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 .
Election/Restrictions
Applicant’s election without traverse of Group II and Species C. and . in the reply filed on 11/3/2025 is acknowledged. Claims 21-38 are currently pending in this application.
Claim Objections
Claims 22-28, 31-35, and 37-38 are objected to because of the following informalities: Claims 22-28, 31-35, and 37-38 each recite “the spacer”, which appears to be referring to – the expandable spacer --, as previously recited. Claims 24 and 33 each recite “the shaft”, which appears to be referring to – the central shaft –.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 26-28, 34, 35, and 38 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.
Claims 26-28, 34, 35, and 38 each recite the limitation "a tube". It is unclear whether applicant is referring to the previously recited “actuation tube” or some other element. For the purpose of further examination, the examiner interprets the tube to be some other element that is not the actuation tube.
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.
Claim(s) 21-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2009/0163934 A1 to Raschdorf, JR., et al. (Raschdorf).
Regarding at least claim 21
Raschdorf teaches devices, systems, and methods for tissue approximation and repair at treatment sites in various anatomical regions, including the heart (abstract). More specifically, Raschdorf teaches that when repairing valves, tissue approximation includes coapting the leaflets of the valves in a therapeutic arrangement which may then be maintained by fastening or fixing the leaflets, for the purpose of treating regurgitation (paragraph 0006). Raschdorf meets the limitations of an expandable spacer assembly comprising: a central shaft (actuator rod; 64); an actuation tube rotatably disposed around the central shaft (actuator rod control; 314 – paragraph 0221 discloses manipulation of the actuator rod control/actuation tube that includes rotation around the actuator rod/central shaft); an expandable spacer (fixation device; 14) having a first end secured to the central shaft (actuator rod; 64 is coupled to the fixation device; 14 via threaded coupling shown in fig. 49) and a second end secured to the actuation tube (paragraph 0221 discloses a second end of the central shaft; 64 secured to the actuation tube; 314 via handle; 316); wherein rotation of the actuation tube relative to the central shaft causes the expandable spacer to expand (paragraph 0222 discloses that rotation of the actuation tube translates the central shaft to manipulate the distal elements; 18 of the spacer).
Regarding at least claim 22
Raschdorf teaches the expandable spacer assembly of claim 1, wherein a locking portion of the central shaft (64) engages a locking portion of the expandable spacer (14) to hold the spacer in a retracted position, an expanded position, and a plurality of positions between the retracted position and the expanded position (paragraph 0165 discloses a locking mechanism for locking the spacer; 14 in a particular position, such as an open, closed or inverted position or any position therebetween).
Regarding at least claim 23
Raschdorf teaches the expandable spacer assembly of claim 1, wherein teeth (threads of the coupling structure; 320 are construed to be teeth as shown in fig. 49) of the central shaft (64) engage teeth of the expandable spacer (threads of the stud; 74 are construed to be teeth as shown in fig. 49) to hold the spacer in a retracted position, an expanded position, and a plurality of positions between the retracted position and the expanded position (paragraph 0165 discloses holding the spacer via the coupling in a retracted position, an expanded position, and a plurality of positions between).
Regarding at least claim 24
Raschdorf teaches the expandable spacer assembly of claim 1, wherein a proximal end of the spacer is coupled to a proximal end of the shaft (stud; 74 is located at a proximal end of the spacer and is coupled to a threaded joiner; 332 at a proximal end of the shaft as shown in fig. 49 and disclosed in paragraph 0223) and a distal end of the spacer is fixed to a distal end of the actuation tube (paragraph 0222 discloses that the distal end of the spacer, which includes distal elements; 18, is manipulated as a result of being at least indirectly fixed to a distal end of the actuator rod control/actuation tube; 314).
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Regarding at least claim 25
Raschdorf teaches the expandable spacer assembly of claim 1, wherein a proximal end of the spacer is greater than a width of a distal end of the expandable spacer when the spacer is in an expanded position (fig. 49 shows that a proximal end of the spacer; 14 has a greater width than a distal end when in an expanded position).
Regarding at least claim 26
Raschdorf teaches the expandable spacer assembly of claim 1, wherein the spacer comprises a tube with a plurality of cuts (the coupling member; 19 is a tube that is shown to have a plurality of cuts; see annotated fig. 49 below).
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Regarding at least claim 27
Raschdorf teaches the expandable spacer assembly of claim 1, wherein the spacer comprises a tube with a plurality of struts (see annotated fig. 49 below).
