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 INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘lateral opening,’ ‘expandable balloon’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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 18 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.
Regarding claim 18, line 3 recites “preferably distal of the expandable balloon” which is a broad range or limitation followed by linking terms (e.g., preferably, maybe, for instance, especially) and a narrow range or limitation within the broad range or limitation is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
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) 1, 2, and 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kugler et al. (US 2020/0108233A1, “Kugler”) in view of Morero et al. (US 20170100141A1, “Morero”) in view of Kahlon (US 11,510,798).
Regarding claims 1, 2, 7, and 11-13, Kugler discloses a recanalization catheter capable of facilitating reentry into a lumen of a vessel having an occlusion therein from a subintimal space in a wall of the vessel, the catheter including a catheter shaft (92, 82, 202; [0065]; Fig. 16) extending from a hub (236; [0067]; Fig. 16). First and second inflatable balloon members (322, 324; Fig. 17; [0071]) are disposed on a distal end region of the catheter shaft. The catheter shaft defines a guidewire lumen (304; 0073, 0074]) extending therethrough and a lateral opening (330; Fig. 17, 18; [0069, 0075]) that opens to an exterior of the catheter shaft between a proximal and distal end of the expandable balloon (Fig. 17). The guidewire lumen is disposed between the first and second inflatable balloon members on a first side of the catheter shaft (Fig. 18). However, Kugler does not disclose an inflation lumen in fluid communication with the first and second inflatable balloon members and an imaging lumen extending through the catheter shaft and capable of receiving an IVUS imaging device therein.
In the same field of endeavor, re-entry catheters, Morero teaches a re-entry catheter including first and second inflatable balloon members that are in fluid communication with first and second inflation lumens [0070]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter of Kugler with first and second inflation lumens in fluid communication with the first and second inflatable balloon members, as taught by Morero, to provide means for separately delivering inflation fluid to the balloon members [0070].
In the same field of endeavor, balloon catheters, Kahlon teaches a balloon catheter (102) including a catheter shaft (108) having an imaging lumen (116) extending therethrough capable of receiving an IVUS imaging device (124; Fig. 1D) therein. An IVUS imaging device is positionable within the imaging lumen to position an IVUS transducer (126; Fig. 1D; C6:L1-20) distal of the first lateral opening (abs). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter of Kugler with an imaging lumen, as taught by Kahlon, to ensure proper positioning during recanalization without deploying a separate IVUS imaging probe [abs].
Regarding claim 8, the combination of Kugler, Morero and Kahlon does not disclose an outer diameter of the catheter shaft as being 0.059 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.033 inches or more. As seen in the combination of Kugler, Morero and Kahlon the diameters of the catheter shaft and guidewire lumen and the distance across the imaging lumen are disclosed to be result effective variables in that changing the diameters such that an outer diameter of the catheter shaft as being 0.059 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.033 inches or more affects the capability of catheter to easily recanalize and re-enter a vessel. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Kugler, Morero and Kahlon to have diameters and distance in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combination of Kugler, Morero and Kahlon by making an outer diameter of the catheter shaft 0.059 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.033 inches or more 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 9, the combination of Kugler, Morero and Kahlon does not disclose an outer diameter of the catheter shaft as being 0.052 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.026 inches or more. As seen in the combination of Kugler, Morero and Kahlon the diameters of the catheter shaft and guidewire lumen and the distance across the imaging lumen are disclosed to be result effective variables in that changing the diameters such that an outer diameter of the catheter shaft as being 0.052 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.026 inches or more affects the capability of catheter to easily recanalize and re-enter a vessel. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Kugler, Morero and Kahlon to have diameters and distance in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combination of Kugler, Morero and Kahlon by making an outer diameter of the catheter shaft 0.052 inches or less, the guidewire lumen having a diameter of about 0.017 inches and a minimum distance across the imaging lumen through a center axis of the imaging lumen being 0.026 inches or more 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, the combination of Kugler, Morero and Kahlon does not disclose a wall thickness of the catheter shaft at all locations along the catheter shaft is at least 0.003 inches. As seen in the combination of Kugler, Morero and Kahlon the diameters of the catheter shaft and guidewire lumen and the distance across the imaging lumen are disclosed to be result effective variables in that changing the wall thickness of the catheter shaft at all locations along the catheter shaft to be at least 0.003 inches affects the capability of catheter to recanalize and re-enter a vessel. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Kugler, Morero and Kahlon to have diameters and distance in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combination of Kugler, Morero and Kahlon by making the wall thickness of the catheter shaft at all locations along the catheter shaft to be at least 0.003 inches 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 5 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kugler et al. (US 2020/0108233A1, “Kugler”) in view of Morero et al. (US 20170100141A1, “Morero”) in view of Kahlon (US 11,510,798), as applied to claim 1 above, and further in view of Cohn et al. (US 2019/0134349A1, “Cohn”).
Regarding claims 5 and 16, the combination of Kugler, Morero and Kahlon do disclose the catheter as taught in claim 1 above, but not disclose that a proximal portion of the catheter shaft has a circular cross-section shape and a distal portion of the catheter shaft has a generally rectangular cross-sectional shape. In the same field of endeavor, catheters, Cohn teaches a catheter shaft (102) may have any suitable cross-sectional shape or variations wherein the cross-sectional shape may be circular, square, rectangular or a combination thereof or the like. For example, the catheter shaft may have a circular cross-sectional shape in a proximal portion. A distal portion may have a different cross-sectional shape than the proximal portion, e.g. square, rectangular [0059]. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal and distal portions of the catheter shaft of the combination of Kugler, Morero and Kahlon with respective circular and rectangular cross-sectional shapes, as taught by Cohn, to provide means for assisting in appropriately positioning the catheter.
Allowable Subject Matter
Claim(s) 3, 4, 6, 14, 15, 19 and 20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhou et al. (US 2014/0200603A1) discloses a lateral opening in a guidewire lumen Kugler et al. (US 2009/0088685A1) discloses a catheter having first and second inflatable balloon members.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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