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 .
Response to Amendment
This Office action is responsive to the amendment filed 04/03/2025. Claims 1, 13 and 20 are amended. Claims 1-20 are currently pending in the application.
Response to Arguments
Applicant's arguments, see pg. 8-11, filed 04/03/2025, with respect to the rejections of claims 13-17 and 19 under 35 U.S.C. 102 and claim 18 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Wallis (US 2018/0092644) fails to teach “wherein the notch comprises a first portion and a second portion where the second portion is substantially orthogonal to said first portion and at the end of said first portion nearest the first end of the inner tubular member” as recited by amended claim 13.
The Examiner disagrees. Wallis teaches an inner tubular member (650, see Fig. 9) having a first end (653, see Fig. 8) and a second end (660, see Fig. 10) and a protrusion (720). Wallis further teaches an outer tubular member including a notch (718, see Fig. 16) that is configured to receive the protrusion of the inner tubular member (notch 718 receives protrusion 720, see Fig. 16), wherein the notch comprises a first portion (724) and a second portion (722) where the second portion is substantially orthogonal to said first portion and at the end of said first portion nearest the first end of the inner tubular member (the second portion 722 is at the end of the first portion 724 closest to the first end 653 of the inner tubular member) as claimed.
Applicant's arguments, see pg. 11-13, with respect to the rejection of claim 20 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that Wallis fails to teach “wherein said notch is formed parallel to an axis formed by a length of the suction member” and “wherein the narrower portion has a width that contacts the protrusion” as recited by amended claim 20.
The Examiner disagrees. Wallis teaches an outer tubular member 700 (see Fig. 16) including a notch 718, wherein said notch is formed parallel to an axis formed by a length of the suction member (portion 724 of the notch is formed parallel to the longitudinal axis of the suction member 900, see Fig. 16), the notch including a wider portion (portion 724 of notch 718 is considered "a wider portion" when the width of the notch is measured along a longitudinal direction of the outer tubular member 700, see Fig. 16) and a narrower portion (portion 722 is considered "a narrower portion" when the width of the notch is measured along a longitudinal direction of the outer tubular member 700, see Fig.16) wherein the narrower portion has a width that contacts the protrusion (the portion 722 has a width that contacts the protrusion 720 in the position shown in Fig. 16).
Applicant’s arguments, see pg. 13-14, with respect to the rejections of claims 1-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chotenovsky et al. (US 2015/0057680), and Cleator (US 2010/0063517), and Rassouli (US 2019/0167911).
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Clam 1 recites the limitation “a first portion of the notch” in line 22 and “a second portion of the notch” in line 26. These limitations should read “the first portion of the notch” and “the second portion of the notch” respectively.
Claim 13 similarly recites “a first portion of the notch” in line 18 and “a second portion of the notch” in line 21 and should be amended in the same way as claim 1.
Appropriate correction is required.
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.
Claims 13-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallis (US 2018/0092644).
Regarding claim 13, Wallis discloses a device (see Fig. 8), comprising: an inner tubular member (650, see Fig. 9) having an inner surface (654), an outer surface (656), a first end (653, see Fig. 8), a second end (660, see Fig. 10), and a protrusion (720, see Fig. 16) on the outer surface, the first end having a first opening (first end 653 has an opening, see Fig. 8) and the second end having a second opening (662, see Fig. 10); a suction member (900) in the inner tubular member (see Fig. 18), the suction member including a handle portion (902), and the handle portion allowing the suction member to be pulled toward and pushed away from the second end of the inner tubular member (as shown in Fig 10, the end of the suction member 900 extends past the opening at the second end of the inner tubular member 660 and using the handle 902, the suction member end can be toward pulled the opening at the second end or pushed away from it to extend past it); and an outer tubular member (700) having an inner configuration corresponding to that of the inner tubular member (see Fig. 8), the outer tubular member including a notch (718, see Fig. 16) that is configured to receive the protrusion of the inner tubular member (notch 718 receives protrusion 720, see Fig. 16), wherein the notch comprises a first portion (724) and a second portion (722) where the second portion is substantially orthogonal to said first portion and at the end of said first portion nearest the first end of the inner tubular member (the second portion 722 is at the end of the first portion 724 closest to the first end 653 of the inner tubular member), wherein a reception of the protrusion of the inner tubular member by the first portion (724) of the notch of the outer tubular member allows movement of the outer tubular member toward the first end of the inner tubular member (when protrusion 720 is within first portion 724, outer tubular member can move towards first end 653 of the inner tubular member since first portion 724 allows for longitudinal movement, see Fig. 16 and [0052]) and a reception of the protrusion of the inner tubular member by the second portion (722) of the notch of the outer tubular member prevents the movement of the outer tubular member toward the first end of the inner tubular member (when the protrusion 720 is within the second portion 722 of notch 718, outer tubular member 700 is prevented from moving towards the first end 653 of the inner tubular since longitudinal movement is prevented within second portion 722, see Fig. 16 and [0052]).
