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 .
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.
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 1, 3-7, 11, 13, 14, 19, 46, and 47 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.
The term “less” in the preamble of claim 1 is a relative term which renders the claim limitation indefinite. The term “less” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is also unclear as to what the fixation device is “less” invasive than. Therefore, the limitation is rendered indefinite.
Claims 3-7, 11, 13, 14, 19, 46, and 47 are also rendered indefinite due to their
dependency from indefinite claim 1.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: "guiding element" in claim 11.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 3, 5-7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (US 5860992) in view of Adams et al. (WO 2005039419) .
Regarding claim 1, Daniel discloses a less invasive fixation device (10 or 10’; see col. 3, lines 30-36) comprising: an elongate tubular member (12, 12’, or 248) having a proximal end (14; or see Figs. 34 and 35, proximal end of elongate shaft 248 is connected to handle 258) and a distal end (16; or see Figs. 34 and 35, distal end of elongate shaft 248 is attached to needle carriage 260), an interior lumen extending between the proximal end and the distal end (see Fig. 3 or 10A-B, rod 29 or 29’ goes through shaft 12 or 12, or see Figs. 34 and 35 and col 19, lines 18-21, first sleeve 250 covers elongate shaft 248 which are both covered by second sleeve 252 creating an interior lumen that extends from a proximal end to a distal end), a needle assembly (see Fig. 4, 10A-B, or 34 and 35) comprising at least one felting needle (22, 22’, or 262) arranged or arrangeable at the distal end of the elongate tubular member (Fig. 4, 10A-B, or 34 and 35), wherein the at least one felting needle is movable relatively to the elongate tubular member (see Fig. 4 or 10A-B, col 9, lines 49-51, needle carriage 20 or 20’ is pivotally connected to distal end 16; see col 19, lines 46-50, the needle 254 will move back and forth in conjunction with the actuators being translated along the elongated shaft), and wherein the at least one felting needle is movable with a reciprocal motion (see Figs. 6-7, θd shows the range of rotational motion of needle 22 or 22’; see col 19, lines 41-46, needles move towards the tissue and away from the tissue in conjunction with the handle 258 being pulled proximally or distally relative to the first and second actuators 257 and 259), and a drive assembly (rod 29 or 29’, or elongate shaft 248) arranged in the interior lumen of the tubular member (see Fig. 3, 10A-B, or 34 and 35), wherein the drive assembly is operably connected to the needle assembly (see Fig. 7 or 10A-B, pin 30 or 30’ connects rod 29 or 29’ to needle carriage 20 or 20’; or 24 connects to needle carriage 260) for moving the at least one felting needle (22, 22’, or 262) with the reciprocal motion (col 9 lines 54-56, rod 29 or 29’ is axially translated to pivot the carriage about pin 32 or 32’; see col 19, lines 46-50, the second actuator is proximally translated to the position illustrated in Fig. 34 to pull the needles 262 completely through the tissue and draw a suture through the tissue) when the at least one felting needle is located at the distal end (see Fig. 7, 10A-B, or 34 and 35) such that a feltable textile can be fixated at a target site (Daniel’s needle is structured and movable as claimed, thereby is fully capable of fixating a feltable textile to a target site as claimed).
Daniel fails to disclose wherein the elongate tubular member is at least partially flexible.
Adams also discloses a fixation device comprising an elongate tubular member (309) with an interior lumen (passageway 316) that extends between the proximal (proximal end 310) and distal ends (distal end 312) and a needle assembly (tissue piercing structure 320) arranged or arrangeable at the distal end of the elongate member (see Fig. 6). Adams teaches the elongate tubular member (309) is at least partially flexible (see [0084]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongate tubular member of Daniel to be partially flexible, as taught by Adams, in order to allow for percutaneous entry and transluminal advancement through the vascular system to a target site (see paragraph [0084]).
The intended use recited in the preamble (“for fixating a feltable textile at a target site in a human or animal”) has been considered but deemed not to impose any structural difference between the claimed invention and Daniel’s modified device. Daniel’s device as modified by Adams is structured as claimed and is capable of being used for fixating a feltable textile at a target site in a human or animal as claimed.
Regarding claim 3, Daniel in view of Adams further discloses the drive assembly is adapted to drive the reciprocal motion with an amplitude of in a range of 2 to 25mm (see col 11, lines 66-67 and col 12, lines 1-6, the needle is passed through an arc having substantially the same radius as the radius of the curvature of the needle and preferably the needle could range from 2mm to 11mm, which falls within the claimed range).
