotzko et al. (US 20190307518 A1), hereinafter Schotzko.
Regarding claim 1,
Schotzko discloses a puncture system (at least fig. 1 (10) and corresponding disclosure in at least [0041]), comprising an interventional navigation system (at least fig. 1 (100, 110, 120, and 150) and corresponding disclosure in at least [0041]) and a puncture instrument (at least fig. 1 (130) and corresponding disclosure in at least [0041]. See also [0085] needle (e.g. instrument 130));
the interventional navigation system (100, 110, 121, and 150) comprises an electromagnetic positioning module (121 and [0008] which discloses an electromagnetic (EM) tracking system and [0041] discloses EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. EM field generator 121 may include various components, such as a specially designed pad to be placed under, or integrated into, an operating table or patient bed. An example of such an EM tracking system is the AURORA™ system sold by Northern Digital Inc), a navigation processing module (100) and a navigation output module (100 and/or at least fig. 2 (212) and corresponding disclosure in at least [0049]),
wherein, the electromagnetic positioning module is connected with an ultrasonic imaging device (at least fig. 1 (140) and corresponding disclosure in at least [0041]) and the puncture instrument (130) (see at least fig. 1 depicting connections) and is configured to obtain position and direction of an ultrasonic image generated by the ultrasonic imaging device and position and direction of the puncture instrument ([0075] which discloses computing device 100 receives EM tracking data from the EM tracking system for ultrasound imager 140 and the instrument 130 at 404. The EM tracking data is representative of positions and orientations of each of the ultrasound sensor and the instrument 130 relative to the region of the patient);
the navigation processing module (100) is connected with the ultrasonic imaging device (140) and the electromagnetic positioning module (see at least fig. 1), configured to generate a puncture path based on the position and direction of the puncture instrument [0076] which discloses Computing device 100 can determine at least one of a position, orientation, or trajectory of the instrument 130 based on the EM tracking data at 408 using any suitable technique or techniques) and orthographically project the puncture instrument and the puncture path onto the ultrasonic image to generate a navigation image that fuses a projection of the puncture instrument and the puncture path based on the position and direction of the ultrasonic image, the position and direction of the puncture instrument, and the puncture path ([0077] which discloses controller 204 of the computing device can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. Any suitable technique or techniques can be utilized to show the target zone. In one or more embodiments, the controller 204 can be adapted to determine the target zone based on user input data and generate the target zone in the GUI based upon the user input data. The computing device 100 can display the GUI 300 on display 206 and/or display 110 and [0058] which discloses Ultrasound image plane 325 can include an ultrasound image (not shown here for the purpose of more clearly depicting the elements being described) based on ultrasound image data captured by ultrasound imager 140 and [0060] which discloses GUI 300 may depict antenna 310 of instrument 130 and at least one of its position, orientation, or trajectory 315 of the instrument as outlines such that the ultrasound image displayed on ultrasound image plane 325 is not obscured by such outlines. GUI 300 further shows the antenna 310 of instrument 130 and at least one of its position, orientation, or trajectory 315 in relation to a plane of the ultrasound image data, i.e., the ultrasound image plane 325);
and the navigation output module is connected with the navigation processing module, configured to output the navigation image based on the set display mode ([0056] Computing device 100 is linked to display 110, thus enabling computing device 100 to control the output on display 110 along with the output on display 206. see at least fig. 3A-3B depicting the output of the navigation image)
Regarding claim 2,
Schotzko further discloses wherein the puncture instrument comprises a puncture needle ([0085] which discloses needle (e.g. instrument 130)) which comprises a sensor mounting portion (i.e. any portion of the needle is considered a sensor mounting portion. See also [0043] which discloses which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument), and the sensor mounting portion is capable of mounting a sensor of the electromagnetic positioning module a concave portion of body surface of the puncture needle (Examiner notes that the needle necessarily has a concave portion of a body surface of the puncture needle which is therefore considered to be capable of mounting a sensor of the electromagnetic positioning module).
