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/Restrictions
Applicant’s election of Species 1 and Species A in the reply filed on 7/2/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 3, 6, 7, 11 and 12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 “resilient ring” of claim 5 must be shown or the feature canceled from the claim. This feature must be shown for a proper understanding of the invention (as required by 37 CFR 1.83(a)) since the claim states that the resilient ring is positioned “between the medicament container and the holder and the electrical engine” and it is unclear how such a ring can be positioned between all three of those elements (especially since the Specification only states that such a ring “can be provided between the medicament container holder and the electrical engine”). No new matter should be entered.
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 Objections
Claims 1, 2, 4, 5 and 9 are objected to because of the following informalities: Claims 1 and 9 include reference characters in parentheses after the introduction of each claimed feature, but claims 2, 4 and 5 do not do this (see the “plunger” of claim 2, the “medicament container holder” of claim 4, and the “resilient ring” of claim 5). Either a reference number should be included after every introduction of a newly-recited feature (i.e. amend claims 2, 4 and 5) or no reference numbers should be provided (i.e. amend claims 1 and 9). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: The term “wherein” should be moved from line 17 to the beginning of line 18 in order to be grammatically correct. The term “wherein” and its following comma should be moved from line 19 to the beginning of line 20 in order to be in the appropriate format. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Line 2 should be amended to recite “resilient ring configured to be positioned between the medicament container” since the “medicament container” is only positively recited in claim 1 and not a part of the claimed “subassembly”. Line 2 should also be amended to recite “the medicament container holder” because the “holder” lacks an article preceding it and to maintain consistency with the language of claim 4. Appropriate correction is required.
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.
Claims 1, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lippe et al. (US Pat 6,171,276).
Re claim 1, Lippe discloses a subassembly (all components of medicament delivery device 1 except for syringe type container 3, needle 4 and piston 5, as seen in Fig 1A; it is noted that all reference characters cited below refer to Fig 1A unless otherwise noted) of a medicament delivery device 1 for expelling medicament from a medicament container 3 of the medicament delivery device (Col 3, Lines 37-41), the subassembly comprising: a housing 2 having a proximal end (to the left in Fig 1A) and a distal end (to the right in Fig 1A); an electrical engine 7 configured to, upon activation, cause expulsion of the medicament out from the medicament container (Col 15, Lines 60-61); a cover structure 8 configured to surround a medicament delivery member 4 at the proximal end of the housing (as seen in Fig 1A), the cover structure being movable in a longitudinal direction of the housing between a retracted position (seen in Fig 1B) in which the medicament delivery member is exposed at a proximal end of the cover structure (as seen in Fig 1B), and an extended position (seen in Fig 1A) with the medicament delivery member covered by the cover structure (as seen in Fig 1A) (Col 15, Line 66 – Col 16, Line 5), an electronic triggering device 11 configured to activate the electrical engine (Col 16, Lines 26-27), the electrical engine and the electronic triggering device being accommodated in the housing (as seen in Fig 1A); the electronic triggering device comprising an electronic non-contact sensor 11 (wherein the sensor 11 has the configuration of 46+47 seen in Fig 4D and described in Col 18, Lines 4-8) configured to sense a movable trigger 10 comprising a sensing area (the entirety of trigger 10) (Col 16, Lines 8-15), wherein the cover structure comprises the sensing area (as seen in Fig 1A), wherein the electronic triggering device is configured to sense that the cover structure is in the retracted position (Col 16, Lines 12-22), and wherein, in response to sensing that the cover structure is in the retracted position, the electronic triggering device is configured to provide a triggering signal to activate the electrical engine (Col 16, Lines 26-27).
Re claim 9, Lippe discloses the electronic non-contact sensor comprising an emitter 46 (Fig 4D; “transmitter” – Col 18, Line 5) configured to transmit a signal and a detector 47 (Fig 4D; “receiver” – Col 18, Line 6) configured to detect a reflected signal from the sensing area, whereby the triggering signal is provided in response to detecting the reflected signal (Col 18, Lines 4-8).
