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 with traverse of Group I, claims 28-42, in the reply filed on September 3rd, 2026, is acknowledged. The traversal is on the ground(s) that it should be no undue burden on the Examiner to consider all claims in a single application. This is not found persuasive because, as pointed out in the Requirement for Restriction/Election dated August 3rd, 2026, the three groups do not share a single inventive concept since they lack a special technical feature because the only shared technical feature does not make a contribution over the prior art in view of Bonner et al. (Pub. No. 2004/0102829). Since the restriction was made under 371, the claims must have unity of invention through sharing a special technical feature, while Applicant is arguing undue burden must be present, which is not a requirement under 371.
The requirement is still deemed proper and is therefore made FINAL.
Claims 43-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 3rd, 2026.
Claim Objections
Claims 34-35 are objected to because of the following informalities: in line 5 of claim 34, “the cutting tool” should read “the cutting blade” for consistency with line 4; and in line 2 of claim 35, “a width of the gap” should read “the width of the gap” for consistency with claim 34. 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 31-33 and 38-40 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 31 recites the limitation "the cutting blade" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. No cutting blade has been previously introduced in the claims. Applicant should amend claim 31 to provide antecedent basis for the cutting blade. Claims 32-33 are rejected for their dependency on claim 31.
Claim 34 recites the limitation “the raised structure” in line 2. There is insufficient antecedent basis for this limitation in the claim. A raised structure was introduced in claim 30, but claim 34 is dependent on claim 29. For the purposes of examination, the limitation will be read as “a raised structure.” Claims 35-36 are rejected for their dependency on claim 34.
Claim 38 recites the limitation “the passage” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. No passage has been previously introduced. Applicant should amend claim 38 to provide antecedent basis for the passage. Claims 39-40 are rejected for their dependency on claim 38
Claim 40 is stated as being dependent on claim 41. However, the claim language of claim 40 refers to multiple limitations that were introduced in claim 39, such as the hemostasis valve, and therefore, claim 40 appears to be intended to be dependent on claim 39. Applicant should amend claim 40 to either change the dependency to claim 39 or to correct the antecedent basis. For the purposes of examination, claim 40 will be considered dependent on claim 39.
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) 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonner et al. (Pub. No. 2004/0102829).
Regarding claim 28, Bonner et al. discloses a cardiac pacemaker electrode lead delivery sheath (10; [0025]; FIGs. 1-3D), comprising:
a sheath base (12), provided with a sheath tube interface (FIG. 1: the connection between 12 and 14);
a sheath tube (14), comprising a cut tube section provided in sequence along an axial direction of the sheath tube ([0027] and FIG. 2: portion of 14 with polymer material 34 and portion of 32 with 34) and an implant tube section (FIG. 2: portion of 32 without 34) disposed at a distal end of the cut tube section (FIG. 2: 32 is at the distal end of the portion of 14), the cut tube section comprising a connecting region (FIG. 2: portion of 14 with polymer material 34) and a buffer region provided in sequence along the axial direction (FIG. 2: portion of 32 with 34), the connecting region being fixedly connected to the sheath tube interface (FIG. 2: 14 and 32 are fixedly attached to each other), the buffer region connecting the connecting region and the implant tube section (FIG. 2: the portion of 32 with 34 connects 14 to the portion of 32 without 34), the buffer region being configured to provide a cutting resistance between the sheath base and the implant tube section ([0027] the portion of 32 with 34 has a cutting resistance), and the magnitude of cutting resistance provided by the buffer region being between the magnitude of cutting resistance provided by the sheath base and the implant tube section ([0027] and FIG. 2: since the portion of 32 with 34 is thicker than the portion of 32 without 34, both due to 34 and to the rounded corners 36, the portion of 32 with 34 has a greater cutting resistance than the portion without 34, and since 32 is softer than the rest of 14, 32 has a lower cutting resistance than 14).
Claim(s) 28-42 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lenker et al. (Pub. No. 2023/0107208).
Regarding claim 28, Lenker et al. discloses a cardiac pacemaker electrode lead delivery sheath (400; [0047]; FIG. 1), comprising:
a sheath base (750; FIG. 3A; this embodiment includes sheath 752, which is the equivalent of 400), provided with a sheath tube interface (756);
a sheath tube (404), comprising a cut tube section provided in sequence along an axial direction of the sheath tube (406) and an implant tube section (408) disposed at a distal end of the cut tube section (FIG. 1), the cut tube section comprising a connecting region (FIG. 1: 404 before 414) and a buffer region provided in sequence along the axial direction (414), the connecting region being fixedly connected to the sheath tube interface (FIG. 1), the buffer region connecting the connecting region and the implant tube section (FIG. 1), the buffer region being configured to provide a cutting resistance between the sheath base and the implant tube section (FIG. 1: 414 provides a cutting resistance between 406 and 408), and the magnitude of cutting resistance provided by the buffer region being between the magnitude of cutting resistance provided by the sheath base and the implant tube section (FIG. 1: 414 is a stepdown, where the thickness of 414 is between the thickness of 406 and the thickness of 408, where the thickness helps determine the cutting resistance).
