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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/12/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29, 49, 50 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 29, 49 and 50 recite that the second clamping surface tapers upwardly from the second end to the first end.
But the specification or the drawings show that the second clamping surface tapers upwardly from the first end to the second end. Fig. 4 illustrates a slope upwardly from first end 27 to second end 29. Further, para [0058] of the specification, referring to Fig. 4, discloses that "second clamping surface tapers outwardly or upwardly from first end 27 to second end 29."
For the purpose of examination, and in the spirit of compact prosecution, the limitations in claims 29, 49 and 50 will be interpreted to cover a second clamping surface that tapers upwardly from the first end to the second end.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 29 and 44-49 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn (U.S. Pub. 2006/0015074 A1, hereinafter “Lynn”), in view of Ballenger et al (U.S. Pat. 3,350,754, hereinafter “Ballenger”), further in view of Gauger et al (U.S. Pat. 8,636,260, hereinafter “Gauger”).
Regarding claim 29, Lynn discloses a pinch clamp device, comprising:
a first arm 120/124 (see Fig. 3) having a first end comprising a lip (forming a ledge125; see Fig. 3);
and a second end comprising a first planar clamping surface (see annotated Fig. 3, below), the first arm forming a first window 150 below the lip (see Figs. 1 and 4);
a second arm 114 (see Fig. 3) having a first end comprising a terminal end 128 (see Fig. 3) and a second end comprising a second clamping surface (see annotated Fig. 3, below) positioned opposite the first clamping surface,
wherein the first clamping surface comprises a first end and a second end, wherein the lip is closer to the second end of the first clamping surface than the first end of the first clamping surface, and wherein the first clamping surface is planar between the first and second ends (see annotated Fig. 3, below);
wherein the second clamping surface comprises a first end and a second end, wherein the terminal end is closer to the second end of the second clamping surface than the first end of the second clamping surface (see Fig. 3, annotated below) and the second clamping surface is planar between the first and second ends (as shown in Fig. 3),
a hinge 118 (see Fig. 3) interconnecting the second end of the first arm and the second end of the second arm, the hinge forming a second window 129 (see Fig. 2) that is aligned with the first window to thereby allow intravenous tubing 104 (see Fig. 1) to extend through the first and second windows and be positioned between the first and second clamping surfaces (see para [0039] disclosing the distance 260 over which the intravenous tubing is positioned), the first arm, second arm and hinge being formed of a rigid or semi-rigid plastic material (see para [0014] disclosing that the clamp can be made of polypropylene),
wherein, in the disengaged configuration, the second clamping surface is inclined relative to the first planar surface (see Fig. 3), wherein in the engaged configuration, the second clamping surface is generally parallel to the first planar surface (see Fig. 6), wherein in response to movement of the pinch clamp device from the disengaged configuration to the engaged configuration, the second clamping surface first contacts and compresses the intravenous tubing disposed adjacent the second ends of the first and second clamping surfaces and thereafter progressively compresses the intravenous tubing toward the first ends of the first and second clamping surfaces (this movement is implicit in the disclosure of Lynn: as the second clamping surface moves toward the first clamping surface, the first end of the second clamping surface (see Fig. 3, annotated below) would contact the tubing first, followed by the second end of the second clamping surface (see Fig. 3, annotated below).
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Lynn, Fig. 3, annotated.
It is noted that Lynn does not appear to disclose a soft polymer material directly located on the first clamping surface and the second clamping surfaces, such that the intravenous tubing is clamped between the soft, polymer material located on the first planar clamping surface and the soft, polymer material located on the second clamping surface in the manner claimed when the pinch clamp device moves from its disengaged position to its engaged configuration, and the soft polymer material having a Shore A durometer hardness of from approximately 15 to approximately 100.
Ballenger discloses a clamp device 10 (see Fig. 1) for clamping flexible material, in the analogous art to the claimed invention (i.e., Ballenger is reasonably pertinent to the problem faced by the inventor of unintentional disengagement of the clamp due to low friction between the engaged surfaces of the pinch clamp; see Applicant’s specification at paras [0004]-[0006]) in which the entire clamp is preferably coated with a rubber or similar material to further increase the effectiveness of the clamp in retaining objects clamped therein (see col. 3, lines 30-35).
A skilled artisan would have found it obvious at the time of the invention to modify the clamp of Lynn so that it is entirely coated with a rubber or similar material (thus per se coating the first and second clamping surfaces with the rubber or similar material), in order to increase the effectiveness of the clamp in retaining the tube clamped therein (see Ballenger at col. 3, lines 47-52), with a reasonable expectation of success.
