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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/27/24 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 9-12 read “wherein the controller is further configured to determine an occlusion hindering the dispensing of liquid medicament out of the reservoir and is further configured to provide a control signal to the actuation member upon determining the occlusion, to move the dispensing member in a reverse direction about a model-based displacement distance.” And Should likely read “wherein the controller is further configured to determine an occlusion hindering the dispensing of liquid medicament out of the reservoir and, upon determining the occlusion, is further configured to provide a control signal to the actuation member[[ upon determining the occlusion,]] to move the dispensing member in a reverse direction about a model-based displacement distance” for grammatical reasons
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.
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:
Claim 1 lines 5-6: “an actuation member configured for moving the dispensing member”. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “an actuation member” is considered a generic placeholder for “means” because “an actuation member” has no specific structural meaning
Prong 2: functional language—configured for moving
Prong 3: not modified by other structural language in the claims—no structure is recited for how the actuation member functions in order to achieve moving the dispensing member. Only the desired outcome of moving is recited.
According to Applicant’s disclosure under 112(f), the “an actuation member configured for moving the dispensing member” is interpreted as a stepper motor (see [0017] of the current Application), motor (see [0018] of the current Application), or equivalent.
Claim 7 lines 3-4: “an actuation member configured for controlling the movement of the dispensing member”. Therefore, claim 7 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “an actuation member” is considered a generic placeholder for “means” because “an actuation member” has no specific structural meaning
Prong 2: functional language—configured for controlling the movement
Prong 3: not modified by other structural language in the claims—no structure is recited for how the actuation member functions in order to achieve controlling the movement of the dispensing member. Only the desired outcome of moving is recited.
According to Applicant’s disclosure under 112(f), the “an actuation member configured for controlling the movement of the dispensing member” is interpreted as a stepper motor (see [0017] of the current Application), motor (see [0018] of the current Application), or equivalent.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
A dispensing member…configured for dispensing in claim 1 lines 3-4 because sufficient structure of the dispensing member “movably arranged within the reservoir” has been recited, failing 112f interpretation at prong 3
The actuation member comprises a stepper motor in claim 3 lines 1-2 because sufficient structure of a stepper motor has been recited, failing 112f interpretation at prong 3
A dispensing member… for dispensing liquid in claim 7 lines 2-3 because sufficient structure of the dispensing member “moveably arranged within the reservoir” has been recited, failing 112f interpretation at prong 3
The actuation member is a stepper motor in claim 9 line 2 because sufficient structure of a stepper motor has been recited, failing 112f interpretation at prong 3
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
(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 1, 2, and 4-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tribe et al. (U.S. PGPUB No. 2003/0205587), hereinafter Tribe.
Regarding claim 1, Tribe discloses an infusion delivery device, comprising:
a reservoir (3, see ‘Figure’ provided below for immediate reference) configured for containing a liquid medicament (see [0002]);
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a dispensing member (35, see [0012]: 35 is a plunger) moveably arranged within the reservoir (3) and configured for dispensing liquid medicament out of (see [0002], [0005], & [0012]) the reservoir (3) through an outlet (5, see [0012]) of the reservoir (3);
an actuation member (9, see [0012]: electric motor, aligning with interpretation of actuation member being a stepper motor or motor under 112f above) configured for moving the dispensing member within the reservoir (see [0012]); and
a controller (11) configured for controlling movement of the dispensing member within the reservoir by the actuation member (see [0012-0014]);
wherein the controller (11) is further configured to determine an occlusion hindering the dispensing of liquid medicament out of the reservoir and is further configured to provide a control signal to the actuation member upon determining the occlusion, to move the dispensing member in a reverse direction (see [0005], [0007], [0013-0014]: control uses sensor 20 to detect occlusion, stop motor, then drive motor in reverse direction) about a model-based displacement distance (see [0008-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, which is a model-based displacement distance).
Regarding claim 2, Tribe discloses the infusion delivery device according to claim 1, and Tribe further discloses wherein the model-based displacement distance takes into account a parameter indicative of the current position of the dispensing member within the reservoir (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, which is a model-based displacement distance, which takes into account the current position of the plunger position within reservoir barrel) and/or a parameter indicative of the temperature of the reservoir and/or a parameter indicative of the temperature of the liquid medicament within the reservoir.
