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 .
Response to Arguments
Applicant’s arguments, see page 6, filed 02/05/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 6, filed 02/05/2026, with respect to the USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity within the claims. The 112b claim rejections have been withdrawn.
Applicant’s arguments, see pages 6-7, filed 02/05/2026, with respect to the rejection(s) of claim(s) 1 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Lorenzo et al (US 20160317158 A1), herein referenced to as “Lorenzo” have been fully considered and are persuasive.
The applicant argues that Lorenzo does not explicitly disclose the claimed limitations of claims 1 and 8, specifically the limitation “the ratio of the second bending stiffness to the first bending stiffness is within the range of 0.6 to 0.8, inclusive”. Specifically, they argue that the ratio is applied incorrectly and the result is 1.5 instead of between 0.6 to 0.8. The examiner agrees.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 as being unpatentable over Lorenzo.
Applicant's arguments, see pages 7-8, filed 02/05/2026 have been fully considered but they are not persuasive. The applicant argues that one of ordinary skill in the art would not be motivated to modify Lorenzo to teach the ratio of the second bending stiffness to the first bending stiffness is within the range of 0.6 to 0.8, inclusive, because Lorenzo appears to teach away from the claimed range since Lorenzo only describes a device in which the bending stiffness of the distal section is stiffer than the bending stiffness of the proximal section.
The examiner respectfully disagrees, as claim 23 of Lorenzo states that “wherein the stiffness of the distal section is softer than the proximal part”, hence Lorenzo does not teach away from the recited claim language.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-14 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo et al (US 20160317158 A1), herein referenced to as “Lorenzo”.
Claim 1
Lorenzo discloses: A medical device 100 (see Figs. 1-2 and 8-13c, [0036]) comprising: an elongate main portion 300 (see Figs. 1-2 and 8-13c, [0038]) having a proximal end proximal end 308 (see Figs. 12A-12B, [0049]) and a distal end distal end 308 (see Figs. 12A-12B, [0049]), the main portion 300 having a first bending stiffness second stiffness (see [0011], which is the stiffness of the proximal portion of the device which includes 300, see [0041]), the main portion 300 having plurality of openings 304 + 306 (see Figs. 2 and 10, [0045]-[0046]) along a length the length of 300 (see Fig. 10) of the main portion 300; an atraumatic distal segment 204 (see Figs. 1-2 and 11-13C, [0039]-[0040]) coupled to, and extending distally from (see Figs. 12A-12B), the distal end distal end 308 of the main portion 300, the distal segment 204 having a second bending stiffness first bending stiffness (see [0011] and [0041]), the atraumatic distal segment 204 having a distal tip 106 (see Fig. 2, [0038]); and wherein the plurality of openings 304 + 306 of the main portion 300 are large enough to allow the distal tip 30 to enter the openings 304 + 306 (see [0046], 200 is able to pass through 306) and engage the main portion 300 and the ratio of the second bending stiffness first bending stiffness to the first bending stiffness second bending stiffness is less than 1 (see claim 23, wherein the stiffness of the distal section is softer than the proximal part).
Lorenzo does not explicitly teach: the ratio is within the range of 0.6 to 0.8, inclusive.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo to have the ratio is within the range of 0.6 to 0.8, inclusive since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo would not operate differently with the ratio is within the range of 0.6 to 0.8, inclusive. Further, applicant places no criticality on the range claimed, see [0015] of applicant’s patent application publication, which also includes the range 0.5 to 1.0 which is larger than 0.6 to 0.8, hence has acceptable values not included in 0.6 to 0.8, hence 0.6 to 0.8 is not critical.
Claim 2
Lorenzo teaches: The medical device of claim 1, see 103 rejection above. Lorenzo further discloses: wherein: the plurality of openings 304 + 306 extends along at least 50% of the length (see Fig. 10, the plurality of openings extend 100% of the length of the main portion, hence at least 50%) of the main portion 300.
Claim 3
Lorenzo discloses: The medical device of claim 1, see 102 rejection above. Lorenzo does not explicitly teach discloses: wherein the ratio of the second bending stiffness to the first bending stiffness is within the range of 0.65 to 0.75, inclusive.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo to have the ratio of the second bending stiffness to the first bending stiffness is within the range of 0.65 to 0.75, inclusive, inclusive since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo would not operate differently with the ratio of the second bending stiffness to the first bending stiffness is within the range of 0.65 to 0.75, inclusive. Further, applicant places no criticality on the range claimed, see [0015] of applicant’s patent application publication, which also includes the range 0.5 to 1.0 which is larger than 0.65 to 0.75, hence has acceptable values not included in 0.65 to 0.75, hence 0.65 to 0.75 is not critical.
Claim 4
Lorenzo teaches: The medical device of claim 1, see 103 rejection above. Lorenzo further discloses: wherein the elongate main portion 300 comprises one of a braid (see [0063], the mesh is described as a “braided end” hence a braid), a mesh (see [0038], 300 is a mesh), and a tube having a plurality of apertures (see [0044], the mesh is a tube, hence a tube with a plurality of apertures).
