DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s argument on Page 6 regarding the objection to the drawings has been fully considered. The objection to the drawings are withdrawn in view of the amendments.
Applicant’s argument on Page 6 regarding the objection to Claim 13 has been fully considered. The objection to Claim 13 is withdrawn in view of the amendment.
Applicant’s argument on Pages 6-7 regarding the rejection of Claim 2 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claim 2 under 35 U.S.C. 112(b) is withdrawn in view of the cancellation of the claim.
Applicant’s argument on Pages 7-9 regarding the rejection of Claims 1, 13, and 21 under 35 U.S.C. 102 over McKinnis in view of Fearnot has been fully considered but is moot under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 9 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
The rejection of Claim 2 is withdrawn in view of the cancelation of the claim.
Claim Objections
Claim 22 is objected to because of the following informalities: the claim should be amended to “[…] treatment fluid to a targeted site […]” in order to make sense grammatically. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: the claim should be amended to “is formed from at least one of […] or compression molding [[or extrusion molding]]” in order to make sense grammatically. Appropriate correction is required.
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.
Claims 1, 3-4, 13, and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson et al. (US 20190209809).
Regarding Claim 1, Isaacson teaches an echogenically enhanced medical device, (Abstract “A medical instrument or device, such as a catheter, has echogenic properties” and [0032] “catheter system 50”), comprising:
a) a body portion configured to be inserted within human or animal tissue, (Fig. 1 and Abstract “an example catheter has a relatively increased radiopacity and echogenicity to facilitate a clinician with detecting the catheter with ultrasound imaging and/or x-ray imaging methods to assist the clinician with the insertion,” and [0021] “cannula 16”), the body portion having a first acoustic impedance, ([0023] “cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material”), wherein the body portion comprises a catheter, ([0021 “catheter 10”), wherein the body portion defines a lumen, ([0021] “lumen 18), extending from a proximal end to a distal end, (Fig. 1 and [0021] “distal end 12 […] proximal end 14”), and an outer surface ([0021] “an outer surface 22 of cannula 16”);
b) wherein the body portion further comprises at least one structured echogenic portion having a second acoustic impedance configured to enhance ultrasonic imaging of the medical device when inserted into a patient, ([0024] “stripes 30 may include radiopaque properties or features. In example embodiments, stripes 30 include a biocompatible thermoplastic polymer material filled with a material or substance opaque to x-rays, thereby rendering stripes 30 visible under fluoroscopy or x-ray imaging.” Where the materials are different, thus they have different acoustic impedances.),
c) wherein the at least one structured echogenic portion comprises a structured shape defining an echogenic lumen and an echogenic outer surface of the catheter, (Fig. 2 and [0023] “one or more stripes 30 are formed encapsulated into wall 34 of cannula 16 while maintaining the smooth outer surface 22 and smooth inner surface 24 of cannula 16.”), wherein the at least one structured echogenic portion is shaped from an echogenic material such that a portion of the catheter is entirely formed from the echogenic material, ([0029] “stripes 30 may include a suitable, relatively dense material to create the echogenicity-enhancing properties of stripes 30.”),
d) wherein the body portion comprises at least two non-echogenic portions (Figs. 1-2 and [0030] “The echogenic features can be staggered, stepped, or placed for better detection of catheter 10. For example, the echogenic properties of catheter 10 or a system including a needle, catheter 10, and/or a flashback notch, for example, can be segmented with echogenic features or properties and non-echogenic features or properties to provide additional information on needle tip, depth, and/or location, for example.”).
Regarding Claim 3, Isaacson teaches all limitations of Claim 1, as discussed above. Furthermore, Isaacson teaches wherein the body portion is formed from one or more of metal material, plastic material, ([0023] “cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material”), ceramic material, and resin-based material.
Regarding Claim 4, Isaacson teaches all limitations of Claim 1, as discussed above. Furthermore, Isaacson teaches wherein the second acoustic impedance is different from the first acoustic impedance ([0023] “cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material” and [0024] “stripes 30 may include radiopaque properties or features. In example embodiments, stripes 30 include a biocompatible thermoplastic polymer material filled with a material or substance opaque to x-rays, thereby rendering stripes 30 visible under fluoroscopy or x-ray imaging.” Where the materials are different, thus they have different acoustic impedances.).
