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 .
Information Disclosure Statement
The information disclosure statement filed 10/14/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. The references crossed out have not been considered.
The information disclosure statement filed 12/28/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It also fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. The references crossed out have not been considered.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] refers to numerous applications that have been issued as patents; if an application has been issued as a Patent, paragraph [0001] should be updated to include the relevant patent number. Paragraph [0001] also refers to numerous applications by their attorney docket number; these references should be removed and each application should only be referred to by its US Patent Application Serial No. (and Patent no., if applicable). Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “plunger interior” on line 20 should be preceded by the article “the” since this feature has been introduced earlier in the claim. The term “member” should be inserted after the phrase “the distal stopper” on line 23 to match the language used earlier in the claim. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The term “member” should be inserted after the phrase “the distal stopper” on line 2 to match the language used in claim 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The phrase “the proximal and distal stoppers” on line 5 should be replaced with the phrase “the proximal and distal stopper members” to match the language used in claim 1. The term “comprising” on line 5 should be replaced with the term “comprises” in order to be grammatically correct. Appropriate correction is required.
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 1-19 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 the term “thereof” on line 3 but it is unclear whether this term is intended to refer to the “cylindrical injection body”, the “proximal opening”, or the “distal needle interface”. For the sake of examination, the term “thereof” is interpreted as referring to the “cylindrical injection body”. Accordingly, it is suggested to amend lines 2-3 to recite “a cylindrical injection body defining a proximal opening and a distal needle interface at a distal end of the cylindrical injection body”. Claims 2-19 are rejected due to their dependence on claim 1.
Claim 12 recites “respective opposing surfaces thereof” on line 6, but claim 12 earlier introduces “the proximal and distal stopper members each includes a respective opposing surface” on lines 1-2. It is unclear if the “respective opposing surfaces” of line 6 are intended to be the same as or different from those of lines 1-2. For the sake of examination, they are interpreted as being the same. Accordingly, it is suggested to amend line 6 to recite “the respective opposing surfaces
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 1-14 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8 and 11-18 of U.S. Patent No. 11,724,042. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the current claims is fully disclosed in the patented claims. Specifically, the subject matter of current claim 1 is fully disclosed in patented claim 1, the subject matter of current claim 2 is fully disclosed in patented claim 3, the subject matter of current claim 3 is fully disclosed in patented claim 3, the subject matter of current claim 4 is fully disclosed in patented claim 11, the subject matter of current claim 5 is fully disclosed in patented claim 15, the subject matter of current claim 6 is fully disclosed in patented claim 16, the subject matter of current claim 7 is fully disclosed in patented claim 17, the subject matter of current claim 8 is fully disclosed in patented claim 18, the subject matter of current claim 9 is fully disclosed in patented claim 12, the subject matter of current claim 10 is fully disclosed in patented claim 13, the subject matter of current claim 11 is fully disclosed in patented claim 14, the subject matter of current claim 12 is fully disclosed in patented claim 4, the subject matter of current claims 13 and 14 is fully disclosed in patented claim 5, and the subject matter of current claim 19 is fully disclosed in patented claim 8.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9-23 of U.S. Patent No. 10,864,330 in view of U.S. Patent No. 11,724,042. The subject matter of current claim 1 is fully disclosed in claim 1 of the ‘330 patent except that claim 1 of the ‘330 patent does not specify that the “syringe body” is “cylindrical”. However, the ‘042 patent teaches a cylindrical syringe body (claim 1). When modified by the ‘042 patent to include the syringe body as “cylindrical”, the subject matter of current claim 1 is fully disclosed in claim 1 of the ‘330 patent. Further, the subject matter of current claim 2 is fully disclosed in claim 2 of the ‘330 patent, the subject matter of current claim 3 is fully disclosed in claim 3 of the ‘330 patent, the subject matter of current claim 4 is fully disclosed in claim 16 of the ‘330 patent, the subject matter of current claim 5 is fully disclosed in claim 20 of the ‘330 patent, the subject matter of current claim 6 is fully disclosed in claim 21 of the ‘330 patent, the subject matter of current claim 7 is fully disclosed in claim 22 of the ‘330 patent, the subject matter of current claim 8 is fully disclosed in claim 23 of the ‘330 patent, the subject matter of current claim 9 is fully disclosed in claim 17 of the ‘330 patent, the subject matter of current claim 10 is fully disclosed in claim 18 of the ‘330 patent, the subject matter of current claim 11 is fully disclosed in claim 19 of the ‘330 patent, the subject matter of current claim 12 is fully disclosed in claim 9 of the ‘330 patent, the subject matter of current claim 13 is fully disclosed in claim 10 of the ‘330 patent, the subject matter of current claim 14 is fully disclosed in claim 11 of the ‘330 patent, the subject matter of current claim 15 is fully disclosed in claim 12 of the ‘330 patent, the subject matter of current claim 16 is fully disclosed in claim 13 of the ‘330 patent, the subject matter of current claim 17 is fully disclosed in claim 15 of the ‘330 patent, the subject matter of current claim 18 is fully disclosed in claim 14 of the ‘330 patent, and the subject matter of current claim 19 is fully disclosed in claim 4 of the ‘330 patent.
