DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite the sensor obtains medical data associated with the blood vessel. “medical data associated with the blood vessel” is a vast category of potential information and data. It appears the current device only relates to sensed physiological data and specifically pressure and flow. It does not appear the specification supports a device that can obtain any medical data associated with the blood vessel.
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 1-21 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. The claim recites obtaining “medical data” associated with the blood vessel. It appears from the specification at ¶3,37 that this refers to pressure and flow data but it is unclear if this is all that medical data could be as it is not specifically defined.
Claim 18 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. It is unclear the relationship of the sensor and jacket to the guidewire. Claim 10 recites that the sensor is at the distal portion so it is unclear if the polymer jacket is then more distal along the guidewire than the sensor and housing.
Claims 19-21 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. The claim recites that the sensor housing is relatively more rigid than the polymer jacket. It is unclear what the scope of relatively more rigid is as it is a term of degree with undefined bounds.
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(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. US 2013/0274618 further in view of Sela et al. US 2009/0192412 further in view of Richardson et al. US 2001/0009980.Regarding claim 1, Hou discloses an apparatus, comprising:
an intravascular guidewire configured to be positioned within a blood vessel ([FIG.2][¶57] guidewire 200) and comprising:
a proximal portion and a distal portion ([FIG.2] proximal end 202 and distal end 204);
a core wire ([¶57] core 220);
a polymer jacket positioned around the core wire ([¶32,57] outer layer 206 which can be a polymer);
a sensor configured to obtain medical data associated with the blood vessel ([¶29] pressure sensor 124),
Hou does not specifically disclose a sensor housing at the distal end.
Sela teaches a similar intravascular sensing guidewire that has a housing for the sensor ([¶36] housing 120 for sensor 112). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing been obvious to one of ordinary skill in the art at the time of filing to combine the device of Hou with the sensor housing of Sela in order to enclose and protect the sensor ([¶32]).
Hou discloses the device has varying flexibility along its length ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition).
Hou does not disclose the polymer jacket comprises a first section with a first hardness and a second section with a second hardness. Richardson teaches a similar intravascular guidewire that has three or more sections of varying flexibility and jacket polymer composition ([FIG.7][¶23] section 62, 64 and 66). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hou with the polymer jacket of Richardson in order to have a continuous variation in shore hardness ([¶25]).
Regarding claim 2, Hou discloses the first hardness is less than the second hardness ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition).
Regarding claim 3, Hou discloses the first hardness is larger than the second hardness, wherein the first section is proximate to the sensor housing, and wherein the second section is proximate to the first section ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition).
Regarding claim 6, Sela teaches the sensor housing comprises a first proximal end and an opposing distal end, wherein the distal end is distal of the proximal end, and wherein the polymer jacket is in direct contact with the proximal end of the sensor housing ([¶36] the housing has a proximal and distal end and the proximal end contacts the jacket/coating).
Regarding claim 4, Hou discloses the guidewire can have a coating of varying compositions of polymers ([¶32,55]) but does not specifically disclose the first section comprises a first composition of at least two polymers, and wherein the second section comprises a second composition of the at least two polymers. Richardson teaches a similar intravascular guidewire that varies its flexibility based on the change in the composition of two or more polymers in the coating ([¶25]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hou with the polymer jacket of Richardson in order to have a continuous variation in shore hardness ([¶25]).
Regarding claim 5, Richardson teaches the polymer jacket comprises a third section with a third hardness, wherein the third section is proximate to the second section such that the second section is disposed directly between the first section and the third section, and wherein the third section comprises a third composition of the at least two polymers ([FIG.7][¶23] section 62, 64 and 66).
Regarding claim 6, Richardson teaches the third hardness is larger than both the first hardness and the second hardness ([¶25] the hardness decrease from proximal to distal end so if the jacket section 62 is the third section it is harder than the second and first sections).
Regarding claim 8, Richardson teaches the guidewire comprising a further polymer jacket comprising a third section with a third hardness and a fourth section with a fourth hardness, wherein the third hardness is larger than the fourth hardness, wherein the fourth section is distal of the third section, and wherein the third section is proximate to the distal end of the sensor housing ([FIG.7][¶25]).
Regarding claims 9, 17 and 18, Hou discloses that the sensors can be at the distal end but not at the tip ([FIG.5] sensors 522 and 524) and Richardson teaches that the polymer jacket is in direct contact with the proximal end of the sensor housing, and wherein the further polymer jacket is in direct contact with the distal end of the sensor housing ([¶25]).
Regarding claim 10 and 19, Hou discloses an apparatus comprising:
an intravascular guidewire configured to be positioned within a blood vessel ([FIG.2][¶57] guidewire 200) and comprising:
a proximal portion and a distal portion ([FIG.2] proximal end 202 and distal end 204);
a core wire ([¶57] core 220);
a polymer jacket positioned around the core wire ([¶32,57] outer layer 206 which can be a polymer);
a sensor configured to obtain medical data associated with the blood vessel ([¶29] pressure sensor 124),
Hou does not specifically disclose a sensor housing. Sela teaches a similar intravascular sensing guidewire that has a housing for the sensor ([¶36] housing 120 for sensor 122). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing been obvious to one of ordinary skill in the art at the time of filing to combine the device of Hou with the sensor housing of Sela in order to enclose and protect the sensor ([¶32]).
Hou discloses the guidewire having varying hardness or flexibility ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition) but does not specifically disclose three sections of the polymer jacket. Richardson teaches a similar intravascular guidewire that has
a first section comprising a first composition of at least two polymers;
a second section comprising a second composition of the at least two polymers; and
a third section comprising a third composition of the at least two polymers and located between the first section and the second section ([¶23] sections 62, 64 and 66),
wherein the third composition comprises a transition between the first composition and the second composition ([¶25] where the sections decrease in hardness or have a continuous decrease in hardness based on the ratio of the two polymers). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hou with the polymer jacket of Richardson in order to have a continuous variation in shore hardness ([¶25]).
Regarding claim 11, Hou discloses the first section comprises a first hardness, and wherein the second section comprises a second hardness different than first hardness ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition).
Regarding claim 12, Hou discloses the first hardness is greater than the second hardness ([¶43,47,56] the distal end can be more flexible than the proximal end based on the size or amount of material or coating composition).
Regarding claim 13, Sela teaches the sensor housing is located at a distal end of the distal portion, and wherein the distal portion terminates at the distal end ([¶FIG.1A]).
Regarding claim 14, Sela teaches the first section of the polymer jacket is in direct contact with the sensor housing ([¶36] the housing has a proximal and distal end and the proximal end contacts the jacket/coating).
Regarding claim 15, Richardson teaches the first composition, the second composition, and the third composition each comprise different percentages of the at least two polymers ([¶25] the jacket is made of two polymers and the flexibility is adjusted based on varying the mixture. Richardson does not specifically state a percentage but mixture of two or polymers can be quantified as percentages).
Regarding claim 16, Sela teaches the polymer jacket is disposed proximal of the sensor housing, and wherein the second section is proximal of the first section and proximal of the third section ([¶36] the housing has a proximal and distal end and the proximal end contacts the jacket/coating).
Regarding claims 20 and 21, Richardson teaches the second section is located proximal of the first section or the second section is located distal of the first section ([¶23,25] any of the three jacket sections can be arbitrarily chosen as the first or second section. Additionally, the durometer of the jacket can varying in a continuous matter where any number of sections could be delineated).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pursley US 6030371 related to changing the mixture of a polymer applied to a guidewire to continuously vary the flexibility or hardness. Cragg et al. US 20180015254 A1 related to a catheter coating that has four or more distinct sections with different durometers.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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