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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 3, 7, 9, and 11 are objected to because of the following informalities:
Regarding claim 3, the claim has a typographical error wherein there is improper antecedent basis where the claim recites “for applying the active ingredient delivery system to the skin of a patient” and should instead recite “for applying the active ingredient delivery system to a patient’s skin”.
Regarding claim 7, the claim has a typographical error wherein there is improper antecedent basis where the claim recites “at the inlet and/or at the outlet” and should instead recite “at an inlet of the pump chamber and/or at an outlet of the pump chamber”.
Regarding claim 9, the claim has a typographical error wherein there is improper antecedent basis where the claim recites “the active ingredient reservoir and/or the pump chamber” and should instead recite “the active ingredient reservoir and/or a pump chamber”.
Regarding claim 11, the claim has a typographical error wherein there is improper antecedent basis where the claim recites “the patient data are transmitted to the control means” and should instead recite “the patient data are transmitted to the at least one control means”.
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.
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 for acquiring 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 § 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 1-13 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.
As per MPEP 2173.05(p)(ll), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
Regarding claim 1, the claim is currently indefinite where it is unclear what is required of the claim where the claim recites “comprising an active ingredient means and an electronic means cooperating therewith”. For the purposes of compact prosecution, Examiner has understood the claim to mean “comprising an active ingredient means and an electronic means configured to cooperate with the active ingredient means”, and this is considered to be a functional requirement, meaning that there is only required to be some kind of cooperation functionally or physically to satisfy the claim limitations.
Further regarding claim 1, the claim is currently indefinite where it is unclear what is required of the claim where the claim recites “the electronic means comprising at least one control means and a pumping means electrically connected thereto”. For the purposes of compact prosecution, Examiner has understood the claim to mean “the electronic means comprising at least one control means and a pumping means electrically connected to the at least one control means”.
Additionally, regarding claim 1, the claim is indefinite where it appears to be drawn to an apparatus (an active ingredient system) and a method step (“which causes the transport of the active ingredient from the active ingredient reservoir to the delivery means”). For the purposes of compact prosecution, Examiner has taken the method step limitation to be a purely functional limitation (“which is configured to cause the transport of the active ingredient from the active ingredient reservoir to the delivery means”).
Claims 2 and 5 are indefinite where they do not clearly define the requirements of the claim where they recite “in particular”.
For claim 2, the claim first requires two components to be “formed as separate components which, in particular, can be manufactured independently of one another”; it appears as though this is a positive requirement that the components can be manufactured independently of one another, however, the recitation of “in particular” makes this unclear. The phrase “in particular” should be removed from the claim.
For claim 5, the claim requires “a receiving area for receiving the active ingredient reservoir, in particular a replaceable active ingredient reservoir”. This renders the claim indefinite because it is unclear of whether or not the active ingredient reservoir is required to be a replaceable active ingredient reservoir or not, or if the receiving area is functionally required to receive a replaceable reservoir or not. For the purposes of compact prosecution, Examiner has understood the claim to mean “a receiving area configured for receiving the active ingredient reservoir, wherein the active ingredient reservoir is a replaceable active ingredient reservoir”.
Claim 9 is considered to be indefinite where it appears to be drawn to an apparatus (an active ingredient system) and a method step (“the pumping means acts on the active ingredient reservoir and/or the pump chamber”). For the purposes of compact prosecution, Examiner has taken the method step limitation to be a purely functional limitation (“the pumping means is configured to act on the active ingredient reservoir and/or the pump chamber”).
Regarding claims 10 and 11, the claims are unclear where claim 10 first appears to require that the patient data is only functionally capable of being acquired (“a sensor means for acquiring patient data” does not positively require the method step of data being acquired and such data being present in the system; Examiner notes that this method step would have to be recited as a functional limitation as the claims are drawn to an apparatus and not a method), while claim 11 seems to positively recite that the patient data is required (“the patient data are transmitted to the control means”). This renders the claims indefinite because it is not clear whether or not the patient data is required as a part of the system. Additionally in claim 11, the patient data is claimed to be “transmitted”, but no structure is present which is meant to do said transmitting. Any further amendment should make clear that this transmission of data additionally follows the requirements set forth in 35 U.S.C. 101 regarding subject matter eligibility.
