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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 38-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,324,888. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims.
Regarding claim 38 of the application, claim 1 of the patent recites an infusion system configured to automatically control an infusion pump (Claim 1, lines 50-51), the system comprising an infusion pump configured to pump an infusion fluid along a flow path, a first acoustic sensor positioned at a first location along the flow path, the first acoustic sensor configured to detect a first acoustic signal (Claim 1, lines 54-56), a second acoustic sensor positioned at a second location downstream from the first acoustic sensor along the flow path, the second acoustic sensor configured to detect a second acoustic signal (Claim 1, lines 58-61). The difference between the application claims and the patent claims lies in the fact that claim 1 of the patent recites additional features and is therefore more specific than the application claim. It has been held that the generic invention is anticipated by the specific invention. See In re Goodman, UAPQ2d 2010 (Fed. Cir. 1993). Therefore, the application claim is not patentably distinct from the patent claim.
Regarding claim 50 of the application, claim 12 of the patent recites a method of controlling an infusion pump configured to pump infusion fluid along a flow path (Claim 12, line 37-39), the method comprising detecting a first acoustic signal from a first acoustic sensor positioned at a first location along the flow path (Claim 12, lines 40-41), detecting a second acoustic signal from a second acoustic sensor positioned at a second location downstream from the first acoustic sensor along the flow path (Claim 12, lines 44-46), determining a first volumetric flow rate of the infusion fluid based on the detected first acoustic signal and the detected second acoustic signal (Claim 12, lines 49-51). The difference between the application claims and the patent claims lies in the fact that claim 12 of the patent recites additional features and is therefore more specific than the application claim. It has been held that the generic invention is anticipated by the specific invention. See In re Goodman, UAPQ2d 2010 (Fed. Cir. 1993). Therefore, the application claim is not patentably distinct from the patent claim.
See table below for full claim correspondence:
Application
38
39
40
41
42
43
44
45
46
47
48
11,324,888
1
2
3
4
5
1
6
7
8
9
10
Application
49
50
51
52
53
54
55
56
57
11,324,888
11
12
13
14
15
6
7
8
9
Claims 38, 40-42, 44-50, and 52-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, and 10 of U.S. Patent No. 12,076,531. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims.
Regarding claim 38 of the application, claim 1 of the patent recites an infusion system for automatically detecting and adjusting a volumetric flow rate delivered by an infusion pump comprising an infusion pump configured to pump infusion fluid (Claim 1, lines 55-57), at least one upstream acoustic sensor located at an upstream location of the flow path, at least one downstream acoustic sensor located at a downstream location of the flow path wherein the at least one downstream acoustic sensor is configured to detect an upstream acoustic signal emitted by the at least one upstream acoustic sensor parallel to the flow path, and the at least one upstream acoustic sensor is configured to detect a downstream acoustic signal emitted by the at least one downstream acoustic sensor parallel to the flow path (Claim 1, lines 61-67, 1-4). The difference between the application claims and the patent claims lies in the fact that claim 1 of the patent recites additional features and is therefore more specific than the application claim. It has been held that the generic invention is anticipated by the specific invention. See In re Goodman, UAPQ2d 2010 (Fed. Cir. 1993). Therefore, the application claim is not patentably distinct from the patent claim.
Regarding claim 50 of the application, claim 8 of the patent recites a method for automatically detecting and adjusting a volumetric flow rate delivered by an infusion pump comprising pumping infusion fluid with an infusion pump along a flow path, detecting an upstream acoustic signal emitted by at least one upstream acoustic sensor parallel to the flow path (Claim 8, lines 16-22), detecting a at least one downstream acoustic signal emitted by the at least one downstream acoustic sensor parallel to the flow path, located at the downstream location of the flow path (Claim 8, lines 26-29). The difference between the application claims and the patent claims lies in the fact that claim 8 of the patent recites additional features and is therefore more specific than the application claim. It has been held that the generic invention is anticipated by the specific invention. See In re Goodman, UAPQ2d 2010 (Fed. Cir. 1993). Therefore, the application claim is not patentably distinct from the patent claim.
