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 .
Claim Objections
Claims 8-9 are objected to because of the following informalities:
Claim 8 Line 4-5 currently states:
“a fluid source fluidically coupled to the first end of the first IV tubing”.
Should be changed to state:
--[[a]] the fluid source fluidically coupled to the first end of the first IV tubing--.
Claim 9 Line 3-4 currently states:
“placing the manual hand pump of IV set adjacent the roller wheel of the mini peristaltic pump;”.
Should be changed to state:
--placing the manual hand pump of the IV set adjacent the roller wheel of the mini peristaltic pump;--.
Appropriate correction is required.
Examiner Note:
As previously noted the claims are directed to the embodiments illustrated in Figs 7-8 & 10 of the instant application.
The instant application uses the language “a manual hand pump” in the claims. When the specification describes the hand pump (see ¶0036, and ¶0040-¶0041) reproduced below – it indicates that in the unactuated state fluid is able flow through the hand pump just like a piece of tubing in a gravity fed system like the one shown in the Figures. Thus when the claims are read in the context of (i.e. in light of) the SPEC the BRI of the language “a manual hand pump” will be read to mean the same thing as a piece of tubing.
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Annotated Paragraphs 0036 & 0040-0041 of Application 19289663
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) 1-2, 4, and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawler USPN 4820281 in view of Jess USPN 4155362.
Regarding Claim 1: Lawler USPN 4820281 discloses the limitations: A mini peristaltic pump system (the pump system is defined by the sum of its claimed parts; A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951 ). In this case, "A mini peristaltic pump system" is a recitation as to the intended use of the claimed structure and therefore not accorded any patentable weight) comprising:
an intravenous (IV) set (the IV set is defined by the sum of its parts, and includes needle 10) comprising:
a manual hand pump (manual hand pump = flexible tubing 8; see examiner note above);
first IV tubing (first IV tubing = elements 6,7 in Figs 1-2) comprising a first end (first end = bottom end of element 6 in Figs 1-2) coupled to an inlet of the manual hand pump (inlet of the manual hand pump = inlet to 8 in Fig 2 that is coupled to the articulated first end) and a second end (second end = top of element 7 in Figs 1-2) configured to fluidly couple with a fluid source (fluid source = 4, as seen in Fig 1 the articulated second end is coupled to the fluid source); and
an outlet of the manual hand pump (an outlet of the manual hand pump = outlet of tubing 8) configured to fluidly couple with an IV set component (IV set component = needle 10, which is part of the IV set (e.g. a component of the IV set) as articulated above; Column 6 Line 38-59); and
a mini peristaltic pump (the mini peristaltic pump is defined by the sum of its parts) comprising:
a base plate (plate like object indicated by element 32 in Fig 3);
a motor 30 disposed on a first side of the base plate (first side = rear side of element 32 in Fig 3 where drive motor 30 is located; additionally the first side of the base plate is the side where motor 30 is supported in Fig 1);
a roller wheel (rotor 34 in Fig 3, Column 7 Line 11-39) disposed on a second side of the base plate (second side = front side of element 32 in Fig 3 where rotor 34 is located) and coupled to the motor (rotor 34 is coupled to motor 30 via drive shaft 36, see Fig 3, Column 7 Line 20-48);
one or more rollers 40 coupled to the roller wheel (Fig 3, Column 7 Line 20-48); and
a profile feature 42 disposed on the base plate (as understood from Fig 1 & 3) adjacent to the roller wheel (Fig 3),
wherein the motor is configured to rotate the roller wheel to move the one or more rollers coupled to the roller wheel (Column 7 Line 24-54) in an orbital path (i.e. elements 40 orbit about motor shaft 36) to peristaltically engage and compress only the manual hand pump (i.e. peristaltically engage flexible tubing 8, Column 7 Line 24-54, Fig 3 – as seen in Fig 3 the rollers 40 only compress and engage the hand pump 8) disposed between the roller wheel and the profile feature (as seen in Fig 3). Lawler USPN 4820281 is silent regarding the limitations: the intravenous set comprising second IV tubing comprising a third end coupled to an outlet of the manual hand pump and a fourth end configured to fluidly couple with an IV set component. The prior art of Jess USPN 4155362 which is directed to administering fluids into the human body with a peristaltic pump (title, abstract) like Lawler USPN 4820281, is noted.
