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 .
Acknowledgments
In the reply, filed on August 6, 2026, Applicant amended claims 1 and 14-15.
Applicant cancelled claims 2 and 12.
Applicant added new claims 47-53.
In the non-final rejection of May 13, 2026, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant cited the indicated references in an information disclosure statement. Concern is withdrawn.
Examiner noted that the information disclosure statement filed October 30, 2023, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant argued: The typographical error for U.S. Patent No. 5,971,953 Bachynsky has been corrected on the attached PTO/SB/08 (Remarks, page 11). However, Examiner did not cite US 5,971,953. Examiner cited US 6,149,626 for having the incorrect name of patentee. Concern is maintained.
Examiner noted that the information disclosure statement filed October 30, 2023, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address the concern. Concern is maintained.
Examiner noted that the information disclosure statement filed October 30, 2023, fails to comply with 37 CFR 1.98(a)(2). Applicant provided copies of the indicated references. Concern is withdrawn.
Examiner objected to the Drawings under 37 CFR 1.83(a). Applicant cancelled claim 12. Objection is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claim 15. Applicant amended claim 15. Objection is withdrawn.
Examiner rejected claim 14 under 35 U.S.C. 112(b). Applicant amended claim 14. Rejection is withdrawn.
Election/Restrictions
Newly submitted claims 50-53 are directed to inventions (Figures 2-23; 24-33) that lack unity with the invention (Figures 50-68) originally claimed for the following reasons:
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Figures 2-23
Figures 24-33
Figures 50-68
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Species I-III lack unity of invention because even though the inventions of these groups require the technical features of an apparatus comprising a housing, a medicament container, an elastomeric member, a medicament container gas chamber, a needle assembly, a needle, a flow restriction assembly, and an energy storage member, these technical features are not special technical features as they do not make a contribution over the prior art in view of Blondino et al (US 10,695,495).
Blondino et al teaches an apparatus (Figures 11-65) comprising a housing (1100), a medicament container (1210), an elastomeric member (1220), a medicament container gas chamber (1211), a needle assembly (1240), a needle (1240), a flow restriction assembly (1550), and an energy storage member (1580).
Since Applicant has received an action on the merits for the originally presented invention (Figures 50-68), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 50-53 are withdrawn from consideration as being directed to nonelected inventions (Figures 2-23; 24-33). See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.[AltContent: rect]
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement filed October 30, 2023, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 6,149,626 has been provided with the incorrect name of patentee of Rachynsky et al. The correct name of patentee for US 6,149,626 is Bachynsky et al. Thus, it is unclear whether Applicant is intending to cite US 6,149,626 or another document to Rachynsky et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed October 30, 2023, 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. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation for understanding of DE 2019296 has been provided
No English translation for understanding of FR 1514210 has been provided
No English translation for understanding of FR 2509615 has been provided
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 15 and 48-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blondino et al (US 10,695,495).
In regards to claim 15, Blondino et al teaches an apparatus (Figures 11-65), comprising:
a housing (1100) defining a primary gas chamber (1132) and an insertion gas flow path (part of 1141)
a medicament container (1210) disposed within the housing, the medicament container containing a medicament (1226) and including an elastomeric member (1220) that seals the medicament within the medicament container, the medicament container and the elastomeric member defining a medicament container gas chamber (1211)
a needle assembly including a needle carrier (1260) and a needle (1240) coupled to the needle carrier, the needle carrier being coupled to the medicament container by a flexible coupling member (1267), the needle carrier defining a portion of a boundary of a needle actuation gas chamber (1268), the needle carrier being configured to move within the housing been between a first needle carrier position (Figure 60) and a second needle carrier position (Figures 62-63), the needle being within the housing when the needle carrier is in the first needle carrier position (Figure 60), the needle being outside of the housing when the needle carrier is in the second needle carrier position (Figures 62-63)
a flow restriction assembly (1550) disposed within the housing, the flow restriction assembly defining a portion of a boundary of the primary gas chamber and a delivery gas flow path, the flow restriction assembly configured to move within the housing to move the medicament container between a first container position (Figure 58) and a second container position (Figures 62-63)
an energy storage member (1580) configured to produce a pressurized gas when the energy storage member is actuated, the pressurized gas flowing into the primary gas chamber to move the medicament container from the first container position (Figure 58) to the second container position (Figures 62-63), a first portion of the pressurized gas flowing within the insertion gas flow path and into the needle actuation gas chamber to move the needle carrier from the first needle carrier position (Figure 60) to the second needle carrier position (Figures 62-63), a second portion of the pressurized gas flowing through the delivery gas flow path and into the medicament container gas chamber to move the elastomeric member within the medicament container (Figures 62-63)
In regards to claim 48, Blondino et al teaches wherein: the housing and the flow restriction assembly define an intermediate gas flow path (1104) disposed downstream of the primary gas chamber and fluidly coupling the primary gas chamber to the insertion gas flow path and the delivery gas flow path.
