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 Amendment
Claims 1-8, 10, 11, 14, 22-27, and 29-31 are pending in the application. Claims 9, 12, 13, 15-21, 28, 32, and 33 have been canceled. Claims 3, 4, 6-8, 10, 14, 24-27, and 29-31 have been amended.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-8, 10, 11, 14, drawn to a system and method for removing a blockage from a vessel.
Group II, claims 22-27 and 29-31, drawn to a steerable catheter and a method of steering a catheter through a vessel.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a catheter and a pulling wire attached to an inside distal end of the catheter that can cause the catheter to compress, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Richter et al. (US 2016/0183963 A1) (“Richter”). Richter discloses (Figures 1-7) a catheter (1) and a pulling wire (10) attached to an inside distal end of the catheter that can cause the catheter to compress (Figures 1A-1E).
During a telephone conversation with Daniel Swirsky on 2/25/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8, 10, 11, and 14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 22-27 and 29-31 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6, 10, 11, and 14 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 3 recites the limitation "the uncompressing" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 3 recites the limitation "the catheter tip" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites the limitation "the full uncompressed length" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 10 recites “wherein a proximal edge of the catheter presses against and/or may be fixedly attached to an outer surface of the movement generator.” The use of “and/or may be” has rendered the claim indefinite because it creates an ambiguous scope, and based on the broadest reasonable interpretation, prevents from determining the metes and bounds of the claim. The claim lacks clarity as to the structural relationship between the proximal edge of the catheter and the outer surface of the movement generator. Appropriate correction is required.
Claim 11 recites the limitation “activating using the controller of a hammering action…” The wording of this limitation is unclear. Appropriate correction is required.
Claim 14 recites that the blockage removal system further comprises a controller including a movement generator configured to pull on the pulling wire and to subsequently release the pulling wire. It is unclear if the controller recited in claim 14 is the same controller that is recited in claim 11, or a different controller. Appropriate correction is required.
Claim 14 recites the limitation "the pulling wire" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim. 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, 2, 4, 7, 8, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richter et al. (US 2016/0183963 A1) (“Richter”).
Regarding claim 1, Richter discloses (Figures 1-7) a system for removing a blockage from a vessel comprising: a catheter (1); and a pulling wire (10) attached to an inside distal end (30) of the catheter (paragraph 0070); wherein pulling on the pulling wire towards a proximal side of the catheter causes the catheter to compress (Figure 1B; paragraph 0072) and wherein subsequent releasing of the pulling wire causes the catheter to un-compress for generating a hammering action at a distal tip of the catheter (Figure 1D; paragraphs 0072, 0074, 0075).
Regarding claim 2, Richter discloses (Figures 1-7) that the catheter (1) includes a portion (20) formed from an elastic material (paragraphs 0070, 0072-0076, 0079).
Regarding claim 4, Richter discloses (Figures 1-7) a controller (paragraphs 0025-0026) including a movement generator (motor/shaker/piezoelectric motor/actuator) configured to pull on the pulling wire and to subsequently release the pulling wire (paragraph 0023 and 0059).
Regarding claim 7, Richter discloses (Figures 1-7) that the catheter (1) is dimensioned for insertion into a blood vessel (paragraph 0037).
Regarding claim 8, Richter discloses (Figures 1-7) that the catheter has an external diameter of between 0.5 to 10 mm (paragraphs 0044-0045).
Regarding claim 11, Richter discloses (Figures 1-7) a method for removing a blockage from a vessel comprising: providing a blockage removal system including a catheter (1) and a controller (paragraphs 0025-0026), wherein the controller is configured to cause the catheter to move with a hammering movement (paragraph 0025); inserting the catheter into the vessel (paragraph 0064); and activating using the controller of a hammering action of the catheter against the blockage to thereby remove the blockage (paragraphs 0064-0065).
Regarding claim 14, Richter discloses (Figures 1-7) that the blockage removal system further comprises a controller (paragraphs 0025-0026) including a movement generator (motor/shaker/piezoelectric motor/actuator) configured to pull on the pulling wire and to subsequently release the pulling wire (paragraphs 0023 and 0059).
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 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Richter et al. (US 2016/0183963 A1) (“Richter”).
Regarding claim 3, Richter discloses that the elastic material has a spring constant of 0.1-10 Newton per mm (paragraph 0070). Further, Richter discloses adjusting the pulling amplitude so that the penetration force is appropriate for the occlusion morphology and hardness (paragraph 0025). Richter discloses providing therapeutic vibration in a distal component at the distal end of the catheter. The force for generating therapeutic vibration of the distal component is provided by the vibrational energy source, which is capable of pulling the pulling member at a distance (x), to generate a tension (T), and then releasing the tension. The pulling member is functionally connected at its distal end, via a distal component, to the spring element. A return force is provided by the spring element, having a spring constant (k), such that the tension in the pulling member may be defined as T=kx. The repeated combination of pulling and releasing of the pulling member generates oscillations in the distal component at a frequency and amplitude to sufficiently penetrate and clear a vessel occlusion (paragraph 0038).
