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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rolling-sock structure that unfurls along one or more bends in claim 1 must be shown or the features canceled from the claims. In particular, Figs. 4A-4E do not show any bends or any structure that unfurls along bends. No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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 and 65-88 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.
Regarding claim 1, it is still unclear what is meant by the term “rolling-sock structure” and it is further unclear how this structure may “unfurl” along “bends.” Even assuming some type of sock-shaped structure, it is unclear why or how it would include bends or bent portions, since a sock would not ordinarily have any bend structures. Examiner reiterates that the flexible film corresponding to the alleged rolling-sock structure in Figs. 4A-4E neither appears to resemble a “sock,” nor does it appear to be able to “roll,” nor does it appear capable of being unfurled, nor does it show one or more “bends.” For examination purposes, the language rolling-sock structure will be interpreted as a flexible reservoir having that can expand via bends.
Claims 65-88 are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 65-67, 69-73, and 75-84 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,443,450 to Kratoska et al. (“Kratoska”) in view of U.S. Patent No. 11,478,623 to Lanigan.
Regarding claim 1, Kratoska teaches a system for delivering an agent to a patient comprising a delivery device (Fig. 1) capable of delivering a first agent to the patient, the delivery device comprising a reservoir (Fig. 2) for storing the first agent, the reservoir comprising a rigid base (18) and a flexible film cover (14) comprising a rolling-sock structure that unfurls along one or more bends (expandable reservoir 14 as best understood in light of 112 rejections above having pleats or bends), wherein the center portion of the reservoir expands upwards as the reservoir is filled with the first agent (reservoir 14 expands upwards), and a penetrable fill port (29), a transcutaneous delivery assembly for delivering the first agent to the patient transcutaneously (column 6, line 63 to column 7, line 12, catheter), a pumping mechanism (column 6, lines 7-17) for receiving the first agent from the reservoir and propelling the first agent to the transcutaneous delivery assembly, a control module (column 2, lines 59-60, programmable pumping means) for controlling at least the pumping mechanism, a power supply (the programmable pumping means inherently has a power supply) for providing energy to at least the control module and the pumping mechanism, and a housing (16) surrounding at least the pumping mechanism, but does not teach the bubble capture element and the claimed dimensions.
Lanigan teaches a bubble capture element (2998) disposed in an interior of the reservoir and configured to trap bubbles (column 49, lines 45-67). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to yield the predictable result of trapping bubbles in order to prevent bubbles from being sent to the patient.
Regarding the major axis, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the major axis of a component (reservoir) of the delivery device of Kratoska to be less than 55 mm, since such a modification would involve a mere change in a size of a component, a change in size is generally recognized as being with the level of ordinary skill in the art. The claimed device would not perform differently than the prior art device, since the claimed device was not patentably distinct from the prior art device as the only difference is the recitation of relative dimensions of the major axis (MPEP 2144.04(IV)(A)).
Furthermore, the claimed dimensions are recognized as a result effective variable, i.e., a variable which achieves a recognized result. It is noted that the reservoir of Kratoska has flexible walls that can collapse and expand depending on the amount of material in the volume of the reservoir, therefore the reservoir of Kratoska already has a variable major axis. In any case the major axis can vary depending on various factors to solve a problem. The major axis can be longer in order to fit higher medicament volumes to suit particular treatment types over an extended period of time, while the major axis can be shorter to fit lower medicament volumes to suit particular treatment types that may be more short-term or immediate, and would also reduce the necessary storage space to save on weight and/or increase portability. Therefore, since the general conditions of the claim (e.g., having the claimed structure as recited above) is disclosed by Kratoska and Lanigan, it is not inventive to discover the optimum working range by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the major axis to be less than 55 mm. Further, in the instant application, Applicant has not disclosed any criticality for the claimed dimensions ([037], [067], [165], & [257]).
Regarding the height, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the height of a component (reservoir) of the delivery device of Kratoska to be less than 10 mm. Since such a modification would involve a mere change in a size of a component, a change in size is generally recognized as being with the level of ordinary skill in the art. The claimed device would not perform differently than the prior art device, since the claimed device was not patentably distinct from the prior art device as the only difference is the recitation of relative dimensions of the height (MPEP 2144.04(IV)(A)).
Furthermore, the claimed dimensions are recognized as a result effective variable, i.e., a variable which achieves a recognized result. It is noted that the reservoir of Kratoska has flexible walls that can collapse and expand depending on the amount of material in the volume of the reservoir, therefore the reservoir of Kratoska already has a variable height. In any case the height can vary depending on various factors to solve a problem. The height can be larger in order to fit higher medicament volumes to suit particular treatment types over an extended period of time, while the height can be shorter to fit lower medicament volumes to suit particular treatment types that may be more short-term, immediate, or simply requiring smaller volumes and would also reduce the necessary storage space to save on weight and/or increase portability. Therefore, since the general conditions of the claim (e.g., having the claimed structure as recited above) is disclosed by Kratoska and Lanigan, it is not inventive to discover the optimum working range by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the height to be less than 10 mm. Further, in the instant application, Applicant has not disclosed any criticality for the claimed dimensions ([038], [068], [165], & [258]).
