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 in the reply filed on 1/2/2026 is acknowledged. The traversal is on the grounds that (1) all of the claims in the application can be examined at the same time without serious burden, (2) the search associated with the elected invention would likely extend into the areas where the non-elected invention would be searched, and (3) examining all of the claims of the application at the same time would not require consideration of an unduly burdensome number of additional claims. This is not found persuasive because the non-elected invention is a method for performing a function (reducing cholesterol crystal embolism) that requires use a specific location (of a lesion in a branched, third blood vessel) and requires the use of a guidewire, none of which is required of the elected device. The search for the specific function, location of use and additional medical components not required by the elected invention would require serious burden, involving areas that the search associated with the elected invention does not require (even if the number of non-elected claims is not unduly burdensome).
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 14-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 13 recites “a second hub”, but since no “first hub” has been recited, the phrase “a second hub” should be amended to recite “a . Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The phrase “the first” spanning lines 1-2 is incomplete and should recite “the first shaft”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft” but this clearance has already been introduced in claim 1. Accordingly, claim 5 should be amended to recite “wherein the first catheter possesses a wall thickness T1[[,]] and the second catheter possesses a wall thickness T2, wherein the wall thickness of the first catheter is greater than the clearance, and wherein the wall thickness of the second catheter is less than the clearance”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 recites “a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft” but this clearance has already been introduced in claim 1. Accordingly, claim 6 should be amended to recite “wherein the first catheter possesses a wall thickness T1[[,]] and the second catheter possesses a wall thickness T2, wherein the clearance is greater than the wall thickness of the first catheter, and wherein the wall thickness of the first catheter is greater than the wall thickness of the second catheter”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Line 2 introduces “a tubular first shaft” and lines 2-3 refer to this as “the tubular first shaft” but the rest of the claim refers to this as just “the first shaft”; in order to maintain consistency of claim language, the term “tubular” should be removed from the phrase “the tubular first shaft” on lines 2-3. Lines 9 and 10-11 recite “the first shaft portion” but no such “portion” has been recited earlier in the claim; in order to maintain proper antecedent basis, the term “portion” should be removed from each occurrence of this phrase. Line 10 recites “the outer diameter of the first shaft portion at a distal end of the tapering part”; since an outer diameter at this particular location has not been previously introduced in the claim, the term “the” in the phrase “the outer diameter” should be replaced with the term “an”. Line 20 recites “a second hub”, but since no “first hub” has been recited, the phrase “a second hub” should be amended to recite “a . Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft” but this clearance has already been introduced in claim 7. Accordingly, claim 12 should be amended to recite “wherein the first catheter possesses a wall thickness T1[[,]] and the second catheter possesses a wall thickness T2, wherein the wall thickness of the first catheter is greater than the clearance, and wherein the wall thickness of the second catheter is less than the clearance”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft” but this clearance has already been introduced in claim 7. Accordingly, claim 13 should be amended to recite “wherein the first catheter possesses a wall thickness T1[[,]] and the second catheter possesses a wall thickness T2, wherein the clearance is greater than the wall thickness of the first catheter, and wherein the wall thickness of the first catheter is greater than the wall thickness of the second catheter”. Appropriate correction is required.
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chou et al. (PG PUB 2018/0207399).
Re claim 1, Chou discloses a catheter assembly 10 (Fig 2A; it is noted that all reference characters cited below refer to Fig 2A unless otherwise noted) comprising: a first catheter 300 comprised of a first shaft 360 that includes a distal end (to the right in Fig 2A) and a proximal end (to the left in Fig 2A) at opposite axial ends of the first shaft (as seen in Fig 2A), the first shaft including a first distal end opening (to the right in Fig 2A, Para 146) at the distal end of the first shaft and a first proximal end opening (to the left in Fig 2A, Para 146) at the proximal end of the first shaft (Para 146), the first catheter including a first lumen 368 (Fig 7B) extending between the first distal end opening and the first proximal end opening (Para 146); a second catheter 200 comprised of a second shaft 222 that includes a distal end (to the right in Fig 2A) and a proximal end (to the left in Fig 2A) at opposite axial ends of the second shaft (as seen in Fig 2A), the second shaft including a second distal end opening (through which tip 346 extends in Fig 2B) at the distal end of the second shaft and a second proximal end opening (at edge 221 in Fig 6E) at the proximal end of the second shaft (Para 102), the second catheter including a second lumen 223 (Fig 6E) extending between the second distal end opening and the second proximal end opening (Para 102), the second shaft being longer than the first shaft (as seen in Fig 2A), the second catheter including a second hub 230+234 at the proximal end of the second shaft (as seen in Fig 2A) and communicating with the second lumen (Para 125 and 132, wherein the tab 234 and element 230 are hollow and fluid is delivered to the second shaft 22 from the element 230 via opening 241), the second catheter having both an outer diameter and an inner diameter at the second distal end opening (inherent as shaft 222 has a lumen that defines the inner diameter); the first catheter being positionable in the second lumen of the second shaft and being axially positionable relative to the second shaft such that a distal portion 346 of the first shaft extends distally beyond the distal end of the second shaft (as seen in Fig 2b); and a clearance between an inner surface of the second shaft and an outer surface of the first shaft at the second distal end opening when the first catheter is positioned in the second lumen of the second shaft and the distal portion of the first shaft extends distally beyond the distal end of the second shaft exceeding 0.1 mm (0.1 mm is equivalent to 0.00394 inches; Para 144 discloses a clearance of 0.003 -0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”).
