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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/25/24 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: [0044] provides reference numeral 31 for a “syringe” but a syringe and/or numeral 31 is not shown in the drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
the headband 40 is not labeled on any of the overall device views (i.e.: FIG. 1 or 2) as described in at least [0045]. Although the individual headband element is shown in a detailed view in FIG. 4, the headband is not labeled on the overall balloon retractor device as recited by at least claim 11 and relevant to the depending claims therefrom. Therefore, a figure of the overall device should depict where the headband 40 is located as is required by the drawings (see MPEP § 608.02.V(h): “Views”). No new matter should be entered. (For example, the headband could be shown as attached to the balloon retractor buckles as recited in claim 13)
The “hollow sheath tube” (50, see FIG. 5) is not labeled on any of the overall device views (i.e.: FIG. 1 or 2) as described in at least [0046]. Although the individual hollow sheath tube element is shown in a detailed view in FIG. 5, the hollow sheath tube is not labeled on the overall balloon retractor device as recited by at least claim 14 and the depending claims therefrom. Therefore, a figure of the overall device should depict where the hollow sheath tube 50 is located as is required by the drawings (see MPEP § 608.02.V(h): “Views”). No new matter should be entered. (Does the hollow sheath tube 50 replace sheath 16 in FIG. 2? Is sheath tube 50 a separate sheath provided on the overall balloon retractor but located internally/externally of sheath 16?)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“three radiopaque parts” as in at least claim 5
the “protruding portion” in at least claim 11
the “radiopaque line” embedded in the hollow sheath tube as in at least claim 16
“another end of the three-way round joint is connected with a main shaft to accommodate the catheter” as in at least claim 17 (the three-way round joint portion 54 that connects to the main shaft, see the current Application’s [0047], is not shown in the overall device views depicting the main shaft 20, such as FIG.1/2. Thus the connection between the joint and the main shaft as claimed is not shown).
The sheath tube auxiliary device comprising “an OVAL bottom” as in at least claim 18. The “elliptical bottom” 58 as described in [0048] is part of the 3-way round joint, not the sheath tube auxiliary device (see 112b rejection below)
A sheath tube positioned “within” the sheath tube auxiliary device as in at least claim 18 (see 112b rejection below)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "50" and "51" have both been used to designate a hollow tube (see FIG.5). [0046] of Applicant disclosure describes a sheath tube 50 provided with a hole 51, but the hole 51 as labeled in FIG. 5 appears to merely label another portion of the sheath 50 and does not depict any “hole” structure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0035] discloses that the length scale 15 (see Fig.1) is “of the handle”. [0036] discloses that the catheter 10 has the length scale 15. Thus, the specification has inconsistent support for the claimed subject matter in claim 3. See 112b rejection of claim 3 below for further explanation. See also MPEP § 2173.03.
Appropriate correction is required.
Claim Objections
Claims 1, 8, 10, 13, and 17 are objected to because of the following informalities:
Claim 1 recites the limitation "the catheter portion" in line 13. There is insufficient antecedent basis for this limitation in the claim and should read –a catheter portion-- for claim language clarity.
Due to claim dependency, claims 2-18 are subsequently rejected under 112b.
Claim 8 lines 4-5 read “a head portion of the main shaft includes a locking sliding block for fixing or loosening the catheter passing through main shaft” and should likely read --a head portion of the main shaft includes a locking sliding block for fixing or loosening the catheter passing through the main shaft-- for grammatical reasons
Claim 10 lines 3-4 read “when needed for controlling fluid injection and maintain pressure within the curved bendable balloon” and should likely read --when needed for controlling fluid injection and maintaining pressure within the curved bendable balloon-- for grammatical reasons
Claim 13 lines 1-2 read “fixing head belt main body” and should likely read --fixing head [[belt]] band main body-- to align with the language presented for the structure in claim 11, from which claim 13 depends
Claim 17 lines 2-3 read “of three-way round joint is connected with the hollow sheath tube” and should likely read --of the three-way round joint is connected with the hollow sheath tube-- for grammatical reasons
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 1-18 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.
