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.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding Claim 1, ">" in lines 9 and 10 should read as "greater than" for purposes of clarity. 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 2-4, 17, and19 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 Claims 2-4, the limitation “deformation rate” in line 1 is unclear, as it is unclear whether “deformation rate” is supposed to be referring back to the “deformation degree” introduced in claim 1. Further clarification is required.
Regarding Claim 17, the limitation “direction of getting away” is unclear, as it is unclear what direction “away” with respect to the distal end of the supporting portion is referring to. Further clarification is required.
Claim 19 recites the limitation "the unfolded position" in line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no “unfolded position” introduced in the claim or any claims from which it depends on. Additionally, the limitations “the angle between the two clamping arms” and “the angle between the two gripping elements” recited in lines 2 and 3 lack insufficient antecedent basis for this limitation in the claim, as there is no angles introduced in the claim or any claims from which it depends on.
Additionally, regarding claim 19, it is unclear how the angle between the two clamping arms would be smaller than the angle between the two elastic arms, as it is required in claim 18 that the pair of elastic arms are in between the clamping arms and the adjusting portion. Additionally, the specification of the Instant Application recites that Figure 9 shows “a clamping portion and a gripper in an unfolded state,” in which it is the opposite (the angle between the two elastic arms is smaller than the angle between the two clamping arms, as the elastic arms are in between the clamping arms and the adjusting portion. Further clarification is required. For purposes of expedited prosecution, the Examiner is interpreting this to mean “the angle between the two elastic arms is smaller than the angle between the two clamping arms”.
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 1-5 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 106491245 A (hereafter –Liu--).
Regarding Claim 1, Liu discloses valve clamping device, comprising: a supporting portion (10) having a certain length (see annotated supporting portion 10 in Figure 3 below); a clamping portion (30) comprising a pair of clamping arms that can be opened and closed relative to each other (see annotated clamping portion 30 and clamping arms in Figure 3 below, see also Figures 13 and 15); and an adjusting portion (20) (see annotated adjustment portion in Figure 3 below); wherein the adjusting portion is arranged outside the supporting portion (see annotated adjusting and supporting portions in Figure 3 below, see also fifth body of text under Preferred Embodiment in the attached translated text), the adjusting portion is deformable (see ninth, twelfth, and thirty third body of text under Preferred Embodiment in the attached translated text denoting that the component 20 is elastic and is deformed), the adjusting portion is a three-dimensional structure with a certain length, width, and thickness (see annotated adjustment portion 20 in Figure 3 below), and the pair of the clamping arms are closed relative to the adjusting portion so that the adjusting portion is deformed (see thirty third body of text under Preferred Embodiment in the attached translated text denoting that the component 20 is elastic and is deformed when the clamping arms are closed), and the deformation degree of the adjusting portion in the thicknesswise direction>the deformation degree of the adjusting portion in the lengthwise direction>the deformation degree of the adjusting portion in the widthwise direction (see Figure 15, the radial direction that the clamp is deforming the adjusting member is the thickness direction).
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Regarding Claim 2, Liu discloses the valve clamping device as claimed in claim 1.
The limitation “wherein a deformation rate of the adjusting portion in the thicknesswise direction ranges from 25% to 65%” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the adjusting portion being disclosed as super elastic and deformable (see thirty third body of text under Preferred Embodiment in the attached translated text denoting that the component 20 is elastic and is deformed when the clamping arms are closed), the adjusting portion would be able to deform in the thickness direction within the range of 25% to 65%.
Regarding Claim 3, Liu discloses the valve clamping device as claimed in claim 1.
The limitation “wherein a deformation rate of the adjusting portion in the lengthwise direction ranges from 10% to 20%” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the adjusting portion being disclosed as super elastic and deformable (see thirty third body of text under Preferred Embodiment in the attached translated text denoting that the component 20 is elastic and is deformed when the clamping arms are closed), the adjusting portion would be able to deform in the lengthwise direction within the range of 10% to 20%.
Regarding Claim 4, Liu discloses the valve clamping device as claimed in claim 1.