A skilled artisan would have found that coating the clamp of Lynn entirely with the rubber or similar material, thus per se coating the first and second clamping surfaces with the same material, would result in the claimed invention, namely, that soft, polymer material located on the second clamping surface would be inclined relative to the soft, polymer material located on the first clamping surfaces, and that as the first and second clamping surfaces are moved from the disengaged position into the engaged position, the polymer material on the second clamping surface would first contact and compress the tubing at the second end of the first and second clamping surface and thereafter compress the first ends of the first and second clamping surfaces. In doing so, the modified device of Lynn would positively displace fluid within the intravenous tubing without “hard kinking” the intravenous tubing.
Further, Gauger discloses a high-friction rubbery material, such as silicone or latex (col. which is used to prevent slipping of an object held by the material, the material having a durometer rating of 30-40, which falls within the claimed range of approximately 15 to approximately 100 (although Gauger does not specify whether the durometer rating is in the shore A scale or shore D scale, it is known that the hardness of soft materials is measured using the shore A scale; Gauger discloses that the material is soft TPE with a durometer of 30-40, or silicone with a durometer of 25-30, which, based on the softness of the materials, would be understood to be measured on the shore A scale; see Gauger at col. 3, lines 31-37 and col.5, lines 61-66).
A skilled artisan would have found it obvious to modify the soft polymer disclosed in Ballenger (rubber) material to have a shore A hardness of approximately 15 to approximately 100, based on the teaching in Gauger that materials with this hardness were known to provide a sticky, high friction coating toa surface (Gauger at col. 5, lines 62-63) that may be easily molded into a variety of shapes (Gauger at col. 3, lines 34-35) is available in a variety of durometers for optimizing its intended use (Gauger at col. 3, lines 34-35).
Regarding claims 44-49, Lynn discloses:
the first and second arms have opposing side surfaces (outward facing surfaces) (as per claim 44);
the second arm includes a grip feature 115 (see Fig. 3) (as per claim 47);
the second clamping surface tapers upwardly from the first end to the second end (see Fig. 3) (as per claim 49).
Since a skilled artisan would have found it obvious at the time of the invention to modify the clamp of Lynn so that it is entirely coated with the claimed soft polymer material, then it would have been per se obvious to coat the various surfaces identified in claims 44-48 as well (i.e., the opposing side surfaces in claim 44; the lip and terminal end in claim 45 to form an interlocking groove; the grip feature in claim 47; and all exterior surfaces of the first arm, second arm and hinge in claim 48), since those surfaces are part of the clamp.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Lynn in view of Ballenger.
Regarding claim 50, , Lynn discloses a pinch clamp device, comprising:
a first arm 120/124 (see Fig. 3) having a first end comprising a lip (forming a ledge125; see Fig. 3);
and a second end comprising a first planar clamping surface (see annotated Fig. 3, below), the first arm forming a first window 150 below the lip (see Figs. 1 and 4);
a second arm 114 (see Fig. 3) having a first end comprising a terminal end 128 (see Fig. 3) and a second end comprising a second clamping surface (see annotated Fig. 3, below) positioned opposite the first clamping surface,
wherein the first clamping surface comprises a first end and a second end, wherein the lip is closer to the second end of the first clamping surface than the first end of the first clamping surface, and wherein the first clamping surface is planar between the first and second ends (see annotated Fig. 3, below);
wherein the second clamping surface comprises a first end and a second end, wherein the terminal end is closer to the second end of the second clamping surface than the first end of the second clamping surface (see Fig. 3, annotated below), wherein the second clamping surface tapers upwardly from the first end to the second end such that when the pinch clamp device is in a disengaged configuration, the first end of the second clamping surface is spaced from the first clamping surface a first distance (labeled as “D1” in Fig. 3, annotated below) and the second end of the second clamping surface is spaced from the first clamping surface a second distance (labeled as “D2” in Fig. 3, annotated below), wherein the second distance is greater than the first distance;
wherein, when the pinch clamp device is in an engaged configuration in which the terminal end is held under the lip, the first and second clamping surfaces are parallel (as shown in Fig. 6 and para [0040] referring to a "flat" surface that compresses the IV tubing) and spaced apart by a third distance, the third distance being less than the second distance (see para [0040], disclosing that a uniform distance is provided between the two opposed clamping surfaces, matched to width of the tube when the tube has a completely compressed lumen; this width is considerably less than the second distance, since the second distance corresponds to a distance considerably larger than the tube in its uncompressed diameter),
a hinge 118 (see Fig. 3) interconnecting the second end of the first arm and the second end of the second arm, the hinge forming a second window 129 (see Fig. 2) that is aligned with the first window to thereby allow intravenous tubing 104 (see Fig. 1) to extend through the first and second windows and be positioned between the first and second clamping surfaces (see para [0039] disclosing the distance 260 over which the intravenous tubing is positioned), the first arm, second arm and hinge being formed of a rigid or semi-rigid plastic material (see para [0014] disclosing that the clamp can be made of polypropylene),
wherein, in the disengaged configuration, the second clamping surface is inclined relative to the first planar surface (see Fig. 3), wherein in the engaged configuration, the second clamping surface is generally parallel to the first planar surface (see Fig. 6), wherein in response to movement of the pinch clamp device from the disengaged configuration to the engaged configuration, the second clamping surface first contacts and compresses the intravenous tubing disposed adjacent the second ends of the first and second clamping surfaces and thereafter progressively compresses the intravenous tubing toward the first ends of the first and second clamping surfaces (this movement is implicit in the disclosure of Lynn: as the second clamping surface moves toward the first clamping surface, the first end of the second clamping surface (see Fig. 3, annotated below) would contact the tubing first, followed by the second end of the second clamping surface (see Fig. 3, annotated below).
