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 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.
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(s) is/are: a sealing part and a connection part.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/these limitation(s) 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20-28 and 30-31 have been considered but are moot because the new ground of rejection over Li et al. US 2016/0287261 in view of Li et al. US 2014/0142612, as discussed below.
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.
Claim 24 is 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.
Claim 24 recites the limitation "the tail portion" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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) 20-25, 29, 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. US 2016/0287261 in view of Li et al. US 2014/0142612 (hereafter, Li et al. ‘612).
Regarding claim 20, Li et al. discloses a left atrial appendage occluder, comprising: a sealing part 11 having a disc-shaped portion (see annotated figure 2 below), a transition portion (portion between the disc shape and the connection part at ends of sealing part, figure 2); a fixing part 12 disposed at one side of the sealing part and having a connection end (see annotated figure 2 below); and a connection part 210 that connects the sealing part and the connection end of the fixing part (see annotated figure 2 below, figure 5), the fixing part comprising a concave zone formed by radially extending from the connection end in a distal direction away from the sealing part (see annotated figure 2 below), and a hung zone formed by extending in a proximal direction from the concave zone towards the sealing part (see annotated figure 2 below), with the hung zone having an edge (see annotated figure 2 below) that defines an opening that faces towards the sealing part (figure 2, opening within space between edge zones toward the connection part), and wherein an edge zone extends from the edge of the hung zone towards the connection part (see annotated figure 2 below); wherein the edge zone has a projected area that partially blocks the opening (edge zone bends inward around the opening toward the connection part, projected area is blocked adjacent the edge zone portions, the opening between the edge zone and the connection part), and a sealing cap 16 (figure 2)
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Li et al. shows the edge zone forming a cross section of the opening, (figure 2), but fails to explicitly discloses wherein the ratio of the projected area of the edge zone on a maximum cross-section of the opening to the area of the maximum cross-section of the opening is greater than 10%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Li et al. to have a ratio of the projected area of the edge zone on a maximum cross-section of the opening to the area of the maximum cross-section of the opening is greater than 10% since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Li et al. would function successfully with the claimed range.
Li et al. fails to disclose a sealing cap covering the transition portion and fixed to the proximal end of the fixed connection component.
Li et al. ‘612 teaches a left atrial appendage occluder (paragraph 0002) comprising a sealing part 11 having a disc-shaped portion (figure 6, paragraph 0068), a transition portion (end of closure disc, paragraph 0068) and a fixed connection component (sleeve, paragraph 0068) having a proximal end (proximal end of sleeve), and a sealing cap 15 covering the transition portion (ends of closure disc, paragraph 0068) and fixed to the proximal end of the fixed connection component (sleeve is fixed via welding, paragraph 0068), for connecting the sealing disc with the fixing part while allowing for adjusting of relative positions and distances between the sealing disc and fixing part (paragraph 0068).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Li et al. with a sealing cap covering the transition portion and fixed to the proximal end of the fixed connection component, as taught by Li et al. ‘612, for connecting the sealing disc with the fixing part while allowing for adjusting of relative positions and distances between the sealing disc and fixing part.
Regarding claim 21, Li et al. discloses wherein each of the sealing part and the fixing part has an expanding diameter (figure 2), and wherein the expanding diameter of the sealing part is greater than the expanding diameter of the fixing part (see annotated figure 2 below).
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Regarding claim 22, Li et al. discloses, wherein the hung zone is provided with at least one anchor 15 facing the sealing part (figure 2); and an inclined angle between each anchor and the hung zone (see annotated figure 2 below).
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Li et al. shows an inclined angle but fails to explicitly disclose the inclined angle between each anchor and the hung zone ranges from 0 degree to 90 degrees.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Li et al. to have an inclined angle between each anchor and the hung zone ranges from 0 degree to 90 degrees since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Li et al. would function successfully with the claimed range.
Regarding claim 23, Li et al. discloses wherein at least a part of the hung zone is generally parallel to the sealing part.
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Regarding claim 24, Li et al. discloses an inclined angle between the hung zone portion and a central axis line of the left atrial appendage occluder (see annotated figure 2 below); and an equivalent bend angle of the tail portion (see annotated figure 2 below, bends inward at the edge toward the edge zone), and the tail portion has a spherical tip (ball at end of edge zone or end of support ends 14, paragraph 0005).
