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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “safety-mechanism” of Claim 2 and the “tamper-evident closure” of Claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Specifically, although “safety-mechanism 13” and “tamper-evident closure 14” are briefly mentioned in Applicant’s Specification, these items are not shown in the drawings. Additionally, the Specification does not provide a sufficient description and detail of these items such that one of ordinary skill in the art could 1) make and/or use these items, or 2) be apprised on what would or would not infringe upon Applicant’s claim.
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(5) for the following reason: several items in the drawings are referenced with an equal sign (=); the use of this unconventional symbol to indicate items and components of the claimed invention render Applicant’s intent unclear. Examples include the following labels:
“8 = 15”
“6 = 4 (Connection Port)”
“9 = 11 (Radiation Chamber)”
“10 = 11 (Opening)”
“17 = 8 (Heater)”
Examiner acknowledges the verbal explanation of the equal sign (=) symbol, as provided by Attorney Bartol via voice message on 27 May 2026. Here, the attorney explained that the label “8=15” indicates a “discharge device 8 compris(ing) a waste container 15”. Examiner further acknowledges that this explanation has support in Applicant’s Specification (see at least para 46).
Regardless, Examiner asserts that this labeling system is unconventional within the American patent system, and it’s meaning is not readily understood by one of ordinary skill in the art. Examiner recommends correction to a more conventional system, such as using “(8, 15)” for closely aligned components, or separately indicating components with the use of arrows. Corrected drawings are required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1, 8, and 14:
Claim 1 requires a reusable reservoir (2), and a supply container (5) fluidly connected to said reusable reservoir via “a first connection port” (6). As best understood by Examiner, this configuration has support in Figs. 1-2 of the present application, wherein the supply container, connection port, reusable container, a “discharge device” (8) and a “waste container” (15) are all fluidly connected by valve 19 (please see the fluid flow path from the supply container to the reservoir, as annotated by Examiner below). Applicant’s Specification also appears to describe this configuration at paras 48 and 52.
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Apparatus Claim 8 additionally requires “a cleansing agent container” (16) fluidly connected to the inner volume (2a) of the reusable reservoir (2).
Method Claim 14 also requires use of the apparatus of Claim 1, further comprising cleansing the inner volume (2a) of the reusable reservoir (2) by flushing the inner volume (2a) of the reusable reservoir (2) with a cleansing agent provided by a cleansing agent container (16) of the filling apparatus (1a). This configuration appears to have support at Fig. 3 of the present application.
However, Fig. 3, per Applicant (see para 53), represents a different embodiment of the claimed invention than that shown at Figs 1-2. In Fig. 3, the supply container 5, cleansing agent container 16, and valve 19 all fluidly connect to the reusable container 2 via a second connection port 21 (please see Fig. 3, as annotated by Examiner, below). Applicant’s Specification also appears to describe the configuration of this second embodiment at para 54.
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Examiner further notes that the second connection port 21 is not claimed in the present claim set. Regardless, the claimed structure and related method of Claims 8 and 14 (wherein fluid connections occur through a second connection port) are fundamentally at odds with the structure established at antecedent Claim 1 (wherein fluid connections occur through a single “first connection port”).
Therefore, Claims 8 and 14 fail to comply with the written description requirement, as the claims contain subject matter not described in either antecedent Claim 1, the Specification, nor the drawings.
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 1-15 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.
Regarding Claim 1, the claim establishes “A filling apparatus for filling a reusable reservoir of a medical dispensing device”, but later refers to both “the reservoir” (see lines 6-7 and line 8 of Claim 1), and “the reusable reservoir” throughout the rest of the claim set. Here, it is unknown if “the reservoir” of Claim 1 is the same as “the reusable reservoir”, or a different component.
Regarding Claim 2, the claim requires a “safety-mechanism”, which is not shown in the drawings (see the above drawing objection). Although the term is mentioned in very broad, general terms in Applicant’s Specification (see para 8, wherein the “safety mechanism” is further characterized as a “safety-switch”), the Specification does not provide sufficient detail such that one of ordinary skill in the art could 1) make and/or use the “safety mechanism”/ ”switch”, or 2) be apprised on what would or would not infringe upon Applicant’s claim.
