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 .
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.
(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.
Claim(s) 1-6, 8-13, 15-17, 21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowland et al (US 2015/0208929; hereafter referred to as RD). Mapping from claim 1, RD anticipates the claim language where:
The “anchoring system for a vascular implant” as claimed is the implant (100) of RD; see Figures 1 and 2;
The “implant having a distal end and a proximal end” as claimed is the implant body (101) with the distal end being either end and the proximal end being the other end and the central axis can be a transverse axis at the center of the implant;
The “anchoring system” as claimed is the anchors (102, 103);
The “distal anchor and a proximal anchor” as claimed are anchor (102) and anchor (103) or vice versa;
The “distal anchor is attached to the distal end of the implant and the proximal anchor is attached to the proximal end of the implant” can be seen by inspection of Figures 1 and 2;
The “distal anchor or said proximal anchor is formed from a flexible member configured to be placed into a retracted position for catheter delivery and placed in an expanded position for placement within a vessel” as claimed is met by the disclosures found in paragraphs 41, 27, 30, 44 and 46 of RD;
The “at least of said distal anchor and said proximal anchor is configured to position said implant against a vessel wall such that said at least one of said distal anchor and said proximal anchor includes self-adjusting properties” as claimed is disclosed as least in paragraphs 46 of RD because “self-adjusting properties” are described as maybe acting to prevent migration (see paragraph 44 of the present specification) as considered inherent to RD in that the anchors thereof also prevent migration (see paragraph 45 of RD), and
The “at least one of the distal anchor or the proximal anchor has formed therein a lobe structure arranged in a manner where a first loop is located on one side of a central loop and extends outwardly from and is attached to the implant and a second loop is located on another side of the central loop and extends away from and is attached to the implant, wherein the central loop extends upwardly from the implant and wherein the lobe structure is formed from a continuous wire” as claimed is met by the structures shown in Figure 2 as the annotated Figure 2 hereinbelow. With respect to the new amendments, the central loop and second loop extends outwardly from the implant in figure 2, where an upward extension is shown in figures 1, 4, and 22, as well as annotated figures 1 and 2 below, where the direction that part 102 extends within can be defined as “upward.”
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Regarding claim 2, the proximal end as claimed can be either end of RD.
Regarding claim 3, since the increased pressure is not compared to a known pressure, the claimed language is considered to be fully met; see paragraph 45 of RD. The mitigation of a movement here includes a mitigation of movement in a proximal direction.
Regarding claims 4 and 12, the Applicant is directed to see paragraphs 4 and 55 of RD.
Regarding claim 5, since the implant is anchored to the vessel was to prevent movement and migration, the claim language is considered to be fully met.
Regarding claim 6, the Applicant is directed to see paragraph 41 of RD.
Regarding claims 8 and 15, the Applicant is directed to see the annotated Figure 2 above and compare it to Figures 3A-3B of the present specification that is called clover-shaped in paragraph 36. Because of this broad meaning of clover-shaped implied by the specification, the Examiner asserts that the structures of RD’s anchors are clover-shaped.
Regarding claims 9, 13, and 16, since the radial force is based upon intended use and the anchor of RD is designed to prevent movement/migration, the anchors of RD are considered to prevent rotation to the extent that this language can be given patentable weight; see paragraph 45 of RD.
Regarding claim 10, the Applicant is directed to see annotated Figures 1 andR 2 above.
Regarding claim 11, the Applicant is directed to see the mapping done with respect to claim 1 supra that matches the recitations of the present claim.
Regarding claim 12, the Applicant is directed to see paragraphs 19, 40, and 55 of RD.
Regarding claim 17, since upwardly is a term based upon intended use and orientation, the claim language is considered fully met by RD.
Regarding claim 21 RD anticipates the claim language where
The “anchoring system for a vascular implant” as claimed is the implant (100) of RD; see Figures 1 and 2;
The “implant having a distal end and a proximal end” as claimed is the implant body (101) with the distal end being either end and the proximal end being the other end and the central axis can be a transverse axis at the center of the implant;
The “anchoring system” as claimed is the anchors (102, 103);
The “distal anchor and a proximal anchor” as claimed are anchor (102) and anchor (103) or vice versa;
The “distal anchor is attached to the distal end of the implant and the proximal anchor is attached to the proximal end of the implant” can be seen by inspection of Figures 1 and 2;
The “distal anchor or said proximal anchor is formed from a flexible member configured to be placed into a retracted position for catheter delivery and placed in an expanded position for placement within a vessel” as claimed is met by the disclosures found in paragraphs 41, 27, 30, 44 and 46 of RD;
The “at least of said distal anchor and said proximal anchor is configured to position said implant against a vessel wall such that said at least one of said distal anchor and said proximal anchor includes self-adjusting properties” as claimed is disclosed as least in paragraphs 46 of RD because “self-adjusting properties” are described as maybe acting to prevent migration (see paragraph 44 of the present specification) as considered inherent to RD in that the anchors thereof also prevent migration (see paragraph 45 of RD),
The “and wherein at least one of the distal anchor or the proximal anchor has formed therein a three lobe structure comprising a first loop, a central loop and a second loop, wherein the first loop is located on one side of the central loop and extends outwardly from and is attached to the implant and a second loop is located on another side of the central loop and extends outwardly from and is attached to the implant, wherein the central loop extends upwardly from the implant and wherein the three lobe structure is formed from a continuous wire” as claimed is met by the structures shown in Figures 1-22 as the annotated Figures 1 and 2 shown above. The central loop and second loop extends outwardly from the implant in figure 2, where an upward extension is shown in figures 1, 4, and 22, as well as annotated figures 1 and 2 above, where the direction that part 102 extends within can be defined as “upward.” Also shown in said above annotated figures 1 and 2 are the location of the central loop with respect to a first and second loop.
