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 Amendment
Claims 10-20 were previously withdrawn. Claims 1-9 are now pending examination.
Response to Arguments
Applicant's arguments filed 10/25/2025 have been fully considered but they are not persuasive.
Regarding the rejection of claim 1 over Montgomery in view of Golden, Applicant argues Montgomery teaches a catheter coupled filter control system while Golden teaches anchors designed for autonomous vessel wall engagement and modifying the system of Montgomery with the system of Golden would be incompatible and counterproductive (Remarks Page 2). Examiner respectfully disagrees. Golden teaches “barbs 26 can be formed from a biodegradable material to facilitate removal and retrievability. That is, after a predetermined time period, the barbs 26 (or 26′) are resorbed thereby allowing the filter to be retrieved with minimal trauma or injury to the native vessel in which the filter is implanted in.” (Paragraph 0035). Thus, the barbs of Golden are not designed to be long lasting and are still capable of allowing the filter to be removed.
Applicant argues that Montgomery’s retrieval requires maintained catheter coupling and precise manipulation. There is no teaching or suggestion in Montgomery stating that added barbs would not allow for the filter to be removed, especially if the barbs have been resorbed.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, the combination of the filter of Montgomery with the barbs of Golden would allow Montgomery’s filter to adhere to the tissue better and prevent premature movement or migration of the filter while the filter is in place. Once the filter is ready to be retrieved, the filter can simply be removed along with the anchors, or the barbs would have been resorbed and would no longer serve as a hinderance to the movement of the filter. The addition of the barbs while the filter of Montgomery is in place would serve to prevent migration of the filter from the tissue and improve adherence compared to the system of Montgomery on its own, thus would be an obvious modification to one of ordinary skill in the art.
Further, claim 1 is additionally rejected over Montgomery in view of Hartley. In response to applicant's argument that Montgomery and Hartley are directed to different approaches. In response to applicant's argument that Montgomery and Hartley are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Montgomery and Hartley are directed to filter devices. As the method of use is not claimed, there is no reason why the methods of use of the devices needs to be the same in order to combine the references. There is no teaching or suggestion in Montgomery stating that added barbs would not allow for the filter to be removed. The anchors of Hartley would be attached to the filter of Montgomery to improve adherence to the tissue while the filter is within the patient and can be removed along with the filter when desired. The addition of the barbs while the filter of Montgomery is in place would serve to prevent migration of the filter from the tissue and improve adherence compared to the system of Montgomery on its own, thus would be an obvious modification to one of ordinary skill in the art.
Thus, the rejections to the claims under U.S.C. 103 is maintained.
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) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery et al. (US 20220296354 A1) (previously of record) in view of Golden (US 20150366648 A1) (previously of record).
Regarding claim 1, 4 and 5, Montgomery discloses an embolic protection device comprising:
a delivery catheter (1300) having a lumen (1306) extending therethrough (Figure 1A-B; Paragraph 0072);
a core wire (1100) slidably disposed within the lumen of the delivery catheter (Paragraph 0045), the core wire having a distal end region (1102) (Figure 1A-B; Paragraph 0046);
an expandable support frame (1212) including a cylindrical distal region (1202) and a conical proximal region (1204+1206) (Figure 1A-B; Paragraph 0050), the conical proximal region coupled to the distal end region of the core wire (Figure 1A; Paragraph 0052); and
a membrane (1210) disposed over the expandable support frame (Figure 1A-B; Paragraph 0051), the membrane comprising a material configured to allow blood flow therethrough while blocking a passage of embolic debris (Paragraph 0058).
Montgomery fails to explicitly disclose a plurality of anchors coupled to the expandable support frame; wherein the expandable support frame includes a plurality of struts, wherein the plurality of anchors is cut from the plurality of struts; wherein the plurality of anchors is configured to extend radially away from the plurality of struts when the delivery catheter is withdrawn from the expandable support frame, and to be pushed back against the plurality of struts when the delivery catheter is moved distally to recapture and re-constrain the expandable support frame.
However, Golden is directed to a filtration device and teaches a plurality of anchors (26) coupled to the expandable support frame (10) (Figure 1; Paragraph 0035); wherein the expandable support frame includes a plurality of struts (12), wherein the plurality of anchors is cut from the plurality of struts (Figure 5-6; Paragraph 0034-36); wherein the plurality of anchors is configured to extend radially away from the plurality of struts when the delivery catheter is withdrawn from the expandable support frame, and to be pushed back against the plurality of struts when the delivery catheter is moved distally to recapture and re-constrain the expandable support frame (Figure 6; Paragraph 0034-35).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Montgomery with the teachings of Golden by incorporating a plurality of anchors coupled to the expandable support frame; wherein the expandable support frame includes a plurality of struts, wherein the plurality of anchors is cut from the plurality of struts; wherein the plurality of anchors is configured to extend radially away from the plurality of struts when the delivery catheter is withdrawn from the expandable support frame, and to be pushed back against the plurality of struts when the delivery catheter is moved distally to recapture and re-constrain the expandable support frame in order to secure the device into tissue and prevent migration while in use. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Montgomery to include a plurality of anchors coupled to the expandable support frame; wherein the expandable support frame includes a plurality of struts, wherein the plurality of anchors is cut from the plurality of struts; wherein the plurality of anchors is configured to extend radially away from the plurality of struts when the delivery catheter is withdrawn from the expandable support frame, and to be pushed back against the plurality of struts when the delivery catheter is moved distally to recapture and re-constrain the expandable support frame, as taught by Golden, as both references and the claimed invention are directed to filtration devices.
