DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/09/2026 has been entered.
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 .
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.
Claim Objections
Claim 1 objected to because of the following informalities:
“a wall” in lines 12-13 should be written “a distal thickness region”
“the wall” in lines 14-15 should be written “the distal thickness region”
“provided” in line 17 should be written “is provided”
“is” in line 17 should be written “,is”
“the wall” in line 18 should be written “the distal thickness region”
“the wedge-shaped element” in line 19 should be written “the wedge-shaped spring element”
“to the wall” in line 18 should be written “of the distal thickness region”
“the reduced thickness region and the proximal-most end of the spring element” in lines 23-24 should be written “the reduced thickness region located distally from the proximal-most end of the spring element”
“the wall” in line 25 should be written “the distal thickness region”
Appropriate correction is required.
Claim 2 objected to because of the following informalities:
“a surgical handheld device” in line 1 should be written “the surgical handheld device”
Appropriate correction is required.
Claim 3 objected to because of the following informalities:
“a surgical handheld device” in line 1 should be written “the surgical handheld device”
Appropriate correction is required.
Claim 8 objected to because of the following informalities:
“a surgical handheld device” in line 1 should be written “the surgical handheld device”
Appropriate correction is required.
Claim 13 objected to because of the following informalities:
“the outer face” in line 2 should be written “an outer face”
Appropriate correction is required.
Claim 16 objected to because of the following informalities:
“a surgical handheld device” in line 1 should be written “the surgical handheld device”
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 1-3, 8, and 10-16 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 1 recites the limitation “the latch element” in lines 7 and 17. It is unclear whether this limitation is referring to each of the latch elements of the at least two spring elements, or one of the latch elements, or a different number of the latch elements.
Claim 1 also recites the limitation “the spring element” in lines 12, 14, 17, 20, 21, 22, and 24. It is unclear whether this limitation is referring to the at least two spring elements recited previously, or one of the at least two spring elements.
Claim 1 also recites the limitation “the wedge-shaped element” in line 19. There is insufficient antecedent basis for this limitation.
Claim 2 recites the limitation “fastening means” in line 2. However, Examiner notes that this limitation was cancelled in claim 1. Therefore, it is unclear whether this limitation is referring to the amended limitation “at least two spring elements” recited in claim 1, or different fastening means.
Claim 3 recites the limitation “fastening means” in line 2. However, Examiner notes that this limitation was cancelled in claim 1. Therefore, it is unclear whether this limitation is referring to the amended limitation “at least two spring elements” recited in claim 1, or different fastening means.
Claim 8 recites the limitation “fastening means” in line 2. However, Examiner notes that this limitation was cancelled in claim 1. Therefore, it is unclear whether this limitation is referring to the amended limitation “at least two spring elements” recited in claim 1, or different fastening means.
Claim 10 recites the limitation “an inner shaft or shaft tube” in lines 1-2 and “inner shaft” in lines 3-4. It is unclear whether these limitations are referring to the “tubular shaft” recited in line 3 of claim 1, or a different inner shaft/shaft tube.
Claim 11 recites the limitation “the inner shaft” in line 3. It is unclear whether this limitation is referring to the “tubular shaft” recited in line 3 of claim 1, or a different inner shaft.
Claim 12 recites the limitation “fastening means” in line 2. However, Examiner notes that this limitation was cancelled in claim 1. Therefore, it is unclear whether this limitation is referring to the amended limitation “at least two spring elements” recited in claim 1, or different fastening means.
Claim 12 also recites the limitation “latch elements” in line 2. It is unclear whether this limitation is referring to each of the latch elements of the at least two spring elements, or all of the latch elements, or a different number of the latch elements.
Claim 12 also recites the limitation “the inner shaft” in lines 2-3. It is unclear whether this limitation is referring to the “tubular shaft” recited in line 3 of claim 1, or a different inner shaft.
Claim 13 recites the limitation “fastening means” in line 3. However, Examiner notes that this limitation was cancelled in claim 1. Therefore, it is unclear whether this limitation is referring to the amended limitation “at least two spring elements” recited in claim 1, or different fastening means.
Claim 13 also recites the limitation “latch elements” in line 3. It is unclear whether this limitation is referring to each of the latch elements of the at least two spring elements, or all of the latch elements, or a different number of the latch elements.
