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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16) in the reply filed on 03/16/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 11/28/2023 and 11/22/2024, have been considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The originally filed specification fails to disclose the specific subject matter of claim 13 (“tamper detection mechanism”).
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 1-13 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 1] The claim recites the functional limitation of “a first medication in a bladder” in the 3rd line of the claim. However, the claim further recites “a medication” in the 5th line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the recitation of “a medication” refers to the previously functionally recited “first medication in a bladder,” or if an additional medication is intended to be present. As such, it is further unclear as to whether the recitation of “a medication” is intended to be positively or functionally recited. For purposes of examination, it is interpreted that “a medication” refers to the previously functionally recited “first medication.”
[Claim 9] The claim recites the limitation of “further comprising an outer shell with a hinge” in the 1st and 2nd lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the recited “outer shell with a hinge” is the same or different structure from the “foldable housing” recited in the 2nd line of independent claim 1. For purposes of examination, it is interpreted that the “outer shell with a hinge” is the same structure as the “foldable housing.”
[Claims 2-13] The claims are rejected based upon their dependency from independent claim 1.
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.
Claims 1, 4, 6, 8, 9, and 13, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puhakka (WO 95/00191).
[Claim 1] Puhakka teaches an infusion unit (figure 1) comprising:
a foldable housing (figure 1, item 7) configured to be secured around an arm (figure 1, item 11) of a person (figures 1 and 2),
at least one internal reservoir (figure 5, item 1) for temporarily holding a first medication in a bladder (the examiner notes the “first medication” and “bladder” are only functionally recited) (figures 2 and 5);
a connection (figure 5, “T-connector”) from the at least one internal reservoir (figure 5, item 1) to an intravenous (IV) line (figure 5, item 2) (page 6, lines 6-18);
a dispensing mechanism (figure 5, item 4) that forces a medication (see 112b interpretation above) from within the at least one internal reservoir (figure 5, item 1) through the intravenous (IV) line (figure 5, item 2) (page 5, lines 1-10),
wherein the at least one internal reservoir (figure 5, item 1) is an IV fluid solution bag (page 4, lines 19-21) that has at least one exit port (figure 5) that connects to the intravenous (IV) line (figure 5, item 2); and
a controller (figures 5 and 6, item 5) that operates (via shutoff valve 16) the dispensing mechanism (figure 5, item 4) based on a predefined parameter (page 6, lines 13-16).
[Claim 4] Puhakka teaches the limitations of claim 1, upon which claim 4 depends. In addition, Puhakka discloses an interface (figure 3) that allows the controller (figures 5 and 6, item 5) to be programmed externally from the foldable housing (figure 1, item 7) (page 4, lines 35-37; page 5, line 1).
[Claim 6] Puhakka teaches the limitations of claim 1, upon which claim 6 depends. Puhakka also teaches the infusion unit (figure 1) comprises at least two internal reservoirs (figure 5, item 1) with a second medication (the examiner notes the recited “second medication” is not required to be different from the previously functionally recited “first medication”) in at least one of the at least two internal reservoirs (figure 5, item 1) (figure 5; page 1; lines 12-29; page 4, lines 19-21).
[Claim 8] Puhakka teaches the limitations of claim 1, upon which claim 8 depends. Puhakka additionally discloses one or both of a flow sensor (figures 3 and 6, item 15) (page 5, lines 26-30) or an air bubble sensor (figures 3 and 6, item 15) (page 6, lines 18-23).
[Claim 9] Puhakka teaches the limitations of claim 1, upon which claim 9 depends. In addition, Puhakka teaches an outer shell (figure 1, item 7) with a hinge (figure 4, item 9) (see 112(b) interpretation above) and a lock (figure 3, item 10) (page 3, lines 7-12; page 4, lines 23-25).
[Claim 13] Puhakka teaches the limitations of claim 1, upon which claim 13 depends. Puhakka also discloses a tamper detection mechanism (figure 3, item 10) (page 3, lines 7-12; page 4, lines 23-25).
Claims 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Savage (PGPub 2016/0199576).
[Claim 14] Savage teaches a wearable infusion unit (figure 1, item 100) comprising:
at least one internal reservoir (figure 2b, item 130) for temporarily holding a medication in a bladder (paragraph [0190]);
a connection (figure 2a, item 215) from the at least one internal reservoir (figure 2b, item 130) to an intravenous (IV) line (figure 2a, item 210) (paragraph [0190]);
a dispensing mechanism (figure 3, item 330) that forces the medication from within the at least one internal reservoir (figure 2b, item 130) through the intravenous (IV) line (figure 2a, item 210) (paragraphs [0204], [0205]);
a controller (figure 4, item 410) (paragraph [0208]); and
one or more physiological sensors (figure 4, item 450) communicatively coupled to the controller (figure 4, item 410) and configured to measure one or more vital statistics (“body temperature, heart rate, pulse, respiratory rate, electrocardiogram signals, respiratory noise, blood pressure and/or blood oxygen saturation”) of a user wearing the wearable infusion unit (figure 1, item 100) (figure 4; paragraph [0208]),
wherein the controller (figure 4, item 410) is configured to receive the one or more measured vital statistics (“body temperature, heart rate, pulse, respiratory rate, electrocardiogram signals, respiratory noise, blood pressure and/or blood oxygen saturation”) from the one or more physiological sensors (figure 4, item 450) (figure 4; paragraph [0208]).
