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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6 August 2026 is acknowledged.
Claims 15 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 August 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
52 as included in Figure 2.
412 as included in Figure 4A.
510 as included in Figure 5A.
600 as included in Figure 6.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Figures 3A – 3C should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
reference character “310” has been used to designate both “first view” (see [0043] and Figure 3A) and what appears to be an element of the pumping mechanism (see Figures 5A – 5B).
reference character “315” has been used to designate both “second view” (see [0043] and Figure 3B) and what appears to be an element of the pumping mechanism (see Figures 5A – 5B).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the pump mechanism is a first pump mechanism and the medical device further comprises a second pump mechanism, the first element is actuated by the first pump mechanism and the second and third elements are actuated by the second pump mechanism” (see Claim 7) and “wherein the body comprises a door and a housing, the door configured to couple to the housing when closed, wherein (i) the first pump mechanism is locate within a part of the housing, and (ii) the second pump mechanism is located within a portion of the door” (see Claim 8) must be shown or the feature(s) canceled from the claim(s). Currently, the Drawings do not show the second pump mechanism being located within a portion of the door. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0045] recites “a flat surface 407 configured to compresses the IV tube flat 320 against a surface 325…”. The Examiner suggests amending this to recite “a flat surface configured to compress[[es]] the IV tube 320 flat [[320]] against a surface 325…” to correct the reference numeral for the IV tube and improve the grammar of the sentence.
[0051] recites “A first view 810 shows a pump mechanism including a first element…”. The Examiner believes this is the incorrect reference numeral for the first view. The Examiner suggests amending this passage to recite “A first view [[810]] 510 shows a pump mechanism including a first element…” to correct the reference numeral.
Note this Specification amendment would also address one of the Drawing Objections above regarding reference numeral 510 in Figure 5A.
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 7, 8, and 9 – 14 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 7 recites:
The medical device of claim 1, wherein the pump mechanism is a first pump mechanism and the medical device further comprises a second pump mechanism, the first element is actuated by the first pump mechanism and the second and third elements are actuated by the second pump mechanism.
Claim 1 recites “the pump mechanism including: a first element…a second element…a third element.”
Claim 7 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear how the second and third elements are part of the first pump mechanism but actuated by the second pump mechanism.
Currently, Claim 1 recites that the pump mechanism includes the second and third elements. Claim 7 then recites that the pump mechanism is a first pump mechanism and that the second and third elements are actuated by the second pump mechanism. Does this mean that components of the first pump mechanism (i.e., the second and third elements) are actuated by the second pump mechanism? In other words, is the first pump mechanism actuated by the second pump mechanism?
Claim 8 depends upon Claim 7 and is rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 9 recites “the second and third elements have a second surface configured to reshape the IV tube.” Claim 9 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear if the second and third elements each comprise a second surface or if the second surface is the combined surfaces of the second and third elements that are configured to reshape the IV tube. Figures 4A – 4C show the second surface at 412, 417. However, the Specification does not include reference numeral 412. This further compounds the indefiniteness regarding the second surface. Is the second surface of the second element at 412, the second surface of the third element at 417, or is the second surface of the second and third elements at the combined surface of 412, 417 in the figures?
Claims 10 – 14 are rejected under 35 U.S.C § 112(b) because of their dependency on Claim 9.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recite “the processor.” This claim limitation lacks antecedent basis within the claims. The lack of antecedent basis renders the claim indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill (US 5,660,529 A).