Allowable Subject Matter
Claims 1-19 would be allowable if rewritten or amended to overcome the objections, the 35 U.S.C. 112(b) rejections and the double patenting rejections set forth in this Office Action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claim 1 could not be found nor was suggested in the prior art of record.
Independent claim 1 requires a system for mixing drug products and injecting, comprising (a) a cylindrical injection body defining a proximal opening and a distal needle interface at a distal end of the cylindrical injection body, (b) proximal and distal stopper members disposed in the cylindrical injection body, wherein the stopper members form a proximal drug chamber therebetween and the distal stopper member and the distal end of the cylindrical injection body form a distal drug chamber therebetween, (c) a plunger member configured to insert the proximal stopper member relative to the cylindrical injection body, wherein the plunger member includes a plunger interior, a needle retention feature disposed in the plunger interior, an energy-storage member disposed in the plunger interior, and an energy-storage member latching member disposed in the plunger interior, (d) a needle hub assembly coupled to the distal needle interface of the cylindrical injection body and including a needle having a needle proximal end feature, a hub, and a needle latching member configured to couple the needle to the hub, wherein (e) the sizes of the drug chambers can be modified by movement of the stopper members relative to the cylindrical injection body, (f) the needle is at least partially retractable into the plunger interior upon insertion of the plunger member relative to the cylindrical injection body to transform the energy-storage member latching member from a latched state to an unlatched state, and (g) the distal stopper member includes a funnel disposed at its distal end that tapers in the proximal direction such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel.
The closest prior art of record is PG PUB 2013/0035664 to Mojdehbakhsh et al. which discloses a system 100 (best seen in Fig 1A,1B,3A,3B) comprising (a) a cylindrical injection body 150 defining a proximal opening (toward the top in the figures) and a distal needle interface (toward the bottom in the figures) at a distal end of the cylindrical injection body, (b) proximal and distal stopper members 160,170 disposed in the cylindrical injection body (as best seen in Fig 3A) wherein the stopper members form a proximal drug chamber therebetween (Para 68), (c) a plunger member 130+200 configured to insert the proximal stopper member relative to the cylindrical injection body (Para 76), wherein the plunger member includes a plunger interior (within 130), a needle retention feature 800 (best seen in Fig 4) disposed in the plunger interior (as seen in Fig 3A), an energy-storage member 270 (best seen in Fig 4) disposed in the plunger interior (as seen in Fig 3A), and an energy-storage member latching member 230 (best seen in Fig 4) disposed in the plunger interior (as seen in Fig 3A), (d) a needle hub assembly 400 coupled to the distal needle interface of the cylindrical injection body (as best seen in Fig 3A) and including a needle 410 having a needle proximal end feature 420, a hub 300, and a needle latching member 600 configured to couple the needle to the hub (as best seen in Fig 8), wherein (e) the sizes of the proximal drug chamber can be modified by movement of the proximal stopper members relative to the cylindrical injection body (Para 68), (f) the needle is at least partially retractable into the plunger interior upon insertion of the plunger member relative to the cylindrical injection body to transform the energy-storage member latching member from a latched state to an unlatched state (as seen in Fig 8; Para 82), However, Mojdehbakhsh does not disclose that the distal stopper member and the distal end of the cylindrical injection body form a distal drug chamber therebetween or that the distal stopper member includes a funnel disposed at its distal end that tapers in the proximal direction such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel. It would not have been obvious to modify Mojdehbakhsh to include a drug chamber between the distal stopper member and the distal end of the cylindrical injection body since no drug is intended to reside between the distal stopper member 170 and the distal end of the cylindrical injection body (Para 68) and it would not have been obvious to one of ordinary skill in the art to modify the distal stopper member 170 to include a funnel since the distal stopper member’s purpose is to cover apertures located on the inner barrel wall 111 (Para 68) and altering the interior shape of the distal stopper member would inhibit the ability of the distal stopper member to perform this function.
Other close prior art includes WO2015/164839 to Diaz et al. which discloses a first embodiment (Fig 54A-54P) which discloses features (a), (b), (d) and (e) and a second embodiment (Fig 59A-59L) which discloses features (a), (c), (d) and (f). Both of these embodiments lack feature (g) but this feature is not novel (see Fig 15 of US Pat 3,980,083 to Elliott, for example) and it would have been obvious to modify Diaz to include this feature to act as an entryway (Col 4, Lines 29-33). However, modification of the first embodiment in view of the second embodiment would not arrive at the claimed invention because Diaz discloses that it is the proximal stopper that acts as a needle retention feature [Para 125] while the claim requires both a proximal stopper and a separate needle retention feature. Therefore, Diaz does not teach a system comprising both stopper members and a needle retention feature as claimed. Additionally, a configuration wherein a needle proximal end feature penetrates two stopper members fully to reach a needle retention feature could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783