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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-16, in the reply filed on 11/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claim 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, Line 2: “over said wire coil\”. There is a backslash “\” that appears to be a grammatical error. 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 7, 13-14 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 "said wire core" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner best understands this limitation to mean “said wire coil”.
Claim 13 recites the limitation "said flexion section of said flexible tubular elongate member" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. The “flexible tubular elongate member” has no flexion section; the “auxiliary flexible tubular elongate member” comprises the flexion section as recited in claim 11. Examiner best understands this limitation to mean “said flexion section of said auxiliary flexible tubular elongate member”
Claim 14 recites the limitation “wherein said flexible tubular elongate member extends through a lumen defined through said flexible tubular elongate member”. This limitation is unclear as to how the flexible tubular elongate member could extend through a lumen defined through itself. Examiner best understands this limitation to mean “wherein said auxiliary flexible tubular elongate member extends through a lumen defined through said flexible tubular elongate member”.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20220022731 A1 Takao.
Regarding claim 1, Takao discloses a flexible tubular elongate member (101, Fig. 1) for use with a retroflexion system (abstract, paragraph 22-25), said flexible tubular elongate member comprising:
an exterior surface (outside surface of 101, Fig. 1) and an interior surface (a channel tube 10 extends through 101, therefore there is an interior surface, Fig. 1, paragraph 25) extending between a proximal end and a distal end of said flexible tubular elongate member (seen in Fig. 1), the interior surface defining one or more lumens through said flexible tubular elongate member between the proximal end and the distal end of said flexible tubular elongate member (Fig. 1, paragraph 25, 27-31, 36); and
a flexion section (103, Fig. 1) along the length of said flexible tubular elongate member between the proximal end and the distal end (paragraph 25-37) configured to be kink-resistant and/or deformation resistant (paragraph 72, 127, 143); wherein:
at least one of the exterior surface or the interior surface of said flexion section is shaped, configured, and/or dimensioned to facilitate flexing of said flexion section (Fig. 3, paragraph 111-127).
Claims 1-2, 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20050065401 A1 Saadat et al. (hereinafter Saadat).
Regarding claim 1, Saadat discloses a flexible tubular elongate member (10, Fig. 1, paragraph 59, main body 10 has a deflectable and/or steerable shaft 20) for use with a retroflexion system (paragraph 17, 73), said flexible tubular elongate member comprising:
an exterior surface (outside surface of 10, Fig. 1) and an interior surface (as seen in Fig. 2a, shaft 20 of the main body 10 has a wall 21 with an interior surface) extending between a proximal end (12, Fig. 1) and a distal end (14, Fig. 1) of said flexible tubular elongate member (seen in Fig. 1), the interior surface defining one or more lumens (23, 24, 26, Fig. 1, 2a) through said flexible tubular elongate member between the proximal end and the distal end of said flexible tubular elongate member (Fig. 1, 2a, paragraph 60, 64); and
a flexion section (20, Fig. 1) along the length of said flexible tubular elongate member between the proximal end and the distal end (seen in Fig. 1) configured to be kink-resistant and/or deformation resistant (paragraph 59, 73-74); wherein:
at least one of the exterior surface or the interior surface of said flexion section is shaped, configured, and/or dimensioned to facilitate flexing of said flexion section (paragraph 59, 73-79).
Regarding claim 2, Saadat discloses the limitations of claim 1, and further discloses wherein at least one of the exterior surface or the interior surface of said flexion section (20) is corrugated (as seen in Fig. 1, exterior surface of shaft 20 is corrugated).
Regarding claim 9, Saadat discloses the limitations of claim 1, and further discloses wherein the cross-sectional shape of the one or more lumens (23, 24, 26) through said flexion section (20) remains substantially the same as said flexion section is flexed (Fig. 9a-10d, paragraph 73-79).
Regarding claim 10, Saadat discloses the limitations of claim 1, and further discloses wherein said flexion section (20) extends along a portion of a distal end (14) of said flexible tubular elongate member (as seen in Fig. 1).