Regarding claim 1, lines 1-2 recite “A curved balloon catheter retractor comprising: a distal end of a catheter is provided with a positioning balloon, close to the distal end of the catheter…”. However, the language is unclear to the examiner because the claim seems to recite the positioning balloon provided “on” a distal end of a catheter and the positioning balloon “close to” the distal end of the catheter. According to Applicant disclosure (see Fig. 7 and [0031]), the positioning balloon (11) is provided on the distal end of the catheter. It appears (see Fig. 7) that the positioning balloon is located “close” to a distal tip of the distal end of the catheter. Therefore, for purposes of examination, the examiner interprets that claim 1 lines 1-2 read “A curved balloon catheter retractor comprising: a distal end of a catheter is provided with a positioning balloon, close to the distal [[end]] tip of the catheter…”, to align with Applicant disclosure regarding proper placement of the positioning balloon along the catheter.
Due to claim dependency, claims 2-18 are subsequently rejected under 112b.
Regarding claim 3, lines 1-2 recite “wherein the handle has a length scale portion for marking the depth of the catheter insertion”. However, in light of the specification and drawings, it is unclear to the examiner if the handle has a length scale portion (see the current Application’s [0035] and Fig.1) or the catheter has the length scale portion (see the current Application’s [0036]). See MPEP § 2173.03: “A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure”. The disclosure in [0036] that the catheter has the length scale portion conflicts with the claim and the disclosure in [0035] and therefore the claim is indefinite. For purposes of examination, the examiner will interpret the claim as it currently reads. However, the discrepancy should be addressed by Applicant upon reply.
Regarding claim 5, lines 1-4 recite “wherein the bendable curved balloon includes three radiopaque parts used for displaying the relative positions of the proximal end of the catheter, a middle part of the bendable curved balloon, and the distal end of the catheter, respectively.” However, in light of the specification, it is unclear to the examiner how the bendable curve balloon includes radiopaque parts for displaying the proximal end of the “catheter” and the distal end of the “catheter”. According to Applicant disclosure, the three radiopaque parts display a proximal, middle, and distal end of the bendable balloon (see at least [0016] & [0037]: three radiopaque parts WITHIN the curved balloon display proximal, middle, distal ends of curved balloon). Therefore, for purposes of examination, the examiner interprets claim 5 lines 1-4 to read “wherein the bendable curved balloon includes three radiopaque parts used for displaying the relative positions of [[the]] a proximal end [[of the catheter]], a middle part [[of the bendable curved balloon]], and [[the]] a distal end of the [[catheter]] bendable curved balloon, respectively”, to best align with Applicant disclosure of the structure.
Claim 13 recites the limitation "the two connecting buckles" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets that claim 13 depends from claim 12 where the two connecting buckles are first introduced.
Regarding claim 18, lines 1-2 recite “further including a sheath tube auxiliary device comprising a flexible solid tube having a smooth head and an oval bottom”. However, in light of the specification, it is unclear to the examiner how the sheath tube auxiliary device comprises “an oval bottom”. According to Applicant disclosure (see Fig. 5 and [0048]), the sheath tube auxiliary device (56) comprises the elliptical bottom (58). However, it appears that the “elliptical bottom” is a part of the 3-way round joint (52), seen in better detail in Fig. 6 and described in [0047]. In [0021] of Applicant disclosure, it is merely stated that the sheath tube auxiliary device comprises the “oval” bottom, but there does not appear to be any other depiction of a “bottom” with a shape likened to an “oval” (see drawing objection above). Perhaps claim 18 means to recite the cylindrical/ “oval” cross-section of the “proximal” (where 56 meets 50 as shown in Fig. 5) end of the sheath? Therefore, for purposes of examination, the examiner interprets that a sheath tube auxiliary device with a cylindrical cross-section meets the claim limitation.
Next, regarding claim 18, line 4 recites “guide a sheath tube positioned within the sheath tube auxiliary device”. However, in light of the specification, it is unclear to the examiner what sheath tube is positioned “within” the sheath tube auxiliary device (see drawing objection above). Applicant only discloses that the sheath tube auxiliary device 56 guides the sheath tube 50 (see Fig. 5 and [0049]). There is not disclosure that sheath tube 50 is inserted WITHIN the sheath tube auxiliary device 56. [0049] appears to discloses that 56/50 enter the cavity, 56 is removed, and then the balloon catheter is inserted through remaining sheath 50. Therefore, for purposes of examination, the examiner interprets that any sheath tube auxiliary device with a sheath tube extending proximally would meet the claimed limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 6-7, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al. (U.S. PGPUB No. 2014/0066939), hereinafter Kaiser.