Regarding claim 14, Wallis discloses the device of claim 13, wherein the outer tubular member includes a handle (714, see Fig. 8), the handle forming a second axis extending away from a first axis formed by center points of the first opening and the second opening of the inner tubular member (the handle 714 forms an axis that is perpendicular to the longitudinal axis of the inner tubular member 650, see Fig. 8), and the inner tubular member includes a tab (652), the tab forming a third axis extending away from the first axis formed by the center points of the first opening and the second opening of the inner tubular member (tabs 652 forms an axis that is perpendicular to the longitudinal axis of the inner tubular member, see Fig. 8).
Regarding claim 15, Wallis discloses the device of claim 14, wherein the second axis and the third axis create an angle of about 0-45 degrees (Fig. 17 shows that the axes of the handle 714 and tabs 652 create a 0-degree angle when the protrusion 720 is in the position shown).
Regarding claim 16, Wallis discloses the device of claim 13, wherein the reception of the protrusion of the inner tubular member by the second portion of the notch of the outer tubular member allows the outer tubular member to be rotated relative to the inner tubular member about a first axis formed by center points of the first opening and the second opening of the inner tubular member (reception of the protrusion 720 in the second portion 722 of notch 718 allows for rotation of the outer tubular member 700 relative to the inner tubular member 650 about the longitudinal axis of the inner tubular member, see Fig. 16-17 and [0052]), and the reception of the protrusion of the inner tubular member by the second portion of the notch of the outer tubular member allows the inner tubular member to be rotated relative to the outer tubular member about the first axis formed by the center points of the first opening and the second opening of the inner tubular member (reception of the protrusion 720 in the second portion 722 of notch 718 allows for rotation of the inner tubular member 650 relative to the outer tubular member 700 about the longitudinal axis of the inner tubular member, see Fig. 16-17 and [0052]).
Regarding claim 17, Wallis discloses the device of claim 13, wherein the protrusion on the outer surface of the inner tubular member is a button shaped protrusion (protrusion 720 is button-shaped, see Fig. 16).
Regarding claim 19, Wallis discloses the device of claim 13, wherein the first portion of the notch is parallel to a first axis formed by center points of the first opening and the second opening of the inner tubular member (the first portion of the notch 724 is parallel to the longitudinal axis of the inner tubular member, see Fig. 16), and the second portion of the notch is perpendicular to the first portion (the second portion of the notch 722 is perpendicular to the first portion 724, see Fig. 16).
Regarding claim 20, Wallis discloses a device (see Fig. 8) comprising: an inner tubular member (650, see Fig. 9) having an inner surface (654), an outer surface (656), a first end (660, see Fig. 10), a second end (653, see Fig. 8), and a protrusion (720, see Fig. 16) on the outer surface, the first end having a first opening (662, see Fig. 10) and the second end having a second opening (second end 653 has an opening, see Fig. 8); a suction member (900) in the inner tubular member (see Fig. 18), the suction member including a handle portion (902), and the handle portion allowing the suction member to be pulled toward and pushed away from the second end of the inner tubular member (see [0055]); and an outer tubular member (700) having an inner configuration corresponding to that of the inner tubular member (see Fig. 8), the outer tubular member including a notch (718, see Fig. 16) that is configured to receive the protrusion of the inner tubular member (notch 718 receives protrusion 720, see Fig. 16), wherein said notch is formed parallel to an axis formed by a length of the suction member (portion 724 of the notch is formed parallel to the longitudinal axis of the suction member 900, see Fig. 16), the notch including a wider portion (portion 724 of notch 718 is considered "a wider portion" when the width of the notch is measured along a longitudinal direction of the outer tubular member 700, see Fig. 16) and a narrower portion (portion 722 is considered "a narrower portion" when the width of the notch is measured along a longitudinal direction of the outer tubular member 700, see Fig.16) wherein the narrower portion has a width that contacts the protrusion (the portion 722 has a width that contacts the protrusion 720 in the position shown in Fig. 16), the narrower portion of the notch contacting the protrusion preventing movement of the outer tubular member toward the first end of the inner tubular member (when protrusion 720 is engaged in the narrower portion 722, outer tubular member 700 is prevented from moving toward the first end of the inner tubular member since portion 722 prevents longitudinal movement).
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wallis (US 2018/0092644).
Regarding claim 18, Wallis discloses the device of claim 13, wherein a length of the protrusion (720) extending away from the inner tubular member is approximately the same as a thickness of the notch (718) formed on the outer tubular member (see Fig. 16).