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Regarding at least claim 28
Raschdorf teaches the expandable spacer assembly of claim 1, wherein the spacer comprises a tube (coupling member; 19) with a plurality of spiral shaped cuts (threads of stud; 74, which is located within coupling portion/tube; 19 are construed to be a plurality of spiral shaped cuts).
Regarding at least claim 29
Raschdorf teaches the expandable spacer assembly of claim 1, wherein the expandable spacer is configured to expand asymmetrically such that a width of a proximal end of the expandable spacer is greater than a width of a distal end of the expandable spacer when the expandable spacer is in an expanded condition (fig. 49 shows an asymmetrical expansion of the spacer; 14 such that a width of the proximal end, which includes distal elements; 18, is greater than a width of a distal end, which includes legs; 68).
Regarding at least claim 30
Raschdorf also meets the limitations of a system for repairing a native valve of a patient (abstract), the system comprising: a delivery catheter; a valve repair device coupled to the delivery catheter (paragraph 0005 discloses a valve repair device coupled to a delivery catheter), wherein the valve repair device comprises: an expandable spacer assembly (fig. 49) comprising: a central shaft (64); an actuation tube (314) rotatably disposed around the central shaft (actuator rod control; 314 – paragraph 0221 discloses manipulation of the actuator rod control/actuation tube that includes rotation around the actuator rod/central shaft); an expandable spacer (14) having a first end secured to the central shaft (the actuator rod; 64 is attached to the spacer via stud; 74) and a second end secured to the actuation tube (paragraph 0221 discloses a second end of the central shaft; 64 secured to the actuation tube; 314 via handle; 316); wherein rotation of the actuation tube relative to the central shaft causes the expandable spacer to expand (paragraph 0222 discloses that rotation of the actuation tube translates the central shaft to manipulate the distal elements; 18 of the spacer).
Regarding at least claim 31
Raschdorf teaches the system of claim 30, wherein a locking portion of the central shaft engages a locking portion of the expandable spacer to hold the spacer in a retracted position, an expanded position, and a plurality of positions between the retracted position and the expanded position (paragraph 0165 discloses a locking mechanism for locking the spacer; 14 in a particular position, such as an open, closed or inverted position or any position therebetween).
Regarding at least claim 32
Raschdorf teaches the system of claim 30, wherein teeth (threads of the coupling structure; 320 are construed to be teeth as shown in fig. 49) of the central shaft (64) engage teeth of the expandable spacer (threads of the stud; 74 are construed to be teeth as shown in fig. 49) to hold the spacer in a retracted position, an expanded position, and a plurality of positions between the retracted position and the expanded position (paragraph 0165 discloses holding the spacer via the coupling in a retracted position, an expanded position, and a plurality of positions between).
Regarding at least claim 33
Raschdorf teaches the system of claim 30, wherein a proximal end of the spacer is fixed to a proximal end of the shaft (stud; 74 is located at a proximal end of the spacer and is coupled to a threaded joiner; 332 at a proximal end of the shaft as shown in fig. 49 and disclosed in paragraph 0223) and a distal end of the spacer is fixed to a distal end of the actuation tube (paragraph 0222 discloses that the distal end of the spacer, which includes distal elements; 18, is manipulated as a result of being at least indirectly fixed to a distal end of the actuator rod control/actuation tube; 314)
Regarding at least claim 34
Raschdorf teaches the system of claim 30, wherein the spacer comprises a tube (coupling member; 19) with a plurality of struts (see annotated fig. 49 below).
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Regarding at least claim 35
Raschdorf teaches the system of claim 30, wherein the spacer comprises a tube (19) with a plurality of spiral shaped cuts (threads of stud; 74, which are located within coupling portion/tube; 19 are construed to be a plurality of spiral shaped cuts).
Regarding at least claim 36
Raschdorf teaches the system of claim 30, wherein the expandable spacer is configured to expand asymmetrically such that a width of a proximal end of the expandable spacer is greater than a width of a distal end of the expandable spacer when the expandable spacer is in an expanded condition (fig. 49 shows an asymmetrical expansion of the spacer; 14 such that a width of the proximal end, which includes distal elements; 18, is greater than a width of a distal end, which includes legs; 68).
Regarding at least claim 37
Raschdorf teaches the system of claim 30, wherein a proximal end of the spacer is greater than a width of a distal end of the expandable spacer when the spacer is in an expanded position (fig. 49 shows that a proximal end of the spacer; 14 has a greater width than a distal end when in an expanded position).
Regarding at least claim 38
Raschdorf teaches the system of claim 30, wherein the spacer comprises a tube with a plurality of cuts (the coupling member; 19 is a tube that is shown to have a plurality of cutouts; see annotated fig. 49 below).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774