Regarding claim 1, Kaiser discloses curved balloon catheter retractor comprising:
a distal end (10) of a catheter (5, see ‘Modified FIG. 23’ below and [0123]: multiple balloons 15. FIG.23’ referenced to show arrangement of the multiple balloons 15a, 15b on the catheter system. FIG. 38F will be referenced for specific balloon structures; [0167] discloses the embodiment of FIG. 38F that is relied upon for structures of the crease (see below), but the overall arrangement of the entire catheter is being shown in FIG. 23’ below which is also used with embodiment of FIG. 38F)
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is provided with a positioning balloon (“15a”, see ‘Modified FIG. 23’ above and ‘Modified FIG. 38F’ below),
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close to the distal [[end]] tip of the catheter (as seen in ‘Modified FIG. 23’ and ‘Modified FIG. 38F’ above), and a bendable curved balloon (“15b”, see ‘Modified FIG. 38F’ above and [0099] & [0167]: curved balloon comprises crease to facilitate bending as shown in FIG. 38G) having a segmented shape (see segments formed by creases in ‘Modified FIG. 38F’ above), and with the entire bendable curved balloon (“15b”), in internal fluid communication (see [0167] and [0170] balloon “15b” is formed of one balloon “15” with creases and thus must be in internal fluid communication at all segments because the segments form one balloon that is inflated),
the positioning balloon (“15a”) and the bendable curved balloon (“15b”) are connected to injection port (port 55, see FIG. 18 and [0125-0126]: lumen 45 and inflation mechanism 50 selectively/ individually inflate each of the multiple balloons 15) at the proximal end (on Kaiser handle 20 as shown in FIG. 18) of the catheter (5) through lumen within the catheter (5, see [0125]: lumen 45 within catheter. See lumen 45 in FIG. 19),
a proximal end (rightward in FIG. 23’) of the catheter (5) is provided with a handle (see ‘Modified FIG. 23’ above, “handle” structure is the proximal end of the catheter that is retained within Kaiser’s externally grasped region 20. This interpretation aligns with Applicant’s disclosure of the “handle” as in the current Application’s FIG. 1 and [0052]. The current Application’s “main shaft” 20, see Fig. 2, [0040-0042], and [0052], is analogous to Kaiser’s externally grasped portion 20.) for adjusting the position of the catheter (see [0125-0127]: externally grasped portion 20 has inflation mechanism 50 and steering mechanism 40), and
wherein in the unused state, the positioning balloon (15a) and the bendable curved balloon (15b) are tightly attached to the catheter (see [0125-0127]: inflation/deflation controllable and therefore in a completely deflated state, the balloons would be close to the catheter and the advancing of catheter occurs in deflated state), and in the use state, a fluid is injected via the injection port (55, see FIG. 18) of the positioning balloon (15a) to inflate the positioning balloon to achieve a desired positioning effect (see [0125-0127]: inflation of each balloon independently controllable), and the fluid is injected into the bendable curved balloon (15b) to bend (see bent configuration in FIG. 38G) the bendable curved balloon (15b) and [[the]] a catheter portion to a desired retraction position deviating to one side (see ‘Modified FIG. 38H’ below and see [0167] & [0170] for description of desirable position of catheter by bending).
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Kaiser (balloon structures of FIG. 38F in use with catheter of FIG. 23’) is silent to the positioning balloon and the bendable curved balloon connected to “respective injection ports” through “lumens” of the catheter.
However, in another embodiment (see FIG. 29), Kaiser teaches a secondary inflation lumen (65) of the catheter (see [0163]) in addition to the first inflation lumen (45) provided with a respective injection port (55, see FIG. 18 and [0125]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the first inflation lumen with respective injection port disclosed by Kaiser FIG. 38F such that there is an additional inflation lumen with respective injection port as taught by Kaiser FIG. 29 for the purpose of providing distinct lumens for the inflation/deflation of each balloon instead of using a valve (see [0125] and [0163]), thus achieving the positioning balloon and the bendable curved balloon connected to “respective injection ports” through “lumens” of the catheter.
