CTNF 18/499,995 CTNF 101660 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. Claims 1-20 are pending and examined below. Information Disclosure Statement The information disclosure statement filed 2/12/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. 06-49-02 The information disclosure statement filed 2/12/2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-5, 7-9, 12, 13, and 15-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by US 2015/0290434 A1 (“Lin”) . Regarding claim 1, Lin discloses a system for deploying an implant to a portion of a patient’s body (see Fig. 1 and [0044]), the system comprising: a delivery catheter (balloon catheter 10, see Fig. 1) including an elongate shaft (elongated catheter shaft 11, see Fig. 1); and a balloon coupled to the elongate shaft (shaft 11 has a multilayer balloon 14 disposed on the distal end of the shaft, see [0044] and Fig. 1) and configured for the implant to be positioned upon (radially expandable stent 16 mounted on multilayer balloon 14, see [0044] and Fig. 1), and having a wall including an inner surface and a first layer (multilayer ballon 14 with wall includes third layer 32 which defines the inner surface of the balloon and the first layer, see [0048] and Fig. 4 ) and a second layer positioned adjacent to the first layer (second layer 31 lies adjacent to third layer 32, see [0048] and Fig. 4) and not being thermally bondable to the first layer (alternative methods of manufacturing the multilayer balloon 14 includes one or more layers added to an extruded or coextruded tube by heat shrinking, dip coating, adhesive or fusion bonding, frictionally engaging, or nesting the additional layers to the tube, which includes non-thermal bonding methods, see [0070]) , the balloon having an axial dimension and a radial dimension (see Annotated Fig. 4) , wherein the balloon is expandable through pressure applied to the inner surface of the wall (balloon is inflated by introducing inflation fluid into the balloon interior to expand the balloon 14 and stent 16, thus the inflation fluid applies pressure to the inner surface of the balloon, see [0044]) , and wherein the wall has a weaker tear strength in the axial dimension than in the radial dimension (Lin discloses at least two layers of the balloon that can be formed of various suitable materials including polyamides and polyesters (see [0051]), which are the same materials used for the first and second layer of the wall of the current application. Thus, Lin inherently discloses that the layers of the balloon have a weaker tear strength in the axial dimension than in the radial dimension as the same materials necessarily have the same material properties) . PNG media_image1.png 282 886 media_image1.png Greyscale Regarding claim 2, Lin further discloses that an outer surface of the wall has a tapered profile (outer surface of multilayer balloon 14 tapers toward the proximal and distal ends, see Fig. 4). Regarding claim 3, Lin further discloses that the first layer is thermally bondable to the elongate shaft (catheter component, such as a balloon or shaft, is surrounded by encapsulating layers made of nylon 11 or nylon 12 or copolymers, such as a polyether block amide (PEBA) material, see [0058] and [0060]. Lin discloses an inner layer (third layer 32) comprise of a polyamide or co-polyamide (see [0026]), which is in the same polymeric family as the encapsulating material of the catheter shaft, and thus the materials are compatible and thermally bondable. Additionally, various components, which can include balloon and catheter, can be joined using conventional bonding methods such as fusion bonding, and thus capable of being thermally bonded, see [0069] and Fig. 4 where third layer 32 is adjacent to outer tubular member 19 of the shaft). Regarding claim 4, Lin further discloses that the first layer comprises a polyamide or co-polyamide (third layer made of a third polymer material is selected from the group consisting of nylon 11, nylon 12, polyether block amide, and combinations thereof, which comprises a polyamide or co-polyamide, see [0026] and claim 48). Regarding claim 5, Lin further discloses that the second layer comprises a polyester (various suitable materials have appropriate Shore durometer hardness can be used to form each of the first, second, and third layers 30, 31, and 32 including but not limited to polyamides, polyurethanes, and polyesters, and thus Lin discloses that the second layer can comprise of polyester, see [0051]). Regarding claim 7, Lin further discloses a third layer positioned radially outward of the second layer (first layer 30 is positioned as an outer layer relative to second layer 31, see [0048] and Fig. 4) and made of a material that is thermally bondable with the first layer (first layer made of a first polymer material and third layer made of a third polymer material can be selected from the group consisting of nylon, 11, nylon 12, polyether block amide, and combinations thereof, and thus the layers are made from the same material family and compatible to be thermally bonded, see [0026]). Regarding claim 8, Lin further discloses that the second layer or the third layer forms an outer surface of the wall (first layer 30 defines an outer surface of the balloon, see [0048] and Fig. 4). Regarding claim 9, Lin further discloses that the second layer comprises 25 percent to 50 percent of a thickness of the wall (second layer can make up about 30% to about 65% of the total wall thickness of the multilayered balloon, see [0061]. The prior art range of about 30-65% substantially overlaps the claimed range of 