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 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(s) 1-11 is/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, the phrase "a sheath" in line 8 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “an integrated outer sheath” previously recited in claim 1 line 1. For the purpose of compact prosecution, they are interpreted to be the same.
Claims 2-11 are rejected by virtue of depending on claim 1.
Regarding claim 1, the phrase “the device body comprises an inserting portion and a holding portion connected front and back” in lines 2-3 renders the claim indefinite because it is unclear what is “connected front and back”. Examiner suggests Applicant to rewrite this limitation.
Regarding claim 2, the phrase “a combination of one or more of the following connection methods” renders the claim indefinite because it is unclear. The word “combination” requires at least two connection methods. However, the word “one or more” requires at least one connection method. So, it is unclear how many is the minimum requirement for claim 2.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilson et al. (WO 2023/212641).
Regarding claim 1, Tilson discloses
A medical device (device shown in figs. 15A-16B and pars. 0225-) with an integrated outer sheath (1535, fig. 15B), comprising:
a device body (1500, fig. 15A), wherein the device body (1500) comprises an inserting portion (distal portion of 1500 – towards the insertion site) and a holding portion (proximal portion of 1500 – away from the insertion site) connected front and back (see fig. 15A), a first outlet (proximal opening of lumen 1501) and a second outlet (proximal opening of lumen 1505) are arranged on the holding portion (see fig. 15A for proximal opening of 1501 and proximal opening of 1505 arranged on proximal portion of 1500), a tip end of the inserting portion is provided with a distal tip (see fig, 15A for distal portion of 1500 comprising a distal end/distal tip), a penetrating first through hole (distal opening of lumen 1501) and a second through hole (distal opening of lumen 1505) are arranged on the distal tip (see fig. 15A for distal opening of 1501 and distal opening of 1505 arranged on distal end/tip of distal portion of 1500), a first tube (1501) is connected to the first through hole (distal opening of 1501), and a terminal end of the first tube (proximal portion of 1501) extends into the holding portion (proximal portion of 1500, see fig. 15A) and communicates with the first outlet (proximal opening of 1501, see fig. 15A); and
a sheath (1535, fig. 15B), wherein both ends of the sheath are connected and sealed with the inserting portion respectively through a connecting structure (1527, see figs. 15A-15C), so that the sheath (1535) is detachably and rotatably sleeved outside the inserting portion (see figs. 15A-15C) to form an overtube of the inserting portion (see fig. 15C); a distal end of the sheath (distal end of 1535) is communicated with the second through hole (distal opening of 1505) of the distal tip (see figs. 15A-15C), a terminal end of the sheath (proximal end of 1535) is communicated with the second outlet (proximal opening of 1505) of the holding portion (see figs. 15A-15C), the sheath (1535) is sleeved outside the first tube (1501), and a gap between the sheath and the first tube (gap between 1535 and 1501, see fig. 15C) is a space used by the sheath to transport objects (Examiner notes: the limitation “used by the sheath to transport objects” is interpreted as functional limitation. See figs. 15A-15C for the diameters of lumen of 1535 being larger than diameters of 1501 and 1505 of 1500; and see par. 0225 for sheath being elongate and flexible. Therefore, gap/space between 1535 and 1501 is capable to transport objects).
Regarding claim 2, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein a connection method of the connecting structure (1527) comprises a combination of one or more of the following connection methods: a snap-fit connection, an interference fit connection, a threaded connection, and a magnetic connection (par. 0023).
Regarding claim 3, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein at least one sealing member (proximal sealing surface of 1527, see annotated figs. 15B-15C below) is arranged between an inner wall of the sheath (within 1535, see annotated figs. 15B-15C below) and an outer wall of the inserting portion (outside of 1500 and on the outer wall of distal portion of 1500 when 1500 being inserted within 1535 as shown in fig. 15C), the sealing member is positioned on one side of the connecting structure away from an end portion of the inserting portion (see annotated figs. 15B-15C below for the sealing member being on the proximal side of 1527 away from the distal side/distal portion of 1500), and the sealing member is fixed on the inner wall of the sheath (see annotated figs. 15B-15C below for the sealing member being fixed on the inner wall of 1535 since 1527 is fixed on 1535).
