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 § 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 5, 12-14 and 16 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.
Claim 5 recites the limitation "the closed loop delivery algorithm" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the time of the termination" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as "the time of the determination".
Claim 13 recites the limitation "the predetermined amount of time from the determination" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 14 is rejected at least because it depends from claim 13.
Claim 16 recites the limitation "the closed loop delivery algorithm" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 11-12, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mandro et al. (Mandro), US 2011/0040247 A1 in view of Kircher, JR. et al. (Kircher) US 2010/0292634 A1.
Regarding claim 11, Mandro discloses an ambulatory infusion pump system, comprising: a pump mechanism (pump assembly 100, P0086) configured to facilitate delivery of insulin to a user (P0080); a communications interface (companion, P0069) adapted to receive glucose levels from a continuous glucose monitor (receiver for receiving continuous glucose monitor signals from the at least one continuous glucose monitor sensor, P0069); at least one processor (microprocessors, P0087) functionally linked to the pump mechanism and the communications interface (P0104), the at least one processor configured to: calculate insulin doses with a delivery algorithm based on glucose levels received from the continuous glucose monitor (P0081); determine that the first target glucose range should be modified from the first target glucose range to a second target glucose range (2 hours post food bolus, P0264); determine an amount of time elapsed since a most recent bolus delivery of insulin has been delivered by the pump mechanism (2 hours post food bolus, P0264); and alter the first target glucose range based on the amount of time since the most recent bolus delivery of insulin (target ranges for glucose altered based on 2 hours post food bolus target, P0264).
Mandro does not explicitly teach the delivery algorithm configured to calculate the insulin doses to maintain a user's glucose levels within a first target glucose range.
However, Kircher teaches a system and method for controlling the dispensing of insulin wherein the delivery algorithm configured to calculate the insulin doses to maintain a user's glucose levels within a first target glucose range (fasting range, P0015 and P0021).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the delivery algorithm of Mandro to to calculate the insulin doses to maintain a user's glucose levels within a first target glucose range for the purpose of achieving the glucose ranges of Mandro.
Regarding claim 12, Mandro in view of Kircher teaches the ambulatory infusion pump system of claim 11, wherein if the amount of time since the most recent bolus delivery of insulin is greater than a predetermined amount of time (Mandro, 2 hours post food bolus, P0264) from the determination to modify the first target glucose range, the processor is configured to alter the first target glucose range to the second target glucose range at the time of the termination to modify the first target glucose range (Mandro, target ranges for glucose altered based on 2 hours post food bolus, P0264).
Regarding claim 15, Mandro in view of Kircher teaches the ambulatory infusion pump system of claim 11, where the at least one processor is configured to determine the most recent bolus delivery of insulin based only on meal boluses manually programmed by a user (Mandro, P0225).
Regarding claim 19, Mandro in view of Kircher teaches the ambulatory infusion pump system of claim 11, wherein the at least one processor is configured to automatically determine that the first target glucose range should be modified from the first target glucose range to the second glucose target range (Mandro, target ranges for glucose altered based on 2 hours post food bolus, P0264).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-19 of U.S. Patent No. 11,951,284 B2 (see table below). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the features of application claims can be found in the patent claims. The difference between claim 1 of the application and claim 1 of the patent lies in the fact that the patent includes more features and is therefore more specific regarding the configuration of the processor. Thus the invention of claim 1 of the patent is in effect a "species" of the "generic" invention of claim 1 of the application. It has been held that the generic invention is anticipated by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of application patent. Similar rationale applies to the remainder of the listed claims.
Claim
Patent
Citation
1
1
2
1
C 12 ln 42-47
3
1
C 12 ln 48-54
4
2
5
3
6
4
7
5
8
6
9
7
10
9
11
11
12
11
C 14 ln 4-8
13
12
14
13
15
14
16
15
17
16
18
17
19
18
20
19
Potentially Allowable Subject Matter
Claims 1-10 are potentially allowed, subject to the §112(b) and double patenting rejections above.
Claims 13-14, 16-18 and 20 are objected to as being dependent upon a rejected base claim, but would be potentially allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, subject to the §112(b) and double patenting rejections above.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed ambulatory infusion pump system.
The closest prior art is Mandro et al. (Mandro), US 2011/0040247 A1.
Regarding claim 1, Mandro fails to teach among all the limitations or render obvious an ambulatory infusion pump system as claimed, which includes varying a transition from a first target glucose range to the second glucose range based on the amount of time since the most recent bolus delivery of insulin, in combination with the total structure and function of the ambulatory infusion pump system as claimed.
Regarding claim 17, Mandro fails to teach among all the limitations or render obvious an ambulatory infusion pump system as claimed, which includes wherein the second target glucose range has a lower low glucose threshold and a lower high glucose threshold than the first glucose target range, in combination with the total structure and function of the ambulatory infusion pump system as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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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.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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