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.
Claim Objections
Claim 1 is objected to because of the following informalities: line 9- “the proximal end of the locking part” should be amended to - - [[the]] a proximal end of the locking part - - since it is clear that the locking part has a proximal end, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: line 10- “the distal end of the limiting through hole” should be amended to - - [[the]] a distal end of the limiting through hole - - since it is clear that the limiting through hole has a proximal end, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: lines 10- 11 –“ the locking ring can be slotted into/penetrate out of the limiting through hole” should be amended to - - the locking ring can be slotted into and/or penetrate out of the limiting through hole - - to correct an apparent typographical error. Appropriate correction is required.
Claims 2- 14 are objected to because they depend off claim 1.
Claim 2 is objected to because of the following informalities: lines 2- 3- “the opening diameter of the distal ends of the first through holes” should be amended to - - [[the]] an opening diameter of the distal ends of the first through holes - - since it is clear that the distal ends of the first through holes have opening diameters, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 3- 4 are objected to because they depend off claim 2.
Claim 2 is objected to because of the following informalities: line 4 - “the opening diameter of the proximal ends of the first through holes” should be amended to - - [[the]] an opening diameter of the proximal ends of the first through holes - - since it is clear that the proximal ends of the first through holes have opening diameters, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 3- 4 are objected to because they depend off claim 2.
Claim 4 is objected to because of the following informalities: line 4 - “the opening diameter of the proximal end of the second through hole” should be amended to - - [[the]] an opening diameter of the proximal end of the second through hole - - since it is clear that the proximal end of the second through hole has an opening diameter, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: line 2- “the distal end of the pull thread” should be amended to - - [[the]] a distal end of the pull thread - - since it is clear the pull thread has a distal end, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 6 is objected to because it depends off claim 5.
Claim 5 is objected to because of the following informalities: line 3- “the proximal end of the pull thread” should be amended to - - [[the]] a proximal end of the pull thread - - since it is clear the pull thread has a proximal end, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: lines 4- 5 –“ the locking ring can be slotted into/penetrate out of the limiting through hole” should be amended to - - the locking ring can be slotted into and/or penetrate out of the limiting through hole - - to correct an apparent typographical error. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: line 2- “the surface of the melt tail end” should be amended to - - [[the]] a surface of the melt tail end - - since it is clear the melt tail end has a surface, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: line 2- “the side wall of the melt tail end” should be amended to - - [[the]] a side wall of the melt tail end - - since it is clear the melt tail end has a side wall, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: line 4- 5- “the cross section of the waist part” should be amended to - - [[the]] a cross section of the waist part - - since it is clear the waist part has a cross section, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: lines 2- 3- “the proximal ends of each group of pull belts” should be amended by - - [[the]] proximal ends of each group of pull belts - - since it is clear each group of pull belts has proximal ends, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: lines 3- 4- “the distal ends of each group of pull belts” should be amended by - - [[the]] distal ends of each group of pull belts - - since it is clear each group of pull belts has distal ends, amending the claim would provide proper antecedent basis. 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.
Claim 7 and claim 13 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.
Claim 7 recites the limitation "the pull thread" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the septal defect" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1 and 13- 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Della et al. (WO 2011/089459 A1).
