DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: line 5 should be amended to - a target location of [[a]] the patient via the delivery catheter; -. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: lines 1-2 should be amended to - wherein the computer processor monitors an injection of the therapeutic to the target location-. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: lines 1-2 should be amended to - wherein the computer processor visualizes a location of the therapeutic in the anatomy based-. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: line 2 should be amended to - infused volume of the therapeutic to the target location-. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 2 should be amended to - infused volume of the therapeutic outside the target location-. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: lines 1-3 should be amended to - wherein the computer processor causes the pump assembly to adjust a flow rate based on imaging data, infused volume, backflow, the target location or an aspect of the anatomy-. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: lines 1-3 should be amended to – the pump assembly to adjust a flow rate based on infused volume, backflow, the target location or an aspect of the anatomy-. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: lines 1-3 should be amended to – the pump assembly to adjust a flow rate based on backflow, the target location or an aspect of the anatomy-. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: lines 1-2 should be amended to – the pump assembly to adjust a flow rate based on the target location or an aspect of the anatomy-. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: lines 1-2 should be amended to – the computer processor causes the pump assembly to adjust a flow rate based on an aspect of the anatomy-. 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 1-19 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.
Regarding claim 1:
The claim recites the limitation "the delivery catheter" in line 5. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the delivery catheter” overlaps with the structure of the “fluid delivery device”. They both are directed to delivering fluid to the patient and further dependent claim 19 indicates that the structure of the fluid delivery device is a catheter. For the sake of examination, the office has assumed that these structures are the seem however the applicant should amend the claim to clarify.
Claims 2-19 are rejected due to their dependence on claim 1.
Regarding claim 6:
The claim recites the limitation "the anatomy" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the image data" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8:
The claim recites the limitation "the target region" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 14-18:
These claims recites the limitation "the anatomy". There is insufficient antecedent basis for this limitation in the claims.
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.
Claims 1-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008083313 A2 to Hirschman et al. (Hirschman).
Hirschman discloses:
Regarding claim 1 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
A closed-loop infusion system (figure 2a-2b), comprising:
a therapeutic delivery system (150/150a and 153 or 153a) configured to deliver a therapeutic (can be various fluids including “dobutamine” as indicated in ¶0095 and ¶00241) to a patient (“P” in figures 2a-2b), the therapeutic delivery system including a pump assembly (152(1) – 152(n) or 152a(1) - 152a(n)) and a fluid delivery device (153 or 153a), wherein the pump assembly is configured to infuse the therapeutic to a target location (heat of the patient as indicated in ¶0095) of a patient (¶0095-0096 indicates the therapeutic material can be supplied to the patient heart and the patients heat can be monitored by 130) via the delivery catheter (153 in accordance with the 35 USC 112(b) rejection above); and
an imaging system (130) configured to obtain an image of the target location (¶0095-0096 indicates the therapeutic material can be supplied to the patient heart and the patients heat can be monitored by 130);
a computer processor (115/110/140/180/190/140/145) communicatively coupled to the therapeutic delivery system and the imaging system (coupled via the connections shown between 110 and 130 and 150 as shown in figures 2a and 2b), wherein the computer processor is configured to control delivery of the therapeutic to the patient based on feedback data from the imaging system (¶0097 indicates “ If patient P is unable to operate a bicycle-type or another physical exertion patient stimulus device 172, for example, because of joint problems or age, pharmacological stressors may be used, such as dobutamine. In this case, fluid injector 152(2), as an example, in fluid handling system 150 is used to deliver dobutamine in gradually increasing quantities until a target heart rate is achieved”).
Regarding claim 2:
The system of claim 1, wherein the imaging system (130) comprises at least one of an MRI system (¶0088), a CT system, an ultrasound system, and an x-ray system (¶0089).
Regarding claim 3:
The system of claim 1, wherein the pump assembly includes a syringe (syringe pump can be used to deliver therapeutics as indicated in ¶00138).
Regarding claim 4:
The system of claim 1, wherein the target location includes a brain (¶0091, ¶00130).