[Claims 15 and 16] Savage teaches the limitations of claim 14, upon which claims 15 and 16 depend. In addition, Savage discloses the controller (figure 4, item 410) is configured to transmit the one or more measured vital statistics (“body temperature, heart rate, pulse, respiratory rate, electrocardiogram signals, respiratory noise, blood pressure and/or blood oxygen saturation”) from the one or more physiological sensors (figure 4, item 450) to a remote computing device (figure 4, items 470/475) (figure 4; paragraphs [0208], [0209]), as well as receive instructions from the remote computing device (figure 4, items 470/475) based on the one or more measured vital statistics (“body temperature, heart rate, pulse, respiratory rate, electrocardiogram signals, respiratory noise, blood pressure and/or blood oxygen saturation”) (figure 4; paragraphs [0208], [0209]).
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Puhakka (WO 95/00191), in view of Savage (PGPub 2016/0199576).
[Claims 2 and 3] Puhakka teaches the limitations of claim 1, upon which claims 2 and 3 depend. Puhakka does not specifically disclose at least one sensor that is configured to monitor at least one vital sign of a person.
However, Savage teaches an infusion unit (figure 1, item 100) comprising at least one monitoring sensor that is configured to monitor at least one of a heart rate, an 02 content, blood pressure and electrocardiogram (paragraphs [0102], [0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught Puhakka, with the use of a monitoring sensor, as taught by Savage, in order to provide increased functionality and safety, by allowing for a means by which patient health might be immediately assessed relative to received treatment.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Puhakka (WO 95/00191), in view of Whitney et al. (USPN 4,345,595).
[Claims 5 and 7] Puhakka teaches the limitations of claims 1 and 6, upon which claims 5 and 7 depend. Puhakka does not specifically disclose each of said at least two reservoirs have an internal volume of 5 ml or less.
However, Whitney teaches an infusion unit (figure 1, item 10) comprising an internal reservoir (figure 2, item 21) having an internal volume of 5 ml or less (column 11, lines 12-26).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the structure taught by Puhakka, with the use of the claimed internal volume, as taught by Whitney, in order to provide increased functionality and versatility, by allowing for a convenient dose of medication to be delivered relative to an appropriate treatment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Puhakka (WO 95/00191), in view of Herskowitz (USPN 5,330,431).
[Claim 10] Puhakka teaches the limitations of claim 1, upon which claim 10 depends. Puhakka does not specifically disclose a sensor configured to detect a presence of the at least one internal reservoir.
However, Herskowitz teaches an infusion unit (figure 1, item 10) comprising a sensor (figure 2, items 162/164) for detecting a presence of a reservoir (figure 4, item 20) (column 6, lines 15-34).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the structure taught by Puhakka, with the use of a presence sensor, as taught by Herskowitz, in order to provide increased functionality and control, by allowing for a means by which a user could be certain a reservoir was present and properly installed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Puhakka (WO 95/00191), in view of Della Bidia (hereinafter ‘Della’) (WO 2018/096408 A1).
[Claim 11] Puhakka teaches the limitations of claim 1, upon which claim 11 depends. Puhakka does not specifically disclose a wireless connection to an external communication device.
However, Della teaches an infusion unit (figure 1, item 1) comprising:
a cylindrical housing (figure 2, item 21) that is configured to be secured around an arm of a person (figure 5);
said infusion unit (figure 1, item 1) further including at least one internal reservoir (figure 2, item 2a) for temporally holding a medication (page 5, line 24 – page 6, line 4);
a connection (figure 3, item 3) from said at least one internal reservoir (figure 2, item 2a) (page 7, lines 5-11);
a dispensing mechanism (figure 3, item 4/41) that forces said medication from within said at least one internal reservoir (figure 2, item 2a) (page 8, lines 14-18), and
a controller (“control unit”) that operates said dispensing mechanism (figure 3, item 4/41) (page 5, lines 4-5);
wherein the infusion unit further comprises a wireless connection to an external communication device (page 5, lines 18-23).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the infusion unit taught by Puhakka, to have included a wireless connection to an external communication device, as taught by Della, in order to provide increased functionality and control, by allowing for a well-known means by which device and patient data might be remotely monitored by a medical professional.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Puhakka (WO 95/00191), in view of White et al. (PGPub 2009/0203329).
[Claim 12] Puhakka teaches the limitations of claim 1, upon which claim 12 depends. Puhakka does not specifically disclose a scanner that is configured to read a label associated with contents of the at least one internal reservoir.
However, White teaches an infusion unit (figure 2, item 10) comprising a scanner (figure 2, item 62) that is configured to read contents of a reservoir (figure 2, item 12) (paragraph [0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the structure taught by Puhakka, with the use of a scanner, as taught by White, in order to provide increased functionality, safety, and control, by allowing for a means by which relevant reservoir content information might by verified by a user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 04/03/2026
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