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Regarding claim 1, Della discloses an occluder, made of a degradable material and comprising a net-shaped framework (Title, p. 3, 6th Paragraph - - The device is in the form of two umbrella-shaped or bell-shaped covers provided with a relatively rigid but flexible self-unfolding structure or frame) and a locking member (21, 31) (Figs. 4- 7), wherein
the net-shaped framework comprises an upper disc surface (10) (Figs. 3A- 7), a waist part (See Fig. 7 - - showing waist part as combination of reference numbers 21 and 22), and a lower disc surface (10’) (Figs. 3A- 7) which are formed in sequence, the lower disc surface (10’) is provided with a melt tail end (MTE) (See Annotated Exploded Fig. 4- 1 - - encircled portion in the proximal end) of the net-shaped framework, and a limiting through hole (24) (Fig. 4) is formed in the melt tail end (MTE); and
the locking member (21, 31) comprises a tensioning part (21) and a locking part (31), wherein the tensioning part (21) is radial, a diffusion end (DE) (See Annotated Exploded Fig. 4- 2 - - encircled portion of the distal end) of the tensioning part (21) is connected to the upper disc surface (10), and a contraction end (CE) (See Annotated Exploded Fig. 4- 2) of the tensioning part (21) is connected to the locking part (31);
a locking ring (25) (Figs. 4- 7) is provided at the proximal end of the locking part (21), the diameter of the locking ring (25) is greater than that of the distal end of the limiting through hole (24), and the locking ring (25) can be slotted into/penetrate out of the limiting through hole (24) in the melt tail end (MTE) by means of deformation (p. 8, 2nd Paragraph - - Thus, the two lids 10 and 10 'can be assembled one against the other, inner face against inner face, the elastic collar 25 of the male stud 21 to snap or "clipping" and permanently subject to the interior of such complementary fastening means 22-24-26, this in a simple, almost automatic manner, the manipulator having just to pull the rod 31 or inner cannula, in the retracted position, relative to the second intermediate cannula 32 of the catheter 30, as illustrated in FIG. 7, to engage the complementary fastening means 21 and 22 and to engage them, which makes it possible to assemble the two caps 10 and 10 'by snap-fastening, by enclosing the wall 7 between the membranes 11-11' deployed lids 10 and 10 '; it is noted that “means of deformation” is interpreted under 35 U.S.C. 112(f) as the elastic deformation of elastic collar 25 snap fitting in order to fit within the bottleneck 26 (See P. [0054] of applicant’s Specification - - “the locking ring 322 has an elastic deformation space”).
Regarding claim 13, Della further discloses wherein the waist part of the net-shaped framework can penetrate through the septal defect of body tissues (See Fig. 7), and when the locking ring (25) is limited in the limiting through hole (24) of the melt tail end (MTE), the locking part (31) drives the tensioning part (21) to enable the upper disc surface (10) to be close to the lower disc surface (10’) (See Figs. 6, 7), so that the upper disc surface (10) and the lower disc surface (10’) produce a clamping force around the septal defect to enable the occluder to occlude the septal defect (See Fig. 7 - - showing clamping of two tissue walls of the atrial septum 7) (p. 8, 2nd Paragraph - - the manipulator having just to pull the rod 31 or inner cannula, in the retracted position, relative to the second intermediate cannula 32 of the catheter 30, as illustrated in FIG. 7, to engage the complementary fastening means 21 and 22 and to engage them, which makes it possible to assemble the two caps 10 and 10 'by snap-fastening, by enclosing the wall 7 between the membranes 11-11' deployed lids 10 and 10 '; it is noted that elastic collar 25 snap fitting is interpreted as driving the male stud 21 by the locking part 22).
Regarding claim 14, Della further discloses wherein the locking ring (25) can enter the limiting through hole (24) and is slotted into the limiting through hole (24) by means of deformation (See Fig. 7) (p. 8, 2d Paragraph - - Thus, the two lids 10 and 10 'can be assembled one against the other, inner face against inner face, the elastic collar 25 of the male stud 21 to snap or "clipping" and permanently subject to the interior of such complementary fastening means 22-24-26 ;it is noted that “means of deformation” is interpreted under 35 U.S.C. 112(f) as the elastic deformation of elastic collar 25 snap fitting in order to fit within the bottleneck 26 (See P. [0054] of applicant’s Specification - - “the locking ring 322 has an elastic deformation space”)).
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) 2- 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Della et al. (WO 2011/089459 A1) in view of Eskuri et al. (US Pub. No. 2007/0179527 A1).
Regarding claim 2, Della discloses the apparatus of claim 1, Della further disclosing wherein the opening diameter of the distal end of the first through hole (OD1) (See Annotated Exploded Fig. 4- 1) is smaller than the diameter of the locking ring (25) (DLR) (See Annotated Exploded Fig. 4- 1 - - dashed line along tapered portions that retain the locking ring (25) inside the limiting through hole (24)), and the opening diameter of the proximal end of the first through hole (OD2) (See Annotated Exploded Fig. 4- 1) is greater than the diameter of the locking ring (25) (DLR), but Della does not disclose
(claim 2) wherein the limiting through hole comprises a plurality of first through holes in serial communication with one another as claimed;
(claim 4) wherein the limiting through hole further comprises a second through hole in communication with the first through hole at the proximal end, and the opening diameter of the distal end of the second through hole is equal to the opening diameter of the proximal end of the second through hole.
