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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 2, 2026 has been entered.
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive in view of the rejections set forth below.
In response to applicant’s argument that the device of Kontos is not an independent device and does not exist separately from the distal end of the second PTCA catheter, 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. Applicant has not specifically pointed out how the language of the claims distinguishes them from the structures in the prior art and instead highlights the differences between the uses of the prior art and the instant invention. Patentability is determined based on the language in the claims. The applicant argues that the support sleeve is ‘an independent standalone device’ separate from the balloon catheter, which is not in the claims. The claims recite that the sleeve has “an internal diameter of a size and shape to receive a balloon catheter” which the lumen of the identified support sleeve of Kontos meets these limitations. The balloon catheter is not positively recited, so an arbitrary catheter with a balloon fitting within the identified sleeve of Kontos meets the limitations and furthermore since the balloon catheter is not positively recited, Kontos does not have to disclose the balloon catheter and any arbitrary balloon catheter can be considered separate from the device disclosed by Kontos and thus the sleeve of Kontos would be considered a ‘independent stand alone device that is separate from the balloon catheter’ and applicant’s arguments are not persuasive.
In response to applicant’s argument that the Kontos sliding means is merely the distal tip of a catheter and is not configured to be inserted completely within a body of a patient, functional limitations are not given full patentable weight. As long as the prior art meets the structural limitations and is capable of performing the recited functions, the prior art meets the limitations. The entire device of Kontos would be capable of being inserted to any arbitrary place within the body of a patient, and would meet the claimed limitations. Kontos need not disclose explicitly disclose performing the function for the prior art to read on the claims. Similarly, applicant’s arguments that Kontos does not teach the claimed support balloon to anchor to the vessel and selectively coupled and decoupled from the balloon catheter (not positively claimed), as long as the prior art is capable of performing the recited functions, the prior art meets the limitations. Since the balloon of Kontos would be capable of being inserted into an arbitrary vessel and contact the walls thereof to keep it relatively in place, it would meet the limitations of ‘anchoring’ the device to the vessel wall. Therefore, applicant’s arguments are not persuasive.
In response to applicant’s argument that the balloon membrane of Kontos is for dilating stenosis and not a support or anchoring balloon, 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. Therefore, since the claim only requires “a support balloon” with no other structural components of the balloon, the balloon 34 of Kontos meets the limitations. Applicant argues that the references fail to show certain features of the invention, however, it is noted that the features upon which applicant relies (i.e., a balloon to anchor the sleeve to the vessel wall) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, if claimed, this would amount to a functional limitation and the prior art is capable of being inflated into an arbitrary vessel enough to resist movement therein and ‘anchor’ the device within a vessel. Applicant argues that the balloon membrane is not directly coupled to an exterior surface of the sleeve, it is noted that the previous rejection identifies 38, which includes 42, as the support sleeve and balloon membrane is coupled directly thereto, as shown in figure 3. Therefore, applicant’s arguments that the Kontos balloon membrane is not a support balloon directly coupled to an exterior surface of the sleeve is not persuasive.
In response to applicant’s argument that the Kontos tube is not an inflation tube for a support balloon and that the identified tube is not a separate inflation tube dedicated to an anchoring support balloon, as shown in the annotated figure below and figure 3, Kontos comprises an inflation tube that provides inflation to the support balloon, and the claims do not require the inflation tube to be a separate inflation tube. Kontos discloses a distinct tubular member for inflation of the support balloon and meets all of the claim limitations. The applicant continues to argue both the intended use of the device as well as features which are not claimed. As stated above, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims and 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. Therefore, applicant’s arguments remain unpersuasive.
In response to applicant’s arguments that the examiner’s proposed combination lacks a rational basis since the examiner has not explained why a skilled artisan would look toa reference teaching balloon catheter dimensions, why the specific length would be selected, or what the proposed combination would solve, obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The examiner has provided that it was taught as a well known length for balloon catheters at the time of the invention and that it would have been within the level of one with ordinary skill in the art at the time of the invention to make the modification 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. The obviousness rejection does not need to specifically provide why one with ordinary skill in the art would have necessarily made the invention, but whether or not it would have been obvious or within the skill of one with ordinary skill in the art to make such a modification. The obviousness rejection does not necessarily have to state a problem that would be solved, since the modification is a mere change in size and the device would work equally well with either designs. Therefore, applicant’s argument is not persuasive.
In response to applicant’s argument that the claimed invention addresses a different problem than Kontos, as stated above, 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.
