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 .
This is the first office action on the merits in response to Applicant’s election filed on 07/28/2026.
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-13 in the reply filed on July 28, 2026 is acknowledged. Applicant’s election withdraws claims 14-20 from further consideration. Claims 1-13 are pending and being examined.
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: FIG. 1B: "22", "24", "26", "28", "31", "33", "35", "37", "38", "40", "42", "44", "46", "81", "83", "85", and "87".
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.
Specification
The disclosure is objected to because of the following informalities:
¶ [0031], line 2: regarding “controller 32”, ref. no. “32” in Fig. 1B does not show a controller. Rather, it points to a fluid line. The ref. no. is believed to be in error for “60”.
¶ [0031], lines 3 and 6: regarding “container 36” (two instances), ref. no. “36” in Fig. 1B does not show a container. Rather, it points to a fluid line. The ref. no. is believed to be in error for either “38”, “40”, “42”, or “44”.
¶ [0034], line 4: regarding “container 48”, ref. no. “48” in Fig. 1B does not show a container. Rather, it points to a patient. The ref. no. is believed to be in error for either “38”, “40”, “42”, or “44”.
Appropriate correction is required.
Claim Objections
Claims 1-6 and 10-13 are objected to because of the following informalities:
Claim 1, lines 2 and 3-4: “the hand pump” (two instances) is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 2, line 2: “the hand pump” is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 3, lines 2 and 4: “the hand pump” (three instances) is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 4, lines 2, 3, and 3-4: “the hand pump” (three instances) is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 5, line 2: “the hand pump” is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 6, line 1: “and/ or” is believed to be in error for --and/or-- (delete extra space)
Claim 10, line 1: “the device” is believed to be in error for --the add-on device-- (see claim 1, line 1)
Claim 11, line 1: “the device” is believed to be in error for --the add-on device-- (see claim 1, line 1)
Claim 12, line 2: “the hand pump” is believed to be in error for --the IV set hand pump-- (see claim 1, line 1)
Claim 13, line 1: “the add on device” is believed to be in error for --the add-on device-- (missing dash)
Claim 13, line 2: “235, mm” is believed to be in error for --235 mm-- (delete extra comma)
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 1-13 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 1 recites the limitation "the IV set" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "grip member" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 depends upon claim 6, not claim 7.
Claims 2-7 and 9-13 are also rejected because they depend upon claim 1.
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.
(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.
Claims 1-3, 5-6, 9, and 11-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gutierrez (US 2025/0352719 A1).
Regarding claim 1, Gutierrez teaches (Figs. 4-8) an add-on device (100) for an intravenous (IV) set hand pump (130 – Figs. 4-6) comprising:
a first member (112) configured to actuate the hand pump; and
a second member (119) hingedly connected (via hinge 110 – Fig. 11) to the first member (112) and configured to receive the hand pump (130);
wherein, when actuated, the add-on device (100) is configured to increase a fluid flow rate downstream (at 134 and 135) of the IV set hand pump (130) beyond a maximum gravity-based fluid flow rate of the IV set (135 – see ¶ [0039], l. 6: “a tubing set 135”) – (see Abstract: “A movable pusher is biased towards the engagement cavity so as to apply force to a plunger of the syringe. The infusion system also includes linkages configured to move transversely in a first direction upon opening of the top portion to cause the pusher to move away from the engagement cavity and move transversely in a second, opposite direction upon closing of the top portion to allow the pusher to retract towards the engagement cavity within the sliding slots”).
Regarding claim 2, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8) wherein the first member (112) comprises a compression section (comprising 102, 114, and 115) that extends into (via plunger 132) the hand pump (130) when the first member (112) is compressed towards the second member (119) – (as described in ¶ [0037] – [0039]).
Regarding claim 3, Gutierrez teaches the invention as claimed and as discussed above for claim 2, and Gutierrez further teaches (Figs. 4-8) wherein the compression section (102, 114, 115) includes a portion (114 and 115) of the first member (112) that gradually compresses the hand pump (130) by compressing (via movement of pusher 102) a portion (plunger 132) of the hand pump (130) closest to a rotational axis (where hinge 110 is located – see Fig. 11) of the add-on device (110) and continues to compress sequential portions (barrel of 130) of the hand pump (130) as the first member (112) continues to rotate (shown by the sequence of figures from Fig. 4 to Fig. 8) toward the second member (119).