Wallis does not expressly disclose the length of the protrusion is greater than a thickness of the notch formed on the outer tubular member. It appears that the device of Wallis would operate equally well with the claimed length since the protrusion is intended to engage with the inner walls of the notch. Further, applicant has not disclosed that the length claimed solves any stated problem or is for any particular purpose, indicating simply that the length of the protrusion "may" be larger than a thickness of the notch (see specification pp. [042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the protrusion of Wallis to have a length greater than a thickness of the notch formed on the outer tubular member because it appears to be an arbitrary design consideration which fails to patentably distinguish over Wallis.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chotenovsky et al. (US 2015/0057680) in view of Cleator (US 2010/0063517), and further in view of Rassouli (US 2019/0167911).
Regarding claim 1, Chotenovsky discloses a ligation device (2, see Fig. 1) for treating hemorrhoids (see abstract) including a locking mechanism (see Fig. 2A and [0061]), comprising: an inner tubular (4) member having an inner surface (9), an outer surface (the outer surface is opposite the inner surface), a first end (12), a second end (10), the first end having a first opening and the second end having a second opening (see Fig. 1); a suction member (16) in the inner tubular member, the suction member including a handle portion (22) and an end portion (28), and the handle portion allowing the end portion of the suction member to be pulled away from the first end of the inner tubular member (see [0059]); and an outer tubular member (30) having an inner configuration corresponding to that of the inner tubular member (see Fig. 1).
Chotenovsky fails to teach a protrusion on the outer surface of the inner tubular member and the outer tubular member including a notch as claimed. Chotenovsky also fails to teach a stopper member attached to the second end of the inner tubular member and preventing the suction member from being entirely pulled out of the inner tubular member.
Cleator, in the same field of art, discloses a similar ligation device (see Fig. 3-4) having an outer tubular member (26), a suction member (16), an inner tubular member (4) having a first end (towards 14, see Fig. 4) and a second end (towards 40, see Fig. 4), a stopper member (45) attached to the second of the inner tubular member, the stopper preventing the suction member from being entirely pulled out of the inner tubular member (see [0040]).
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 device of Chotenovsky to include a stopper member at the second end of the inner tubular member, as taught by Cleator, since doing so would prevent reuse of the device (see Cleator [0040]).
The combination of Chotenovsky and Cleator fails to teach a protrusion on the outer surface of the inner tubular member and the outer tubular member including a notch as claimed.
However, it is noted that Chotenovsky discloses the device having a locking arrangement formed by a protrusion on the outer surface of the inner tubular member and a lug on the inner surface of the outer sleeve which prevents longitudinal movement of the outer sleeve toward the first end of the inner tubular member until the sleeve is unlocked by the user to prevent unintentional deployment of a ligation band (see [0061]).
Rassouli teaches a locking mechanism (see Fig. 6) between an inner tubular member (114) having a first end (towards 144) and a second end (170) and an outer tubular member (146), where the inner tubular member has a protrusion (150) on the outer surface of the inner tubular member and the outer tubular member has a notch (128) that is configured to receive the protrusion of the inner tubular member (see Fig. 7-8), wherein the notch comprises a first portion (176) that is formed parallel to an axis formed by a length of the outer tubular member and wherein the notch comprises a second portion (178) at an end of the first notch closest to the first end of the inner tubular member (when the inner tubular member 114 is inserted into the outer tubular member 146, the second portion of the notch 178 is closer to the first end 170 of the inner tubular member, see Fig. 3-4), wherein a reception of the protrusion of the inner tubular member by the first portion of the notch of the outer tubular member allows movement of the outer tubular member toward the first end of the inner tubular member and a reception of the protrusion of the inner tubular member by the second portion of the notch of the outer tubular member prevents the movement of the outer tubular member toward the first end of the inner tubular member (when protrusion 150 is within the first portion 176 of the notch, the outer tubular member is capable of longitudinal movement toward and away from the first end of the inner tubular member and when the protrusion 150 is within the second portion 178 of the notch, longitudinal movement of the outer tubular member relative to the inner tubular member is prevented).
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 locking mechanism of Chotenovsky with the locking mechanism taught by Rassouli since doing so would have yielded only predictable results, namely, the locking mechanism of Rassouli in the device of Chotenovsky would similarly prevent longitudinal movement of the outer sleeve relative to the inner sleeve until the outer sleeve is unlocked by a user. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the limitation “the notch… is formed parallel to an axis formed by a length of the suction member,” in the device of the combination of Chotenovsky, Cleator and Rassouli the first portion of the notch would be parallel to an axis formed by a length of the suction member since the first portion would be parallel to the longitudinal axis of the outer tubular member and the outer tubular member is concentric with the suction member in the device of Chotenovsky (see Fig. 1 of Chotenovsky).
