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 .
Response to Amendment
Applicant’s amendments with respect to claims filed on 8/14/2025 have been entered. Claims 1 and 5-19 remain pending in this application and are currently under consideration for patentability under 37 CFR 1.104. Claims 2-4 have been canceled.
The amendments and remarks filed on 8/14/2025 are sufficient to cure the previous 35 U.S.C.112 (b) rejections set forth in the Non-Final office action mailed on 06/02/2025.
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.
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, 7-8, 10-12 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (Patent No. 5,634,896) in view of Wang et al. (Pub. No. 2009/0093774).
Regarding claim 1, Bryant et al. teaches a medical fluid pump (14, Fig. 1) comprising: an upper housing shell (top portion of 82, see Fig. 10 below); a lower housing shell (bottom portion of 82, see Fig. 10 below) secured to the upper housing shell (top portion of 82, see Fig. 1 illustrating the lower portion of 82 secured to the upper portion of 82); a front lid (106, Fig. 7) pivotably hinged to the lower housing shell (see Fig. 7 illustrating 106 pivotably hinged to the lower portion of 82 and see Col. 12, lines 6-9); a circuit board (98, Fig. 9) with control devices (devices of 98 that permit receiving and transmitting see Col. 11, lines 53-55); a drive (24/P1/P2/102/PA1/PA2, see Figs. 8 and 12A, see Col. 8, lines 9-19 and Col. 13, lines 25-35); and an energy storage (90/92, Figs. 9 and 10), wherein: the circuit board (98) is secured to the upper housing shell (top portion of 82, see Fig. 9 illustrating 98 secured to the inner surface of the top portion of 82), the drive (24/P1/P2/102/PA1/PA2) is secured to the upper housing shell (top portion of 82, see Fig. 10 illustrating the top and bottom portions of 82 and 100 individually and see Fig. 1 illustrating the top and bottom portion of 82 and 100 secured to each other; it should be noted that all of the components of the device are either directly or indirectly secured to each other), with at least a portion of the drive (lower surface of 24 opposite of where 24 is indicated in Fig. 6) located directly between the circuit board (98) and the lower housing shell (the bottom portion of 82, Fig. 10 below, it is the Examiner’s position that as a result of 98 being located on the inner surface of the top portion of 82, and the lower surface of 24 being located between the upper housing 82 and the lower housing of 82; the bottom surface of 24 is located directly between 98 and the bottom surface of the lower housing 82), and the energy storage (90/92) is provided and fixed in the lower housing shell (bottom surface of bottom portion of 82, see Fig. 9).
Examiner’s Annotated Fig. 10
[AltContent: textbox (lower housing shell)][AltContent: arrow][AltContent: textbox (bottom surface of lower housing shell)][AltContent: arrow][AltContent: textbox (upper housing shell)][AltContent: arrow]
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Bryant et al. does not specifically teach that the circuit board is a printed circuit board. However, Wang et al. teaches a medical pump (device in Fig. 1) comprising a printed circuit board (see [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant et al. by forming the circuit board to be a printed circuit board as taught by Wang et al. because Wang et al. teaches that the printed circuit board is a control means (see [0048]) just as the circuit board taught by Bryant; hence, the modification would yield the same predictable results of communicating with other control components of the device.
Regarding claim 7, Bryant et al. in view of Wang et al. teaches further comprising a communication module (T1/T2/T3/T4, Fig. 9 and see Col. 11, lines 48-54 where T1-T4 communicates with 98) fixed to the upper housing shell (top portion of 82, see Fig. 9).
Alternative Rejection of Claim 7 to Reject Claim 15
Regarding claim 7, Bryant et al. in view of Wang et al. teaches further comprising a communication module (16, 367, 370, and the key pad, see Fig. 2 and Col. 24, lines 58-65) ) fixed to the upper housing shell (top portion of 82, see Figs. 2 and 9).
Regarding claim 8, Bryant et al. in view of Wang et al. teaches wherein the printed circuit board (modified 98) fixed to the upper housing shell (see Fig. 9) by first spacers (spacers, Fig. 9 below) spaced from the upper housing shell (top portion of 82; see Fig. 9 where the portion indicated below as first spacers of 98 are fixed to the upper portion of 82).
[AltContent: textbox (first spacers)]Examiner’s Annotated Fig. 9
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Regarding claim 10, Bryant et al. in view of Wang et al. teaches wherein the printed circuit board (modified 98) is fixed to and spaced apart from the upper housing shell (top portion of 82) by the first spacers (first spacers, Fig. 9 above, see Fig. 9 illustrating that 98 is fixed to the upper portion of 82 and spaced apart from the upper portion of 82 via the first spacers as indicated in Fig. 9 above).