However, Richter fails to explicitly disclose that uncompressing of the catheter imparts a force at the catheter imparts a force at the catheter tip of between 10 N and 1000 N.
Richter discloses that the force imparted at the distal tip by uncompressing the catheter is a result effective variable in that adjusting the distance (x) that the catheter is compressed changes the force imparted on the occlusion. Adjusting the force imparted at the catheter tip allows appropriate force to be imparted for the occlusion morphology and hardness. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the force imparted to be within the claimed range, as it involves only adjusting the distance (x) that the catheter is compressed (because the spring constant remains constant). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the force imparted at the distal tip of the catheter to be between 10 N and 1000 N as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, Richter discloses the movement generator imparts a continual hammering rate of several cycles/second (Hz) to several hundred cycles/second (paragraph 0025).
However, Richter fails to explicitly disclose a continual hammering rate of up to 100 cycles/second.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hammering rate disclosed by Richter to be up to 100 cycles/second, since it has been held that “[i]n the case where the claimed range ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range, indicating “a hammering rate of between 1 to 100 cycles/sec may be provided” (see page 14, lines 4-5 of Specification).
Regarding claim 6, Richter discloses adjusting the pulling amplitude so that the penetration force is appropriate for the occlusion morphology and hardness (paragraph 0025). Richter discloses providing therapeutic vibration in a distal component at the distal end of the catheter. The force for generating therapeutic vibration of the distal component is provided by the vibrational energy source, which is capable of pulling the pulling member at a distance (x), to generate a tension (T), and then releasing the tension. The pulling member is functionally connected at its distal end, via a distal component, to the spring element. A return force is provided by the spring element, having a spring constant (k), such that the tension in the pulling member may be defined as T=kx. The repeated combination of pulling and releasing of the pulling member generates oscillations in the distal component at a frequency and amplitude to sufficiently penetrate and clear a vessel occlusion (paragraph 0038).
However, Richter fails to explicitly disclose that the catheter has a compressed length that is between 1 mm and 10 mm shorter than the full uncompressed length of the catheter.
Richter discloses that the force imparted at the distal tip by uncompressing the catheter is a result effective variable in that adjusting the distance (x) that the catheter is compressed changes the force imparted on the occlusion. Adjusting the compressed length of the catheter to be between 1 mm and 10 mm shorter than the full uncompressed length of the catheter adjusts the force imparted at the catheter tip and allows appropriate force to be imparted for the occlusion morphology and hardness. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the compressed length of the catheter as it involves adjusting a dimension of a component (spring) that is disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify compressed length of the catheter to be between 1 mm and 10 mm shorter than the full uncompressed length of the catheter as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Richter et al. (US 2016/0183963 A1) (“Richter”) in view of Stevens (US 5,116,350).
Regarding claim 10, Richter discloses that the movement generator is configured to pull and then subsequently release the pulling wire (paragraphs 0023 and 0059). However, Richter fails to disclose the movement generator includes at least one disc with a protruding rod and the pulling wire includes an engagement bar on a proximal end of the pulling wire. Further, Richter fails to disclose a proximal edge of the catheter presses against and/or may be fixedly attached to an outer surface of the movement generator.
In the same field of endeavor, Stevens teaches (Figures 5 and 6) a movement generator (70) that includes at least one disc (86) with a protruding rod (88) and a pulling wire (40) that includes an engagement bar (72) on a proximal end of the pulling wire (Column 5, lines 3-43). Stevens teaches that the movement generator is configured to pull and release the pulling wire to create a reciprocating motion. Richter teaches (Figures 5 and 6) that the catheter may be fixedly attached to an outer surface of the movement generator (Column 5, lines 3-10).
Richter discloses the claimed invention except that the movement generator is generically disclosed as a motor/shaker/piezoelectric motor/actuator instead of at least one disc with a protruding rod, the pulling wire including an engagement bar on a proximal end of the pulling wire, and a proximal edge of the catheter presses against and/or may be fixedly attached to an outer surface of the movement generator. Stevens shows that this movement generator configuration is an equivalent structure known in the art. Therefore, because these two movement generator configurations were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the movement generator configuration taught by Stevens for the movement generator configuration disclosed by Richter. Substitution of one known element for another element providing the same function to yield predictable results (creating reciprocating motion of the pulling wire to compress and un-compress the distal tip of the catheter to generate the hammering action) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Deckard et al. (US 2012/0165850 A1) disclose (Figures 6a-7) a movement generator configured to pull and subsequently release an engagement bar (604) on a proximal end of a pulling wire (paragraphs 0058-0062).
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771