With regards to claim 1, Hill discloses a medical device (see Figure 1), comprising:
a body (10) configured to receive and secure an intravenous (IV) tube (16) in an extended position (see Col. 4, lines 14 – 34 “The linear peristaltic pump control box is constructed to releasably engage a flexible tubing 16 along an engagement pathway 18” and Figure 1), the IV tube configured to allow for the transportation of a fluid (see Col. 7, lines 4 – 22 “As the rotation continues, a wave-like action will pump fluid through IV tubing 16, as depicted with the flow direction arrow 84” and Fig. 6);
a pump mechanism (20) (see Col. 4, lines 14 – 34) residing within the body (see Col. 4, liens 14 – 34 and Figure 1), the pump mechanism including:
a first element (24) (see Col. 4, lines 35 – 55) positioned along a first axis (see Examiner annotated Figure 4 below; hereinafter referred to as “Fig. A”) and configured to, when actuated, move in a first direction (98) (see Fig. 7) along the first axis to compress the IV tube when the IV tube is received and secured in the body (see Col. 7, line 40 – Col. 8, line 3 “Also, it can be seen that pumping element 24 is now moved upward with respect to the housing 22, as schematically indicated with vertical movement arrow 98. It will also be noted that in this position, tubing 16 becomes partially compressed because of the partial upward actuation and movement of pumping plate 24.”),
a second element (32i) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) positioned along a second axis perpendicular to the first axis and configured to, when actuated, move in a second direction along the second axis and perpendicular to the first direction to provide a first force against a first side of the IV tube (see Col. 9, lines 16 – 30 “The relative motion between cam slots 80i and 80ii and cam followers 82i and 82ii will act to pivot the reshaping fingers 26i and 26ii outward at the bottom and inward at the top, so that the reshaping jaws 32i and 32ii contact the previously compressed IV tubing 16 in opposed horizontal directions, thereby returning tubing 16 toward its original shape and an opened condition.” Here the horizontal direction inward of the reshaping jaw 32i is the second direction.),
a third element (32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) positioned along the second axis opposite the second element and configured to, when actuated, move in a third direction along the second axis opposite the second direction to provide a second force against a second side of the IV tube, the second force opposing the first force (see Col. 9, lines 16 – 30 “The relative motion between cam slots 80i and 80ii and cam followers 82i and 82ii will act to pivot the reshaping fingers 26i and 26ii outward at the bottom and inward at the top, so that the reshaping jaws 32i and 32ii contact the previously compressed IV tubing 16 in opposed horizontal directions, thereby returning tubing 16 toward its original shape and an opened condition.” Here the horizontal direction inward of the reshaping jaw 32ii is the third direction.).
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With regards to claim 2, Hill discloses the claimed invention of claim 1, and Hill further discloses the medical device further comprising:
a processor (11) (see Col. 4, lines 14 – 34 and Col. 6, lines 11 – 27) configured to:
cause the first element (24) (see Col. 4, lines 35 – 55) to be actuated at a first time (see Fig. 8) compressing the IV tube (16) and causing the fluid to flow (see Col. 9, lines 4 – 15), and
cause the second and third elements (32i, 32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) to be contemporaneously actuated at a second time (see Fig. 9) distinct from the first time, wherein, at the second time, the second element provides the first force against the first side of the IV tube and the third element provides the second force against the second side of the IV tube and cause the IV tube to rebound to a resting state (see Col. 9, lines 16 – 40).
With regards to claim 3, Hill discloses the claimed invention of claim 2, and Hill further discloses wherein the first, second, and third elements (24, 32i, 32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) are synchronized such that the first, second, and third elements are actuated in unison with the second and third elements being actuated in directions opposite to the second and third directions (see Col. 9, lines 4 – 15 “the reshaping jaws 32i and 32ii at the top will be moved outward and will provide ample clearance for complete compression of IV tubing 16 to a closed and completely flattened condition” here the outward horizontal direction of each reshaping jaw 32i and 32ii is the opposite directions of the second and third directions), respectively, at the first time (see Fig. 8), and the first element (24) being actuated in a direction (102) opposite the first direction at the second time (see Fig. 9 and Col. 9, lines 16 – 30 “This will move pumping plate 24 downward, as indicated by motion arrow 102, so that tubing 16 becomes partially opened”).
With regards to claim 4, Hill discloses the claimed invention of claim 3, and Hill further discloses wherein the first element (24) (see Col. 4, lines 35 – 55) is actuated a third time following the second time (see Fig. 9) only after the IV tube (16) is rebound to a resting configuration (see Col. 9, line, 16 – Col. 10, line 11).
With regards to claim 5, Hill discloses the claimed invention of claim 1, and Hill further discloses wherein the first element (24) (see Col. 4, lines 35 – 55) comprises a first plurality of members (24a, 24b, 24c, 24d, 24e, 24f, 24g, and 24h) (see Col. 6, lines 39 – 49), and each member of the first plurality of members is moved sequentially from a first end to a second end (see Figure 3 where the first end is at 24a and the second end is at 24h) (see Col. 6, line 54 – Col. 7, line 3).
