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 arguments, see pages 8-12, filed 02/03/2026, with respect to the Species Election requirement have been fully considered and are persuasive. The Species Election requirement, dated 11/03/2025, has been withdrawn.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 06/02/2023, 08/11/2023, 04/19/2024, and 02/03/2026, have been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “14” has been used to designate both “skin” and “a set.” Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “16” has been used to designate both a “shallow access member” and a “subcutaneous access member.” Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “30” has been used to designate both a “shallow analyte sensor” and a “deeper analyte sensor.” Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “pumping arrangement” in claims 19, 35, and 36.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 19-38 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.
[Claims 19, 35, and 36] The claims recite the limitation of “a set in fluid communication with the delivery device.” There is a lack of antecedent basis for the limitation of “the delivery device” in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if “the delivery device” refers to the previously recited “infusion device,” or if a new structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that “the delivery device” refers to the previously recited “infusion device.”
[Claim 25] The claim recites the limitation of “the second portion.” There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, as it is unclear if the claim was intended to depend from independent claim 19 (lacking antecedent basis), or if the claim was intended to depend from dependent claim 24 (providing antecedent basis). For purposes of examination, it is interpreted that the claim depends directly from dependent claim 24.
[Claim 35] The term “shallow” in claim 35 is a relative term which renders the claim indefinite. The term “shallow” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the intended functionality of the “shallow access member” is rendered indefinite. For purposes of examination, it is interpreted that any “access member” meets the limitations of the claim.
[Claim 35] The claim recites the limitation of “at least one subcutaneous access member” in the 8th-10th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this refers to the previously recited “subcutaneous access member” (5th line of the claim), or if additional access members are intended to be recited. For purposes of examination, it is interpreted that the claim only recites one “subcutaneous access member.”
[Claims 36-38] The term “shallow” in claims 36-38 is a relative term which renders the claim indefinite. The term “shallow” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the intended functionality of the “shallow analyte sensor” is rendered indefinite. For purposes of examination, it is interpreted that any “analyte sensor” meets the limitations of the claims.
[Claims 36-38] The term “deep” in claims 36-38 is a relative term which renders the claim indefinite. The term “deep” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the intended functionality of the “deep analyte sensor” is rendered indefinite. For purposes of examination, it is interpreted that any “analyte sensor” meets the limitations of the claims.
[Claims 20-34, 37, and 38] The claims are rejected based upon their dependency from independent claims 19 and 36.
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)(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 19-21, 23-24, 26, 30, 35-36, and 38, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hezkiahu et al. (PGPub 2024/0024572).
[Claim 19] Hezkiahu teaches a medical agent administration system (figure 5, items 10/26/38/50/100; paragraph [0061]) comprising:
an infusion device (figure 5, items 50/100) including a delivery assembly including at least one sensor (figure 12, items 130/134/138/142/146), a reservoir (figure 2, item 52), and at least one pumping arrangement (figure 2, item 56; paragraph [0056]) (paragraphs [0061], [0069]);
a set (figure 4, items 10/22/42/26) in fluid communication with the delivery device (see 112b interpretation above) (figure 5, items 50/100), the set (figure 4, items 10/22/42/26) including at least one intradermal access member (figure 4, items 22/42; paragraph [0102]); and
a controller (figure 12, item 150) configured to govern operation of the at least one pumping arrangement (figure 2, item 56) (paragraphs [0056], [0072], [0132]), the controller (figure 12, item 150) in data communication (figure 12; paragraph [0073]) with the at least one sensor (figure 12, items 130/134/138/142/146) and configured to analyze data from the at least one sensor (figure 12, items 130/134/138/142/146) and determine a change in depth of the at least one access member (figure 4, items 22/42) has occurred based on the data from the at least one sensor (figure 12, items 130/134/138/142/146) (paragraph [0098]).
[Claim 20] Hezkiahu teaches the limitations of claim 19, upon which claim 20 depends. In addition, Hezkiahu teaches the at least one sensor (figure 12, items 130/134/138/142/146) is configured to generate a data signal (“characteristics detected and/or measured by the needle sensor 142 can be transmitted from the needle sensor 142 to the controller 150 via one or more electronic signals”) which varies in relation to a delivery impedance from the at least one access member (figure 4, items 22/42) (paragraph [0098]).
[Claim 21] Hezkiahu teaches the limitations of claim 19, upon which claim 21 depends. Hezkiahu further discloses the system (figure 5, items 10/26/38/50/100) further comprises at least one analyte monitor (figure 12, item 130) (“one or more parameters measured by the priming sensor 130 can be used to quantify how much medicament is present”) (paragraphs [0077]-[0086]).
[Claim 23] Hezkiahu teaches the limitations of claim 19, upon which claim 23 depends. Hezkiahu also teaches the controller (figure 12, item 150) is in communication with at least one smart device (figure 12, item 178) and the infusion device (figure 5, items 50/100) (figure 12; paragraphs [0069], [0071], [0073]).
