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 .
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 5-6, in the reply filed on 08/06/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2024, 06/16/2026, and 08/05/2026 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
As to the limitation of ‘configured to inject a liquid pharmaceutical composition into an injection target without using an injection needle’, ‘for ejecting the liquid pharmaceutical composition toward the injection target’, and ‘for pressurizing the liquid pharmaceutical composition contained in the storage section during operation, thereby ejecting the liquid pharmaceutical composition from the ejection port toward the injection target’, it is noted that the instant claims are composition claims and future intended use, such as the use of the injector to inject a liquid pharmaceutical into a target, is not given patentable weight. Thus, any composition comprising an injector comprising: a storage section containing the liquid pharmaceutical composition; a nozzle section communicating with the storage section, the nozzle section having an ejection port; and a pressurization section, wherein the liquid pharmaceutical compositions contains a nucleic acid and a divalent cation, and a total concentration of the divalent cation is 0.0406 mM or more and less than 81.1 mM, will meet this limitation.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Oda (EP2620175A1, published 01/10/2018, hereafter Oda) in view of Pitard (FR2868953A1, published 10/21/2005, Google English translation, hereafter Pitard).
In regards to instant claim 5, Oda claims a syringe for injecting an injection objective substance into an injection target area of a living body without using an injection needle, the syringe comprising: an ignition device which include an ignition charge containing a fuel component and an oxidizing agent component; a combustion chamber into which a combustion product produced by a reaction of the fuel component and the oxidizing agent component during combustion of the ignition charge is allowed to flow and which accommodates a gas generating agent that is combustible by the combustion product to generate a predetermined gas; an enclosing unit which encloses the injection objective substance; a pressurizing unit which is constructed to pressurize the injection objective substance enclosed in the enclosing unit by means of a pressure in the combustion chamber; and a flow passage unit which defines a flow passage so that the injection objective substance, which is pressurized by the pressurizing unit, is allowed to inject to the injection target area of the living body (claim 1). Figure 7(a) of Oda demonstrates a sample syringe which has a combustion chamber (9) so that the pressure is applied to the injection solution enclosed in the through hole (14) by the aid of the piston (6) ([0052]). Further Figure 7(a) of Oda teaches as a result, the injection solution ML is pushed or extruded to the forward end side of the syringe 1 together with the sealing members (7, 8) ([0052]). Then Figure 7(a) of Oda teaches when the sealing member 8 is accommodated in the recess (10), then the injection solution ML passes through the flow passage (11) and the nozzles (4), and the injection solution ML is allowed to inject to the injection target ([0052]). Oda teaches the objective substance can be a liquid ([0015-0016]). Oda teaches the syringe may be used to deliver DNA to cells or tissue ([0092]). Oda further teaches the syringe can be preferably used for directly delivering an antigen gene is administered in order to enhance the immunity against the pathogen (aka vaccine) ([0093]). Lastly, Oda teaches the uses of nucleic acid injected into the dermis ([0057] and [0059]).
Although Oda teaches the use of the syringe for delivery of nucleic acid, DNA and vaccines, it fails to teach the nucleic acid/DNA/vaccine is in a mixture with a cation at the desired concentration as claimed by instant claims 5-6.
In regards to instant claim 5, Pitard claims a composition for the intracellular transfer of nucleic acid (title). Pitard claims the composition comprises an effective amount of nucleic acid and an effective amount of at least one inorganic cation salt (claim 1). Further, Pitard claims comprises 0.5 to 6 mmol of divalent cation (claim 7). Pitard teaches the formulations are in the form of an injectable formulation into the desired organ, into a skeletal muscle for example, or in a form suitable for topical administration (on skin and / or mucosa) (page 5, paragraph 7). Pitard teaches the invention is particularly interesting for gene therapy, specifically vaccination (page 2, description, paragraph 3). Lastly, Pitard teaches the combination of an effective amount of inorganic cation and copolymer effects the efficiency for intracellular transfection of nucleic acid (page 2, description, paragraph 13).