Re claim 2, Chou discloses a push rod 366 on a proximal end side of the first shaft (as seen in Fig 2A).
Re claim 3, Chou discloses that the distal portion of the first shaft includes a tapered part extends to the distal end of the first shaft (the entire distal portion 346 is tapered, as seen in Fig 7A-7C, Para 141), the clearance exceeding 0.1 mm when an entirety of the tapered part of the first shaft is distal of the distal end of the second shaft (Para 144).
Re claim 4, Chou discloses that the first catheter further comprises a rod 366 fixed to the first shaft and extending in a proximal direction away from the proximal end of the first shaft (as seen in Fig 2A), the rod possessing a proximal end (to the left in fig 2A) that is positioned proximal of the proximal end of the second shaft when the first catheter is positioned in the second lumen of the second shaft and the distal portion of the first shaft extends distally beyond the distal end of the second shaft (as seen in Fig 2B).
Re claim 5, Chou discloses that the first catheter possesses a wall thickness T1 (wherein Para 146 and 148 disclose an inner diameter of 0.019 – 0.024 inches, a first outer diameter of 0.062 – 0.064 inches and a second outer diameter of 0.080 - 0.082 inches; these values result in a thickness1 ranging from 0.019 inches to 0.0225 inches in the location of the first outer diameter and a thickness ranging from 0.028 inches to 0.0315 inches in the location of the second outer diameter), the second catheter possess a wall thickness T2 (wherein Para 107 and 108 disclose an inner diameter of 0.040 – 0.100 inches and an outer diameter from 0.082 – 0.086 inches; these values result in a minimum thickness near zero and a maximum thickness of 0.023) and a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft (as set forth in the rejection of claim 1 above, 0.01 mm is equivalent to 0.00394 inches and Para 144 discloses a clearance of 0.003 – 0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”), wherein T2 < CL < T1 (when T1 = 0.0315 inches, CL = 0.01 inches, and T2 = < 0.01 inches).
Re claim 6, Chou discloses that the first catheter possesses a wall thickness T1 (wherein Para 149 disclose that the rod 366 of first catheter 300 has an outer diameter of 0.0275 inches and an inner diameter of 0.021 inches; these values result in a thickness2 of 0.00325 inches), the second catheter possess a wall thickness T2 (wherein Para 107 and 108 disclose an inner diameter of 0.040 – 0.100 inches and an outer diameter from 0.082 – 0.086 inches; these values result in a minimum thickness near zero and a maximum thickness of 0.023) and a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft (as set forth in the rejection of claim 1 above, 0.01 mm is equivalent to 0.00394 inches and Para 144 discloses a clearance of 0.003 – 0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”), wherein T2 < T1 < CL (when CL = 0.01, T1 = 0.00325, and T2 = <0.00325).
