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 .
Claim Interpretation
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: dose adjustment means in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 1-10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kas (US 2,825,334) in view of Knox et al. (US 3,353,537).
With regard to claims 1-3, 5, 6, 8, 9, and 13-15, Kas teaches a device for dispensing a fluid product comprising a pump (10) (pump components as detailed later in the rejection for moving fluid between 40 and 28) connected to a reservoir (Fig. 1 member 40) (40) containing several doses of fluid product and to a dispensing head (Fig. 1 member 28) (50) provided with a dispensing opening (opening necessarily present) (58), said pump (10) comprising a body (Fig. 1 member 12) (20) containing a metering chamber (21) (Figs. 1 and 3 space within 12) in which a piston (not shown Col. 1 line 57) (22) connected to a piston rod (Fig. 1 member 16) (25) provided with a push-button (Fig. 1 member 18) (26) slides, said button configured to be pressed by a user to actuate the pump (10), a return spring (Fig. 1 member 20) (27) cooperating with said piston (22) and/or said piston rod (25) to automatically return said piston (22) to a rest position after each actuation (Col. 1 lines 59-61); wherein said body (20) comprises downstream of said metering chamber (21), a T-like connection (Fig. 3 in the area of 26 and 32) (24), of which a first branch is connected to said metering chamber (Fig. 1 branch of 26 to the right of 32) (21), a second branch is connected to said reservoir (Fig. 3 member 32) (40) and a third branch is connected to said dispensing head (Fig. 3 branch of 26 to the left of 32) (50), a first valve (41) is provided in said second branch of said T-like connection (Fig. 3 member 46) (24) and a second valve (51) is provided in said third branch of said T-like connection (Fig. 3 member 48) (24), said first and second valves (41, 51) are urged by first and second springs (45, 55) against first and second respective valve seats (43, 53) (Fig. 3). Kas does not disclose dose adjustment means. However, Knox et al. teach a similar multi-dose injection device in which the extent of the plunger is adjusted by screwing/unscrewing a bush and locked in position via a nut (Fig. 1 bush 48 nut 54, Col. 7 lines 15-20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to adjust the positioning of the plunger in Kas using a bushing and lock nut as in Konx et al. as this is beneficial to adjust the amount delivered depending on the desired dose.
With regard to claim 4, see member 30 (Fig. 3).
With regard to claim 7, see Fig. 3 member 34.
With regard to claim 10, the needle is taken as curved as it has curved walls.
With regard to claim 12, see portion 10 (Fig. 3).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kas (US 2,825,334) in view of Knox et al. (US 3,353,537) as applied to claim 1 above, and further in view of Anderson et al. (US 6,063,054).
With regard to claim 11, Kas teaches a device substantially as claimed. Kas does not explicitly disclose a spray nozzle. However, Anderson et al. teach a similar multi-dose injection device (abstract) in which the outlet may be connected to a needle or fluid may be sprayed depending on the desired mode of delivery (Figs. 6b and 6c, Col. 5 lines 30-45). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a spray in Kas as Anderson et al. teach equivalently using a needle or spray depending on desired delivery.
Response to Amendment
The amendments are sufficient to overcome the previous objection and rejections under 35 U.S.C. 112.
Response to Arguments
Applicant's arguments filed October 7, 2025 have been fully considered but they are not persuasive. Applicant argues the adjusting mechanism of Knox cannot be use in Kas. As combined the delivery system including the adjustment mechanism of Knox would be incorporated into Kas to substitute the piston so that the dosage may be controlled. As such 51 is considered as part of the piston rod along with 60 and the dose adjustment means is around 51. The push button includes 37. The piston incudes 56, the spring includes 66. Both mechanisms are manually actuated for inoculations.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783