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 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(s) 28, 31 is/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 28 recites the limitation "wherein each of the tubes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that a parent app. 15/309193 (abandoned) recited similar features in claim 14 in which there was “an inner tube and an outer tube” which seems to be equivalent to claim 21’s (on which instant claim depends from) “an inner wall, an outer wall”. Also, instant claim 35 recites “cathere comprising an inner tube and an outer tube”. For examination purposes below, it will be assumed that a similar interpretation should be taken, that the tubes mechanically correspond to the inner and outer wall of catheter.
Claim 31 recites the limitation "wherein each of the tubes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that a parent app. 15/309193 (abandoned) recited similar features in claim 14 in which there was “an inner tube and an outer tube” which seems to be equivalent to claim 21’s (on which instant claim depends from) “an inner wall, an outer wall”. Also, instant claim 35 recites “cathere comprising an inner tube and an outer tube”. For examination purposes below, it will be assumed that a similar interpretation should be taken, that the tubes mechanically correspond to the inner and outer wall of catheter.
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(s) 21-24, 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Oren (WO 2012114333 A1; 8/30/2012; cited in parent application 15/309193 (now abandoned) prosecution history), hereinafter Oren, in view of Wahlstrom (WO 9509575 A1; 4/13/1995; cited in parent application 15/309193 (now abandoned) prosecution history).
Regarding claim 21, Oren teaches a system for removal of undesirable material from a vasculature of a subject (Abstract), the system comprising:
a pulsed laser (p. 9 lines 17-26) coupled to a catheter comprising an inner wall, an outer wall (Fig. 1A-1B),
and a plurality of optical fibers positioned between the inner wall and outer wall, such that laser energy is emitted from the fibers (Fig. 1A-1B; Fig. 2; p. 6 lines 29-31).
Oren does not explicitly teach wherein a ratio of a total core area from which the laser energy is emitted to a total distal tip area of the catheter is in the range of about 25% to about 50%. However, Oren teaches the device dimensions that could encompass the recited range as explained in the Examiner’s Answer of 15/309193 p. 3:
In the interest of clarity, the Examiner will endeavor to clearly depict with calculations from dimensions that are readily gleaned from the prior art of record and as such is accurate to the best of his knowledge with respect to what is taught by the prior art. Primary reference Oren teaches on p. 19 lines 3-5 that there is an external diameter of 5 mm, and optical fibers ranging from 0.1-0.2 mm diameter (equivalent to 100-200 microns). Oren further teaches on p. 20 lines 1-5 that fiber core diameters range from 40-250 microns with an example catheter circumference of 15 mm. Oren next teaches that 300 fibers (p. 20 lines 4-5) can be used. Oren also teaches on p. 21 lines 26-27 that catheters of different dimensions can be used ranging from 1.3-7 mm. Oren depicts on Fig. 1A-1B the different optical fibers 104 within the catheter; the Examiner counts 39 optical fibers depicted in Fig. 1 B (via manually counting instances of 104).
Therefore, at least from primary reference Oren as a whole, a person of ordinary skill in the art understands that:
optical fiber diameter can range from 40-250 microns;
catheter diameter can range from 1.3-15 mm;
the number of optical fibers can range from 39-300.
Putting it together, this indicates that the total core area from which said flux of energy is emitted is calculated by:
optical fiber diameter range = 40-250 microns - this is equivalent to optical fiber radius= (40-250)/2 microns= 20-125 microns; (because diameter= 2 X radius)
an individual optical fiber area range = π X (optical fiber radius)2 = π X (20-125 microns)2 = 1256.64-49087.39 micron2;
total core area from which said flux of energy is emitted range = individual optical fiber area range X the number of optical fibers range;
and so,
total core area from which said flux of energy is emitted range= (1256.64- 49087.39 micron2) X (39-300) = 49008.96-14726215.56 micron2.
Similarly, the total area of the blunt distal tip is calculated by:
catheter diameter range = 1.3-15 mm - this is equivalent to catheter radius= (1.3- 15)/2 mm= 0.65-7.5 mm; (because diameter= 2 X radius)= 650-7500 microns;
total area of blunt distal tip range= π X (catheter radius)2 = π X (650-7500 microns)2 = 1327322.9-176714586.76 micron2.
The ratio of total core area from which said flux of energy is emitted to total area of blunt distal tip range is then
total core area from which said flux of energy is emitted ÷ total area of blunt distal tip X 100.
A person of ordinary skill in the art can then choose within the range for:
total core area from which said flux of energy is emitted range = 49008.96- 14726215.56 micron2; and
total area of blunt distal tip range = 1327322.9-176714586. 76 micron2.
