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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/1/26 has been entered.
Specification
The disclosure is objected to because of the following informalities: reference should not be made to claims in the specification, as on page 3.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 5/1/26 have been fully considered but they are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to select the values within the lower boundaries of the claimed range, the examiner recognizes that 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, MPEP 2131.03 states a range could be considered “anticipated” when a specific example in the prior art has the feature with the values within the claimed range. Thus, since Cox states (page 16, line 22) the micropores can be 10 microns which could reasonably interpreted to equate to provide at least 10 pores (see Fig. 6) within the claimed range of at least 30 µm2 to at most 750 µm2 there is thus an overlap of the claimed range. Applicant contends there is such a large disparity in values outside the claimed range by the covering of Cox for the dimensions of macropores it does not support an obviousness for the claimed range. However, the examiner must remind the Applicant the claim(s) recite at least 10 pores having the values claimed which as already mentioned include overlap and anticipatory evidence for the micropores in the covering of Cox, such that the reference does apply. Further it must be noted that when treating stenotic or necrotic, blockages one uses smaller diameter pores, see Amiridze (WO 2010/014447) and thus it is obvious to one of ordinary skill in the art to select values in the lower range of the pore sizes disclosed by Cox in view of the teaching.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17,23,26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2008/151204) in view of Holzer et al. (2018/0338847) and also Amiridze (WO 2010/014447). Cox et al. disclose (abstract) a medical system for the treatment of stenosis in intracranial blood vessels. Cox further discloses (page 6, lines 29,30) a compressible and self-expandable implant for covering the stenosis. Fig. 16 shows the implant 100 having a mesh structure at least a section of which is provided with a covering 108 produced from an electrospun fabric (page 32, lines 1-4,6) having pores of different sizes (Fig. 6,page 13, lines 32-34, page 14, lines 1-4). Fig. 6 shows the covering includes at least 10 pores 24 with a size of at least 30 µm² over an area of 100000 µm² (page 16, lines 13-28, pore size lower limit 10 µm, which are circular(round) and thus have an area of πr², which is, respectively 78.54 µm², thus all pores defined as the micropores have a size value of at least 30 µm² over any area, which includes 100000 µm²) and thus illustrated pore arrangements are applicable for use with the mesh and covering shown in Fig. 6. MPEP 2131.03 states a range could be considered “anticipated” when a specific example in the prior art has the feature with the values within the claimed range. Thus, since Cox states (page 16, line 22) the micropores can be 10 microns which could reasonably interpreted to equate to provide at least 10 pores (see Fig. 6) within the claimed range of at least 30 µm2 to at most 750 µm2 there is thus an overlap of the claimed range since the claimed range is covered by the prior art range including the values. Amiridze teaches (page 8, lines 21-23, page 9, lines 1,2,4-6) that an expandable implant is covered with a fabric using pores that have a size of at least 30 µm² and at most 750 µm² since it has values that can be considered to abut the claimed range and lie entirely within the boundaries. Thus, it would have been obvious to one of ordinary skill in the art to select pore size within a covering of at least 30 pm2 over an area of 100000 pm2 and also the pores are at most 750 um2 in size per consideration of the teaching of Amiridze on the stent device of Cox et al. as modified also with Holzer such that one can prevent clots or thrombus from passing through the covering when placed at an aneurysm, see Amiridze Fig. 5. It is noted Cox et al. did disclose balloon catheters are known (page 3, lines 9-15), however Cox was silent a balloon catheter was used for dilating the stenosis and for delivering the implant into the blood vessel. Holzer et al. teach (Fig. 8) a balloon catheter 802 to deliver a porous covering 104 to a vessel. Holzer et al. further teach (paragraph 146) a balloon catheter is used to deliver an implant having a mesh and covering to a vessel and dilate and deliver the implant. It would have been obvious to one of ordinary skill in the art to use a balloon catheter as taught by Holzer et al. with the implant of Cox et al. such that it provides the surgeon the ability to expand manually the section of placement in a vessel and be appropriately dilated or open to have the correct lumen dimension flow path. Regarding claim 23, Cox discloses values for the pores to be of a diameter at least 4 µm (above) and also pores can be at most 750 µm² falls within range (page 16, lines 13-28, pore size lower limit value 10 µm, which are
