DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/29/2026 has been entered.
Response to Amendment
Claims 1 and 5 have been amended; claims 1-15 and 17-18 remain pending.
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.
Third in claim 1, the limitation “delivery means” is being interpreted under 35 U.S.C. 112(f). The limitation uses the term “means”, is modified by functional language as the recitation of a delivery means can be interpreted as a means for delivery, and is not modified with sufficient structure such as to accomplish its functional delivery capabilities. The corresponding structure and equivalents thereof which would apply to the recited delivery means is thus the hollow microneedles as disclosed in Applicant’s Specification and equivalents thereof, such as single needles or patches used for diffusion which allow for drug delivery through a patient’s skin. Sufficient structure for this delivery means is provided in claim 8 (hollow needles), and thus in claim 8 that is the structure which is required.
Fourth in claim 1, the limitation “control means” is being interpreted under 35 U.S.C. 112(f). The limitation uses the term “means”, is modified by functional language as the recitation of a control means can be interpreted as a means for controlling, and is not modified with sufficient structure such as to accomplish its functional controlling capabilities. The control means are thus considered to be a control unit and equivalents thereof, such as microprocessors, circuitry, microcontrollers, or the like.
Fifth in claim 1, the limitation “pumping means” is being interpreted under 35 U.S.C. 112(f). The limitation uses the term “means”, is modified by functional language as the recitation of a pumping means can be interpreted as a means for pumping, and is not modified with sufficient structure such as to accomplish its functional pumping capabilities. The pumping means are thus considered to be piezoelectric pumps, eccentric actuators, and their equivalents, such as peristaltic pumps, roller pumps, or other pumping mechanisms which cause fluid to be moved within a chamber and/or vessel.
In claim 10, the limitation “sensor means” is being interpreted under 35 U.S.C. 112(f). The limitation uses the term “means”, is modified by functional language as the recitation of a sensing means can be interpreted as a means for sensing and is further claimed as being used functionally where it is configured to acquire patient data, and is not modified with sufficient structure such as to accomplish its functional sensing capabilities. The sensing means are thus considered to be one or multiple sensors which can gather data related to the patient and their equivalents.
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: the claimed active ingredient means and the electronic means in claim 1.
Neither of these claim limitations have any functional requirements placed on them in claim 1, and thus the three-prong test fails at step B, as they are simply referred to as an active ingredient means and an electronic means with no additional functional limitations.
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 § 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.
Claim(s) 1-6 and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020169439, henceforth Flaherty) in view of Hansen et al. (US 20090118682, henceforth Hansen).
Regarding claim 1, Flaherty discloses an active ingredient system (fluid delivery device 10, fig. 2) for delivering an active ingredient ([0034], the ingredient is a fluidic drug), comprising an active ingredient means (disposable assembly 800, fig. 2), wherein the active ingredient means contains at least one pharmaceutical active ingredient (see fig. 6 and see [0045], reservoir 30 of assembly 800 comes prefilled with liquid drugs); and an electronic means (reusable assembly 700, fig. 2), the electronic means configured to cooperate with the active ingredient means ([0035], the assemblies are assembled together for use which means they cooperate with each other), wherein the active ingredient means comprises an active ingredient reservoir (reservoir 30, fig. 2) that is fluidically connected to a delivery means (exit port assembly 70, fig. 2) such that the at least one pharmaceutical active ingredient is contained in the active ingredient reservoir of the active ingredient means (see [0045]), and wherein the electronic means comprises at least one control means (microcontroller 50, fig. 2) and a pumping means (see [0049], meter control portion 46 which is a part of reusable assembly 700 has a motorized drive which effects pumping from metering portion 48, and the drive of portion 46 is the claimed pumping means) electrically connected to the at least one control means (see [0048] and [0049], microcontroller 50 is what controls meter control portion 46 and the drive thereof through electrical connections), which is configured to cause the transport of the active ingredient from the active ingredient reservoir to the delivery means (see at least [0048] and [0049]).
Flaherty additionally discloses the use of an adhesive in the active ingredient means (see fig. 2, disposable assembly 800 includes adhesive layer 201).