In response to applicant’s argument that the ribbons of Ainsworth serve an entirely different function than the claimed flat coupling wire and that the instant invention flat coupling wire is not embedded in the catheter wall for structural reinforcement purposes and that the wire is positioned within the internal diameter of the sleeve to contact, the claim only recites that the wire is configured to contact tan internal surface of the sleeve and does not recite that it is positioned within the internal diameter of the sleeve as argued by applicant. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., separate independent wire positioned within the internal diameter of the sleeve) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Although Ainsworth teaches a different function and suggestion for incorporating a wire as claimed, obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, since Ainsworth teaches it was known in the art at the time of the invention to make the internal surface of catheter sleeves formed of a plurality of reinforcing wire ribbons (31) to improve pushability and the claim merely requires a wire configured to contact the balloon catheter, which is not positively claimed, and an internal surface of the sleeve, Ainsworth provides a sufficient teaching such that it would have been obvious to one with ordinary skill in the art at the time of the invention to make the sleeve of Kontos further comprise a flat shaped wire having a width that is greater than a height (ribbon shaped) on the internal surface of the sleeve, in order to improve the pushability of the sleeve of the support sleeve disclosed by Kontos, wherein the wire would subsequently contact the balloon catheter. Therefore, applicant’s arguments are not persuasive. Applicant’s arguments with respect to claim 11 are unpersuasive for the same reasons, since the examiner maintains that obviousness is properly established to meet the claimed limitations.
In response to applicant’s argument with respect to claim 5 that Plain teaches a coating to reduce friction which teaches away from the claimed limitation, however, the applicant only cites one sentence of paragraph 0045 of Plain, whereas right after the cited sentence, Plain teaches “control wires may have surface features, be wrapped with wire windings, or be coated with “Sticky” material to increase friction… Coatings or surface structures such as scales with one-way frictional effects may also be applied to control wires” which teaches a coating that increases friction as claimed. Therefore, it appears that applicant has only selectively cited the teaching reference and has not considered all of the teachings provided by the prior art and applicant’s arguments are not persuasive.
In response to applicant’s argument that the winch mechanism serves a fundamentally different function from the claimed winch, as stated above, although the prior art teaches a different function and suggestion for incorporating the winch as claimed, obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Since Hartley teaches it was known in the art at the time of the invention to utilize a winch assembly (74) operable to pull a pull wire (paragraph 0053) while allowing for the wire to be locked at a particular position. The examiner maintains it would have been within the level of one with ordinary skill in the art at the time of the invention to further include a winch assembly, as taught as a known pulling mechanism at the time of the invention, coupled to the wire of Kontos such that pulling wire in the proximal direction tightens or loosens the loop of Kontos to selectively restrict or allow relative movement between the balloon catheter and the support sleeve and in order for the wire to be locked at a particular position for added control. Therefore, applicant’s arguments are not persuasive.
In response to applicant’s arguments regarding Sandridge, the examiner does not rely on Sandridge to teach including a hypotube and its functions, but merely that a hypotube was a known material for balloon catheters at the time of the invention and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. Therefore, applicant’s arguments with respect to the functionality of the hypotube of Sandridge is not persuasive.
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.
Claims 1, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523).
Regarding claims 1 and 13, Kontos et al (hereafter Kontos) discloses a support sleeve for use with a balloon catheter, the support sleeve comprising: a sleeve (38 which includes 42, figure 3, sliding guide means), tubular in shape having a proximal end, a distal end and an internal diameter of a size and shape to receive a balloon catheter (C:7, L:13-29); said sleeve configured to move in relation to and over said balloon catheter and said sleeve is configured to allow movement of said balloon catheter in relation to said sleeve (C:7, L:13-20); said sleeve configured to be inserted completely within a body of a patient (the entire sleeve 38 could be inserted completely within an arbitrary body location of a patient); a support balloon (34) directly coupled to an exterior surface of the sleeve (figure 2-3); and an inflation tube (38) in fluid communication with the support balloon, wherein the inflation tube enables a fluid to be provided to the support balloon in order to inflate the support balloon (C:6, L:15-20), further comprising a coupling portion (figure 7) that provides for selectively coupling the support sleeve to a balloon catheter arranged within the internal diameter of the sleeve (71, C:6, L:58-69), wherein the coupling portion is a wire (71, 69) configured to contact the balloon catheter and an internal surface of the sleeve to restrict relative movement between the balloon catheter and the support sleeve (C:6, L:58-69; balloon catheter is inserted through the wire, and wire contacts internal surface of sliding guide means in figure 7).
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Kontos further discloses the sleeve (sliding guide mean) runs along the outside of the support balloon (C:6, L:45-50), and that the sleeve will only be slightly longer than the length of the balloon chamber (C:7. L:1-12). However, Kontos does not specifically disclose the actual axial lengths of the sleeve or the support balloon. However, Devens, Jr. et al (hereafter Devens) teaches it was known in the art at the time of the invention for vascular angioplasty balloon catheters (C:2, L:9) to have a length of about 8 to 40mm (C:4, L:35-37). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the support balloon of Kontos have an axial length between 5mm and 20mm, as taught as known in the art by Devens, as well as subsequently making the sleeve having a length (‘a length’ is sufficiently broad to encompass a length of 42) slightly longer than the length of the balloon chamber such that it is 30mm, 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 8, Kontos in view of Devens teaches all of the limitations set forth in claim 1, wherein the support balloon is configured to be inflated to a diameter about equal to a diameter of a blood vessel adjacent to a narrowed blood vessel segment within a patient (C:7, L:20-29; C:8, L:1-8).