25-50%, and discloses the claimed range with sufficient specificity). Regarding claim 12, Lin further discloses that a burst pressure of the balloon is at least about 7.5 atmospheres (multilayer balloon can have a rated burst pressure of about 15 to about 30 atm when blow molded, and thus the balloon would be capable of withstanding a burst pressure of at least 7.5 atmosphere, see [0067]). Regarding claim 13, Lin further discloses that the wall has a hoop strength of at least 24,000 pounds per square inch (multilayered balloons in accordance with the disclosed subject matter and the control monolithic balloon each had a hoop strength greater than 30,000 psi, see [0079]). Regarding claim 15 , Lin further discloses the implant (radially expandable stent 16), wherein the implant comprises a prosthetic heart valve (implant specified is radially expandable stent 16, see [0044] and Fig. 4), and the balloon is configured to dilate the prosthetic heart valve when the prosthetic heart valve is positioned on the wall (the disclosed subject matter is suited for angioplasty and delivery of a stent to a vasculature, see [0041]. More specifically, balloon catheter 10 with the balloon in the inflated configuration to expand the stent against the wall of the body lumen 18, see [0044] and Fig. 4) . Regarding claim 16, Lin further discloses a system for deploying an implant to a portion of a patient’s body (see [0044] and Fig. 1) , the system comprising: a delivery catheter (balloon catheter 10, see Fig. 1) including an elongate shaft (elongated catheter shaft 11, see Fig. 1) ; and a balloon coupled to the elongate shaft (shaft 11 has a multilayer balloon 14 disposed on the distal end of the shaft, see [0044] and Fig. 1) and configured for the implant to be positioned upon (radially expandable stent 16 mounted on multilayer balloon 14, see [0044] and Fig. 1) , and having a wall including a blend of a semi-crystalline polymer and an amorphous polymer (intermediate layer can comprise of a blend of semi-crystalline Nylon 12 (e.g. Grilamid L25 Nylon) and amorphous Nylon 12 (e.g. Grilamid TR 55 Nylon), see [0056], [0057], and Table 2) and having an inner surface (multilayer ballon 14 with wall includes third layer 32 which defines the inner surface of the balloon, see [0048] and Fig. 4) , the balloon having an axial dimension and a radial dimension (see Annotated Fig. 4) , wherein the balloon is expandable through pressure applied to the inner surface of the wall (balloon is inflated by introducing inflation fluid into the balloon interior to expand the balloon 14 and stent 16, thus the inflation fluid applies pressure to the inner surface of the balloon, see [0044]) , and wherein the wall has a weaker tear strength in the axial dimension than in the radial dimension (Lin discloses a layer of a wall that comprises of a blend of semi-crystalline Nylon 12 (e.g. Grilamid L25 Nylon) and amorphous Nylon 12 (e.g. Grilamid TR 55 Nylon) (see [0056], [0057], and Table 2), which are the exact same materials that the semi-crystalline polymer and the amorphous polymer may comprise of in the blend of the wall of the current application, respectively. Thus, Lin inherently discloses that the wall of the balloon has a weaker tear strength in the axial dimension than in the radial dimension as the same blend of materials necessarily have the same material properties) . PNG media_image1.png 282 886 media_image1.png Greyscale Regarding claim 17, Lin further discloses that the semi-crystalline polymer comprises a semi-crystalline polyamide (Nylon 12 (Grilamid L25) is a semi-crystalline polyamide, see [0051], [0056], and Table 2). Regarding claim 18, Lin further discloses that the semi-crystalline polymer comprises semi-crystalline nylon 12 (see [0056], [0057], and Table 2 for semi-crystalline Nylon 12 (Grilamid L25)). Regarding claim 19, Lin further discloses that the amorphous polymer comprises a transparent amorphous nylon (amorphous nylon (Grilamid TR 55) is transparent, with transparency inherent in the material’s property and further evidenced by Applicant’s Specification, see Specification [0102], and also Lin [0056] and Table 2). Regarding claim 20, Lin further discloses that the semi-crystalline polymer has a melting temperature that is higher than a glass transition temperature of the amorphous polymer (Lin discloses the identical semi-crystalline polymer (Grilamid L25) and amorphous polymer (Grilamid TR 55) in the same blend; the claimed thermal relationship is an intrinsic property of those materials that necessarily comes from their identity, and this is further evidenced by Applicant’s Specification showing the inherent melting temperature of semi-crystalline polymer (~178 degrees Celsius) and glass transition temperature of amorphous polymer (~160 degrees Celsius), see Specification [0104], and also Lin [0056] and Table 2) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0290434 A1 (“Lin”) in view of US 2004/0191443 A1 (Hamlin) . Regarding claim 6, Lin does not disclose that the second layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a thermoplastic elastomer copolyester, or combinations thereof, however Hamlin discloses a similar multilayer catheter balloon that includes a second layer composed of polyethylene terephthalate (PET) (PET outer layer 56, see [0036] and Fig. 5). Hamlin teaches that the PET layer affords the desired burst strength and limited radial expansion characteristic when inflated (see [0018]). 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 second layer disclosed by Lin to comprise of PET, as taught by Hamlin, in order to remain flexible while exhibiting the desired high burst strength and low radial expansion when inflated . 