Regarding Claim 13, Isaacson teaches a method for preparing an echogenically enhanced medical device, ([0007] “a method for forming a stripe in a cannula of a catheter” and [0039] “In the detailed description above, numerous specific details are set forth to provide a thorough understanding of claimed subject matter. However, it will be understood by those skilled in the art that claimed subject matter can be practiced without these specific details. In other instances, methods, devices, or systems that would be known by one of ordinary skill have not been described in detail so as not to obscure claimed subject matter.”), comprising the steps of:
a) providing a medical device, (Abstract “A medical instrument or device, such as a catheter, has echogenic properties” and [0032] “catheter system 50”), having a body portion configured to be inserted within human or animal tissue, (Fig. 1 and Abstract “an example catheter has a relatively increased radiopacity and echogenicity to facilitate a clinician with detecting the catheter with ultrasound imaging and/or x-ray imaging methods to assist the clinician with the insertion,” and [0021] “cannula 16”), the body portion having a first acoustic impedance, ([0023] “cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material”), wherein the body portion comprises a catheter, ([0021 “catheter 10”), wherein the body portion defines a lumen, ([0021] “lumen 18), extending from a proximal end to a distal end, (Fig. 1 and [0021] “distal end 12 […] proximal end 14”), and an outer surface ([0021] “an outer surface 22 of cannula 16”);
b) forming at least one structured echogenic portion having a second acoustic impedance, ([0024] “stripes 30 may include radiopaque properties or features. In example embodiments, stripes 30 include a biocompatible thermoplastic polymer material filled with a material or substance opaque to x-rays, thereby rendering stripes 30 visible under fluoroscopy or x-ray imaging.” Where the materials are different, thus they have different acoustic impedances.),
c) wherein the at least one structured echogenic portion is configured to enhance ultrasonic imaging of the medical device when inserted into a patient, wherein the at least one structured echogenic portion comprises a structured shape defining an echogenic lumen and an echogenic outer surface of the catheter, (Fig. 2 and [0023] “one or more stripes 30 are formed encapsulated into wall 34 of cannula 16 while maintaining the smooth outer surface 22 and smooth inner surface 24 of cannula 16.”), wherein the at least one structured echogenic portion is shaped from an echogenic material such that a portion of the catheter is entirely formed from the echogenic material, ([0029] “stripes 30 may include a suitable, relatively dense material to create the echogenicity-enhancing properties of stripes 30.”),
d) wherein the body portion comprises a first non-echogenic portion extending from the proximal end to the at least one structured echogenic portion and a second non-echogenic portion extending from the at least one structured echogenic portion to the distal end ([0030] “The echogenic features can be staggered, stepped, or placed for better detection of catheter 10. For example, the echogenic properties of catheter 10 or a system including a needle, catheter 10, and/or a flashback notch, for example, can be segmented with echogenic features or properties and non-echogenic features or properties to provide additional information on needle tip, depth, and/or location, for example.”).
Regarding Claim 22, Isaacson teaches all limitations of Claim 1, as discussed above. Furthermore, Isaacson teaches wherein the proximal end of the catheter includes a hub configured thereon for mating communication with a fluid delivery device, ([0022] “catheter adapter 15 is configured to couple to a cooperating small-bore fitting or connection, tubing, a hub, or another suitable connection such that lumen 18 provides a fluid flow path through catheter 10” and [0031] “Small-bore connector 40 is configured to removably couple to any suitable medical device or component, for example, a cooperating small-bore fitting, a device, or a medical tubing. The medical device, component, or tubing may include a cooperating element, such as a cooperating small-bore connector, to facilitate coupling the medical device, component, or tubing, for example, to catheter 10.”), wherein the catheter includes an open distal tip or the infusion holes to deliver a treatment fluid [to] a targeted site within a patient ([0003] “IV catheter,” where it is understood that an IV catheter is utilized to deliver fluids, medications, blood products, etc. to a patient intravenously, and therefore has an open distal tip or infusion holes to deliver the fluid.).
Regarding Claim 23, Isaacson teaches all limitations of Claim 1, as discussed above. Furthermore, Isaacson teaches wherein the at least one structured echogenic portion is formed from extrusion molding, compression molding, or extrusion molding [sic] ([0023] “stripes 30 are formed in cannula 16 using a suitable method or technique to maintain the smooth outer surface 22 and inner surface 24 of cannula 16. For example, cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material, through an array of dies aligned such that each stripe 30 is formed between and bonded to extruded material forming adjacent transparent wall portions 32 of a wall 34 of cannula 16.”).
Regarding Claim 24, Isaacson teaches all limitations of Claim 1, as discussed above. Furthermore, Isaacson teaches wherein the at least two non-echogenic portions includes a first non-echogenic portion extending from the proximal end to the at least one structured echogenic portion and a second non-echogenic portion extending from the at least one structured echogenic portion to the distal end (Figs. 1-2 and [0030] “The echogenic features can be staggered, stepped, or placed for better detection of catheter 10. For example, the echogenic properties of catheter 10 or a system including a needle, catheter 10, and/or a flashback notch, for example, can be segmented with echogenic features or properties and non-echogenic features or properties to provide additional information on needle tip, depth, and/or location, for example.”).
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (US 20190209809) in view of McKinnis et al. (US 20140221828).