Re claim 7, Chou discloses a catheter assembly 10 (Fig 2A; it is noted that all reference characters cited below refer to Fig 2A unless otherwise noted) comprising: a first catheter 300 comprised of a first shaft 360 and a rod 366 fixed to the tubular first shaft (as seen in Fig 2A), the first shaft including a distal end (to the right in Fig 2A) and a proximal end (to the left in Fig 2A) at opposite axial ends of the first shaft (as seen in Fig 2A), the first shaft including a first distal end opening (to the right in Fig 2A, Para 146) at the distal end of the first shaft and a first proximal end opening (to the left in Fig 2A, Para 146) at the proximal end of the first shaft (Para 146), the first catheter including a first lumen 368 (Fig 7B) extending between the first distal end opening and the first proximal end opening (Para 146), the rod extending away from the proximal end of the first shaft (as seen in Fig 2A), the first shaft including a distal portion 346 that is a tapering part (as seen in Fig 7C, Para 141) that tapers so that an outer diameter of the first shaft portion at the proximal end of the first shaft at a proximal end of the tapering part is greater than an outer diameter of the first shaft at a distal end of the tapering part (as seen in Fig 7C, Para 141), the first shaft possessing an axial length from the distal end of the first shaft to the proximal end of the first shaft (as seen in Fig 2A); a second catheter 200 comprised of a second shaft 222 that includes a distal end (to the right in Fig 2A) and a proximal end (to the left in Fig 2A) at opposite axial ends of the second shaft (as seen in Fig 2A), the second shaft including a second distal end opening (through which tip 346 extends in Fig 2B) at the distal end of the second shaft and a second proximal end opening (at edge 221 in Fig 6E) at the proximal end of the second shaft (Para 102), the second catheter including a second lumen 223 (Fig 6E) extending through an axial extent of the second shaft from the second distal end opening to the second proximal end opening (Para 102), the second shaft possessing an axial length from the distal end of the second shaft to the proximal end of the second shaft (as seen in Fig 2A), the second catheter including a second hub 230+234 at the proximal end of the second shaft (as seen in Fig 2A), the second catheter having both an outer diameter and an inner diameter at the second distal end opening (inherent as shaft 222 has a lumen that defines the inner diameter); the axial length of the second catheter being greater than the axial length of the first catheter (as seen in Fig 2b); the first catheter being positionable in the second lumen of the second shaft and being axially positionable relative to the second shaft such that the tapering part of the first shaft extends distally beyond the distal end of the second shaft (as seen in Fig 2b); and a clearance between an inner surface of the second shaft and an outer surface of the first shaft at the second distal end opening when the first catheter is positioned in the second lumen of the second shaft and the tapering part of the first shaft is positioned distally beyond the distal end of the second shaft exceeding 0.1 mm (0.1 mm is equivalent to 0.00394 inches; Para 144 discloses a clearance of 0.003 – 0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”).
Re claim 8, Chou discloses that the rod possesses a proximal end (to the left in Fig 2A) that is positioned proximal of the proximal end of the second shaft when the first catheter is positioned in the second lumen of the second shaft and the tapering part of the first shaft is positioned distally beyond the distal end of the second shaft (as seen in Fig 2B).
Re claim 9, Chou discloses a hub 364 fixed to the proximal end of the rod (as seen in Fig 2A).
Re claim 10, Chou discloses that the rod is a solid rod (“the proximal portion 366 having no guidewire lumen”, Para 149).
Re claim 11, Chou discloses that the rod and the first shaft are other than coaxial (Para 149, “the proximal portion 366 can extend eccentric […] to the distal lumen portion 222”).
Re claim 12, Chou discloses that the first catheter possesses a wall thickness T1 (wherein Para 146 and 148 disclose an inner diameter of 0.019 – 0.024 inches, a first outer diameter of 0.062 – 0.064 inches and a second outer diameter of 0.080 - 0.082 inches; these values result in a thickness3 ranging from 0.019 inches to 0.0225 inches in the location of the first outer diameter and a thickness ranging from 0.028 to 0.0315 in the location of the second outer diameter), the second catheter possess a wall thickness T2 (wherein Para 107 and 108 disclose an inner diameter of 0.040 – 0.100 inches and an outer diameter from 0.082 – 0.086 inches; these values result in a minimum thickness near zero and a maximum thickness of 0.023) and a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft (as set forth in the rejection of claim 7 above, 0.01 mm is equivalent to 0.00394 inches and Para 144 discloses a clearance of 0.003 – 0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”), wherein T2 < CL < T1 (when T1 = 0.0315 inches, CL = 0.01 inches, and T2 = < 0.01 inches).
Re claim 13, Chou discloses that the first catheter possesses a wall thickness T1 (wherein Para 149 disclose that the rod 366 of first catheter 300 has an outer diameter of 0.0275 inches and an inner diameter of 0.021 inches; these values result in a thickness4 of 0.00325 inches), the second catheter possess a wall thickness T2 (wherein Para 107 and 108 disclose an inner diameter of 0.040 – 0.100 inches and an outer diameter from 0.082 – 0.086 inches; these values result in a minimum thickness near zero and a maximum thickness of 0.023) and a clearance CL exists between an inner surface of the second shaft and an outer surface of the first shaft (as set forth in the rejection of claim 7 above, 0.01 mm is equivalent to 0.00394 inches and Para 144 discloses a clearance of 0.003 – 0.010 inches, so any of the values above 0.00394 inches reads on a clearance “exceeding 0.1 mm”), wherein T2 < T1 < CL (when CL = 0.01, T1 = 0.00325, and T2 = <0.00325).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2014/0358123 to Ueda et al., PG PUB 2017/0239447 to Yang et al. and PG PUB 2020/0023168 to Hayakawa et al. each disclose a catheter assembly substantially similar to that of the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Wherein thickness is calculated as (outer diameter – inner diameter)/2.
2 Wherein thickness is calculated as (outer diameter – inner diameter)/2
3 Wherein the thickness is calculated as (outer diameter – inner diameter)/2.
4 Wherein the thickness is calculated as (outer diameter – inner diameter)/2.