Regarding claim 29, Lenker et al. further discloses the buffer region provides a cutting resistance that decreases in magnitude from a side close to the connecting region to a side close to the implant tube section (FIG. 1: the thickness of 414 decreases distally from the side of 406 to the side of 408).
Regarding claim 30, Lenker et al. further discloses an inner wall of the buffer region is provided with a raised structure such that the buffer region provides the cutting resistance (FIG. 1: the taper of 414 is the raised structure).
Regarding claim 31, Lenker et al. further discloses the raised structure comprises a first raised structure capable of being cut when a cutting blade cuts the buffer region (FIG. 1: the taper of 414 could be cut by a blade), the first raised structure extends in a circumferential direction of an inner wall of the sheath tube (FIG. 1: the taper of 414 is a circumferential taper extending within 404), and a thickness of the first raised structure decreases from a side close to the connecting region to a side close to the implant region (FIG. 1: the thickness of 414 decreases distally from the side of 406 to the side of 408).
Regarding claim 32, Lenker et al. further discloses a quantity of the first raised structures is one (FIG. 1: the taper of 414 is a single raised structure). Since “when the quantity of the first raised structures is plural” is a conditional statement, when the condition is not satisfied, the claim limitation is considered satisfied, and having one first raised structure means the quantity of first raised structure is not plural.
Regarding claim 33, Lenker et al. further discloses the first raised structure has a groove for guiding the cutting direction of the cutting blade ([0104] a linear groove can be formed in the tip, which is 400 in the embodiment of FIG. 1, for guiding a blade); the groove opens along the axial direction of the sheath tube ([0104] the groove is linear, which places the groove in the axial direction of 404) and is recessed from the surface of the first raised structure toward the inner wall of the sheath tube ([0104] and FIG. 1: a linear groove through 414 would necessarily cause a recess from the surface of the taper of 414 towards the inner wall of 404).
Regarding claim 34, Lenker et al. further discloses a raised structure comprises a second raised structure (414) comprising a first raised portion and a second raised portion ([0104] the linear groove in 414 would create two hemispheres, where the hemispheres are each a raised portion), the first raised portion and the second raised portion having a gap therebetween ([0104] the groove), the gap having a width configured to grip a cutting blade to provide frictional resistance to the cutting blade to cut the buffer region ([0104] the groove grips the blade, which would create frictional resistance).
Regarding claim 35, Lenker et al. further discloses the portion of the gap close to the connecting region forms a flare (FIG. 1: 414 is tapered, and [0104] the groove would go through 414 and thereby by tapered).
Regarding claim 36, Lenker et al. further discloses a quantity of the second raised structures is one (FIG. 1: the taper of 414 is a single raised structure). Since “when the quantity of the second raised structures is plural” is a conditional statement, when the condition is not satisfied, the claim limitation is considered satisfied, and having one first raised structure means the quantity of first raised structure is not plural.
Regarding claim 37, Lenker et al. further discloses the sheath tube is formed by machining a plurality of sections of high polymer materials of different hardness in an axial direction ([0047] 402 and 404 can be made of polymers, which are clarified in [0076] as being hard polymeric materials; the varying thickness changes the hardness of the section), and the hardness of the sheath tube decreases from a proximal end close to the sheath base to a distal end far from the sheath base (FIG. 1: the thickness of the proximal end of 404 near 402 is less than the thickness of the distal end of 404 around 408, thereby decreasing the hardness of 404).
Regarding claim 38, Lenker et al. further discloses the sheath base (1008; Annotated FIG. 6A below; [0069]; an embodiment showing the handle portion of the sheath) comprises a sheath base body (FIG. 6A: the body of 1008 distal to the sideport), a side branch ([0070] 1008 can have a sideport), and a handle (FIG. 6A: the body of 1008 proximal to the sideport), the sheath base body is provided with a sheath cap interface (FIG. 6A: the portion of 1008 connecting 1008 to 1004), and a channel ([0070] 1008 can have a through lumen) communicating the sheath tube interface and the sheath cap interface ([0070] the through lumen of 1008 connects the cap interface with the tube interface), the handle is connected to the sheath base body (FIG. 6A: the body and the handle are connected to each other as part of 1008), and the side branch passes through the handle and communicates with a passage (FIG. 6A: the sideport has a passage); the wall thickness on the side of the sheath tube body close to the sheath tube interface is less than the wall thickness on the side close to the sheath cap interface (FIG. 6A: the wall thickness of 1008 varies in both the tube interface and the cap interface, resulting in the wall thickness closer to the tube interface being thinner at points than at points closer to the cap interface).