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Regarding claim 4, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein at least one sealing member (proximal sealing surface of 1527, see annotated figs. 15B-15C above) is arranged between the inner wall of the sheath (within 1535, see annotated figs. 15B-15C below) and an outer wall of the inserting portion (outside of 1500 and on the outer wall of distal portion of 1500 when 1500 being inserted within 1535 as shown in fig. 15C), and the sealing member is fixed on the outer wall of the inserting portion (see annotated figs. 15B-15C below for the sealing member being fixed on the outer wall of 1500 since 1500 is inserted into and fixed on 1535).
Regarding claim 6, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein the sheath is an elastically deformable flexible tube (see par. 0021 for the material of the sheath: “flexible, thin, resilient material”, “elastomers”, “rubber-like properties”.
Regarding claim 7, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein both the inner wall and an outer wall of the sheath are provided with a hydrophilic layer (see par. 0055 for “coating the inside (and …the outside) of the internal sheath or sheaths with a hydrophilic coating”).
Regarding claim 9, Tilson discloses
The medical device with the integrated outer sheath according to claim 1, wherein the inserting portion (distal portion of 1500) further comprises a protective tube (Examiner interpreted the middle portion of 1500 being a protective tube), at least one end of the protective tube is connected to the distal tip or the holding portion (Examiner notes: since 1500 is made of the proximal portion, the middle portion, and the distal portion. All of the portions are connected with each other), the protective tube (middle portion of 1500) is sleeved outside the first tube (1501), the sheath (1535) is sleeved outside the protective tube (see fig. 15C), and an inside and outside of the protective tube are interconnected (inside of 1500 and outside of 1500 are interconnected to form 1500).
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.
Claim(s) 5, 8, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tilson et al. (WO 2023/212641).
Regarding claim 5, Tilson discloses the medical device with the integrated outer sheath according to claim 1, except for wherein an inner diameter of the distal end of the sheath is smaller than an inner diameter of other portions of the sheath.
However, different embodiments of Tilson (embodiment in fig. 41B or embodiment in fig. 41C) teaches an inner diameter of the distal end of the sheath is smaller than an inner diameter of other portions of the sheath (see figs. 41B or 41C and par. 0277).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tilson embodiment in figs. 15A-16B such that the inner diameter of the distal end of the sheath is smaller than the inner diameter of other portions of the sheath, as taught by Tilson other embodiments, for the purpose of allowing the disposal/removal of the sheath cleaner and easier, and also facilitating the installation of the sheath (par. 0277 of Tilson).
Regarding claim 8, Tilson discloses the medical device with the integrated outer sheath according to claim 1, as set forth above, except for wherein the outer wall of the sheath is provided with raised patterns.
However, different embodiment of Tilson (embodiment in fig. 46A) teaches the outer wall of the sheath having raised patterns (see fig. 46A for zig zag region).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tilson embodiment in figs. 15A-16B such that the outer wall of the sheath having raised/zig zag patterns, as taught by Tilson embodiment, for the purpose of allowing the system to be inserted into small/tight area of the patient (pars. 0287-0288 of Tilson).
Regarding claim 10, Tilson discloses the medical device with the integrated outer sheath according to claim 8, as set forth above, except for wherein a plurality of leakage holes are arranged on the protective tube.
However, different embodiments of Tilson (embodiment in fig. 8A, and embodiment in fig. 11) teaches a plurality of leakage holes arranged on the tube (see figs. 8A and 11, pars. 0212, 0216).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tilson embodiment in figs. 15A-16B such that the tube comprises a plurality of holes, as taught by Tilson other embodiments, for the purpose of providing direct communication with each of the lumens of the tubes when needed (par. 0216 of Tilson).
Regarding claim 11, Tilson discloses the medical device with the integrated outer sheath according to claim 1, as set forth above, except for wherein an anti-slip structure is arranged on the outer wall of a proximal end of the sheath.
However, different embodiment of Tilson (embodiment in fig. 40B) teaches the outer wall of a proximal end of the sheath comprising a collar/anti-slip structure (see fig. 40B).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tilson embodiment in figs. 15A-16B such that the proximal end of the sheath comprising a collar, as taught by Tilson other embodiment, for the purpose of improving the ability to manually grasp and control the position of the sheath with respect to the device body and providing an airtight seal (par. 0274 of Tilson).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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