The limitation “wherein a deformation rate of the adjusting portion in the widthwise direction ranges from 3% to 12%” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the adjusting portion being disclosed as super elastic and deformable (see thirty third body of text under Preferred Embodiment in the attached translated text denoting that the component 20 is elastic and is deformed when the clamping arms are closed), the adjusting portion would be able to deform in the widthwise direction within the range of 3% to 12%.
Regarding Claim 5, Liu discloses the valve clamping device as claimed in claim 1, wherein the adjusting portion is made of shape memory material (see ninth body of text under Preferred Embodiment in the attached translated text denoting that the component 20 can be a shape memory material).
The claimed phrase “and has been heat-set” is being treated as a product by process limitation; that is the adjusting portion is heat set. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Liu as modified is silent as to the process used to make the shape memory material, it appears that the adjusting portion would be the same as that claimed.
Regarding Claim 9, Liu discloses the clamping device as claimed in claim 1, wherein one end of the adjusting portion is fixedly connected with the supporting portion, and the other end is free relative to the supporting portion (see annotated adjusting portion ends in Figure 3 above).
Regarding Claim 10, Liu discloses the valve clamping device as claimed in claim 1, wherein the valve clamping device further includes a driving part configured to drive the relative opening and closing of the pair of clamping arms (see annotated driving part 40 in Figure 3 above, see also fourth and fifth body of text under Preferred Embodiment in the attached translated text).
Regarding Claim 11, Liu discloses the valve clamping device as claimed in claim 10, wherein the driving part (40) includes a pair of connecting rods (420) and an elastic closing unit (41), one end of each of the connecting rods is rotatably connected to one of the clamping arms (see annotated closing unit 41 and connecting rods 420 in Figure 11 below, see also twenty ninth and thirtieth bodies of text under Preferred Embodiment in the attached translated text denoting that each connecting rod body 420 of first connecting end 426 through a second pivot 423 with the clamp 31 of the second connection hole 315 is rotatably connected), and the other end of the each connecting rods is connected to the supporting portion (see also thirtieth body of text under Preferred Embodiment in the attached translated text denoting that each connecting rod 420 of the second end 427 by a third pivot 425 and the support part 10 of the strip guide 14 is connected), one end of the elastic closing unit is connected to the connecting rod (see thirty sixth body of text under Preferred Embodiment in the attached translated text denoting that component 425 of connecting rods are connected to the closing unit 41), and the other end of the elastic closing unit is connected to the clamping arm (see also twenty fifth body of text under Preferred Embodiment in the attached translated text denoting that the each of the first ring 414 are sleeved on the one clamping member 31 of the connecting rod 316).
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Regarding Claim 12, Liu discloses the valve clamping device as claimed in claim 10, wherein the driving part (40) includes a pair of connecting rods (420), a driving shaft (425) and a connecting seat (427), one end of each of the connecting rods is rotatably connected to one of the clamping arms (see twenty ninth and thirtieth bodies of text under Preferred Embodiment in the attached translated text denoting that each connecting rod body 420 of first connecting end 426 through a second pivot 423 with the clamp 31 of the second connection hole 315 is rotatably connected), and the other end of each of the connecting rods is rotatably connected to the connecting seat (see also thirtieth body of text under Preferred Embodiment in the attached translated text denoting that each connecting rod 420 of the second end 427 by a third pivot 425 and the support part 10 of the strip guide 14 is connected), one end of the drive shaft is connected to the connecting seat (425 is connecting to the connecting seat 427 through the connecting rod, as shown in Figure 12), and the other end of the drive shaft is movably fitted in the supporting portion (see also thirtieth body of text under Preferred Embodiment in the attached translated text denoting that each connecting rod 420 of the second end 427 by a third pivot 425 and the support part 10 of the strip guide 14 is connected).
Regarding Claim 13, Liu discloses the valve clamping device as claimed in claim 1, wherein a surface of the clamping arm facing the adjusting portion is provided with a plurality of protrusions, and when the clamping arm is closed relative to the adjusting portion, the protrusions abut against the adjusting portion (see annotated protrusions and adjusting portion in Figure 3 above).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over CN 106491245 A (hereafter –Liu--), in view of WO 2017059406 A1 (hereafter –Speziali--).
Regarding Claim 6, Liu discloses the valve clamping device as claimed in claim 1, wherein the adjusting portion includes a mesh structure (see tenth body of text under Preferred Embodiment in the attached translated text denoting that the component 20 can be a shape memory material).