07-21-aia AIA Claim s 10, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0290434 A1 (“Lin”) . Regarding claim 10, Lin does not disclose wherein the wall has an outer diameter compliance of between 10 percent growth per atmosphere and 16 percent growth per atmosphere between 4 atmospheres to 8 atmospheres when normalized by a diameter of the balloon. However, Lin further discloses that the multilayer balloon can have a compliance of about 0.015 to about 0.035 mm/atm within the working pressure range (e.g., between about 8-12 atm to about 15-30 atm) (see [0067]). Lin teaches that its balloon may alternatively be configured to have a semicomplaint radial expansion beyond the nominal working diameter at pressures above a nominal pressure (see [0066]). Lin further teaches that compliance may be modified through material selection, layer thickness, blow-up-ratio (BUR), and processing conditions (see [0056], [0061] and [0072]- [0074]). It further recognizes compliance as a result-effective variable affecting balloon performance and teaches adjusting balloon construction and processing parameters to obtain the desired compliance characteristic (see [0072]). 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 compliance of the balloon disclosed by Lin, including optimizing the amount of diameter growth per atmosphere over a selected pressure range, through routine adjustment of known parameters such as material selection, layer thickness, and blow-molding conditions in order to achieve desired balance of flexibility, softness, and controlled expansion. The determination of an optimum or workable value of a result-effective variable ordinarily involves only routine experimentation and is within the level of ordinary skill in the art, with no showing of criticality. Regarding claim 11, Lin does not disclose that the wall has an outer diameter compliance of between 0.30 millimeters per atmosphere and 0.42 millimeters per atmosphere between 4 atmospheres to 8 atmospheres . However, Lin further discloses that the multilayer balloon can have a compliance of about 0.015 to about 0.035 mm/atm within the working pressure range (e.g., between about 8-12 atm to about 15-30 atm) (see [0067]). Lin teaches that its balloon may alternatively be configured to have a semicomplaint radial expansion beyond the nominal working diameter at pressures above a nominal pressure (see [0066]). Lin further teaches that compliance may be modified through material selection, layer thickness, blow-up-ratio (BUR), and processing conditions (see [0056], [0061] and [0072]- [0074]). It further recognizes compliance as a result-effective variable affecting balloon performance and teaches adjusting balloon construction and processing parameters to obtain the desired compliance characteristic (see [0072]). 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 compliance of the balloon disclosed by Lin, including optimizing the amount of diameter growth per atmosphere over a selected pressure range, through routine adjustment of known parameters such as material selection, layer thickness, and blow-molding conditions in order to achieve desired balance of flexibility, softness, and controlled expansion. The determination of an optimum or workable value of a result-effective variable ordinarily involves only routine experimentation and is within the level of ordinary skill in the art, with no showing of criticality. Regarding claim 14, Lin does not disclose that the tear strength of the wall in the radial dimension is at least 20 percent higher than in the axial dimension , however Lin teaches that balloon strength characteristics are affected by the material, layer thickness, blow-up-ratio (BUR), and processing conditions (see [0061] and [0072]- [0074]). It further recognizes that the relative tear strengths in the radial and axial dimensions constitute result-effective variables that can be adjusted by routine optimization of known balloon design parameters, including material composition, layer thickness, and blow-molding conditions, in order to achieve desired strength and characteristics. 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 balloon disclosed by Lin to optimize the tear strength in the radial dimension to be 20% stronger, as it is routine optimization of the known balloon parameters taught by Lin. Discovering the optimum or workable value of a result-effective variable is within the level of ordinary skill in the art and would have been obvious absent a showing of criticality for the claimed value. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /N.C.N./Examiner, Art Unit 3774 /KATRINA M STRANSKY/Primary Examiner, Art Unit 3700 Application/Control Number: 18/499,995 Page 2 Art Unit: 3774 Application/Control Number: 18/499,995 Page 3 Art Unit: 3774 Application/Control Number: 18/499,995 Page 4 Art Unit: 3774 Application/Control Number: 18/499,995 Page 5 Art Unit: 3774 Application/Control Number: 18/499,995 Page 6 Art Unit: 3774 Application/Control Number: 18/499,995 Page 7 Art Unit: 3774 Application/Control Number: 18/499,995 Page 8 Art Unit: 3774 Application/Control Number: 18/499,995 Page 9 Art Unit: 3774 Application/Control Number: 18/499,995 Page 10 Art Unit: 3774 Application/Control Number: 18/499,995 Page 11 Art Unit: 3774 Application/Control Number: 18/499,995 Page 12 Art Unit: 3774 Application/Control Number: 18/499,995 Page 13 Art Unit: 3774 Application/Control Number: 18/499,995 Page 14 Art Unit: 3774
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