Regarding claim 4, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, but Kaiser (balloon structures of FIG. 38F in use with catheter of FIG. 23’) is silent to “wherein the catheter is made of a material that is not easily twisted.”
However, in a separate embodiment (see FIG. 95), Kaiser teaches a catheter (205) wherein the catheter (205) is made of a material that is not easily twisted (see [0222]: catheter includes kink resistant braid 270 over catheter shaft 260, aligning with Applicant disclosure in at least [0036]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter shaft of Kaiser (balloon structures of FIG. 38F in use with catheter of FIG. 23’) to be made of a material that is not easily twisted as taught by Kaiser (FIG. 95) for the purpose of providing excellent column strength to the catheter (see [0221]), thus achieving “wherein the catheter is made of a material that is not easily twisted.”
Regarding claim 6, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser further discloses wherein the length of the bendable curved balloon is preferably 9-11 cm (see [0150]: balloon 15 can be 75mm==7.5cm or MORE, disclosing the claimed range, depending on various design considerations.).
Regarding claim 7, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser further discloses wherein the number of curved balloon segments is 4 (see ‘Modified FIG. 38Fi’ below).
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Kaiser (balloon structure of the embodiment of FIG. 38F with the catheter of FIG. 23’) is silent to the number of curved balloon segments being specifically “in the range of 5 to 8.”
However, Kaiser further teaches that the number of creases (74, see FIG. 38Fi’ above), which form the number of balloon segments, are formed at locations where folding is preferred (see [0169]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to increase the number of creases forming the balloon segments disclosed in Kaiser (FIG. 38F) as taught by Kaiser ([0169]) for the purpose of increasing the number of locations along the balloon that are preferably folded (see [0169]), thus achieving wherein the number of curved balloon segments is “in the range of 5 to 8.”
Regarding claim 14, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser discloses further comprising a hollow sheath tube (56, see FIG. 23’) which is a fixed non-rotating protective portion (see [0146]: sheath 56, aligning with Applicant disclosure in Fig. 5 and [0046]).
Regarding claim 18, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 14, and Kaiser discloses further including a sheath tube auxiliary device (57, see FIG. 23A) comprising a flexible solid tube (see [0148-0149]: tube 57 has curved end and therefore is flexible) having a smooth head (see [0149]) and an oval bottom (see oval opening/ cross section in FIG. 23A as interpreted under 112b), wherein the sheath tube auxiliary device (57) is a flexible solid tube to smoothly enter a human body cavity (see [0148-0149]: 57 placed first) and guide a sheath tube positioned within the sheath tube auxiliary device (proximally extending portion of tube 57) to prevent damage by the sheath tube during insertion, and enable smooth removal prior to insertion of the catheter into the sheath tube in the use state (see [0148-0149]: sheath 57 guides catheter into place until balloon reaches desired location. Thus sheath 57 can be/ enables removal prior to insertion of the catheter in the USE state/ where balloons are inflated).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 1 above, and further in view of Schulz (U.S. PGPUB No. 2017/0014605).
Regarding claim 2, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser (balloon structures of FIG. 38F in use with catheter of FIG. 23’) further discloses wherein, in the unused state (see [0146]: prior to inflation==unused state), the positioning balloon (15a, see ‘Modified FIG. 23’ above) and the bendable curved balloon (15b, see ‘Modified FIG. 23’ above) are tightly attached to the catheter (see [0125-0127]: inflation/deflation controllable and therefore in a completely deflated state, the balloons would be tightly attached to the catheter.) and covered by (See [0146]: balloons retained beneath sheath 56) a tubular protective shield (56), and the tubular protective shield (56) is removed in the use state (see [0146]: retractable sheath removed after delivery of balloons).
Kaiser (balloon structures of FIG. 38F in use with catheter of FIG. 23’) does not explicitly state that the tubular protective shield is “rigid”.