circular(round) and thus have an area of πr², which results in 78.54 µm² a value falling in the claimed range per the teaching of Amiridze. Regarding claims 26,27, Cox discloses (page 32, lines 6-8) the covering is securely connected to the mesh structure via mechanical means or chemical means and the mesh structure is sheathed with a bonding agent at least one of in parts or in sections, and wherein the bonding agent forms a mechanical interlock between the covering and the mesh structure. With respect to claim 28, Cox et al. disclose (page 21) the covering is produced from a plastic material. Regarding claim 29, Cox shows (Fig. 12) the covering formed from filaments oriented and disposed in a network-like manner. It is also noted that Cox et al. also disclose (page 18, lines 13-20) the filament thickness can be within a range of 50nm to 50,000 nm or alternatively 0.05 µm to 50 µm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cox such that the filament thickness is between 0.1 µm and 3 µm, since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Regarding claims 30,31 Cox discloses (page 19, lines 32-34) the covering has a biocompatible coating and it can contain heparin.
Claim(s) 17,19-23,26-31,33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2008/151204) in view of (DE 202014102615) and also Amiridze (WO 2010/014447). Cox et al. disclose (abstract) a medical system for the treatment of stenosis in intracranial blood vessels. Cox further discloses (page 6, lines 29,30) a compressible and self- expandable implant for covering the stenosis. Fig. 16 shows the implant 100 having a mesh structure at least a section of which is provided with a covering 108 produced from an electrospun fabric (page 32, lines 1-4,6) having pores of different sizes (Fig. 6,page 13, lines 32-34, page 14, lines 1-4). Fig. 6 shows the covering includes at least 10 pores 24 with a size of at least 15 µm² (claim 33) or 30 µm² (claims 17,36) over an area of 100000 µm² (page 16, lines 13-28, pore size lower limit 10 µm, which are circular(round) and thus have an area of πr², which is, respectively 78.54 µm², thus all pores defined as the micropores have a size value of at least 30 µm² over any area, which includes 100000 µm²) and thus illustrated pore arrangements are applicable for use with the mesh and covering shown in Fig. 6. MPEP 2131.03 states a range could be considered “anticipated” when a specific example in the prior art has the feature with the values within the claimed range. Thus, since Cox states (page 16, line 22) the micropores can be 10 microns which could reasonably interpreted to equate to provide at least 10 pores (see Fig. 6) within the claimed range of at least 30 µm2 to at most 750 µm2 there is thus an overlap of the claimed range since the claimed range is covered by the prior art range including the values. Amiridze teaches (page 8, lines 21-23, page 9, lines 1,2,4-6) that an expandable implant is covered with a fabric using pores that have a size of at least 30 µm² and at most 750 µm² since it has values that can be considered to abut the claimed range and lie entirely within the boundaries. Thus, it would have been obvious to one of ordinary skill in the art to select pore size within a covering of at either at least 15 µm2 or least 30 µm2 over an area of 100000 µm2 and also the pores are at most 750 µm2 in size per consideration of the teaching of Amiridze on the stent device of Cox et al. as modified also with Holzer such that one can prevent clots or thrombus from passing through the covering when placed at an aneurysm, see Amiridze Fig. 5. It is noted Cox et al. did disclose balloon catheters are known (page 3, lines 9- 15), however Cox was silent a balloon catheter was used for dilating the stenosis and for delivering the implant into the blood vessel. DE '615 teach (Fig. 4) a balloon catheter 12 to deliver a self-expanding device 21 to a vessel. DE '615 further teach (abstract) a balloon catheter is used to deliver an implant with two channels to provide the surgeon control of the balloon and self-expanding device individually. It would have been obvious to one of ordinary skill in the art to use a balloon catheter as taught by DE '615 with the implant of Cox et al. such that it provides the surgeon the ability to expand manually the section of placement in a vessel and be appropriately dilated or open to have the correct lumen dimension flow path. With respect to claims 