Claim 14 recites the limitation “the inner shaft” in line 2 It is unclear whether this limitation is referring to the “tubular shaft” recited in line 3 of claim 1, or a different inner shaft.
Claim 15 recites the limitation “an inner shaft or shaft tube” in line 2 and “inner shaft” in lines 4-7. It is unclear whether these limitations are referring to the “tubular shaft” recited in line 3 of claim 1, or a different inner shaft/shaft tube.
Claim 16 is rejected as being dependent upon a rejected base claim.
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.
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.
Claim(s) 1-3, 8, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi, (US 20020035311) in view of Hidaka et al., (US 6095970; hereinafter Hidaka).
Regarding claim 1, Ouchi (Figure 1) discloses an insulation insert (10) for a surgical handheld device, a tubular insulation insert (10) being able to be releasably coupled with a proximal end region to a distal end of a tubular shaft (1), wherein the proximal end region of the insulation insert (10) defines a spring element (element X shown in annotated Figure 1 below) that includes a latch element (10a) extending into an interior of the insulation insert (10), the latch element (10a) is designed as a snap-fit hook and is arranged at a free end of the spring element (X), the spring element (X) provided at a reduced thickness region located proximal to a distal wall of the insulation insert (10), the spring element (X) has a first thickness and the distal wall of the insulation insert (10) has a second thickness that is greater than the first thickness; the latch element (10a) provided at a proximal-most end of the spring element (X), is wedge-shaped (rounded wedge), and has a height that corresponds to a distal wall thickness of the wall of the insulation insert (10) such that a third thickness of the wedge-shaped element (10a) is greater than the first thickness of the spring element (X); the spring element (X), in a reduced thickness region located distally from the proximal-most end of the spring element (X) has a reduced thickness relative to the second thickness to the distal wall of the insulation insert (10) located distally from the reduced thickness region and the proximal-most end of the spring element (X); and the second thickness of the distal wall of the insulation insert (10) defines a ring-shaped shoulder (shown at the proximal end of the distal wall of the insert 10 just distal to the distal end of spring element X in annotated Figure 1 below) of an inner wall of the insulation insert (10), the ring-shaped shoulder being configured to abut against a distal end face (distal face of distal end 2 of shaft 1) of the tubular shaft (1) when the ring-shaped shoulder is coupled to the tubular shaft (1), ([0018], [0021]-[0023]).
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Annotated Figure 1 from the Ouchi reference
Ouchi fails to disclose that the spring element is at least two spring elements. However, Hidaka (Figure 20) teaches an insulation insert (730) for a surgical handheld device comprising multiple spring elements with corresponding latch elements (755) circumferentially surrounding the insulation insert (730), (Col. 12, lines 32-55). 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 circumferential spring element disclosed by Ouchi into at least two spring elements with corresponding latch elements, as taught by Hidaka, because Hidaka teaches that both a singular circumferential spring element and multiple spring elements are both viable methods to attach an insulation insert to a tubular shaft (Hidaka; Col. 12, lines 32-55). Furthermore, it has been held that deconstructing a formerly integral structure into various elements or parts involves only routine skill in the art. MPEP 2144.04 (V)(C).
Regarding claim 2, Ouchi/Hidaka further teaches wherein two or four or six or more fastening means (Hidaka; corresponding to individual projection means 755) are arranged lying opposite each other on a circumference of the proximal end region (shown in Figure 20 of Hidaka, there may be at least two fastening means 755 corresponding to the locations shown in Figure 20, which are arranged lying opposite each other on a circumference of the proximal end region).
Regarding claim 3, Ouchi/Hidaka further teaches wherein three or more fastening means are arranged on a circumference of the proximal end region. Ouchi/Hidaka fails to teach that the three or more fastening means are arranged at an angle of 120° or at equal angles relative to each other on a circumference of the proximal end region. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ouchi/Hidaka to include the three or more fastening means arranged at an angle of 120° or at equal angles relative to each other on a circumference of the proximal end region since the angle of separation between the fastening means would simply determine the result of how many fastening means are included and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Regarding claim 8, Ouchi/Hidaka further teaches wherein the fastening means (Hidaka; corresponding to individual projection means 755) are arranged in pairs next to each other and the pairs are arranged lying opposite each other on a circumference of the proximal end region (shown in Figure 20 of Hidaka, there may be at least two fastening means 755 corresponding to the locations shown in Figure 20, which are arranged in pairs next to each other, wherein the pairs are arranged lying opposite each other on a circumference of the proximal end region).