However, Eskuri teaches an occluder in the same field of endeavor (Title, Abstract)
(claim 2) wherein the limiting through hole (222) (Fig. 2A) comprises a plurality of first through holes (224) (Figs. 2A, 2B) in serial communication with one another as claimed (P. [0018] - - In various embodiments, surfaces of the lumen 216 define first engaging elements 224. As shown in FIG. 2A, the first engaging elements 224 can be positioned along and extend along the lumen 216 from the opening 222 toward the distal end 220 of the first elongate body 212. In various embodiments, the first engaging elements 224 include surfaces defining a number of projections 226 and indentations 228. As shown in FIG. 2A, the projections 226 and indentations 228 are symmetrically arranged along a longitudinal axis of the first elongate body 212, such that each indentation 228 and each projection 226 alternate along the longitudinal axis. As will be discussed herein, the first engaging elements 224 of the first elongate body 212 and a second engaging element 236 of the second elongate body 214 can interact to adjust the distance between the first and second occluder pads 238 and 240 and to secure the adjusted distance);
(claim 4) wherein the limiting through hole (222) further comprises a second through hole in communication with the first through hole at the proximal end (See Fig. 2A - - showing openings between projections 226 associated with each engaging element 224), and the opening diameter of the distal end of the second through hole is equal to the opening diameter of the proximal end of the second through hole (See Fig. 2A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the limiting through hole associated with Della to comprise a plurality of first through holes in serial communication with one another according to the teachings of Eskuri because it would allow the user to adjust the distance between the upper and lower disc surfaces and to secure the adjusted distance (See Eskuri - - P. [0018]).
Additionally, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the single limiting through hole associated with Della into a plurality of first through holes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 3, Della in view of Eskuri discloses the apparatus of claim 2, Della further disclosing wherein longitudinal sections of the first through holes are trapezoidal (See Annotated Exploded Fig. 4 - - showing the two solid parallel lines (OD1, OD2) separated by the tapered surfaces of the interior of bottleneck 26 forming a trapezoid shape).
Regarding claim 8, Della discloses the apparatus of claim 1, but Della does not disclose
(claim 8) wherein an external thread is formed on the surface of the melt tail end, and the occluder is connected to an external push device through the external thread.
However, Eskuri teaches an occluder in the same field of endeavor (Title, Abstract)
(claim 8) wherein an external thread (790) (Fig. 7C) is formed on the surface of the melt tail end (712) (Fig. 7C - - it is noted that while 712 is analogous to the melt tail end, the positioning of the external push device is opposite that of Della and the external push device is not incorporated into the rejection), and the occluder is connected to an external push device (788) (Fig. 7) through the external thread (790) (P. [0075] - - In various embodiments, the method can further include adjusting the distance between the first and second occluder pads 712 and 714 to occlude the PFO 792. In one embodiment, the distance between the first and second occluder pads can be adjusted by imparting a pulling force on the first occluder pad 738 so as to compress tissue surrounding the first side 794 of the PFO 792 with the first occluder pad 712 while moving the second occluder pad 740 toward the first occluder pad 738. To do this, the pulling member 790 can be reversibly attached to first elongate body 712 of the occlusion device 710 and a pulling force can be exerted on the pulling member 790 so as to pull the first elongate body 712 toward the second occluder pad 740, as shown in FIG. 7C; It would have been obvious to a person having ordinary skill in the art to connect the external thread to the proximal push device (cannula 32) associated with Della in order to assist in the pushing because changing the orientation of pushing and pulling is within the skill of a person having ordinary sill in the art).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the occluder associated with Della in order to include an external thread connected to an external push device according to the teachings of Eskuri because it would allow the distance between the first and second discs be adjusted by imparting a force on a first disc so as to compress tissue surrounding the first side of the tissue opening while moving the second disc toward the first disc (Eskuri - - Ps. [0073], [0075]).
Claim(s) 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Della et al. (WO 2011/089459 A1) in view of Kothwala (WO 2019/064308 A1).