Regarding claim 23, since the increased force is not compared to a known force, the claimed language is considered to be fully met; see paragraph 45 of RD. The mitigation of a movement here includes a mitigation of movement in a proximal direction after deployment into a vessel.
Claim(s) 1-6, 9-13, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et al (US 8,021,307; hereafter referred to as White). Mapping from claim 1, White anticipates the claim language where:
The “anchoring system for a vascular implant” as claimed is the implant assembly (76); see Figure 19 of White;
The “implant having a distal end and a proximal end” as claimed is the device (78) with the distal end being either end and the proximal end being the other end of the main broadest section;
The “anchoring system” as claimed is the petal wire structure (80);
The “distal anchor and a proximal anchor” as claimed are anchor (80) and other anchor (80) or vice versa;
The “distal anchor is attached to the distal end of the implant and the proximal anchor is attached to the proximal end of the implant” can be seen by inspection of Figure 19;
The “distal anchor or said proximal anchor is formed from a flexible member configured to be placed into a retracted position for catheter delivery and placed in an expanded position for placement within a vessel” as claimed is met by the disclosures on column 5, lines 18-29 and column 2, lines 35-37;
The “at least of said distal anchor or said proximal anchor is configured to position said implant against a vessel wall such that said at least one of said distal anchor or said proximal anchor includes self-adjusting properties” as claimed is disclosed as least on column 5, lines 18-29 of White because “self-adjusting properties” are described as maybe acting to prevent migration (see paragraph 44 of the present specification) as considered inherent to White in that the anchors thereof also prevent migration (see column 1, lines 32-46) by their nature as acting as anchors, and
The “at least one of the distal anchor or the proximal anchor has formed therein a lobe structure arranged in a manner where a first loop is located on one side of a central loop and extends outwardly from the implant and a second loop is located on another side of the central loop extends outwardly from and is attached to the implant, wherein the central loop extends upwardly from the implant and wherein the lobe structure is formed from a continuous wire” as claimed is met by the structures shown in Figure 19 as the annotated Figure 19 hereinbelow. With respect to the new amendments, the central loop and second loop extends outwardly from and is attached to the implant in annotated figure 19 below, where an upward extension is shown in said figure and in figures 6-8, where the direction that part 80 extends within can be defined as “upward.”
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Regarding claim 2, the Applicant is directed to see annotated Figure 19.
Regarding claim 3, the Applicant is directed to see column 8, lines 28-47. The mitigation of a movement here includes a mitigation of movement in a proximal direction.
Regarding claim 4, see column 8, line 58 to column 9, line 6 and column 2, lines 28-47.
Regarding claim 5, the anchors are designed to prevent all movement and the limitations of the claim are directed to an intended use; see column 8, lines 28-47.
Regarding claim 6, see column 5, lines 18-24.
Regarding claims 9 and 10, see annotated Figure 19.
Regarding claim 11, see the mapping done for claim 1 above.
Regarding claim 12, see column 3, lines 53-68.
Claim(s) 1-6, 8-13, 15-17, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Campbell et al (US 2017/0164845; hereafter referred to as CL). Mapping from claim 1, CL anticipates the claim language where:
The “anchoring system for a vascular implant” as claimed is the sensor assembly (10); see Figure 6B and paragraph 57 of CL;
The “implant having a distal end and a proximal end” as claimed is the sensor (12) with the distal end being either end and the proximal end being the other end;
The “anchoring system” as claimed is the fixation members (30a, 30b);
The “distal anchor and a proximal anchor” as claimed are anchor (30a) and other anchor (30b) or vice versa;
The “distal anchor is attached to the distal end of the implant and the proximal anchor is attached to the proximal end of the implant” can be seen by inspection of Figure 6B;
The “distal anchor or said proximal anchor is formed from a flexible member configured to be placed into a retracted position for catheter delivery and placed in an expanded position for placement within a vessel” as claimed is met by the disclosure in paragraph 10 of CL;
The “at least of said distal anchor and said proximal anchor is configured to position said implant against a vessel wall such that said at least one of said distal anchor and said proximal anchor includes self-adjusting properties” as claimed is disclosed as least by paragraph 10 of CL because “self-adjusting properties” are described as maybe acting to prevent migration (see paragraph 44 of the present specification) as considered inherent to CL in that the anchors thereof also prevent migration (see paragraph 74 of CL) by their nature as acting as anchors, and
The “at least one of the distal anchor or the proximal anchor has formed therein a lobe structure arranged in a manner where a first loop is located on one side of a central loop and extends outwardly from and is attached to the implant and a second loop is located on another side of the central loop and extends outwardly from the implant, wherein the central loop extends upwardly from the implant and wherein the lobe structure is formed from a continuous wire” as claimed is met by the structures shown in Figure 6B as the annotated Figure 6B hereinbelow. With respect to the new amendments, the central loop and second loop extends outwardly from and is attached to the implant in annotated figure 6B below, where an upward extension is shown in said figure and in figure 8 in the application, where the direction that parts 30a and 30b extend within can be defined as “upward.”