Claim 5
Lorenzo teaches: The medical device of claim 1, see 103 rejection above. Lorenzo further discloses: wherein the distal segment 204 is one of a coil (see [0039], standard embolic coil), a helical coil (see [0039], a standard embolic coil is a helical coil), a tube (see Figs. 1-2, [0039], the coil forms a tube-like shape), a braid (will not be examined here due to being an optional claim limitation in the alternative) and a flexible rod (see [0039], a standard embolic coil is a flexible rod).
Claim 6
Lorenzo teaches: The medical device of claim 1, see 103 rejection above. Lorenzo further discloses: further comprising: an atraumatic proximal portion 202 (see Figs. 7 and 12A-12B, [0039], 202 is coupled to extends proximally from a proximal 308) coupled to, and extending proximally from, the proximal end proximal 308 of the braided portion 300.
Claim 7
Lorenzo teaches: The medical device of claim 1, see 103 rejection above. Lorenzo further discloses: wherein the medical device 100 is a vaso-occlusive device (see [0036], vascular occlusion device).
Claim 8
Lorenzo discloses: A vaso-occlusive device 100 (see Figs. 1-2 and 8-13c, [0036]), comprising: an elongate braided portion 300 (see Figs. 1-2 and 8-13c, [0038], see [0063], the mesh is described as a “braided end” hence a braid) comprising a plurality of elongate strands braided together (see [0063], a braided mesh, is formed by braided together elongate strands), the braided portion 300 having a proximal end proximal end 308 (see Figs. 12A-12B, [0049]) and a distal end distal end 308 (see Figs. 12A-12B, [0049]), the braided portion 300 having a first bending stiffness second stiffness (see [0011], which is the stiffness of the proximal portion of the device which includes 300, see [0041]), the braided portion 300 having a plurality of openings 304 + 306 (see Figs. 2 and 10, [0045]-[0046]) along a length the length of 300 (see Fig. 10) of the braided portion 300; a distal coil segment 204 (see Figs. 1-2 and 11-13C, [0039]-[0040]) coupled to, and extending distally from (see Figs. 12A-12B), the distal end distal end 308 of the braided portion 300, the distal coil segment 204 having a second bending stiffness first bending stiffness (see [0011] and [0041]), the atraumatic coil segment 204 having a distal tip 106 (see Fig. 2, [0038]); and wherein the openings 304 + 306 of the braided portion 300 are large enough to allow the distal tip 106 to enter the opening 304 + 306 (see [0046], 200 is able to pass through 306) and engage the main portion, and the ratio of the second bending stiffness first bending stiffness to the first bending stiffness second bending stiffness is less than 1 (see claim 23, wherein the stiffness of the distal section is softer than the proximal part).
Lorenzo does not explicitly teach: the ratio is within the range of 0.6 to 0.8, inclusive.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lorenzo to have the ratio is within the range of 0.6 to 0.8, inclusive since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lorenzo would not operate differently with the ratio is within the range of 0.6 to 0.8, inclusive. Further, applicant places no criticality on the range claimed, see [0015] of applicant’s patent application publication, which also includes the range 0.5 to 1.0 which is larger than 0.6 to 0.8, hence has acceptable values not included in 0.6 to 0.8, hence 0.6 to 0.8 is not critical.
Claim 9
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: wherein: the plurality of openings 304 + 306 extends along at least 50% of the length (see Fig. 10, the plurality of openings extend 100% of the length of the main portion, hence at least 50%) of the main portion 300.
Claim 10
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: further comprising: a proximal coil segment 202 (see Figs. 7 and 12A-12B, [0039], 202 is coupled to extends proximally from a proximal 308) coupled to, and extending proximally from, the proximal end proximal 308 of the braided portion 300.
Claim 11
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: wherein the braided portion 300 has a delivery configuration (see [0043], collapsed state) when restrained within a delivery catheter 10 (see Figs. 1-2, [0043]) and a deployed configuration (see Figs. 12A-12B, [0042], deployed state of 300) when released from a delivery catheter 10.
Claim 12
Lorenzo teaches: The vaso-occlusive device of claim 11, see 103 rejection above. Lorenzo further discloses: wherein the delivery configuration (see Figs. 1-2) is a substantially linear shape (see Figs. 1-2, [0036] and [0043], axially stretched/compressed), and the deployed configuration is a three-dimensional shape (see Fig. 20A-1) having a cross-sectional dimension of at least three times the cross-sectional dimension of the delivery configuration (see [0007] and Fig. 1A, the inner diameter of 10, the microcatheter, is 0.010 inches or 0.254 mm, and the mesh, 300, is compressed within 10, and when expanded as seen in Fig. 20A, is 2mm diameter, which is more than three times the cross-sectional dimension when compressed).
Claim 13
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: wherein the braided portion 300 is formed of a shape memory material (see [0044], nitinol, which is a shape memory material as known in the art).
Claim 14
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: wherein the braided portion 300 is formed of one of platinum (see [0044], platinum), a platinum alloy (will not be examined here due to being an optional claim limitation in the alternative), and a platinum-tungsten alloy (will not be examined here due to being an optional claim limitation in the alternative).
