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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 17, 2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a mixing activation mechanism and a mixing system in claim 1 and a vent lockout mechanism in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 1 recites “a mixing activation housing including a mixing activation mechanism” which invokes 35 U.S.C. 112(f). However, the written description fails to disclose the structure, material, or acts for performing the function to clear link the structure to the function. The claimed embodiment is drawn to the system with a pressurized gas. In these Figures member 106 is referred to as a mixing activation housing. The claim has been amended to recite the housing as separate from the mechanism and the mechanism as extending from the housing and movable with respect to the housing but it is not clear what components constitute the mechanism. Claim 3 recites the activation mechanism partially encloses the gas chamber. The gas chamber is partially enclosed by 106, it is not clear what additional components for them structure of the activation mechanism as separate from the housing and also partially enclose the gas chamber. For purposes of the rejection any structure which provides an output to open the fluid communication assembly is considered and the housing is taken to partially enclose the gas chamber. Further claim 1 recites, the first and second medicaments are transferred from the first container to the second container, however, initially only the first medicament is present in the first container and transferred to the second container, it is not until the transfer occurs from the second container to the first that both medicaments are present. Similarly, in light of these amendments, the clause beginning “a mixing trigger…” is unclear regarding the transfer of components between containers.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarnoff et al. (US 4,689,042) in view of KraMer et al. (US 2013/0331788 A1), Edwards et al. (US 2008/0103490 A1), Choi (US 2021/0213202 A1), and Harper et al. (US 2005/0177100 A1).
With regard to claims 1 and 3-11, Sarnoff et al. teach a mixing and drug delivery system comprising: a housing (Fig. 1 member 12) configured to hold a first container (Fig. 1 member 18) and a second container (Fig. 1 member 20), where in the first container contains a first medicament component (Fig. 1 member 104) and the second container contains a second medicament component (Fig. 1 member 108); a first seal associated with the first container (Fig. 1 member 90); a second seal associated with the second container (Fig. 1 member 100); a mixing activation mechanism (Fig. 1 member 136 and 116); a fluid communication assembly (Fig. 1 member 48) having a fluidic channel (Fig. 1, channel includes the channel in 62, 56 provides a fluid transfer channel) configured to receive a first output from the mixing activation mechanism, whereupon receiving the first output from the mixing activation mechanism causes the fluid communication assembly to open, remove or otherwise pierce the first seal and the second seal and create a fluidic pathway between the first container and the second container (Col. 7 lines 28-64); a mixing system configured to alternately transfer the first and second medicaments between the first and second containers during a mixing phase (Fig. 1 at least members 106 and 110); and a needle delivery assembly configured to be in fluid communication with the first and second containers during a delivery phase (Fig. 1 including at least 50). Sarnoff et al. do not disclose a pressurized gas chamber and trigger. However, KraMer et al. teach equivalently using a spring or gas as an energy source ([0057]). Further, Edwards et al. teach a gas pressurized injection system in which gas is directed to a plurality of plungers which may be separately actuated, a tab is removed to allow the pressurized gas canister to be punctured to release the gas (Fig. 2 [0050], tab 11710). Additionally, Choi teach using a valve actuated by a trigger to control the flow of gas relative to a piston for delivery ([0045], Fig. 5 trigger 310 the face of which forms a button, valve including at least components of 100, 200 and necessary flow channels). 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 pressurized gas cartridge as an energy source in place of the springs in Sarnoff et al. as KraMer et al. teach such is an art effective equivalent means for delivery and further to arrange such a gas canister and to use a valve to control the flow of gas into the respective chambers of Sarnoff et al. as in Edwards as this prevents premature delivery and to actuate the plungers as in Choi as Choi teaches this to be an art effective means for regulating gas flow and would yield the same predictable result of actuating the plungers for mixing and delivery. Sarnoff et al. teach shaking the device to mix the substances (Col. 8 lines 40-41) but do not disclose the combined substances move from the second container back to the first. However, Harper et al. teach transferring the substances back and forth between chambers to more thoroughly mix components than just by shaking ([0055]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to move the combined substances back and forth between the containers in Sarnoff et al. as Harper et al. teach this provides more thoroughly mixed substances as compared to shaking. As combined a gas canister would be arranged in parallel with the containers of Sarnoff et al. similar to Edwards et al.; a safety tab would be incorporated around the canister the exterior would form a mixing activation housing and the components of Sarnoff would extend from such housing. The removal of the tab would allow the gas canister to be activated to release gas to initially move the first plunger in conjunction with operation of the valve as combined by Choi, the valve would then be moved after the contents from the first container are transferred to allow the gas pressure into the space in the area of the former spring which works with to move the substances back to the first container. The operation of the valves may continue to mix the substances, once delivery is desired the process for needle insertion may be carried out and the gas controlled for delivery.
With regard to claim 2, Sarnoff et al. has base and sidewalls which are at a right angle, further 40 is at a right angle to 34, a lower portion may be held forming a handle (Fig. 1).
With regard to claim 12, the embodiment of Fig. 1 does not disclose a delivery seal. However, the embodiment of Fig. 5 shows a seal 264 in the fluid transfer channel. 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 seal in the channel in the embodiment of Fig. 1 as this would additionally prevent mixing prior to activation and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. As combined the fluid transfer channel is taken as the portion cut-off from the needle and the mixing phase begins at initial activation.
With regard to claim 13, see the bottom face of 52 which covers the outlet (Fig. 1).
With regard to claims 14 and 15, member 34 is taken as the needle shield it is locked in place to the housing via 36 (Fig. 1). There is no recitation as to the functionality of a ‘bump trigger.’ The stored energy member is 52 (Fig. 1).
With regard to claims 16-20, Choi discloses openings are used to vent air to the outside which would be necessary to allow the piston to move back and forth (see at least [0047]), o rings 230 obstruct openings (Fig. 5, [0034]). The rod of 200 forms a slide actuator and the flanges of 210 and 220 form at least one ramped portion and a camming component (Fig. 5).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding the rejection under 35 U.S.C. 112 as it applies to the support for the interpretation under 112(f) see the rejection above. Applicant has amended the claim but has not pointed to what structure is considered as the mixing activation mechanism as separate from the mixing activation housing.
Conclusion
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
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