Regarding claim 11, Bryant et al. in view of Wang et al. teaches that the herein the drive (24/P1/P2/102/PA1/PA2) is fixed to the upper housing shell (upper portion of 82, see Figs. 9 and 10) but does not teach by second spacers. However, Wang et al. teaches spacers (126, Fig. 3) for connecting elements of a pump device to one another (see [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant et al. in view of Wang et al. by adding the connections to the upper portion of 82 and the pneumatic actuator module for connecting the 24 to the upper portion of 82 because Wang et al. teaches that it is known in the art to use connectors for connecting various components of a medical pump to one another (see [0055]). It should be noted with such modification 24/P1/P2/102/PA1/PA2 is connected to 82 via 126 as a result of 24/P1/P2/102/PA1/PA2 being located within 76.
Regarding claim 12, Bryant et al. in view of Wang et al. does not specifically teach wherein the second spacers extend further from an inner surface of the upper housing shell than the first spacers. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the heights of the first and second spacers such that the second spacers 126 extend further from the upper portion of 82 than the first spacers because it has been held that differences in size or proportion is not a basis for patentability when the device and/or method would not perform any differently due to the size/proportion differential.
Regarding claim 16, Bryant et al. in view of Wang et al. teaches wherein the drive (90) is spaced apart from the lower housing shell (lower portion of 82, see Fig. 9) to prevent the drive from being in contact with any fluid accumulated in the lower housing shell (it should be noted that this is a functional recitation and it is the Examiner’s position that 90 is spaced a part from the front portion of the lower portion of 82 where 24 for is located thereby preventing 90 from being in direct contact with fluid accumulated in 24 within the lower portion of 82).
Regarding claim 17, Bryant et al. in view of Wang et al. teaches wherein the printed circuit board (98) is connected via one or more connectors (connectors, Fig. 9 below) to the upper housing shell (upper portion of 82) separately from the lower housing shell (lower portion of 82) but does not specifically teach the drive is connected via one or more connectors to the upper housing shell separately from the lower housing shell .
[AltContent: textbox (connectors)]Examiner’s Annotated Fig. 9
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However, Wang teaches connectors (126, Fig. 3) for connecting elements of a pump device to one another (see [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant et al. in view of Wang et al. by adding the connections to the upper portion of 82 and the pneumatic actuator module for connecting the 24 to the upper portion of 82 because Wang et al. teaches that it is known in the art to use connectors for connecting various components of a medical pump to one another (see [0055]). It should be noted with such modification 24/P1/P2/102/PA1/PA2 is connected to 82 via 126 as a result of 24/P1/P2/102/PA1/PA2 being located within 76.
Regarding claim 18, Bryant et al. in view of Wang et al. teaches wherein the printed circuit board (98) and the drive (24/P1/P2/102/PA1/PA2) are independently connected directly to the upper housing shell (upper portion of 82, see rejections of claim 17 above indicating the independent and separate connectors) via respective ones of the one or more connectors (see Fig. 9 above and 126 of Wang).
Regarding claim 19, Bryant et al. in view of Wang et al. teaches wherein the front lid (106) comprises operating elements (112/115,148, Fig. 7, see Col. 12, lines 6-24 and Col. 14, lines 42-50; it is the Examiners position that elements 112. 115 and 148 are all operating elements as they provide some functionality for operation of the device) and/or a display device.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (Patent No. 5,634,896) in view of Wang et al. (Pub. No. 2009/0093774) in view of Farrell et al. (Pub. No. 2012/0271226).
Regarding claim 14, Bryant et al in view of Wang et al. does not teach wherein the drive comprises at least one of: a motor, a transmission, or a drive spindle. However, in the same field of endeavor Farrell et al. teaches a medical fluid pumping system (Fig. 1) having a drive (112, 135A/B and stepper motors, see Figs. 3-4 and [0101] and [0137]) comprises at least one of: a motor (see [0101]), a transmission, or a drive spindle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant et al. in view of Wang et al. by adding the motors and pistons to the device and substituting the cassette and 76 of the device taught by Bryant in view of Wang for 108 and 110 of the device taught by Farrell et al. because teaches that such configuration and component are a simple and cost effective (see [0151]) is known in the art for dialysis systems. Further, the modification is an art equivalent modification that would yield the same predictable result of moving fluid through the cassette.
With this modification the drive includes a motor.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (Patent No. 5,634,896) in view of Wang et al. (Pub. No. 2009/0093774) in view of Kopychev et al. (Pub. No. 2010/0271296) in view of Kamen et al. (Pub. No. 2012/0185267).
Regarding claim 15, Bryant et al. in view of Wang et al. does not teach wherein the communication module comprises a wireless communication module. However, Kopychev et al. teaches user interface (50, Fig. 1) comprising a wireless communication module (66, Fig. 1, see [0038]) and Kamen et al. teaches a display (display on 1, Fig. 1 i.e. tablet) comprising a wireless communication module (see [0302]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the user interface taught by Bryant et al. in view of Wang et al. by adding the transceiver taught by Kopychev et al. because Kopychev et al. teaches that it is known in the art to use wireless communication between medical components (see [0038]) and further, Kamen et al. teaches that providing a user interface with wireless communication permits the user to wireless transfer medical information to remote locations such as a nursing station (see [0302]) thereby providing others with access to the patient’s medical data (see [0302]).