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Ainsworth et al (US 5451209).
Regarding claim 4, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the wire is a flat-shaped wire having a width that is greater than a height. However, Ainsworth et al (hereafter Ainsworth) teaches it was known in the art at the time of the invention to make the internal surface of catheter sleeves formed of a plurality of reinforcing wire ribbons (31) to improve pushability (C:3, L:61-69). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the sleeve of Kontos further comprise a flat shaped wire having a width that is greater than a height (ribbon shaped) on the internal surface of the sleeve, in order to improve the pushability of the sleeve of the support sleeve disclosed by Kontos, wherein the wire would subsequently contact the balloon catheter (it is noted the balloon catheter is not positively claimed, so any arbitrary balloon catheter abutting the inner surface of the sleeve of Kontos would be in contact with the wire, and increased stiffness of the sleeve of Kontos would result in restricting the relative movement between the balloon catheter and the support sleeve when the arbitrary balloon catheter is tightly fit within the sleeve of Kontos).
Regarding claim 11, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the support sleeve comprises a flexible tube having a braided filament coupled to an interior surface of the flexible tube. However, Ainsworth et al (hereafter Ainsworth) teaches it was known in the art at the time of the invention to make the internal surface of intravascular catheter sleeves formed of a braided filament coupled to an interior surface of the flexible tube (C:3, L:61-69; claim 1). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the support sleeve of Kontos comprise a flexible tube having a braided filament coupled to an interior surface of the flexible tube, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 3 above, and further in view of Plain et al (US 20050288766).
Regarding claim 5, Kontos in view of Devens teaches all of the limitations set forth in claim 3, but is silent to a coating layer on the wire. However, Plain et al (hereafter Plain) teaches it was known in the art at the time of the invention for control wires to be coated with a coating layer having a coefficient of friction sufficient to restrict relative movement between the wire and other components of the device (paragraph 0045). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to coat the wire (71, 69) of Kontos with a coating layer having a coefficient of friction sufficient to restrict the relative movement between the balloon catheter and the support sleeve in order to maintain the spacing and rotational position of the balloon catheter within the support sleeve for proper positioning of the device during a procedure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 2 above, and further in view of Hartley et al (US 20110230947).
Regarding claim 6, Kontos in view of Devens teaches all of the limitations set forth in claim 2, wherein the coupling portion is a wire (69), and the wire has a loop (69) for receiving the balloon catheter (C:6, L:58-69), and wherein the loop can tighten or loosen by pulling or extending the wire (71) in the proximal or distal direction in order to selectively restrict or allow relative movement between the balloon catheter and the support sleeve (C:8, L:39-51). Kontos does not disclose a winch to tighten or loosen the loop of the wire. However, Hartley et al (hereafter Hartley) teaches an intravascular device, wherein it was known in the art at the time of the invention to utilize a winch assembly (74) operable to pull a pull wire (paragraph 0053) while allowing for the wire to be locked at a particular position. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to further include a winch assembly, as taught as a known pulling mechanism at the time of the invention, coupled to the wire (69) of Kontos such that pulling wire in the proximal direction tightens or loosens the loop of Kontos to selectively restrict or allow relative movement between the balloon catheter and the support sleeve and in order for the wire to be locked at a particular position for added control.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Pierpont et al (US 8608691).
Regarding claim 9, Kontos in view of Devens teaches all of the limitations set forth in claim 1, wherein the support balloon comprises: a first support balloon (34), wherein the first support balloon is positioned to inflate outward from the outer surface of the sleeve (figure 1). However, Kontos does not teach the support balloon comprises a second support balloon, wherein the second support balloon is positioned to inflate inward from an inner surface of the sleeve. However, Pierpont teaches it was known in the art at the time of the invention for a balloon dilation catheters to comprise internal balloons (30) that can be inflated to secure a balloon dilation catheter to an anchoring catheter (18; C:3, L:25-30; C:2, L:16-26). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include an second support balloon on the inner surface of the sleeve of the device of Kontos, as taught as known in the art at the time of the invention by Pierpont, in order to secure the support sleeve to the balloon catheter.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Sandridge (US 5299575).
Regarding claim 10, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the inflation tube is a hypo-tube. However, Sandridge teaches it was known in the art at the time of the invention for guiding balloon catheters to utilize a hypo-tube to provide an inflation medium to a support balloon (C:2, L:53-64). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the inflation tube of Kontos a hypotube as known in the art by Sandridge, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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