With regards to claim 6, Hill discloses the claimed invention of claim 1, and Hill further discloses wherein the second element (32i) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) comprises a second plurality of members (see the jaw 32i of each reshaping finger 26a, 26b, 26c, 26d, 26e, 26f, 26h in Figure 3) and the third element (32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) comprises a third plurality of members (see the jaw 32ii of each reshaping finger 26a, 26b, 26c, 26d, 26e, 26f, 26h in Figure 3), wherein (i) each member of the second plurality of members is moved sequentially from a first end to a second end (see Figure 3 where the first end is at 26a and the second end is at 26h) (see Col. 7, lines 4 – 53), and (ii) each member of the third plurality of members is moved sequentially from a first end to a second end (see Figure 3 where the first end is at 26a and the second end is at 26h) (see Col. 7, lines 4 – 53).
With regards to claim 7, Hill discloses the claimed invention of claim 1, and Hill further discloses wherein the pump mechanism (20) (see Col. 4, lines 14 – 34) is a first pump mechanism (60) (see Col. 5, line 60 – Col. 6, line 10) and the medical device (see Figure 1) further comprises a second pump mechanism (54, 56) (see Col. 5, lines 43 – 59), the first element (24) (see Col. 4, lines 35 – 55) is actuated by the first pump mechanism (see Col. 7, line 62 – Col. 9, line 40) and the second and third elements (32i, 32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) are actuated by the second pump mechanism (see Col. 4, lines 43 – 59 and Col. 8, line 40 – Col. 9, line 3).
With regards to claim 8, Hill discloses the claimed invention of claim 7, and Hill further discloses wherein the body (10) comprises a door (40, 52) (see Col. 4, line 56 – Col. 5, line 34 and Col. 5, lines 43 – 59) and a housing (22) (see Col. 4, lines 14 – 34), the door configured to couple to the housing when closed (see Figures 6 – 9 and Col. 4, line 56 – Col. 5, line 59), wherein (i) the first pump mechanism (60) (see Col. 5, line 60 – Col. 6, line 10) is located within a part of the housing (see Figures 1 – 2 and the location of the drive cams 60), and (ii) the second pump mechanism (54, 56) (see Col. 5, lines 43 – 59) is located within a portion of the door (see Figure 2 which shows the latch pivot 54 being located within a portion of the door 40, 52).
With regards to claim 9, Hill discloses the claimed invention of claim 1, and Hill further discloses wherein the first element (24) (see Col. 4, lines 35 – 55) includes a first surface (see Figures 6 – 9 where the IV tubing 16 is compressed) that compresses the IV tube (16) (see Col. 8, line 40 – Col. 9, line 3), and the second and third elements (32i, 32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53) have a second surface configured to reshape the IV tube (see Col. 4, lines 35 – 55 “ The pairs of opposed interdigitated reshaping fingers 26i and 26ii each have corresponding opposed jaws 32i and 32ii. Each pair of opposed jaws preferably defines a substantially cylindrical opening having a diameter corresponding to the diameter of the flexible tubing 16.” Col. 9, lines 16 – 30 “Where the reshaping jaws 32i and 32ii are in the shape of concave arcs of a cylinder, with the same radius as the tubing 16, the tubing 16 will be reshaped to its original circular cross-sectional shape.” Col. 9, line 41 – Col. 10, line 11. Here the substantially cylindrical opening that is a concave arc of a cylinder is the second surface of the second and third elements).
With regards to claim 10, Hill discloses the claimed invention of claim 9, and Hill further discloses wherein the first surface is a flat surface (see Figures 6 – 9 where the IV tubing 16 is compressed) configured to compress the IV tube (16) (see Col. 8, line 40 – Col. 9, line 3) flat against a surface (see at 36 in Figure 8) of the body (10), and the second surface is a concave surface configured to reshape the IV tube (see Col. 4, lines 35 – 55, Col. 9, lines 16 – 30 “Where the reshaping jaws 32i and 32ii are in the shape of concave arcs of a cylinder, with the same radius as the tubing 16, the tubing 16 will be reshaped to its original circular cross-sectional shape.”, and Col. 9, line 41 – Col. 10, line 11).