Regarding claim 2, Montgomery further discloses wherein the cylindrical distal region defines a distal terminal end of the expandable support frame, wherein the distal terminal end has a diameter substantially the same as a diameter of the cylindrical distal region (Figure 1A-B; Paragraph 0051).
Regarding claim 3, Montgomery further discloses wherein the expandable support frame is self-expanding (Paragraph 0051).
Regarding claim 8, Montgomery discloses the embolic protection device of claim 1 but fails to explicitly disclose wherein a length of the cylindrical distal region is greater than a length of the conical proximal region.
There are three choices available to a person of ordinary skill in the art for the length of the cylindrical region in relation to the conical region: either the length of the cylindrical region can be greater than the length of the conical region, the length of the cylindrical region can be equal to the length of the conical region, or the length of the cylindrical region can be less than the length of the conical region. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Claim(s) 1-3, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Hartley et al. (US 20040176832 A1) (previously of record).
Regarding claim 1 and 6, Montgomery discloses an embolic protection device comprising:
a delivery catheter (1300) having a lumen (1306) extending therethrough (Figure 1A-B; Paragraph 0072);
a core wire (1100) slidably disposed within the lumen of the delivery catheter (Paragraph 0045), the core wire having a distal end region (1102) (Figure 1A-B; Paragraph 0046);
an expandable support frame (1212) including a cylindrical distal region (1202) and a conical proximal region (1204+1206) (Figure 1A-B; Paragraph 0050), the conical proximal region coupled to the distal end region of the core wire (Figure 1A; Paragraph 0052); and
a membrane (1210) disposed over the expandable support frame (Figure 1A-B; Paragraph 0051), the membrane comprising a material configured to allow blood flow therethrough while blocking a passage of embolic debris (Paragraph 0058).
Montgomery fails to explicitly disclose a plurality of anchors coupled to the expandable support frame, wherein at least some of the plurality of anchors project through the membrane.
However, Hartley is directed to an implantable vascular device and teaches a plurality of anchors (30) coupled to the expandable support frame (25) (Figure 5-7; Paragraph 0048), wherein at least some of the plurality of anchors project through the membrane (36) (Figure 5-7; Paragraph 0049).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Montgomery such that a plurality of anchors coupled to the expandable support frame, wherein at least some of the plurality of anchors project through the membrane, as taught by Hartley, as both references and the claimed invention are directed to vascular devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Montgomery with the teachings of Hartley by incorporating a plurality of anchors coupled to the expandable support frame, wherein at least some of the plurality of anchors project through the membrane in order to secure the device into tissue and prevent migration while in use.
Regarding claim 2, Montgomery further discloses wherein the cylindrical distal region defines a distal terminal end of the expandable support frame, wherein the distal terminal end has a diameter substantially the same as a diameter of the cylindrical distal region (Figure 1A-B; Paragraph 0051).
Regarding claim 3, Montgomery further discloses wherein the expandable support frame is self-expanding (Paragraph 0051).
Regarding claim 8, Montgomery discloses the embolic protection device of claim 1 but fails to explicitly disclose wherein a length of the cylindrical distal region is greater than a length of the conical proximal region.
There are three choices available to a person of ordinary skill in the art for the length of the cylindrical region in relation to the conical region: either the length of the cylindrical region can be greater than the length of the conical region, the length of the cylindrical region can be equal to the length of the conical region, or the length of the cylindrical region can be less than the length of the conical region. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Golden and further in view of Pah (US 20100305604 A1) (previously of record).
Regarding claim 7, Montgomery as modified by Golden teaches the embolic protection device of claim 1, but fails to explicitly disclose wherein when expanded, the expandable support frame has an outer diameter of between 20 mm and 50 mm.
However, Pah is directed to a blood filter and teaches wherein when expanded, the expandable support frame (filter 2) has an outer diameter of between 30 mm and 60 mm, which encompasses the claimed range of 20 mm and 50 mm (Paragraph 0036; 0083).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameter of the expandable support frame of Montgomery such that when expanded, the expandable support frame has an outer diameter of between 20 mm and 50 mm as taught by Pah, since it has been held change in size/proportion does not distinguish over the prior art and Montgomery is silent to specific dimensions of the expandable support frame. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Regarding claim 9, Montgomery as modified by Golden teaches the embolic protection device of claim 8, but fails to explicitly disclose wherein a total length of the expandable support frame is between 25 mm and 100 mm.
However, Pah teaches wherein a total length of the expandable support frame (filter 2) is between around 50 mm to 160 mm, which encompasses the claimed range of 25 mm and 100 mm (Paragraph 0083).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameter of the expandable support frame of Montgomery a total length of the expandable support frame is between 25 mm and 100 mm as taught by Pah, since it has been held change in size/proportion does not distinguish over the prior art and Montgomery is silent to specific dimensions of the expandable support frame. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771