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 .
Election/Restrictions
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 27th, 2026.
Claims 1-15 and 20 are being examined in this application.
Claim Objections
Claims 6 and 15 are objected to because of the following informalities: typographical errors.
Claim 6 recites “all fluid paths of the medicament; and all medicament…”
Claim 15 recites “and/or interior thereof; wherein the barrier… in an air tight manner; and wherein the barrier…”
Examiner recommends adding a new line for every additional limitation listed after each semicolon “;”. 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 1-15 and 20 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.
Claims 1, 12 and 20 recite “the pod”. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “A medicament injector according to any claim 1…” in line 1. This is unclear because there is only one independent claim 1 from which the claim depends. For examination purposes, examiner interprets the claim to mean a medicament injector according to claim 1.
Claims 2-11 and 13-15 recite “A medicament injector…”. This is unclear since these claims are dependent. Examiner interprets the claims to mean the medicament injector.
Claims 8 and 10 recites “the cartridge (and/or syringe and needle assembly)” there is insufficient antecedent basis for this limitation in the claim. Additionally, the use of parentheses renders the claim indefinite, because it is unclear whether the enclosed text is an optional example or absolute limitation, thus failing to distinctly point out the claimed invention.
All remaining claims are also rejected as they depend from rejected independent claims. Appropriate action is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “barrier member is configured to…” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-9, 12, 14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 20230019820 A1, herein, Kim).
Regarding claim 1, Kim discloses a medicament injector (medicament injector 40 – Fig.1) comprising:
an applicator (a cartridge applicator 42 – Fig.1) including a drive element (plunger 44 – Fig.1); and
an interchangeable pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly loadable into the applicator so as to couple thereto, with subsequent retraction thereof actuating the drive element to engage the pod or cartridge assembly so as to output a medicament (medicament 92 – Fig.2) automatically therefrom (“the plunger shown in an injecting-position so as to direct medicament from within the cartridge through the valve body, through the medicament-output end”, see para [0031], Fig.19), with the applicator being configured to thereafter automatically eject the pod or cartridge assembly (“once the medicament from the pre-filled cartridge has fully been administered, the cartridge will automatically eject from the injector device and decouple”, see para [0186]).
Regarding claim 2, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to any claim 1, wherein loading of the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly into the applicator (a cartridge applicator 42 – Fig.1) functions to prime the drive element (plunger 44 – Fig.1) and/or store potential energy, and subsequent retraction of the pod or cartridge assembly into the applicator releases the stored potential energy and causes the drive element to engage with the pod or cartridge assembly so as to output the medicament (“once the cartridge is inserted and loaded into the accepting injector device, pressure applied to the front of the injector device (facing the patient) will further activate a mechanism to deliver the medicament”, see para [0178]).
Regarding claim 3, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein the energy required to manually insert the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly into the applicator (cartridge applicator 42 – Fig.1) is stored and subsequently released to automatically output the medicament from the pod or cartridge assembly (“once the cartridge is inserted and loaded into the accepting injector device, pressure applied... will further activate a mechanism to deliver the medicament”, see para [0178]). and thereafter automatically eject the pod or cartridge assembly from the applicator (“once the medicament from the pre-filled cartridge has fully been administered, the cartridge will automatically eject from the injector device and decouple”, see para [0186]).
Regarding claim 4, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein the drive element (plunger 44 – Fig.1) comprises spring (spring 84 – Fig.2) biased telescoping members which are movable from a primed or retracted position in a pre-injection mode, to an extended position in an injection mode (“the retaining member 76 is biased towards a closed or extended position, in which the catch extends within the cartridge-accepting receptacle 70, via a resilient member, in this example a spring 84”, see para [0107]).
Regarding claim 5, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein the applicator (a cartridge applicator 42 – Fig.1) has a receptacle (receptacle 70 – Fig.2) via which the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly is front-loaded into the applicator and through which the pod or cartridge assembly is ejected thereafter (“the medicament is accessible via the applicator, when the cartridge is inserted into the cartridge accepting receptacle. The barrier member is moves back to the closed position when the cartridge is removed from the cartridge-accepting receptacle”, see para [0007]).
Regarding claim 6, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein one or more of:
the applicator (a cartridge applicator 42 – Fig.1) is inhibited from contacting fluid medicament (“a pre-injection mode of the cartridge and the valve thus inhibits access to the medicament 92”, see para [0114], Fig.2);
the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly comprises all fluid paths ("the cartridge includes an elongate, hollow body 96 with a bore 98 within which the medicament is contained and received ", see para [0109]) of the medicament (medicant 92 – Fig.2); and
all medicament contacting and/or fluid path components thereof are automatically ejected from the applicator thereafter following administration of the medicament (“once the medicament from the pre-filled cartridge has fully been administered, the cartridge will automatically eject from the injector device and decouple”, see para [0186]).
