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 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) 1-4, 6, 10, 12-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,652,260 (“Fenton”), U.S. Publication No. 2017/0056604 (“Cowan”), U.S. Publication No. 2019/0060566 (“Ledford”), and AU2907399 (“Lohmeier”).
Regarding Claims 1 and 6, Fenton discloses a device (10) for administering a medical liquid (i.e. the contents of 20), the device comprising:
A receiving region (24) for receiving a hollow body (20) containing the medical liquid;
A cover (18) connected to the receiving region and moveable between an opened position (Fig. 2) and a closed position (Fig. 1);
A drive (inter alia 32 – see also the piston/plunger 34, the motor 50…etc.) configured for acting on the hollow body when the hollow body is received in the receiving region such that the medical liquid is conveyed;
The receiving region being accessible when the cover is in the opened position (see Fig. 2), and at least the filling level of the hollow body being covered by the cover when the cover is in the closed position (see Fig. 1).
Fenton discloses the invention substantially as claimed except that that the invention further comprises a “display unit” for graphically displaying a filling level of the hollow body based on one or more operating parameters of the drive. However, such displays are well-known in the art. For example, Cowan discloses a related medical fluid delivery device which comprises a display unit (118) for graphically displaying a filling level of the hollow body (12), the display unit configured for displaying the filling level of the hollow body based on one or more operating parameters of the drive (e.g. piston position 26 which can be determined via a variety of means including determining the position of the plunger/piston - Par. 235, 236; Fig. 49). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Fenton with a display unit which displays a filling level of the hollow body based upon one or more operating parameters of the drive, as disclosed by Cowan, in order to permit a clear, known, and predictable interface for the user for monitoring the fill volume of the syringe.
Fenton, as modified, discloses the invention substantially as claimed except that that the device comprises a control unit configured to prompt a user to input and/or select a specific hollow body type corresponding to the hollow body. However, Ledford discloses a related device which comprises a control unit configured to prompt a user to select a specific hollow body type corresponding to the hollow body type (Par. 24) so that the information about that hollow body type can be used to calculate and determine the proper settings of the device, the information comprising model/manufacturer/size of the syringe, wherein the control unit includes a memory in which hollow body data specifically relevant to conveying the medical liquid are stored, and wherein the control unit is configured to control the drive based on the hollow body data (Par. 21, 24). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Fenton to provide a control unit for receiving a user input/selection of a specific hollow body type corresponding to the specific hollow body type to be received within the device, as disclosed by Ledford, in order to ensure that system can accurately determine the dispensed and remaining volume through correlation of the plunger movement to a dispensed dosage based upon the syringe parameters.
Fenton, as modified, discloses the invention substantially as claimed except that display unit is configured to “display an image of the specific hollow body type and display the filling level of the hollow body on the image of the specific hollow body type”. Specifically, while Ledford does disclose that the display can be configured to display “an identification of a syringe” on the display, Ledford fails to explicitly disclose that the displayed “identification” is “image data of hollow body types”. Although, Cowan discloses that the display may be configured for display of “a graphical representation of the syringe… that illustrates the real-time volume remaining within the syringe” (Par. 235). However, there is no disclosure that this graphical display is of an “image of the specific hollow body type”, as opposed to wholly generic representation of a syringe.
However, Lohmeier discloses a related delivery device with a display (Fig. 6) configured to provide graphical display of the fill level of different syringe types (see Fig. 6), wherein the display comprises image data (503) stored in memory which corresponds to the specific syringe type (re: syringe volume, see Fig. 6 – i.e. 50mL, 20mL, and 10mL syringes wherein each representative syringe is displayed specific as per syringe type through the inclusion of the syringe size indicia), the display being used to illustrate syringe volume and fill level depending on the specifics of the syringe (see Fig. 6 0603A-603F). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the display of modified Fenton to provide image data provided from the syringe type library, as disclosed by Lohmeier, in order to provide a unique graphical representative of the syringe (based on syringe hollow body type, e.g. volume) and fill volume that can be recognized by the user to determine the original capacity of the syringe and the instant fill volume.
Regarding Claims 2, 4, 14, and 15, Fenton discloses the drive is designed as a linear drive (i.e. the position of the piston and plunger 34 which affects fluid delivery is linear) and, as modified in view of Cowan, provides that the one or more operating parameters of the drive comprises a translation position/feed of the linear drive (see 574, Cowan), the translation position of the linear drive being a directly related function of the filling level of the hollow body (see 576, Cowan).
Regarding Claim 3, Fenton, as modified in view of Cowan, provides for the drive to include a position sensor for detecting the translation position of the drive (see Cowan 570, 572, 574; Par. 235), the position sensor being configured for directly detecting the translation position of the drive (see 574 – Par. 235).
