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.
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Claim(s) 1-13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-5 of U.S. Patent No. 11,116,895. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, ‘895 claims (see Clm. 1)
An infusion pump configured for pumping fluid through a tubular administrative set at a desired flow rate over a specified duration, comprising:
a pumping mechanism releasably receiving the tubular administrative set and configured to exert a force on the tubular administrative set to create a flow of fluid from an outlet of the tubular administrative set; and
a controller connected to said pumping mechanism and configured for operating said pumping mechanism; said controller being configured to:
determine a first pulse frequency to obtain a target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate
determine a second pulse frequency based on the target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate, said second pulse frequency being different from said first pulse frequency;
output a control signal to said pumping mechanism for operating said pumping mechanism at said first pulse frequency; and
output a second control signal to said pumping mechanism for operating said pumping mechanism at said second pulse frequency to compensate for a degradation of a material of the administrative set.
As such, Claim 1 of the reference patent anticipates the instant claim.
Regarding Claim 2, Clm. 1 anticipates this claim.
Regarding Claim 3, this claim is not found verbatim in the claims of the issued reference patent, but must be understood to be inherent to Clm. 1 inasmuch as the claim requires a “desired flow rate” and a “specified duration”, i.e. input related to the intended volume, which is then used by the controller to determine what adjustments must be made to accomplish this target.
Regarding Claim 4, while this claim does not appear verbatim in the issued claims of the reference patent, it presents as obvious based upon the claimed control algorithm, i.e. the “TUBING DEGRADATION FUNCTION” (Clm. 1) inasmuch as a lookup table is merely one known and obvious way of arranging a historical data set.
Regarding Claims 5 and 6, these claims are obviated by Clm. 2 which presents the two claimed conditions as alternatives to one another, either of which would have been obvious to employ depending upon the specific tubing used.
Clm. 7 is anticipated by Clm. 4.
Clm. 8 is anticipated by Clm. 5
Regarding Claims 9-10, while this claim limitation is not found verbatim in the issued reference patent claims it is held to be an obvious subset of possible wear conditions for tubing degradation as set forth in issued Clm. 1 – i.e. wear will result in combinations of geometric changes (e.g. flattening of the tubing) and/or mechanical changes (e.g. loss of elasticity of the tubing).
Clm. 11 is anticipated by Clm. 1.
Clm. 12 is anticipated by Clm. 1.
Clm. 13 is anticipated by Clm. 1.
Claim(s) 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-8 of U.S. Patent No. 11,951,282. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, the ‘282 reference patent claims (see Clm. 1):
An infusion pump configured for pumping fluid through a tubular administrative set at a desired flow rate over a specified duration, comprising:
a pumping mechanism releasably receiving the tubular administrative set and configured to exert a force on the tubular administrative set to create a flow of fluid from an outlet of the tubular administrative set; and
a controller connected to said pumping mechanism and configured for operating said pumping mechanism; said controller being configured to:
determine a first pulse frequency to obtain a target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate;
determine a second pulse frequency based on the target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate, said second pulse frequency being different from said first pulse frequency; output a control signal to said pumping mechanism for operating said pumping mechanism at said first pulse frequency; and
output a second control signal to said pumping mechanism for operating said pumping mechanism at said second pulse frequency to compensate for a degradation of a material of the administrative set.
As such, Clm. 1 of the reference patent anticipates the instant claim 1.
Regarding Claim 2, Clm. 1 anticipates this claim.
Regarding Claim 3, Clm. 3 anticipates this claim.
Regarding Claim 4, Clm. 7 anticipates this claim.
Regarding Claims 5-6, Clm. 2 obviates this claim by reciting both possible arrangements in alternative form.
Regarding Claim 7, Clm. 4 anticipates this claim.
Regarding Claim 8, Clm. 5 anticipates this claim.
Regarding Claims 9 and 10, Clm. 6 anticipates this claim.
Regarding Claim 11, Clm. 1 anticipates this claim.
Regarding Claim 12, Clm. 4 anticipates this claim.