Regarding claim 5, Della discloses the apparatus of claim 1, but Della does not disclose
(claim 5) wherein the locking part further comprises a pull thread, the distal end of the pull thread is fixed on the upper disc surface, and the proximal end of the pull thread is wound to form the locking ring;
However, Kothwala teaches an occluder in the same field of endeavor (Abstract)
(claim 5) wherein the locking part further comprises a pull thread (32) (Figs. 1- 2) the distal end (34) (Fig. 1) of the pull thread (32) is fixed on the upper disc surface (12) (Figs. 1- 2) and the proximal end (36) (Figs. 1- 2) of the pull thread (32) is wound to form the locking ring (40) (Figs. 1- 2) (Ps. [0020], [0022] - - the occluder 100 has a locking system 30. The locking system 30 keeps the upper disc 12 and the lower disc 14 of the occluder 100 anchored to the tissue wall containing an opening and/or defect effectively. The locking system 30 of the occluder 100 includes a suture 32, and an anchor 40 coupled to the suture 32. The suture 32 includes a first end 34 and a second end 36. The first end 34 of the suture 32 may be attached to the neck of the first end 11 of the frame 10. Similarly, the second end 36 of the suture 32 may pass through the neck of the second end 13 of the frame 10; The suture 32 may be attached at one of the disc and knotting is done at the opening of another disc. The anchor 40 is attached above the knot. In an embodiment, when a pulling force is applied to the loose end of the suture, the occluder 100 is locked and provides complete closure at the site of a defect; it is noted since suture 32 is wound into a knot above which the anchor is disposed such that the anchor 40 includes the knot made in the suture 32, the proximal end of the pull thread (32) is broadly interpreted as being wound to form the locking ring (40)).
The pull thread and locking ring taught by Kothwala performs the same function of pulling and locking the upper disc surface and lower disc surface to provide a complete closure at the site of a defect as the rod (31) and male stud (21) associated with Della. Thus, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute one known element (pull thread and locking ring taught by Kothwala) for another (rod (31) and male stud (21) associated with Della) since the substitution would have yielded predictable results, namely, pulling and locking the upper disc surface and lower disc surface to provide a complete closure at the site of a defect (Kothwala - - Ps. [0020], [0022]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 9, Della discloses the apparatus of claim 1, but Della does not disclose
(claim 9) wherein the side wall of the melt tail end is further provided with a developing ring arranged surrounding the limiting through hole. It is noted “developing ring” is interpreted as visual under fluoroscopy or other imaging devices (See P. [0051] of applicant’s Specification - - “in the surgical imaging process, when the locking ring 322 is pulled, the locking ring 322 will pass the developing ring 142, so that whether the occluder is locked can be clearly judged to realize visual operations, thereby significantly increasing efficiency of the operation”).
However, Kothwala teaches an occluder in the same field of endeavor (Abstract)
(claim 9) wherein the side wall of the melt tail end (13) (Figs. 1- 2) is further provided with a developing ring (22) (Fig. 1) arranged surrounding the limiting through hole (P. [0021] - - the frame 10 of the occluder 100 may include a plurality of markers on first end 11 and/or second end 13 of the frame 10. The markers are used to visualize the position of the occluder 100 during fluoroscopy imaging. In an exemplary embodiment, a first marker 20 is positioned on the first end 11 and a second marker 22 is positioned on the second end 13 of the occluder 100 … The markers 20 and 22 may include without limitation, radiopaque markers Stainless steel, Platinum, Gold, Platinum-lridium, Tantalum, etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the melt tail end associated with Della to include a developing ring according to the teachings of Kothwala because it would allow the user to visualize the position of the occluder during fluoroscopy imaging (Kothwala - - P. [0021]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Della et al. (WO 2011/089459 A1) in view of Kothwala (WO 2019/064308 A1) as applied to claim 5 above, and further in view of Chen (CN 103654883 A).
Regarding claim 6, Della in view of Kothwala discloses the apparatus of claim 5, Della further disclosing wherein the opening diameter of the distal end of the limiting through hole (OD1) is smaller than the opening diameter of the proximal end of the limiting through hole (OD2) (See Annotated Exploded Fig. 4-1), the locking ring (25) can enter/penetrate out of the limiting through hole (24) from the opening at the distal end of the limiting through hole (OD1) by means of deformation (p. 12, 6th Paragraph - - In the case of the present invention, the recognized flexibility and shape memory properties of the polydioxanones are particularly advantageous precisely for the realization of the flexible reinforcement which must return to its initial shape, ie its flared campaniform neutral configuration as well as for the realization of the assembly means which must have flexible forms of complementary male and female studs, to be inserted elastically by snapping into a complementary form of receptacle having a flexible tubular wall having a recess with an elastic annular shrink neck; it is noted Della discloses an elastically deforming male (25) and female (26) parts of the locking assembly which is interpreted under 35 U.S.C. 112(f) as means of deformation (See P. [0054] of applicant’s Specification - - “the locking ring 322 has an elastic deformation space”)).