However, Jess USPN 4155362 does disclose the limitations: an intravenous (IV) set (the IV set is defined by the sum of its parts and includes the needle on the outlet side of element 19 which is used to deliver the fluids to the human body as known in the art) comprising:
a manual hand pump (manual hand pump = tubing 14, Figs 1-3, Column 4 Line 15-58);
first IV tubing (first IV tubing = 12,13) comprising a first end (first end = bottom end of 13) coupled to an inlet of the manual hand pump (inlet of the manual hand pump = top end of element 14 that is coupled to the articulated first end as shown in Fig 1) and a second end (second end = top end of element 12) configured to fluidly couple with a fluid source (fluid source = 11; as seen in Fig 1 the articulated second end is coupled to the fluid source 4); and
second IV tubing (second IV tubing = needle adaptor 19, Column 4 Line 15-26, since fluid inherently passes through element 19 in order to pass from tubing 14 to the needle, in the IV shown in Fig 1, element 19 is broadly considered to be IV tubing) comprising a third end (third end = top end of element 19 in Fig 1) coupled to an outlet of the manual hand pump (outlet of the manual hand pump = bottom end of tubing 14 which is connected to the articulated third end as shown in Fig 1 & Fig 3a) and a fourth end (fourth end = bottom end of element 19 in Fig 1 & Fig 3a) configured to fluidly couple with an IV set component (IV set component = needle of the IV set as articulated above, see Fig 1 & Fig 3a, and also Column 4 Line 15-26).
Hence it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the needle adaptor/second IV tubing 19 of Jess USPN 4155362 to connect the outlet of the hand pump 8 to the needle/IV set component in the system of Lawler USPN 4820281, in light of the teachings of Jess USPN 4155362, in order to be able to easily attach an appropriately sized needle to receive the pumped fluid (Jess – Column 4 Line 15-26, Fig 1, & Fig 3a).
Regarding Claim 2: Lawler USPN 4820281 discloses the limitations: further comprising an enclosure (= housing of pump 32 in Fig 1, Column 7 Line 30-32) enclosing one or more of the base plate, the motor, the roller wheel, the rollers and the profile feature (as understood from Fig 1 & 3 the base plate, the roller wheel, the rollers and/or the profile feature are located within the housing of pump 32 of Lawler).
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Annotated Figure 1 of Lawler USPN 4820281 (Attached Figure D)
Regarding Claim 4: Lawler USPN 4820281 discloses the limitations: further comprising a fastener (see Annotated Figure 1 of Lawler USPN 4820281 (Attached Figure D) above) configured to mount the mini peristaltic pump on an IV pole (1, Column 6 Line 38-47; as seen in Attached Figure D the identified fastener mounts the pump 32 to the pole 1).
Regarding Claim 6: Lawler USPN 4820281 discloses the limitations: wherein a change in motor speed causes a change in a frequency of hand pump compressions by the one or more rollers (moto 30 rotates the rollers 40, accordingly an increase (i.e. change) in the speed of motor 30, would inherently cause the rollers to speed up, thus increasing (i.e. changing) a frequency of compressions of the manual hand pump (e.g. tubing 8) between the rollers 40 and element 42; conversely when the rollers 40 are rotated slower by the motor 30 the frequency (e.g. compressions per minute) that element 8 (the manual hand pump) is compressed by the three rollers 40 will inherently be less)).
Regarding Claim 7: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses the limitations recited in Claim 1.
Additionally Regarding Claim 7: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses the claimed limitations except for:
“wherein the mini peristaltic pump is configured to hang from the manual hand pump”. It would have been an obvious matter of design choice to --design the mini peristaltic pump to be able to hang from the manual hand pump--, since no stated problem is solved or unexpected results obtained in having the mini peristaltic pump being configured to either hang from the hand pump versus the design taught by Lawler USPN 4820281 as modified by Jess USPN 4155362. Applicant has not disclosed why it is important/critical that the mini peristaltic pump is configured to hang from the manual hand pump and has not demonstrated that this feature solves any stated problem or is for any particular purpose. Specifically, ¶0044 of the SPEC indicates that this is done to couple the pump directly on the tubing of the IV set (i.e. the hand pump) instead of to an IV pole (similar to how the pump taught by Lawler USPN 4820281 as modified by Jess USPN 4155362 is directly located on tubing 8 of the IV set in Fig 1). Thus, when the mini peristaltic pump is designed to be able to hang from the manual hand pump the pump taught by Lawler USPN 4820281 as modified by Jess USPN 4155362 will also meet Applicant’s disclosed functional limitation of being coupled directly on the tubing of the IV seat (i.e. the hand pump) instead of to an IV pole.
