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 .
Claim Objections
Claims 1-2 are objected to because of the following informalities:
On lines 9-10 of claim 1, “patient interaction component an adhesive to adhere the drug delivery device to skin of a patient” should read “patient interaction component, and an adhesive to adhere the drug delivery device to skin of a patient” to correct an obvious typo.
On lines 1-2 of claim 2, “wherein the patient interaction component is a push button” should read “wherein the button is a push button” because claim 1 already establishes that the patient interaction component is a button.
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:
Patient interaction component in claims 1, 18, and 19
Drive component in claims 1, 18, and 19
Mechanism for providing audio feedback to the user in claim 13
Mechanism for providing haptic or vibrational feedback to the user in claim 14
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.
See par. [0053] for the patient interaction component
See par. [0064] for the drive component
See par. [0072] for the audio, haptic, and vibrational feedback mechanism
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20 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.
In regard to claim 19, the limitation “cause the drive component to expel the portion of the liquid drug as a single dose or over multiple doses, wherein the multiple doses are substantially a same amount of the liquid drug” renders the claim indefinite. It is unclear if the applicant is reciting that the drive component has the ability to perform both (single and multiple doses) or if the applicant is reciting either or. For the purposes of this action, the examiner is using the latter interpretation. Claim 20 suffers from the same deficiency. Amendments are encouraged if the applicant’s intent is the former interpretation.
Claim Rejections - 35 USC § 102
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) 1-12, 15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Both et al. (US 2011/0166512; hereafter Both).
In regard to claim 1, Both discloses an on-body drug delivery device (10), comprising: a container (32) configured to store a liquid drug (see par. [0041]); a drive component (42) configured to expel at least a portion of the liquid drug from the container (see par. [0042]); a housing (20, 22) to cover at least one of the container or the drive component (see par. [0039] and at least Fig. 5), wherein the housing includes a top portion (20) having a patient interaction component (26), wherein the patient interaction component is a button (see par. [0040] and at least Fig. 2), and wherein the drive component (42) is configured to be responsive to actuation of the patient interaction component (see par. [0042]), and an adhesive (54) to adhere the drug delivery device to skin of a patient (see par. [0047]).
In regard to claim 2, Both discloses wherein the patient interaction component (26) is a push button (see par. [0040]).
In regard to claim 3, Both discloses wherein the patient interaction component (26) is further operable to activate the drug delivery device (see par. [0040]-[0042]).
In regard to claim 4, Both discloses wherein the patient interaction component (26) is operable to: start, stop, and/or restart the flow of the liquid drug from the container for delivery of the liquid drug to the patient to enable the patient to dispense multiple doses of the liquid drug (see par. [0113]: Both outlines a scenario of starting, stopping, and then resuming drug delivery based on interaction with start button 26).
In regard to claim 5, Both discloses wherein the drive component (42) is operable to: deliver a bolus of the liquid drug in response to actuation of the patient interaction component (26) by the patient (see par. [0042]).
In regard to claim 6, Both discloses wherein the actuation of the patient interaction component (26) causes the drive component (42) to deliver the liquid drug to the patient over a series of start and stop intervals for a multiple dose delivery to the patient (see par. [0113]: Both outlines a scenario of starting, stopping, and then resuming drug delivery based on interaction with start button 26; the system is clearly capable of starting and stopping multiple times).
In regard to claim 7, Both discloses, wherein actuation of the patient interaction component (26) causes the drive component to deliver multiple doses of the stored liquid drug over a period of time, wherein each of the multiple doses includes substantially the same amount of the liquid drug (functional limitation; see cited areas in claim 6; a patient can operate the device for the same amount of periods if desired by controlling the start button 26).
In regard to claim 8, Both discloses wherein times between delivery of each of the multiple doses is approximately equal (functional limitation; the patient can choose equal delivery times).
In regard to claim 9, Both discloses having an idle state (304), an activation state (306), and a delivery state (312), wherein the on-body drug delivery device enters the activation state based upon user input via the patient interaction component (see “System Behavior”; par. [0100]+).