Regarding claim 5, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8 and 13) wherein the second member (119) further comprises a ledge (105 – Fig. 13) configured to secure the hand pump (130 – Figs. 4-8) in the add-on device (100) – (¶ [0042], ll. 3-8: “The spring block 105 can have a size and shape so as to receive a barrel portion of the syringe 130 and, when the mechanical infusion pump 100 is assembled, can form a syringe receiving cavity extending from an aperture through which an outlet 134 of the syringe 130 extends and configured to receive a barrel of the syringe 130”).
Regarding claim 6, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8) wherein the first member (112) and/ or the second member (119) comprises a grip portion (top surface of 112 or bottom surface of 119).
Regarding claim 9, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8) wherein a distance between the first member (112) and the second member (119) is not fixed (as shown by the various positions of 112 relative to 119 between Figs. 4, 5, and 7/8).
Regarding claim 11, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8) wherein the device (100) provides a mechanical leverage of three (¶ [0006] discusses various force ranges. Also intended use, see below).
The limitation “the device provides a mechanical leverage of three” is a statement of intended use and the structure of the device as taught by Gutierrez can perform the function, depending on the amount of force applied (as discussed in ¶ [0006]). It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function”, In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959); “[A]pparatus claims cover what a device is, not what a device does” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), MPEP 2114 (I). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), MPEP 2112.01.
Regarding claim 12, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 11-12) wherein the first member (112) and/or the second member (119) further comprises a window (128) for viewing the hand pump (130) – (¶ [0043], ll. 14-16).
Claim 10 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gutierrez (US 2025/0352719 A1), and as evidenced by Thill (US 4,202,333).
Regarding claim 10, Gutierrez teaches the invention as claimed and as discussed above for claim 1, and Gutierrez further teaches (Figs. 4-8) wherein the device (110) is reusable by disconnecting with a first IV set (135) and attaching to a second IV set (¶ [0039], l. 9: “Various type of tubing sets can be used”) without disconnecting either the first or second IV sets (135) from a fluid source or from a delivery catheter assembly (¶ [0039], ll. 6-7: “a tubing set 135 to deliver medication to a patient”) – (also intended use).
It is noted that Thill teaches (Figs. 1 and 5) a similar device (10) comprising a second member (24) hingedly connected (via pins 76) to a first member (53 – Fig. 5) and configured to receive a hand pump (12 – Fig. 1). Thill further teaches “The device may, however, be used in ways other than that indicated both for medical or other uses. For example, one or more of the devices 10 may be used to dispense fluids into a standard intravenous administration set” (col. 7, ll. 7-11).
The limitation “the device is reusable by disconnecting with a first IV set and attaching to a second IV set without disconnecting either the first or second IV sets from a fluid source or from a delivery catheter assembly” is a statement of intended use and the structure of the device as taught by Gutierrez can perform the function (as evidenced by Thill). It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function”, In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959); “[A]pparatus claims cover what a device is, not what a device does” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), MPEP 2114 (I). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), MPEP 2112.01.
Claims 1-2, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiejima (EP 0744182 A2: IDS reference).
Regarding claim 1, Hiejima teaches (Figs. 3A-3B) an add-on device for an intravenous (IV) set hand pump (90 – see col. 1, ll. 30-33: “This chamber 90 is connected to a first conduit communicating with a medical container and a second conduit communicating with a catheter or the like”) comprising:
a first member (84) configured to actuate the hand pump (90); and
a second member (86 – Fig. 3A) hingedly connected (via pin 116 – Fig. 3A) to the first member (84) and configured to receive the hand pump (90);
wherein, when actuated, the add-on device is configured to increase a fluid flow rate downstream (at first or second conduit mentioned in col. 1, ll. 30-33) of the IV set hand pump (90) beyond a maximum gravity-based fluid flow rate of the IV set (Fig. 2 shows an IV set) – (see col. 1, ll. 39-43: “When the patient has pushed the push button 84, the chamber 90 is depressed by the floating plate 100, as illustrated in Figs. 3b and 3c, thereby delivering the liquid drug to the body of the patient through the conduit”).
Regarding claim 2, Hiejima teaches the invention as claimed and as discussed above for claim 1, and Hiejima further teaches (Figs. 3A-3B) wherein the first member (84) comprises a compression section (push button 84) that extends into (via floating plate 100) the hand pump (90) when the first member (84) is compressed towards the second member (86) – (as shown in Fig. 3B).