Regarding claim 5, Daniel in view of Adams further discloses the at least one felting needle points in a distal direction of the elongate tubular member (see Fig. 10A, tip of needle 22’ is pointed in a distal direction of the elongate tubular member).
Regarding claim 6, Daniel in view of Adams further discloses the reciprocal motion of the at least one felting needle (22) is linear or rotational (see Figs. 6 and 7, θf and θd both show the range of motion the needle is an arc that centers around pin 32 thus showing the reciprocal motion is rotational).
Regarding claim 7, Daniel in view of Adams further discloses the drive assembly comprises an elongate driving wire or tube (see col 6 lines 17-25, needle driver comprises a rod made of Nitinol that is interpreted to be a wire which is defined by merriam-webster.com as a “metal in the form of a very flexible thread or slender rod”) that extends from a proximal side of the elongate tubular member (see Fig. 3, rod 29 goes through shaft 12) to the needle assembly (see Fig. 7, rod 29 is connected to needle carriage 20 at the distal end), and wherein the elongate driving wire or tube is operably connected to the needle assembly such that the driving elongate wire or tube causes the reciprocal motion of the at least one felting needle (col 9, lines 54-56, rod 29 is axially translated to pivot the carriage about pin 32).
Regarding claim 14, Daniel in view of Adams further discloses the fixation device additionally comprises: a holding assembly (see Figs. 34 and 35, clamping members 254 and 256 are located near the distal end of the elongate shaft) for the feltable textile (a holder for clamping a layer of tissue is fully capable of holding a feltable textile), wherein the holding assembly comprises at least one holder (254 and 256) for securing the textile to the holding assembly, wherein the textile is in a folded position (a holder 254 and 256 for clamping a layer of tissue is fully capable of securing a folded feltable textile to the holding assembly as claimed).
Claim(s) 4, 13, 19, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Adams as applied to claim 1 above, and further in view of Wright et al. (US 5201880).
Regarding claim 4, Daniel in view of Adams fails to disclose wherein the fixation device additionally comprises the feltable textile and wherein the feltable textile is arranged or arrangeable such that at least one felting needle penetrates the feltable textile with the reciprocal motion.
Wright discloses an annuloplasty ring (200) that is sutured to tissue (Fig. 11). Wright teaches the annuloplasty ring (200) comprises a feltable textile (see col 6 lines 60-65, describing the device is composed of a tubular body of textile nature, and a textile is feltable by a needle) and the feltable textile is arranged or arrangeable such that at least one felting needle penetrates the feltable textile with the reciprocal motion (see col 9, lines 38-40, Fig. 11 shows a plan view of the device for tricuspid valve repair that is sutured in place, thereby is arrangeable on Daniel’s modified fixation device such that the at least one felting needle 22 penetrates the feltable textile with the reciprocal motion). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixation device of Daniels in view of Adams to additionally comprise a feltable textile arrangeable such that at least one felting needle penetrates the feltable textile with the reciprocal motion, as taught by Wright, in order to use the fixation device for repairing mitral or tricuspid valve disorders (see Daniel col 2, lines 52-58).
Regarding claim 13, Daniel in view of Adams fails to disclose the fixation device comprising the textile, wherein the textile has an annular shape and/or forms an annuloplasty ring.
Wright discloses an annuloplasty ring (200) that is sutured to tissue (Fig. 11). Wright teaches the annuloplasty ring (200) is a textile that has an annular shape and/or forms an annuloplasty ring (see col 6, lines 60-65, the device is composed of a tubular body of textile nature). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified fixation device of Daniels in view of Adams to additionally comprise a feltable textile that has an annular shape, as taught by Wright, in order to use the fixation device for repairing mitral or tricuspid valve disorders (see col 1, lines 6-8)
Regarding claim 19, Daniel in view of Adams fails to disclose an implant comprising the feltable textile.
Wright discloses an implant (200) that is sutured to tissue (Fig. 11). Wright teaches the implant (200) is a feltable textile (see col 6, lines 60-65, the device is composed of a tubular body of textile nature, and a textile is feltable with a needle). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified fixation device of Daniels in view of Adams to be part of a set that comprises the fixation device and a feltable textile implant, as taught by Wright, in order for the fixation device to be used for repairing mitral or tricuspid valve disorders (see col 1, lines 6-8).
Regarding claim 46, Daniel in view of Adams and Wright discloses the set as recited in claim 19 and Wright further teaches that the feltable textile has an annular shape (see col 6, lines 60-65, the device is composed of a tubular body).
Claim(s) 11 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Adams as applied to claim 1 above, and further in view of Gordon (US 5364408).