Regarding claim 11, Saadat discloses a system for retroflexing a flexible elongate member (first arm 30, Fig. 1, paragraph 61) of a medical device (2, Fig. 1) (paragraph 17, 73), said system comprising:
an elongated actuation component (96, Fig. 12a-13b, 17c-b, 21a-d, 27a-28b) extending along said flexible elongate member and having a proximal end and a distal end (paragraph 84-96);
a distal mount (66, Fig. 15) configured to be mounted with respect to the distal end of the flexible elongate member (seen in Fig. 15);
a pivot mount (16, Fig. 3a-d) configured to be mounted with respect to the flexible elongate member proximal to the distal mount (seen in Fig. 3b-d); and
an auxiliary flexible tubular elongate member (second arm 30, Fig. 1) configured to extend along the flexible elongate member (seen in Fig. 2, 3b-6, 15) and having a proximal end (32, Fig. 1) and a distal end (34, Fig. 1) (paragraph 61);
wherein:
the distal end of said auxiliary flexible tubular elongate member is operatively associated with said distal mount (66) (seen in Fig. 15);
the distal end of said actuation component (96) is operatively associated with said distal mount to cause flexion of the distal end of the flexible elongate member when said actuation component is pulled proximally (paragraph 84-96);
an actuation region of said actuation component pivots with respect to said pivot mount when said actuation component is pulled proximally to cause the flexible elongate member to retroflex (paragraph 84-96, seen in Fig. 17, 17a-c, actuation region of actuation component (96) is within the linkages (62) of the arm (30) and pivots with respect the pivot mount (16, Fig. 3a-d) when actuation component is pulled proximally);
said auxiliary flexible tubular elongate member comprises a flexion section (section of linkages 62 of distal end 34, Fig. 11-15), operatively associated with said distal mount to flex when said actuation component is pulled proximally (paragraph 84-96);
said flexion section is configured to be kink-resistant and/or deformation resistant when flexed (paragraph 74); and
one or more lumens (38, 114, Fig. 1, 2a, 14, 16b) are defined through said flexion section and have a cross-sectional shape unaffected and unchanged by flexing of said flexion section (seen in Fig. 16b, 17c).
Regarding claim 12, Saadat discloses the limitations of claim 11, and further discloses further comprising a flexible tubular elongate member (10, Fig. 1, paragraph 59) having a proximal end (12, Fig. 1) and a distal end (14, Fig. 1) with a lumen (23, 24, 26, Fig. 1, 2a) extending therebetween (paragraph 60, 64):
wherein:
said actuation component (96) extends through the flexible tubular elongate member lumen (Fig. 1-6, 15, actuation component (96) extends through arms (30) and arms (30) extend through lumen 26, therefore the actuation component (96) extends through the flexible tubular elongate member lumen (26));
said flexible tubular elongate member is configured to be mounted with respect to the flexible elongate member with the distal end (14) of the flexible tubular elongate member proximal to the distal end (34) of the flexible elongate member (30) (seen in Fig. 2-6);
the distal end of said flexible tubular elongate member forms said pivot mount (16) for said actuation component (seen in Fig. 3c-d, arms (30) pivot at pivot mount (16), actuation component (96) within arms (30) therefore pivot at the pivot mount (16)); and
said auxiliary flexible tubular elongate member (30) extends along said flexible tubular elongate member (10) with said flexion section (section of linkages 62 of distal end 34) extending distally beyond the distal end of the distal end (14) of said flexible tubular elongate member to be operatively associated with said distal mount (66) (seen in Fig. 2, 3b-6, 15, 20).
Regarding claim 13, Saadat discloses the limitations of claim 12, and further discloses wherein said flexion section (section of linkages 62 of distal end 34) of said auxiliary flexible tubular elongate member (30) does not extend to the proximal end (12) of said flexible tubular elongate member (10) (seen in Fig. 1-2, 11).
Regarding claim 14, Saadat discloses the limitations of claim 12, and further discloses wherein said auxiliary flexible tubular elongate member (30) extends through a lumen (26) defined through said flexible tubular elongate member (10) (paragraph 60-61, Fig. 1).
Regarding claim 15, Saadat discloses the limitations of claim 11, and further discloses wherein:
said flexion section has an exterior surface (outside surface of section of linkages 62 of distal end 34) and an interior surface (inside surface of section of linkages 62 of distal end 34), the interior surface defining the lumen through said flexion section (seen in Fig. 1, 2a, 14, 16b);
and at least one of the exterior surface or the interior surface of said flexion section is shaped, configured, and/or dimensioned to facilitate flexing of said flexion section (Fig. 1-6, 11-20, paragraph 84-93).
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.
Claims 3-4, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of US 5380304 A Parker.
Regarding claim 3, Saadat discloses the limitations of claim 2,
Saadat is silent on wherein said flexion section is reinforced.