Regarding claim 2, Chotenovsky further discloses wherein the outer tubular member includes a handle (42, see Fig. 2A), the handle forming a second axis extending away from a first axis formed by center points of the first opening and the second opening of the inner tubular member (the handle 42 forms an axis that is perpendicular to the longitudinal axis of the inner tubular member 4, see Fig. 1), and the inner tubular member includes a tab (see annotated Fig. 1 below), the tab forming a third axis extending away from the first axis formed by the center points of the first opening and the second opening of the inner tubular member (the tab forms an axis that is perpendicular to the longitudinal axis of the inner tubular member, see Fig. 4).
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Regarding claim 3, Chotenovsky further discloses wherein the second axis and the third axis create an angle of about 0-45 degrees (Fig. 1 shows that the axes of the handle 42 and the tab at the proximal end of the inner tubular member create a 0-degree angle).
Regarding claim 4, Rassouli further teaches wherein the reception of the protrusion of the inner tubular member by the second portion of the notch of the outer tubular member allows the outer tubular member to be rotated relative to the inner tubular member about a first axis formed by center points of the first opening and the second opening of the inner tubular member (reception of the protrusion 150 in the second portion 178 of notch 128 allows for rotation of the outer tubular member 146 relative to the inner tubular member 114 about the longitudinal axis of the inner tubular member, see Fig. 6 and [0054]).
Regarding claim 5, Rassouli further teaches the reception of the protrusion of the inner tubular member by the second portion of the notch of the outer tubular member allows the inner tubular member to be rotated relative to the outer tubular member about a first axis formed by center points of the first opening and the second opening of the inner tubular member (reception of the protrusion 150 in the second portion 178 of notch 128 allows for rotation of the inner tubular member 146 relative to the inner tubular member 114 about the longitudinal axis of the inner tubular member, see Fig. 6 and [0054]).
Regarding claim 6, Rassouli further teaches the protrusion on the outer surface of the inner tubular member is a button shaped protrusion (protrusion 150 is button shaped, see Fig. 6).
Regarding claim 7, Rassouli further teaches wherein a length of the protrusion (150, see Fig. 3-4) extending away from the inner tubular member is approximately the same as the thickness of the notch (128) formed on the outer tubular member.
Rassouli does not expressly disclose the length of the protrusion is greater than a thickness of the notch formed on the outer tubular member. It appears that the device of Chotenovsky, Cleator, and Rassouli would operate equally well with the claimed length since the protrusion is intended to engage with the inner walls of the notch. Further, applicant has not disclosed that the length claimed solves any stated problem or is for any particular purpose, indicating simply that the length of the protrusion “may” be larger than a thickness of the notch (see specification pp. [042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the protrusion of Chotenovsky, Cleator, and Rassouli to have a length greater than a thickness of the notch formed on the outer tubular member because it appears to be an arbitrary design consideration which fails to patentably distinguish over Chotenovsky, Cleator, and Rassouli.
Regarding claim 8, Rassouli further teaches the first portion of the notch is parallel to a first axis formed by center points of the first opening and the second opening of the inner tubular member, and the second portion of the notch is perpendicular to the first portion (first portion 176 is parallel to the longitudinal axis of the inner tubular member 146 and the second portion of the notch is perpendicular to the first portion, see Fig. 6 and [0052]).
Regarding claim 9, Rassouli further teaches the first portion of the notch and the second portion of the notch form an L-shape on the outer tubular member (first and second portions 176 and 178 of the slot 128 forms an l-shape, see Fig. 6).
Regarding claim 10, Chotenovsky further discloses the end portion of the suction member includes a side surface and a top surface (suction member 16 has a side surface along the longitudinal direction of the suction member and a top surface perpendicular to the side surface, see annotated Fig. 16 below).
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Regarding claim 11, Chotenovsky further discloses the side surface of the end portion of the suction member is substantially parallel to the inner surface of the inner tubular member that is adjacent to the first opening of the inner tubular member (the side surface of the suction member 16 has a parallel portion that it is parallel to the inner surface of the inner tubular member 4 adjacent to the first opening, see annotated Fig. 16 above).
Regarding claim 12, Chotenovsky further discloses the side surface of the end portion of the suction member and the inner surface of the inner tubular member that is adjacent to the first opening of the inner tubular member form an angle of about 30 degrees or more (the side surface has an angled portion that forms an angle with the inner surface of the inner tubular member 4 adjacent to the first opening, see annotated Fig. 16 above).
Chotenovsky fails to expressly teach that the angle is 30 degrees or more.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the suction member side surface and the inner tubular member inner surface of Chotenovsky to form an angle of 30 degrees or more since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Chotenovsky would not operate differently with the claimed angle since the side surface of the suction member is intended to be angled relative to the inner surface of the inner tubular member, the device would function appropriately having the claimed angle. Further, Applicant places no criticality on the range claimed, indicating simply that the angle “may” be within the claimed range (specification pp. [052]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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