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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a modular injection system, classified in A61M5/1413.
II. Claim 14, drawn to a method for preparing an injection device for an injection, classified in A61M2205/60.
III. Claim 15, drawn to a modular, semi-disposable injection system, classified in A61M2205/583.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method as claimed can be practiced with another materially different product, such as a product that only has an automatic drive member and does not include a manual drive unit. Additionally, the product as claimed can be used in a materially different process such as a process that does not involve priming.
Inventions I and III are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have materially different designs as one requires a manual drive unit comprising a manual drive member and the other does not. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions III and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method as claimed can be practiced with another materially different product, such as a product that only has one automatic drive member and does not include a second automatic drive unit. Additionally, the product as claimed can be used in a materially different process such as a process that does not involve priming.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The different inventions would require a different search. For example, a search for invention I would require a search for a manual drive unit not required in a search for Invention II or III. A search for invention II would require searching for a priming operation not required in a search for Invention I or III.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an 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 may be made with or without traverse. To reserve 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 upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should 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. In either instance, 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.
During a telephone conversation with Bridget M. Hayden on 3/13/26 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 14-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected 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 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.
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.
Claim(s) 1 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jennings et al. (US 2013/0274655 A1, hereafter “Jennings”) in view of Ahlstrand et al. (US 4,968,299, hereafter “Ahlstrand”).
As to claim 1, Jennings discloses a modular injection system, comprising:
a first injection device (auto-injector of Figs. 1A-9B), comprising:
a first reservoir unit (1) comprising a reservoir (2) filled with medication, a housing (1.3) for holding the reservoir (para 0058) and a plunger rod (3.2) adapted to advance a piston (3.3) inside the reservoir to dispense the medication (para 0086-0087); and
a first automatic drive unit (3) releasably attachable to the first reservoir unit (para 0059) and comprising an automatic drive member (“driving means”, e.g. a motor) automatically driven by a power source (para 0030, 0100) and adapted to be releasably coupled to the plunger rod (3.2) (see para 0024, 0057, 0132); and
a second injection device (also depicted in Figs. 9A, 9B, albeit interpreted to include a second/different front-end device 1 – see below), comprising:
a second reservoir unit (implicit as Jennings describes that front-end device 1 can be disposable in para 0021, 0106; thus, a second reservoir unit is attached to the reusable back-end device); and
wherein the first reservoir unit and the second reservoir unit are identical (implicit as it is described that front-end device 1 can be disposable in para 0021, 0106 and the back-end device is reusable in para 0016, 0024, 0044, i.e. that it can be used with multiple reservoir units).
Jennings does not expressly recite the second injection device comprising a manual drive unit coupled to the second reservoir unit and comprising a manual drive member manually driven and coupled to a plunger rod of the second reservoir unit.
Ahlstrand discloses a modular injection system comprising a first injection device (see embodiment in Figs. 1-5) as well as a second injection device (embodiment of Figs. 9-11) comprising a second reservoir unit (24+1); and a manual drive unit coupled to the second reservoir unit and comprising a manual drive member (35) manually driven and coupled to a plunger rod (30) of the second reservoir unit (see para beginning line 15 col. 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Jennings such that the second injection device comprises a manual drive unit coupled to the second reservoir unit and comprising a manual drive member manually driven and coupled to a plunger rod of the second reservoir unit based off of Ahlstrand. One would have been motivated to do so in order to provide an alternative means of injecting medication that does not require powered components (see different embodiments in Figs. 1-5, 6-8, 9-11 and lines 15-54 col. 7 of Ahlstrand).
As to claim 7, Jennings in view of Ahlstrand teaches the modular injection system according to claim 1 as described above. Jennings further discloses wherein the automatic drive member comprises an electric motor (3.5, see para 0024, 0057), and wherein the first automatic drive unit further comprises a controller (“electronic control unit”) and a communication module (interpreted as any/all components used for relaying commands from the control unit to the motor), wherein the controller is adapted to control the electric motor based on injection information received via the communication module (see para 0033, 0103).
As to claim 8, Jennings in view of Ahlstrand teaches the modular injection system according to claim 1 as described above. Jennings further discloses wherein the first automatic drive unit further comprises injection status sensing means for monitoring an injection status, and storage means for storing acquired injection status information (see para 0023, 0026, 0096).
As to claim 9, Jennings in view of Ahlstrand teaches the modular injection system according to claim 8 as described above. Jennings further discloses wherein at least the first reservoir unit or the second reservoir unit comprises a machine-readable tag (RFID or barcode reading) with identification information on the medication inside the reservoir or uniquely identifying the reservoir unit, and wherein the first automatic drive unit comprises a tag reader adapted to read the identification information of the machine-readable tag (see para 0098).
As to claim 10, Jennings in view of Ahlstrand teaches the modular injection system according to claim 9 as described above. Jennings further discloses wherein based on the identification information of the machine-readable tag, the first automatic drive unit is adapted to control an electric motor of the automatic drive member (see para 0095, 0098).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jennings in view of Ahlstrand as applied to claim 1 above, and further in view of Both et al. (US 2011/0166512 A1, hereafter “Both”).