Regarding Claim 21, Isaacson teaches a method for identifying an echogenically enhanced medical device within a body of a patient, (Abstract “an example catheter has a relatively increased radiopacity and echogenicity to facilitate a clinician with detecting the catheter with ultrasound imaging and/or x-ray imaging methods to assist the clinician with the insertion, placement, and/or maintenance of the catheter, for example.”), the method comprising the steps of:
a) providing a medical device, (Abstract “A medical instrument or device, such as a catheter, has echogenic properties” and [0032] “catheter system 50”), having a body portion configured to be inserted within human or animal tissue, (Fig. 1 and Abstract “an example catheter has a relatively increased radiopacity and echogenicity to facilitate a clinician with detecting the catheter with ultrasound imaging and/or x-ray imaging methods to assist the clinician with the insertion,” and [0021] “cannula 16”), the body portion having a first acoustic impedance, ([0023] “cannula 16 may be formed during a die extrusion process by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as a polyurethane or fluoropolymer material”), wherein the body portion comprises a catheter, ([0021 “catheter 10”), wherein the body portion defines a lumen, ([0021] “lumen 18), extending from a proximal end to a distal end (Fig. 1 and [0021] “distal end 12 […] proximal end 14”), and an outer surface of the catheter ([0021] “an outer surface 22 of cannula 16”);
b) forming at least one structured echogenic portion on the medical device body portion, the structured echogenic portion having a second acoustic impedance, ([0024] “stripes 30 may include radiopaque properties or features. In example embodiments, stripes 30 include a biocompatible thermoplastic polymer material filled with a material or substance opaque to x-rays, thereby rendering stripes 30 visible under fluoroscopy or x-ray imaging.” Where the materials are different, thus they have different acoustic impedances.), wherein the structured echogenic portion is configured to enhance ultrasonic imaging of the medical device when inserted into the body of the patient, wherein the at least one structured echogenic portion comprises a structured shape defining an echogenic lumen and an echogenic outer surface of the catheter, wherein the at least one structured echogenic portion is shaped from an echogenic material such that a portion of the catheter is entirely formed from the echogenic material, (Fig. 2 and [0023] “one or more stripes 30 are formed encapsulated into wall 34 of cannula 16 while maintaining the smooth outer surface 22 and smooth inner surface 24 of cannula 16.”), wherein the at least one structured echogenic portion is shaped from an echogenic material such that a portion of the catheter is entirely formed from the echogenic material, ([0029] “stripes 30 may include a suitable, relatively dense material to create the echogenicity-enhancing properties of stripes 30.”), and defines the echogenic lumen and the echogenic outer surface of the catheter, (Fig. 2 and [0023] “one or more stripes 30 are formed encapsulated into wall 34 of cannula 16 while maintaining the smooth outer surface 22 and smooth inner surface 24 of cannula 16.”), wherein the body portion comprises at least one non-echogenic portion ([0030] “The echogenic features can be staggered, stepped, or placed for better detection of catheter 10. For example, the echogenic properties of catheter 10 or a system including a needle, catheter 10, and/or a flashback notch, for example, can be segmented with echogenic features or properties and non-echogenic features or properties to provide additional information on needle tip, depth, and/or location, for example.”); and
c) inserting the body portion of the medical device into the body of the patient (Abstract “an example catheter has a relatively increased radiopacity and echogenicity to facilitate a clinician with detecting the catheter with ultrasound imaging and/or x-ray imaging methods to assist the clinician with the insertion”).
However, Isaacson does not explicitly teach receiving data signals from an autonomous ultrasound imaging system, the data signals comprising information related to a plurality of ultrasound waves generated by an ultrasound probe of the autonomous ultrasound imaging system; and identifying the structured echogenic portion of the body portion of the medical device using the received data signals by identifying the at least one of the structured shape or the discontinuous pattern of the structured echogenic portion.
In an analogous non-linear echogenic marker field of endeavor, McKinnis teaches a method for identifying an echogenically enhanced medical device within a body of a patient, the method comprising the steps of:
a) receiving data signals, ([0030] “a transducer which emits ultrasound signals is applied (e.g. against the patient's body) so that its signals are directed toward medical device 100. At least a portion of the ultrasound signals hit the medical device 100 and a portion of the signals are reflected back towards the transducer.”), from an autonomous ultrasound imaging system, ([0020] “ultrasound imaging systems”), the data signals comprising information related to a plurality of ultrasound waves generated by an ultrasound probe, ([0022] “a transducer emits an ultrasound signal and the signal is reflected partially as it encounters changes in the medium through which it travels.”), of the autonomous ultrasound imaging system ([0020] “the medical device 100 is configured to work in conjunction with existing ultrasound consoles, probes, and pulse sequences used within a variety of ultrasound imaging systems.”); and
b) identifying the structured echogenic portion of the body portion of the medical device using the received data signals, ([0032] “The echogenic region 106 enhances the visibility of the medical device during ultrasound imaging procedures by producing a reflection with a signal pattern that is not produced by body tissue and which is readily differentiable from tissue.”), by identifying the at least one of the structured shape or the discontinuous pattern of the structured echogenic portion ([0032] “the echogenic subregions 108 have sharp corners, straight boundaries or borderlines and a relatively heterogenic structure in the illustrated embodiment, which allows the echogenic region 106 to produce images with characteristic features which are readily differentiable from body tissue. When imaged using an ultrasound imaging system, the sharp corners of subregions 108 are visually distinct from surrounding body tissue, allowing a physician to more easily and readily identify the position of the medical device 100.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to combine the teachings of Isaacson and McKinnis because the combination allows for accurate localization of subcutaneous devices within the body, as taught by McKinnis in [0002], which minimizes any unintentional damage to the patient.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795