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. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,744,777 (the ‘777 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-5 are recited by claims 1-5 of the ‘777 patent. Therefore, in making or using the invention of claims 1-5 of the ‘777 patent, one of ordinary skill in the art would also make or use the invention of claims 1-5.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 10,507,285 to Dunki-Jacobs et al. (Dunki-Jacobs) in view of US Patent 9,895,487 to Duncan (Duncan).
Regarding claim 1, Dunki-Jacobs discloses a disposable fluid transfer device (208) comprising an injector support surface (surface on which injector 203 is supported) configured to receive an injection device (203) thereon, a fluid transfer port (shown in Fig. 21; the port leading into the lower end of injector 203) extending upwardly from the support surface for transfer of liquid into an injection device when received on the support surface, a lyophilized drug vial adapter (adapter holding vial 202M) configured to receive a vial containing a lyophilized drug (202M), a diluent vial adapter (adapter holder vial 202D) configured to receive a vial containing a diluent (202D), a fluid flow path (shown in Fig. 21). Dunki-Jacobs does not disclose a syringe adapter configured to receive a syringe and the fluid flow path may be placed in communication between the lyophilized drug vial adapter and syringe adapter, between the diluent vial adapter and the syringe adapter and between the syringe adapter and the fluid transfer port, and a manual valve in the fluid flow path for selectively placing the diluent vial adapter in communication with the syringe adapter, placing the lyophilized drug vial adapter in communication with the syringe adapter or placing the syringe adapter in communication with fluid transfer port. Duncan teaches a fluid transfer device including a syringe adapter (adapter to which syringe T is connected) configured to receive a syringe (T) and a fluid flow path (path connecting the vial(s), syringe(s) and fluid outlet) may be placed in communication between the drug vial adapter and syringe adapter, between the diluent vial adapter and the syringe adapter and between the syringe adapter and the fluid transfer port (by turning the valve to the various positions, each of these connections can be made; see Figs. 2, 5 and 8), and a manual valve (60) in the fluid flow path for selectively placing the diluent vial adapter in communication with the syringe adapter, placing the lyophilized drug vial adapter in communication with the syringe adapter or placing the syringe adapter in communication with fluid transfer port (Figs. 2, 5 and 8) such that the drug can be mixed without the need for a power source (see title). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dunki-Jacobs to include a syringe, manual valve and flow path as taught by Duncan such that the drug can be mixed manually without the need for a power source or pressure cylinder.
Regarding claim 2, Dunki-Jacobs further discloses a releasable harness (see Figs. 22 and 23; the harness is not labeled but is shown in the figures securing the top of the injector 203 to the fluid transfer device 208) for holding an injection device coupled to the transfer device.
Regarding claim 3, Dunki-Jacobs further discloses an injection device (203) coupled thereto and releasably held in the coupled position.
Regarding claim 4, Dunki-Jacobs further discloses the injection device includes and internal resilient expandable member (col. 14, lines 47-49) and a filling port (shown in Fig. 21) for introducing liquid into the expandable member and wherein the fluid transfer port of the transfer device extends into the filling port when the injection device is coupled to the transfer device.
Regarding claim 5, Dunki-Jacobs further discloses the support has an upper face and a lower face (upper and lower faces shown in Fig. 22-23), the injection device being receivable against the upper face (Figs. 22-23). Dunki-Jacobs does not disclose the valve and fluid flow path being carried on the lower face of the support surface. However, there are a limited number of places the valve and flow path can be located (i.e. upper face, lower face, or a combination thereof). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to carry the valve and flow path on the lower face, since it has been held that a mere rearrangement of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04(VI)(C). Such a change requires only selecting one of a number of identified, predictable solutions with a reasonable expectation of success. Further, positioning the manual valve and flow path in which the valve is located on the lower face keeps the vials and injection device clear of the valve so that the valve is more easily accessible to the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLAS A ARNETT whose telephone number is (571)270-5062. The examiner can normally be reached M- F, 8AM - 3PM.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 December 22, 2025