Regarding claim 4, Hiejima teaches the invention as claimed and as discussed above for claim 2, and Hiejima further teaches (Figs. 3A-3B) wherein the compression section (push button 84) includes arcuate portions (84 comprises an arc as shown in Figs. 3A-3B) that have varying degrees of curvature (curvature varies from left to right end of the arc; for example, at the left end, the curvature is zero, whereas in the middle of the arc, the curvature is non-zero) along the first member (84) such that the hand pump (90) is compressed in a rolling fashion (as shown in Fig. 3B) from one end of the hand pump (left end of 90) toward an opposite end of the hand pump (right end of 90) as the first member (84) is compressed towards the second member (86) – (intended use).
The limitation “such that the hand pump is compressed in a rolling fashion from one end of the hand pump toward an opposite end of the hand pump as the first member is compressed towards the second member” is a statement of intended use and the structure of the device as taught by Hiejima can perform the function. It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function”, In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959); “[A]pparatus claims cover what a device is, not what a device does” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), MPEP 2114 (I). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), MPEP 2112.01.
Regarding claim 6, Hiejima teaches the invention as claimed and as discussed above for claim 1, and Hiejima further teaches (Figs. 3A-3B) wherein the first member (84) and/ or the second member (86) comprises a grip portion (the arc of 84 is a grip portion).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hiejima (EP 0744182 A2: IDS reference), in view of Jaros (US 2022/0331562 A1).
Regarding claim 7, Hiejima teaches the invention as claimed and as discussed above for claim 6, and Hiejima further teaches (Figs. 3A-3B) wherein the grip portion (arc of 84) comprises a shaped surface (top surface of arc) having one or more grip members (the arc is a grip member).
However, Hiejima does not teach that the one or more grip members comprises at least one of a circular shape, an oblong shape and an outer arcuate groove.
Jaros teaches (Figs. 1 and 67) a medical device (100 – Fig. 1) having a base (190), the base (190) have one or more grip members (812 – Fig. 67) that comprises at least one of a circular shape, an oblong shape and an outer arcuate groove (as shown in Fig. 67, grip members 812 have a circular shape).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hiejima such that the one or more grip members comprises at least one of a circular shape, an oblong shape and an outer arcuate groove, in order to complement fingertips of the user and to allow the user to have improved grip when squeezing, as taught by Jaros (¶ [0569], ll. 10-13).
Regarding claim 8, Hiejima teaches the invention as claimed and as discussed above for claim 6, and Hiejima further teaches (Figs. 3A-3B) a grip member (the arc of 84 is a grip member).
However, Hiejima does not teach wherein each grip member is sized and shaped to receive a finger of a hand.
Jaros teaches (Figs. 1 and 67) a medical device (100 – Fig. 1) having a base (190), the base (190) have one or more grip members (812 – Fig. 67), wherein each grip member (812) is sized and shaped to receive a finger of a hand (¶ [0569], ll. 10-11).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hiejima such that each grip member is sized and shaped to receive a finger of a hand, in order to complement fingertips of the user and to allow the user to have improved grip when squeezing, as taught by Jaros (¶ [0569], ll. 10-13).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 2025/0352719 A1).
Regarding claim 13, Gutierrez teaches the invention as claimed and as discussed above for claim 1, except for wherein an overall length of the add on device is 225 mm, 230 mm, 235, mm, 240 mm, 245 mm, 250 mm, 255 mm, 260 mm, 265 mm, or 270 mm.
It is noted the Gutierrez teaches “The size of the mechanical infusion pump is such that it can be handheld so that the top housing 112 can be selectively opened or closed by a user holding the bottom housing in one hand and opening the top housing 112 in the user's other hand” (¶ [0034], ll. 6-10). Therefore, Gutierrez’s add-on device is believed to be roughly the size of a human hand, which has an average length of 188 to 193 mm.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Gutierrez such that an overall length of the add on device is 225 mm, 230 mm, 235, mm, 240 mm, 245 mm, 250 mm, 255 mm, 260 mm, 265 mm, or 270 mm, since it has been held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (in this case, the only difference between the prior art and claim 13 is that claim 13 requires a length of the add-on device to be a value slightly greater than an average length of a human hand) 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 Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A); see also In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."), MPEP 2144.05 (II)(A).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/ /GERALD L SUNG/ Primary Examiner, Art Unit 3741 Examiner, Art Unit 3741
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