See table below for full claim correspondence:
Application
38
40
41
42
44
45
46
47
48
12,076,531
1
2
3
3
4
1
1
4
4
Application
49
50
52
53
54
55
56
57
12,076,531
4
8
2
3
8
8
8
10
Claim Objections
Claims 45-46 and 55-56 are objected to because of the following informalities:
Claim 45, line 2, reads “associated the first acoustic signal”, should read, “associated with the first acoustic signal”.
Claim 46, line 2, reads “associated the second acoustic signal”, should read, “associated with the second acoustic signal”.
Claim 55, line 2, reads “associated the first acoustic signal”, should read, “associated with the first acoustic signal”.
Claim 56, line 2, reads “associated the second acoustic signal”, should read, “associated with the second acoustic signal”.
Appropriate correction is required.
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 38-41, 43-44, 47-54, and 57 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Johnson et al. (US Pub No. 20120035535 A1, herein, Johnson).
Regarding claim 38, Johnson discloses an infusion system (10 – Fig.1) comprising:
an infusion pump (12 – Fig.1) configured to pump an infusion fluid along a flow path (16 – Fig.1A)(“vary the fluid flow rate within the tubing using the pump” – Para [0030]);
a first acoustic sensor (24 -Fig.1A) positioned at a first location along the flow path (Fig.1A), the first acoustic sensor configured to detect a first acoustic signal (“receive acoustic signals directed at or through the tubing” – Para [0016], “first acoustic signal received by a CMUT sensor” – Para [0031]); and
a second acoustic sensor (26 – Fig.1A) positioned at a second location downstream from the first acoustic sensor along the flow path (Fig.1A), the second acoustic sensor configured to detect a second acoustic signal (“receive acoustic signals directed at or through the tubing” – Para [0016], “a second acoustic signal that is generated by one of the sensors” – Para [0031]).
Regarding claim 39, Johnson discloses the infusion system as set forth above, wherein the first acoustic signal originated from the second acoustic sensor (“first acoustic signal received by a CMUT sensor 24 or 26” – Para [0031]) and the second acoustic signal originated from the first acoustic sensor (“a second acoustic signal that is generated by one of the sensors” – Para [0031]).
Regarding claim 40, Johnson discloses the infusion system as set forth above, wherein the first acoustic sensor comprises a first transducer and the second acoustic sensor comprises a second transducer (“first and second capacitive micromachined ultrasonic transducer (hereinafter CMUT) sensors 24 and 26” – Para [0029]).
Regarding claim 41, Johnson discloses the infusion system as set forth above, wherein the first acoustic sensor comprises a first transmitter and a first receiver and the second acoustic sensor comprises a second transmitter and a second receiver (“capacitive micromachined ultrasonic transducer sensor assembly adapted to operatively couple with the tubing to transmit and receive acoustic signals directed at the tubing” – Para [0042], “transmitting transducer 24 or 26” – Para [0040], “emitting and receiving modes“ – Para [0033]).
Regarding claim 43, Johnson discloses the infusion system as set forth above, further comprising a controller (14 – Fig.1) configured to: determine a first volumetric flow rate of the infusion fluid based on the detected first acoustic signal and the detected second acoustic signal (“The sensor 24 and 26 can be used to determine a fluid flow rate of fluid in the tube with the controller” – Para [0031], “The controller determines the actual fluid flow rate based on the determined inner diameter and the determined flow velocity” – Para [0016]), and control the infusion pump to pump the infusion fluid at a second volumetric flow rate based on the detected first volumetric flow rate (“The controller adjusts the operation of the pumping mechanism to adjust or vary the flow rate” – para [0016], “ based on any of these readings or characteristics the controller 14 utilizes an algorithm to cause the pump 12 to vary the fluid flow rate” – Para [0031]).
Regarding claim 44, Johnson discloses the infusion system as set forth above, wherein the first volumetric flow rate of the infusion fluid is calculated over each stroke of the infusion pump (“force sensors to infer internal pressure information during peristaltic pumping and an algorithm to adjust pump speed accordingly, such an algorithm can be used to determine precise flow rate variances for the output of the sensors” – Para [0030]).