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Lynn, Fig. 3, annotated.
It is noted that Lynn does not appear to disclose a soft polymer material directly located on the first clamping surface and the second clamping surfaces, such that the intravenous tubing is clamped between the soft, polymer material located on the first planar clamping surface and the soft, polymer material located on the second clamping surface in the manner claimed when the pinch clamp device moves from its disengaged position to its engaged configuration, and the soft polymer material having a Shore A durometer hardness of from approximately 15 to approximately 100.
Ballenger discloses a clamp device 10 (see Fig. 1) for clamping flexible material, in the analogous art to the claimed invention (i.e., Ballenger is reasonably pertinent to the problem faced by the inventor of unintentional disengagement of the clamp due to low friction between the engaged surfaces of the pinch clamp; see Applicant’s specification at paras [0004]-[0006]) in which the entire clamp is preferably coated with a rubber or similar material to further increase the effectiveness of the clamp in retaining objects clamped therein (see col. 3, lines 30-35).
A skilled artisan would have found it obvious at the time of the invention to modify the clamp of Lynn so that it is entirely coated with a rubber or similar material (thus per se coating the first and second clamping surfaces with the rubber or similar material), in order to increase the effectiveness of the clamp in retaining the tube clamped therein (see Ballenger at col. 3, lines 47-52), with a reasonable expectation of success.
A skilled artisan would have found that coating the clamp of Lynn entirely with the rubber or similar material, thus per se coating the first and second clamping surfaces with the same material, would result in the claimed invention, namely, that soft, polymer material located on the second clamping surface would be inclined relative to the soft, polymer material located on the first clamping surfaces, and that as the first and second clamping surfaces are moved from the disengaged position into the engaged position, the polymer material on the second clamping surface would first contact and compress the tubing at the second end of the first and second clamping surface and thereafter compress the first ends of the first and second clamping surfaces. In doing so, the modified device of Lynn would positively displace fluid within the intravenous tubing without “hard kinking” the intravenous tubing.
Response to Arguments
Applicant's arguments filed 07/21/2026 have been fully considered, but are not persuasive for the reasons set forth above and in this section.
Specifically, Applicant argued (Remarks, pg. 2) that:
Lynn appears to disclose that the clamp includes a "flat" surface that compresses the intravenous tubing. See Lynn ¶ 40. Lynn further explains that a "uniform distance is provided between the two opposed clamping surfaces, matched to the width of the tube when the tube has a completely compressed lumen." Lynn ¶ 40. Thus, Lynn appears to describe opposing clamping surfaces that compress the tubing to a closed condition. However, Lynn does not appear to disclose that the tubing is first contacted at one longitudinal end of the clamping surfaces and thereafter progressively compressed along the length of the tubing during closure of the clamp. Nothing in Lynn appears to teach or suggest that the tubing undergoes a controlled, sequential compression beginning adjacent one end of the clamping surfaces and progressing toward the opposite end.
But the “flat” surface referred to in Lynn refers to the shape of the clamping surfaces that achieve the desired compression of the clamp after latching, i.e., when the clamp is in the engaged position. Applicant’s own invention also has a similarly “flat” surface when in its engaged position (see Applicant’s Fig. 4D).
Fig. 3 of Lynn shows the clamp in its disengaged position. The first end of the clamping surface has a height (D1) that is less than the height (D2) of the second end. Thus, as the clamp is moved from the disengaged position to the engaged position, the first end of the clamping surface would contact and clamp the tube before the second end. This produces the same sequential clamping operation as Applicant’s claimed invention. In particular, both Lynn and Applicant’s invention include a clamping surface that is inclined relative to another, flat clamping surface (see Applicant’s Fig. 4A). Accordingly, a skilled artisan would have reasonably expected Lynn’s clamp to operate in the same manner as Applicant’s clamp because the corresponding inclined and flat surfaces produce the same sequential engagement of the tube.
Providing a coating of a soft polymer on the entire clamp, as taught in Ballenger, would not have changed the clamp’s principle of operation. The two clamping surfaces (one being inclined relative to the other), now being modified to be coated with a soft polymeric material, would result in the soft polymeric material of the two clamping surfaces to engage one another in the same way: as the clamp is moved from the disengaged position to the engaged position, the soft polymeric material coated on the first end of the clamping surface would contact and clamp the tube before the soft polymeric material located on the second end.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/22/2026
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