Regarding claim 65, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the penetrable fill port comprising an access septum (28).
Regarding claim 66, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the reservoir further comprises a drain port (23).
Regarding claim 67, Kratoska and Lanigan teach the 9system according to claim 1 as shown above, Kratoska further teaching the reservoir comprising the first agent (12).
Regarding claims 69 and 70, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the pumping mechanism comprises a MEMS component including a fluid control valve (flow regulator 30).
Regarding claim 71, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching that the reservoir is capable of storing at least a three-day supply of the first agent (what amounts to a three-day supply can vary greatly depending on the type of agent and the treatment regimen, in the instant case, without any specific agent or amount claimed, the reservoir of Kratoska is capable of storing a three-day supply of some agent, especially if only a very small amount would be required each day.
Regarding claim 72, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching a fill device (55) configured to fill the reservoir with the first agent.
Regarding claim 73, Kratoska and Lanigan teach the system according to claim 72 as shown above, Kratoska further teaching the fill device being configured to apply a vacuum to the reservoir to assist in the filing (column 6, lines 35-62).
Regarding claim 75, Kratoska and Lanigan teach the system according to claim 74 as shown above, wherein the transcutaneous delivery assembly of Kratoska is capable of being connected to the delivery device at the same time as being inserted into the patient (the catheter needs to be attached to the delivery device at the same time as the patient in order to convey the agent to the patient).
Regarding claim 76, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the control module (168) comprising an algorithm configured to control the delivery of at least the first agent (the programmable pumping means inherently has algorithms).
Regarding claim 77, Kratoska and Lanigan teach the system according to claim 76 as shown above, Kratoska further teaches the algorithm being capable of altering the flow rate of the delivery of the first agent based on fluid flow information (the programmable pumping means is inherently capable of altering flow rates).
Regarding claim 78, Kratoska and Lanigan teach the system according to claim 1 as shown above, but are silent as to mass of the delivery device, and do not specifically disclose the claimed range. It is noted that the delivery device has been defined as the reservoir and fill port.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the delivery device taught by Kratoska to have a mass less than 20, 15, 12, 10, 9, or 8 grams, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the delivery device of Kratoska would not operate differently with the claimed masses, as these masses would be suitable for providing ease of transport and simpler manufacturing by using less materials.
Regarding claim 79, Kratoska and Lanigan teach the system according to claim 1 as shown above, but do are silent regarding the length of the major axis of the delivery device.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the major axis of a component (reservoir) of the delivery device of Kratoska to be less than 45, 40, 38, 36, or 33 mm. Since such a modification would involve a mere change in a size of a component, a change in size is generally recognized as being with the level of ordinary skill in the art. The claimed device would not perform differently than the prior art device, since the claimed device was not patentably distinct from the prior art device as the only difference is the recitation of relative dimensions of the major axis (MPEP 2144.04(IV)(A)).
Furthermore, the claimed dimensions are recognized as a result effective variable, i.e., a variable which achieves a recognized result. It is noted that the reservoir of Kratoska has flexible walls that can collapse and expand depending on the amount of material in the volume of the reservoir, therefore the reservoir of Kratoska already has a variable major axis. In any case the major axis can vary depending on various factors to solve a problem. The major axis can be longer in order to fit higher medicament volumes to suit particular treatment types over an extended period of time, while the major axis can be shorter to fit lower medicament volumes to suit particular treatment types that may be more short-term or immediate, and would also reduce the necessary storage space to save on weight and/or increase portability. Therefore, since the general conditions of the claim (e.g., having the claimed structure as recited above) is disclosed by Kratoska and Lanigan, it is not inventive to discover the optimum working range by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the major axis to be less than 45, 40, 38, 36, or 33 mm. Further, in the instant application, Applicant has not disclosed any criticality for the claimed dimensions ([037], [067], [165], & [257]).
Regarding claim 80, Kratoska and Lanigan teach the system according to claim 1 as shown above, but do are silent regarding the height of the delivery device.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the height of a component (reservoir) of the delivery device of Kratoska to be less than 8, 7.5, or 6.5 mm. Since such a modification would involve a mere change in a size of a component, a change in size is generally recognized as being with the level of ordinary skill in the art. The claimed device would not perform differently than the prior art device, since the claimed device was not patentably distinct from the prior art device as the only difference is the recitation of relative dimensions of the height (MPEP 2144.04(IV)(A)).