Regarding claim 5:
The system of claim 1, wherein computer processor monitors an injection of therapeutic to the target location (monitors the heart as indicated in ¶0096 via 130 and further injects therapeutic material for the heart).
Regarding claim 6:
The system of claim 5, wherein computer processor visualizes a location of therapeutic in the anatomy based on the image data (monitors the heart as indicated in ¶0096).
Regarding claim 7:
The system of claim 1, wherein the computer processor automatically identifies an anatomical volume (monitors the heart or volume of interest as indicated in ¶0096) of interest based on data from the imaging system (130).
Regarding claim 8:
The system of claim 7, wherein the computer processor forms boundary lines that identify the volume of interest on an image of the target region (monitors the heart as indicated in ¶0096 and indicates if it is beyond normal or beyond the boundary line of normal).
Regarding claim 9:
The system of claim 1, wherein the computer processor calculates an infused volume of therapeutic to the target location (¶0097 indicates that an amount of “dobutamine” is determined and inject).
Regarding claim 10:
The system of claim 9, wherein the computer processor controls the pump assembly (152(1) – 152(n) or 152a(1) - 152a(n)) based upon the infused volume (¶0097 indicates that an amount of “dobutamine” and that it is incrementally increased until the desired heart rate is achieved).
Regarding claim 11:
The system of claim 10, wherein the computer processor automatically turns the pump assembly (152(1) – 152(n) or 152a(1) - 152a(n)) on or off (¶0097 indicates how the “dobutamine” is delivered until the heart rate is achieved and then the delivery is stopped or turned off).
Regarding claim 12:
The system of claim 10, wherein the computer processor automatically adjusts a flow rate of the therapeutic to the target location (¶0097 indicates how the “dobutamine” is delivered until the heart rate is achieved).
Regarding claim 13:
The system of claim 1, wherein the computer processor (115/110/140/180/190/140/145) calculates an infused volume of therapeutic outside the target location (multiple injectors 152 can be used to inject other therapeutics not directed to the heart as indicated in ¶00241 where insulin or other drugs can be injected and their amounts would be calculated by the computer processor).
Regarding claim 14:
The system of claim 10, wherein the computer processor causes the pump to adjust a flow rate based on imaging data, infused volume, backflow, target location or an aspect of the anatomy (¶0097 indicates how the “dobutamine” is delivered until the heart rate or certain aspect of anatomy is achieved).
Regarding claim 15:
The system of claim 10, wherein the computer processor causes the pump to adjust a flow rate based on infused volume, backflow, target location or an aspect of the anatomy (¶0097 indicates how the “dobutamine” is delivered until the heart rate or certain aspect of anatomy is achieved).
Regarding claim 16:
The system of claim 10, wherein the computer processor causes the pump to adjust a flow rate based on backflow, target location or an aspect of the anatomy (¶0097 indicates how the “dobutamine” is delivered until the heart rate or certain aspect of anatomy is achieved).
Regarding claim 17:
The system of claim 10, wherein the computer processor causes the pump to adjust a flow rate based on target location or an aspect of the anatomy (¶0097 indicates how the “dobutamine” is delivered until the heart rate or certain aspect of anatomy is achieved).
Regarding claim 18:
The system of claim 10, wherein the computer processor causes the pump to adjust a flow rate based on an aspect of the anatomy (¶0097 indicates how the “dobutamine” is delivered until the heart rate or certain aspect of anatomy is achieved).
Regarding claim 19:
The system of claim 1, wherein the fluid delivery device (153 or 153a) is a catheter (¶0090 indicates 153 can be a catheter).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20210016000-A1
Singh
See the delivery system 12 and processor 26
US-20100228087-A1
Shener
See the display unit 14, imaging system 12 and delivery system 15a
US-20230310799-A1
Piferi
See the imaging system 20 and delivery system 50
WO-2007047852-A2
FIRLIK
See the imaging system 816 and the delivery system 130
WO-2007033103-A1
BARRETT
See the delivery system 10
WO-2011130107-A2
PIFERI
See the imaging system 20 and delivery system 50
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
