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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
Paragraph [1310]: International Application No. PCT/US2018/013855, U.S. Patent Application No. 15/872,162 (now U.S. Patent No. 10,332,623), U.S. Patent Application No. 16/421,639 (now U. S. Patent No. 10,937,537), U.S. Patent Application No. 17/186,896
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
The information disclosure statement filed October 30, 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 has been placed in the application file, but the information referred to therein has not been considered:
No copy of WO 2005/050526 has been provided
No copy of WO 2016/160341 has been provided
No copy of International Search Report and Written Opinion for PCT/US2022/028334 has been provided
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, an actuation solenoid (claim 12, line 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 3, “it” should be changed to “the needle coupling member”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 15 is objected to because of the following informalities:
In regards to claim 15, line 8, “medicament container” should be changed to “the medicament container”.
In regards to claim 15, line 14, “with” should be changed to “within”.
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.
Claim 14 is 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.
In regards to claim 14, line 4 recites “a first substance”. Claim 14 depends upon claim 1. Claim 1, lines 3-4 recite “a medicament”. It is unclear whether the two terms are related or different.
In regards to claim 14, lines 5-6 recite “a second substance”. Claim 14 depends upon claim 1. Claim 1, lines 3-4 recite “a medicament”. It is unclear whether the two terms are related or different.
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 1, 3-11, and 13-15 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 1, 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) 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 defining a portion of a boundary of a needle actuation gas chamber (1268), the needle carrier configured to move within the housing 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), the needle carrier being in fluid communication with the medicament container when the medicament container is in the 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 3, Blondino et al teaches a medicament coupling member (1267) having a first end portion and a second end portion and defining a flow passageway between the first end portion and the second end portion (Figure 39), the medicament container movably coupled to the first end portion of the medicament coupling member between the first container position (Figure 58) and the second container position (Figures 62-63), wherein when the medicament container is in the first container position the medicament container is fluidically isolated from the flow passageway (Figure 58), when the medicament container is in the second container position the medicament container is in fluid communication with the flow passageway (Figures 62-63); and wherein the needle carrier is coupled to the second end portion of the medicament coupling member to place the needle in fluid communication with the flow passageway (Figures 62-63).
In regards to claim 4, Blondino et al teaches wherein: the needle assembly is coupled to the medicament coupling member via a flexible member (1268) positioned between the second end portion and the needle assembly (Figure 39).
In regards to claim 5, 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 6, Blondino et al teaches wherein: the insertion gas flow path is configured in a parallel arrangement with the delivery gas flow path (Figures 62-63).
In regards to claim 7, 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).
In regards to claim 8, Blondino et al teaches a retraction spring (1295) configured to move the needle assembly towards the first needle carrier position (Figure 65).
In regards to claim 9, Blondino et al teaches an expandable assembly being configured to transition from a first configuration to a second configuration when the elastomeric member moves within the medicament container, the expandable assembly including: a first member coupled to the elastomeric member, a second member coupled to the first member, and a valve member coupled to the second member, the valve member configured to move from a first valve position to a second valve position when the expandable assembly transitions from the first configuration to the second configuration to release the pressurized gas from the primary gas chamber to an exterior volume surrounding the housing (column 45, lines 52-66).
In regards to claim 10, Blondino et al teaches wherein: the housing defines a vent portion circumscribing the valve member, the vent portion defining an inlet orifice in fluid communication with the primary gas chamber and an outlet orifice in fluid communication with the exterior volume; the valve member includes a first seal member positioned between the inlet orifice and the medicament container gas chamber to fluidically isolate the medicament container gas chamber from the inlet orifice and the outlet orifice; the valve member includes a second seal member positioned between the inlet orifice and the outlet orifice when the valve member is in the first valve position to fluidically isolate the primary gas chamber from the exterior volume; and the second seal member being positioned between the inlet orifice and the medicament container gas chamber when the valve member is in the second valve position to place the primary gas chamber in fluid communication with the exterior volume (column 45, lines 52-66)(column 46, lines 8-13).
In regards to claim 11, Blondino et al teaches a system actuation assembly, the system actuation assembly including: an input surface (1510) configured to receive a force input, and an inclined plane (1570) coupled to the input surface, the inclined plane being positioned to develop a linear motion of the energy storage member in response to the force input (column 43, lines 61-66).
In regards to claim 13, Blondino et al teaches wherein the medicament container is a first medicament container containing a first portion of the medicament (1226), the apparatus further comprising: a second medicament container containing a second portion of the medicament (1227).
In regards to claim 14, Blondino et al teaches wherein the elastomeric member is a first elastomeric member (1220), the medicament container further including: a second elastomeric member (1221), the first elastomeric member and the second elastomeric member defining, at least in part, a first volume containing a first substance (1226), the second elastomeric member and a portion of the medicament container defining a second volume containing a second substance (1227), a movement of the second elastomeric member placing the first volume in fluid communication with the second volume (Figure 59).
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) 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 coupled to medicament container by a coupling member (1267) that selectively places the needle in fluid communication with the medicament container, the needle carrier defining a portion of a boundary of a needle actuation gas chamber (1268), the needle carrier 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 is in the second needle carrier position (Figures 62-63)
a flow restriction assembly (1550) disposed with 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)
Claim Rejections - 35 USC § 103
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Blondino et al, as applied to claim 1 above, and further in view of Brown et al (WO 2011/005679).
In regards to claim 12, Blondino et al is silent about an actuation solenoid positioned to develop a linear motion of the energy storage member in response to an input signal. Brown et al teaches an apparatus (Figures 13-14) comprising an actuation solenoid (1372) positioned to develop a linear motion of an energy storage member (1370) in response to an input signal (page 22, lines 32-34, to page 23, lines 1-2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus, of Blondino et al, with an actuation solenoid, as taught by Brown et al, as such upon actuation, will release gas from the energy storage member to drive the elastomeric member and the medicament container (page 22, lines 32-34, to page 23, lines 1-2).
Allowable Subject Matter
Claim 2 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 2, 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 2 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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