DETAILED ACTION
This is in response to the Patent Application filed 10/5/2023 wherein claims 1-12 are presented for examination.
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 .
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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “111” in Figures 2a and 2b, “112” in Figures 2a and 2b, “103” in Figures 2a and 2b, 104”, in Figures 2a and 2b “118” in Figures 2a and 2b, “119” in Figures 2a and 2b, “213” in Figures 3a and 3b, “214” in Figures 3a and 3b, “211” in Figures 3a and 3b, “212” in Figures 3a and 3b, “232b” in Figures 3a and 3b, “222b” in Figures 3a and 3b, “233b” in Figures 3a and 3b, “223b” in Figures 3a and 3b, “215” in Figures 3a and 3b, “224” in Figures 3a and 3b, “225” in Figures 3a and 3b, “216” in Figures 3a and 3b, “205” in Figures 3a and 3b, “203” in Figures 3a and 3b, “220” in Figures 3a and 3b, “206” in Figures 3a and 3b, “204” in Figures 3a and 3b, “218” in Figures 3a and 3b, “219” in Figures 3a and 3b, “221” in Figures 3a and 3b, “202” in Figures 3a and 3b, “248” in Figures 3a and 3b, “311” in Figure 4, “312” in Figure 4, “303” in Figure 4, and “304” in Figure 4.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 Objections
Claims 1 are objected to because of the following informalities:
“the body” (Claim 1, line 8) is believed to be in error for - - a body - -;
“a body” (Claim 1, line 12) is believed to be in error for - - the body - -;
“a warning signal” (Claim 9, line 8) is believed to be in error for - - the warning signal - -.
Appropriate correction is required.
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.
Claim 1 recites “infusion means for infusing a substance into a body” in lines 11-12, which is interpreted under 35 U.S.C. 112(f) as corresponding to a cannula, catheter, needle, or nozzle as described on Page 1 of Applicant’s specification.
Claim 1 recites “a transport means” in line 17, which is interpreted under 35 U.S.C. 112(f) as corresponding to a conduit, tube, hose, or the like as described on Page 1 of Applicant’s specification.
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: “transport element” in claim 1, line 6; “infusion element” in claim 1, line 11.
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 1-12 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 limitation “transport element” (Claim 1, line 6) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Applicant’s disclosure repeats the term “transport element” but does not describe any structure that performs the transport function of the element as claimed.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites the limitation "said substance" in lines 7-8. It is unclear as to which of the substances said substance is referring.
Claim 1 recites the limitation “a second connector in line 18". It is unclear if the “second connector” recited in line 18 is referring to the same “second connector” recited in line 15 or a different second connector.
Claims 2-12 are rejected for the same reasons discussed above based on their dependency to claim 1.
Claim 9 recites the limitation "a warning signal" in line 8. It is unclear if the “warning signal” recited in claim 9 is referring to the same “warning signal” recited in claim 1 or a different warning signal.
Claims 10-12 are rejected for the same reasons discussed above based on their dependency to claim 9.
Claim 12 recites the limitation "said electronical and/or electrical and/or optical circuit" in line 2. 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 1-5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Butterfield et al. (US 2004/0193453) in view of Damiano et al. (US 2018/0117296).
Regarding Independent Claim 1, Butterfield teaches (Figures 1-6) a system for regulating the concentration of glucose in the blood of a person (see Figure 4), said system comprising:
a device (20) for selectively supplying at least two substances (within 40 and 42), said device comprising:
at least two receiving spaces (spaces on 46 for mounting containers 40 and 42; see Figure 1) for accommodating at least two reservoirs (40 and 42) containing said substances (within 40 and 42);
at least two ports (at 106; see Figure 4) for connecting to a respective transport element (32, 34), and
a controller (60) for controlling said device (20) such that a certain amount of said substance (from 40, 42) is supplied and thereby infused (Paragraph 0028) into the body of the person (48) via a respective infusion set (via 24, 26),
at least two infusion sets (24, 26), each infusion set (24, 26) comprising:
an infusion element (24, 26) comprising an infusion means (70) for infusing a substance (from 40 or 42) into a body of said person (48), said infusion means (70) comprising an inlet end (at the upstream end of pump 70 near 80; see Figure 4) for receiving said substance (from 40, 42) and an outlet end (at the downstream end of pump 70 near 88; see Figure 4) for infusing said substance (from 40, 42) into said body (48),
said transport element comprising a transport means (32, 34; the conduit between reservoir 40, 42 and the pump 70; see Figure 4);
wherein said system (see Figure 4) comprises a mischanneling detection system (112) for detecting mischanneling of the infusion element (23, 26) and transport element (32, 34) and/or for detecting mischanneling of the transport element (23, 26) and port (106), and wherein said controller (60) is arranged for controlling said device (20) to not supply said substance (from 40, 42) and/or provide a warning signal to said person is mischanneling is detected (see Paragraph 0055).