Della in view of Kothwala does not disclose
(claim 6) the locking ring comprises a plurality of locking ring units connected in series as claimed.
However, Chen teaches an occluder in the same field of endeavor (P. [0047])
(claim 6) the locking ring comprises a plurality of locking ring units (22a, 22b, 22c, 22d) connected in series, and the locking ring units (22a, 22b, 22c, 22d) can enter/penetrate out of the limiting through hole (24) one by one from the opening at the distal end of the limiting through hole (24) (See Figs. 12, 13) (Ps. [0079], [0080] - - the locking member comprises a locking ball 22a, 22b and is connected on the drawing space of at least one adjusting ball, adjusting ball such as depicted in FIG. 13 22c, 22d. each adjusting the diameter of the ball is less than the minimum diameter of passage, and two adjusting ball of diameter sum or any one locking ball are greater than the near end diameter 24 of the channel and any one regulating the diameter of the ball … Transition between the four ball length setting can preferably locking balls 22a and 22b between wire length is 7 ~ 25 mm, to substantially accommodate the thickness of the distance with the defect location between far-end sealing unit 42 and the near end blocking unit 43. the locking ball 22b, the balls 22c and 22d can be arranged in equal distance, such as distance can be I to 2 mm for adjusting the closure device to achieve the best state).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the single locking ring associated with Della in view of Kothwala such that the locking ring comprises a plurality of locking ring units connected in series as taught by Chen such that the locking ring units can enter/penetrate out of the limiting through hole associated with Della in view of Kothwala one by one from the opening at the distal end of the limiting through hole by means of deformation because it would allow the transition length between multiple anchor settings to substantially adjust the closure device to accommodate the thickness of the distance with the defect location (Chen - - Ps. [0079], [0080]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Della et al. (WO 2011/089459 A1) in view of Kothwala (WO 2019/064308 A1) and Park (KR 20210070230 A).
Regarding claim 7 in view of the rejection under 35 U.S.C. 112(b) above, Della discloses the apparatus of claim 1, but Della does not disclose
(claim 7) a pull thread
(claim 7) wherein the pull thread is made of a degradable material, and a developing thread is wound on the pull thread.
However, Kothwala teaches an occluder in the same field of endeavor (Abstract)
(claim 7) wherein the locking part further comprises a pull thread (32) (Figs. 1- 2) the distal end of the pull thread (32) is fixed on the upper disc surface (12) (Figs. 1- 2) and the proximal end of the pull thread (32) is wound to form the locking ring (40) (Figs. 1- 2) (Ps. [0020], [0022] - - the occluder 100 has a locking system 30. The locking system 30 keeps the upper disc 12 and the lower disc 14 of the occluder 100 anchored to the tissue wall containing an opening and/or defect effectively. The locking system 30 of the occluder 100 includes a suture 32, and an anchor 40 coupled to the suture 32. The suture 32 includes a first end 34 and a second end 36. The first end 34 of the suture 32 may be attached to the neck of the first end 11 of the frame 10. Similarly, the second end 36 of the suture 32 may pass through the neck of the second end 13 of the frame 10; The suture 32 may be attached at one of the disc and knotting is done at the opening of another disc. The anchor 40 is attached above the knot. In an embodiment, when a pulling force is applied to the loose end of the suture, the occluder 100 is locked and provides complete closure at the site of a defect; it is noted since suture 32 is wound into a knot above which the anchor is disposed such that the anchor 40 includes the knot made in the suture 32, the proximal end of the pull thread (32) is broadly interpreted as being wound to form the locking ring (40)).
The pull thread and locking ring taught by Kothwala performs the same function of pulling and locking the upper disc surface and lower disc surface to provide a complete closure at the site of a defect as the rod (31) and male stud (21) associated with Della. Thus, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute one known element (pull thread and locking ring taught by Kothwala) for another (rod (31) and male stud (21) associated with Della) since the substitution would have yielded predictable results, namely, pulling and locking the upper disc surface and lower disc surface to provide a complete closure at the site of a defect (Kothwala - - Ps. [0020], [0022]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Modified Della does not disclose
(claim 7) wherein the pull thread is made of a degradable material, and a developing thread is wound on the pull thread.
