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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/28/2026 has been entered.
Response to Amendment
The Amendment filed 1/28/2026 has been entered. Claims 1-15, 17-19 and 21 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection, 112(a) and 112(b) rejections previously set forth in the Final Office Action mailed 12/9/2025.
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 1-15 and 21 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 recitation “a top surface” in line 17 renders the claim indefinite because the claim is unclear if “an uppermost surface” recited in claim 1, line 4 and “a top surface” are same or different. For examination purposes, examiner construes that “an uppermost surface” and “a top surface” is same surface.
Claims 2-15 and 21 being dependent on claim 1 are also rejected.
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Winsor et al. (US 3,034,504) in view of Mackal (US 8,308,128 B2) and further in view of Smith et al. (US 2006/0129110 A1).
Regarding claim 17, Winsor discloses an infusion set (figure 1) comprising:
a drip chamber 22;
a connector tube 30; and
a levered flow regulation clamp assembly 84 (figure 1) comprising:
a housing (housing of element 84) having an open-ended structure (structure is open due to presence of an opening to accommodate element 50, 90 and element 98) and comprising:
two opposing side walls 88, each side wall comprising a rectangular bottom portion (portion of element 88 touching element 86) and a curvilinear top portion (portion of element 88 opposite to element 86 is curvilinear) extending upward from an uppermost surface (upper most surface of portion of element 88 touching element 86) of the rectangular bottom portion; and
a bottom wall 86 connecting the side walls 88, the side walls 88 and the bottom wall 86 defining a housing channel (channel formed inside element 84), and a bottom portion (portion of channel inside element 84 closer to element 86) of the housing channel defining a tube channel (channel that accommodates element 50) configured to receive an intravenous tube 50; and
a slider 90 coupled to the housing, the slider 90 comprising:
a body (body of element 90);
a cam 94 disposed at a first end (end of element 90 comprising element 94) of the body;
a gripping portion 96 disposed at a second end (end of element 90 comprising element 96) of the body; and
an axle 92 rotatably disposed within associated axle openings (opening in element 88 that accommodates element 92) in the opposing side walls 88 of the housing,
wherein the body of the slider 90 is configured to rotate about the axle 92 in the housing channel with the gripping portion 96 at an open position (position when element 90 is not squeezing element 50) at a first end of the curvilinear top portion (portion of element 88 closer to element 84 or 86) and the gripping portion 96 at a closed position (column 3, lines 51-57) at a second end of the curvilinear top portion (see “SE” in figure 2 below). Winsor is silent regarding an axle being two opposing axles.
However, Mackal teaches a design of a slider clamp (figure 1) comprising two opposing axles 32 for the purpose of using an alternative configuration to rotate the clamp with respect to the housing (column 6, lines 6-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the axle of Winsor to incorporate two opposing axles as taught by Mackal for the purpose of using an alternative configuration to rotate the clamp with respect to the housing (column 6, lines 6-10).
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Winsor further is silent regarding the gripping portion extending widthwise past each of the side walls.
However, Smith teaches a design of a clamp apparatus (figure 1) the gripping portion 44 (figure 2) extending widthwise past each of the side walls 54 for the purpose of facilitating the gripping of the body using an alternative design (paragraph 0042, lines 10-15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the gripping portion of Winsor to incorporate the gripping portion extending widthwise past each of the side walls as taught by Smith for the purpose of facilitating the gripping of the body using an alternative design (paragraph 0042, lines 10-15).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Winsor et al. (US 3,034,504) in view of Mackal (US 8,308,128 B2) in view of Smith et al. (US 2006/0129110 A1) and further in view of Burkholz et al. (US 2017/0120040 A1).
Regarding claim 18, Winsor/Mackal/Smith (hereinafter referred as “modified Winsor ‘04”) discloses the claimed invention substantially as claimed, as set forth above in claim 17. Modified Winsor is silent regarding further comprising a friction pad configured to provide a defined level of frictional engagement between the body of the slider and the curvilinear top portion, wherein the levered flow regulation clamp assembly is configured to be self-locking based on a frictional force from the friction pad being greater than a rotational tendency of the cam from fluid forces pushing the intravenous tube against the cam.
However, Burkholz discloses a design of a clamp (figure 2A) comprising a friction pad 40 (figures 2B, 5) wherein the levered flow regulation clamp assembly 10 is configured to be self-locking based on a frictional force (paragraph 0054, paragraph 0055, lines 8-12) from the friction pad 40 being greater than a rotational tendency of the cam 26 from fluid forces pushing the intravenous tube 70 against the cam for the purpose of increasing the friction between two engaging surfaces (paragraph 0054) and prevent unintended disengagement (paragraph 0055, lines 8-12).