Regarding Claim 13, while this limitation does not appear verbatim in the issued claims it can be resolved by Clm. 1 which requires an algorithm which determines pulse rate frequency based on “a degradation of a material” via historical data. As such, in order for the data to be relevant consideration must be made as to the type of material used in the tubing inserted into the pumping mechanism, otherwise the control algorithm (which is based on material type) would not be relevant to the actual (or expected) wear conditions of the actual tubing used.
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.
Claim(s) 1, 5-6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2011/0318198 (“Johnson”).
Regarding Claim 1, Johnson discloses an infusion pump (100; Abstract) configured for pumping fluid through a tubular administrative set (16) at a desired flow rate over a specified duration, comprising:
a pumping mechanism (13) releasably receiving the tubular administrative set (Fig. 1) and configured to exert a force on the tubular administrative set to create a flow of fluid from an outlet of the tubular administrative set (see Fig. 9; Par. 30, 31); and
a controller (14) connected to said pumping mechanism (see Fig. 9) and configured for operating the pumping mechanism; said controller being configured to:
Determine a first pulse frequency to obtain a target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate (Par. 4, 43, 44);
determine a second pulse frequency based on the target fluid volume of fluid infused over a portion of the specified duration and the desired flow rate, said second pulse frequency being different from said first pulse frequency (Par. 6, 43, 44, 65);
output a control signal to said pumping mechanism for operating said pumping mechanism at said first pulse frequency (Par. 4, 41); and
output a second control signal to said pumping mechanism for operating said pumping mechanism at said second pulse frequency to compensate for a degradation of a material of the administrative set (Par. 3, 6, 59, 18).
Regarding Claim 5, Johnson fails to explicitly suggest that there are instances wherein the first pulse frequency is greater than the second pulse frequency – i.e. the pump slows over time to compensate for degradation. However, since the algorithm of Johnson is based upon actual sensor measurements, Examiner submits that depending on the type of tubing used the change in frequency will decrease should the pump be paired with tubing which becomes stiffer over time as measured by the force sensor (Par. 17). To the extent that the tubing is not particularly required by the claim, no such explicit reference to the use of such tubing in Johnson is required to anticipate the instant claim.
Regarding Claim 6, Johnson discloses that the first pulse frequency is less than the second pulse frequency (i.e. the pump rate is increased to achieve the same flow rate over time – Par. 6).
Regarding Claim 8, Johnson discloses the controller comprises (see Par. 59 – wherein the processor and memory can be local or remote):
a processor;
a memory connected to said processor; and
non-transitory instructions stored in said memory and executable by said processor for causing said processor to:
determine said second pulse frequency; and
output the second control signal to said pumping mechanism for operating said pumping mechanism at said second pulse frequency.
Regarding Claims 9 and 10, Johnson discloses the second pulse frequency is based on a geometric attribute of a tube of the tubular administrative set (Par. 3, 36, 39, 41).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0318198 (“Johnson”) as applied above, and further in view of U.S. Publication No. 2009/0124963 (“Hogard”).
Regarding Claim 7, Johnson discloses the invention substantially as claimed except that that the invention further comprises “a sensor connected to said pumping mechanism for sensing a volume of fluid infused from the tubular administrative set.” While Johnson does suggest that various sensors (22, 62) can be implemented in the system a “volume sensor” is not explicitly one of them. However, Hogard discloses that it is known to provide peristaltic pumps with various volume sensors to sense a volume of fluid infused from the tubular administrative set (see Par. 108, 132, 135). It would have been obvious for one having ordinary skill in the art at the time the invention was made to include a volume sensor connected to the pumping mechanism for sensing an actual volume of fluid infused through the set, as disclosed by Hogard, in order to ensure that the actual volume infused continues to match the expected volume infused thereby serving as a further check to the degradation adjustment algorithm thereby ensuring accurate dosing over time.
Allowable Subject Matter
Claim(s) 2-4 and 11-13 is/are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure – see U.S. Patent No. 4,670,007 (“Wheeldon”) particularly as applied over the claims in the Final and Non-Final Office Actions for US 15/892,207.
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 02/12/2026