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 with traverse of Species I (Figures 6A-6B) in the reply filed on August 8, 2025, is acknowledged. The traversal is on the ground(s) that: Applicant traverses on the grounds that no serious search and/or examination burden would be present if the restriction were not required (Remarks, page 7).
This is not found persuasive because there is a serious search and/or examination burden for the patentably distinct species because: the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification, the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter, and the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Further, Applicant identified claims 1-13 and 16-20 as encompassing elected Species I (Figures 6A-6B) (Remarks, page 7). Examiner disagrees. Only claims 1-9 and 18-20 encompass elected Species I (Figures 6A-6B).
Claim 10 recites: wherein the flexible sleeve comprises one or more stretch resistant fibers positioned within a wall of the flexible sleeve. However, Species I (Figures 6A-6B) does not teach this claim feature.
Non-elected Species II (Figures 7A and 7C, in which sleeve 502 of Figure 7A replaces sleeve 502 of Figure 7C) teaches wherein the flexible sleeve 502 comprises one or more stretch resistant fibers 800 positioned within a wall of the flexible sleeve. And non-elected Species III (Figures 7B-7C) teaches wherein the flexible sleeve 502 comprises one or more stretch resistant fibers 800 positioned within a wall of the flexible sleeve.
Thus, Examiner withdraws claim 10 from examination as not encompassing elected Species I (Figures 6A-6B). Claims 11-13 and 16-17 are also withdraw by virtue of being dependent upon claim 10 (Applicant has already withdrawn claims 14-15 dependent upon claim 10).
Currently, claims 1-9 and 18-20 are under examination as encompassing elected Species I (Figures 6A-6B).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
U.S. Patent No. 10,806,462
The information disclosure statement filed July 19, 2021, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 9775706 has been provided with the incorrect name of patentee of Paterson. The correct name of patentee of US 9775706 is Peterson. Thus, it is unclear whether Applicant is intending to cite US 9775706 or another document to Paterson
The citation for US 10282851 has been provided with the incorrect name of patentee of Gorochow. The correct name of patentee of US 10282851 is Baik. Thus, it is unclear whether Applicant is intending to cite US 10282851 or another document to Gorochow
The citation for US 20170100143 has been provided with the incorrect name of patentee of Granfield. The correct name of patentee of US 20170100143 is Grandfield. Thus, it is unclear whether Applicant is intending to cite US 20170100143 or another document to Granfield
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed September 22, 2021, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 9775706 has been provided with the incorrect name of patentee of Paterson. The correct name of patentee of US 9775706 is Peterson. Thus, it is unclear whether Applicant is intending to cite US 9775706 or another document to Paterson
The citation for US 20170100143 has been provided with the incorrect name of patentee of Granfield. The correct name of patentee of US 20170100143 is Grandfield. Thus, it is unclear whether Applicant is intending to cite US 20170100143 or another document to Granfield
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed December 16, 2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy of JP H10-507090 has been provided for consideration (only a machine translation has been provided)
Specification
The abstract of the disclosure is objected to because:
In line 3, “flexible tubular section” should be changed to “the flexible tubular section”
In line 4, “proximal hypotube” should be changed to “the proximal hypotube”
In lines 4-5, “The stretch resistant tube” should be changed to “The stretch resistant member”
In lines 5-6, “the proximal and distal hypotubes” should be changed to “the proximal hypotube and the distal hypotube”
Line 7 recites “one or more stretch resistant fibers”. Line 4 previously recites “a stretch resistant member”. It is unclear whether the two terms refer to the same component or to different components
In lines 8-9, “an outer surface” should be changed to “the outer surface”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 4-5, and 18-20 are objected to because of the following informalities:
In regards to claim 1, line 13, “stretch resistant member” should be changed to “the stretch resistant member”.
In regards to claim 4, line 4, “the distal end” should be changed to “a distal end”.
In regards to claim 5, line 1, “where in” should be changed to “wherein”.
In regards to claim 18, line 11, “the first, second, and third lumen” should be changed to “the first lumen, the second lumen, and the third lumen”.
In regards to claim 19, line 1, “the step of selecting” should be changed to “the selecting”.
In regards to claim 19, line 5, “and” should be changed to “or”.
In regards to claim 20, line 1, “the step of detachably attaching” should be changed to “the detachably attaching”.
In regards to claim 20, line 2, “a distal end” should be changed to “the distal end”.
In regards to claim 20, line 6, “a compressed first hypotube” should be changed to “the compressed first hypotube”.
Appropriate correction is required.
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.
Claim 19 is 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.
In regards to claim 19, line 5 recites “a stretch resistant fiber”. Claim 19 depends upon claim 18. Claim 18, line 8 recites “a stretch resistant member”. It is unclear whether the two terms refer to the same component or to different components.