Regarding claim 16, Ouchi/Hidaka further teaches including additional spring elements (Hidaka; spring element holding latch 755) that are provided around the insert (10) such that each spring element is spaced apart from an adjacent spring element (Hidaka; Col. 12, lines 32-55: multiple spring elements holding corresponding latch element 755 are provided around the insert 10 spaced apart from each other).
Claim(s) 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brockmann et al., (US 20200246062; hereinafter Brockmann) in view of Ouchi and Hidaka.
Regarding claim 10, Brockmann discloses a surgical handheld device, in particular a resectoscope, with an inner shaft (38) or shaft tube and with an outer shaft (36) or outer tube, and with an insulation insert (10), the insulation insert (10) being able to be coupled releasably to the inner shaft (38), and the outer shaft (36) being movable over the inner shaft (38) and the insulation insert (10), ([0046]-[0052], [0058]). Brockmann fails to disclose that the insulation insert is one as claimed in claim 1. However, Ouchi/Hidaka teaches an insulation insert as claimed in claim 1, as explained in the rejection of claim 1 above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the insulation insert disclosed by Brockmann with an insulation insert as taught by Ouchi/Hidaki since both insulation inserts perform the same function of providing an insulative cover at the distal end of the device and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 11, Brockmann (Figures 1 and 9) further discloses that an outer circumference of a proximal end region of the insulation insert (10) is dimensioned in such a way that it can be pushed over a distal end of the inner shaft (38), ([0046]-[0052], [0058]).
Regarding claim 12, Brockmann/Ouchi/Hidaka further teaches that a wall of the inner shaft has openings in which latch elements of fastening means of the insulation insert engage for releasable coupling of the insulation insert to the inner shaft. Specifically, the modified device includes at least two of the resilient fastening means arranged in this configuration as taught by Hidaka (Hidaka; Figure 20; Col. 12, lines 32-55), wherein the wall of the distal end of the device include holes to hold the fastening means (755). Therefore, the modified device would include holes/openings in a wall of the inner shaft to releasably couple the insulation insert to the inner shaft.
Regarding claim 13, Brockmann (Figures 1 and 9) further discloses that a distance between an inner face of the outer shaft (36) and the outer face of the insulation insert (10) is less than the height of latch elements of the fastening means of the insulation insert (10), ([0046]-[0052], [0058]).
Regarding claim 14, Brockmann (Figures 1 and 9) further discloses that components (components of instrument 24) can be guided or conveyed through the inner shaft (36) and/or the insulation insert (10), ([0046]-[0052], [0058]).
Regarding claim 15, Brockmann/Ouchi/Hidaka teaches a method for manipulating a surgical handheld device, in particular a resectoscope, as claimed in claim 10 with an inner shaft (Brockmann; 38) or shaft tube and with an outer shaft (Brockmann; 36) or outer tube, and with an insulation insert (taught by Ouchi/Hidaka, substituting the insulation insert 10 disclosed by Brockmann) to prepare the handheld device for use, the insulation insert (taught by Ouchi/Hidaka, substituting the insulation insert 10 disclosed by Brockmann) is first of all coupled with a proximal end to a distal end of the inner shaft (Brockmann; 38), and then the inner shaft (Brockmann; 38) is guided with the insulation insert (Brockmann; 10) into the outer shaft (Brockmann; 36), and, after the use of the handheld device, the inner shaft (Brockmann; 38) with the insulation insert (Brockmann; 10) is guided out of the outer shaft (Brockmann; 36), and then the insulation insert (Brockmann; 10) is uncoupled from the inner shaft (Brockmann; 38), (Brockmann; [0046]-[0052], [0058]).
Response to Arguments
Applicant’s arguments, filed 02/09/2026, with respect to the newly amended limitations of claim 1, have been fully considered and are persuasive. Therefore, the rejection of claim 1 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art references Ouchi and Hidaka. Ouchi discloses a base insulation insert with a single circumferential spring element and Hidaka teaches that a single circumferential spring element of an insulation insert with a corresponding single circumferential latch element may be separated into multiple spring elements with corresponding latch elements. Therefore, the new Ouchi/Hidaka combination teaches the invention as claimed at least in amended claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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