Re claim 10, Lippe discloses that the electronic non-contact sensor is an optical sensor or an ultrasound sensor (Col 18, Lines 4-8 disclose that the switch employs radiation and Col 9, Lines 48-51 disclose that the radiation can be optical).
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.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lippe et al. (US Pat 6,171,276) in view of Gross et al. (US Pat 5,062,834).
Re claim 2, Lippe discloses that the electrical engine is configured to generate propellant gas (Col 6, Lines 62-64 – “the pump may include any kind of pressure source, such as mechanical or electrolytic pressure build-up”) that is configured to propel a plunger 5 of the medicament container in the proximal direction of the medicament container (Col 15, Lins 60-61), but does not explicitly disclose that the gas is configured to flow into the medicament container in order to do this propelling. Gross, however, teaches a subassembly (Fig 1; it I noted that all reference characters cited below refer to Fig 1 unless otherwise noted) comprising an electrical engine 32 (Col 3, Line 31) configured to generate a propellant gas that is configured to flow into a medicament container 2 (as seen in Fig 1, electrolyte 8b is within the medicament container and Col 3, Lines 2-4 and Lines 58-62 disclose that the electrolyte generates gas that expands chamber 2b of the medicament container) and propel a plunger 4 of the medicament container in the proximal direction of the medicament container in order to expel a medicament 6 out from the medicament container (Col 3, Lines 52-57) to allow for the rate of administering to be better controlled by direct action on the plunger (Col 3, Lines 66-68). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lippe to include the subassembly arranged such that the propellant gas flows into the medicament container to propel the plunger, as taught by Gross, for the purpose of allowing for the rate of administering to be better controlled by direct action on the plunger (Col 3, Lines 66-68).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lippe et al. (US Pat 6,171,276)/Gross et al. (US Pat 5,062,834) in view of Alexandre et al. (PG PUB 2007/0167906).
Re claims 4 and 5, Lippe discloses all the claimed features except that the subassembly comprises a medicament container holder gas-tightly sealed to the electrical engine for holding the medicament container (as required by claim 4), that the subassembly comprises a resilient ring configured to be positioned between the medicament container and the medicament container holder and the electrical engine (as required by claim 5), or that the medicament container holder is connected to the electrical engine through a screw thread engagement (as required by claim 5).
Gross teaches a medicament container holder 24 for holding the medicament container (as seen in Fig 1) that is connected to the electrical engine through a screw thread engagement (Col 3, Line 32-34) for the purpose of allowing for the electrical engine to be directly attached to the medicament container (Col 3, Lines 52-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lippe to include a medicament container holder with a threaded engagement for the electrical engine, as taught by Gross, for the purpose of allowing for the electrical engine to be directly attached to the medicament container (Col 3, Lines 52-57). Gross does not explicitly disclose that the connection between the medicament container holder and the electrical engine is gas-tightly sealed or that there is a resilient ring configured to be positioned between the medicament container and the medicament container holder and the electrical engine.
Alexandre, however, teaches a subassembly (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) comprising an electrical engine 70 and a medicament container holder 2 connected thereto by a screw thread engagement (as seen in Fig 1 and like in Gross), wherein the connection between the medicament container holder and the electrical engine is gas-tightly sealed via a resilient ring (Para 40 – “circular O-ring”; seen in Fig 1 but unlabeled) configured to be positioned between a medicament container 3 and the medicament container holder and the electrical engine (as seen in Fig 1) for the purpose of ensuring asepsis of the medicament container (Para 40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lippe/Gross to include a resilient ring to provide a gas-tight seal between the container holder and the electrical engine, as taught by Alexandre, for the purpose of ensuring asepsis of the medicament container (Para 40).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2016/0296699 to Cabiri, PG PUB 2019/0001069 to Carlsson, and PG PUB 2020/0179611 to Holmqvist each disclose sensing collapse/retraction of a cover structure and using that sensing to trigger activation of a delivery means. PG PUB 2009/0067989 to Estes and PG PUB 2016/0015885 to Pananen each disclose an optical sensor comprising an emitter and a detector to detect the presence of a sleeve within a housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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