In regards to instant claim 6, Pitard claims the divalent cations are chosen from Ca++ and Mg++ cations and their mixtures (claim 6).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a syringe with the delivery of a nucleic acid composition to the dermis as outlined by Oda by addition of a cation such as Mg++ or Ca++ at a concentration of 0.5 to 6 mmol (0.5 to 6 mM) to the nucleic acid composition as outlined by Pitard under TSM, see MPEP 2143(G). As outlined by Pitard, adding an effective amount of cation effects the efficiency for intracellular transfection of nucleic acid which would motivate someone skilled in the art to advantageously combine a cation with the syringe nucleic acid composition of Oda as it would have a reasonable expectation of success.
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 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 9-11 of copending Application No. 18/867,730 (reference application) in view of Pitard (FR2868953A1, published 10/21/2005, Google English translation, hereafter Pitard). Although the claims at issue are not identical, they are not patentably distinct from each other.
18/867,730 claims an injector configured to inject a liquid pharmaceutical composition into an injection target without using an injection needle, the injector comprising: a storage section containing the liquid pharmaceutical composition; a nozzle section communicating with the storage section, the nozzle section having an ejection port for ejecting the liquid pharmaceutical composition toward the injection target; and a pressurization section for pressurizing the liquid pharmaceutical composition contained in the storage section during an operation, thereby ejecting the liquid pharmaceutical composition from the ejection port toward the injection target, wherein the liquid pharmaceutical composition contains a biofunctional substance, and has an osmotic pressure of more than 400 mOsmol/kg and 1000 mOsmol/kg or less (claim 11). Claim 1 of 18/867,730 claims a liquid pharmaceutical composition comprising a biofunctional substance that is injected into an injection target by an injector configured to inject the liquid pharmaceutical composition into the injection target without using an injection needle. Claim 2 of 18/867,730 claims the composition comprises a pharmacologically acceptable agent and claim 10 claims the biofunctional substance is a nucleic acid. Claim 9 of 18/867,730 claims the liquid pharmaceutical composition, wherein the injection into the injection target using the injector configured to inject the liquid pharmaceutical composition into the injection target without using an injection needle is injection into injection target by jet injection.
18/867,730 claims a nucleic acid injector, however it fails to claim the addition of a cation at the desired concentration as claimed by instant claims 5-6.
In regards to instant claim 5, Pitard claims a composition for the intracellular transfer of nucleic acid (title). Pitard claims the composition comprises an effective amount of nucleic acid and an effective amount of at least one inorganic cation salt (claim 1). Further, Pitard claims comprises 0.5 to 6 mmol of divalent cation (claim 7). Pitard teaches the formulations are in the form of an injectable formulation into the desired organ, into a skeletal muscle for example, or in a form suitable for topical administration (on skin and / or mucosa) (page 5, paragraph 7). Pitard teaches the invention is particularly interesting for gene therapy, specifically vaccination (page 2, description, paragraph 3). Lastly, Pitard teaches the combination of an effective amount of inorganic cation and copolymer effects the efficiency for intracellular transfection of nucleic acid (page 2, description, paragraph 13).
In regards to instant claim 6, Pitard claims the divalent cations are chosen from Ca++ and Mg++ cations and their mixtures (claim 6).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a injector with the delivery of a nucleic acid composition as outlined by 18/867,730 by addition of a cation such as Mg++ or Ca++ at a concentration of 0.5 to 6 mmol (0.5 to 6 mM) to the nucleic acid composition as outlined by Pitard under TSM, see MPEP 2143(G). As outlined by Pitard, adding an effective amount of cation effects the efficiency for intracellular transfection of nucleic acid which would motivate someone skilled in the art to advantageously combine a cation with the syringe nucleic acid composition of 18/867,730 as it would have a reasonable expectation of success.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611
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