In regards to claim 19, line 6 recites “a stretch resistant fiber”. Claim 19 depends upon claim 18. Claim 18, line 8 recites “a stretch resistant member”. It is unclear whether the two terms refer to the same component or to different components.
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 1, 5, 7-9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al (US 2014/0058435), and further in view of Fearnot et al (US 5,069,674).
In regards to claim 1, Jones et al teaches a delivery member (Figures 16-25, medical implant deployment system 200) for delivering an implantable medical device to a target location of a body vessel, the delivery member comprising:
a distal hypotube (260) comprising a distal end (263) shaped to receive the implantable medical device
a flexible tubular section (270) affixed to a proximal end of the distal hypotube (Figure 17), the flexible tubular section comprising openings (gasps between windings of wire 271) therethrough
a proximal hypotube (240) affixed to a proximal end of the flexible tubular section (Figure 17)
a lumen extending through the distal hypotube, the flexible tubular section, and the proximal hypotube (Figures 16-17)
a flexible sleeve (246) covering at least a majority of the outer surface of the flexible tubular section (Figure 17)
Jones et al does not teach a stretch resistant member positioned outside of the lumen, affixed to the proximal hypotube, affixed to the distal hypotube, and extending along at least a portion of an outer surface of the flexible tubular section, and the flexible sleeve covering at least a majority of the outer surface of stretch resistant member. Fearnot et al teaches a delivery member (Figures 1 and 3, catheter 100) comprising a stretch resistant member (116) positioned outside of a lumen (Figure 3), affixed to a proximal hypotube (proximal portion of coil 105), affixed to a distal hypotube (distal portion of coil 105), and extending along at least a portion of an outer surface of a flexible tubular section (middle portion of coil 105), and a flexible sleeve (104) covering at least a majority of the outer surface of the flexible tubular section and stretch resistant member (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery member, of Jones et al, with a stretch resistant member and the flexible sleeve covering at least a majority of the outer surface of stretch resistant member, as taught by Fearnot et al, as such will prevent the stretching of the flexible tubular section for whatever reason (column 5, lines 66-68, to column 6, lines 1-3) such as providing a further measure of safety (column 3, lines 61-66).
In regards to claim 5, in the modified delivery member of Jones et al and Fearnot et al, Jones et al teaches where in the flexible tubular section comprises: a wire (271) wound to form the flexible tubular section and defining a portion of the lumen (Figures 16-17); however, Jones et al is silent about the wire comprising a diameter measuring from about 0.0008 inch to about 0.005 inch. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the wire, of the modified delivery member of Jones et al and Fearnot et al, to comprise a diameter measuring from about 0.0008 inch to about 0.005 inch, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified delivery member, of Jones et al and Fearnot et al, would not operate differently with the claimed diameter. Further, it appears that Applicant places no criticality on the range claimed for the diameter.
In regards to claim 7, in the modified delivery member of Jones et al and Fearnot et al, Jones et al teaches wherein the flexible sleeve is affixed to the proximal hypotube and the distal hypotube (Figures 16-17).
In regards to claim 8, in the modified delivery member of Jones et al and Fearnot et al, Jones et al is silent about wherein the flexible sleeve comprises a wall thickness measuring from about 0.001 inch to about 0.003 inch. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible sleeve, of the modified delivery member of Jones et al and Fearnot et al, to comprise a wall thickness measuring from about 0.001 inch to about 0.003 inch, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified delivery member, of Jones et al and Fearnot et al, would not operate differently with the claimed wall thickness. Further, it appears that Applicant places no criticality on the range claimed for the wall thickness.
In regards to claim 9, in the modified delivery member of Jones et al and Fearnot et al, Jones et al teaches wherein the delivery member comprises a length measurable from the proximal end of the flexible tubular section to the distal end of the distal hypotube (Figures 16-17); however, Jones et al is silent about wherein the length measures about 40 cm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the length, of the modified delivery member of Jones et al and Fearnot et al, to measure about 40 cm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified delivery member, of Jones et al and Fearnot et al, would not operate differently with the claimed length. Further, it appears that Applicant places no criticality on the value claimed for the length.
