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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/26/2026 has been entered.
Response to Amendment
The Amendment filed on 1/26/2026 has been entered. Claims 1-18 remain pending in the application. Claims 4-10 and 17-18 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 6/9/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 10/27/2025.
Election/Restrictions
Claim 1 is allowable. Claims 4-10 and 17-18, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between species I-II and subspecies 1-4, as set forth in the Office action mailed on 1/31/2025 is hereby withdrawn and claims 4-10 and 17-18 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claim 4 objected to because of the following informalities:
Line 2-3 recites “the infusion cannula wall”. Claim 4 depends on claim 3. Claim 3, 2, and 1 refer to the infusion cannula wall as the wall of the infusion cannula. Examiner suggests replacing “the infusion cannula wall” in line 2-3 of claim 4 with “the wall of the infusion cannula” to put the claim in clearer form.
Line 3 recites “the infusion cannula wall”. Claim 4 depends on claim 3. Claim 3, 2, and 1 refer to the infusion cannula wall as the wall of the infusion cannula. Examiner suggests replacing “the infusion cannula wall” in line 3 of claim 4 with “the wall of the infusion cannula” to put the claim in clearer form.
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 3-10 and 17-18 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.
In regard to claim 3,
Line 3 recites “the infusion cannula is installed to the working position”. Claim 3 depends on claim 2 and claim 1. Claim 1 states that “the mounting unit is movable relative to the housing from the pre-installation position to a working position”. The working position and the pre-installation position are positions of the mounting unit, not the infusion cannula in claim 1. For examination purposes Examiner construes the mounting unit to be installed to the working position. Examiner suggests amending claim 1 to replace “the mounting unit is movable relative to the housing from the pre-installation position to a working position” in line 15-16 of claim 1 with “the mounting unit is configured to move relative to the housing to move the infusion cannula from the pre-installation position to a working position”. Examiner notes line 17-18 of claim 1 should also be amended to replace “the mounting unit moves from the pre-installation position to the working position” with “the mounting unit moves the infusion cannula from the pre-installation position to the working position”.
Examiner notes claim 4 is similarly rejected by virtue of its dependency on claim 5.
In regard to claim 4,
Line 4-5 recites “the infusion cannula is installed to the working position”. Claim 4 depends on claim 3, claim 2, and claim 1. Claim 1 states that “the mounting unit is movable relative to the housing from the pre-installation position to a working position”. The working position and the pre-installation position are positions of the mounting unit, not the infusion cannula in claim 1. For examination purposes Examiner construes the mounting unit to be installed to the working position. Examiner suggests amending claim 1 to replace “the mounting unit is movable relative to the housing from the pre-installation position to a working position” in line 15-16 of claim 1 with “the mounting unit is configured to move relative to the housing to move the infusion cannula from the pre-installation position to a working position”. Examiner notes line 17-18 of claim 1 should also be amended to replace “the mounting unit moves from the pre-installation position to the working position” with “the mounting unit moves the infusion cannula from the pre-installation position to the working position”.
In regard to claim 5,
Line 3-4 recites “a needle cavity of the infusion steel needle is used for infusion of the drugs”. It is unclear if a method step is being claimed due to positively stating “is used”. Additionally, it is unclear if the drugs, which are not positively required in claim 1, are now positively required in claim 5. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “a needle cavity of the infusion steel needle is used for infusion of the drugs” to be “a needle cavity of the infusion steel needle is configured to be used for infusion of the drugs”. Examiner suggests replacing “a needle cavity of the infusion steel needle is used for infusion of the drugs” in line 3-4 of claim 5 with “a needle cavity of the infusion steel needle is configured to be used for infusion of the drugs”.
Examiner notes claims 6-9 are similarly rejected by virtue of their dependency on claim 5.
In regard to claim 6,
Line 2 recites “the infusion cannula is installed to the working position”. Claim 6 depends on claim 5, claim 2, and claim 1. Claim 1 states that “the mounting unit is movable relative to the housing from the pre-installation position to a working position”. The working position and the pre-installation position are positions of the mounting unit, not the infusion cannula in claim 1. For examination purposes Examiner construes the mounting unit to be installed to the working position. Examiner suggests amending claim 1 to replace “the mounting unit is movable relative to the housing from the pre-installation position to a working position” in line 15-16 of claim 1 with “the mounting unit is configured to move relative to the housing to move the infusion cannula from the pre-installation position to a working position”. Examiner notes line 17-18 of claim 1 should also be amended to replace “the mounting unit moves from the pre-installation position to the working position” with “the mounting unit moves the infusion cannula from the pre-installation position to the working position”.
Line 3 recites “the skin”. Line 2-3 of claim 6 recites “a skin” and claim 1, which claim 6 depends on, also introduces skin in line 18 of claim 1. It is unclear which skin “the skin” of line 3 of claim 6 refers to. For examination purposes Examiner construes the skin of claim 6 and 1 to be the same. Examiner suggests replacing “a skin” in line 2-3 of claim 6 with “the skin”.