Regarding claim 7, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein upon the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly being ejected, the applicator (a cartridge applicator 42 – Fig.1) is reusable with the drive element (plunger 44 – Fig.1) thereof being re-configured and/or configured to return to a native state to receive a subsequent said pod or cartridge assembly ("the cartridge will automatically eject from the injector device and decouple. This will return the injector and cartridge back into its native closed state and in some instances allow subsequent coupling of the injector with additional cartridges”, see para [0186]).
Regarding claim 8, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly includes a medicament-containing cartridge (“cartridge 90 receives a medicament 92 within an interior 94 thereof”, see para [0109], Fig.1) (and/or syringe and needle assembly) therewithin or wherein the pod or cartridge assembly is shaped to receive the cartridge (and/or syringe and needle assembly) therewithin.
Regarding claim 9, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 1, wherein the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly is resiliently biased to extend about a needle (needle 52 – Figs.18-19) in a locked protected needle pre-injection mode and wherein the medicament is biased outwards from the needle when the pod or cartridge assembly is inserted into the applicator (a cartridge applicator 42 – Fig.1) and the pod or cartridge assembly is moved from the locked protected needle pre-injection mode to a partially retracted mode which automatically moves the needle to a deployed position (“insertion of the cartridge into the cartridge-accepting receptacle 70 causes the cartridge to move from the pre-injection mode seen in FIG. 1, to an injection mode in which the medicament is accessible via the needle 52 seen in FIG. 19”, see para [0117]).
Regarding claim 12, Kim discloses a medicament injector (medicament injector 40 – Fig.1) comprising:
an applicator (a cartridge applicator 42 – Fig.1);
an interchangeable pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly including or being shaped to receive a medicament-containing cartridge (and/or syringe and needle assembly) (“cartridge 90 receives a medicament 92 within an interior 94 thereof”, see para [0109], Fig.1); and
a barrier member (“barrier member, in this example valve 108”, see para [0112], Fig.1) coupled to the pod or cartridge assembly (“valve 108 is pivotably coupled and thus rotatable relative to the body 96 of the cartridge 90”, see para [0112]), wherein one or more of i) the barrier member is configured to inhibit access to the medicament until the pod or cartridge assembly is inserted within, coupled to and/or snap-fit connected to the applicator (“insertion of the cartridge 90 into the applicator 42 causes the valve 108 to rotate from its closed position seen in FIG. 1 to its open position seen in FIG. 16, and enables the medicament 92 seen in FIG. 17 to be accessible by the applicator 42”, see para [0117]), and ii) the barrier member is configured such that removal thereof to enable access to the medicament requires the pod or cartridge assembly to be inserted within, coupled to and/or snap fit connected with the applicator (“removing the cartridge 90 from the cartridge-accepting receptacle 70 by, for example, pushing rearwards on the lever 111 as seen by arrow of numeral 91, causes the valve 108 to move from its open position to its closed position seen in FIG. 1, see para [0120])
Regarding claim 14, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 12, wherein the pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly being received by and/or coupling to the applicator (a cartridge applicator 42 – Fig.1) functions to automatically release the barrier member from the pod or cartridge assembly (“insertion of the cartridge 90 into the applicator 42 causes the valve 108 to rotate from its closed position seen in FIG. 1 to its open position seen in FIG. 16, and enables the medicament 92 seen in FIG. 17 to be accessible by the applicator 42”, see para [0117].
Regarding claim 20, Kim discloses a medicament injector (medicament injector 40 – Fig.1) comprising:
an applicator (a cartridge applicator 42 – Fig.1);
an interchangeable pod (interchangeable cartridge 90 – Fig.1) or cartridge assembly loadable into the applicator so as to couple thereto (“cartridge 90 receives a medicament 92 within an interior 94 thereof”, see para [0109], Fig.1);
a medicament outputting means which automatically outputs a medicament (medicament 92 – Fig,2) from the pod or cartridge assembly upon subsequent retraction of the pod or cartridge relative to the applicator (“once the cartridge is inserted and loaded into the accepting injector device, pressure applied... will further activate a mechanism to deliver the medicament”, see para [0178]); and
an ejection means which automatically ejects the pod or cartridge assembly from the applicator after outputting of the medicament from the pod or cartridge assembly (“once the medicament from the pre-filled cartridge has fully been administered, the cartridge will automatically eject from the injector device and decouple”, see para [0186]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim.
Regarding claim 10, the embodiments of Kim as depicted in Figs.1-19 disclose the medicament injector (medicament injector 40.1 – Fig.20) according to claim 8, as recited above.
The embodiments do not appear to expressly disclose wherein the medicament injector includes:
a first coupling mechanism via which the pod or cartridge assembly and the applicator couple together, the first coupling mechanism inhibiting axial movement of the pod or cartridge assembly outwardly of the applicator in a first instance and enabling retraction of a forward end portion of the pod or cartridge assembly relative to the applicator, which decouples the first coupling mechanism and initiates an automatic injection process;
a second coupling mechanism that inhibits axial movement of the cartridge (and/or syringe and needle assembly) relative to the pod or cartridge assembly and decouples upon initiation of the automatic injection process, to enable the needle assembly to move outwards of the pod or cartridge assembly to a deployed position via which the medicament is outputted therefrom; and
a third coupling mechanism which promotes positioning of the needle assembly in the deployed position until the medicament has been outputted from the cartridge (and/or syringe and needle assembly), with removable of inward pressure on the forward end portion of the pod or cartridge assembly thereafter enabling the pod or cartridge assembly to be automatically ejected from the applicator.
However, the embodiments of Kim as depicted in Figs. 20-37 disclose wherein the medicament injector includes:
a first coupling mechanism (resilient catch members 210 and 212 – Fig.25E) via which the pod (cartridge-accepting receptacle 70.1 – Fig.25E) or cartridge assembly and the applicator (cartridge applicator 42.1 – Fig.25E) couple together, the first coupling mechanism inhibiting axial movement of the pod or cartridge assembly outwardly of the applicator in a first instance and enabling retraction of a forward end portion (retaining member 76.1 - Fig.20) of the pod or cartridge assembly relative to the applicator, which decouples the first coupling mechanism and initiates an automatic injection process (“the depressor has a pre-injection position/mode or needle protected mode seen in FIG. 35 in which flange 134 of the depressor is space-apart from flange 172 of the depressor housing 154. The depressor 44.1 is linearly movable or retractable”, see para [0127]);
a second coupling mechanism (protrusions 138 and 140 – Fig.21E ) that inhibits axial movement of the cartridge (and/or syringe and needle assembly) relative to the pod or cartridge assembly and decouples upon initiation of the automatic injection process, to enable the needle assembly (needle assembly 128 – Fig.20) to move outwards of the pod or cartridge assembly to a deployed position via which the medicament (medicament 92 – Fig.1) is outputted therefrom (“depressor 44.1 is linearly movable or retractable via the protrusions 138 and 140 seen in FIG. 21E and guide channels 180 and 182 seen in FIG. 22E, from the pre-injection position of FIG. 35 to an injection position seen in FIG. 37 to deploy needle 52.1”, see para [0127]); and
a third coupling mechanism (valve housing 230 – Fig.33A) which promotes positioning of the needle assembly in the deployed position until the medicament has been outputted from the cartridge (and/or syringe and needle assembly) (under broadest reasonable interpretation, examiner interprets the valve housing as a structure capable of controlling, regulating or directing by opening or closing the passageway, hence, promoting the positions of the needle when deployed (“valve housing 230 has a pair of spaced-apart lower recessed regions 244 and 246 along sides thereof. As seen in FIG. 33A, the valve housing 230 is shaped to slidably extend within bore 196 of the cartridge-accepting receptacle 70.1 with protrusions 209 and 211 extending within the recessed regions 244 and 246 of the valve housing.”, see para [0134])), with removable of inward pressure on the forward end portion of the pod or cartridge assembly thereafter enabling the pod or cartridge assembly to be automatically ejected from the applicator (“once the medicament from the pre-filled cartridge has fully been administered, the cartridge will automatically eject from the injector device and decouple”, see para [0186]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament injector disclosed in Kim (embodiments depicted in Figs.1-19) with the first, second and third coupling mechanism taught by Kim (embodiments depicted in Figs. 20-27). A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (plunger) for another known element (depressor) in the art to obtain the predictable result of controlling movement between the cartridge and applicator (see MPEP § 2143.I.B), thus achieving a coupled cartridge to administer the injection.
Regarding claim 11, the embodiments of Kim as depicted in Figs.1-19 disclose the medicament injector (medicament injector 40 – Fig.1) according to claim 1, as recited above.
The embodiments do not appear to expressly disclose a safeguard mechanism coupled to the pod or cartridge assembly, the safeguard enabling axial movement of the pod or cartridge assembly relative to the applicator during an injection mode and upon the pod or cartridge assembly being removed from the applicator thereafter, inhibiting reinsertion of the pod or cartridge assembly into the applicator once more.
However, the embodiments of Kim as depicted in Figs.20-37 disclose a safeguard mechanism (valve 108 – Fig.26) coupled to the pod (interchangeable cartridge 90.1 – Fig.26) or cartridge assembly, the safeguard mechanism enabling axial movement of the pod or cartridge assembly relative to the applicator (a cartridge applicator 42 – Fig.1) during an injection mode (“insertion of valve 108.1 into the cartridge-accepting receptacle 70.1 causes gears 258 and 112.1 to engage with each other, such that the valve 108.1 moves from the closed position seen in in FIG. 33B to an open position seen in FIG. 34B”, see para [0139]) and upon the pod or cartridge assembly being removed from the applicator thereafter, inhibiting reinsertion of the pod or cartridge assembly into the applicator once more (under broadest reasonable interpretation, examiner interprets removing the pod from the applicator as disconnecting/decoupling leading them to be fully separated, hence inhibiting reinsertion since the injector has moved back to the closed position, see Fig.26 ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiments depicted in Figs.1-19 with the embodiments depicted in Figs.20-37 to disclose a medicament injector with a safeguard mechanism (“Like parts have like numbers and function as the embodiment shown in FIGS. 1 to 19 with the addition of “.1”. Medicament injector 40.1 is similar to medicament injector 40 as shown in FIGS. 1 to 19”, see para [0121]).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, in view of Belisle (US 20220176042 A1, herein, Belisle).
Regarding claim 13, Kim discloses A medicament injector (medicament injector 40 – Fig.1) according to claim 12, recited above.
Kim does not appear to expressly disclose wherein the medicament injector includes a locking mechanism that inhibits removal of the barrier member until the pod or cartridge assembly is inserted within, coupled to and/or snap-fit connected to the applicator; and
wherein the barrier member couples to the pod or cartridge assembly via a male member and a female member shaped to receive the male member, with insertion of the pod or cartridge assembly into the applicator causing the male member to dislodge from the female member at least in part.
Belisle teaches wherein the medicament injector includes a locking mechanism (clutch assembly 150 – Fig.1A) that inhibits removal of the barrier member (cartridge assembly cap 240 – Fig.5C) until the pod or cartridge assembly (cartridge assembly 200 – Fig.2) is inserted within, coupled to and/or snap-fit connected to the applicator (autoinjector 100 – Fig.4B) (“cartridge assembly cap 240 and the grip tube 250 are removable from the cartridge assembly 200 after the cartridge assembly 200 is fully inserted into the auto injector 100 ”, see para [0142]); and
wherein the barrier member couples to the pod or cartridge assembly via a male member (protruding tabs 242 – Fig.5C) and a female member (needle shroud 210 – Fig.5A) shaped to receive the male member, with insertion of the pod or cartridge assembly into the applicator causing the male member to dislodge from the female member at least in part (“cartridge assembly cap 240 comprises distally protruding tabs 242 abutting the proximal end 226 of the lock tube 220 thereby preventing proximal movement of the lock tube 220 relative to the needle shroud 210 when the cartridge assembly cap 240 is connected with the needle shroud 210”, see para [0141]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Kim to include a locking mechanism that inhibits removal of the barrier member as taught by Belisle so that it further “enables the auto-injector to be reset and ready for use with a new cartridge assembly and syringe” (Belisle para [0018]).
Regarding claim 15, Kim discloses a medicament injector (medicament injector 40 – Fig.1) according to claim 12, recited above including one or more of:
wherein the barrier member is shaped to promote sterility of the pod or cartridge assembly and/or interior thereof (“mechanism allows for a one direction barrier/sterile seal breaking action to allow medicament penetration into injector device from the loaded cartridge followed by injection into the patient while maintaining closed sterile space of the medication”, see para [0181]).
Kim does not appear to expressly disclose wherein the barrier member is shaped to extend about the needle in an airtight manner; and
wherein the barrier member is shaped to inhibit inadvertent deployment of the needle when the pod or cartridge assembly is being inserted into the applicator.
Belisle teaches wherein the barrier member (cartridge assembly cap 240 – Fig.5C) is shaped to extend about the needle in an airtight manner (coupling of the cartridge assembly cap 240 and the needle shroud 210, as seen in Figs.5A-5C); and
wherein the barrier member is shaped to inhibit inadvertent deployment of the needle when the pod or cartridge assembly (cartridge assembly 200 – Fig.2) is being inserted into the applicator (“cartridge assembly cap 240 comprises distally protruding tabs 242 abutting the proximal end 226 of the lock tube 220 thereby preventing proximal movement of the lock tube 220 relative to the needle shroud 210... cartridge assembly cap 240 and the grip tube 250 are removable from the cartridge assembly 200 after the cartridge assembly 200 is fully inserted into the auto injector 100”, see para [0141]- [0142])).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Kim to include a barrier member that is shaped to inhibit inadvertent deployment of the needle when cartridge assembly is being inserted as taught by Belisle so that it further “enables the auto-injector to be reset and ready for use with a new cartridge assembly and syringe” (Belisle para [0018]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