Claim 11 is further indefinite where it does not clearly define the requirements of the claim where it recites “and are particularly taken into account when controlling the pumping means”. The word “particularly” should be removed as it renders the claim unclear, and further specification should be added as to what makes up being “taken into account” as claimed.
Claims 3-4, 6-8, and 12-13 are indefinite based on their dependency on, and thus requirement of the indefinite limitations of, claim 1.
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.
Claim(s) 1-6 and 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty (US 20020169439, henceforth Flaherty).
Regarding claim 1, Flaherty discloses an active ingredient system (fluid delivery device 10, fig. 2) for delivering an ingredient ([0034], the ingredient is a fluidic drug), in particular a pharmaceutical active ingredient ([0034]), preferably over a longer period of time and/or time intervals ([0042], the device delivers fluid at desired time intervals), comprising an active ingredient means (disposable assembly 800, fig. 2) and an electronic means (reusable assembly 700, fig. 2) cooperating therewith ([0035], the assemblies are assembled together for use which means they cooperate with each other), the active ingredient means comprising an active ingredient reservoir (reservoir 30, fig. 2) fluidically connected to a delivery means (exit port assembly 70, fig. 2), and the electronic means comprising 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 thereto (see [0048] and [0049], microcontroller 50 is what controls meter control portion 46 and the drive thereof through electrical connections), which causes the transport of the active ingredient from the active ingredient reservoir to the delivery means (see at least [0048] and [0049]).
Regarding claim 2, Flaherty 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, in particular, 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 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 the skin of a patient ([0046]).
Regarding claim 4, Flaherty 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 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) 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), in particular a replaceable active ingredient reservoir (see [0045], reservoir 30 can be assembled to be removable and replaceable).
Regarding claim 6, Flaherty 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 discloses the active ingredient system of claim 1 wherein the pumping means acts on the active ingredient reservoir and/or the 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 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]) for acquiring patient data (the flow sensor of [0068] is considered to be functionally for acquiring 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 discloses the active ingredient system of claim 10 wherein the patient data are transmitted to the control means (see [0066], data from sensors goes to microprocessor 50) and are particularly taken into account 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]).
Regarding claim 12, Flaherty 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 discloses the active ingredient system of claim 1 wherein the electronic means comprises an energy storage (power supply 80, fig. 4).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020169439, henceforth Flaherty) as applied to claim 6 above, and further in view of Gray (US 20120209183, henceforth Gray).
Regarding claim 7, Flaherty discloses the active ingredient system of claim 6 wherein the pump chamber comprises a valve (inlet valve 41, outlet valve 42, fig. 5A) at the inlet and/or the 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) as applied to claim 1 above, and further in view of Yodfat et al. (US 20110160697, henceforth Yodfat).
Regarding claim 8, Flaherty 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yodfat et al. (US 20070106218) is considered relevant prior art regarding teaching use of a pump on a pumping chamber in a fluid infusion device.
Smeys et al. (US 20220409051) is considered relevant prior art regarding teaching use of a pump on a pumping chamber in a fluid infusion device where the device has a disposable and reusable portion similar to the claimed arrangement.
O’Connor et al. (US 20200023123) is considered relevant prior art regarding a drug delivery device with multiple components similar to the claimed arrangement but lacking electronics.
Stutz (US 20080051716) is considered relevant prior art regarding a removable reservoir assembled onto a base plate with an attached reusable electronics assembly.
Ramdas et al. (US 20110264028) is considered relevant prior art regarding teaching use of a patch with a plurality of microneedles in a transdermal drug delivery system.
Kamen et al. (US 20100185175, previously made of record) is considered relevant prior art similar to the claimed invention.
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.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783