Examiner notes claims 7-9 are similarly rejected by virtue of their dependency on claim 6.
In regard to claim 7,
Line 3 recites “an outer/inner surface of the hose wall”. It is unclear what is meant by “an outer/inner surface”. It is unclear if “an outer/inner surface” refers to “an outer surface or an inner surface of the hose wall”. It is unclear how a surface can be both an outer/inner surface. Additionally, there is insufficient antecedent basis for “the hose wall”. A wall of the hose has not been previously introduced. For examination purposes Examiner construes “an outer/inner surface of the hose wall” to be “an outer surface or an inner surface of a wall of the hose”. Examiner suggests replacing “an outer/inner surface of the hose wall” in line 3 of claim 7 with “an outer surface or an inner surface of a wall of the hose”. Examiner notes if claim 7 is amended as suggested above, “the hose wall” in claim 9 should also be replaced with “the wall of the hose” to put claim 9 in clearer form.
Examiner notes claims 8-9 are similarly rejected by virtue of their dependency on claim 7.
In regard to claim 8,
Line 2 recites “the infusion cannula is installed to the working position”. Claim 8 depends on claim 7, claim 6, claim 5, claim 2, and claim 1. Claim 1 states that “the mounting unit is movable relative to the housing from the pre-installation position to a working position”. The working position and the pre-installation position are positions of the mounting unit, not the infusion cannula in claim 1. For examination purposes Examiner construes the mounting unit to be installed to the working position. Examiner suggests amending claim 1 to replace “the mounting unit is movable relative to the housing from the pre-installation position to a working position” in line 15-16 of claim 1 with “the mounting unit is configured to move relative to the housing to move the infusion cannula from the pre-installation position to a working position”. Examiner notes line 17-18 of claim 1 should also be amended to replace “the mounting unit moves from the pre-installation position to the working position” with “the mounting unit moves the infusion cannula from the pre-installation position to the working position”.
Line 1-2 recites “the cannula-wall electrode located on the outer wall surface of the infusion steel needle”. Claim 8 depends on claim 7. Claim 7 requires the cannula-wall electrode to be located on an outer/inner surface of the hose wall, or to be located on the outer wall surface of the infusion steel needle. It is unclear if claim 8 is positively requiring the cannula-wall electrode to be located on the outer wall surface of the infusion steel needle as the cannula-wall electrode located on the outer wall surface of the infusion steel needle is further defined. For examination purposes Examiner construes claim 8 to positively require the cannula-wall electrode located on the outer wall surface of the infusion steel needle. Examiner suggests replacing “wherein: when the infusion cannula is installed to the working position, the cannula-wall electrode located on the outer wall surface of the infusion steel needle is exposed in a subcutaneous tissue fluid or covered in whole or in part by the hose” in line 1-4 of claim 8 with “wherein: the cannula-wall electrode is located on the outer wall surface of the infusion steel needle; when the infusion cannula is installed to the working position, the cannula-wall electrode located on the outer wall surface of the infusion steel needle is exposed in a subcutaneous tissue fluid or covered in whole or in part by the hose”.
Examiner notes claim 9 is similarly rejected by virtue of its dependency on claim 8.
In regard to claim 10,
Line 2 recites “a plurality of electrically conductive areas”. Claim 10 depends on claim 2 and claim 1. Claim 1 requires the infusion cannula to comprise a conductive area. It is unclear if a plurality of electrically conductive areas of claim 10 includes the conductive area of claim 1 or is in addition to the conductive area of claim 1. For examination purposes Examiner construes the plurality of electrically conductive areas to be in addition to the conductive area of claim 1. Examiner suggests replacing “the infusion cannula comprises a plurality of electrically conductive areas” in line 2 of claim 10 with “the infusion cannula comprises a plurality of electrically conductive areas and the conductive area”.
Line 3-4 recites “a plurality of electrically conductive-area electrodes”. Claim 10 depends on claim 2 and claim 1. Claim 1 requires the infusion cannula to comprise a conductive-area electrode and also requires the integrated drug infusion device to comprise a plurality of electrodes. It is unclear if a plurality of electrically conductive-area electrodes includes the conductive-area electrode or plurality of electrodes of claim 1 or is in addition to the conductive-area electrode and plurality of electrodes of claim 1. For examination purposes Examiner construes the plurality of electrically conductive-area electrodes to be in addition to the conductive-area electrode of claim 1. Examiner suggests replacing “the infusion cannula comprising a plurality of electrically conductive-area electrodes” in line 3-4 of claim 10 with “the infusion cannula comprising a plurality of electrically conductive-area electrodes, the conductive-area electrode, and the plurality of electrodes”.
Line 4 recites “the different electrically conductive-area electrodes”. It is unclear which conductive-area electrodes line 4 is referring to. For examination purposes Examiner construes “the different electrically conductive-area electrodes” to be “the plurality of electrically conductive-area electrodes”. Examiner suggests replacing “the different electrically conductive-area electrodes” in line 4 of claim 10 with “the plurality of electrically conductive-area electrodes”.
