DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed August 9, 2025.
Election/Restrictions
1. Applicant’s election without traverse of Group II, claims 16-27, in the reply filed on August 9, 2025 is acknowledged. Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
2. Claims 16-27 are pending and currently under consideration for patentability.
Please note: While it is clear that applicant’s intention is to withdraw claims 1-15 via the August 9, 2025 election, the new claim set submitted on the same date continues to identify claims 1-15 as “(Original)” rather than “(Withdrawn)”. For the purpose of examination, claims 1-15 are considered as having the (Withdrawn) status identifier.
Priority
3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on April 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Double Patenting
5. 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.
6. Claims 16-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-15 and 17-18 of U.S. Patent No. 12,343,509. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 6-15 and 17-18 contain additional limitations requiring pressurized sterile liquid, rather than the pressurized sterile fluid of the instant claims, and is thus more specific, in effect making the invention of patented claims 6-15 and 17-18 a "species" of the "generic" invention of instant claims 16-27. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Allowable Subject Matter
7. Claims 16-27 are allowable over prior art; however, the claims remain rejected under double patenting, as outlined above, and this rejection must be overcome (i.e. via terminal disclaimer) prior to allowance.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Smith et al. (USPGPUB 2008/0097306), Reboul (US PGPUB 2004/0158204), and Perry, Jr. et al. (USPGPUB 2018/0239370).
Smith, while disclosing a similar package (12; abstract; [0022]; Fig. 1) comprising: a syringe assembly (10) comprising: a barrel (22) defining a chamber (14) therein; sterile fluid in the chamber (14; [0013]; [0022-0023]); a plunger (26) including a piston (24) slidable in the chamber (14) in a sealing relation to displace the fluid in the chamber (14; [0026]; [0029]; [0034]); and a needle assembly (23 and 16) extending distally from the barrel (22) and in fluid communication with the chamber (14) of the barrel (22; [0024]; [0026]), fails to reasonably disclose, alone or in combination, the unique combination of claimed structure; wherein sterile fluid within the chamber of the syringe assembly is pressurized sterile fluid which is retained in the chamber when the plunger is stationary, and a seal configured to retain the pressurized sterile fluid in the chamber between the piston of the plunger and the seal when the plunger is stationary.
Reboul, while disclosing a similar syringe assembly (4; Figs. 1, 4-8; [0037]; [0052]; [0091]) comprising: a barrel (43) defining a chamber (33) therein; sterile fluid ([0001-0002]) in the chamber (44; Fig. 5); a plunger including a piston (42) slidable in the chamber (44) in a sealing relation to displace a fluid in the chamber ([0083]; [0087]); and a needle assembly (41; 5; 6; 26; and 7) extending distally from the barrel (43) and in fluid communication with the chamber (44) of the barrel ([0081]; [0083]), fails to reasonably disclose, alone or in combination, the unique combination of claimed structure; wherein sterile fluid within the chamber of the syringe assembly is pressurized sterile fluid which is retained in the chamber when the plunger is stationary and a seal configured to retain the pressurized sterile fluid in the chamber between the piston of the plunger and the seal when the plunger is stationary. Since a vessel of Reboul is required in order to supply sterile air to the empty syringe within the kit, one having ordinary skill in the art would not look to Reboul and reasonably consider it obvious to supply the assembly with both a sterile fluid filled vessel and a pressurized fluid filled syringe assembly.
Perry, while disclosing similar syringe assembly (abstract; Figs. 15, 16): comprising a barrel (200) defining a chamber (203) therein; fluid in the chamber (203); a plunger (202) slidable in the chamber (203) in a sealing relation to displace the fluid in the chamber (203; [0069-0070]); a seal (fluid flow control apparatus, 10 and sealing ball, 70) configured to retain the fluid in the chamber (203) between the plunger (202) and the seal (10) when the plunger is stationary ([0005]; [0048]), fails to reasonably disclose, alone or in combination, the unique combination of claimed structure; wherein the fluid within the chamber of the syringe assembly is pressurized sterile fluid which is retained in the chamber when the plunger is stationary, and a seal configured to retain the pressurized sterile fluid in the chamber between the piston of the plunger and the seal when the plunger is stationary. While the seal disclosed by Perry is fully capable of retaining pressurized fluid within the chamber when the plunger is stationary by tailoring the seal to a specific cracking pressure, the prior art of record lacks an express teaching of pressurized sterile fluid retained within a syringe chamber of a syringe assembly, as instantly claimed.
This unique combination of claimed structure which is not disclosed or suggested by the prior art of record, alone or in combination, imparts a novel and non-obvious function of the claimed invention. Namely, such a configuration of claimed structure results in: an improved syringe assembly for pressurizing a medication vial, which eliminates the risk of transmission of pathogens and allows for safer delivery of medication to the patient; the syringe assembly being pre-equipped with pressurized sterile fluid in order to better facilitate sterile pressurization of the medication vial and in-turn better facilitate transfer of medication to the syringe assembly, as outlined by applicant in paragraph [0033] of the Specification, as originally filed.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
LaVallo et al. (US 5,000,738) discloses a protective syringe with frangible barrel.
Alchas (US PGPUB 2003/0075168) discloses a nasal-delivery device with spray nozzle.
Chhikara et al. (US PGPUB 2016/0206512) discloses pressure-regulating fluid transfer systems.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781