Burkholz discloses that element 40 could be applied to various surfaces of the clamp to increase the friction (paragraph 0054) where unintended disengagement needs to be prevented. Therefore, one of ordinary skill in the art when modifying modified Winsor ’04 in view of Burkholz could apply at various locations of the clamp assembly of modified Winsor to maintain the position of the slider with respect to the housing therefore, modified Winsor in view of Burkholz would result in having a friction pad configured to provide a defined level of frictional engagement between the body of the slider and the curvilinear top portion.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the clamp assembly of modified Winsor ’04 to incorporate a friction pad configured to provide a defined level of frictional engagement between the body of the slider and the curvilinear top portion, wherein the levered flow regulation clamp assembly is configured to be self-locking based on a frictional force from the friction pad being greater than a rotational tendency of the cam from fluid forces pushing the intravenous tube against the cam as taught by Burkholz for the purpose of increasing the friction between two engaging surfaces (paragraph 0054) and prevent unintended disengagement (paragraph 0055, lines 8-12).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Winsor et al. (US 3,034,504) in view of Mackal (US 8,308,128 B2) in view of Smith et al. (US 2006/0129110 A1) and further in view of Miyaraha (US 2008/0029721 A1).
Regarding claim 19, modified Winsor ‘04 discloses the claimed invention substantially as claimed, as set forth above in claim 17. Winsor is further silent regarding wherein a top surface of at least one bottom rectangular portion comprises a top surface configured to prevent the second end of the body of the slider from rotating into the tube channel past the closed position.
However, Mackal teaches wherein a top surface of at least one bottom rectangular portion 18 comprises a stop surface (see “S” in figure 1 above) configured to prevent the second end of the body of the slider 30 from rotating into the tube channel past the closed position (element “S” in figure 1 above would prevent the further rotation of element 30 due to engagement with element 28) for the purpose of allowing the slider to remain in closed position while reducing tubing wear and abrasion (column 2, lines 4-7, column 3, lines 6-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the clamp assembly of Winsor ’04 to incorporate wherein a top surface of at least one bottom rectangular portion comprises a top surface configured to prevent the second end of the body of the slider from rotating into the tube channel past the closed position as taught by Mackal for the purpose of allowing the slider to remain in closed position while reducing tubing wear and abrasion (column 2, lines 4-7, column 3, lines 6-9).
Modified Winsor ’04 is further silent regarding wherein at least one top curvilinear portion comprises a stop member extending into the housing channel, the stop member configured to prevent the slider from rotating outside of the housing channel past the open position.
However, Miyaraha teaches a design of a clamp assembly (figure 2) wherein at least one top curvilinear portion (portion of element 1 comprising element 8) comprises a stop member 14, 6 extending into the housing channel (hollow portion inside element 1), the stop member 14, 6 configured to prevent the slider 8, 4 from rotating outside of the housing channel past the open position (position shown in figure 4) for the purpose of preventing the disengagement of the slider from the top curvilinear portion when placed in the open position (paragraph 0058, lines 4-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the at least one top curvilinear portion of modified Winsor ’04 to incorporate a stop member extending into the housing channel, the stop member configured to prevent the slider from rotating outside of the housing channel past the open position as taught by Miyaraha for the purpose of preventing the disengagement of the slider from the top curvilinear portion when placed in the open position and maintain the slider in the open position (paragraph 0058, lines 4-9).
Allowable Subject Matter
Claims 1-15 and 21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Mackal (US 8,308,128 B2), discloses a levered flow regulation clamp assembly comprising a housing having an open-ended structure and comprising two opposing side walls, each side wall comprising a rectangular bottom portion and a curvilinear top portion, a bottom wall connecting the side wall, a slider coupled to the housing but is silent regarding a curvilinear top portion extending upward from an uppermost surface of the rectangular bottom portion and wherein a top surface of at least one rectangular bottom portion comprises a stop surface configured to prevent the second end of the body of the slider from moving past a bottommost portion of the curvilinear top portion into the tube channel within the rectangular bottom portion and past the closed position in combination with other claimed limitations of claim 1.
Claims 2-15 and 21 being dependent on claim 1 are also allowable.
Response to Arguments
Applicant’s arguments with respect to claim 17 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783