DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 21 is objected to because of the following informalities:
line 2 should be amended to -a proximal and distal end, the [[catheter]] device comprising-.
Line 19 should be amended to -a length of each driving section of the driving sections, the slot configured-. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: lines 8-9 should be amended to – each anchor including a helical anchor body defining anchor body-. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
Cooperating features (claims 37 and 50)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Features (Cooperating features - claims 37 and 50)
coupled with functional language
that prevent pure translation of the anchors within the driver passageway while allowing helical movement of the anchors within the driver passageway(Cooperating features - claims 37 and 50)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 37 and 50 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
protrusion (¶00212) (Cooperating features - claim 37)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 42:
The limitation “comprise a slot in one of the inner and outer drivers” (emphasis added by the examiner) in line 2 is new matter. There is nothing in the original disclosure that indicates that the slot is in the inner driver. This is not shown in the figures or indicated in the specification (not in the original disclosure) and for this reason the claim amendment indicating the slot can be in the inner driver is new matter. For this reason, the claim limitation is rejected.
Claim 43 is rejected due to its dependence on claim 42.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-28 and 37-53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21:
The claim is unclear because of the limitation “the driving section” in line 22. The limitation is unclear because the driving section/sections has been introduced different way through the claim raising a question as to which on this refers to. For example, there are the respective driving sections of line 6 and each driving section of line 18. Its unclear which one this limitation refers to since it only refers to a single driving section. This is also the case for the same limitation in 21 as well.
Claims 22-28 are rejected due to their dependence on claim 21.
Regarding claim 27:
The limitation “the driving section” in line 2 is unclear. This limitation is unclear because its not clear if this refers to the “each driving section” in lines 1-2 of the “respective driving section” in claim 21 on which this claim depends. For the sake of examination, the office has assumed that this refers to the “each driving section” of claim 27.
Claims 28 is rejected due to its dependence on claim 27.
Regarding claim 37:
The claim limitation “a plurality of anchors” in line 5 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a plurality of anchors” in line 1 of this claim which raises a question of if two plurality of anchors are required by the claim or only one. For the sake of examination, the office has assumed that only one plurality of anchors is required by the claim.
Claims 38-49 are rejected due to their dependence on claim 37.
Regarding claim 49:
The claim recites the limitation "the anchor" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 50:
The claim limitation “a plurality of anchors” in line 8 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a plurality of anchors” in line 1 of this claim which raises a question of if two plurality of anchors are required by the claim or only one. For the sake of examination, the office has assumed that only one plurality of anchors is required by the claim.
Claims 51-53 are rejected due to their dependence on claim 50.
Claim Rejections - 35 USC § 102
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.
Claims 21, 25-28, 37-38, 44, 47-48, 50-51 and 53 rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120022557 A1 to Cabiri.
Cabiri discloses:
Regarding claim 21:
A device (figures 1a, 1b, 6a-6b, 9c-9d) for insertion into a lumen (see the lumen within 204 as shown in figures 9c/9d) of an elongated catheter (204) having a proximal and distal end (see the ends of the catheter as shown in figures 9c-9b), the catheter device comprising:
an elongate tubular outer driver (34) sized to fit into the catheter lumen;
an elongate inner driver (36), the inner and outer drivers (34/36) concentric relative to each other (as shown in figure 4c) and defining a driver passageway (see the passageway between 34 and 36) therebetween;
a plurality of anchors (32) positioned within the driver passageway (gap between 34 and 36) adjacent respective driving sections (62) within the driver passageway (gap between 34 and 36), each anchor including a helical anchor body (60) defining anchor body proximal and distal ends (see 106 and the opposite end of 60) and an anchor body passageway (see the gap between turns of 60) extending therethrough between the anchor body proximal and distal ends (see 106 and the opposite end of 60);
cooperating features (see the slot for receiving 106 in 62 which is consistent with the 35 USC 112(f) interpretation above) on both of the inner and outer drivers (34/36) within the driver passageway (gap between 34 and 36) and on the proximal end (106) of each of the anchors (32) that prevent pure translation of the anchors (32) within the driver passageway (gap between 34 and 36) while allowing helical movement (see the forward and rotation movement of the anchor as shown in figure 4b) of the anchors (32) within the driver passageway (gap between 34 and 36); and
an actuator (surgeon or tool the surgeon uses to rotate 36 as mentioned in ¶0168 that is further connected to the torque limiting element mentioned in ¶0169) operatively coupled to the inner and outer drivers (34/36) and operable for selectively rotating the inner and outer drivers (34/36) relative to each other to sequentially deliver each anchor (32) of the plurality of anchors (32) helically from the driver passageway (gap between 34 and 36) into biological tissue (90);
wherein the cooperating features comprise:
a slot (see the slot A in figure 1 below for receiving 106) extending along a length (as shown in figure 6B) of each driving section (62), the slot (A in figure 1 below) configured to direct a respective anchor (32) of the plurality of anchors (32) helically along the respective driving section (driven by the driving section 62); and
a torque section (102) connected to a proximal end of the driving section (at the proximal end of the driving section 62), the torque section (102) configured to transmit torque between the actuator (32) and the driving section (transmits a torque from 36/38 to 62).