Regarding claim 47, Johnson discloses the infusion system as set forth above, wherein the first volumetric flow rate is determined based on a length between the first location and the second location (Fig.2A, “determine the distance between the transducers” – Para [0035]).
Regarding claim 48, Johnson discloses the infusion system as set forth above, wherein the first volumetric flow rate is determined based on a first time it takes the first acoustic signal to travel between the second acoustic sensor and the first acoustic sensor (“Transit time difference is one method used to measure the flow rate” – Para [0033], “The acoustic signal propagates in the fluid and is collected by the opposite probe. The propagation times in the upstream and downstream directions are measured.” – Para [0033]).
Regarding claim 49, Johnson discloses the infusion system as set forth above, wherein the first volumetric flow rate is determined based on a first time it takes the second acoustic signal to travel between the first acoustic sensor and the second acoustic sensor (“Transit time difference is one method used to measure the flow rate” – Para [0033], “The acoustic signal propagates in the fluid and is collected by the opposite probe. The propagation times in the upstream and downstream directions are measured.” – Para [0033]).
Regarding claim 50, Johnson discloses a method of determining a volumetric flow rate of an infusion fluid along a flow path (16 – Fig.1A) in an infusion pump (12 – Fig.1), the method comprising:
detecting a first acoustic signal (“first acoustic signal received by a CMUT sensor” – Para [0031]) from a first acoustic sensor (24 -Fig.1A) positioned at a first location (Fig.1A) along the flow path (“receive acoustic signals directed at or through the tubing” – Para [0016]);
detecting a second acoustic signal (“a second acoustic signal that is generated by one of the sensors” – Para [0031], “receive acoustic signals directed at or through the tubing” – Para [0016]) from a second acoustic sensor (26 – Fig.1A) positioned at a second location downstream from the first acoustic sensor along the flow path (Fig.1A); and
determining a first volumetric flow rate of the infusion fluid based on the detected first acoustic signal and the detected second acoustic signal (“The sensor 24 and 26 can be used to determine a fluid flow rate of fluid in the tube with the controller” – Para [0031], “The controller determines the actual fluid flow rate based on the determined inner diameter and the determined flow velocity” – Para [0016]).
Regarding claim 51, Johnson discloses the method of determining a volumetric flow rate as set forth above, wherein the first acoustic signal originated from the second acoustic sensor (“first acoustic signal received by a CMUT sensor 24 or 26” – Para [0031]) and the second acoustic signal originated from the first acoustic sensor (“a second acoustic signal that is generated by one of the sensors” – Para [0031]).
Regarding claim 52, Johnson discloses the method of determining a volumetric flow rate as set forth above, wherein the first acoustic sensor comprises a first transducer and the second acoustic sensor comprises a second transducer (“first and second capacitive micromachined ultrasonic transducer (hereinafter CMUT) sensors 24 and 26” – Para [0029]).
Regarding claim 53, Johnson discloses the method of determining a volumetric flow rate as set forth above, wherein the first acoustic sensor comprises a first transmitter and a first receiver and the second acoustic sensor comprises a second transmitter and a second receiver (“capacitive micromachined ultrasonic transducer sensor assembly adapted to operatively couple with the tubing to transmit and receive acoustic signals directed at the tubing” – Para [0042], “transmitting transducer 24 or 26” – Para [0040], “emitting and receiving modes“ – Para [0033]).
Regarding claim 54, Johnson discloses the method of determining a volumetric flow rate as set forth above, wherein the first volumetric flow rate of the infusion fluid is calculated over each stroke of the infusion pump (“force sensors to infer internal pressure information during peristaltic pumping and an algorithm to adjust pump speed accordingly, such an algorithm can be used to determine precise flow rate variances for the output of the sensors” – Para [0030]).
Regarding claim 57, Johnson discloses the method of determining a volumetric flow rate as set forth above, wherein the first volumetric flow rate is determined based on a length between the first location and the second location (Fig.2A, “determine the distance between the transducers” – Para [0035]).