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Regarding claims 3 and 5, see paragraph 45 of CL.
Regarding claim 4, see paragraph 38 of CL.
Regarding claim 6, see paragraph 55 of CL.
Regarding claim 8, see annotated Figure 6B.
Regarding claim 12, see paragraph 38 of CL.
Regarding claim 21 CL anticipates the claim language where
The “anchoring system for a vascular implant” as claimed is the sensor assembly (10); see Figure 6B and paragraph 57 of CL;
The “implant having a distal end and a proximal end” as claimed is the sensor (12) with the distal end being either end and the proximal end being the other end;
The “anchoring system” as claimed is the fixation members (30a, 30b);
The “distal anchor and a proximal anchor” as claimed are anchor (30a) and other anchor (30b) or vice versa;
The “distal anchor is attached to the distal end of the implant and the proximal anchor is attached to the proximal end of the implant” can be seen by inspection of Figure 6B;
The “distal anchor or said proximal anchor is formed from a flexible member configured to be placed into a retracted position for catheter delivery and placed in an expanded position for placement within a vessel” as claimed is met by the disclosure in paragraph 10 of CL;
The “at least of said distal anchor and said proximal anchor is configured to position said implant against a vessel wall such that said at least one of said distal anchor and said proximal anchor includes self-adjusting properties” as claimed is disclosed as least by paragraph 10 of CL because “self-adjusting properties” are described as maybe acting to prevent migration (see paragraph 44 of the present specification) as considered inherent to CL in that the anchors thereof also prevent migration (see paragraph 74 of CL) by their nature as acting as anchors, and
The “and wherein at least one of the distal anchor or the proximal anchor has formed therein a three lobe structure comprising a first loop, a central loop and a second loop, wherein the first loop is located on one side of the central loop and extends outwardly from and is attached to the implant and a second loop is located on another side of the central loop and extends outwardly from and is attached to the implant, wherein the central loop extends upwardly from the implant and wherein the three lobe structure is formed from a continuous wire” as claimed is met by the structures shown in Figure 6B as the annotated Figure 6B above. With respect to the new amendments, the central loop and second loop extends outwardly from and is attached to the implant in annotated figure 6B below, where an upward extension is shown in said figure and in figure 8 in the application, where the direction that parts 30a and 30b extend within can be defined as “upward.”
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) 7, 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over CL alone. CL meets the claim language as explained in the Section 102 rejection utilizing CL but fails to disclose the overall lengths of the central loop(s) as compared to the other loops as claimed. However, since the central loop is clearly longer, the mere relative proportions or sizes are not considered to be unobvious in that the device would not function any different due to the different proportions/sizes. In other words, there is no evidence that an over length of the broad range of “over 200 percent the length of the first and second loops” would result in a patentably different property or function. MPEP 2133.04(IV)(A) is incorporated herein as follows:
A. Changes in Size/Proportion (MPEP 2144.04 IV. A.)
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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.
Response to Arguments
Applicant's arguments filed January 9th, 2025 have been fully considered but they are not persuasive.
With respect to the prior arts not teaching loops, Examiner argues that, Rowland and White teach lobes that are equivalent to loops as per the understood definition that a loop is a curving or doubling of a line so as to form a closed or partially open curve. While the initial figure cited in Rowland did not appear to teach three distinct loops, figure 1 of Rowland (that is annotated above) does show three distinct looping members. With respect to White, examiner states that, as the defined central lobe (now central loop) is between a first loop and a second loop, White will still read upon the definition for a central loop as no further geometry is explicitly claimed in the independent claims that will limit the exact placement of a defined central loop. As the central loop is between a first and second loop in White, the central loop is in a central position with respect to both other loops. Additionally, independent claim 1 only claims a placement in a vessel, White will still read upon the placement limitations in the presented claims. With respect to the arguments against Campbell, applicant argues that the first and second loops are not disclosed as being attached to the implant. Examiner disagrees. While a direct attachment is not present, examiner argues that all three loops are connected to part 34 as, should part 34 move, all three loops will also move. As the lobe structure is formed from a continuous wire, as required in claim 1, a connection of the three loops is present such that the loops will be connected to the central implant portion through the other loop members, even if the loop members are not directly touching the implant portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Alexander (US Pub No.: 2009/0248028) considered for an anchoring system with two looping members 804a and 804b. Schwartz (US Patent No.: 6,783,499) discloses an anchoring system in the abstract with looping members depicted in figure 12A.
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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/AREN PATEL/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774