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Figure 1 - figure 6b of Cabiri, annotated by the examiner
Regarding claim 25:
The device as defined in claim 21, each driving section (62) further comprising a plurality of first slits (see the slit B in figure 1 above) and a plurality of second slits (see the slit C in figure 1 above), wherein at least one of the plurality of first and plurality of second slits (B and C in figure 1 above) extend between at least a portion of a surface (extend between the opposite faces of 62 as shown in figure 1 above) of the respective driving section (62).
Regarding claim 26:
The device as defined in claim 25, wherein at least one of the plurality of first and plurality of second slits (B and C in figure 1 above) are circumferential (see the slits arranged around the inner circumference of 62).
Regarding claim 27:
The device as defined in claim 21, each driving section (62) further comprising at least one backbone region (see the region D in figure 1 above) extending along a length of the driving section (62).
Regarding claim 28:
The device as defined in claim 27, each driving section (62) further comprising at least one intermediate section (see the section E in figure 1 above extends between D and A when view from plane F in figure 1 above) extending between adjacent backbone regions or between one of the at least one backbone region (D in figure 1 above) and the slot (A in figure 1 above).
Regarding claim 37:
A device (figures 1a, 1b, 6a-6b, 9c-9d) for delivering a plurality of anchors (32) into tissue, comprising:
an elongate tubular outer driver (34);
an elongate inner driver (36), the inner and outer drivers (34/36) concentric relative to each other and defining a driver passageway (gap between 34 and 36) therebetween;
a plurality of anchors (32) positioned adjacent one another (see figure 4d) within the driver passageway (gap between 34 and 36), each anchor (32) including a helical anchor body (60) defining anchor body proximal and distal ends (see 106 and the opposite end of 60) and an anchor body passageway (see the gap between turns of 60) extending therethrough between the anchor body proximal and distal ends (see 106 and the opposite end of 60);
cooperating features (see the protrusions of 66 to engage the tool 38) on both of the inner and outer drivers (34/36) within the driver passageway (gap between 34 and 36) and on the proximal end (106) of each of the anchors (32) that prevent pure translation (causes a helical rotation with the translation as shown in figure 4b) of the anchors (32) within the driver passageway (gap between 34 and 36) while allowing helical movement (see the forward and rotation movement of the anchor as shown in figure 4b) of the anchors (32) within the driver passageway (gap between 34 and 36); and
an actuator (surgeon or tool the surgeon uses to rotate 36 as mentioned in ¶0168 that is further connected to the torque limiting element mentioned in ¶0169) operatively coupled (mounted to the inner and outer drivers to rotate the inner driver 36 which means the inner drive rotates relative to the outer driver) to the inner and outer drivers (34/36) and operable for selectively rotating the inner and outer drivers (34/36) relative to each other to sequentially deliver each anchor (as shown in figure 4b) of the plurality of anchors (32) helically from the driver passageway (gap between 34 and 36) into tissue (90).
Regarding claim 38:
The device of claim 37, wherein the inner and outer drivers (34/36) are axially rotatable relative to each other (inner driver 36 spins relative to the outer driver 36) and longitudinally fixed relative to each other (when inner driver 36 is not extended they are fixed relative to each other).
Regarding claim 44:
The device of claim 37, wherein the actuator (surgeon or tool the surgeon uses to rotate 36 as mentioned in ¶0168 that is further connected to the torque limiting element mentioned in ¶0169) is configured such that one or more additional anchors (32) proximal to a distal-most first anchor of the plurality of anchors (32) advances distally to a distally adjacent driving section (as shown in figure 2 below, the anchor 32 of H is driven toward the driving section 62 of anchor G as the further most/first anchor 32 is driven into the tissue 90) when the one of the inner and outer drivers (34/36) is rotated to advance the first anchor (as shown in figure 2 below) from the driver passageway (gap between 34 and 36).