A cursory check ensures that a selection from between these ranges results in a ratio that encompasses the recited 25-50%:
total core area from which said flux of energy is emitted = 1000000 micron2;
total area of blunt distal tip range= 2000000 micron2;
leads to a ratio of 1000000 + 2000000 X 1 00 = 50%.
Likewise,
total core area from which said flux of energy is emitted = 1000000 micron2;
total area of blunt distal tip range= 4000000 micron2;
leads to a ratio of 1000000 + 4000000 X 100 = 25%.
And so on.
Furthermore, Walhstrom teaches in the same field of endeavor (Abstract; Fig. 2; Fig. 10) the general conditions by which one would wish to choose the relative dimensions of the optical fiber and “guard assembly” in that “the geometry and relative dimensions of the optical fiber 23 and guard assembly 68 are important in order to minimize the photo degradation of lead 2 from laser energy 64” (p. 14 lines 20-37; Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. As such, a person of ordinary skill in the art would understand the combination of Oren and Walhstrom to teach the claimed ratio of between 25%-50% as a result of routine optimization of the relative dimensions.
Regarding claim 22, in the combination of Oren and Wahlstrom, Oren teaches wherein the laser is a third harmonic Nd:YAG laser emitting at about 355nm (p. 15 lines 23-24).
Regarding claim 23, the combination of Oren and Wahlstrom does not explicitly teach wherein the laser energy is at least 50 mJ/mm2. However, Oren does teach energy in the range if 10-100 mJ (p. 15 lines 29-30) and tuning based on area to minimize undesirable thermal effects (p. 15 lines 5-10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 24, in the combination of Oren and Wahlstrom, Oren teaches wherein the catheter is configured for injection of a fluid (p. 11 lines 3-4).
Regarding claim 27, in the combination of Oren and Wahlstrom, Oren teaches wherein the catheter comprises a blade at a distal end of the catheter (Fig. 1A, 106; p. 8 lines 30-34; p. 17 lines 28-33).
Regarding claim 28, in the combination of Oren and Wahlstrom, Oren does not teach wherein each of the tubes has a blunt distal edge in the same axial plane as the output end of the plurality of fibers, such that when a distal force is applied to the catheter, the blunt distal edges push through the undesirable material in the vasculature in a region where the laser energy is emitted from the fibers. However, Wahlstrom teaches in the same field of endeavor (Abstract; Fig. 2; Fig. 10) wherein each of the tubes has a blunt distal edge in the same axial plane as the output end of the plurality of fibers (Fig. 10A; p. 14 lines 9-20 “optical fibers 43 may also be flush with the distal end of 46 of guard band 53 and the distal end 47 of guard ring 54”), such that when a distal force is applied to the catheter, the blunt distal edges push through the undesirable material in the vasculature in a region where the laser energy is emitted from the fibers (Fig. 14; p. 12 lines 1-3 “pushed; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Oren and Wahlstrom to include these features as taught by Wahlstrom because this enables safe laser removal of an implanted lead (p. 8 line 20 to p. 9 line 6).
Regarding claim 29, in the combination of Oren and Wahlstrom, Oren teaches wherein the wavelength of said pulsed laser is between 320 nm and 420 nm (p. 15 lines 1-2 “355 nm”).
Regarding claim 30, in the combination of Oren and Wahlstrom, Oren teaches wherein a pulse width of the laser is less than 15 ns (p. 15 line 3 “10 ns”).
Regarding claim 31, in the combination of Oren and Wahlstrom, Oren does not teach wherein each of the tubes has a blunt distal edge in the same axial plane as the output end of the plurality of fibers, such that when a distal force is applied to the catheter, the blunt distal edges push through the undesirable material in the vasculature in a region where the laser energy is emitted from the fibers. However, Wahlstrom teaches in the same field of endeavor (Abstract; Fig. 2; Fig. 10) wherein each of the tubes has a blunt distal edge in the same axial plane as the output end of the plurality of fibers (Fig. 10A; p. 14 lines 9-20 “optical fibers 43 may also be flush with the distal end of 46 of guard band 53 and the distal end 47 of guard ring 54”), such that when a distal force is applied to the catheter, the blunt distal edges push through the undesirable material in the vasculature in a region where the laser energy is emitted from the fibers (Fig. 14; p. 12 lines 1-3 “pushed; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Oren and Wahlstrom to include these features as taught by Wahlstrom because this enables safe laser removal of an implanted lead (p. 8 line 20 to p. 9 line 6).
In the combination of Oren and Wahlstrom, Oren teaches wherein the wavelength of said pulsed laser is between about 320 nm and about 420 nm (p. 15 lines 1-2 “355 nm”).