Butterfield does not explicitly teach that said infusion element comprises a first connector for connecting to a second connector of a transport element of the infusion set, a second connector arranged at an outlet end of the transport means that is connectable to said first connector of said infusion element such that in a connected condition in which the second connector of the transport element is connected to the first connector of the infusion element a medium through flow connection is provided between the outlet end of the transport means and the inlet end of the infusion means for feeding the substance to the infusion means, or a third connector arranged at an inlet end of the transport means for connecting to said port such that in a connected condition in which the third connector is connected to said port through flow connection is provided between said reservoir accommodated in said receiving space and the inlet end of the transport means for receiving said substance from said reservoir.
Damiano teaches (Figures 1-69E) an infusion element (001) that comprises a first connector (110, 120) for connecting to a second connector (210, 220) of a transport element (310) of an infusion set (20), and a second connector (210, 220) arranged at an outlet end of the transport means (310, 320; see Figures 2 and 4A) that is connectable to said first connector (110, 120) of said infusion element (001) such that in a connected condition (see Figures 1-2) in which the second connector (210, 220) of the transport element (310, 320) is connected to the first connector (110, 120) of the infusion element (at 20) a medium through flow connection is provided (see Figures 1-4A) between the outlet end (see Figures 1-2) of the transport means (at 310, 320) and the inlet end (at 110, 120) of the infusion means (at 20) for feeding the substance (from respective reservoirs; see Paragraph 0140) to the infusion means (at 20), and a third connector (412) arranged at an inlet end (see Figures 2 and 4A) of the transport means (at 310, 320) for connecting to a port (510; see Figure 14) such that in a connected condition (see Figures 15-16) in which the third connector (412) is connected to said port (510) through flow connection (via 316) is provided between said reservoir (see Paragraph 0140) accommodated in said receiving space (the shape of the reservoir; see Paragraphs 0140-0142) and the inlet end (at 412) of the transport means (310) for receiving said substance from said reservoir (see Paragraphs 0140-0142).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Butterfield to have the infusion element comprise a first connector for connecting to a second connector of a transport element of the infusion set, a second connector arranged at an outlet end of the transport means that is connectable to said first connector of said infusion element such that in a connected condition in which the second connector of the transport element is connected to the first connector of the infusion element a medium through flow connection is provided between the outlet end of the transport means and the inlet end of the infusion means for feeding the substance to the infusion means, or a third connector arranged at an inlet end of the transport means for connecting to said port such that in a connected condition in which the third connector is connected to said port through flow connection is provided between said reservoir accommodated in said receiving space and the inlet end of the transport means for receiving said substance from said reservoir, as taught by Damiano, in order to provide connection between medicament reservoirs and an infusion set and to help prevent cross channeling of medicaments and to ensure safe use of a multi-medicament infusion system (Paragraphs 0139-0143 of Damiano).
Regarding Claim 2, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein said mischanneling detection system (112) is arranged for detecting mischanneling of the infusion element (24, 26) and transport element (32, 34) and/or for detecting mischannelling of the transport element (32, 34) and port (106) when the first connector of the infusion element is connected to the second connector of the transport element and/or when the third connector of the transport element is connected to the port, respectively (see Paragraph 0055).
It is noted that Damiano also teaches (Figures 1-69E) detecting mischanneling when the first connector of the infusion element is connected to the second connector of the transport element and/or when the third connector of the transport element is connected to the port, respectively (see Paragraph 0364).
Regarding Claim 3, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein said mischanneling detection system (112) is arranged for electronically and/or electrically detecting mischanneling (Paragraph 0055).
Regarding Claim 4, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein said transport element (32, 34) and/or said infusion element (24, 26) comprises an electronically and/or electrically detectable feature (at 80, 82).
Regarding Claim 5, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein said infusion element (24) comprises at least one first memory (110, 80, 82) and wherein said controller (112) is arranged to read information (see Paragraph 0044 and 0057) from the at least one first memory (110, 80, 82) and is arranged to detect said mischannelling based on the information read from (Paragraph 0044 and 0055-0057) the at least one first memory (110, 80 , 82).