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Figure 2- figures 4a and 4b of Cabiri, annotated by the examiner
Regarding claim 47:
The device of claim 37, wherein the inner and outer drivers (34/36) are flexible (as shown in figure 1a where the drivers bend).
Regarding claim 48:
The device of claim 47, wherein the outer driver comprises one or more backbone regions (40) comprising slits (see the slit surrounding 72) formed in driving sections (40) of the outer driver (36).
Regarding claim 50:
A system for delivering a plurality of anchors (32) into tissue, comprising:
a) an elongate catheter (204) comprising proximal and distal ends (see the ends of the catheter as shown in figures 9c-9d) and a lumen (see the lumen within 204 as shown in figures 9c/9d) extending therebetween, the catheter sized to fit within and move through a patient's vasculature (toward the heart as shown in figures 9c/9d); and
b) a driver (34/36) comprising a distal portion (as shown in figure 9G) received through the lumen (see the lumen within 204 as shown in figures 9c/9d) comprising:
an elongate tubular outer driver (34) sized to fit within the lumen of catheter;
an elongate inner driver (36), the inner and outer drivers (34/36) concentric relative to each other and defining a driver passageway (gap between 34 and 36) therebetween;
a plurality of anchors (32) positioned adjacent one another within the driver passageway (gap between 34 and 36), each anchor including a helical anchor body (60) defining anchor body proximal and distal ends (see 106 and the opposite end of 60) and an anchor body passageway (see the gap between turns of 60) extending therethrough between the anchor body proximal and distal ends (see 106 and the opposite end of 60); and
cooperating features (see the slot for receiving 106 in 62 which is consistent with the 35 USC 112(f) interpretation above) on both of the inner and outer drivers (34/36) within the driver passageway (gap between 34 and 36) and on the proximal end (106) of each of the anchors (32) that prevent pure translation of the anchors (32) within the driver passageway (gap between 34 and 36) while allowing helical movement (see the forward and rotation movement of the anchor as shown in figure 4b) of the anchors (32) within the driver passageway (gap between 34 and 36); and
c) an actuator (surgeon or tool the surgeon uses to rotate 36 as mentioned in ¶0168 that is further connected to the torque limiting element mentioned in ¶0169) operatively coupled to the inner and outer drivers (34/36) and operable for selectively rotating the inner and outer drivers (34/36) relative to each other (36 is rotated relative to 34 which results in the anchor 32 being driven forward and helically into the tissue 90 as shown in figure 4B) to sequentially deliver each anchor of the plurality of anchors (32) helically from the driver passageway (gap between 34 and 36) into tissue.
Regarding claim 51:
The system of claim 50, further comprising a guide (206 as shown in figure 4D) configured to extend from the catheter lumen (204) beyond the distal end and to be inserted through (as shown in figure 4d) and protrude from the inner driver (36).
Regarding claim 53:
The system of claim 51, wherein the actuator (surgeon or tool the surgeon uses to rotate 36 as mentioned in ¶0168 that is further connected to the torque limiting element mentioned in ¶0169) is on the proximal end (106) of the catheter (opposite end from distal end of 204 as shown in figure 9B).
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.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120022557 A1 to Cabiri as applied to claim 51 above, and further in view of US 20110190750 A1 to Pageard.
Regarding claim 52:
Cabiri fails to disclose:
The system of claim 51, wherein the guide comprises a tip configured to be adhered to tissue using cryoadhesion.
Pageard teaches:
A system that includes a catheter (26) for ablation (¶0023). The reference further teaches that the distal end of the device is anchored using cryoadhesion (¶0023)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cabiri to use cryoadhesion on the tip in Cabiri as taught by Pageard in order to anchor the tip for the anchoring procedure (Pageard, ¶0023).
Allowable Subject Matter
Claims 22, 24, 39-43, 45-46 and 49 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see remarks, filed 11/11/25, with respect to the rejection(s) of claim(s) 21, 25-28, 37-38, 44, 46-48, 50-53 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cabiri.
Regarding the 35 USC 112(a) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn. New rejections have been made based on the amendments to the claims.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn. New rejections of the claims have been made based on the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783