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 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 first displacement mechanism in claims 21, 22, 28, and 38, a second displacement mechanism in claims 26, 27, 30, 38, and 40, a first actuation assembly in claim 28 and 38, a delivery assembly in claims 29 and 30, a second actuation assembly in claims 30, 39, and 40.
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 § 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 21-35 and 37-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarnoff et al. (US 4,689,042) in view of Buchine et al. (US 2013/0178823 A1) and Harper (US 2005/0177100 A1).
With regard to claim 21, Sarnoff et al. teach a medication mixing device comprising: a housing (Fig. 10 member 580) containing a first chamber (Fig. 10 member 546) and a second chamber (Fig. 10 member 532), the first chamber having an outlet and the second chamber having an inlet (outlet is distal opening of 546 inlet is proximal opening of 532); a first medicament component provided in the first chamber, wherein the first medicament component being provided in liquid form (Col. 18 lines 58-60); a second medicament component provided in the second chamber, the second medicament component being dry (Col. 18 lines 42-44); a valve assembly being disposed between the first chamber and the second chamber, the valve assembly being configured to move between an open state wherein the outlet of the first chamber is aligned with the inlet of the second chamber (the inlet and outlet are aligned along the longitudinal axis) to selectively allow fluid communication between the first chamber and the second chamber, and a closed state to prevent fluid communication between the first chamber and the second chamber (Fig. 10 members 548 and 550, see transition to Fig. 11, Col. 19 line 60-Col. 20 line 2, the valve moves between closed and open positions); a first displacement mechanism (Fig. 10 member 542), the first displacement mechanism being configured to cause movement of the first medicament component from the first chamber into the second chamber, thus causing the first medicament component and the second medicament component to mix thus resulting in a mixed medicament compound (see transition to Fig. 11, Col. 20 lines 10-15 and lines 26-29); and wherein a movement of the valve assembly to the open state causes the first displacement mechanism to displace the first medicament component from the first chamber into the second chamber (Col. 20 lines 10-25). Sarnoff et al. do not specifically disclose the dry medicament is an epinephrine compound. However, Buchine et al. teach epinephrine is a beneficial substance that is suitable and desirable as medicament to deliver as a dry component which must be mixed prior to injection as liquid epinephrine suffers from limitations regarding shelf-life and exposure limitations and providing it in a dry form helps ensure it is fresh and potent when used ([0015], [0016], [0019]). 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 epinephrine as the dry medicament in Sarnoff et al. as Buchine et al. teach epinephrine is a beneficial treatment substance and providing it as a dry substance is desired as this ensures freshness and potency. Sarnoff et al. do not show how the outlet of the first chamber is misaligned with the inlet of the second chamber in the closed state. However, Harper et al. teach a mixing syringe in which the valve includes 147 which operates to open and close the connection between the chambers ([0066]) which results in alignment and misalignment between the inlet and outlet (see Reference Figure 1 below, Fig. 7 shows the misaligned position the inlet faces in an opposing direction from the outlet as shown, the inlet and outlet are separated and not in connection with each other and are misaligned as the openings do not intersect, Fig. 8 shows the aligned position in which the openings connect). 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 an outlet of the first chamber (modify 550 of Sarnoff et al.) and configure the seal of the second chamber (modify 542 of Sarnoff et al.) in Sarnoff et al. to have an inlet, outlet, and valve assembly as in Harper et al. as this would yield the same predictable result of allowing the components to mix and would provide equivalent device operation.
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With regard to claim 22, see Fig. 10 member 564, transition to Fig. 12, Col. 20 lines 51-56.
With regard to claims 23 and 24, see Fig. 10 members 546 and 532.
With regard to claim 25, see Fig. 10 bottom portion of 147 as provided by Harper et al. as combined.
With regard to claims 26 and 27, see Figs. 10-12 member 554, the term lower is relative, 554 is connected to the lower portion of the valve as combined with Harper et al.
With regard to claim 28, the first actuation assembly includes at least member 518 (Fig. 10), Col. 19 lines 41-52, Col. 20 lines 10-18.
With regard to claim 29, see Fig. 10 member 536.
With regard to claim 30, Sarnoff et al. teach a second actuation assembly (Fig. 10 includes components of the second releasing assembly 520, Col. 19 lines 21-35, Col. 20 lines 30-45); a delivery assembly being operatively connected to the second chamber (Fig. 10 member 536); wherein during a second actuation the second actuation assembly is configured to release a second portion of energy from the pre-loaded energy source (Col. 20 lines 30-45); and wherein, upon release of the second portion of energy from the pre-loaded energy source, a second displacement mechanism forces the mixed medicament compound out of the second chamber through the delivery assembly (Col. 20 lines 30-56).
With regard to claim 31, see Fig. 10 member 522.
With regard to claims 32 and 33, a first actuation assembly can be considered to include 580, 522, and 518 which includes cap 576 which is capable of being rotated and is removed to release the plunger (Col. 19 lines 41-52).
With regard to claim 34, the needle shield assembly includes 526 and resilient member 538 taken as a secondary spring (Figs. 10-12).
With regard to claim 35, the shield can also be taken to include 522 which moves within 580 to actuate the spring (Col. 20 lines 34-45).
With regard to claim 37, member 522 is cylindrical tube and the interior space is taken as a channel.