Liu fails to discloses a porosity of the mesh structure ranges from 30% to 80%.
Speziali discloses a webbed mesh implant for repairing a native heart valve. Speziali teaches a porosity of the mesh structure ranges from 30% to 80% (see page 8, lines 19-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the mesh structure of Liu to have a porosity of the mesh structure ranges from 30% to 80%, as by doing so would enable the structure to have a flexible material having a combination of solid material and open space therein and capable of conforming to aspects of the native valve tissue (see page 8, lines 19-25).
Regarding Claim 7, Liu as modified discloses the valve clamping device as claimed in claim 6, wherein the mesh structure is woven by a plurality of filaments(see twelfth body of text under Preferred Embodiment in the attached translated text denoting that the component 20 can be a shape memory material).
Liu fails to discloses a diameter of each of the filaments is in a range from 0.06 mm to 0.20 mm.
The Instant Application does not disclose having the diameter of each of the filaments range from 0.06 mm to 0.20 mm solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Liu’s woven mesh structure would perform equally and function as intended with the filaments of the structure being of any certain reasonable size, including having a diameter of 0.06 mm to 0.20 mm. Therefore, it would have been obvious to one having ordinary skill in the art to have the diameter of the filaments of the mesh structure be in a range from 0.06 mm to 0.20 mm, as an obvious matter of design choice within the skill of the art. Additionally, it would have been obvious to one having ordinary skill in the art to have the diameter of the filaments of the mesh structure be in a range from 0.06 mm to 0.20 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claim 8, Liu as modified discloses the valve clamping device as claimed in claim 7.
The claimed phrase “wherein the weaving manner of the filament is selected from at least one of a single-strand weaving manner, a double-strand weaving manner or a mixed weaving manner of single and double strands” is being treated as a product by process limitation; that is the wherein the weaving manner of the filament is selected from at least one of a single-strand weaving manner, a double-strand weaving manner or a mixed weaving manner of single and double strands. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Liu as modified is silent as to the process used to weave the mesh structure, it appears that the adjusting portion would be the same as that claimed.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over CN 106491245 A (hereafter –Liu--), in view of US 20160331523 A1 (hereafter –Chau--), in even further view of US 20200383782 A1 (hereafter –Basude--).
Regarding Claim 14, Liu discloses the valve clamping device as claimed in claim 1.
Liu fails to disclose wherein the adjusting portion has at least one set of first barbs provided on an area thereof opposite to the clamping arm, and a length of each of the first barbs is in a range from 0.3mm to 3mm.
Chau discloses a valve clamping device, comprising: a clamping portion (4104) comprising a pair of clamping arms that can be opened and closed relative to each other (see annotated clamping arms in Figure 125E below, see paragraph [0302]); and an adjusting portion (4102) (see annotated adjustment portion in Figure 125E below); a supporting portion (4112); wherein the adjusting portion is arranged outside the supporting portion the adjusting portion is deformable (see paragraph [0302]). Chau teaches wherein the adjusting portion has at least one set of first barbs provided on an area thereof opposite to the clamping arm (see annotated barbs in Figure 125E below), and wherein the first barb is inclined in a direction toward a distal end of the supporting portion (see annotated supporting portion and distal end in Figure 125E below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the valve clamping device of Liu to have the adjusting portion has at least one set of first barbs provided on an area thereof opposite to the clamping arm, wherein the first barb is inclined in a direction toward a distal end of the supporting portion, as by doing so would enable the adjusting portion to engage the native leaflets as taught by Chau (see paragraph [0302]).
Liu further fails to disclose a length of each of the first barbs is in a range from 0.3mm to 3mm.
Basude discloses a valve clamping device, comprising: a clamping portion comprising a pair of clamping arms that can be opened and closed relative to each other, (see annotated clamping arms in Figure 70 below, see paragraph [0379]), and an adjusting portion with barbs (see annotated adjustment portion and barbs in Figure 70 below). Basude teaches a length of each of the first barbs is in a range from 0.3mm to 3mm (see paragraph [0237] denoting the barbs can be 1.5 mm long).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the valve clamping device of Liu as modified to have a length of each of the first barbs is in a range from 0.3mm to 3mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claim 15, Liu as modified discloses the valve clamping device as claimed in claim 14, wherein the first barb is inclined in a direction toward a distal end of the supporting portion (see claim 14 rejection above).