Regarding Claim 4, the claim requires a “tamper-evident closure”, which is not shown in the drawings (see the above drawing objection). Although the term is mentioned in very broad, general terms in Applicant’s Specification (see para 10), the Specification does not provide sufficient detail such that one of ordinary skill in the art could 1) make and/or use the “tamper-evident closure”, or 2) be apprised on what would or would not infringe upon Applicant’s claim.
Regarding Claim 11, the claim requires “A medical dispensing device system, comprising: a reusable reservoir for a medical dispensing device; and a filling apparatus for filling the reusable reservoir according to claim 1.” However, “a filling apparatus” is already established at antecedent Claim 1. It is unknown if “a filling apparatus” of Claim 11 is the same component as “a filling apparatus” of antecedent Claim 1, or an additional component.
Regarding Claims 8 and 14, the scope of the claims is indefinite, as explained above in the rejection of Claims 8 and 14 under 35 USC 112(a).
Regarding Claims 2-15, these claims depend upon Claim 1, and therefore suffer the same deficiencies in addition to the ones detailed above for Claims 2, 4, 11, 8, and 14.
Allowable Subject Matter
Examiner reserves comments on the patentability of Claims 1-7, 9-13, and 15, pending resolution of the rejections under 35 USC 112(b) as detailed above.
Examiner reserves further comment on the patentability of Claims 8 and 14, pending resolution of the rejections of these claims under 35 USC 112(a) as detailed above. With specific regard to Claims 8 and 14, Applicant is cautioned against adding new matter to the application.
Examiner acknowledges that the concept of Claim 1 as currently claimed appears to be novel over the prior art. Specifically, the prior art fails to disclose:
(Claim 1) “A filling apparatus for filling a reusable reservoir of a medical dispensing device, the filling apparatus comprising…
a receiving portion configured for holding a reusable reservoir of the medical dispensing device…
a sterilization device configured for sterilizing the inner volume of the (reusable) reservoir,
the sterilization device comprising a radiation source configured to provide radiation within the radiation chamber and also comprising a radiation chamber configured for housing the reusable reservoir,
the radiation chamber including an access opening configured to be opened or closed and a protective barrier configured to hinder radiation from leaving the radiation chamber; and
a discharging device configured to discharge deposit from the reusable reservoir, the discharging device configured for fluidly connecting to the inner volume of the reusable reservoir”
in combination with the other limitations set forth in the independent claim.
Sholten et al. (US 8,839,828, and provided by Applicant on the Information Disclosure Statement filed 30 June 2025) is the closest prior art of record. However, the Sholten reference is silent on these above recited features as underlined above. Furthermore, it would not have been obvious to modify the Sholten reference to arrive at these above recited features without improper hindsight reasoning. In addition, amending the Sholten reference to include the above recited features would improperly change the principle of operation of the Sholten reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- US 2006/0189926 A1 discloses a filling apparatus comprising a waste container and sterilization means for fluid passageways. However, the ‘926 reference is silent on a reusable container sterilized via radiation means, as required by Applicant’s Claim 1.
- US 2017/0007500 A teaches that it is known to replace a reservoir when empty, so is silent on the above novel features of Applicant’s Claim 1.
- US 2022/0153028 A1 teaches “a jet injection system (10)” with medical dispensing applicability, featuring a reusable container (see para 19), and the use of “laser radiation”. However, the radiation of the ‘028 reference appears to be utilized solely for dispensing purposes, and not sterilization as required in Applicant’s present Claim 1. Examiner concludes that it would amount to impermissible hindsight to modify the ‘028 reference to arrive at the invention as claimed by Applicant, there being no motivation to do so, and doing so would likely “break” the workings of the ‘028 reference.
- US 20190111202 A1 teaches radiation sterilization via ultraviolet light of container 14. However, the ‘202 reference does not explicitly describe container 14 as being “reusable”, and is further silent on a discharging device as required by Applicant’s Claim 1. Examiner concludes that it would amount to impermissible hindsight to modify the ‘202 reference to arrive at the invention as claimed by Applicant, there being no motivation to do so, and doing so would likely “break” the workings of the ‘202 reference.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M AFFUL whose telephone number is (571)272-8421. The examiner can normally be reached Monday - Thursday: 7:30 AM - 5:00 PM Eastern Time.
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, Craig Schneider can be reached at 5712723607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M AFFUL/Primary Examiner, Art Unit 3753
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