Flaherty does not disclose that the active ingredient means is formed from a foil. Hansen teaches a pre-filled reservoir formed of a foil ([0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the reservoir of Flaherty from a foil as in Hansen for allowing for visual inspection of the contents of the reservoir prior to use (see at least Hansen [0015] and [0043]). Thus, in the modified device of Flaherty and Hansen, the active ingredient means would be made from a foil where a portion of the active ingredient means, the container of the reservoir, is made from a foil as in Hansen.
{Examiner notes that all subsequent references are drawn to Flaherty unless stated otherwise.}
Regarding claim 2, Flaherty as modified by Hansen (henceforth Flaherty as modified) discloses the active ingredient system of claim 1 wherein the active ingredient means and the electronic means are formed as separate components (see fig. 2, assemblies 700 and 800 are shown as being separate components) which can be manufactured independently of one another (see fig. 2, since they are shown as being not integrally formed, they can be manufactured independently of one another as claimed).
{The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. In this case, two separate components could be manufactured independently or together in practice, but since they are separate as claimed, they meet the functional limitation where they could be manufactured independently.}
Regarding claim 3, Flaherty as modified discloses the active ingredient system of claim 1 wherein the active ingredient means comprises a skin contact surface (adhesive layer 201, fig. 2) for applying the active ingredient delivery system to a patient’s skin ([0046]).
Regarding claim 4, Flaherty as modified discloses the active ingredient system of claim 3 the active ingredient means comprises a connecting surface (the top surface of disposable assembly 800 as shown in fig. 2 where connection projections 803 protrude from is the claimed connecting surface) opposite the skin contact surface (see fig. 2, the top surface is opposite the bottom most surface where adhesive layer 201 is located) for connection to the electronic means (see [0050], [0051], the top surface of disposable assembly 800 is for connection to reusable assembly 700 via connection projections 803).
Regarding claim 5, Flaherty as modified discloses the active ingredient system of claim 1 wherein the active ingredient means comprises a receiving area (the space in disposable assembly 800 where reservoir 30 is shown inside housing 802 is considered to be a receiving area as claimed, see fig. 2) configured for receiving the active ingredient reservoir (reservoir 30 is considered to be received since it is contained in housing 802 as shown in fig. 2), wherein the active ingredient reservoir is a replaceable active ingredient reservoir (see [0045], reservoir 30 can be assembled to be removable and replaceable).
Regarding claim 6, Flaherty as modified discloses the active ingredient system of claim 1 wherein a pump chamber (accumulating chamber 43, fig. 5A) is provided between the active ingredient reservoir and the delivery means (see figs. 4 and 5, the fluid moves from reservoir 30 into chamber 43 and then to exit port assembly 70).
Regarding claim 9, Flaherty as modified discloses the active ingredient system of claim 1 wherein the pumping means is configured to act on the active ingredient reservoir and/or a pump chamber ([0049], the drive of portion 46 causes fluid to flow from the reservoir 30 to exit port assembly 70, thus it acts on it as claimed).
Regarding claim 10, Flaherty as modified discloses the active ingredient system of claim 1 wherein the electronic means comprises a sensor means (flow sensor of sensor assembly 710 as disclosed in [0068]) configured to acquire patient data (the flow sensor of [0068] is considered to be functionally configured to acquire patient data as claimed where it acquires data relating to the flow of medicament delivered to a patient, which is patient data as it is data pertaining to the patient).
Regarding claim 11, Flaherty as modified discloses the active ingredient system of claim 10 wherein the patient data is transmitted to the control means (see [0066], data from sensors goes to microprocessor 50), and wherein the at least one control means is configured to take into account the patient data when controlling the pumping means (see [0044], dispenser 40 including the claimed dispensing means is controlled by processor 50 and in part is controlled by blockage conditions which are sensed by the flow sensor of [0068]) such that the active ingredient is conveyed by the pumping means at predetermined times over a predetermined duration (see at least [0042], [0044], and [0066]; the claimed times are the needed time intervals of [0042] and are modifiable based on sensor data as in [0044]).