In regard to claim 10, Both discloses wherein the on-body drug delivery device operates in the delivery state (312) based on patient input via the patient interaction component (see par. [0113]).
In regard to claim 11, Both discloses wherein the housing (20, 22) further comprises: an opening (30) enabling viewing of an amount of the liquid drug stored in the container (see par. [0052]).
In regard to claim 12, Both discloses further comprising a light emitting diode (LED) (28) for providing feedback to the user in response to a user input to the patient interaction component (see par. [0045]-[0046]).
In regard to claim 15, Both discloses further comprising a sensor (24) for monitoring operation of the on-body drug delivery device (see par. [0039]- sensor 24 monitors contact with the patient).
In regard to claim 18, Both discloses a drug delivery device (10), comprising: a plurality of housing components (20, 22) including a top portion (20) and a base (22), wherein the top portion and base are configured to couple together (see Fig. 3) and the top portion includes a patient interaction component (26); a container (32) configured to store a liquid drug and fit within the plurality of housing components (see Figs. 2-3; see par. [0041]); and a drive component (42) configured to expel a portion of the liquid drug from the container and fit within the plurality of housing components (see at least Fig. 5), wherein the drive component (42) is responsive to actuation of the patient interaction component (26) (see par. [0040]-[0042] and at least Fig. 2).
In regard to claim 19, Both discloses a drug delivery device (10), comprising: a drive system including a drive component (42) configured to expel a portion of a liquid drug from a container (32)(see par. [0042]), wherein the liquid drug is stored within the container (32); and a patient interaction component (26) operable to, in response to an activation input, cause the drive component (42) to expel the portion of the liquid drug as a single dose or over multiple doses, wherein the multiple doses are substantially a same amount of the liquid drug (see 112 rejection above; see par. [0040]-[0042] and par. [0113]; the Both system can deliver in one big dose or stop and start to perform multiple doses; the same amount is a functional limitation as the user can choose equal delivery times to deliver by operating the start button 26).
In regard to claim 20, Both discloses wherein the multiple doses are expelled over a series of start and stop intervals (the Both system can deliver in one big dose or stop and start to perform multiple doses; the same amount is a functional limitation as the user can choose equal delivery times to deliver by operating the start button 26).
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) 13-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Both in view of Askarinya et al. (US 8,979,799; hereafter Askarinya).
In regard to claims 13-14 and 17, Both fails to expressly disclose further comprising a mechanism for providing audio feedback to the user and/or further comprising a mechanism for providing haptic or vibrational feedback to the user, and fails to expressly disclose a flow sensor.
In a similar on-body injector, Askarinya discloses device monitoring features. In one embodiment, the electronic injector can verify the flow rate of the therapeutic agent using a MEMS flow meter to assure that it is correct. When the flow rate is too high, the electronic injector can stop the injection to avoid an excessive delivery of the therapeutic agent. When the flow rate is too low, the electronic injector can stop the pump to avoid buildup of excessive delivery pressure due to an obstruction in the flowpath, such as a kink in the tubing. In either situation, the electronic injector can send a warning to the patient via a vibration, auditory signal, and/or visual signal through either the electronic injector or paired mobile device indicating that the injection has stopped (see col. 26, lines 14-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Both with the flow sensor/feedback mechanisms of Askarinya in order to provide a flow monitoring features and feedback features to the on-body injector to ensure proper device function.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Both in view of McCullough (US 2016/0175527).
In regard to claim 16, Both fails to disclose wherein the sensor is operable to determine how much liquid drug remains in the drug delivery device.
In a similar on-body injector, McCullough discloses an indicator 290 that mirrors the internal motion of the plunger 112 externally to the housing 122 to permit visualization. Once the proximity sensor 120 detects that the injector 100 has become detached from the patient, the indicator 290 would be decoupled from the plunger 112, such that the indicator 290 would reflect the portion of the dose remaining in the reservoir 102. (see Figure 13 and par. [0113]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Both with the indicator of McCullough in order to provide external means for indicating the amount of drug left in the reservoir, particularly if a window is not present.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,129,943. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patented claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783