Regarding Claim 8: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses the limitations:
a controller (Lawler – the controller is defined by the sum of its parts and includes element 32’ as illustrated in Fig 1, Column 16, Line 19-38) operationally coupled to the mini peristaltic pump (Lawler – the controller 32’ includes drive circuity 26 which controls motor 30 of the pump, Column 6 Line 60-Column 7 Line 19 – thus the controller is inherently operationally coupled to the pump as claimed); and
the fluid source (Lawler – 4) fluidically coupled to the first end of the first IV tubing (Lawler – the fluid source 4 is coupled to the first/bottom end of the first IV tubing via the first IV tubing (6,7) and the second end of the first IV tubing),
wherein the controller is configured to control a speed of orbital rotation of the one or more rollers (Lawler – control a speed that rollers 40 rotate about motor shaft 36) to provide a set flow rate of fluid (Lawler – to provide a predetermined flow rate from pump 32 described in Column 6 Line 60-Column 7 Line 19) from the manual hand pump out through the second IV tubing downstream of the mini peristaltic pump (Lawler – the speed of the pump inherently controls the rate at which the fluid is delivered to the needle/patent after being pumped – as understood from Figs 1-3, Column 6 Line 24-47; in the combination of prior art the controller of Lawler would inherently control/provide a set flow rate of fluid from the manual hand pump 8, through the second IV tubing/needle adaptor 19 of Jess – that is located downstream of the mini peristaltic pump as claimed).
Regarding Claim 9: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses in the above mentioned Figures and Specifications the mini peristaltic pump system of claim 1. Additionally, it has been held that: under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986), MPEP §2112.02 I. Accordingly, Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses limitations:
placing the manual hand pump of the IV set adjacent the roller wheel of the mini peristaltic pump (in order to operate the device of Lawler as modified by Jess as intended, the manual hand pump 8 of Lawler (e.g. the manual hand pump of the IV set) would inherently have to be placed between the roller wheel 34 and the profile feature (e.g. be placed adjacent the roller wheel 34 of the mini peristaltic pump of Lawler));
operating the motor coupled to the roller wheel to rotate the roller wheel (in order to operate the device of Lawler as modified by Jess as intended, the motor 30 of Lawler would inherently have to operate/rotate the roller wheel 34 of the mini peristaltic pump of Lawler));
rotating the one or more rollers coupled to the roller wheel in an orbital pattern (in order to operate the device of Lawler as modified by Jess as intended, the one or more rollers 40 of Lawler would inherently be rotated in an orbital pattern as shown in Fig 3 of Lawler); and
peristaltically engaging and compressing the manual hand pump (i.e. compressing and engaging element 8 (the manual hand pump of Lawler) as described at Column 7 Line 20-46 of Lawler in order to operate the device of Lawler as modified by Jess as intended) by the one or more rollers (i.e. by the one or more rollers 40 of Lawler) to replace manual squeezing of the manual hand pump by a user (since during the normal operation of the device of Lawler as modified by Jess, element 8 of Lawler (e.g. the manual hand pump) is squeezed between rollers 40 of Lawler and profile feature 42 of Lawler – manual squeezing of element 8 (the manual hand pump) by a user, is not necessary as claimed, to operate the device of Lawler as modified by Jess as intended), thereby reducing user hand fatigue from the manual hand pump (since the manual/performed by hand operation of squeezing element 8 of Lawler (e.g. the manual hand pump) is not necessary – hand fatigue is inherently reduced) and increasing fluid flow rate (since the squeezing function is performed by a machine which does not need to rest like a human/user would, the prior art device increases fluid flow rate compared to manual squeezing, since the machine does not need to rest like a human/user would- when operating the device of Lawler as modified by Jess as intended) to reduce fluid transfusion time (increased fluid flow rate inherently reduces fluid transmission time for a particular volume).
Claim(s) 3 & 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawler USPN 4820281 in view of Jess USPN 4155362 as applied to claim 1 above, and further in view of Shim USPN 4278085.
Regarding Claim 3: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses in the above mentioned Figures and Specifications the limitations set forth in claim 1. Lawler USPN 4820281 does not disclose the limitations: wherein the enclosure comprises an openable portion configured to provide access for placement of the manual hand pump inside the enclosure.
However Shim USPN 4278085 does disclose the limitations:
an enclosure (enclosure = housing 20 and platen assembly 36) enclosing one or more of the base plate, the motor, the roller wheel, the rollers and the profile feature (as understood from Figs 2-5, the enclosure (20,36) encloses the motor (101,110), the rollers 41, and/or the profile feature (50,51)); and
wherein the enclosure comprises an openable portion (openable portion = platen assembly 36) configured to provide access for placement of the manual hand pump inside the enclosure (as understood from Figs 2-4, element 36 is able to be opened by sliding, so that element 18 (the manual hand pump) can be placed inside the enclosure as claimed, Column 4 Line 1-11).