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 42 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of DelCastilio et al. (US Pub No. 20110137241 A1, herein, DelCastilio).
Regarding claim 42, Johnson discloses the infusion system as set forth above, but Johnson does not expressly disclose wherein the first receiver and the second receiver each comprise at least one noise cancelling component.
DelCastilio teaches an infusion system (10 – Fig.1) wherein a receiver (26 – Fig.1) comprises at least one noise cancelling component (“a noise reduction filter” – Para [0021]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the first and the second receiver of Johnson to comprise at least one noise cancelling component as taught by DelCastilio since the noise cancelling component suppresses the peaks and valleys of the signal and the patient or operator induced artifacts, which quickly detects an occlusion within the infusion system and to reduce the number of false alarms (DelCastilio, Para [0021]).
Claims 45-46 and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Bennison (US Pub No. 20090082676 A1).
Regarding claim 45, Johnson discloses the infusion system as set forth above, but Johnson does not expressly disclose wherein the first volumetric flow rate is determined based on a first phase delay associated with the first acoustic signal.
Bennison teaches an infusion system (10 – Fig.1) wherein a volumetric flow rate is determined based on a phase delay associated with an acoustic signal (“The phase is simply the difference in timing between the incident wave and the reflected wave” – Para [0049], “the quiescent phase is different at each flow rate, and the phase difference increases with increasing flow rate, suggesting a greater phase difference as the flow rate increases” – Para [0049]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the first volumetric flow rate of Johnson to be determined based on a first phase delay associated with the first acoustic signal as taught by Bennison since it is useful in detecting access disconnects and leaks (Bennison, Para [0048]).
Regarding claim 46, Johnson discloses the infusion system as set forth above, but Johnson does not expressly disclose wherein the first volumetric flow rate is determined based on a second phase delay associated with the second acoustic signal.
Bennison teaches an infusion system (10 – Fig.1) wherein a volumetric flow rate is determined based on a phase delay associated with an acoustic signal (“The phase is simply the difference in timing between the incident wave and the reflected wave” – Para [0049], “the quiescent phase is different at each flow rate, and the phase difference increases with increasing flow rate, suggesting a greater phase difference as the flow rate increases” – Para [0049]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the first volumetric flow rate of Johnson to be determined based on a second phase delay associated with the second acoustic signal as taught by Bennison since it is useful in detecting access disconnects and leaks (Bennison, Para [0048]).
Regarding claim 55, Johnson discloses the method of determining a volumetric flow rate as set forth above, but Johnson does not expressly disclose wherein the first volumetric flow rate is determined based on a first phase delay associated with the first acoustic signal.
Bennison teaches an infusion system (10 – Fig.1) wherein a volumetric flow rate is determined based on a phase delay associated with an acoustic signal (“The phase is simply the difference in timing between the incident wave and the reflected wave” – Para [0049], “the quiescent phase is different at each flow rate, and the phase difference increases with increasing flow rate, suggesting a greater phase difference as the flow rate increases” – Para [0049]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the first volumetric flow rate of Johnson to be determined based on a first phase delay associated with the first acoustic signal as taught by Bennison since it is useful in detecting access disconnects and leaks (Bennison, Para [0048]).
Regarding claim 56, Johnson discloses the method of determining a volumetric flow rate as set forth above, but Johnson does not expressly disclose wherein the first volumetric flow rate is determined based on a second phase delay associated with the second acoustic signal.
Bennison teaches an infusion system (10 – Fig.1) wherein a volumetric flow rate is determined based on a phase delay associated with an acoustic signal (“The phase is simply the difference in timing between the incident wave and the reflected wave” – Para [0049], “the quiescent phase is different at each flow rate, and the phase difference increases with increasing flow rate, suggesting a greater phase difference as the flow rate increases” – Para [0049]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the first volumetric flow rate of Johnson to be determined based on a second phase delay associated with the second acoustic signal as taught by Bennison since it is useful in detecting access disconnects and leaks (Bennison, Para [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm 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, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights