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 .
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-13, drawn to an article.
Group II, claim(s) 14-20, drawn to a method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of receive a signal from the sensor and operate one or more of the plurality of valves to dispense the active pharmaceutical ingredient through one or more of the plurality of outlets based at least in part on the sensed direction of gravity, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Jones et al. (US 2018/0070857 A1) in view of Krijnsen et al. (US 2010/0042043 A1). Jones teaches receive a signal (paragraphs 0414, 0417) from the sensor and operate one or more of the plurality of valves (paragraph 0417, lines 10-13, paragraph 0336) to dispense the active pharmaceutical ingredient through one or more of the plurality of outlets based at least in part on the sensed characteristic. Jones is silent regarding the sensed characteristic being sensed direction of gravity.
However, Krijnsen teaches an automatic drug administration wherein the sensed characteristic being sensed direction of gravity (paragraph 0024) for the purpose of releasing the drug when the patient is in specific position or posture (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the sensed characteristic of Jones to incorporate the sensed direction of gravity as taught by Krijnsen for the purpose of releasing the drug when the patient is in specific position or posture (paragraph 0024).
During a telephone conversation with John Harmon on 11/3/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites the limitation “the drug delivery device” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2018/0070857 A1) in view of Krijnsen et al. (US 2010/0042043 A1).
Regarding claim 1, Jones discloses an article 100 (figure 1) configured for administration to a subject (paragraph 0005), the article comprising:
a reservoir (paragraph 0315, lines 1-5, “storage reservoir”) configured to contain an active pharmaceutical ingredient 105;
a plurality of outlets (paragraph 0112);
a plurality of valves (paragraph 0109), wherein each outlet of the plurality of outlets is in selective fluid communication with the reservoir through an associated valve of the plurality of valves (paragraphs 0174-0177, paragraph 0154, lines 16-19);
a sensor (paragraph 0417) configured to sense a location; and
a processor (paragraph 0045, paragraph 0417, lines 17-20, “microcontroller”) configured to receive a signal from the sensor, wherein the processor is configured to operate one or more of the plurality of valves to dispense the active pharmaceutical ingredient through one or more of the plurality of outlets based at least in part on the sensed location.
Jones is silent regarding a sensor configured to sense a direction of gravity.
However, Krijnsen teaches an automatic drug administration wherein the sensed characteristic being sensed direction of gravity (paragraph 0024) for the purpose of releasing the drug when the patient is in specific position or posture (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the sensed characteristic of Jones to incorporate the sensed direction of gravity as taught by Krijnsen for the purpose of releasing the drug when the patient is in specific position or posture (paragraph 0024).
Regarding claim 2, Jones discloses wherein the one or more of the plurality of valves is oriented at least partially vertically downwards relative to the sensed direction of gravity (see figure 40 where at some point, the one or more of the plurality of valves is oriented at least partially downwards relative to the sensed direction of gravity).
Regarding claim 3, Jones discloses wherein the one or more of the plurality of valves is oriented in a direction that is within 450 or less of the sensed direction of gravity (see figure 40 where at some point, the one or more of the plurality of valves is oriented in a direction that is within 450 or less of the sensed direction of gravity).
Regarding claim 4, Jones discloses further comprising a potential energy source (paragraphs 0016, 0053-0055) configured to apply a pressure to the reservoir to dispense the active pharmaceutical ingredient through the one or more of the plurality of outlets.
Regarding claim 5, Jones discloses wherein the potential energy source is compressed gas (paragraph 0053).
Regarding claim 6, Jones discloses wherein the potential energy source is a spring (paragraph 0055).
Regarding claim 7, Jones discloses wherein the potential energy source includes a reaction chamber (paragraph 0052, 0386).
Regarding claim 8, Jones discloses wherein the potential energy source is an explosive material (paragraphs 0008, 0313, 0309).
Regarding claim 9, Jones discloses wherein each one of the plurality of valves includes a heat rupturable membrane 5808a (figure 58, paragraph 0463, lines 10-12) and a heater (paragraph 0463, lines 17-18) configured to heat the heat rupturable membrane.
Regarding claim 10, Jones discloses wherein the heater is a resistive heater disposed in and/or the heat rupture membrane, and wherein the processor is further configured to selectively apply a current to the resistive heater of the individual valves to selectively operate the one or more of the plurality of valves (paragraph 0463, lines 14-18).
Claim(s) 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2018/0070857 A1) in view of Krijnsen et al. (US 2010/0042043 A1) and further in view of Jones (US 2019/0282791 A1, hereinafter referred as “Jones ‘91”).
Regarding claim 11, Jones/Krijnsen (hereinafter referred as “modified Jones”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Jones further discloses wherein each one of the plurality of vales includes a dissolvable membrane 5808a disposed on a conductive layer (a layer of element 5808a contacting with element 5808b, paragraph 0463, lines 12-18) but is silent regarding wherein the conductive support layer is configured to be electrolytically dissolved.
However, Jones ’91 teaches a design of an article wherein the conductive support layer is configured to be electrolytically dissolved (paragraphs 0064, 0055) for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the conductive layer of modified Jones to incorporate wherein the conductive support layer is configured to be electrolytically dissolved as taught by Jones ’91 for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Regarding claim 12, modified Jones discloses the claimed invention substantially as claimed, as set forth above in claim above. Modified Jones is silent regarding further comprising a first negative electrode configured to be exposed to an exterior of the drug delivery device, and a second positively electrode electrically connected to the conductive support layer.
However, Jones ’91 teaches further comprising a first negative electrode configured to be exposed to an exterior of the drug delivery device (device formed by components inside two end caps), and a second positively electrode electrically connected to the conductive support layer (paragraphs 0064, 0055) for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the article of modified Jones to incorporate further comprising a first negative electrode configured to be exposed to an exterior of the drug delivery device, and a second positively electrode electrically connected to the conductive support layer as taught by Jones’ 91 for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Regarding claim 13, modified Jones discloses the claimed invention substantially as claimed, as set forth above in claim 1. Jones further discloses the processor configured to dissolve the membrane (paragraph 0463). Modified Jones is silent regarding wherein the processor is further configured to selective apply a voltage potential between the first electrode and the conductive support layer to electrolytically dissolve the conductive support layer.
However, Jones ’91 teaches wherein the processor is further configured to selective apply a voltage potential between the first electrode and the conductive support layer to electrolytically dissolve the conductive support layer (paragraph 0064, 0055) for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the article of modified Jones to incorporate wherein the processor is further configured to selective apply a voltage potential between the first electrode and the conductive support layer to electrolytically dissolve the conductive support layer as taught by Jones ’91 for the purpose of using a well-known alternative form of a valve to open the opening when desired (paragraph 0032).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783