Hence 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 enclosure (= housing of pump 32) of Lawler USPN 4820281 with the enclosure (enclosure = housing 20 and platen assembly 36) of Shim USPN 4278085 in order to protect the motor of the pump, by surrounding the motor with the structure of the enclosure.
Regarding Claim 5: Lawler USPN 4820281 as modified by Jess USPN 4155362 discloses in the above mentioned Figures and Specifications the limitations set forth in claim 1. Lawler USPN 4820281 does not disclose the limitations: wherein the profile feature is positionally adjustable on the base plate, wherein adjustment of the position of the profile plate adjusts a size of a gap between the roller wheel and the profile feature.
However Shim USPN 4278085 does disclose the limitations:
an enclosure (enclosure = housing 20 and platen assembly 36) enclosing one or more of the base plate, the motor, the roller wheel, the rollers and the profile feature (as understood from Figs 2-5, the enclosure (20,36) encloses the motor (101,110), the rollers 41, and/or the profile feature (50,51)); and
wherein the profile feature is positionally adjustable on the base plate (operation of control knob 37 adjusts the position of the profile feature (50,51) – on the base plate (see Figs 3-4), Column 4 Line 1-11, Column 4 Line 25-40, Column 5 Line 3-15), wherein adjustment of the position of the profile plate adjusts a size of a gap between the roller wheel and the profile feature (as understood from Figs 2-4 & Column 4 Line 1-11 – adjustment of the position of the profile plate changes a distance (i.e. a size of a gap) between the roller wheel 40 and the profile feature (50,51) as claimed).
Hence 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 base plate (plate like object indicated by element 32 in Fig 3) and the profile feature 42 of Lawler USPN 4820281 with the base plate (= plate structure indicated by element 20 in Figs 4-5), the profile feature (50,51), and control knob 37 of Shim USPN 4278085 in order to facilitate insertion or removal of the tubing/hand pump (Shim – Column 4 Line 1-10).
Examiner's Note: The Examiner respectfully requests of the Applicant in preparing responses, to fully consider the entirety of the references as potentially teaching all or part of the claimed invention.
It is noted, REFERENCES ARE RELEVANT AS PRIOR ART FOR ALL THEY CONTAIN. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments (see MPEP § 2123).
Additionally the origin of the drawing is immaterial. For instance, drawings in a design patent can anticipate or make obvious the claimed invention, as can drawings in utility patents. When the reference is a utility patent, it does not matter that the feature shown is unintended or unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). (See MPEP § 2125).
The Examiner has cited particular locations in the reference(s) as applied to the claims above for the convenience of the Applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claims, typically other passages and figures will apply as well.
Furthermore: with respect to the prior art and the determination of obviousness, it has been held that Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The "mere existence of differences (i.e. a gap) between the prior art and an invention DOES NOT ESTABLISH the inventions nonobviousness." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). Rather, in determining obviousness the proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. And factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap. (See MPEP § 2141).
Response to Arguments
Applicants’ arguments, see Page 8 ¶1, filed 06/24/2026, with respect to the rejection(s) of claim(s) 1 under §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lawler USPN 4820281 in view of Jess USPN 4155362.
Additionally, the following is noted:
In response to applicant's argument (Page 6 ¶1 & Page 7 ¶1-Page 8 Line 6) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., hand pump 140 in the Figs of the instant application is larger in diameter/volume than IV tubing & thus Lawler does not disclose a manual hand pump) are not recited in the rejected claim(s) – that is to say that the rejected do not require the hand pump to be larger in diameter than the IV tubing as argued by applicant. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, Applicant misinterprets the principle that claims are interpreted in the light of the specification. Although the hand pump 140 is shown in Fig 2 as having a larger diameter/volume than IV tubing 160 are as examples or embodiments in the specification, they were not claimed explicitly. Nor were the words that are used in the claims defined in the specification to require these limitations. A reading of the specification provides no evidence to indicate that these limitations must be imported into the claims to give meaning to disputed terms. Constant v. Advanced Micro-Devices, Inc., 7 USPQ2d 1064. Accordingly, applicants’ arguments directed to features which are not claimed are not convincing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lampropoulos USPN 7182750 – teaches a modularized infusion pump system.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH S HERRMANN whose telephone number is (571)270-3291. The examiner can normally be reached 8:00 AM - 5:00 PM EST.
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, ESSAMA OMGBA can be reached at 469-295-9278. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES G FREAY/ Primary Examiner, Art Unit 3746
/JOSEPH S. HERRMANN/ Examiner, Art Unit 3746
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