Regarding claim 4, Tribe discloses the infusion delivery device according to claim 1, and Tribe further discloses wherein the model-based displacement distance takes into account a parameter indicative of the pressure exerted by the liquid medicament within the reservoir on the dispensing member (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, Fmax is a parameter indicative of the pressure Fmax by the liquid medicament).
Regarding claim 5, Tribe discloses the infusion delivery device according to claim 1, and Tribe further discloses wherein the model-based displacement distance takes into account a parameter indicative of the compressibility of the liquid medicament within the reservoir (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, Fmax is a parameter indicative of the pressure Fmax by the liquid medicament and such a measured pressure is inherently related to the compressibility of the liquid).
Regarding claim 6, Tribe discloses the infusion delivery device according to claim 1, and Tribe further discloses wherein the model-based displacement distance is provided by a look-up table (see [0014]: “The control unit 11 compares the output from the sensor 20 with the contents of the memory 110 and, if the force exceeds Fmax…”).
Regarding claim 7, Tribe discloses a method for controlling an infusion delivery device having (3, see ‘Figure’ provided below for immediate reference) configured for containing a liquid medicament (see [0002]),
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a dispensing member (35, see [0012]: 35 is a plunger) moveably arranged within the reservoir (3) for dispensing liquid medicament out of (see [0002], [0005], & [0012]) the reservoir (3) through an outlet (5, see [0012]), and an actuation member (9, see [0012]: electric motor, aligning with interpretation of actuation member being a stepper motor or motor under 112f above) configured for controlling the movement of the dispensing member (see [0012]), wherein the method comprises:
determining by a controller (11) an occlusion of the outlet hindering the dispensing of the liquid medicament out of the reservoir (see [0005], [0007], [0013-0014]: control uses sensor 20 to detect occlusion, stop motor, then drive motor in reverse direction); and
providing a control signal by the controller (11) to the actuation member (9) upon determining the occlusion, to move the dispensing member (35) in a reverse direction (see [0005], [0007], [0013-0014]: control uses sensor 20 to detect occlusion, stop motor, then drive motor in reverse direction) by a model-based displacement distance (see [0008-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, which is a model-based displacement distance).
Regarding claim 8, Tribe discloses the method for controlling an infusion delivery device according to claim 7, and Tribe further discloses wherein the step of determining the model-based displacement distance is based on one or more of:
a parameter indicative of the current position of the dispensing member within the reservoir (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, which is a model-based displacement distance, which takes into account the current position of the plunger position within reservoir barrel);
a parameter indicative of the temperature of the reservoir;
a parameter indicative of the temperature of the medicament within the reservoir;
a parameter indicative of the pressure exerted on the dispensing member by the liquid medicament within the reservoir (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, Fmax is a parameter indicative of the pressure Fmax by the liquid medicament);
a parameter indicative of the compressibility of the liquid medicament within the reservoir (see [0005-0009] and [0014]: motor driven a displacement distance equivalent to an assigned 10%*Fmax, Fmax is a parameter indicative of the pressure Fmax by the liquid medicament and such a measured pressure is inherently related to the compressibility of the liquid); and
a parameter indicative of the compressibility of the reservoir.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tribe as applied to claim 1 above, and further in view of Yodfat et al. (U.S. PGPUB No. 2012/0192951), hereinafter Yodfat.
Regarding claim 3, Tribe discloses the infusion delivery device according to claim 1, but Tribe is silent to “wherein the actuation member comprises a stepper motor, wherein the model-based displacement distance takes into account an average number of missed steps per train for the stepper motor and/or the motor current.”
