DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The abstract of the disclosure is objected to.
As stated in MPEP 608.01(b), “A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains”. The abstract appears to pertain to subject matter in one of the parent/family and does not pertain to the language of the instantly claimed invention. I.e. the abstract is drawn to the carrier + control spring while the instant claims focus on a first spring, a second spring, an audible indication or a tactile indication, etc…
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
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.
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 20 and 38 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 20 recites “wherein the auto-injector is configured such that, upon the predetermined amount of proximal movement of the plunger rod relative to the second part, the audible indication and the tactile indication are produced” which is unclear in the context of claim 16 which recited “wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second spring and causes an audible indication or a tactile indication to be produced”. It is not apparent whether claim 20 is referring to a second instance of the audible indication and/or the tactile indication as the claim appears to refer to a different timeframe/causation, i.e. “upon the predetermined amount of proximal movement of the plunger rod relative to the second part” versus movement of the second part in the distal direction. The examiner recommends clarifying what components actually produce the audible indication and/or the tactile indication (similar to claim 26) and/or clarifying when the audible indication and/or the tactile indication are produced.
Claim 38 recites “upon the predetermined amount of proximal movement of the plunger rod relative to the second part, the audible indication and the tactile indication are produced” which is unclear in the context of claim 34 which recited “wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second spring and causes an audible indication or a tactile indication to be produced”. It is not apparent whether claim 38 is referring to a second instance of the audible indication and/or the tactile indication as the claim appears to refer to a different timeframe/causation, i.e. “upon the predetermined amount of proximal movement of the plunger rod relative to the second part” versus movement of the second part in the distal direction. The examiner recommends clarifying what components actually produce the audible indication and/or the tactile indication (similar to claim 26) and/or clarifying when the audible indication and/or the tactile indication are produced.
Allowable Subject Matter
Claims 16-19, 21-37, and 39-51 are allowed.
Claims 20 and 38 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 1, the closest prior art appears to be Grunhut et al. (US 2009/0312705 A1, hereafter “Grunhut”).
Grunhut discloses an auto-injector (1; see Figs. 1-17) comprising:
a housing (19);
a plunger rod (28) configured to displace a stopper (7) of a syringe (5) to dispense a medicament (3) from the syringe when the syringe is disposed in the housing;
a first spring (30) disposed in a distal portion of the housing biasing the plunger rod in a proximal direction relative to the housing (para 0090);
a first part (19a) disposed within the distal portion of the housing and comprising a proximally- extending resilient arm (20) releasably held in contact with an opening (opening located below radial stop 29) of the plunger rod to limit proximal movement of the plunger rod relative to the first part (para 0106, 0118).
However, Grunhut is silent to a second part disposed within the distal portion of the housing and releasably coupled to the plunger rod; and
a second spring disposed within the distal portion of the housing biasing the second part in a distal direction relative to the housing,
wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second spring and causes an audible indication or a tactile indication to be produced.
Claims 17-33 depend from claim 1.
Independent claims 34 and 43 recite limitations that are largely similar to claim 1, and are thus considered allowable for similar reasons noted above.
Claims 35-42 depend from claim 34 and claims 44-51 depend from claim 43.
Conclusion
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.
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, 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
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