However, Parker teaches a flexible introducer sheath (10, Fig. 1-2) comprising an exterior surface (outside surface of 10 seen in Fig. 1-2), an interior surface (inside surface of inner tube 22 seen in Fig. 2-4), a flexion section (section where wire coil (23, Fig. 2-4) extends between the proximal end (15, Fig. 1-2) of the sheath and the distal end (13, Fig. 1-2) of the sheath), and wherein the flexion section is reinforced (col. 2 line 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Parker to have wherein said flexion section is reinforced in order to provide reinforcement, kink-resistance and strength to the sheath as disclosed by Parker (col. 2 line 2-11, col. 8 line 21-27).
Regarding claim 4, the combination of Saadat and Parker teaches the limitations of claim 3, and Parker further discloses wherein said flexion section includes a wire coil (23, Fig. 2-4) between the exterior surface and the interior surface thereof reinforcing said flexion section (as seen in Fig. 2-4).
Regarding claim 6, Saadat discloses the limitations of claim 1.
Saadat is silent on wherein said flexion section includes a wire coil between the exterior surface and the interior surface thereof to facilitate flexion of said flexion section.
However, However, Parker teaches a flexible introducer sheath (10, Fig. 1-2) comprising an exterior surface (outside surface of 10 seen in Fig. 1-2), an interior surface (inside surface of inner tube 22 seen in Fig. 2-4), a flexion section (section where wire coil (23, Fig. 2-4) extends between the proximal end (15, Fig. 1-2) of the sheath and the distal end (13, Fig. 1-2) of the sheath), and wherein the flexion section includes a wire coil (23, Fig. 2-4) between the exterior surface and the interior surface thereof to facilitate flexion of said flexion section (col. 2 line 2-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Parker to have wherein said flexion section includes a wire coil between the exterior surface and the interior surface thereof to facilitate flexion of said flexion section, in order to provide reinforcement, kink-resistance and strength to the sheath as disclosed by Parker (col. 2 line 2-11, col. 8 line 21-27).
Regarding claim 7, the combination of Saadat and Parker teaches the limitations of claim 6, and Parker further discloses wherein said flexion section further comprises an outer tubular core layer (36, Fig. 3-4) over said wire coil (23) and an inner tubular core layer (12, Fig. 3-4) within said wire coil (23), thereby forming a multi-layer wall of said flexion section (as seen in Fig. 3-4).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Parker as applied to claim 4 above, and further in view of US 20180015254 A1 Cragg et al. (hereinafter Cragg).
Regarding claim 5, the combination of Saadat and Parker teaches the limitations of claim 4.
The combination is silent on wherein the exterior surface and the interior surface are corrugated as a result of the shape of said wire coil therebetween.
However, Cragg teaches a flexible catheter shaft (300, Fig. 5-6) having an exterior surface (outside surface of tubular membrane 316 (Fig. 6)) and an interior surface (inside surface of tubular membrane 316 (Fig. 6)) and the exterior surface and interior surface are corrugated as a result of the shape of a wire coil (314, 318, Fig. 6) therebetween (Fig. 5-7a, paragraph 41-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Saadat with Parker with the teachings of Cragg to have wherein the exterior surface and the interior surface are corrugated as a result of the shape of said wire coil therebetween in order to provide flexibility while reducing the likelihood of kinking as disclosed by Cragg (paragraph 44).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of US 5911715 A Berg et al. (hereinafter Berg).
Regarding claim 8, Saadat discloses the limitations of claim 1.
Saadat is silent on wherein one or more wall regions of said flexion section has alternating thick and thin wall thicknesses.
However, Berg teaches a flexible guide catheter (54, fig. 10-11) having a flexion section (61, Fig. 10-11) wherein one or more wall regions has alternating thick and thin wall thicknesses (col. 8 line 48-51, as seen in Fig. 11 with alternating grooves (66) and raised portions (68)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Berg to have wherein one or more wall regions of said flexion section has alternating thick and thin wall thicknesses in order to provide more flexibility as disclosed by Berg (col. 8 line 41-43, 52-55).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Cragg.
Regarding claim 16, Saadat discloses the limitations of claim 11.
Saadat is silent on wherein said flexion section is reinforced with a wire coil.
However, Cragg teaches a flexible catheter shaft (300, Fig. 5-6) having a flexion section (302, Fig. 5-6) reinforced with a wire coil (314, 318, Fig. 5-7a, paragraph 41-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Cragg to have wherein said flexion section is reinforced with a wire coil in order to provide flexibility while reducing the likelihood of kinking as disclosed by Cragg (paragraph 44).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771