In regards to claim 49, Blondino et al teaches wherein the flow restriction assembly includes: an assembly body (1550) having a first outer surface (1552) coupled to the medicament container and a second outer surface (1551) that forms the portion of the boundary of the primary gas chamber, the assembly body having an inner surface at least partially defining the delivery gas flow path (Figure 32); a flow restriction member (1570) within the delivery gas flow path, the flow restriction member being configured to regulate a flow of the second portion of the pressurized gas into the medicament container gas chamber that acts on the elastomeric member; and a restriction member access cover (1554/1556) coupled to the assembly body, the restriction member access cover and the assembly body defining the delivery gas flow path (Figure 32).
Response to Arguments
Applicant's arguments filed August 6, 2026, have been fully considered but they are not persuasive:
In regards to claim 15, Applicant argued: With this response, independent claim 15 is amended to recite that the needle carrier is coupled to the medicament container by a "flexible coupling member." Blondino makes no mention nor suggestion of a "coupling member," much less a "flexible coupling member" as required by amended independent claim 15. In the Office Action, the first portion (1267) of an inner surface (1266) of a container mounting portion 1265 of the carrier (1260) (See col. 26 In. 62 to col. 27 In. 3) is identified as being equivalent to the claimed coupling member. Blondino does not teach nor suggest that the first portion (1267) is flexible. To the contrary, rigidity is suggested by the statement "the container-mounting portion 1265 of the carrier 1260 can selectively engage a corresponding portion of the medicament container 1210 to at least temporarily maintain the medicament container 1210 in a fixed position relative to the carrier 1260." (See, col. 27 In. 14-18.) Therefore, the cited references, alone and in combination fail to teach or suggest each and every element of independent claim 15. Accordingly, Applicant respectfully requests that the rejection of independent claim 15 be withdrawn and independent claim 15 and the claims that depend therefrom be allowed (Remarks, page 13). Examiner disagrees. Blondino et al teaches the needle carrier (1260) being coupled to the medicament container (1210) by a flexible coupling member (1267). Further, Blondino et al states: Any of the devices and/or medicament containers shown and described herein can be constructed from any suitable material. Such materials include glass, plastic (including thermoplastics such as cyclic olefin copolymers), or any other material used in the manufacture of prefilled syringes containing medications (column 51, lines 47-52). As 1267 is part of the device (Figures 11-65), it is understood that 1267 is made of glass, plastic (including thermoplastics such as cyclic olefin copolymers), or any other material used in the manufacture of prefilled syringes containing medications. It is known in the art that glass and plastic (including thermoplastics such as cyclic olefin copolymers) can have some level of flexibility, thus it is understood that 1267 is flexible.
Allowable Subject Matter
Claims 1, 3-11, and 13-14 are allowed.
In regards to independent claim 1, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an apparatus, as claimed, specifically including the first portion of the pressurized gas having a pressure that is greater than a pressure of the second portion of the pressurized gas.
Blondino et al (US 10,695,495) teaches an apparatus (Figures 11-65) comprising: an energy storage member (1580) configured to produce a pressurized gas when the energy storage member is actuated, the pressurized gas flowing into the primary gas chamber (1132) to move the medicament container (1210) from the first container position (Figure 58) to the second container position (Figures 62-63), a first portion of the pressurized gas flowing within the insertion gas flow path (part of 1141) and into the needle actuation gas chamber (1268) to move the needle carrier (1260) from the first needle carrier position (Figure 60) to the second needle carrier position (Figures 62-63), a second portion of the pressurized gas flowing through the delivery gas flow path and into the medicament container gas chamber (1211) to move the elastomeric member (1220) within the medicament container (Figures 62-63).
However, Blondino et al does not teach the first portion of the pressurized gas having a pressure that is greater than a pressure of the second portion of the pressurized gas, as Blondino et al instead teaches the first portion of the pressurized gas having a pressure that is less than a pressure of the second portion of the pressurized gas: the gas pressure within the medicament cavity 1141 can exert an insertion force sufficient to overcome a reaction force exerted by the bias member 1295 of the medicament container assembly 1200. In response to the insertion force, the medicament container 1210, the carrier 1240 and the needle 1240 contemporaneously move within the housing 1100 in the distal direction. The movement of the needle 1240 in a distal direction causes the distal end portion 1242 of the needle 1240 to exit the housing 1100 and enter the body of a patient prior to administering the medicament, thereby placing the medical injector 1000 in the sixth configuration. The insertion force associated with the gas pressure causes the carrier 1260 and the medicament container 1210 to move within the medicament cavity 1141 a predetermined distance (to facilitate needle insertion). In some embodiments, the predetermined distance can be associated with a position at which the carrier 1260 is in contact with the housing 1100, thereby completing the needle insertion operation. As such, further distal movement of the carrier 1260, the medicament container 1210 and/or the needle 1240 is substantially prevented.