Regarding claim 8,
Schotzko further teaches wherein an outer diameter of a distal portion of a needle rod is smaller than an outer diameter of a proximal portion of the needle rod (See at least fig. 3A depicting a needle having a pointed tip thus having an outer diameter of a distal portion of the needle rod which is smaller than an outer diameter of a proximal portion of the needle rod)
Regarding claim 37,
Schotzko further discloses wherein the puncture system comprises one of:
When the puncture instrument and the ultrasonic image are in a coplanar state and a non-coplanar state, the navigation image is displayed differently (see at least fig. 3A and 3C), the projection of the puncture path is displayed differently (see at least fig. 3A and 3C) , the projection of the puncture instrument is displayed differently (see at least figs. 3A and 3C and [0060] which discloses the controller 204 is further adapted to determine an intersection between the instrument 130 and the plane of the ultrasound image data 325 and display an indicator of the intersection between the instrument and the plane of the ultrasound image data in the GUI 400. For example, when the instrument 130 does not intersect ultrasound image plane 325, the antenna 310 can be depicted as shadowed (e.g. dimmed or greyed-out)),
When the puncture instrument and the ultrasonic image are in a non-coplanar state an intersection point of the puncture path with the ultrasonic image is displayed differently from other points on the projection of the puncture path and projections of two portions of the puncture path on two sides of the ultrasonic image are displayed respectively in different ways (see at least fig. 3A and [0060])
Regarding claim 45,
Schotzko further discloses wherein the puncture path in a straight line shape is formed by extending in the direction of the puncture instrument (see at least figs. 3A-3C)
Regarding claim 46,
Schotzko further discloses wherein the electromagnetic position module comprises a first sensor connected to a probe of the ultrasonic imaging device ([0042] which discloses Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor), and a second sensor connected to the puncture instrument ([0043] which discloses an exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument)
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schotzko in view of Glossop et al. (US 20100217117 A1), hereinafter Glossop.
Regarding claim 4,
Schotzko teaches the elements of claim 2 as previously stated. It is not made explicitly clear if the puncture needle is tubular, one end of a tubular cavity of the puncture needle is opened at a proximal end of the puncture needle, the other end of the tubular cavity is closed at a distal end of the puncture needle, thus Schotzko fails to explicitly teach the cited features.
Nonetheless, Glossop, in a similar field of endeavor involving needle guidance, teaches a puncture needle is tubular, one of a tubular cavity of the puncture needle is opened at a proximal end of the puncture needle, the other end of the tubular cavity is closed at a distal end of the puncture needle and a sensor mounting portion is formed by the tubular cavity ([0053] which discloses puncture needle 203 may be formed by, for example, welding or shaping a sharp tip onto a hollow tube portion. In such cases, a position indicating element may be placed inside the distal portion of the hollow tube portion adjacent to the sharp tip).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Schotzko to include a puncture needle as taught by Glossop in order to allow for a the sensor to be positioned in an interior space of the needle. Such a modification would ensure proper tracking of the needle without adding extra material/elements to the exterior of the needle thereby enhancing the safety/comfort of inserting the needle. Furthermore, such a modification amounts to a simple substitution of one known puncture needle for another yielding predictable results with respect to needle insertion of a patient, thereby rendering the claim obvious (MPEP 2143).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schotzko in view of Ries et al. (US 20220218316 A1), hereinafter Ries.
Regarding claim 6,
Schotzko teaches the elements of claim 2 as previously stated. Schotzko fails to explicitly teach wherein the puncture needle comprises a needle head and a needle rod, and the needle head and the needle rod are connected by welding or threading; wherein the proximal end of the needle head comprises a connection portion, the needle rod is tubular, and when the needle head is connected with the needle rod, the connection portion is inserted into the tubular cavity of the needle rod.
Ries, in a similar field of endeavor involving needle guidance, teaches wherein a puncture needle comprises a needle head (at least fig. 5 (3.4) and corresponding disclosure in at least [0035]) and a needle rod (at least fig. 5 (3.3) and corresponding disclosure in at least [0035]), and the needle head and the needle rod are connected by welding ([0035] which discloses parts 3.3 to 3.5 are fixedly interconnected by welding) wherein the proximal end of the needle head comprises a connection portion (see at least fig. 5 and 8 depicting the connection portion at a proximal end of the needle head), the needle rod is tubular (See at least figs. 5 and 8 and [0034] which discloses hollow obturator tube 3.3), and when the needle head is connected with the needle rod, the connection portion is inserted into the tubular cavity of the needle rod (see at least fig. 8).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Schotzko to include a needle head and a needle rod as taught by Ries in order to provide a needle having a passage for providing a sensor accordingly. Such a modification would allow for a needle which allows for an internal sensor which would reduce the discomfort of the surgeon/patient and improve the safety/accuracy of the system (see for example [0006] of Ries). Additionally/alternatively, such a modification amounts to merely a simple substitution of one known needle configuration for another yielding predictable results with respect to surgical needle guidance thereby rendering the claim obvious (MPEP 2144).