The combination of Oren and Wahlstrom does not teach wherein an effective wall thickness of the catheter is in the range of about 200 µm to about 400 µm. However, the combination of Oren and Wahlstrom teaches the general conditions by which one would wish to choose the relative dimensions of the optical fiber and wall (Wahlstrom p. 14 lines 20-37 “in order to minimize the photo degradation of lead 2 from laser energy 64”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oren and Wahlstrom as applied to claim 21 above, and further in view of Steinke (US 20050251116 A1; 11/10/2005).
Regarding claim 25, the combination of Oren and Wahlstrom does not teach wherein the laser energy is configured to ablate the undesirable material via photomechanical mechanisms. However, Steinke teaches in the same field of endeavor (Abstract; [0012]) wherein the laser energy is configured to ablate the undesirable material via photomechanical mechanisms ([0078] “photodisruption…shock wave…cavitation bubble”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Oren and Wahlstrom to include this feature as taught by Steinke because this is suitable for ablating undesirable material in vasculature ([0078]); MPEP 2144.07 art recognized suitability for an intended purpose.
Regarding claim 26, in the combination of Oren, Wahlstrom, and Steinke, Steinke teaches wherein the photomechanical mechanisms include shockwaves ([0078] “shock wave”).
Claim(s) 35-36, 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oren (WO 2012114333 A1; 8/30/2012; cited in parent application 15/309193 (now abandoned) prosecution history), hereinafter Oren, in view of Wahlstrom (WO 9509575 A1; 4/13/1995; cited in parent application 15/309193 (now abandoned) prosecution history), and further in view of Steinke (US 20050251116 A1; 11/10/2005).
Regarding claim 35, Oren teaches a system for removal of undesirable material from a vasculature of a subject (Abstract), the system comprising:
a pulsed laser (p. 9 lines 17-26) coupled to a plurality of optical fibers, such that a laser energy is emitted from the fibers (Fig. 1A-1B; Fig. 2; p. 6 lines 29-31), and
a catheter comprising an inner tube and an outer tube (Fig. 1A-1B), the plurality of optical fibers being positioned between the inner and outer tubes (Fig. 1A-1B; Fig. 2; p. 6 lines 29-31).
Oren does not teach wherein the inner and outer tube each comprise a blunt edge for cutting the undesirable material upon application of a distal force on the catheter. However, Wahlstrom teaches in the same field of endeavor (Abstract; Fig. 2; Fig. 10) wherein the inner and outer tube each comprise a blunt edge (Fig. 10A; p. 14 lines 9-20 “optical fibers 43 may also be flush with the distal end of 46 of guard band 53 and the distal end 47 of guard ring 54”) for cutting the undesirable material upon application of a distal force on the catheter (Fig. 14; p. 12 lines 1-3 “pushed; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Oren and Wahlstrom to include these features as taught by Wahlstrom because this enables safe laser removal of an implanted lead (p. 8 line 20 to p. 9 line 6).
In the combination of Oren and Wahlstrom, Oren does not explicitly teach wherein a ratio of a total core area from which the laser energy is emitted to a total distal tip area of the catheter is in the range of about 25% to about 50%. However, Oren teaches the device dimensions that could encompass the recited range as explained in the Examiner’s Answer of 15/309193 p. 3:
In the interest of clarity, the Examiner will endeavor to clearly depict with calculations from dimensions that are readily gleaned from the prior art of record and as such is accurate to the best of his knowledge with respect to what is taught by the prior art. Primary reference Oren teaches on p. 19 lines 3-5 that there is an external diameter of 5 mm, and optical fibers ranging from 0.1-0.2 mm diameter (equivalent to 100-200 microns). Oren further teaches on p. 20 lines 1-5 that fiber core diameters range from 40-250 microns with an example catheter circumference of 15 mm. Oren next teaches that 300 fibers (p. 20 lines 4-5) can be used. Oren also teaches on p. 21 lines 26-27 that catheters of different dimensions can be used ranging from 1.3-7 mm. Oren depicts on Fig. 1A-1B the different optical fibers 104 within the catheter; the Examiner counts 39 optical fibers depicted in Fig. 1 B (via manually counting instances of 104).
Therefore, at least from primary reference Oren as a whole, a person of ordinary skill in the art understands that:
optical fiber diameter can range from 40-250 microns;
catheter diameter can range from 1.3-15 mm;
the number of optical fibers can range from 39-300.
Putting it together, this indicates that the total core area from which said flux of energy is emitted is calculated by:
optical fiber diameter range = 40-250 microns - this is equivalent to optical fiber radius= (40-250)/2 microns= 20-125 microns; (because diameter= 2 X radius)
an individual optical fiber area range = π X (optical fiber radius)2 = π X (20-125 microns)2 = 1256.64-49087.39 micron2;
total core area from which said flux of energy is emitted range = individual optical fiber area range X the number of optical fibers range;
and so,
total core area from which said flux of energy is emitted range= (1256.64- 49087.39 micron2) X (39-300) = 49008.96-14726215.56 micron2.