With regards to claim 11, Hill discloses the claimed invention of claim 9, and Hill further discloses wherein the second surface (see Col. 4, lines 35 – 55 “ The pairs of opposed interdigitated reshaping fingers 26i and 26ii each have corresponding opposed jaws 32i and 32ii. Each pair of opposed jaws preferably defines a substantially cylindrical opening having a diameter corresponding to the diameter of the flexible tubing 16.” Col. 9, lines 16 – 30 “Where the reshaping jaws 32i and 32ii are in the shape of concave arcs of a cylinder, with the same radius as the tubing 16, the tubing 16 will be reshaped to its original circular cross-sectional shape.” Col. 9, line 41 – Col. 10, line 11. Here the substantially cylindrical opening that is a concave arc of a cylinder is the second surface of the second and third elements) includes one or more actuators (60a, 60b, 60c, 60d, 60e, 60f, and 60h), and the second surface dynamically adjusts (see Col. 4, lines 35 – 55, Col. 9, lines 16 – 30, and Col. 9, line 41 – Col. 10, line 11 where the dynamic adjustment is the movement of each reshaping finger 26a – 26h), using the one or more actuators, to conform with the IV tube (16) being used (see Col. 6, line 39 – Col. 7, line 3 and Col. 7, line 62 – Col. 9, line 40) .
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) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Miyazaki et al. (US 2008/0138218 A1) (hereinafter referred to as “Miyazaki”).
With regards to claim 12, Hill discloses the claimed invention of claim 11, and Hill further discloses a processor (11) (see Col. 4, lines 14 – 34 and Col. 6, lines 11 – 27) configured to:
adjust the contour of the second surface (see Col. 4, lines 35 – 55 “ The pairs of opposed interdigitated reshaping fingers 26i and 26ii each have corresponding opposed jaws 32i and 32ii. Each pair of opposed jaws preferably defines a substantially cylindrical opening having a diameter corresponding to the diameter of the flexible tubing 16.” Col. 9, lines 16 – 30 “Where the reshaping jaws 32i and 32ii are in the shape of concave arcs of a cylinder, with the same radius as the tubing 16, the tubing 16 will be reshaped to its original circular cross-sectional shape.” Col. 9, line 41 – Col. 10, line 11. Here the substantially cylindrical opening that is a concave arc of a cylinder is the second surface of the second and third elements. See Figures 6 and 8 where the second surface adjusts in contour), via the one or more actuators (60a, 60b, 60c, 60d, 60e, 60f, and 60h), such as to change the shape of the second surface to substantially mate with a portion of the IV tube (16) (see Figure 6 - 9 which shows the shape of the second surface changing to substantially mate with a portion of the IV tube 16).
However, Hill is silent with regards to:
a processor configured to:
upon receiving the IV tube, detect an identifier associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter, an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material;
based on the identifier, adjust the contour of the second surface, via the one or more actuators, such as to change the shape of the second surface to substantially mate with a portion of the IV tube.
Nonetheless Miyazaki, which is within the analogous art of micropumps, tube units, and control units (see abstract and title), teaches a medical device (10) (see [0083]) further comprising:
a processor (200) (see [0082]) configured to:
upon receiving the IV tube (100) (see [0077] and see Figures 2 and 6), detect an identifier (130) (see [0077] “The IC tag 130 is affixed to the lower surface side of the tube unit 100, i.e., on the side of the shelf-like section 202”) associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter (see [0018] and [0086] “The IC tag 130 stores therein tube individual data for use to correct any variation observed in the quantity of discharge of a fluid. Such a variation is caused due to a difference among tubes to be attached, e.g., the inner diameter of the tube 50 to be attached”), an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material;
based on the identifier adjust the operation of the pumping mechanism of the medical device (see [0099] – [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of the medical device of Hill in view of a teaching of Miyazaki such that the processor is configured to upon receiving the IV tube, detect an identifier associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter, an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material; and based on the identifier, adjust the contour of the second surface, via the one or more actuators, such as to change the shape of the second surface to substantially mate with a portion of the IV tube. One of ordinary skill in the art would have been motivated to make this modification because Miyazaki teaches that this configuration increases the accuracy of discharge of the fluid, prevents attachment of a tube not made for the micropump, and reduces the cost of running the pump. See [0010] and [0154] of Miyazaki.
With regards to claim 14, Hill discloses the claimed invention of claim 9, and Hill further discloses wherein the processor (11) (see Col. 4, lines 14 – 34 and Col. 6, lines 11 – 27) is further configured to:
determine a compression force to compress the IV tube (16) (see Col. 6, lines 11 – 27), the first force to be applied against the first side of the IV tube (see Col. 8, line 40 – Col. 9, line 30), and the second force to be applied against the second side of the IV tube (see Col. 8, line 40 – Col. 9, line 30); and
generate the compression force, the first force, and the second force via actuation of the first, second, and third elements (24, 32i, 32ii) (see Figure 4, Col. 4, lines 35 – 55, and Col. 7, lines 37 – 53), respectively.