Claims 12, 24, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Schotzko in view of Ebnet (US 20220175416 A1), hereinafter Ebnet.
Regarding claim 12,
Schotzko teaches the elements of claim 2 as previously stated. Schotzko fails to explicit teach wherein the puncture needle comprises an auxiliary portion, the auxiliary portion sleeves outside the needle rod, and a friction coefficient of the auxiliary portion is smaller than that of the needle rod.
Ebnet, in a similar field of endeavor involving surgical needles, teaches wherein a puncture needle (see at least figs. 1-4) comprises an auxiliary portion (at least fig. 4 (22) and corresponding disclosure in at least [0121]) the auxiliary portion sleeves outside a needle rod (at least fig. 4 (6 and/or 5) and corresponding disclosure in at least [0121]), and a friction coefficient of the auxiliary portion is smaller than that of a needle rod ([0036] which discloses the tubular hollow body can be sealed, for example, by a plastic coating, for example a PTFE coating, on the inside and/or outside of the tubular hollow body. The tubular hollow body can be made of a metal, for example stainless steel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the puncture needle of Schotzko to include an auxiliary portion and needle rod as taught by Ebnet in order to provide a puncture system which allows an outer tubular body to remain in a body part of a living being (Ebnet [0001]) while providing sufficient sealing between elements of the puncture system, such that not exchange of fluids can take place between the inner tubular body and the outer tubular body and that undesired suction of air can also be avoided during aspiration (Ebnet [0012]). Furthermore, such a modification amounts to merely a simple substitution of one known puncture needle system for another yielding predictable results with respect to surgical needle guidance thereby rendering the claim obvious MPEP 2143).
Regarding claim 24,
Schotzko teaches the elements of claim 2 as previously stated. Schotzko further teaches wherein the puncture instrument comprises an interventional catheter instrument, which comprises: a guide tube ([0044] which discloses any suitable instrument or device 130 can be utilized with the system 10, e.g., one or more implantable devices, implant delivery devices, therapy delivery devices, surgical devices, mechanical circulatory support (e.g. LVAD) devices, coronary stent devices, heart valve devices, heart valve repair devices, cardiac ablation devices, cardiac lead devices, drug delivery devices, catheter delivery devices, and endoscopic delivery devices), however, does not explicitly teach the puncture instrument comprising both the puncture needle of claim 2 and the interventional catheter instrument and further does not explicitly teach a flexible sleeve which sleeves outside the guide tube.
Ebnet, in a similar field of endeavor involving puncture instruments, teaches the a puncture instrument (at least fig. 4 (1) and corresponding disclosure in at least [0114]) comprises a puncture needle (at least fig. 4 (5) and corresponding disclosure in at least [0114]) and an interventional catheter instrument (at least fig. 4 (6 and 7) and corresponding disclosure in at least [0114]) which comprises:
a guide tube (6); and
a flexible sleeve (7 and [0110] which discloses Thus, the sterile sleeve 4 can be formed for example from a solid material, wherein the puncture system 1 with the inner tubular body 6 and the outer tubular body 7 inside the body of a patient has flexible properties and, by means of the outer sleeve 4 outside the body, has a stabilizing effect on the puncture system 1) which sleeves outside the guide tube (6) (see at least fig. 4);
wherein the flexible sleeve and the guide tube are capable of moving relatively to each other so that a distal end of the flexible sleeve extends beyond a distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sleeve ([0006] which discloses [0006] It is proposed that the puncture system has a manually actuatable fixing element which can be moved by manual actuation at least into a fixing position and into a release position, wherein, in the fixing position, the longitudinal displaceability [0007] of the inner tubular body relative to the outer tubular body and/or [0008] of the puncture needle relative to the inner tubular body and/or [0009] of the puncture needle relative to the outer tubular body).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the puncture system of Schotzko to include an interventional catheter instrument as taught by Ebnet in order to provide a puncture system which allows an outer tubular body to remain in a body part of a living being (Ebnet [0001]) while providing sufficient sealing between elements of the puncture system, such that not exchange of fluids can take place between the inner tubular body and the outer tubular body and that undesired suction of air can also be avoided during aspiration (Ebnet [0012]). Furthermore, such a modification amounts to merely a simple substitution of one known puncture needle system for another yielding predictable results with respect to surgical needle guidance thereby rendering the claim obvious MPEP 2143).