In regards to claim 18, Jones et al teaches a method of constructing a delivery member (Figures 16-25, medical implant deployment system 200) for delivering an implantable medical device (230), the method comprising:
selecting a first hypotube (260) comprising a first lumen therethrough (Figures 16-17)
selecting a second hypotube (240) comprising a second lumen therethrough (Figures 16-17)
forming a flexible tubular section (270) extending from a distal end of the second hypotube to a proximal end of the first hypotube such that the flexible tubular section defines a third lumen therethrough (Figures 16-17)
selecting a flexible sleeve (246)
covering at least a majority of an outer surface of the flexible tubular section with the flexible sleeve (Figures 16-17)
detachably attaching the implantable medical device to the delivery member approximate a distal end of the first hypotube (Figure 21)
Jones et al does not teach affixing a distal portion of a stretch resistant member to the first hypotube and affixing a proximal portion of the stretch resistant member to the second hypotube, wherein an intermediate portion of the stretch resistant member is positioned outside of the first, second, and third lumen. Fearnot et al teaches a method of constructing a delivery member (Figures 1 and 3, catheter 100), the method comprising: affixing a distal portion of a stretch resistant member (116) to a first hypotube (distal portion of coil 105) and affixing a proximal portion of the stretch resistant member to a second hypotube (proximal portion of coil 105), wherein an intermediate portion (middle portion of coil 105) of the stretch resistant member is positioned outside of a first, second, and third lumen (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Fearnot et al, with affixing a distal portion of a stretch resistant member to the first hypotube and affixing a proximal portion of the stretch resistant member to the second hypotube, wherein an intermediate portion of the stretch resistant member is positioned outside of the first, second, and third lumen, as taught by Fearnot et al, as such will prevent the stretching of the flexible tubular section for whatever reason (column 5, lines 66-68, to column 6, lines 1-3) such as providing a further measure of safety (column 3, lines 61-66).
Claims 2-3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al and Fearnot et al, as applied to claims 1 and 18 above, and further in view of Lorenzo (US 2019/0192162).
In regards to claim 2, in the modified delivery member of Jones et al and Fearnot et al, Jones et al teaches:
an engagement system (266/276) movable to engage and deploy the implantable medical device engaged at the distal end of the distal hypotube, the engagement system comprising:
a loop wire (266/268) extended through an opening in the implantable medical device thereby engaging the engagement system to the implantable medical device and movable to retract from the opening in the implantable medical device (Figure 18B)
a pull wire (276) extended through the lumen, engaged to the loop wire thereby engaging the engagement system to the implantable medical device, and movable to retract proximally (Figure 18B)
Jones et al does not teach the loop wire movable to retract from the opening in the implantable medical device to deploy the implantable medical device, as Jones et al instead teaches the loop wire movable to extend from the opening in the implantable medical device to deploy the implantable medical device (Figure 25). And Jones et al does not teach the pull wire movable to retract proximally to disengage the loop wire to deploy the implantable medical device, as Jones et al instead teaches the pull wire movable to extend distally to deploy the implantable medical device (Figure 25). Lorenzo teaches a delivery member (Figures 1A-3A, 5A-8, 11A-13, detachment system 10) for delivering an implantable medical device (12) to a target location of a body vessel, the delivery member comprising: an engagement system (400/140) movable to engage and deploy the implantable medical device engaged at a distal end of a distal hypotube (300), the engagement system comprising: a loop wire (400) extended through an opening in the implantable medical device thereby engaging the engagement system to the implantable medical device and movable to retract from the opening in the implantable medical device to deploy the implantable medical device (Figure 11D), and a pull wire (140) extended through a lumen, engaged to the loop wire thereby engaging the engagement system to the implantable medical device, and movable to retract proximally to disengage the loop wire to deploy the implantable medical device (Figure 11C). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the loop wire and the pull wire, of the modified delivery member of Jones et al and Fearnot et al, to be the loop wire movable to retract from the opening in the implantable medical device to deploy the implantable medical device, and the pull wire movable to retract proximally to disengage the loop wire to deploy the implantable medical device, as taught by Lorenzo, as such a loop wire and such a pull wire will allow for locking and secure engagement with the implantable medical device, which is later released for delivery of the implantable medical device (paragraphs [0039][0045]).
In regards to claim 3, in the modified delivery member of Jones et al, Fearnot et al, and Lorenzo, Jones et al does not teach wherein the distal hypotube comprises a compressible portion movable from a compressed condition to an elongated condition, and wherein the engagement system maintains the compressible portion in the compressed condition when engaged to the implantable medical device. Lorenzo teaches wherein the distal hypotube comprises a compressible portion (306) movable from a compressed condition to an elongated condition, and wherein the engagement system maintains the compressible portion in the compressed condition when engaged to the implantable medical device (Figures 11A-11B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal hypotube and the engagement system, of the modified delivery member of Jones et al, Fearnot et al, and Lorenzo, to be the distal hypotube comprising a compressible portion movable from a compressed condition to an elongated condition, and the engagement system maintaining the compressible portion in the compressed condition when engaged to the implantable medical device, as taught by Lorenzo, as such a distal hypotube will expand/return to its original shape and “spring” forward imparting an elastic force to the medical device to “push” it away to ensure a clean separation and delivery of the medical device when the engagement system is released from the medical device (paragraph [0045]).