With the medicament container 1210 in a distal position (the needle fully inserted), the gas within the medicament cavity 1141 continues to apply gas pressure to the medicament container 1210 including a proximal surface of the first elastomeric member 1220. Thus, when the gas pressure within the medicament cavity 1141 exceeds a given threshold, the gas pressure exerts an injection force on the first elastomeric member 1220 sufficient to move the first elastomeric member 1220 in the distal direction within the medicament container 1210. As shown in FIG. 62, the first elastomeric member 1220 can be in contact with the second elastomeric member 1221 such that the gas pressure exerts a force sufficient to move both the elastomeric members 1220 and 1221 in the distal direction. The distal movement of the elastomeric members 1220 and 1221 generates a pressure upon the medicament contained within the medicament container 1210, thereby allowing at least a portion of the medicament to flow out of the medicament container 1210 via the needle 1240, as indicated by the arrow JJ in FIG. 63. Furthermore, when the elastomeric members 1220 and 1221 are disposed in a distal position within the medicament container 1210, the medical injector 1000 has delivered a dose of the reconstituted medicament. As such, the medical injector 1000 is placed in the seventh configuration (FIG. 63) (column 44, lines 37-67, to column 45, lines 1-15).
Thus, independent claim 1 is allowed. Dependent claims 3-11 and 13-14 are allowed by virtue of being dependent upon independent claim 1.
Claim 47 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.
In regards to dependent claim 47, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an apparatus, as claimed, specifically including wherein the first portion of the pressurized gas has a pressure that is greater than a pressure of the second portion of the pressurized gas.
Blondino et al does not teach wherein the first portion of the pressurized gas has a pressure that is greater than a pressure of the second portion of the pressurized gas, as Blondino et al instead teaches wherein the first portion of the pressurized gas has a pressure that is less than a pressure of the second portion of the pressurized gas: the gas pressure within the medicament cavity 1141 can exert an insertion force sufficient to overcome a reaction force exerted by the bias member 1295 of the medicament container assembly 1200. In response to the insertion force, the medicament container 1210, the carrier 1240 and the needle 1240 contemporaneously move within the housing 1100 in the distal direction. The movement of the needle 1240 in a distal direction causes the distal end portion 1242 of the needle 1240 to exit the housing 1100 and enter the body of a patient prior to administering the medicament, thereby placing the medical injector 1000 in the sixth configuration. The insertion force associated with the gas pressure causes the carrier 1260 and the medicament container 1210 to move within the medicament cavity 1141 a predetermined distance (to facilitate needle insertion). In some embodiments, the predetermined distance can be associated with a position at which the carrier 1260 is in contact with the housing 1100, thereby completing the needle insertion operation. As such, further distal movement of the carrier 1260, the medicament container 1210 and/or the needle 1240 is substantially prevented.
With the medicament container 1210 in a distal position (the needle fully inserted), the gas within the medicament cavity 1141 continues to apply gas pressure to the medicament container 1210 including a proximal surface of the first elastomeric member 1220. Thus, when the gas pressure within the medicament cavity 1141 exceeds a given threshold, the gas pressure exerts an injection force on the first elastomeric member 1220 sufficient to move the first elastomeric member 1220 in the distal direction within the medicament container 1210. As shown in FIG. 62, the first elastomeric member 1220 can be in contact with the second elastomeric member 1221 such that the gas pressure exerts a force sufficient to move both the elastomeric members 1220 and 1221 in the distal direction. The distal movement of the elastomeric members 1220 and 1221 generates a pressure upon the medicament contained within the medicament container 1210, thereby allowing at least a portion of the medicament to flow out of the medicament container 1210 via the needle 1240, as indicated by the arrow JJ in FIG. 63. Furthermore, when the elastomeric members 1220 and 1221 are disposed in a distal position within the medicament container 1210, the medical injector 1000 has delivered a dose of the reconstituted medicament. As such, the medical injector 1000 is placed in the seventh configuration (FIG. 63) (column 44, lines 37-67, to column 45, lines 1-15).
Thus, dependent claim 47 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 15.
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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