However, Schulz teaches a balloon catheter (see FIG. 1A-B and [0016]: may be double ballon catheter), wherein, in an unused state (shown in FIG. 1A), the balloon (see “uninflated balloon” in FIG. 1A) is covered (see [0015]: removable sheath covers all of uninflated balloon) by a rigid tubular protective shield (“sheath” in FIG. 1A-B and see [0012] & [0015]: rigid sheath and [0017]: other exemplary materials for sheath) and tightly attached to the catheter (as shown in FIG. 1A), and the rigid tubular protective shield (see “sheath” in FIG. 1B) is removed (see [0015]: sheath removed after balloon inflation) in the use state (use state shown in FIG. 1B with balloon inflated).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retractable sheath disclosed in Kaiser to be formed of a material that provides rigidity to the catheter tube as taught by Schulz for the purpose of forming the protective sheath with a stiffness that eases catheter insertion (see [0015]), thus achieving the tubular protective shield is “rigid”.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 1 above, and further in view of Orr et al. (U.S. PGPUB No. 2017/0348512), hereinafter Orr.
Regarding claim 3, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, but Modified Kaiser is silent to “wherein the handle has a length scale portion for marking the depth of the catheter insertion.”
However, Orr teaches a catheter (1222) with a handle (see ‘Modified FIG. 29’ below, the “handle” is a proximal end of the catheter, aligning with Applicant’s disclosure of the “handle” as in at least Fig. 1 and [0052]),
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wherein the handle has a length scale portion (markings 1236 forming length scale, see [0169]: markings on catheter tube 1222, aligning with Applicant disclosure of the length scale portion in [0036]) for marking the depth of the catheter insertion (see [0169]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle disclosed in Kaiser to include the length scale portion as taught by Orr for the purpose of determining the catheter insertion depth (see [0169]), thus achieving “wherein the handle has a length scale portion for marking the depth of the catheter insertion”.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 1 above, and further in view of Brucker et al. (U.S. PGPUB No. 2019/0314109), hereinafter Brucker.
Regarding claim 5, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser further discloses wherein the bendable curved balloon includes radiopaque parts (see [0156]: fluoroscopic markings can be disposed on balloon), but Kaiser is silent to the bendable curved balloon includes “three radiopaque parts used for displaying the relative positions of [[the]] a proximal end [[of the catheter]], a middle part [[of the bendable curved balloon]], and [[the]] a distal end of the [[catheter]] bendable curved balloon, respectively”
However, Brucker teaches a curved balloon catheter (see FIG. 1B), wherein the curved balloon (120) includes three radiopaque parts (see marker bands 160) used for displaying the relative positions of [[the]] a proximal end (see ‘Modified FIG. 1B’ below) [[of the catheter]],
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a middle part [[of the bendable curved balloon]] (see ‘Modified FIG. 1B’ above), and [[the]] a distal end (see ‘Modified FIG. 1B’ above) of the [[catheter]] bendable curved balloon (120), respectively.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the radiopaque portions of the bendable curved balloon disclosed in Kaiser to be placed specifically at the proximal end, middle part, and distal end as taught by Brucker for the purpose of serving as visualization indicia for the balloon section of the catheter and/or to seal portions of the balloon (see [0063]), thus achieving the bendable curved balloon includes “three radiopaque parts used for displaying the relative positions of [[the]] a proximal end [[of the catheter]], a middle part [[of the bendable curved balloon]], and [[the]] a distal end of the [[catheter]] bendable curved balloon, respectively”.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 1 above, and further in view of Tavallaei et al. (U.S. PGPUB No. 2021/0052854), hereinafter Tavallaei.
Regarding claim 8, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser further discloses wherein the proximal end of the catheter (“handle” as shown in “Modified FIG. 23’ above) includes a main shaft (20, see FIG. 23’) for holding the catheter (5, see [0124-0127]), the catheter passing through the main shaft (see [0124] at least shaft 35 of catheter extends through main shaft 20), and the main shaft (20) includes a mechanism (40, see FIG. 18) for adjusting the position of the catheter and the bendable curved balloon (see [0124-0127]).
Kaiser is silent to the main shaft for “rotating” the catheter, “and a proximal end of the main shaft includes a fixing screw for clamping the catheter passing through the main shaft, and a head portion of the main shaft includes a locking sliding block for fixing or loosening the catheter passing through main shaft.”