Regarding Claim 10, Fenton, as modified, discloses the invention substantially as claimed except that that the memory stores “color codes” of medical liquids and the control unit is configured to display “a liquid designation or background of the liquid designation and/or a filling level corresponding to the color code of the medical liquid”. However, Lohmeier discloses that retrieved syringe can be color coded wherein a specific color is assigned to a specific medicament to allow that information to be conveyed in the graphical representation of the filling level (503 – Pg. 27-28). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the display of Fenton to provide for color coded display of retrieved medicaments associated with the syringe data, as disclosed by Lohmeier, in order to allow for color coding of medication classes in order to provide quick visual survey of the fill levels and confirmation that the correct medicament is provided as per the designated order.
Regarding Claim 12, Fenton discloses the receiving region is accessible in the opened position of the cover for loading the hollow body (see Fig. 2) and/or for reading the filling level of the medical liquid (see Fig. 2).
Regarding Claim 13, Fenton, as modified by Cowan, provides for the one or more operating parameters of the drive are relevant to conveying the liquid (i.e. the position of the driver is relevant for conveying the liquid).
Regarding Claim 16, Fenton, as modified by Ledford discloses the control unit is configured to prompt the user to input and/or select the specific hollow body type corresponding to the hollow body in response to a predetermined user input (Ledford- Par. 35 – i.e. the prompt to select a specific syringe model is made after the user has confirmed that they have provided and syringe and wish to perform a specific procedure).
Regarding Claim 17, Fenton, as modified by Ledford and Lohmeier, discloses the specific hollow body type comprises one or more of size/volume (see Ledford, Par. 21, 24; Lohmeier, Fig. 6) and model/manufacturer (see Ledford, Par. 24).
Regarding Claim 19, Fenton discloses the device is a syringe pump (see Fig. 2).
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,652,260 (“Fenton”), U.S. Publication No. 2017/0056604 (“Cowan”), U.S. Publication No. 2019/0060566 (“Ledford”), and AU2907399 (“Lohmeier”) as applied above, and further in view of U.S. Publication No. 2018/0008787 (“Schriver”).
Regarding Claims 8 and 18, Fenton, as modified, discloses the invention substantially as claimed except that critical filling levels of the hollow body types are stored in the memory, wherein the critical filling levels include a critical filling level of the specific hollow body type, and wherein the control unit is configured to output a signal when the filling level of the hollow body falls below the critical filling level. However, Schriver discloses a related delivery device wherein the system is configured to retrieve and display a critical filling level associated with the syringe type and output a warning signal when the filling level of the syringe falls below this threshold (Par. 65, 72, 75), wherein alarms/alerts can be optical (see Par. 95) or audible (Par. 99). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Fenton to retrieve a critical filling level associated with the inserted syringe, as disclosed by Schriver, and generate a warning if this critical fill level is exceeded in order to alter a user when the remaining volume of fluid is low or insufficient to perform the designated procedure.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,652,260 (“Fenton”) in view of U.S. Publication No. 2017/0056604 (“Cowan”), U.S. Publication No. 2019/0060566 (“Ledford”), AU2907399 (“Lohmeier”), and U.S. Publication No. 2018/0008787 (“Schriver”) as applied above, and further in view of JP 2006-34719 (“Keisuke”)
Regarding Claim 9, Fenton, as modified discloses the invention substantially as claimed except that for disclosing that the control unit is configured to display the filling level of the hollow body on the display unit permanently or in response to a predetermined user input and/or when the filling level of the hollow body falls below the critical filling level. However, Keisuke discloses a related device (Fig. 1) having a display which is provided with an on/off switch (10a) for the display to permit the display to be turned off and on in response to a predetermined user input. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the display of Fenton with an on/off switch, as disclosed by Keisuke, in order to permit the display to be turned off when it is not needed to conserve power or reduce distractions for the patient or clinician when use of the display is not desired.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 8) that “However, Lohmeier does not state or suggest that images of specific hollow body types are shown on the display. Instead, all the syringe representations are identical…. Note, in particular, that every one of the syringe representations shown in the display is identical in shape and size, regardless of the medicant or volume of the syringe.” However, this is not persuasive. Examiner notes that Figure 6 of Lohmeier clearly illustrates that the respective syringe representations are in fact NOT identical inasmuch as each specific hollow body type has its particular size/volume displayed in clear indicia as part of the display (see e.g. 50mL, 20mL, 10mL) thereby differentiating the displayed syringe hollow bodies by type (different maximum fill volumes denoting a specific differentiation in syringe “type”). As such, these displayed images clearly constitute a specific image of “the specific hollow body type” consistent with the broadest reasonable interpretation of the term. Particularly,
the instant specification makes it clear that the broadest reasonable interpretation of “specific hollow body type” is inclusive to volume (see Clm. 17; Par. 54) where the specification recites “the control unit can be configured to prompt a user to input and/or select a hollow body type of the received hollow body, in particular a size, a volume and/or manufacturer” (Par. 54). Here, the breadth of “hollow body type” can be inferred to be inclusive to a graphical display of, at least, the specific volume of the syringe. Lohmeier clearly teaches displaying a specific graphical representation of the syringes inclusive to display of their particular volume. The displayed syringes are of different hollow body types (re: volume) and the displayed graphical representations of Lohmeier visually convey that information in clear satisfaction of the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/27/2026