However, Hill is silent with regards to the processor being further configured to:
upon receiving the IV tube, detect an identifier associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter, an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material;
based on the identifier, determine a compression force to compress the IV tube, the first force to be applied against the first side of the IV tube, and the second force to be applied against the second side of the IV tube; and
generate the compression force, the first force, and the second force via actuation of the first, second, and third elements, respectively.
Nonetheless Miyazaki, which is within the analogous art of micropumps, tube units, and control units (see abstract and title), teaches a medical device (10) (see [0083]) further comprising:
a processor (200) (see [0082]) configured to:
upon receiving the IV tube (100) (see [0077] and see Figures 2 and 6), detect an identifier (130) (see [0077] “The IC tag 130 is affixed to the lower surface side of the tube unit 100, i.e., on the side of the shelf-like section 202”) associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter (see [0018] and [0086] “The IC tag 130 stores therein tube individual data for use to correct any variation observed in the quantity of discharge of a fluid. Such a variation is caused due to a difference among tubes to be attached, e.g., the inner diameter of the tube 50 to be attached”), an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material;
based on the identifier adjust the operation of the pumping mechanism of the medical device (see [0099] – [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of the medical device of Hill in view of a teaching of Miyazaki such that wherein the processor is further configured to: upon receiving the IV tube, detect an identifier associated with the IV tube, the identifier including one or more of an IV tube type, an IV tube diameter, an IV tube wall thickness, IV tube shape, IV tube pliability, IV tube flexibility, and an IV tube material; based on the identifier, determine a compression force to compress the IV tube, the first force to be applied against the first side of the IV tube, and the second force to be applied against the second side of the IV tube; and generate the compression force, the first force, and the second force via actuation of the first, second, and third elements, respectively. One of ordinary skill in the art would have been motivated to make this modification because Miyazaki teaches that this configuration increases the accuracy of discharge of the fluid, prevents attachment of a tube not made for the micropump, and reduces the cost of running the pump. See [0010] and [0154] of Miyazaki.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill and Meiri (US 5,024,586 A).
With regards to claim 13, Hill discloses the claimed invention of claim 9, however, Hill is silent with regards to wherein the second surface includes deformable material, and the second surface dynamically adjusts to conform with the IV tube being used.
Nonetheless Meiri, which is within the analogous art of accurate peristaltic pump for non-elastic tubing (see abstract and title), teaches the second surface (see the surface of the elastic semicircular sections 3 and 4 in Figure 3 that contacts the tube 14) includes deformable material (see Col. 2, lines 21 – 23 “The elastic sections shown here are made of elastomeric polymer material such as rubber or polyurathane but a set of suitable springs can be substituted.”), and the second surface dynamically adjusts to conform with the IV tube (14) being used (see Abstract and Col. 2, lines 21 – 23) (here the elastic sections 3, 4 dynamically adjust to conform with the IV tube 14 as force is applied to the tubing 14 via the rotor 5 based on their elastic material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the second surface of the second and third elements of the medical device of Hill modified in view of a teaching of Meiri such that the second surface includes deformable material, and the second surface dynamically adjusts to conform with the IV tube being used. One of ordinary skill in the art would have been motivated to make this modification because Meiri teaches the elastic material fully restores the initial cross-section of the tube. See abstract of Meiri. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material of the second surface of the second and third elements of the medical device of Hill in view of a teaching of Meiri, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ho et al. (US 2003/0214412 A1).
Zhou (US 2010/0229978 A1).
Wang et al. (US 2011/0158823 A1).
Jones (US 2012/0320135 A1).
Konishi (US 2013/0064701 A1).
Brown (US 2013/0091953 A1).
Ueda et al. (US 2014/0243745 A1).
Meng et al. (US 2022/0133994 A1).
Kobayashi et al. (US 4,648,812 A).
Durrum et al. (US 5,033,943 A).
Natwick et al. (US 5,039,279 A).
Natwick et al. (US 5,055,001 A).
Lawless et al. (US 5,078,362 A).
Natwick et al. (US 5,158,437 A).
Natwick et al. (US 5,180,287 A).
Natwick et al. (US 5,219,279 A).
Natwick et al. (US 5,322,422 A).
O’Leary (US 5,549,460 A).
Hill et al. (US 6,234,773 B1).
Ueda et al. (US 9,463,275 B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 10/07/2026
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