However, Park teaches a suture which solves the pertinent problem of allowing visualization of the tissue closure procedure to accurately determine the position of the of the suture (Abstract, 1st Paragraph; p. 2, 2d Paragraph; p. 3, 4th Paragraph, p. 3, 9th- 10th Paragraph)
(claim 7) wherein the pull thread (10) (Figs. 1- 2, 7) is made of a degradable material, and a developing thread (20) (Figs. 1- 2) is wound on the pull thread (p. 2, Abstract, 1st Paragraph; p. 2, 2d Paragraph; p. 3, 4th Paragraph, p. 3, 9th- 10th Paragraph - - The present invention relates to a biodegradable double structure comprising: a core portion made of a biodegradable monofilament; and a sheath portion in which biodegradable multifilaments are formed in the form of a braid along the outer circumferential surface of the core portion, wherein at least one of the core portion and the sheath portion includes a radiopaque material; The present invention relates to a biodegradable double structure with improved radiopacity by applying a braid shape, and specifically, a radiopaque material while having a core part or a sheath part in which the filament is in the form of a braid. It relates to a biodegradable double structure that can accurately determine the position of the double structure inserted into the body through radiation; Since the braid shape of the biodegradable double structure sheath part of the present invention is manufactured based on physical bonding, it does not cause thermal or chemical transformation, so that it is possible to impart uniform radiopacity to the surface of the biodegradable yarn; As a result, by producing the sheath portion of the biodegradable multifilament in the form of a braid, even if a small amount of radiopaque material is injected, there is an effect of exhibiting uniform radiopacity with high efficiency in the biodegradable double structure; The radiopaque material of the present invention is applied only to the sheath portion, and the core portion may be limited to a biodegradable material having a different decomposition rate while not exhibiting radiopacity and excellent biocompatibility).
It is noted that since the outer sheath (20) is a braided multifilament, the outer sheath is broadly interpreted as being wound on the pull thread (10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the pull thread associated with Della in view of Kothwala such that the pull thread is made of a degradable material (core monofilament portion) having a developing thread (braided multifilament outer sheath) wound on the pull thread because it would allow for improved and uniform radiopacity of the pull thread, thereby allowing for determining an accurate position of the pull thread during a procedure (Park - - Abstract, 1st Paragraph; p. 2, 2d Paragraph; p. 3, 4th Paragraph, p. 3, 9th- 10th Paragraph).
Claim(s) 10- 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Della et al. (WO 2011/089459 A1) in view of Chen (CN 103654883 A) and Sakamoto et al. (US Pub. No. 2016/0074023 A1).
Regarding claim 10, Della discloses the apparatus of claim 1, but Della does not disclose
(claim 10) further comprising flow blocking membranes, wherein the flow blocking membranes are made of a degradable material and comprise a first flow blocking membrane covering an inner wall of the upper disc surface, a second flow blocking membrane located on the cross section of the waist part, and a third flow blocking membrane covering an inner wall of the lower disc surface.
However, Chen teaches an occluder in the same field of endeavor (P. [0047])
(claim 10) further comprising flow blocking membranes (66a, 66b, 66c) (Fig. 17), wherein the flow blocking membranes (66a, 66b, 66c) comprise a first flow blocking membrane (66a) covering an inner wall of the upper disc surface, a second flow blocking membrane (66b) located on the cross section of the waist part, and a third flow blocking membrane (66c) covering an inner wall of the lower disc surface (Ps. [0086], [0089], [0090] - - To increase the occluder implant blocking effect of the defect part, the stopper may also be sewn with the choked flow film, number of choked flow membrane may be different and choked flow membrane is provided with a through hole for a locking member. It should be noted that the flow stopping film is provided here only as an example, and is not to limit the invention. In addition, flow resistant membrane of the same can be set, and can be set according to need choose choked flow film plugging in other embodiment the position and quantity; FIG. 17 shows stopper [0090] is sewed with three flow resistant membrane (66a, 66b, and 66c). Specifically, in the stopper 40. The near end capping unit 43 and far-end sealing unit in 42 and far-end sealing unit 42 in the proximal unit 43 of connection part 45 (i.e., usually called waist) are set with resistance film).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the occluder associated with Della in order to include flow blocking membranes according to the teachings of Chen because it would increase the occluder implant blocking effect of the septal defect (Chen - - P. [0086]).
