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 .
Status of Claims
This action is in response to Applicant’s response to restriction requirement.
Claims 1-20 are pending.
Non-elected claims 2-11 and 18-19 are withdrawn from consideration.
Claims 1, 12-17, and 20 are currently under examination.
Election/Restrictions
Applicant’s election without traverse encompassing claims 1, 12-17, and 20 (corresponding to Species Group III drawn to pivoting bearing arms with clearance path in figures 5-14) in reply filed June 26, 2026 is acknowledged.
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, 12-17, and 20 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.
The claims use overlapping and ambiguous terminology for the “roller clamp control mechanism assembly,” the “roller clamp control mechanism,” and the “roller clamp assembly.”
It is unclear whether these terms refer to the same structure, the standard roller clamp (fig. 5-14, elements 501-502), the retrofit control unit/bearing assembly (figs. 5-14, elements 504-510), or the entire combination. For example, claim 1 recites both the “assembly” and the “mechanism” that “adapts to the roller clamp,” while claim 12 uses “roller clamp assembly” to describe the structure that slides over and adjusts the roller wheel – a function performed only by the control unit. The specification does not provide clear guidance to resolve ambiguity. Appropriate action is required.
Claim 12 (and its dependent claims) recites the limitation "the roller clamp assembly" in first and last lines of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate action is required.
For purposes of examination, the Examiner interprets the claims as follows:
The term “roller clamp control mechanism assembly” refers to the combined device 500 represented in figs. 5-14 and elements 501-510.
The term “roller clamp control mechanism” refers to the retrofit bearing assembly that is able to slide over roller wheel 501 and snap to roller wheel’s 501 position as shown in figs. 9-14.
All instances of the term “roller clamp assembly” refer to either “roller clamp control mechanism assembly” or “roller clamp control mechanism” as deemed appropriate and are detailed claim by claim below.
In claim 12, “roller clamp assembly” in the first sentence is interpreted to mean “roller clamp control mechanism assembly” in order to maintain proper antecedent basis. The “roller clamp assembly” in the last sentence in interpreted to mean “roller clamp control mechanism” in order to maintain proper antecedent basis.
In claim 13, “roller clamp assembly” is interpreted to mean “roller clamp control mechanism assembly.”
In claim 14, the first instance of “roller clamp assembly” is interpreted to mean “roller clamp control mechanism assembly.” The second instance of “roller clamp assembly” is interpreted to mean “roller clamp control mechanism.”
In claim 15, “roller clamp assembly” is interpreted to mean “roller clamp control mechanism assembly.”
In claim 16, both instances of “roller clamp assembly” are interpreted to mean “roller clamp control mechanism assembly.”
In claim 17, “roller clamp assembly” is interpreted to mean “roller clamp control mechanism assembly.”
In claim 20, “roller clamp assembly” is interpreted to mean “roller clamp control mechanism.”
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.
Claims 1 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Valentini (US Publication No. 2014/0066893), hereinafter, Valentini, in view of Young (US Patent No. 4,553,963), hereinafter, Young.
Regarding claim 1, Valentini discloses a roller clamp housing (boxlike structure 2 in fig. 4; para [0031]) configured to receive a portion of a connector tube of an infusion set (boxlike structure 2 comprises two open ends forming aperture 3 through which a connector tube 4 (connection tubing 24 from gravity infusion set in fig. 1) can pass in figs. 4-5; para [0031]), the housing comprising:
two opposing side walls (opposing side walls 27 in figs. 2-3, para [0010]) spaced apart from each other, each side wall having an opposing guide groove (guide grooves 30 in figs. 2-3) longitudinally positioned in an interior surface (guide grooves 30 are aligned with each other and face each other; para [0010-0011]);
a guide wall (guide wall 31 in fig. 2-3, para [0011-0013]) disposed between the side walls, the guide wall converging along its length toward the position of the guide grooves (guide wall 31 converges along its length toward the position of the guide grooves 30; para [0012]);
a roller wheel (roller 28 in figs. 3; para [011]) having two axial projections slidingly seated in the guide grooves, the roller configured to move along a longitudinal axis of the housing as the projections slide in the guide grooves (two axial projections of the roller wheel are slidingly seated in the guide grooves so that the roller can move in the aperture of the further wall as the projections slide in the grooves; para [0018]), wherein spacing between the guide wall and the roller wheel decreases over a length of the guide wall (spacing between the guide wall and the further wall decreases over the length of the guide wall and the further wall; para [0018]).
Valentini fails, however, to disclose a roller clamp control mechanism assembly that comprises a roller clamp control mechanism which adapts to the roller clamp to control the position of the roller clamp.
Young teaches a roller clamp control mechanism assembly that comprises a roller clamp control mechanism (Young: motorized controller 47 in figs. 1-2 and 5) which adapts to the roller clamp to control the position of the roller clamp (Young: motorized controller 47 is adapted for automatically controlling the flow of fluid through the tube 21 by appropriately rotating the rotary member 29; col. 3, lines 46-54).
