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 were received on 10/14/2025. These drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “224” points to one feature in Fig 9 and another feature in Fig 10. Reference character “224” is supposed to point to the “droplet shaped icon” (Para 45) and does point to this feature in Fig 10, but not in Fig 9. Instead, reference characters “224” appears to point to the a sidewall of the expandable member 58 in Fig 9. 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. 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.
Specification
The amended Abstract was received 10/14/2025. This Abstract is acceptable.
Claim Objections
Claim 13 objected to because of the following informalities: The phrase “the housing” on lines 2 and 3 should be amended to recite “the disc-shaped housing” since this is how the housing is referred to throughout the rest of the claims. Appropriate correction is required.
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 9, 10, 16 and 17 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.
Claim 9 depends on cancelled claim 8 and lacks proper antecedent basis for the phrase “the arcuate shield” on line 3. Because claim 8 is cancelled, it is unclear what claim that claim 9 is intended to depend from. Because claims 15 and 20 introduce an “arcuate shield”, it is unclear whether claim 9 is intended to depend from one of these claims or is intended to introduce “an arcuate shield”. Therefore, claim 9 is indefinite. Claim 10 is rejected due to its dependence on claim 10. For the sake of examination, claim 9 is interpreted as reciting dependence on claim 15.
Claim 16 recites that the button includes a color treatment of “the same color as a shield” but it is unclear if the “shield” is a component of the “injection device” or just a hypothetical element that the color of the button is being compared to. Therefore, claim 16 is indefinite. For the sake of examination, the “shield” is interpreted as being a component of the “injection device”. Accordingly, it is suggested to amend claim 16 to recite “The injection device of claim 12 further comprising a shield, wherein the button includes a button color treatment of the same color as [[a]] the shield”.
Claim 17 depends on cancelled claim 8, lacks proper antecedent basis for the phrase “the shield” on line 2, and requires the fluid fill indicator to be “positioned on the clear plastic [of the disc-shaped housing]” while claim 1 requires it to be positioned “on the arcuate window”. Because claim 8 is cancelled, it is unclear what claim that claim 17 is intended to depend from. Because claims 15 and 20 introduce an “arcuate shield” and claim 16 introduces “a shield”, it is unclear whether claim 17 is intended to depend from one of these claims or is intended to introduce “a shield”. Because claim 1 requires the fluid fill indicator to be “on the arcuate window”, it is unclear how it can be “positioned on the clear plastic [of the disc-shaped housing” as recited in claim 17. Therefore, claim 17 is indefinite. For the sake of examination, claim 17 is interpreted as reciting dependence on claim 16 and with the phrase “and the fluid fill indicator” removed from the claim.
Allowable Subject Matter
Claims 1-3, 6, 7, 11, 12 14, 15, 18 and 20 are allowed, claim 13 would be allowed if amended to overcome the objection set forth above, and claims 9, 10, 16 and 17 would be allowed if amended to overcome the 35 USC 112(b) rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claim could not be found nor was suggested in the prior art of record. Independent claim 1 has been amended to require the subject matter of now-cancelled dependent claims 4 and 5 (which require the arcuate droplet icon of the fluid fill indicator to be on the arcuate window and to include an enlarged head portion corresponding to the elastomeric bladder being expanded and a tapered tail portion corresponding to the elastomeric bladder being contracted) and to require the arcuate droplet icon of the fluid fill indicator to be more opaque than the arcuate window. This requirement overcomes the combination of Navarro, Buckles, Sonderegger and Mosebach set forth in the last Office Action (and which remains the closest prior art of record). Specifically, although the combination of Sonderegger and Mosebach teaches a fluid fill indicator in the form of an arcuate window that is shaped like a droplet comprising an enlarged head portion and a tapered tail portion (see the rejection of claims 4-7 in the 4/11/2025 Non-Final Rejection), that indicator itself is a window – not an icon on a window that is more opaque than the window, as claimed. Absent a teaching to do so, it would not have been obvious to one of ordinary skill in the art to modify Sonderegger’s or Mosebach’s windows to include an opaque droplet-shaped indicator thereon as doing so would inhibit the ability to visualize the fluid level through the window. Additionally, an injection device comprising these features in combination with the other features recited in claim 1 could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783