However, Tavallaei teaches a catheter steering device (see FIG. 6), including a catheter (130), wherein the proximal end (see FIG. 5B for internal visual of proximal end of catheter 130 affixed to slideblock 146 as described in [0092]) of the catheter (130) includes a main shaft (110B, see [0092]: handle 110B) for holding and rotating the catheter (see [0146]: handle 110B holds catheter in slide 146 and rotates via roller wheels), and a proximal end (see ‘Modified FIG. 6’ below—proximal end of main shaft is enclosed by rectangular outline)
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of the main shaft (110B) includes a fixing screw (148) for clamping the catheter passing through the main shaft (see [0092]: “fastening” screw 148 and thus screw 148 reasonably “for” clamping as required by the functional language recitation), and a head portion (see ‘Modified FIG. 6’ above—head portion of main shaft is enclosed by rounded-corner rectangular outline) of the main shaft (110B) includes a locking sliding block (146) for fixing or loosening the catheter passing through main shaft for adjusting the position of the catheter (see [0090]: slide allows advancing and retracting of catheter and thus reasonably for “fixing”/ holding in place the catheter to adjust catheter position).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main shaft disclosed in Kaiser to include a rotating mechanism for the catheter as taught by Tavallaei for the purpose of allowing manipulation of the catheter via at least two degrees of freedom (see [0003]), thus achieving the main shaft for “rotating” the catheter.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main shaft disclosed in Kaiser to include, at the proximal end, a fixing screw for clamping the catheter as taught by Tavallaei for the purpose of locking the position of the catheter (see [0092]), thus achieving “a proximal end of the main shaft includes a fixing screw for clamping the catheter passing through the main shaft”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main shaft disclosed in Kaiser to include, at a head portion, a locking sliding block for fixing the catheter as taught by Tavallaei for the purpose of providing an extraction/ withdrawal mechanism for the catheter (see [0090]) and subsequently providing a push/pull degree of freedom (see [0003]), thus achieving “a head portion of the main shaft includes a locking sliding block for fixing or loosening the catheter passing through main shaft”.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 1 above, and further in view of Sarna et al. (U.S. PGPUB No. 2019/0126010), hereinafter Sarna.
Regarding claim 9, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 1, and Kaiser further discloses wherein a tube (see tube extending proximally from port 55 in FIG. 18 and [0125]: port connects to fluid reservoir) is secured at one end of the curved balloon catheter retractor and is interconnected with a syringe (see [0159]: syringe can be provided to inflate balloon via port and syringe is connected such as by luer type/ other fitting. See FIG.91 for visual), and another end (tube connected to inflation port 55 as seen in FIG. 18) of the tube is connected to an injection port (55) of the curved balloon or positioning balloon at the distal end of the catheter (see [0125] and [0159]).
Kaiser is silent to the tube being a “high-pressure braided” tube.
However, Sarna teaches a balloon catheter (160, see FIG. 8C and [0105]) wherein a high-pressure braided tube (168, see [0105]: 168 formed with braid reinforcement to withstand pressurization) is secured at one end of the balloon catheter (160) and is interconnected with a syringe (172, see [0105]: inflation device 172 as shown in FIG. 8C may be syringe and is connected to tubing 168), and another end of the high-pressure braided tube is connected to an injection port (166, see FIG. 8B for visual and [0105]) of the catheter.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tube disclosed in Kaiser to be a high-pressure braided tube as taught by Sarna for the purpose of ensuring the tube withstands the pressurization delivered to the system when inflating the balloon via the syringe device (see [0105]), thus achieving the tube being a “high-pressure braided” tube.
Regarding claim 10, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 9, and Kaiser further discloses wherein the catheter (5, see FIG. 23’) is further provided with a two-way valve (see [0126]) having a switch in a middle portion (see [0126]: valve controllable between at least open/closed position and therefore must have a switch within==a middle portion), which can be connected between the injection port and the high-pressure braided tube when needed for controlling fluid injection and maintain pressure within the curved bendable balloon (see [0125-0127]: valve is for controlling inflation through port and from tube/ reservoir and therefore “can be” connected between the port and the braided tube “for” controlling fluid injection and maintain pressure within balloon) .