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 roller clamp of Valentini to include a roller clamp control mechanism which adapts to the roller to control the position of the roller clamp, as taught by Young, in order to provide automated flow rate adjustment in the gravity infusion set.
Regarding claim 16, Valentini, as modified in claim 1, discloses a gravity infusion set (gravity infusion set; para [0004-0009]) comprising:
a piercing spike (piercing spike 20 in fig. 1);
a drop chamber (drop chamber 22 in fig. 1);
a connector tube (connection tubing 24 in fig. 1);
a fitting (Luer fitting 25 in fig. 1); and
a roller clamp assembly (combined devices of Valentini and Young), the roller clamp assembly comprising:
a housing (boxlike structure 2 in fig. 4; para [0031]) configured to receive a portion of a connector tube of an infusion set (boxlike structure 2 comprises two open ends forming aperture 3 through which a connector tube 4 (connection tubing 24 from gravity infusion set in fig. 1) can pass in figs. 4-5; para [0031]), the housing comprising:
two opposing side walls (opposing side walls 27 in figs. 2-3, para [0010]) spaced apart from each other, each side wall having an opposing guide groove (guide grooves 30 in figs. 2-3) longitudinally positioned in an interior surface (guide grooves 30 are aligned with each other and face each other; para [0010-0011]);
a guide wall (guide wall 31 in fig. 2-3, para [0011-0013]) disposed between the side walls, the guide wall converging along its length toward the position of the guide grooves (guide wall 31 converges along its length toward the position of the guide grooves 30; para [0012]);
a roller wheel (roller 28 in figs. 3; para [011]) having two axial projections slidingly seated in the guide grooves, the roller configured to move along a longitudinal axis of the housing as the projections slide in the guide grooves (two axial projections of the roller wheel are slidingly seated in the guide grooves so that the roller can move in the aperture of the further wall as the projections slide in the grooves; para [0018]), wherein spacing between the guide wall and the roller wheel decreases over a length of the guide wall (spacing between the guide wall and the further wall decreases over the length of the guide wall and the further wall; para [0018]); and
a roller clamp control mechanism (Young: controller 47 in figs. 1-2 and 5) which adapts to the roller clamp to control the position of the roller clamp (Young: controller 47 is adapted for automatically controlling the flow of fluid through the tube 21 by appropriately rotating the rotary member 29; col. 3, lines 46-54).
Regarding claim 17, Valentini, as modified in claim 1, discloses a method of adjusting a fluid flow rate through a connector tube coupled to a fluid source (connection tubing 24 together with drop chamber 22 with drop generator 23 from gravity infusion set in fig. 1), the method comprising:
inserting the connector tube through a housing (boxlike structure 2 in fig. 4; para [0031]) of a roller clamp assembly (combined devices of Valentini and Young) having a roller wheel (roller 28 in figs. 3; para [011]) and a roller clamp control mechanism (Young: controller 47 in figs. 1-2 and 5) which adapts to the roller clamp to control a position of the roller clamp (Young: controller 47 is adapted for automatically controlling the flow of fluid through the tube 21 by appropriately rotating the rotary member 29; col. 3, lines 46-54);
controlling the roller clamp control mechanism using a control unit (Young: apparatus 11 includes controller 47 in fig. 1) to compress the connector tubing (connection tubing 24 from gravity infusion set in fig. 1) with the roller wheel (roller 28 in figs. 3; para [011]) to produce an adjustment that causes a change in the fluid flow rate through the connector tube (Young: tube 21 received by roller clamp 25 between rotary member 29 and ram 37 is progressively further restricted, and the flow of fluid through the tube is correspondingly diminished; col. 3, lines 26-45).
Allowable Subject Matter
Claims 12-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 12 is allowable over the prior art of record.
The closest prior art is Valentini in view of Young. Valentini discloses a standard roller clamp with a roller wheel movable in guide grooves of a housing. Young teaches a motorized controller for adjusting roller position in a roller clamp.
However, the combination does not teach or suggest the specific limitation of claim 12: a roller clamp control mechanism comprising two rotating bearings each fixed within a respective bearing arm which pivots about a fixed axis of the bearing arm, and a bearing clearance path for the rotating bearings to slide through, wherein the bearing clearance path allows the bearing arm of each rotating bearing to rotate inward but not outward, and wherein the roller clamp assembly is able to slide over the roller wheel and adjust the roller wheel position.
Claims 13-15 depend from claim 12 and are allowable due to their dependency.
Claim 20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 20 (which depends from claim 17) is allowable over the prior art of record for the same reasons as claim 12. It recites the method of claim 17 further comprising the specific roller clamp control mechanism structure of claim 12 (pivoting bearing arms with clearance path and slide-over engagement). The prior art lacks this structure in the context of the claimed method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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