Regarding Claim 16, Liu as modified discloses the valve clamping device as claimed in claim 15.
Liu as modified discloses wherein the included angle between the first barb and the tangent at the connection with the outer surface of the adjusting portion is less than 90 degrees.
Basude discloses wherein the included angle between the first barb and the tangent at the connection with the outer surface of the adjusting portion is less than 90 degrees (see paragraph [0241]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the valve clamping device of Liu as modified to have the included angle between the first barb and the tangent at the connection with the outer surface of the adjusting portion is less than 90 degrees, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 17, Liu as modified discloses the valve clamping device as claimed in claim 14.
Liu as modified fails to disclose wherein along the direction of getting away from the distal end of the supporting portion, the length of the first barb gradually increases.
Basude teaches multiple possible barb lengths, one being 1 mm and 1.5 mm (see paragraph [0119] and [0237]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the invention to have wherein along the direction of getting away from the distal end of the supporting portion, the length of the first barb gradually increases, as it is disclosed by the specification of Basude that including embodiments comprising of various combinations or sub-combinations of the specific features and aspects of the embodiments would be apparent to those skilled in the art (see paragraph [0269]). Additionally, it would have been obvious to one of ordinary skill before the effective filing date of the invention to have wherein along the direction of getting away from the distal end of the supporting portion, the length of the first barb gradually increases, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over CN 106491245 A (hereafter –Liu--), in view of US 20180325661 A1 (hereafter –Delgado--).
Regarding Claim 18, Liu discloses the valve clamping device as claimed in claim 1.
Liu fails to disclose wherein the valve clamping device further includes a gripper, the gripper includes a pair of elastic arms, each of the elastic arms is located between one of the clamping arms and the adjusting portion, and the elastic arm and the clamping arm cooperate to clamp a leaflet.
Delgado discloses a valve clamping device, comprising: a clamping portion comprising a pair of clamping arms (126) (see annotated clamping arms and portion in Figure 2 below, see paragraph [0114]); and an adjusting portion (102) (see annotated adjustment portion in Figure 2 below). Delgado teaches wherein the valve clamping device further includes a gripper (128), the gripper includes a pair of elastic arms (128), each of the elastic arms is located between one of the clamping arms and the adjusting portion, and the elastic arm and the clamping arm cooperate to clamp a leaflet (see annotated gripper in Figure 2 below, see also paragraph [0117]), wherein when both the clamping arms and the gripper are in the unfolded state, the angle between the two clamping arms is smaller than the angle between the two elastic arms (see Figure 2 below, see also Figure 3).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the valve clamping device of Liu to further include a gripper, the gripper includes a pair of elastic arms, each of the elastic arms is located between one of the clamping arms and the adjusting portion, and the elastic arm and the clamping arm cooperate to clamp a leaflet, the angle between the two elastic arms is smaller than the angle between the two clamping arms in the unfolded position, as by doing so would enable the device to engage and/or penetrate the native leaflet tissue to help retain the native leaflets (see paragraph [0117]).
Regarding Claim 19, Liu as modified discloses the valve clamping device as claimed in claim 18, wherein when both the clamping arms and the gripper are in the unfolded state, the angle between the two clamping arms is smaller than the angle between the two elastic arms (see claim 18 rejection above).
Regarding Claim 20, Liu as modified discloses the valve clamping device as claimed in claim 19.
Liu as modified fails to disclose wherein the elastic arm is provided with at least one set of second barbs on the surface facing the clamping arm.
Delgado teaches wherein the elastic arm is provided with at least one set of second barbs on the surface facing the clamping arm (see paragraphs [0117], see also barbs in Figure 2 above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the valve clamping device of Liu to further include on the elastic arm at least one set of second barbs on the surface facing the clamping arm, as by doing so would enable the gripper elements to frictionally engage the native leaflet tissue (see paragraph [0117]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130066342 A1: This reference has clamping portions, clamping arms, barbs on the clamping arms, and a supporting portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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