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser in view of Tavallaei as applied to claim 8 above, and further in view of Robinson (U.S. PGPUB No. 2019/0015636).
Regarding claim 11, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 8, but Modified Kaiser is silent to “further provided with a fixing head band for a patient's head having a main body portion with a large hole for accommodating a protruding portion behind the patient's head, such that the protruding portion is more comfortable to wear.”
However, Robinson teaches a catheter system (see FIG. 12 and [0058-0059]) further provided with a fixing head band (14, see FIG. 1 and [0060]) for a patient's head (see [0054]: strap 14 various length for attaching to areas such as head) having a main body portion (28, see FIG. 1 and [0037]) with a large hole (68, see FIG. 1 and [0046]) for accommodating a protruding portion (see [0041]: a portion of the catheter, see FIG. 12 with catheter C through hole 68) behind the patient's head (see [0041]: hole for holding catheter==a protruding portion and thus could be used anywhere such as “behind the patient’s head” as supported by [0054]), such that the protruding portion (portion of catheter through 68 see FIG. 12) is more comfortable to wear (see [0004]: Robinson’s device “more comfortable” than strap attached by adhesive).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Modified Kaiser to be provided with a fixing headband as taught by Robinson for the purpose of securing the medical device to the patient (see [0060]) at the head (see [0054]), thus achieving “further provided with a fixing head band for a patient's head having a main body portion with a large hole for accommodating a protruding portion behind the patient's head, such that the protruding portion is more comfortable to wear.”
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser in view of Tavallaei and Robinson as applied to claim 11 above, and further in view of Bierman et al. (U.S. PGPUB No. 2006/0124133), hereinafter Bierman.
Regarding claim 12, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 11, but Modified Kaiser is silent to “wherein the main shaft has two connecting buckles for connecting the fixing headband such that the main shaft and the entire catheter are fixed relative to the patient's head.”
However, Bierman teaches a catheter system with a main shaft (10, see FIG. 10) and a fixing headband (110, see FIG. 5A and [0076]: head pad 110), wherein the main shaft (10, see FIG. 10) has two connecting buckles (330, see [0102]: anchoring mechanism and see [0098]: fasteners known in the art) for connecting the fixing headband (110, see FIG. 5A) such that the main shaft and the entire catheter are fixed relative to the patient (see [0102-0109] and FIG. 12 in use).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main shaft taught by Modified Kaiser to include two connecting buckles as taught by Bierman for the purpose of providing a connection between the headband, patient, and catheter that prevents undesirable motion of the catheter (see [0114]) while allowing the connection to be removed if necessary (see [0117]), thus achieving “wherein the main shaft has two connecting buckles for connecting the fixing headband such that the main shaft and the entire catheter are fixed relative to the patient's head.”
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser in view of Tavallaei and Robinson as applied to claim 12 above, and further in view of Tse et al (U.S. PGPUB No. 2015/0119742), hereinafter Tse.
Regarding claim 13, the modified system of Kaiser teaches the curved balloon catheter retractor of claim [[11]] 12, but Kaiser is silent to “characterized in that the fixing head belt main body is provided with four connecting belts, and the connecting belt is provided with a string of connecting holes which can clamp and connect with the two connecting buckles of the head portion of the main shaft.”
However, Robinson teaches a catheter system (see FIG. 12 and [0058-0059]) further provided with a fixing head band (14, see FIG. 1 and [0060]) for a patient's head (see [0054]: strap 14 various length for attaching to areas such as head), the fixing head band (14) characterized in that the fixing head belt main body (28) is provided with connecting belts (strap portion 16 and 18, see FIG. 1 and [0052]), and the connecting belt (16/18) is provided with a string of connecting holes (76, see FIG. 11) which can clamp and connect with the two connecting buckles of the head portion of the main shaft (see [0052-0053]: holes 76 for connecting with buckle fastener 78 and thus “can” clamp and connect with two connecting buckles).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Modified Kaiser to be provided with a fixing headband characterized with the connecting belts and holws as taught by Robinson for the purpose of securing the medical device to the patient (see [0060]) at the head (see [0054]), thus achieving “characterized in that the fixing head belt main body is provided with connecting belts, and the connecting belt is provided with a string of connecting holes which can clamp and connect with the two connecting buckles of the head portion of the main shaft.”