Claim(s) 5-6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (Patent No. 5,634,896) in view of Wang et al. (Pub. No. 2009/0093774) in view of Mauthe (Pub. No. 2015/0027561).
Regarding claim 5, Bryant et al. in view of Wang et al. teaches further comprising a power adapter (90, Fig. 9) arranged in the upper housing shell (top portion of 82; it is the Examiner’s position that when the top portion of 82 is positioned in the configuration of Fig. 1 at least the top portion of 90 is located within the top portion of 82). Bryant does not specifically teach that the power adapter is fixed to the upper housing shell. However, Mauthe teaches a power adapter (power supply in 40, see Fig. 1 and [0035] fixed to an upper housing shell (14, Fig. 1 also see Fig. 3a).
It would have been obvious to one of ordinary skill in the are before the effective filing date of the invention to modify the device taught by Bryant by fixing the power adapter to the upper housing because Mauthe recognizes that such configuration is known in the art of medical fluid pumps (see Figs. 1 and 3a) and it has been held that rearranging of parts of an invention involves only routine skill in the art.
Regarding claim 6, Bryant et al. in view of Wang et al. in view of Mauthe does not specifically teach wherein the power adapter is fixed to a portion of the upper housing shell that is perpendicular to the printed circuit board.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device taught by Bryant et al. in view of Wang et al. in view of Mauthe by fixing 90 to the top portion of 82 in a manner perpendicular to element 98 because it has been held rearranging of parts involves only routine skill in the art.
Regarding claim 16, in the event it is found that Bryant et al. in view of Wang et al. does not teach wherein the drive is spaced apart from the lower housing shell to prevent the drive from being in contact with any fluid accumulated in the lower housing shell. Mauthe teaches a power adapter (power supply in 40, see Fig. 1 and [0035] fixed to an upper housing shell (14, Fig. 1 also see Fig. 3a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant by fixing the power adapter to the upper housing because Mauthe recognizes that such configuration is known in the art of medical fluid pumps (see Figs. 1 and 3a) and it has been held that rearranging of parts of an invention involves only routine skill in the art. It is the Examiner’s position that with this modification 90 is fixed to the upper portion of 82; thereby preventing 90 from being in contact with any fluid accumulated in the lower housing shell.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (Patent No. 5,634,896) in view of Wang et al. (Pub. No. 2009/0093774) in view of Strowe et al. (Patent No. 4,838,857).
Regarding claim 9, Bryant et al. in view of Wang et al. does not teach further comprising a linear potentiometer arranged in the lower housing shell. However, Strowe et al. teaches a medical fluid pump (10, Fig. 1) further comprising a linear potentiometer (65, Fig. 2) arranged in a lower housing (14, see Figs. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Bryant et al. in view of Wang et al. by adding the linear potentiometer taught by Strowe et al. to the piston element 102 for determining if the travel distance of the piston is a sufficient distance to expel liquid contents (see Col. 5, lines 5-26).
Allowable Subject Matter
Claim 13 is 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.
Response to Arguments
Applicant's arguments filed 08/142025 have been fully considered but they are not persuasive.
Regarding Bryant applicant argues that claim 1 has been amended to recite that the drive is “located directly between the printed circuit board and the lower housing shell” and Bryant does not teach such configuration. Applicant states that it is clear from Bryant’s disclosure that the entire pneumatic actuator module 76 is located at the front of the machine while the circuit board 98 is located at the middle of the machine; thus, no part of Bryant’s pneumatic actuator module 76 is located between 98 and the lower housing shell and it would not have been obvious to modify Bryant to arrive at the claimed structure.
The Examiner respectfully disagrees. First, it should be noted that the amended claim limitation recites that “at least a portion of the drive located directly between printed circuit board and the lower housing. The Examiner’s annotated Fig. 10 below illustrate that a portion of 24 is located directly between the upper portion of 82 when 98 is located and the lower portion of 82.
Examiner’s Annotated Figs. 9 and 10
[AltContent: textbox (lower housing shell)][AltContent: arrow][AltContent: textbox (location where “a portion of 24” that is directly between the upper and lower housing shell is located)][AltContent: arrow][AltContent: textbox (upper housing shell)][AltContent: arrow]
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Seemingly, by referring to Figs. 2-3 of the present disclosure applicant is attempting to argue that the drive is located directly under and in alignment with the circuit board between the circuit board and the lower housing. However, it should be noted that this specific configuration is not claimed and directly between under the broadest reasonable interpretation just requires that 24 is directly between not necessarily aligned or under 98 and the lower portion of 82. Therefore, for the aforementioned reasons and in light of the amendments a new rejection is made under Bryant et al. in view of Wang et al. (see rejection above).
Conclusion
Applicant's 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 TIFFANY LEGETTE-THOMPSON whose telephone number is (571)270-7078. The examiner can normally be reached 7:00 am - 4:00 pm.
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TIFFANY LEGETTE-THOMPSON
Supervisory Patent Examiner
Art Unit 1723
/TIFFANY LEGETTE/Supervisory Patent Examiner, Art Unit 1723
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