[Claim 24] Hezkiahu teaches the limitations of claim 19, upon which claim 24 depends. Hezkiahu also discloses the delivery assembly is split between a first portion (figure 5, item 104) of the infusion device (figure 5, items 50/100) and a second portion (figure 5, item 106) of the infusion device (figure 5, items 50/100) removably coupled to the first portion (figure 5, item 104) (figures 5-7; paragraph [0094]).
[Claim 26] Hezkiahu teaches the limitations of claim 19, upon which claim 26 depends. In addition, Hezkiahu teaches the at least one sensor (figure 12, items 130/134/138/142/146) includes a pressure sensor (figure 12, item 130) configured to monitor volumes of fluid delivered from the infusion device (figure 5, items 50/100) to the set (figure 4, items 10/22/42/26) (paragraph [0081]).
[Claim 30] Hezkiahu teaches the limitations of claim 19, upon which claim 30 depends. Hezkiahu also teaches the at least one sensor (figure 12, items 130/134/138/142/146) includes an acoustic volume sensor (“air bubble sensor”) comprising a variable volume chamber (volume of flow within cannula) and the data from the at least one sensor (figure 12, items 130/134/138/142/146) is indicative of a volume of fluid in the variable volume chamber (volume of flow within cannula) (paragraph [0107]).
[Claim 35] Hezkiahu teaches a medical agent administration system (figure 5, items 10/26/38/50/100; paragraph [0061]) comprising:
an infusion device (figure 5, items 50/100) including a delivery assembly including at least one sensor (figure 12, items 130/134/138/142/146) and at least one pumping arrangement (figure 2, item 56; paragraph [0056]) (paragraphs [0061], [0069]);
a set (figure 4, items 10/22/42/26) in fluid communication with the delivery device (see 112b interpretation above) (figure 5, items 50/100), the set (figure 4, items 10/22/42/26) including at least one shallow (see 112b interpretation above) access member (figure 4, item 42) and at least one subcutaneous access member (figure 4, item 22); and
a controller (figure 12, item 150) configured to govern operation of the at least one pumping arrangement (figure 2, item 56) (paragraphs [0056], [0072], [0132]), the controller in data communication (figure 12; paragraph [0073]) with the at least one sensor (figure 12, items 130/134/138/142/146) and configured to compare data (from sensor 146) from the at least one sensor (figure 12, items 130/134/138/142/146) related to fluid deliveries to the shallow access member (figure 4, item 42) and at least one subcutaneous access member (see 112b interpretation above) (figure 4, item 22) and determine a change in depth of one or more of the shallow access member (figure 4, item 42) and at least one subcutaneous access member (see 112b interpretation above) (figure 4, item 22) has occurred based on the data (from sensor 146) from the at least one sensor (figure 12, items 130/134/138/142/146) (paragraph [0104]).
[Claims 36 and 38] Hezkiahu teaches a medical agent administration system (figure 5, items 10/26/38/50/100; paragraph [0061]) comprising:
an infusion device (figure 5, items 50/100) with a delivery assembly including at least one pumping arrangement (figure 2, item 56; paragraph [0056]) (paragraphs [0061], [0069]);
a set (figure 4, items 10/22/42/26/130) in fluid communication with the delivery device (see 112b interpretation above) (figure 5, items 50/100), the set (figure 4, items 10/22/42/26/130) including at least one access member (figure 4, items 22/42; paragraph [0102]), a shallow (see 112b interpretation above) analyte sensor (figure 12, item 130), and a deep (see 112b interpretation above) analyte sensor (figure 12, item 130) (paragraph [0082]); and
a controller (figure 12, item 150) configured to govern operation of the at least one pumping arrangement (figure 2, item 56) (paragraphs [0056], [0072], [0132]) to selectively deliver fluid from the infusion device (figure 5, items 50/100) to the at least one access member (figure 4, items 22/42), the controller (figure 12, item 150) in data communication (figure 12; paragraph [0073]) with the shallow (figure 12, item 130) and deep analyte sensors (figure 12, item 130); and
wherein the controller (figure 12, item 150) is configured to compare data from the shallow (figure 12, item 130) and deep analyte sensors (figure 12, item 130) and generate a notification when a relationship between data from the shallow (figure 12, item 130) and deep analyte sensors (figure 12, item 130) breaches a predefined criteria (paragraphs [0084], [0085]), wherein predefined criteria is determined from historical data collected from the shallow analyte sensor (figure 12, item 130) and deep analyte sensor (figure 12, item 130) (paragraphs [0084], [0085]).
Allowable Subject Matter
Claims 22, 27-29, 31-34, and 37, 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.
Claim 25 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
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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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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/JASON E FLICK/Primary Examiner, Art Unit 3783 05/28/2026
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