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. elongated tubular structure, elastic expandable tubular element) 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.
Claims 21-39 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.
Claims 37 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of a method to use the catheter accessory with the catheter per claim 37 and the steps of a method of using the assembly of claim 38.
Regarding claims 21-39, all dependent claims are indefinite because they depend from an indefinite base claim 21. In claim 21 there is an inconsistency in the language of the preamble and that of body of the claim thus making their scope unclear. The preamble recites “A catheter accessory for use with a catheter” with the catheter only functionally recited, e.g. for use with a catheter, thus indicating that the claims are directed to the subcombination, catheter accessory. However, lines 1-4 positively recite the catheter and portions thereof, e.g. intervention accessory, distal portion outer diameter, proximal portion, an intermediate portion, intermediate portion outer diameter, as an element of the invention, e.g. the catheter having a distal portion outer diameter, a proximal portion for handling the catheter and an intermediate portion, thus indicating that the claims are directed to the combination of the catheter accessory and the catheter. As such it is unclear whether applicant intends the claims to be drawn to the combination or the subcombination. Applicant is hereby required to indicate which, the combination (catheter accessory and catheter) or subcombination (catheter accessory) the claims are intended to be drawn and make the language consistent with this intent. For examination purposes, the claims will be considered as drawn to the combination.
Claim Objections
Claim 21 is objected to because of the following informalities:
Line 16, please change “to expand the catheter accessory” to “the catheter accessory is configured to expand”.
Line 16, please change “to collapse” to “the catheter accessory is configured to collapse”.
Appropriate correction is required.
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, 29, 35 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2013/0096604A1, “Hanson”) in view of Boyle et al. (US 2003/0004537A1, “Boyle”).
Regarding claims 21 and 37, Hanson discloses a catheter accessory for use with a catheter. The catheter (102; [0035]) has a distal portion including an intervention accessory (114; Figs. 1, 4). The catheter has a distal portion outer diameter, a proximal portion for handling the catheter, an intermediate portion located between the distal portion and the proximal portion and having an intermediate portion outer diameter (Fig. 1). The catheter accessory (116) includes an elongated tubular structure capable of coaxially mounting on the intermediate portion, attaching to the intermediate portion and providing a pre-determined flexural rigidity and a pre-determined flexibility simultaneously to the intermediate portion covered by the elongated tubular structure [0031, 0055]. The elongated tubular structure having a default shape (pre-selected; Fig. 1B) and size for operation which is characterized by a lumen with an inside diameter which is larger than or equal to the intermediate portion outer diameter and smaller than the distal portion outer diameter (diameter size of the expanded balloon; 114), holding the catheter accessory onto the intermediate portion [0055] and completely proximal to the distal portion (Fig. 1B) including the intervention accessory during the operation. The elongated tubular structure is made of a material [0063; shape memory material, e.g. nitinol] and includes an expandable portion (402) that is shaped to be capable of undergoing elastic deformation when a force is applied by a mounting accessory from inside outwardly. It is noted that the mounting accessory is not positively recited. The catheter accessory is capable of expanding radially to a mounting mode by insertion of the mounting accessory into a tubular opening of the catheter accessory, wherein the mounting mode has an expanded inner diameter larger than the distal portion outer diameter for sliding the distal portion comprising the intervention accessory through and completely across the lumen during installation. However, Hanson does not expressly disclose that the catheter accessory is capable of collapsing radially back to the default shape and size with an inner operation diameter larger than the outer intermediate portion diameter when the force is not applied anymore from inside outwardly due to removal of the mounting accessory from within the catheter accessory, after the distal portion including the intervention accessory has slid through and completely across the lumen.
In the same field of endeavor, expandable sheaths, Boyle teaches an expandable sheath that is radially expandable when subjected to an outward radial force and is biased to contract or collapse when the radial force is removed [0018]. 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 formed the expandable portion of Hanson with bias means to contract after an outwardly force is removed, as taught by Boyle, to provide column strength and prevent buckling of the catheter during use and providing means to avoid damaging vessel walls during delivery to a procedure site [0019]. With this modification, the catheter accessory is capable of collapsing radially back to the default shape and size with an inner operation diameter larger than the outer intermediate portion diameter when the force is not applied anymore from inside outwardly due to removal of the mounting accessory from within the catheter accessory, after the distal portion including the intervention accessory has slid through and completely across the lumen.
Regarding claim 22, the combination of Hanson and Boyle discloses a force that is capable of being applied along a length of the elongated tubular structure and thereby the elongated tubular structure is configured to expand radially along its length to the mounting mode and to collapse radially back to the default shape and size along the length of the elongated tubular structure [0018; Boyle, [0059]; Hanson].
Regarding claim 23, as seen in the combination of Hanson and Boyle, the flexural rigidity of the elongated structure is disclosed to be result effective variables in that changing the rigidity such that the pre-determined flexural rigidity of the elongated structure is between about 0.0001 Pascal x meter4 (Pa m4) and about 0.002 Pa m4 affects the pushability of the catheter through the vasculature. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Hanson and Boyle to have the pre-determined flexural rigidity 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 Hanson and Boyle by pre-determined flexural rigidity of the elongated structure is between about 0.0001 Pascal x meter4 (Pa m4) and about 0.002 Pa m4 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 24, as seen in the combination of Hanson and Boyle, the sheath thickness of the elongated structure is disclosed to be result effective variables in that changing the sheath thickness of the elongated structure is between about 0.1 millimeter (mm) and about 3mm affects the pushability of the catheter through the vasculature. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Hanson and Boyle to have the sheath thickness 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 Hanson and Boyle by a sheath thickness of the elongated structure is between about 0.1 millimeter (mm) and about 3mm 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 29, the combination of Hanson and Boyle discloses that the elongated tubular structure is an elastic expandable tubular element which is capable to radially expand by a deformation without causing a permanent deformation or plasticity and is made of a polymeric material having a high deformability in its elastic zone [0063; Hanson].
Regarding claim 35, the combination of Hanson and Boyle discloses a back-end elongated element (outwardly flared portion; [0013]; Hanson) attached to the elongated tubular structure at the proximal.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2013/0096604A1, “Hanson”) in view of Boyle et al. (US 2003/0004537A1, “Boyle”), as applied to claim 21 above, and further in view of Starksen et al. (US 2014/0155783A1, “Starksen”).
Regarding claim 27, the combination of Hanson and Boyle does not disclose that the elongated tubular structure is a stent-like structure. In the same field of endeavor, stiffening sheaths, Starksen teaches a stiffening sheath that may be formed of shape memory material and or a braided mesh [stent-like structure;0058]. 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 formed the elongated tubular structure of the combination of Hanson and Boyle of a stent-like structure (braided mesh), as taught by Starksen, to provide greater torsional stiffness [0058].
Allowable Subject Matter
Claims 25, 26, 28, 30-34, 36, 38 and 39 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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. Tieu et al. (US 2010/0268201A1) and Robertson (US 2011/0106055A1) discloses stiffening tubes used to increase pushability.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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