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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, each of the medical device delivery system, drug delivery system, and aspiration system being arranged within the inner shaft of claim 3; each of the sensor, implantable cardioverter-defibrillator electrode, implantable cardioverter-defibrillator lead, nerve simulation device, intervascular coil, scoring element, scoring balloon, intravascular lithotripsy device, aspiration device, aneurysm embolization device, needle, intravascular ultrasound (IVUS) system, camera, catheter, microcatheter, ablation catheter, guiding catheter, and balloon catheter arranged within the inner shaft of claim 5; the reinforcement materials of claim 17; the handle of claim 22; the stopper or locking mechanism of claim 23; the marker or ruler of claim 24; and the stepwise decreasing of diameter of claim 36 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 36, and 44 are objected to because of the following informalities:
In claims 1, 36, and 44, instances of “rolled out” should be changed to “rolled-out” for further clarification.
Appropriate correction is required.
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 1, 3-6, 15-17, 22-25, 27, 29, 30, 33, 36, 38, 41, 42, and 44 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 1 recites a range of length for the catheter and a range of length of the rolling membrane. However, since the rolling membrane is a part of the overall catheter, without any additional structure or distinction, it is unclear how the catheter and the rolling membrane can have separate length ranges. For example, as it pertains to length, the rolling membrane could be interpreted as the same as the catheter, then claim 1 would have two ranges for the same element which is also indefinite. If it is intended that the length of the catheter is the exposed outer shaft or perhaps the state when the rolling membrane is fully extended, or some other state of the rolling membrane relative to the outer shaft or inner shaft, such a limitation should be clearly recited.
Claim 4 recites the catheter comprising no stent, no stent structure, no guiding element, and no guidewire. However, claim 3, upon which claim 4 depends, positively recites a medical device or medical device delivery system, and a drug delivery system. Any of the elements negated in claim 4 could be interpreted as the medical device, medical device delivery system, or a drug delivery system claim 3 given the broadest reasonable interpretation, the negation of a positively recited element is indefinite.
Claims 1, 23, 29, and 33 recite the term “and/or,” which is indefinite since the metes and bounds of the claim cannot be ascertained. It is unclear if one or both terms separated by the conjunction “and/or” are being positively recited, and if only one of the terms it is intended, it is unclear which of the two are being positively recited. Additionally, in several cases, the “and/or” separates a series of non-equivalent alternatives, which further obfuscates what is being positively recited. Another example is that dependent claims further limiting the inner shaft are indefinite for optional instances where only the other shaft is being recited, likewise dependent claims further limiting the outer shaft are indefinite for optional instances where only the inner shaft is being recited. For purposes of examination, all instances of “and/or” will be interpreted as “or” or as best understood.
Claims 22-24 recites aspects of the handle, however, the drawings do not show the handle and the specification merely mentions the handle and associated elements such as the stopper, locking mechanism, marker, and ruler without any additional or clear explanation. It is unclear where the handle is located, if it is perhaps part of the outer shaft, the inner shaft, or another structure altogether. Without any additional information, the metes and bounds of these limitations cannot be envisioned or understood and are thereby indefinite.
Claim 44 recites a method (or process) in the preamble in combination with the catheter according to claim 1, which is a product. It is unclear which statutory class claim 44 belongs to. For clarification, method claims should be claimed separately from product claims to avoid confusion. For the purpose of examination, the method limitations of claim 44 will be interpreted as purely functional limitations. It is noted that if claim 44 is amended into a clear, separate, independent method claim, that the method claim may be subject restriction or withdrawal by constructive election by original presentation.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 6, 15, 22-25, 27, 30, 38, 41, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) alone.
Regarding claim 1, Johnson teaches a catheter (10, Figs. 1-2) configured to cross a stenosis or a chronic total occlusion comprising a rolling membrane (26) defining an inner volume (32) that can be pressurized, the rolling membrane being configured to roll out in a longitudinal direction into a rolled-out state (from Fig. 1 to Fig. 2), and an inner shaft (14) or an outer shaft (15), but does not specify the dimensions.
Johnson discloses that balloon catheters are manufactured with balloons of a variety of sizes and a physician, having determined the axial length and diameter of a stenosis, will select a catheter of appropriate size and then perform the angioplasty procedure (column 1, lines 25-28). The range of the outer diameter and lengths of the catheter/rolling membrane are result effective variables in that changing the length or diameter of the catheter is necessary to provide appropriate treatment that may vary according to the size of the stenosis to be treated. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Johnson to provide a driving force within the claimed range, as it involves only selecting the appropriate size or changing the variable length of the rolling membrane which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter length, rolling membrane outer diameter, and the rolling membrane to be in the range from 80 to 200 cm, 1.5 to 5.0 mm, and 4 cm to 60 cm, respectively, as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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 3, Johnson teaches a catheter (10, Figs. 1-2) comprising a rolling membrane (26) defining an inner volume (32) that can be pressurized, the rolling membrane being configured to roll out in a longitudinal direction into a rolled-out state (from Fig. 1 to Fig. 2), an inner shaft (14) attached to the rolling membrane and a medical device or medical device delivery system (guidewire 12) arranged within the inner shaft.
Regarding claim 4, Johnson teaches the catheter according to claim 3 as shown above, Johnson further teaching no stent, no stent structure, no guiding element and no guidewire (at least Fig. 24, it is noted that the catheter is empty prior to use and any of the claimed elements can simply be removed from the catheter).
Regarding claim 6, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching an outer shaft (15).