Regarding claim 12, Flaherty as modified discloses the active ingredient system of claim 10 wherein the active ingredient means comprises a recess into which the sensor means protrudes (see [0068], “The sensors of the reusable assembly 700 may protrude through or make contact with the housing 802 of disposable assembly 800”, the space which the sensors protrude through is considered to be a recess as claimed).
Regarding claim 13, Flaherty as modified discloses the active ingredient system of claim 1 wherein the electronic means comprises an energy storage (power supply 80, fig. 4).
Regarding claim 14, Flaherty as modified discloses the active ingredient system of claim 1 wherein the foil of the active ingredient means is a plastic foil (see Hansen [0046], the provided foil compounds are different plastic blends of polymers which form the claimed foil).
Regarding claim 15, Flaherty as modified discloses the active ingredient system of claim 14 wherein the plastic foil comprises multiple layers (see Hansen [0043], the foil has multiple layers where two layers combine to make the reservoir as taught).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020169439, henceforth Flaherty) in view of Hansen et al. (US 20090118682, henceforth Hansen) as applied to claim 6 above, and further in view of Gray (US 20120209183, henceforth Gray).
Regarding claim 7, Flaherty as modified discloses the active ingredient system of claim 6 wherein the pump chamber comprises a valve (inlet valve 41, outlet valve 42, fig. 5A) at an inlet of the pump chamber and/or an outlet of the pump chamber (see fig. 5A, Flaherty discloses valves at both locations).
Flaherty does not explicitly disclose that the valve is a check valve. Gray teaches that check valves can be added in fluid paths upstream and downstream of where pumping is occurring to inhibit retrograde flow from occurring ([0257]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added check valves to the valve assembly of Flaherty both upstream and downstream of where the pumping is occurring, which is chamber 43 in Flaherty, to inhibit retrograde flow from occurring as in Gray ([0257]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020169439, henceforth Flaherty) in view of Hansen et al. (US 20090118682, henceforth Hansen) as applied to claim 1 above, and further in view of Yodfat et al. (US 20110160697, henceforth Yodfat).
Regarding claim 8, Flaherty as modified discloses the active ingredient system of claim 1 wherein the delivery means comprises a hollow needle (flexible cannula 72 is a hollow needle and is a part of exit port assembly 70, see fig. 2).
Flaherty does not disclose that the delivery means comprises hollow needles. Yodfat teaches that transdermal drug administration can be achieved either through use of a single cannula or through a plurality of hollow microneedles (see at least [0047] and [0109]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the single needle of Flaherty with a plurality of microneedles as in Yodfat as Yodfat teaches that these can be equivalently used by one of ordinary skill in the art for delivery of fluidic dugs ([0047]) and further that use of a plurality of hollow microneedles can provide a benefit of avoiding pain caused by needle insertion ([0109]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020169439, henceforth Flaherty) in view of Hansen et al. (US 20090118682, henceforth Hansen) as applied to claim 1 above, and further in view of Kube et al. (US 20200029902, henceforth Kube, previously made of record in the IDS filed 02/26/2026).
Regarding claim 17, Flaherty as modified discloses the active ingredient system of claim 1 wherein the electronic means includes circuitry (see [0042]).
Flaherty as modified does not disclose the active ingredient system wherein the electronic means is formed from a foil. Kube teaches that electronic circuitry in wearable patch medical devices can be printed onto multilayer flexible foils (see at least Kube [0013], [0060], and [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the electronic circuitry of Flaherty from a deformable multilayer foil as in Kube as Kube teaches this assembly to have desirable flexibility characteristics to allow for flexibility of the device (see at least Kube [0060]).
Regarding claim 18, Flaherty as modified discloses the active ingredient system of claim 17 wherein the foil of the electronic means is a plastic foil (see at least Kube [0060], the foil includes the use of a thin polymer film to allow for flexibility and stretchability, where the thin polymer film is a plastic foil as claimed).
Response to Arguments
Examiner initially notes regarding the Claim Interpretation section that the meanings of all claim terms are adequately defined with clear meanings.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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