Furthermore, the claimed dimensions are recognized as a result effective variable, i.e., a variable which achieves a recognized result. It is noted that the reservoir of Kratoska has flexible walls that can collapse and expand depending on the amount of material in the volume of the reservoir, therefore the reservoir of Kratoska already has a variable height. In any case the height can vary depending on various factors to solve a problem. The height can be larger in order to fit higher medicament volumes to suit particular treatment types over an extended period of time, while the height can be shorter to fit lower medicament volumes to suit particular treatment types that may be more short-term, immediate, or simply requiring smaller volumes and would also reduce the necessary storage space to save on weight and/or increase portability. Therefore, since the general conditions of the claim (e.g., having the claimed structure as recited above) is disclosed by Kratoska and Lanigan, it is not inventive to discover the optimum working range by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the height to be less than 8, 7.5, or 6.5 mm. Further, in the instant application, Applicant has not disclosed any criticality for the claimed dimensions ([038], [068], [165], & [258]).
Regarding claim 81, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the delivery device being capable of delivering the first agent after being filled and then stored for at least 90, 120, 180, 270, or 365 days at a temperature of no more than 30°C (given that this limitation is functional, the delivery device of Kratoska is fully capable of delivery the first agent after being filled and being stored for 90 days or after being kept at 30°C).
Regarding claim 82, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the delivery device comprising at least a first portion (16), but Kratoska does not teach rotation.
Lanigan teaches a delivery device comprising at least a first portion (102) that can be rotated (column 19, lines 46-51). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first portion of Kratoska rotatably detachable to yield the predictable result of attaching a housing to base. The housing and base of Kratoska are already attached, Lanigan merely shows one alternative manner of attachment as known in the art.
Regarding claim 83, Kratoska and Lanigan teach the system according to claim 82 as shown above, Lanigan further teaching rotation of the first portion of Kratoska fluidly connects the reservoir to the pumping mechanism (Fig. 3).
Regarding claim 84, Kratoska and Lanigan teach the system according to claim 82 as shown above, wherein rotation of the first portion initiates a priming of the pumping mechanism (the housing needs to be attached to the base in order for priming to occur).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Kratoska and Lanigan as applied to claim 67 above, and further in view of U.S. Patent Publication No. 2002/0169439 to Flaherty.
Regarding claim 68, Kratoska and Lanigan teach the system according to claim 67 as shown above, but do not mention when the first agent is deposited.
Flaherty teaches a first agent being deposited in the reservoir prior to shipment of the delivery device to the patient ([0120]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have deposited the first agent into the reservoir of Kratoska prior to shipment as taught by Flaherty, for convenience and ease of use. Pre-filling reservoirs is well-known in the art, it allows the patient or practitioner to skip the step of filling the reservoir to allow use of the device right away, and to avoid any complications that could occur during filling.
Claims 74 and 85-88 are rejected under 35 U.S.C. 103 as being unpatentable over Kratoska and Lanigan as applied to claim 1 above, and further in view of U.S. Patent No. 5,545,143 to Fischell.
Regarding claim 74, Kratoska and Lanigan teach the system according to claim 1 as shown above, Kratoska further teaching the transcutaneous delivery assembly of comprises a proximal portion including a distal portion including a skin-penetrating element (column 7, lines 7-12, catheter), but does not show the septum.
Fischell teaches a transcutaneous delivery assembly comprising a proximal portion including a septum (24). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the transcutaneous delivery assembly of Fischell with the device of Kratoska, because Kratoska is designed to deliver an agent to a patient via a tube connected to the outlet port 23 and Fischell merely shows one manner in which such an agent may be delivered to the patient.
Regarding claim 85, Kratoska and Lanigan teach the system according to claim 82 as shown above, but do not show the second portion.
Fischell teaches at least a second portion (43/44, Fig. 5) that can be rotated (column 7, line 47-67). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the second portion of Fischell into the device of Kratoska to yield the predictable result of providing a means of attachment for the transcutaneous delivery assembly. As previously shown, the device of Kratoska is intended to be used with a transcutaneous delivery assembly, Fischell merely shows one type of art-recognized attachment thereto.
Regarding claim 86, Kratoska, Lanigan, and Fischell teach the system according to claim 85 as shown above, Fischell further teaching rotation of the second portion fluidly connects the pumping mechanism to the transcutaneous delivery assembly (column 7, line 47-67).
Regarding claim 87, Kratoska and Lanigan teach the system according to claim 1 as shown above, but do not teach an insertion device.
Fischell teaches an insertion device (22) operably coupled to the delivery device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the transcutaneous delivery assembly of Fischell which would include the insertion device with the device of Kratoska, because Kratoska is designed to deliver an agent to a patient and Fischell merely shows one manner in which such an agent may be delivered to the patient.
Regarding claim 88, Kratoska, Lanigan, and Fischell teach the system according to claim 87 as shown above, Fischell further teaching the insertion device (22) being capable of inserting the transcutaneous delivery assembly through the skin of the patient (Fig. 4).
Response to Arguments
It is noted that in the amendment filed 03/18/2026, in the last two lines of claim 1, the terms “of less than 10 mm” were not underlined.
The drawings were received on 03/18/2026. These drawings are not acceptable.
Applicant's arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn. However new drawing objections have been issued as shown above.
Applicant’s arguments and amendments with respect to 112(b) rejections have been fully considered and are not persuasive. The new claim language is considered indefinite as shown above.
Applicant's arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kratoska and Lanigan.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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