Claim 16
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo further discloses: wherein the braided portion 300 is formed of one of a platinum-gold alloy (will not be examined here due to being an optional claim limitation in the alternative), and nitinol (see [0044], nitinol).
Claim 17
Lorenzo teaches: A method of using the vaso-occlusive device of claim 8, see 103 rejection above, comprising: advancing a delivery catheter 10 (see Figs. 1-2, [0036]-[0037]) within a patient’s vascular system (see [0037], catheter is placed near the aneurysm and 100 is pushed out of the catheter into the aneurysm) to a target anatomical cavity aneurysm (see [0037]); inserting the vaso-occlusive device 100 into a proximal end 14 (see Fig. 1, [0037]) of the delivery catheter 10 and advancing the vaso-occlusive device 100 within the delivery catheter 10 to the target anatomical cavity (see [0036]-[0037], catheter is placed near the aneurysm and 100 is pushed out of the catheter into the aneurysm); and advancing (see [0037], pushed out) the vaso-occlusive device 100 out of the delivery catheter 10 and into the anatomical cavity aneurysm.
Claim 18
Lorenzo discloses: The method of claim 17, see 103 rejection above. Lorenzo further discloses: wherein the vaso-occlusive device 100 is advanced in the delivery catheter 10 in a restrained, delivery configuration (see [0043], collapsed state), and the vaso-occlusive device 100 expands into a deployed configuration (see Figs. 12A-12B, [0042], deployed state of 300, see also Fig. 20A) different from the delivery configuration (see [0043], collapsed state) upon being advanced into the anatomical cavity aneurysm.
Claim 19
Lorenzo teaches: A vaso-occlusive assembly 100 + 10 + 20 (see Fig. 1, [0037]), comprising: the vaso-occlusive device of claim 1, see 103 rejection above; and a pusher member 20 (see Fig. 1, [0037]) detachably coupled to the vaso-occlusive device 100 (see [0037], pushed out/deploy); and a detachment device known mechanisms to release the vascular occlusion device (see [0037]) detachably coupling the pusher member 20 to the vaso-occlusive device 100, wherein the detachment device known mechanisms to release the vascular occlusion device comprises one of electrolytic (see [0037], electrical), mechanical connector (see [0037], mechanical), heating (see [0037], thermal mechanism) and dissolving (will not be examined here due to being an optional claim limitation in the alternative).
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo in view of Hebert et al (US 20200138422 A1), herein referenced to as “Hebert”.
Claim 15
Lorenzo teaches: The vaso-occlusive device of claim 8, see 103 rejection above. Lorenzo does not explicitly disclose: wherein the braided portion is formed of one of gold, and a gold alloy.
However, Hebert in a similar field of invention teaches a vaso-occlusive device 630 (see Fig. 32) with a braided portion 632 + 634 (see Fig. 32) and a distal coil segment 637 (see Fig. 32). Hebert further teaches: wherein the braided portion 632 + 634 is formed of one of gold (see [0139], the tubular body 12, which 632 equates to, is made of gold), and a gold alloy (see [0139], gold alloy, such as platinum-gold).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Hebert and have an braided portion of a vaso-occlusive device with gold or gold alloy. This is due to gold and gold alloy (see [0139]) for braided portions of a vaso-occlusive device is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 20
Lorenzo teaches: A method (see [0036]-[0037]) of using the vaso-occlusive assembly of claim 19, see 103 rejection above, comprising: inserting the vaso-occlusive assembly 100 + 20 into the delivery catheter 10 (see Fig. 1) and advancing the vaso-occlusive device 100 within the delivery catheter 10 to the target anatomical cavity (see [0036]-[0037], catheter is placed near the aneurysm and 100 is pushed out of the catheter into the aneurysm); and advancing (see [0037], pushed out) the vaso-occlusive device 100 out of the delivery catheter 10 and into the anatomical cavity aneurysm.
Lorenzo does not explicitly disclose: advancing a guidewire into a patient’s vasculature system to a target anatomical cavity and; advancing a delivery catheter over the guidewire to the target anatomical cavity.
However, Hebert in a similar field of invention teaches a vaso-occlusive device 630 (see Fig. 32) with a braided portion 632 + 634 (see Fig. 32) and a distal coil segment 637 (see Fig. 32) and a delivery catheter 80 (see [0232]). Hebert further teaches: advancing a guidewire guide wire/delivery wire (see [0232]) into a patient’s vasculature system to a target anatomical cavity (see [0232], aneurysm is accessed by the wire) and; advancing a delivery catheter 80 over the guidewire to the target anatomical cavity (see [0232], the RX catheter, 80, is inserted over the guide wire after the aneurysm is accessed by the wire).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of Hebert and teach a method of using the vaso-occlusive assembly with advancing a guidewire into a patient’s vasculature system to a target anatomical cavity and; advancing a delivery catheter over the guidewire to the target anatomical cavity. Motivation for such can be found in Hebert, as the delivery wire can serve to control micrograft linear movement relative to the wire (see [0149]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771