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Li et al. fails to explicitly disclose the inclined angle between the hung zone portion and a central axis line of the left atrial appendage occluder ranges from 0 degree to 85 degrees, or an equivalent bend angle of the end portion ranges from 0 degree to 180 degrees.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Li et al. to have an inclined angle between the hung zone portion and a central axis line of the left atrial appendage occluder ranges from 0 degree to 85 degrees, or an equivalent bend angle of the end portion ranges from 0 degree to 180 degrees since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Li et al. would function successfully with the claimed range.
Regarding claim 25, Li et al. discloses wherein the sealing part has a proximal end and the fixing part has a distal end, but fails to explicitly disclose wherein a relative distance between the proximal end of the sealing part and the distal end of the fixing part is 4-70 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Li et al. to have a relative distance between the proximal end of the sealing part and the distal end of the fixing part is 4-70 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Li et al. would function successfully with the claimed range.
Regarding claim 30, Li et al. discloses a left atrial appendage occluder having a sealing cap (connecting nut 16, paragraph 0005, figure 2) as disclosed and discussed above, but fails to discloses wherein the equivalent diameter of the sealing cap is 2-5 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Li et al. to have a equivalent diameter of the sealing cap is 2-5 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Li et al. would function successfully with the claimed range.
Regarding claim 31, Li et al. discloses wherein the connection part defines a central axis, and wherein the opening has a cross-section that is perpendicular to the central axis (see annotated figure 2 below).
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Regarding claims 32 and 33, Li et al. discloses a left atrial occluder wherein the disc-shaped portion comprises a first flat surface adjoined to the fixed connection component, and an inclined surface connected with the first flat surface, wherein the disc shaped portion further comprises a second flat surface connected with the inclined surface (see annotated figure 2 below; Examiner notes a flat surface may still be an inclined surface, as they are not mutually exclusive).
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Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable Li et al. US 2016/0287261 in view of Li et al. US 2014/0142612 (hereafter, Li et al. ‘612) and further in view of Lingren et al. US 2017/0095256.
Regarding claim 26-28, Li discloses a left atrial appendage occluder, comprising a sealing part and a fixing part has a radial deformation capacity and an axial deformation capacity (radial deformation of and axial deformation of the sealing and fixing part), but fails to explicitly disclose wherein the radial deformation capacity of the sealing part is greater than that of the fixing part, and/or the axial deformation capacity of the sealing part is greater than that of the fixing part, wherein with the application of the same axial force, a displacement of the sealing part along a direction of the axial force is greater than a displacement of the fixing part along the direction of the axial force, wherein with the application of the same radial force, a displacement of the sealing part along a direction of the radial force is greater than a displacement of the fixing part along the direction of the radial force.
Lingren et al. teaches a left atrial appendage occluder (figure 2b, paragraph 0001), comprising a sealing part 101 and a fixing part 106 (figure 2a) wherein the radial deformation capacity of the sealing part is greater than that of the fixing part (paragraph 0007, 0027, 0030, 0033, anchoring or fixing portion 105 has higher stiffness, stiffness being construed as the extent in which the portion resists deformation in response to an applied force), and/or the axial deformation capacity of the sealing part is greater than that of the fixing part (paragraph 0007, 0027, 0030, 0033, anchoring or fixing portion 105 has higher stiffness, stiffness being construed as the extent in which the portion resists deformation in response to an applied force), wherein with the application of the same axial force, a displacement of the sealing part along a direction of the axial force is greater than a displacement of the fixing part along the direction of the axial force (paragraph 0007, 0027, 0030, 0033, anchoring or fixing portion 105 has higher stiffness, stiffness being construed as the extent in which the portion resists deformation in response to an applied force), wherein with the application of the same radial force, a displacement of the sealing part along a direction of the radial force is greater than a displacement of the fixing part along the direction of the radial force (paragraph 0007, 0027, 0030, 0033, anchoring or fixing portion 105 has higher stiffness, stiffness being construed as the extent in which the portion resists deformation in response to an applied force) for fixating the device against the walls of the LAA and seal thereto (paragraph 0030, 0033).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Li et al. with a radial deformation capacity of the sealing part being greater than that of the fixing part, and/or the axial deformation capacity of the sealing part being greater than that of the fixing part, wherein with the application of the same axial force, a displacement of the sealing part along a direction of the axial force is greater than a displacement of the fixing part along the direction of the axial force, wherein with the application of the same radial force, a displacement of the sealing part along a direction of the radial force is greater than a displacement of the fixing part along the direction of the radial force, as taught by Lingren et al., to provide a device which can be conformable and be better fixed and sealed against the walls of the LAA.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C.L/ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771