Modified Della does not explicitly disclose
(claim 10) wherein the flow blocking membranes are made of a degradable material as claimed;
(claim 11) wherein the tensioning part comprises a plurality of groups of degradable pull belts, the proximal ends of each group of pull belts gather to be fixed on the locking part, and the distal ends of each group of pull belts penetrate through the third flow blocking membrane, the second flow blocking membrane and the first flow blocking membrane in sequence to be dispersedly fixed on the upper disc surface;
(claim 12) wherein each group of pull belts is composed of a plurality of degradable threads.
However, Sakamoto teaches an occluder in the same field of endeavor (Abstract)
(claim 10) further comprising a flow blocking membrane (160) (Figs. 2A, 2B), made of a degradable material (See Figs. 2A, 2B - - showing a flow blocking membranes as a porous cylindrical layer) (Ps. [0026], [0046], [0047] - - According to the present invention, the medical material is readily releasable and left to indwell in a target area to be treated within a living body, and allows minimally invasive catheterization procedure with simple operation without an intricate mechanism. In addition, the medical material of the present invention poses little possibility of occurrence of a failure in the body in some distant future even if it remains in the body; In the defect hole closing material 100, a porous cylindrical layer 160, which is composed of any one of a nonwoven cloth, a sponge, a film, and a composite of them that are made of a bioabsorbable material, is placed on the inner surface of the cylindrical body; the first cylindrical section 110, the second cylindrical section 120, the string 140 (including the string used for constriction at the substantially central section 130), and the porous cylindrical layer 160 constitute the defect hole closing material 100 of the present embodiment. All of these constituent components are made of a bioabsorbable material, wherefore the defect hole closing material 100 exhibits bioabsorbability in its entirety).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the flow membranes associated with Della in view of Chen to be degradable according to the teachings of Sakamoto because it would provide a medical material which is readily releasable and left to indwell in a target area to be treated within a living body, facilitate minimally invasive catheterization procedure without an intricate mechanism, and pose little possibility of occurrence of a failure in the body in some distant future even if it remains in the body (Sakamoto - - Ps. [0026], [0046], [0047]).
Modified Della does not disclose
(claim 11) wherein the tensioning part comprises a plurality of groups of degradable pull belts, the proximal ends of each group of pull belts gather to be fixed on the locking part, and the distal ends of each group of pull belts penetrate through the third flow blocking membrane, the second flow blocking membrane and the first flow blocking membrane in sequence to be dispersedly fixed on the upper disc surface;
(claim 12) wherein each group of pull belts is composed of a plurality of degradable threads.
However, Sakamoto teaches an occluder in the same field of endeavor (Abstract)
(claim 11) wherein the tensioning part comprises a degradable pull belt (140) (Figs. 1- 2B, 5- 11), the proximal ends of pull belt gather to be fixed on the locking part, and the distal end of pull belt penetrates through the third flow blocking membrane, the second flow blocking membrane and the first flow blocking membrane in sequence to be dispersedly fixed on the upper disc surface (See Fig. 1) (P. [0068] - - the second cylindrical section 120 alone may be diametrically expanded first and then moved close to the first cylindrical section 110, and whereafter the first cylindrical section 110 may be diametrically expanded and then moved close to the second cylindrical section 120. In this case, the defect hole closing material can be changed in form variously with ease by … adding two or more strings 140 ; it is noted that the individual loop 140 is similar to applicant’s an individual loop 311 found in Fig. 7 of the instant application).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the degradable pull belt group (140) associated with Sakamoto to comprise a plurality of groups of pull belts since Sakamoto discloses that the procedure of sequentially expanding and pulling the upper disc surface (120) and the lower disc surface (110) could be facilitated by adding two or more degradable pull belt groups (140) (Sakamoto - - P. [0068]).
(claim 12) wherein the pull group (140) is composed of a degradable thread (P. [0047] - - the first cylindrical section 110, the second cylindrical section 120, the string 140 (including the string used for constriction at the substantially central section 130), and the porous cylindrical layer 160 constitute the defect hole closing material 100 of the present embodiment. All of these constituent components are made of a bioabsorbable material, wherefore the defect hole closing material 100 exhibits bioabsorbability in its entirety).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the pull groups associated with modified Della to be degradable according to the teachings of Sakamoto because it would provide a medical material which is readily releasable and left to indwell in a target area to be treated within a living body, facilitate minimally invasive catheterization procedure without an intricate mechanism, and pose little possibility of occurrence of a failure in the body in some distant future even if it remains in the body (Sakamoto - - Ps. [0026], [0046], [0047]).
Conclusion
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771