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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 5-6, 9, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mintz et al. U.S. Publication No. (2022/0175404 A1).
With respect to claim 1, Mintz et al. discloses a catheter (shown in figs.1-8) comprising:
an elongated body (12) and [0068]-[0069] comprising a distal body portion (16B, fig.1) and [0069] and defining a body inner lumen (26B) and [0069, least one body lumen 26B (also referred to as a body inner lumen)]; and
an expandable member (20) coupled to and extending from the distal body portion (16B, fig.1) and comprising an expandable support member or frame [0075] and a polymer jacket (48) and [0076],
wherein the expandable member (20) defines an expandable member inner lumen (26C) and [0074],
wherein the expandable member inner lumen (26C) is in fluid communication with the body inner lumen (26B) and [0074, expandable member lumen 26C is in fluid communication with inner lumen 26B of the elongated body 12],
wherein the expandable support member or frame comprises a tubular body [0075, expandable frames include an expandable stent-like structure or an expandable tubular braid or weave] and is configured to self-expand to expand the expandable member inner lumen radially outward [0075, expandable member 20 can include a frame configured to expand radially outward, thereby expanding lumen 26C radially outward], and
wherein the polymer jacket (48) at least partially overlays the expandable support member or frame (70) and comprises a polymer loaded with a radiographic material [0129], the radiographic material configured to be visible via medical imaging [0133].
With respect to claim 5, Mintz et al. discloses the radiographic material comprises at least one of tungsten, barium sulfate, bismuth or tantalum [0133].
With respect to claim 6, Mintz et al. discloses the polymer jacket comprises about 50% to 90% radiographic material by weight [0133].
With respect to claim 9, Mintz et al. discloses the elongated body comprises a body polymer jacket coupled to the polymer jacket, and wherein the body polymer jacket comprises a body polymer different than the polymer of the polymer jacket [0084].
With respect to claim 12, Mintz et al. discloses the expandable support member includes a tapered portion (20B) defining a taper between a first elongated support member dimension and a second elongated support member dimension, and wherein the elongated body further comprises: an inner liner (64) located radially inward to at least a portion of the polymer jacket, wherein the inner liner extends along at least a portion of the tapered portion of the expandable support member [0119] and [0121] and (fig.3).
With respect to claim 13, Mintz et al. discloses the inner liner is a first inner liner (64) comprising a first liner material, and wherein the elongated body further comprises: a second inner liner (18) located radially inward to at least a portion of the polymer jacket and comprising a second liner material, wherein the second inner liner (18) is proximal to first inner liner (64) such that the second inner liner abuts the first inner liner (as shown in fig.3), wherein the second inner liner and the first inner layer are in a common radial layer of the elongated body, and wherein the first liner material is different than the second liner material [0119] and [0121] and (fig.3).
With respect to claim 14, Mintz et al. discloses the expandable member is configured to expand radially outward via the expandable support member from a collapsed configuration to an expanded configuration, wherein when the expandable member is in the collapsed configuration, the expandable member is configured to navigated through an introducer sheath (56), and wherein when the expandable member is in the expanded configuration, the expandable member is radially expanded relative to the collapsed configuration and configured to engage a thrombus [0003], [0008] and [0075].
With respect to claim 15, Mintz et al. discloses the elongated body further comprises: a structural support member (28) comprising a coil and configured to maintain a cross-sectional shape of the elongate body [0113], wherein the structural support member (28) longitudinally overlaps with the expandable support member (as shown in fig.3) and [0117].
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al. as applied to claim 1 above, and further in view of Plamthottam U.S. Patent No. (11,046,846 B2).
With respect to claim 2, Mintz et al. substantially discloses the invention as claimed except the polymer jacket comprises a Styrenic Block Copolymer (SBC).
Plamthottam however, teaches articles such as (balloon dilatation catheters, cervical ripening balloons, stent implantation balloons, retrieval balloon catheters) are normally made by a dip forming process from solutions or dispersions of natural or synthetic polymers ([Col.1], lines 31-33] comprising a dip formable composition comprising block copolymer is a styrene-ethylene-butylene-styrene block copolymer ([Col.3], lines 4-6) and ([Col.5], lines 43-62).
In view of the teachings of Plamthottam, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polymer jacket of Mintz et al. by incorporating a Styrenic Block Copolymer (SBC) to improve the strength properties and tactile sensitivity of the product, in this instance, the polymer jacket ([Col.1], lines 66-67) and ([Col.2]. line 1) of Plamthottam.
With respect to claim 3, the combination of Mintz et al./Plamthottam substantially discloses the invention as claimed. Plamthottam further teaches the SBC comprises at least one of Styrene-Ethylene-Butylene-Styrene (SEBS) or hydrogenated (styrene-isoprene-styrene) (SIS) ([Col.3], lines 4-6).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al./Plamthottam as applied to claim 2 above, and further in view of Fine et al. U.S. Publication No. (2023/0056245 A1).