However, Yodfat teaches an infusion delivery device comprising a reservoir (220, see FIG. 3A and [0101]), a dispensing member (see [0101]: plunger not shown), an actuation member (motor 131, see [0101-0102]), and a controller (132, see FIG. 4 and [0103]) configured to determine an occlusion (see [0109]) and further configured to provide a control signal to the actuation member to move the dispensing member in a reverse direction (see FIG. 5, [0109], and [0115]: controller detects error and then rotates motor in reverse) about a model-based displacement distance (see [0129-0130]: missed steps and [0115] & [0135]: duration of reverse rotation can be adaptive), wherein the actuation member (131) comprises a stepper motor (see [0015] & [0105]: “motor” includes stepper motors), wherein the model-based displacement distance takes into account an average number of missed steps per train for the stepper motor (see [0015], [0130], and [0130]) and/or the motor current (see [0010], [0015], [0022], [0117]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electric motor actuation member disclosed in Tribe with the stepper motor actuation motor taught in Yodfat. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (an electric motor disclosed in Tribe) for another known element (a stepper motor taught in Yodfat) in the art to obtain the predictable result of forming the actuation member for a driving mechanism of a fluid delivery device (see MPEP § 2143.I.B), thus achieving “wherein the actuation member comprises a stepper motor.” Further, Yodfat teaches electric motors (i.e. a DC motor) and stepper motors as obvious variants (see Yodfat [0015]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the model-based displacement distance disclosed in Tribe to take into account an average number of missed steps per train for the stepper motor as taught by Yodfat for the purpose of monitoring the stepper motor missed steps to indicate current device conditions (see [0130]) and/or to provide an adaptive reverse duration for the controller dependent on the device condition (see [0115] & [0135]), thus achieving wherein the model-based displacement distance takes into account an average number of missed steps per train for the stepper motor and/or the motor current.”
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tribe as applied to claim 7 above, and further in view of Yodfat (U.S. PGPUB No. 2012/0192951).
Regarding claim 9, Tribe discloses the method for controlling an infusion delivery device according to claim 7, but Tribe is silent to “wherein the actuation member is a stepper motor, wherein the step of determining the model-based displacement distance is based on one or more of: an average number of missed steps per train for the stepper motor; and/or the motor current.”
However, Yodfat teaches a method for controlling an infusion delivery device having an actuation member (motor 131, see FIG. 3A and [0101-0102]) and a dispensing member (see [0101]: plunger not shown), wherein the method comprises determining by a controller (132, see FIG.4 and [0103]) an occlusion (see [0109]) and providing a control signal by the controller to move the dispensing member in a reverse direction (see FIG. 5, [0109], and [0115]: controller detects error and then rotates motor in reverse) by a model-based displacement distance (see [0129-0130]: missed steps and [0115] & [0135]: duration of reverse rotation can be adaptive), wherein the actuation member (131) is a stepper motor (see [0015] & [0105]: “motor” includes stepper motors), wherein the step of determining the model-based displacement distance is based on one or more of: an average number of missed steps per train for the stepper motor (see [0015], [0130], and [0130]); and/or the motor current (see [0010], [0015], [0022], [0117]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electric motor actuation member disclosed in the method of Tribe with the stepper motor actuation motor taught in Yodfat. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (an electric motor disclosed in Tribe) for another known element (a stepper motor taught in Yodfat) in the art to obtain the predictable result of forming the actuation member for a driving mechanism of a fluid delivery device (see MPEP § 2143.I.B), thus achieving “wherein the actuation member is a stepper motor.” Further, Yodfat teaches electric motors (i.e. a DC motor) and stepper motors as obvious variants (see Yodfat [0015]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the step of determining the model-based displacement distance disclosed in Tribe to be based on an average number of missed steps per train for the stepper motor as taught by Yodfat for the purpose of monitoring the stepper motor missed steps to indicate current device conditions (see [0130]) and/or to provide an adaptive reverse duration for the controller dependent on the device condition (see [0115] & [0135]), thus achieving “wherein the step of determining the model-based displacement distance is based on one or more of: an average number of missed steps per train for the stepper motor; and/or the motor current.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Blomquist et al. (U.S. PGPUB No. 2010/0262078) teaches temperature based adjustments for occlusion detection systems (see at least [0081]), relevant to at least claims 2 & 8
Favreau (U.S. PGPUB No. 2014/0055073) teaches a stepper motor (232, see FIG. 2 and [0022]) driving a dispensing member (222) within a reservoir (206), a controller (700, see FIG. 7) controlling movement within the reservoir by the stepper motor (see [0038-0044]) and configured for determining an occlusion in the reservoir and responding to the occlusion by controlling the stepper motor to move a model-based displacement distance (see [0045-0061]), relevant to at least claims 3 & 9
Poetschke (U.S. PGPUB No. 2020/0164142) teaches wherein the actuation member comprises a stepper motor, wherein the model-based displacement distance takes into account an average number of missed steps per train for the stepper motor (see S02 in FIGURE 2 and [0013-0017] and [0041-0058]), relevant to at least claims 3 & 9
John (U.S. PGPUB No. 2015/0018758) teaches an infusion device with a control unit accessing look-up tables via database loaded into the software (see [0081-0087]), relevant to at least claim 6
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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