Modified Kaiser in view of Robinson is silent to “four” connecting belts
However, Tse teaches a headband device (40, see Fig. 5 for visual of sole device) with four connecting belts (44, see Fig. 7 and [0019] for 4 straps).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to increase the number of connecting belts disclosed in Modified Kaiser in view of Robinson to be four connecting belts as taught by Tse.
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the two identified (Tse teaches the headband device with 3 or 4 belts, see Fig. 6 compared to Fig. 7 and [0019]), predictable (how to increase the number of straps extending from main body see [0020]) solutions with a reasonable expectation of success for forming the headband main body with four connecting belts instead of two, thus achieving “four” connecting belts.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 14 above, and further in view of Trask et al. (U.S. PGPUB No. 2009/0312786), hereinafter Trask.
Regarding claim 15, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 14, but Kaiser is silent to “wherein the hollow sheath tube includes a hole for spraying developing solution to display the position of the bendable curved balloon when in the use state.”
However, Trask teaches a hollow sheath tube (32, see FIG. 5A), wherein the hollow sheath tube (the distal end 33) includes a hole (71-78) for spraying developing solution to display the position of the bendable curved balloon when in the use state (see [0040]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hollow sheath tube disclosed in Kaiser with a hole for spraying developing solution as taught by Trask for the purpose of visually enhancing the site in which the practitioner will work (see [0040]), thus achieving “wherein the hollow sheath tube includes a hole for spraying developing solution to display the position of the bendable curved balloon when in the use state.”
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 14 above, and further in view of Fischer, JR. et al. (U.S. PGPUB No. 2013/0338637), hereinafter Fischer.
Regarding claim 15, the modified system of Kaiser teaches the curved balloon catheter retractor of claim 14, but Kaiser is silent to “wherein a radiopaque line is embedded within the hollow sheath tube and may be observed under X-ray.”
However, Fischer teaches a balloon catheter (see Fig. 2b) with a hollow sheath tube (140), wherein a radiopaque line (see [0034]: radiopaque marking such as a line) is embedded within the hollow sheath tube (140) and may be observed under X-ray (see [0034]: markings “embedded” and radiopaque inherently observed under X-ray).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hollow sheath tube disclosed in Kaiser to be embedded with a radiopaque line as taught by Fischer for the purpose of enhancing visualization to make precise positioning of the shaft easier (see [0034]), thus achieving “wherein a radiopaque line is embedded within the hollow sheath tube and may be observed under X-ray”.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kaiser as applied to claim 14 above, and further in view of Appling et al. (U.S. PGPUB No. 2018/0117284), hereinafter Appling.
Regarding claim 17, the modifies system of Kaiser teaches the curved balloon catheter retractor of claim 14, but Kaiser is silent to “wherein a bottom of the hollow sheath tube includes a three-way round joint, wherein one end of three-way round joint is connected with the hollow sheath tube, and another end of the three-way round joint is connected with a main shaft to accommodate the catheter, and a side edge of the three-way round joint is provided with a hole for injecting developing solution.”
However, Appling teaches a catheter system with a hollow sheath tube (62, see FIG. 1), wherein a bottom (38, see [0049]) of the hollow sheath tube (62) includes a three-way round joint (40, see [0049-0050]), wherein one end (see ‘Modified FIG. 1’ below)
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of three-way round joint (40) is connected with the hollow sheath tube (62), and another end (see ‘Modified FIG. 1’ above) of the three-way round joint (40) is connected with a main shaft (20) to accommodate a catheter (see [0048]: hub 20 has guidewire opening to thread through dilator), and a side edge (see ‘Modified FIG. 1’ above) of the three-way round joint (40) is provided with a hole (see [0060]) for injecting developing solution (see [0060]: fluid communication to joint 40 from flush port 100 and thus the hold is reasonably “for” injecting a fluid such as a developing solution).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hollow sheath tube disclosed by Kaiser to include a three-way round joint as taught by Appling for the purpose of removing the entirety of the sheath introduction system by way of the three way round joint