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Regarding claim 39, Lenker et al. further discloses a hemostasis valve ([0070] 1008 can have a hemostasis valve), an inlet of the hemostasis valve being provided at the sheath cap interface (FIG. 6A: the cap interface connects with the distal inlet of the hemostasis valve), and an outlet of the hemostasis valve passing through the sheath cap interface into the channel (FIG. 6A: the channel passes through the proximal outlet of the hemostasis valve); the hemostasis valve being provided with an elastic structure for covering the outlet (hemostasis valves have a seal which is more elastic than the surrounding structure to allow for sealing the tube from liquids while permitting some solid passage) and the elastic structure can be pushed open by a pushing force to expose the outlet (the elastic structure of a hemostasis valve can be pushed open to allow passage of items, such as medical instruments), and being automatically closed to close the outlet after the pushing force being released (the elastic structure of a hemostasis valve seals the outlet when the instrument is no longer being pushed through); a reinforcing rib being provided on the outer periphery of the hemostasis valve close to the elastic structure (FIG. 6A: the portion of the hemostasis valve which surrounds the elastic structure).
Regarding claim 40, Lenker et al. further discloses the hemostasis valve is fixed at the sheath cap interface via a sheath cap (904; [0064]), the sheath cap comprises a sheath cap body ([0064] the proximal end hub of 600), a bayonet ([0064] bayonet mount), and a device channel (606), the sheath cap body comprises a sheath cap top ([0064] the proximal end hub of 600 has a body) and an annular sidewall connected to the sheath cap top ([0064] the proximal end hub of 600 has a distal wall which is circumferential around 900), the bayonet opens on the annular sidewall ([0064] the bayonet mount opens on the distal wall of the proximal end hub), and the device channel extends from the sheath cap top to the annular sidewall ([0064] 606 extends the length of 600); the outer wall of the sheath base body is provided with a clamping block (902), the outer edge of the inlet of the hemostasis valve abuts between the sheath cap interface and sheath cap top (FIGs. 5-6A: the hemostasis valve distal end attaches to the proximal end of the proximal end hub of 600), and the clamping block is clamped into the bayonet of the sheath cap ([0064] 902 is clamped to the bayonet mount).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al. in view of Leung et al. (Pub. No. 2023/0149675).
Regarding claim 41, Lenker et al. discloses the invention as claimed in claim 28, as discussed above. Lenker et al. does not disclose the sheath tube comprises at least a first tube section provided at a distal end of the implant tube section, the first tube section has a first curved section and a second curved section, the first curved section is provided at a distal end of the first tube section; wherein the included angle between the first bending surface of the first curved section and the second bending surface of the second curved section is not less than 45 degrees, and the hardness of the first curved section is less than the hardness of the second curved section.
Leung et al. discloses a sheath tube (300; FIG. 6A), wherein the sheath tube comprises at least a first tube section provided at a distal end of the implant tube section (80), the first tube section has a first curved section (FIG. 6A: the distal tip of 80) and a second curved section (FIG. 6A: the proximal portion of 80 coming out of 50), the first curved section is provided at a distal end of the first tube section (FIG. 6A); wherein the included angle between the first bending surface of the first curved section and the second bending surface of the second curved section is not less than 45 degrees (FIG. 6A: 80 loops several times), and the hardness of the first curved section is less than the hardness of the second curved section (FIG. 6A: the distal tip of 80 is not as thick as the rest of 80, and therefore not as hard) for the purpose of allowing the first tube section to come out of the implant tube section and complete the heart procedures ([0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the implant tube section of Lenker et al. to have a first tube section with two curved sections that have an included angle not less than 45 degrees with the hardness of the distal section being less than the hardness of the proximal section, for the purpose of allowing the first tube section to come out of the implant tube section and complete the heart procedures.
Regarding claim 42, Lenker et al. as modified further discloses the first tube section comprises at least a braid ([0064] the sheath can be made using braids), the braid is made from braided wires ([0064] the braid is made of braided wires), a diameter of the braided wire of the second curved section ranges from 0.04 mm to 0.06 mm ([0066] the inner wall is made up of the braid, and that thickness is 0.001 to 0.005 inches, or 0.025 to 0.127 mm; the thickness will be equivalent to the diameter of the braided wires making up the braid), and a braid density of the second curved section ranges from 50 to 70 (this limitation does not say what the units of the density are; for example, the braid density could be in units of 1/50th of the amount of braid in the sheath, in which case, the sheath has 50 of those units and satisfies the limitation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