With respect to claim 4, the combination of Mintz et al./Plamthottam substantially discloses the invention as claimed except the SBC includes maleic anhydride functional groups.
Fine et al. however, teaches a catheter (abstract) comprising an outer layer 147 of the outer jacket 140 is composed of polyurethane or polyurethane/Styrene Block Copolymer (SBC) [0252], wherein the polymer jacket comprises a thermally bondable member constructed from maleic anhydride [0487].
In view of the teachings of Fine et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the SBC of Mintz et al./Plamthottam by incorporating maleic anhydride functional groups in order to improve the strength and durability of the polymer jacket which directly impacts lifespan and efficiency.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al.
With respect to claim 7, Mintz et a. substantially discloses the invention as claimed except the radiographic material defines a particle size of about 100 nanometers to about 10 micrometers. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the radiographic material of Mintz et al. having a particle size of about 100 nanometers to about 10 micrometers configured to be visible via medical imaging, as applicant appears to have placed no criticality on the claimed range (see pp. [012]3 indicating “…Example 7. The catheter of any of examples 1 through 6, wherein the radiographic material defines a particle size of about 100 nanometers to about 10 micrometers…”, 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.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al. as applied to claim 1 above, and further in view of Fine et al. U.S. Publication No. (2023/0056245 A1).
With respect to claim 8, Fine et al. substantially discloses the invention as claimed except the polymer of the polymer jacket comprises a Shore A hardness of about 30A to about 80A.
Fine et al. however, teaches a catheter comprising an outer jacket (140) having a shore hardness (durometer) in the ranging between about 10 and about 95 Shore A [0192].
In view of the teachings of Fine et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polymer jacket of Mintz et al. by incorporating a polymer jacket having a Shore A hardness of about 30A to about 80A in order to improve the strength of the polymer jacket.
Claim(s) 10-11 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al. as applied to claim 1 above, and further in view of Vale et al. (EP 3875046 A1).
With respect to claim 10, Mintz et al. substantially discloses the invention as claimed except the elongated body comprises a distal tip polymer jacket distal to the polymer jacket, the distal tip polymer jacket configured to encapsulate a distal end of the expandable support member.
Vale et al., however, teaches a catheter comprising a flexible cover can be disposed to form a sleeve around at least a part of the support tube and at least a part of the strut framework of the expansile tip. The cover can be formed from a ductile elastomer, which has the advantages of being soft and flexible with resistance to tearing and perforation due to a high failure strain. The cover can encapsulate the tip framework and support tube so that it makes up both the inner and outer surfaces of the catheter. As an alternative, the cover can be one or more polymer jackets which can be fused together and adhered, reflowed, or stitched to the strut framework ([Page 4], 5th paragraph].
In view of the teachings of Vale et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the elongated body of Mintz et al. by incorporating a distal tip polymer jacket distal to the polymer jacket, the distal tip polymer jacket configured to encapsulate a distal end of the expandable support member for atraumatic contact with the walls of a blood vessel.
With respect to claim 11, Mintz et al. substantially discloses the invention as claimed except the distal tip polymer jacket comprises a distal tip polymer, wherein the distal tip polymer is harder than the polymer of the polymer jacket such that the distal end of the expandable support member is not exposed to vasculature of a patient.
Vale et al., however, teaches a catheter comprising a flexible cover can be disposed to form a sleeve around at least a part of the support tube and at least a part of the strut framework of the expansile tip. The cover can be formed from a ductile elastomer, which has the advantages of being soft and flexible with resistance to tearing and perforation due to a high failure strain. The cover can encapsulate the tip framework and support tube so that it makes up both the inner and outer surfaces of the catheter. As an alternative, the cover can be one or more polymer jackets which can be fused together and adhered, reflowed, or stitched to the strut framework ([Page 4], 5th paragraph], wherein, at least portions of the framework 112 of the expansile tip 200 and the support tube 124 may be covered by ([Page10], 6th paragraph] a flexible cover 118 or polymer jacket. The expansile tip 200 can assume the expanded configuration by self-extending radially outward from the longitudinal axis 114 of the clot retrieval catheter 110 upon exiting the distal end 72 of the outer catheter 30. In one example, a highly elastic cover 118 or polymer jacket stretches as the tip expands and can follow the contours of the underlying strut framework ([Page 11], 1st paragraph]; wherein in addition to or in place of a cover 118, a length of the tip extending proximal from the distal end 211 can define a dip zone 220 which designates the portion of the tip which can be further dip coated with a low-friction elastomer, as shown in (Fig.10) and ([Page 16], 6th paragraph].
In view of the teachings of Vale et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal tip polymer jacket of Mintz et al. comprising a distal tip polymer, wherein the distal tip polymer is harder than the polymer of the polymer jacket such that the distal end of the expandable support member is not exposed to vasculature of a patient thereby protecting the vasculature of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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