Regarding claim 11, Daniel in view of Adams fails to disclose wherein the elongate tubular member comprises at least one guiding element for the drive assembly in the interior lumen.
Gordon also discloses a fixation device (30) comprising an elongate tubular member (outer housing 32) having a lumen (see Fig. 2) and a drive assembly (42). Gordon teaches the elongate tubular member (32) comprises at least one guiding element (see Figs. 2 and 7, driver retainer 70; this limitation is being interpreted under 112(f) as a circular, ring-shaped, concentric lead element (see page 17 of the instant specification) and equivalents thereof) for the drive assembly (42; via hole 72) in the interior lumen (see Fig. 2). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the driving assembly of Daniel in view of Adams wherein the elongate tubular member comprises at least one guiding element for the drive assembly in the interior lumen, as taught by Gordon, so as to allow for precision of movement and not cause unnecessary damage to the surrounding tissue (see col 2, lines 45-48).
Regarding claim 47, Daniel in view of Adams and Gordon discloses the at least one guiding element (see Gordon, 70) comprises at least one ring-shaped concentric lead element (see Gordon Figs. 2 and 7).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Adams and Gordon.
Regarding claim 48, Daniel discloses a fixation device (10 or 10’; see col. 3, lines 30-36) comprising: an elongate tubular member (12 or 12’) having a proximal end (14) and a distal end (16), an interior lumen extending between the proximal end and the distal end (see Fig. 3, rod 29 or 29’ goes through shaft 12 or 12’), a needle assembly (see Fig. 4 or 10A-B) comprising at least one felting needle (22 or 22’) arranged or arrangeable at the distal end of the elongate tubular member (Fig. 4 or 10A-B depicts the distal end of tubular member), wherein the at least one felting needle is movable relatively to the elongate tubular member (see Fig. 4 or 10A-B, col 9, lines 49-51, needle carriage 20 is pivotally connected to distal end 16), and wherein the at least one felting needle is movable with a reciprocal motion (see Fig. 6-7, θd shows the range of motion of needle 22 or 22’) and a drive assembly (rod 29 or 29’ and pin 30 or 30’) arranged in the interior lumen of the tubular member (see Fig. 6-7, rod 29 or 29’ is located inside the tubular member with pin 30 or 30’ attached to its end) and operably connected to the needle assembly (see Fig. 6-7, pin 30 or 30’ connects rod 29 or 29’ to needle carriage 20 or 20’) for moving the at least one felting needle with the reciprocal motion (col 9 lines 54-56, rod 29 or 29’ is axially translated to pivot the carriage about pin 32 or 32’) when the at least one felting needle is located at the distal end (see Fig. 7 or 10A-B) such that the feltable textile can be fixated at the target site (Daniel’s needle is structured and movable as claimed, thereby is fully capable of fixating a feltable textile to a target site as claimed), wherein the drive assembly includes an elongate driving wire or tube (see col 6 lines 17-25, needle driver comprises a rod made of Nitinol that is interpreted to be a wire or tube which is defined by merriam-webster.com as a “metal in the form of a very flexible thread or slender rod”).
Daniel fails to disclose wherein the elongate tubular member is at least partially flexible.
Adams discloses a fixation device comprising an elongate tubular member (309) with an interior lumen (passageway 316) that extends between the proximal (proximal end 310) and distal ends (distal end 312) and a needle assembly (tissue piercing structure 320) arranged or arrangeable at the distal end of the elongate member (see Fig. 6). Adams teaches the elongate tubular member (309) is at least partially flexible (see [0084]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongate tubular member of Daniel to be partially flexible, as taught by Adams, in order to allow for percutaneous entry and transluminal advancement through the vascular system to a target site (see paragraph [0084]).
Daniel in view of Adams fails to disclose a spring operably connected between the elongate tubular member and the driving wire or tube.
Gordon also discloses a fixation device (30; see Fig. 2) comprising an elongate tubular member (outer housing 32) and a driving wire or tube (42). Gordon teaches a spring (driver spring 74) operably connected between the elongate tubular member (32) and the driving wire or tube (42; see Fig. 7). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the driving assembly of Daniel to include a spring operably connected between the elongate tubular member and driving wire as taught by Gordon in order to ensure penetration of the needle through the tissue and textile (see col 2, lines 57-62).
The intended use recited in the preamble (“for fixating a feltable textile at a target site in a human or animal”) has been considered but deemed not to impose any structural difference between the claimed invention and Daniel’s modified device. Daniel’s device as modified by Adams and Gordon is structured as claimed and is capable of being used for fixating a feltable textile at a target site in a human or animal as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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/JUSTIN ZHI-DE YAO/ Patent Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774