Regarding claim 15, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching the rolling membrane is more flexible than the outer shaft or the inner shaft (the balloon by virtue of being foldable is more flexible than the shafts that control the movement of the balloon).
Regarding claim 22, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching a handle (16 or proximal portion of 14 indicated by reference numeral 25 in Fig. 1).
Regarding claim 23, Johnson teaches the catheter according to claim 22 as shown above, Johnson further teaching the handle (16) comprises a stopper (24) or locking mechanism configured to avoid advancement of the rolling membrane in the longitudinal direction and/or rotation of the rolling membrane.
Regarding claim 24, Johnson teaches the catheter according to claim 22 as shown above, Johnson further teaching the handle (proximal portion of 14) comprises a marker (25).
Regarding claim 25, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching the catheter comprises a guiding element (12).
Regarding claim 27, Johnson teaches the catheter according to claim 25 as shown above, Johnson further teaching the guiding element comprises a guidewire (12).
Regarding claim 30, Johnson teaches the catheter according to claim 25 as shown above, Johnson further teaching the guiding element comprises an atraumatic distal tip (column 1, last paragraph, “olive” wires).
Regarding claim 38, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching the rolling membrane comprises a drug or is at least partially covered by a drug coating layer (column 8, lines 18-22).
Regarding claim 41, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching the rolling membrane is configured to be extendable in the longitudinal direction at a higher extent than in a radial direction (Fig. 2).
Regarding claim 42, Johnson teaches the catheter according to claim 1 as shown above, Johnson further teaching the inner shaft is at least partially located within the inner volume of the rolling membrane (Fig. 1 or 2).
Regarding claim 44, Johnson teaches a method for using a catheter according to claim 1 as shown above, Johnson further teaching the capability of use (see 112 rejection above for interpretation) in at least crossing stenosis (40), wherein the rolling membrane defines an inner volume (32) that can be pressurized and wherein the rolling membrane is configured to roll out in the longitudinal direction into the rolled-out state (Fig. 2).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) in view of U.S. Patent Publication No. 2008/0167629 to Dann et al. (“Dann”).
Regarding claim 5, Johnson teaches the catheter according to claim 3 as shown above, but does not teach the claimed medical device.
Dann teaches the alternative use of a guidewire-type medical device and at least a medical device comprising electrodes, a nerve simulation device, a scoring element, a needle, an intravascular ultrasound (IVUS) system, a camera, a catheter, a microcatheter, a guiding catheter or a balloon catheter in a similar type of device ([0008]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the guidewire of Johnson with a catheter, electrode, or needle as taught by Dann to yield the predictable result of providing therapeutic or diagnostic treatment based on user needs ([0046]).
Regarding claim 16, Johnson teaches the catheter according to claim 1 as shown above but does not mention the claimed relative thicknesses.
Dann teaches a rolling membrane (100, Fig. 3C) having a smaller wall thickness than an outer shaft (400). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wall thickness of the rolling membrane of Johnson to be thinner than at least the outer shaft as taught by Dann to yield the predictable result of providing a thin enough membrane to provide sufficient flexibility for eversion or rolling of the membrane in and out of the outer tube.
Additionally or in the alternative it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Johnson to have a thinner rolling membrane, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Johnson would not operate differently with the claimed relative thicknesses, as these relative thicknesses would be suitable for providing sufficient flexibility to the rolling membrane and sufficient rigidity for the inner and outer shaft.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) in view of U.S. Patent Publication No. 2011/0152760 to Parker.
Regarding claim 17, Johnson teaches the catheter according to claim 1 as shown above, but does not show the braid.
Parker teaches an outer shaft or inner shaft being reinforced by a metal braid, a metal alloy braid, a polymer braid or by reinforcing fibers ([0030]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have reinforced the inner or outer shaft of Johnson with braiding as taught by Parker in order to provide a desired level of flexibility or stiffness ([0030]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) in view of U.S. Patent No. 5,269,792 to Simpson.
Regarding claim 29, Johnson teaches the catheter according to claim 25 as shown above, but does not show the different stiffness.
Simpson teaches a guiding element comprises regions of different stiffness (column 4, lines 54-58). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the stiffness of the guidewire of Johnson as taught by Simpson to allow the guidewire to be more flexible at its distal tip relative to the remaining length of the guidewire in order facilitate insertion and operation to suit particular needs and applications.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) in view of U.S. Patent Publication 2015/0133737 to BACICH et al. (“Bacich”).
Regarding claim 33, Johnson teaches the catheter according to claim 1 as shown above, but does not teach spikes or grooves.
Bacich teaches a rolling membrane (6) comprising spikes, circumferential grooves, and/or circumferential peaks at its outer surface ([0072]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rolling membrane of Johnson with spikes or grooves as taught by Bacich to provide increased friction or holding power within the vessel ([0072]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,039,721 to Johnson et al. (“Johnson”) in view of U.S. Patent Publication No. 2011/0172598 to Sampognaro et al. (“Sampognaro”).
Regarding claim 36, Johnson teaches the catheter according to claim 1 as shown above including an outer diameter of the rolling membrane (26) in a rolled-out state, but does not show the outer diameter decreasing.
Sampognaro teaches an outer diameter decreasing along a longitudinal direction continuously from a proximal end to a distal end (Fig. 2, [0031]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rolling membrane of Johnson to have a decreasing outer diameter as taught by Sampognaro to suit various needs and applications as well as facilitate penetration into and/or through occlusive material ([0032]).
Additionally or in the alternative, such a modification would be considered a simple change in shape and it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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