Line 4-5 recites “the different electrically conductive areas”. It is unclear which conductive-areas line 4-5 is referring to. For examination purposes Examiner construes “the different electrically conductive-areas” to be “the plurality of electrically conductive-areas”. Examiner suggests replacing “the different electrically conductive-areas” in line 4-5 of claim 10 with “the plurality of electrically conductive-areas”.
In regard to claim 17,
Line 3 recites “the output ends”. There is insufficient antecedent basis for the limitation in this claim. Claim 17 depends on claim 1. Claim 1 introduces a single output end of the program unit. It is unclear which output ends “the output ends” of claim 17 refers to. For examination purposes Examiner construes “the output ends” to be “the output end”. Examiner suggests clarifying what is meant by “the output ends” in line 3 of claim 17.
Line 3-4 recites “the program unit controlling whether each infusion subunit delivers the drugs”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Examiner suggests replacing “the program unit controlling” in line 3 with “the program unit configured to control”.
Line 4 recites “each infusion subunit”. Line 2 introduces a plurality of infusion subunits. It is unclear if each infusion subunit refers to the plurality of infusion subunits or to specific infusion subunits of the plurality of infusion subunits. For examination purposes Examiner construes “each infusion subunit” to be “each infusion subunit of the plurality of infusion subunits”. Examiner suggests replacing “each infusion subunit” in line 4 of claim 17 with “each infusion subunit of the plurality of infusion subunits”.
In regard to claim 18,
Line 3 recites “different parts”. Line 2 recites “a plurality of parts”. It is unclear if the different parts of line 3 are of the plurality of parts or are in addition to the plurality of parts. For examination purposes Examiner construes the different parts to be of the plurality of parts. Examiner suggests replacing “different parts” in line 3 of claim 18 with “different parts of the plurality of parts”.
Allowable Subject Matter
Claims 1-2 and 11-16 are allowed.
The following is an examiner’s statement of reasons for allowance:
In regard to claim 1,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations an integrated drug infusion device as claimed in claim 1 comprising the mounting unit is movable relative to the housing from the pre-installation position to a working position in combination with wherein the mounting unit is configured such that when the mounting unit moves from the pre-installation position to the working position, the infusion cannula is inserted into skin, the infusion cannula connects with the infusion unit such that the drugs are capable of being injected into a body through the infusion cannula, and the plurality of electrodes electrically connects the plurality of electrically connective regions respectively to input the signal of the analyte data in the body fluid to the program unit.
Yodfat (U.S. PG publication 20120277667) discloses an integrated drug infusion device (paragraph [0002], see figure 1A-5, 10-17B) comprising a mounting unit (item 20) and a housing (housing of item 10; see figure 7). The mounting unit 20 of Yodfat is not configured such that when the mounting unit moves from the pre-installation position to the working position, the infusion cannula is inserted into skin, the infusion cannula connects with the infusion unit such that the drugs are capable of being injected into a body through the infusion cannula, and the plurality of electrodes electrically connects the plurality of electrically connective regions respectively to input the signal of the analyte data in the body fluid to the program unit. In an alternative interpretation of Yodfat, item 20 is construed as the housing and item 304 is construed as the mounting unit which is configured to hold the infusion cannula 300 as shown in figure 13A and 17A. The mounting unit 304 is movable relative to the housing from the pre-installation position to a working position (as shown in figure 13B compared to figure 13A and as shown in figure 17B as compared to figure 17A) wherein the mounting unit is configured such that when the mounting unit moves from the pre-installation position to the working position, the infusion cannula is inserted into skin (see figure 17B and 13B). The infusion cannula however does not connect with the infusion unit such that the drugs are capable of being injected into a body through the infusion cannula, and the plurality of electrodes do not electrically connect the plurality of electrically connective regions respectively to input the signal of the analyte data in the body fluid to the program unit when the mounting unit 304 is moved from the pre-installation position to the working position. Item 10 must be separately attached in order for the infusion cannula to connect with the infusion unit (item 230 and 240) such that the drugs are capable of being injected into a body through the infusion cannula, and in order for the plurality of electrodes to electrically connect the plurality of electrically connective regions respectively to input the signal of the analyte data in the body fluid to the program unit (item 130). The subject matter of the mounting unit is movable relative to the housing from the pre-installation position to a working position in combination with wherein the mounting unit is configured such that when the mounting unit moves from the pre-installation position to the working position, the infusion cannula is inserted into skin, the infusion cannula connects with the infusion unit such that the drugs are capable of being injected into a body through the infusion cannula, and the plurality of electrodes electrically connects the plurality of electrically connective regions respectively to input the signal of the analyte data in the body fluid to the program unit could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 1 is allowed.
Dependent claims 2 and 11-16 are allowed by virtue of being dependent upon allowed independent claim 1.
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.”
Claims 3-10 and 17-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783