Similarly, the total area of the blunt distal tip is calculated by:
catheter diameter range = 1.3-15 mm - this is equivalent to catheter radius= (1.3- 15)/2 mm= 0.65-7.5 mm; (because diameter= 2 X radius)= 650-7500 microns;
total area of blunt distal tip range= π X (catheter radius)2 = π X (650-7500 microns)2 = 1327322.9-176714586.76 micron2.
The ratio of total core area from which said flux of energy is emitted to total area of blunt distal tip range is then
total core area from which said flux of energy is emitted ÷ total area of blunt distal tip X 100.
A person of ordinary skill in the art can then choose within the range for:
total core area from which said flux of energy is emitted range = 49008.96- 14726215.56 micron2; and
total area of blunt distal tip range = 1327322.9-176714586. 76 micron2.
A cursory check ensures that a selection from between these ranges results in a ratio that encompasses the recited 25-50%:
total core area from which said flux of energy is emitted = 1000000 micron2;
total area of blunt distal tip range= 2000000 micron2;
leads to a ratio of 1000000 + 2000000 X 1 00 = 50%.
Likewise,
total core area from which said flux of energy is emitted = 1000000 micron2;
total area of blunt distal tip range= 4000000 micron2;
leads to a ratio of 1000000 + 4000000 X 100 = 25%.
And so on.
Furthermore, Walhstrom teaches in the same field of endeavor (Abstract; Fig. 2; Fig. 10) the general conditions by which one would wish to choose the relative dimensions of the optical fiber and “guard assembly” in that “the geometry and relative dimensions of the optical fiber 23 and guard assembly 68 are important in order to minimize the photo degradation of lead 2 from laser energy 64” (p. 14 lines 20-37; Fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. As such, a person of ordinary skill in the art would understand the combination of Oren and Walhstrom to teach the claimed ratio of between 25%-50% as a result of routine optimization of the relative dimensions.
The combination of Oren and Wahlstrom does not teach wherein the energy emitted from the fibers is configured to create photomechanical ablation of the undesirable material. However, Steinke teaches in the same field of endeavor (Abstract; [0012]) wherein the energy emitted from the fibers is configured to create photomechanical ablation of the undesirable material ([0078] “photodisruption…shock wave…cavitation bubble”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Oren and Wahlstrom to include this feature as taught by Steinke because this is suitable for ablating undesirable material in vasculature ([0078]); MPEP 2144.07 art recognized suitability for an intended purpose.
Regarding claim 36, the combination of Oren, Wahlstrom, and Steinke does not explicitly teach wherein the laser energy is at least 50 mJ/mm2. However, Oren does teach energy in the range if 10-100 mJ (p. 15 lines 29-30) and tuning based on area to minimize undesirable thermal effects (p. 15 lines 5-10); as does Steinke ([0057]; [0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 38, in the combination of Oren, Wahlstrom, and Steinke, Oren teaches wherein the laser is a third harmonic Nd:YAG laser emitting at about 308 nm or about 355nm (p. 15 lines 23-24).
Regarding claim 39, in the combination of Oren, Wahlstrom, and Steinke, Steinke teaches wherein the photomechanical ablation creates shockwaves in the target tissue ([0078] “shock wave”).
Regarding claim 40, the combination of Oren, Wahlstrom, and Steinke teaches wherein each of the tubes has a blunt distal edge in the same axial plane as the output end of the plurality of fibers (Wahlstrom Fig. 10A; p. 14 lines 9-20 “optical fibers 43 may also be flush with the distal end of 46 of guard band 53 and the distal end 47 of guard ring 54”), such that when a distal force is applied to the catheter, the blunt distal edges push through the undesirable material in the vasculature in a region where the laser energy is emitted from the fibers (Wahlstrom Fig. 14; p. 12 lines 1-3 “pushed; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.),
wherein the wavelength of said pulsed laser is between about 320 nm and about 420 nm (Oren p. 15 lines 1-2 “355 nm”).
The combination of Oren, Wahlstrom, and Steinke does not teach wherein an effective wall thickness of the catheter is in the range of about 200 µm to about 400 µm. However, the combination Oren, Wahlstrom, and Steinke teaches the general conditions by which one would wish to choose the relative dimensions of the optical fiber and wall (Wahlstrom p. 14 lines 20-37 “in order to minimize the photo degradation of lead 2 from laser energy 64”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claims 32-34, 37 are 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:
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 32 when taken as a whole, comprising, in addition to the other recited claim elements, wherein a beam propagation ration (M2) of an original pulsed laser beam generated by the pused laser is greater than or equal to 10.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 37 when taken as a whole, comprising, in addition to the other recited claim elements, wherein a beam propagation ration (M2) of an original pulsed laser beam generated by the pused laser is greater than or equal to 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792