With regard to claim 38, Sarnoff et al. teach a medication mixing and delivery system comprising: a housing (Fig. 10 member 580) containing a first chamber (Fig. 10 member 546) and a second chamber (Fig. 10 member 532), the first chamber having an outlet and the second chamber having an inlet (outlet is distal opening of 546 inlet is proximal opening of 532); a first medicament component provided in the first chamber (Col. 18 lines 58-60); a second medicament component provided in the second chamber, the second medicament component being dry (Col. 18 lines 42-44); a valve assembly disposed between the first chamber and the second chamber, the valve assembly being configured to move between an open state wherein the outlet of the first chamber is aligned with the inlet of the second chamber (the inlet and outlet are aligned along the longitudinal axis) to selectively allow fluid communication between the first chamber and the second chamber, and a closed state to prevent fluid communication between the first chamber and the second chamber (Fig. 10 members 548 and 550, see transition to Fig. 11, Col. 19 line 60-Col. 20 line 2, the valve moves between closed and open positions); a first displacement mechanism, the first displacement mechanism being provided6App No.: 16/423,344 Docket No.: Wind-024-PCT-US-Cont-2in association with the first chamber (Fig. 10 member 554); a second displacement mechanism, the second displacement mechanism being provided in association with the second chamber (Figs. 10-12 member 542); a first actuation assembly coupled to a pre-stored energy source provided within the housing and associated with the first displacement mechanism, whereupon actuation of the first actuation assembly causes the pre-stored energy source to release a first portion of energy and the first displacement mechanism to displace the first medicament component from the first chamber into the second chamber so as to mix with the second medicament component thus resulting in a mixed medicament compound (Fig. 10 member 518 release spring 564, Col. 19 lines 41-52, Col. 20 lines 10-18); and a needle assembly in fluid communication with the second chamber (Fig. 10 member 536). Sarnoff et al. do not specifically disclose the dry medicament is an epinephrine compound. However, Buchine et al. teach epinephrine is a beneficial substance that is suitable and desirable as medicament to deliver as a dry component which must be mixed prior to injection as liquid epinephrine suffers from limitations regarding shelf-life and exposure limitations and providing it in a dry form helps ensure it is fresh and potent when used ([0015], [0016], [0019]). 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 epinephrine as the dry medicament in Sarnoff et al. as Buchine et al. teach epinephrine is a beneficial treatment substance and providing it as a dry substance is desired as this ensures freshness and potency. Sarnoff et al. do not show how the outlet of the first chamber is misaligned with the inlet of the second chamber in the closed state. However, Harper et al. teach a mixing syringe in which the valve includes 147 which operates to open and close the connection between the chambers ([0066]) which results in alignment and misalignment between the inlet and outlet (see Reference Figure 1 above, Fig. 7 shows the misaligned position the inlet faces in an opposing direction from the outlet as shown, the inlet and outlet are separated and not in connection with each other and are misaligned as the openings do not intersect, Fig. 8 shows the aligned position in which the openings connect). 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 an outlet of the first chamber (modify 550 of Sarnoff et al.) and configure the seal of the second chamber (modify 542 of Sarnoff et al.) in Sarnoff et al. to have an inlet, outlet, and valve assembly as in Harper et al. as this would yield the same predictable result of allowing the components to mix and would provide equivalent device operation.
With regard to claims 39 and 40, see Fig. 10 includes components of the second releasing assembly 520, Col. 19 lines 21-35, Col. 20 lines 30-56.
With regard to claims 41 and 42, a first actuation assembly can be considered to include 580, 522, and 518 which includes cap 576 which is capable of being rotated and is removed to release the plunger (Col. 19 lines 41-52).
Allowable Subject Matter
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed October 21, 2025 have been fully considered but they are not persuasive. Applicant argues the structure of Sarnoff is not a valve but rather a piercing mechanism that opens communication between chambers. As it opens communication the Examiner maintains this function as a valve to selectively transition flow conditions. Regardless, Sarnoff is not relied upon alone to teach a valve. Further, Harper is relied upon to teach additional limitations regarding the valve. The references are considered together. Applicant argues Harper combines separate embodiments; it is not clear where the embodiments are combined. Applicant argues Sarnoff cannot be modified with Harper as it would require a redesign and would no longer function as intended. It is not clear why Sarnoff would not function as intended, instead of the piercing the piston in Sarnoff to open communication, the very similar tip of Harper is moved in conjunction with a piston to open flow through the piston. The Examiner finds the same result would occur and the device would function as intended to mix components for delivery. Regarding Applicant’s request for interview, if Applicant would like to discuss the Application, they are invited to contact the Examiner by phone prior to filing a formal response.
Response to Amendment
The affidavit under 37 CFR 1.132 filed October 21, 2025, which appears to be a resubmission of the affidavit filed February 24, 2023, is insufficient to overcome the rejection of claims 21-35 and 37-42 based upon 35 U.S.C. 103 as set forth in the last Office action because: Sarnoff is relied upon in conjunction with Harper to teach the full features of the valve. As such the arguments to Sarnoff alone are moot. The piercing of Sarnoff through the piston is substituted for the features of Harper. Harper is not addressed in the affidavit. Generally, the Examiner would note the affidavit contends there is a release in Sarnoff but no control, Sarnoff controls when the release occurs, the Examiner finds this to control the movement/flow of the substances. The Examiner maintains a pre-existing passage is not a requirement of a valve. The affidavit contends valves which re-seal are not valves but rather a different category of device, again the Examiner maintains these control flow in line with the definitions noted in the affidavit.
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.
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, 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