In regards to claim 20, in the modified method of Jones et al and Fearnot et al, Jones et al does not teach wherein the step of detachably attaching the implantable medical device to the delivery member approximate a distal end of the first hypotube further comprises: compressing the first hypotube; and detachably attaching the implantable medical device to the delivery member approximate the distal end of a compressed first hypotube. Lorenzo teaches a method of constructing a delivery member (Figures 1A-3A, 5A-8, 11A-13, detachment system 10) for delivering an implantable medical device (12), wherein a step of detachably attaching the implantable medical device to the delivery member approximate a distal end of a first hypotube (300) further comprises: compressing the first hypotube; and detachably attaching the implantable medical device to the delivery member approximate the distal end of a compressed first hypotube (306) (Figures 11A-11B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the step of detachably attaching the implantable medical device to the delivery member approximate a distal end of the first hypotube, of the modified method of Jones et al and Fearnot et al, to further comprise compressing the first hypotube, and detachably attaching the implantable medical device to the delivery member approximate the distal end of a compressed first hypotube, as taught by Lorenzo, as such a first hypotube will expand/return to its original shape and “spring” forward imparting an elastic force to the medical device to “push” it away to ensure a clean separation and delivery of the medical device when an engagement system is released from the medical device (paragraph [0045]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al and Fearnot et al, as applied to claim 1 above, and further in view of Kellett (US 8,202,292).
In regards to claim 4, in the modified delivery member of Jones et al and Fearnot et al, Jones et al teaches wherein the flexible tubular section comprises: a non-radiopaque proximal coil (proximal portion of distal actuator element 270) extending from the proximal end of the flexible tubular section; a non-radiopaque distal coil (distal portion of distal actuator element 270) extending from the distal end of the flexible tubular section; however, Jones et al does not teach a radiopaque central coil extending between the non-radiopaque proximal coil and the non-radiopaque distal coil, as Jones et al instead teaches a non-radiopaque central coil (middle portion of distal actuator element 270) extending between the non-radiopaque proximal coil and the non-radiopaque distal coil. Kellett teaches a delivery member (Figure 5) wherein a flexible tubular section (208) comprises: a non-radiopaque proximal coil (a segment of stainless steel coil) extending from a proximal end of the flexible tubular section; a non-radiopaque distal coil (a segment of stainless steel coil) extending from a distal end of the flexible tubular section; and a radiopaque central coil (a segment of platinum coil (which is radiopaque) extending between the non-radiopaque proximal coil and the non-radiopaque distal coil (column 9, line 67, to column 10, lines 1-4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the central coil, of the modified delivery member of Jones et al and Fearnot et al, to be a radiopaque central coil, as taught by Kellett, as such will allow for identifying the location of the delivery member using imaging technology (e.g., fluoroscope imaging) (column 9, line 67, to column 10, lines 1-4)(column 4, lines 63-67, to column 5, line 1).
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al and Fearnot et al, as applied to claims 1 and 18 above, and further in view of Que et al (US 8,926,650).
In regards to claim 6, in the modified delivery member of Jones et al and Fearnot et al, Jones et al is silent about wherein the flexible sleeve comprises a polymer, and wherein the flexible sleeve comprises additives effective to increase lubricity of the polymer. Que et al teaches a delivery member (Figure 1A) wherein a flexible sleeve (30) comprises a polymer, and wherein the flexible sleeve comprises additives effective to increase lubricity of the polymer (column 6, lines 36-39). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible sleeve, of the modified delivery member of Jones et al and Fearnot et al, to comprises a polymer and additives effective to increase lubricity of the polymer, as taught by Que et al, as such will allow for smooth movement of the delivery member by reducing frictional forces (column 6, lines 36-39)(column 6, lines 64-67)(column 9, lines 19-23).
In regards to claim 19, in the modified method of Jones et al and Fearnot et al, Jones et al is silent about wherein the step of selecting the flexible sleeve further comprises: selecting the flexible sleeve comprising a polymer and further comprising at least one of: an additive effective to increase lubricity of the polymer, a stretch resistant fiber comprising a polymer, and a stretch resistant fiber comprising a metal. Que et al teaches a method of constructing a delivery member (Figure 1A) wherein a step of selecting a flexible sleeve (30) further comprises: selecting the flexible sleeve comprising a polymer and further comprising: an additive effective to increase lubricity of the polymer (column 6, lines 36-39). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the step of selecting the flexible sleeve, of the modified method of Jones et al and Fearnot et al, to further comprise: selecting the flexible sleeve comprising a polymer and further comprising: an additive effective to increase lubricity of the polymer, as taught by Que et al, as such will allow for smooth movement of the delivery member by reducing frictional forces (column 6, lines 36-39)(column 6, lines 64-67)(column 9, lines 19-23).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783