As to claim 2, Jennings in view of Ahlstrand teaches the modular injection system according to claim 1, but is silent to wherein the first injection device further comprises a signaling unit coupled to the first automatic drive unit and comprising a light signaling means for signaling an injection status of the first injection device.
Both discloses a signaling unit coupled to the first automatic drive unit and comprising a light signaling means (28) for signaling an injection status of an injection device (10; see Fig. 2, para 0040, 0042, 0045, 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Jennings (as already modified above) such that the first injection device further comprises a signaling unit coupled to the first automatic drive unit and comprising a light signaling means for signaling an injection status of the first injection device. One would have been motivated to do so in order to relay signals to a user regarding operation of Jennings (see para 0040, 0042, 0045, 0046 of Both).
As to claim 3, Jennings in view of Ahlstrand and Both teaches the modular injection system according to claim 2 as described above. Modified Jennings does not expressly recite wherein the injection system further comprises a third injection device comprising: a third reservoir unit; a second automatic drive unit; and a display unit coupled to the second automatic drive unit and comprising a display adapted for alphanumerically displaying an injection status of the third injection device, wherein the first reservoir unit and the third reservoir unit are identical, and the first automatic drive unit and the second automatic drive unit are identical. However, Jennings does disclose use of displays adapted for alphanumerically displaying an injection status of its respective injection devices (see para 0027, 0097). Therefore, the limitations required by claim 3 appear to be nothing more than a duplication of parts already described/taught by modified Jennings. In other words, Jennings (in view of Ahlstrand and Both) teaches all the individual components required by claim 3, and arriving at the system of claim 3 would have involved a mere duplication of components already taught by Jennings with no change in their respective functions. Therefore It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Jennings such that the injection system further comprises a third injection device comprising: a third reservoir unit; a second automatic drive unit; and a display unit coupled to the second automatic drive unit and comprising a display adapted for alphanumerically displaying an injection status of the third injection device, wherein the first reservoir unit and the third reservoir unit are identical, and the first automatic drive unit and the second automatic drive unit are identical. One would have been motivated to do so in order to provide an additional injection device in combination with the first and second injection devices (see MPEP 2144.04 VI.).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jennings in view Ahlstrand and Both as applied to claim 3 above, and further in view of Toporek (US 2021/0077735 A1).
As to claim 4, Jennings in view of Ahlstrand teaches the modular injection system according to claim 3 as described above.
Modified Jennings is silent to wherein the first injection device comprises a dose setting member coupled to the first automatic drive unit for manually setting or correcting a dose.
Toporek discloses wherein an injection device (100) comprises a dose setting member (203 and/or 230) coupled to a first automatic drive unit for manually setting or correcting a dose (see para 0043-0045).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Jennings (as already modified above) further such that the first injection device comprises a dose setting member coupled to the first automatic drive unit for manually setting or correcting a dose. One would have been motivated to do so in order to allow for adjustment of an amount of medication to be delivered to a patient (see para 0043-0045 & claim 13 of Toporek).
Allowable Subject Matter
Claims 5, 6, and 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 5, Jennings in view of Ahlstrand teaches the modular injection system according to claim 1 as described above. However, modified Jennings is silent to wherein the first injection device comprises an interface member adapted to be coupled to the housing and comprising a plunger rod driver adapted to be coupled to the plunger rod of the first injection device, wherein the plunger rod driver comprises a coupling element adapted to releasably couple the plunger rod driver to the automatic drive member in combination with the limitations of claim 1.
As to claim 6, Jennings in view of Ahlstrand teaches the modular injection system according to claim 1 as described above. However, modified Jennings is silent to wherein the manual drive unit further comprises a dose setting member, a housing, and a retaining member with an engaging element, wherein during dose setting, the manual drive member can be moved in a longitudinal direction relative to the manual drive unit housing, and the manual drive member can be held by the engaging element in a rotationally fixed manner relative to the housing, and wherein during dose dispensing, the manual drive member is released from the engaging element and can rotate relative to the housing in combination with the limitations of claim 1.
As to claim 11, Jennings in view of Ahlstrand teaches the modular injection system according to claim 9 as described above. Modified Jennings further teaches wherein the first automatic drive unit is adapted to determine an amount of dispensed medication or an amount of the medication remaining inside the reservoir based on the acquired injection status information (see para 0023, 0034), but is silent to being adapted to assign the amount to the read identification information of the corresponding reservoir unit in combination.
Claim 12 depends from claim 11.
As to claim 13, Jennings in view of Ahlstrand teaches the modular injection system according to claim 9 as described above. Modified Jennings is silent to wherein the first automatic drive unit comprises a unique identifier, and wherein the first automatic drive unit is adapted to transmit an identifier set comprising the unique identifier and the identification information to a database in combination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yodfat et al. (US 2010/0292651 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783