19,34 Cox et al. did not disclose a catheter of which is a balloon catheter having at least two channels and a balloon, wherein an inflation channel of the at least two channels is in fluid communication with the balloon, and a delivery channel of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening and a distal outlet opening for deploying the implant. (DE 202014102615) teach (Figs. 2-5) a balloon catheter with at least two channels (10,11) and a balloon 12. DE '615 teach an inflation channel 10 of the at least two channels is in fluid communication with the balloon, and a delivery channel 11 of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening 13 and a distal outlet opening for deploying the implant. It would have been obvious to one of ordinary skill in the art to use a balloon catheter with at least two channels and a balloon, wherein an inflation channel of the at least two channels is in fluid communication with the balloon, and a delivery channel of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening and a distal outlet opening for deploying the implant as taught by DE 202014102615 in the stent delivery system of Cox et al. such that it can be easily controlled and provide a low profile system for protection of the vessel. Regarding claim 36, Cox discloses the claimed invention except for the specific balloon catheter. The same teachings explained above for claim 19 and motivation is used for the same obviousness rejection. Regarding claim 20, abstract of DE '615 can be understood to consider the self-expandable stent to be compressed if placed within the working channel and have it passed therethrough. With respect to claims 21,35 DE '615 teaches (page 2 of translation) the balloon catheter comprises three X-ray markers, wherein a first X-ray marker is disposed in a region of 3 the distal outlet opening of the delivery channel, a second X-ray marker is disposed in a region of a distal balloon end, and a third X-ray marker is disposed in a region of a proximal balloon end. Regarding claim 22, DE '615 teaches (page 2 of translation) the delivery channel has a friction-reducing inner coating for a translational movement of the implant in the delivery channel. Regarding claim 23, Cox discloses values for the pores to be of a diameter at least 4 µm (above) and also pores can be at most 750 µm² falls within range (page 16, lines 13-28, pore size lower limit value 10 µm, which are
circular(round) and thus have an area of πr², which results in 78.54 µm² a value falling in the claimed range per the teaching of Amiridze. Regarding claims 26,27, Cox discloses (page 32, lines 6-8) the covering is securely connected to the mesh structure via mechanical means or chemical means and the mesh structure is sheathed with a bonding agent at least one of in parts or in sections, and wherein the bonding agent forms a mechanical interlock between the covering and the mesh structure. With respect to claim 28, Cox et al. disclose (page 21) the covering is produced from a plastic material. Regarding claim 29, Cox shows (Fig. 12) the covering formed from filaments oriented and disposed in a network-like manner. It is also noted that Cox et al. also disclose (page 18, lines 13-20) the filament thickness can be within a range of 50nm to 50,000 nm or alternatively 0.05 µm to 50 µm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cox such that the filament thickness is between 0.1 µm and 3 µm, since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Regarding claims 30,31 Cox discloses (page 19, lines 32-34) the covering has a biocompatible coating and it can contain heparin.
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Cox et
al. (WO 2008/151204) in view of Holzer et al. (2018/0338847) and also Amiridze (WO 2010/014447) as applied to claim 31 above, and further in view of Dinh et al. (5554182). Cox et al. in view of Holzer et al. and also Amiridze is explained supra. However, Cox et al. as modified by Holzer et al. and also Amiridze did not explicitly disclose the heparin is one of covalently bonded to the fibrin or incorporated into the fibrin. Dinh et al. teach (col. 8, lines 30-37) a stent having a coating of heparin incorporated into fibrin. It would have been obvious to one of ordinary skill in the art to have the heparin incorporated in the fibrin coating as taught by Dinh et al. on the stent of Cox et al. as modified with Holzer and also Amiridze such that it provides a stable fibrin coating to assist with clotting control and stability, col. 2, lines 25-31 of Dinh.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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, Thomas Barrett can be reached at 571-272-4746. 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.
/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
Prosecution Insights