Regarding claim 33,
Schotzko, as modified, teaches the elements of claim 24 as previously stated. Ebnet, as applied to claim 24 above, further teaches wherein the inner diameter of the flexible sleeve is greater than the outer diameter of the guide tube (Examiner notes that in order for the guide tube to fit within the flexible sleeve and be displaceable therein, this is necessary).
Examiner notes that Schotzko, as currently modified, fails to explicitly teach wherien the thickness specification of the guide tube comprises: 13G, 14G, 15G, and 16G, and a length of the guide tube is 42 cm to 57 cm; and the inner diameter of the flexible sleeve is greater than the outer diameter of the guide tube of .1 mm to 2 mm.
Nonetheless, Ebnet further discloses in [0057] which discloses The diameters here can be made specific to the particular use. For example, it is conceivable for the puncture system to be made available in large diameters and also smaller diameters and in [0123] which discloses For example, it is always conceivable to vary the number, length or size of the individual elements.
Examiner thus notes that it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the thickness, length and diameters to the claimed range as a matter of routine optimization where it is noted that the teachings of Ebnet suggest the ability to modify the diameters, length, and size of the individual elements as desired, having expected results regarding catheter use in the body, thereby rendering the claim obvious. Examiner further notes that the claimed ranges lack criticality as the originally filed specification in at least [0052], [0063], [00165], [00202] disclose merely examples of the thicknesses/lengths and explicitly discloses that the thicknesses/lengths are not limited thereto and further does not provide any specificity as to the criticality of the claimed thicknesses/lengths which would have unexpected results. (see also [0064] disclosing the same nature of the inner diameter to outer diameter without disclosing criticality of the claimed range).
Regarding claim 35,
Schotzo, as modified, teaches the elements of claim 24 as previously stated. Ebnet, as applied to claim 24 above further teaches wherein the interventional catheter instrument comprises a connector (at least fig. 5 (17) and corresponding disclosure in at least [0122]) through which a proximal end of the guide tube is connected with a proximal end of the flexible sleeve (see at least fig. 5 and [0122] which discloses it would also be conceivable for the outer tubular body 7 to be received in the longitudinally slotted sleeve. Examiner notes that in such an embodiment the proximal end of the outer tube 7 and the guide tube 6 are connected through the connector), and the guide tube and the flexible sleeve are able to move relative to each other through the connector ([0122] which discloses It is clear that, after the union nut 18 has been tightened, the puncture needle 5 and the inner tubular body 6 are pressed into the longitudinally slotted sleeve 17 and the longitudinal displaceability is in this way reduced. The matter of in which layers the longitudinal displaceability is reduced is not limited to this illustrative embodiment. It would also be conceivable for the outer tubular body 7 to be received in the longitudinally slotted sleeve 17, such that the longitudinal displaceability of all three layers can be reduced or canceled).
Allowable Subject Matter
Claim 25 is 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.
The following is a statement of reasons for the indication of allowable subject matter: Examiner notes that the closest prior art remains to be Schotzko and Ebnet as applied to claim 24. Examiner notes that while Ebnet teaches the distal end of the flexible sleeve is provided with a shrunk portion (see at least fig. 4 (9)), Ebnet fails to explicitly teach an inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube, and that the shrunk portion is provided with a weakened portion which is easy to be damaged; when the interventional catheter instrument abuts against a puncture target, the weakened portion is capable of being destroyed by causing the guide tube to move to the distal end relative to the flexible sleeve, so that the guide tube extends beyond the distal end of the flexible sleeve as required by the claim, as Ebnet teaches the inner diameter of the shrunk portion is greater than an outer diameter of the guide tube and does not dislose any weakened portion that is capable of being destroyed by causing the guide tube to move to the distal end relative to the flexible sleeve. A person having ordinary skill in the art would not have been motivated to have modified Ebnet or Schotzko as modified by Ebnet to include such a shrunk portion as recited by the claims, as such a modification would have required impermissible hindsight. For at least these reasons, the combination of elements is found to distinguish over the prior art collectively.
Claim 30 would be allowable for being dependent on allowable claim 25 if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797