Regarding Claim 9, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) a use of a system (see Figure 4) according to claim 1, said use comprising the steps, to be performed in any order of:
detecting mischannelling (see Paragraph 0055) of the transport element (32, 34) and port (106) and/or of the infusion element (23, 26) and transport element (32, 34) using said mischanneling detection system (112), and
not infusing said substance (from 40, 42) and/or providing a warning signal to said person (48) if mischanneling is detected (see Paragraph 0055).
Butterfield in view of Damiano does not teach, as discussed so far, connecting the third connector of each of the transport elements to said port of the device and/or connecting the second connector of each of the transport elements to said first connector of said infusion element,
Damiano teaches (Figures 1-69E) connecting the third connector (412) of each of the transport elements (310, 320) to said port (510) of the device (see Figures 1-2) and/or connecting the second connector (210, 220) of each of the transport elements (310, 320) to said first connector (110, 120) of said infusion element (001).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Butterfield in view of Damiano to have the third connector of each of the transport elements to said port of the device and/or connecting the second connector of each of the transport elements to said first connector of said infusion element, as taught by Damiano, for the same reasons discussed above in claim 1.
Regarding Claim 10, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein detecting mischannelling (see Paragraph 0055) of the transport element (32, 34) and port (106) and/or of the infusion element (23, 26) and transport element (32, 34) using said mischanneling detection system (112) is performed by electronically and/or electrically and/or optically detecting mischannelling (see Paragraph 0055).
Regarding Claim 11, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield further teaches (Figures 1-6) wherein detecting mischannelling (see Paragraph 0055) of the transport element (32, 34) and port (106) and/or of the infusion element (23, 26) and transport element (32, 34) using said mischanneling detection system (112) is performed by reading information from (Paragraph 0044 and 0055-0057) the at least one first and/or second memory (110, 80 , 82).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Butterfield et al. (US 2004/0193453) in view of Damiano et al. (US 2018/0117296) as applied to claim 5 above, and further in view of Vanderveen (US 2006/0206356).
Regarding Claim 6, Butterfield in view of Damiano teaches the invention as claimed and as discussed above. Butterfield in view of Damiano does not teach, as discussed so far, wherein the at least one first memory and/or second memory is a writable memory and wherein said controller is arranged for writing said at least one writable first and/or second memory.
Vanderveen teaches (Figures 1-6) a first memory (58, 72) that is a writable memory (Paragraph 0021 and 0026) and wherein a controller (50, 70) is arranged for writing said first memory (58, 72; see Figure 1, Paragraph 0021, and Paragraph 0026).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Butterfield in view of Damiano to have the at least one first memory be a writable memory and wherein said controller is arranged for writing said at least one writable first memory, as taught by Vanderveen, in order to automatically enter data received by a CPU into a database stored in the CPU’s memory or disk storage (Paragraph 0030 of Vanderveen).
Regarding Claim 7, Butterfield in view of Damiano and Vanderveen teaches the invention as claimed and as discussed above. Butterfield in view of Damiano and Vanderveen does not teach, as discussed so far, wherein said controller is arranged for writing said at least one writable first and/or second memory with information indicative of the type of substance to be or that was infused by that infusion element and/or transport element, respectively, such that after writing said at least one writable first and/or second memory with said information said mischannelling can be detected by said controller reading said information.
Vanderveen teaches (Figures 1-6) wherein the controller (58, 70) is arranged for writing said at least one writable first memory (58, 72) with information indicative of the type of substance to be or that was infused by the infusion element and/or transport element (via 60), respectively, such that after writing said at least one writable first memory (58, 72) with said information said mischanneling can be detected by said controller (58, 70) reading said information (via 60, see Paragraph 0006 and claim 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Butterfield in view of Damiano and Vanderveen to have the controller be arranged for writing said at least one writable first memory with information indicative of the type of substance to be or that was infused by that infusion element and/or transport element, respectively, such that after writing said at least one writable first memory with said information said mischannelling can be detected by said controller reading said information, as taught by Vanderveen, in order to prevent inadvertent switching of lines from a source that would result in improper delivery of the medication contained in the source (Paragraph 0041 of Vanderveen).
Allowable Subject Matter
Claims 8 and 12 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach in combination with the other limitations of the claims: “wherein said mischanneling detection system is arranged to detect mischannelling when said electronical and/or electrical and/or optical circuit is not a closed circuit when the first connector of the infusion element is connected to the second connector of the transport element and/or when the third connector of the transport element is connected to the port” (Claim 8, lines 3-7) and “detecting if said electronical and/or electrical and/or optical circuit is not a closed circuit when the first connector of the infusion element is connected to the second connector of the transport element and/or when the third connector of the transport element is connected to the port” (Claim 12, lines 2-5).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the attached PTO-892 Notice of References Cited.
Conclusion
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
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