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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 11/12/25. As directed by the amendment: claims 1, 7 and 11 have been amended. Claim 8 has been cancelled. Claims 14 and 15 are added.
Thus, claims 1-7 & 9-15 are pending in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto et al (US 20040249276 A1) in view of Halbich (US 5716345 A).
Regarding claim 1, Nemoto et al disclose a cartridge adapter (400) for a drug delivery device (100), the cartridge adapter comprising: a body (401) having a first end and a second end positioned opposite the first end (see annotated figure below), the body (401) comprising a first clamp member, a second clamp member spaced from the first clamp member (see annotated figure below), and a connection interface (rear portion of lower surface of body 401) configured to be received by a recess (114) inside a housing (110) of a drug delivery device (100, para 0043-44) and wherein the first and second clamp members are configured to exhibit a biasing force against a cartridge of after engagement therewith (para 0043 and 0048, fig 1b).
Nemoto et al fail to explicitly teach the first and second clamp members are moveable relative to each other and configured to receive and engage a plurality of different sized cartridges for a drug delivery device but teach liquid syringes having sizes other than the maximum size are combined with respective dedicated cylinder adapters and placed in the recess in the main injector body (para 0009) and further disclose said adapter is made of plastic (para 0055).
However, Halbich discloses a cartridge adapter (32a) for a drug delivery device (see fig 9), the cartridge adapter (32a) comprising: a body (body of cradle 32a) having a first end and a second end positioned opposite the first end (portion 39a has first end and second end forming a body), the body comprising a first clamp member (left curved portion 72, see fig 13), a second clamp member (left curved portion 72, see fig 13) spaced from the first clamp member (see fig 13), wherein the first and second clamp members are moveable relative to each other and configured to receive and engage a plurality of different sized cartridges for a drug delivery device (col 5, lines 35-50), and wherein the first and second clamp members are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith (col 5, lines 35-50 and col 7, lines 43-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first and second clamps of the adapter of Nemoto et al to be moveable relative to each other and configured to receive and engage a plurality of different sized cartridges for a drug delivery device and are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith as taught by Halbich. This would provide the benefit of having an unique adapter which can accommodate different sizes of cartridges instead of having a plurality of different sized cartridges dedicated for different cylinder adapters in order to minimize time consuming of changing adapter during usage and manufacture cost (col 5, lines 35-50).
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Regarding claim 2, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the first clamp member extends from the first end of the body to the second end of the body, and wherein the second clamp member extends from the first end of the body to the second end of the body (see annotated figure above).
Regarding claim 3, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the body and the first and second clamp members are integrally formed with each other (see annotated figure above).
Regarding claim 4, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the connection interface comprises a dovetail (417, see fig 2a).
Regarding claim 5, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the first and second clamp members are arcuate (see annotated figure above).
Regarding claim 6, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the body, the first and second clamp members, and the connection interface are integrally formed with each other (see figs 1, 2 and annotated figure above).
Regarding claim 7, Nemoto et al disclose a drug delivery device (100) comprising: a housing (110) including a first connection interface (113) comprising a recess (114) inside the housing (fig 3); a first cartridge (211) configured to receive a medicament (para 0035-38), the cartridge having a first diameter; a second cartridge configured to receive a medicament, the second cartridge having a second diameter, the second diameter is larger than the first diameter (para 0009, the drug delivery device is configure to hold various size of cylinder); a drive assembly (116) received within the housing (fig 3) and configured to engage the cartridge and dispense medicament from the cartridge (para 0008); a needle actuator assembly (212) received within the housing (see fig 3), the needle actuator assembly comprising a patient needle configured to pierce a patient's skin (para 0038 and 0057) and a cartridge adapter (400) comprising a body (401) having a first end and a second end positioned opposite the first end (see annotated figure above), the body comprising a first clamp member, a second clamp member spaced from the first clamp member (see annotated figure above), and a second connection interface (rear portion of lower surface of body 401) configured to be received by the recess inside the housing of the drug delivery device (para 0043-44) and wherein the first and second clamp members are configured to exhibit a biasing force against a cartridge of after engagement therewith (para 0043 and 0048, fig 1b).
Nemoto et al fail to explicitly teach the first and second clamp members are moveable relative to each other, the first and second clamp members receiving and engaging at least one of the first cartridge and the second cartridge.
Nemoto et al teach liquid syringes having sizes other than the maximum size are combined with respective dedicated cylinder adapters and placed in the recess in the main injector body (para 0009) and further disclose said adapter is made of plastic (para 0055).
However, Halbich discloses an injector comprises a cartridge adapter (32a) for a drug delivery device (see fig 9), the cartridge adapter (32a) comprising: a body (body of cradle 32a) having a first end and a second end positioned opposite the first end (portion 39a has first end and second end forming a body), the body comprising a first clamp member (left curved portion 72, see fig 13), a second clamp member (left curved portion 72, see fig 13) spaced from the first clamp member (see fig 13), wherein the first and second clamp members are moveable relative to each other and configured to receive and engage a plurality of different sized cartridges for a drug delivery device (col 5, lines 35-50), and wherein the first and second clamp members are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith (col 5, lines 35-50 and col 7, lines 43-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first and second clamps of the adapter of Nemoto et al to be moveable relative to each other and configured to receive and engage a plurality of different sized cartridges for a drug delivery device and are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith as taught by Halbich. This would provide the benefit of having an adapter which can accommodate different sizes of cartridges instead of having a plurality of different sized cartridges dedicated for different cylinder adapters to minimize time consuming of changing adapter during usage and manufacture cost (col 5, lines 35-50).
Regarding claim 9, Nemoto et al in view of Halbich disclose the drug delivery device of claim 7, wherein the first clamp member extends from the first end of the body to the second end of the body, and wherein the second clamp member extends from the first end of the body to the second end of the body (fig 2a and annotated figure above).
Regarding claim 10, Nemoto et al in view of Halbich disclose the drug delivery device of claim 7, wherein the body and the first and second clamp members are integrally formed with each other (see fig 2a and annotated figure above).
Regarding claim 11, Nemoto et al in view of Halbich disclose the drug delivery device of claim 7, wherein the second connection interface comprises a dovetail (417, see fig 2a).
Regarding claim 12, Nemoto et al in view of Halbich disclose the drug delivery device of claim 7, wherein the first and second clamp members are arcuate (see annotated figure above).
Regarding claim 13, Nemoto et al in view of Halbich disclose the drug delivery device of claim 7, wherein the body, the first and second clamp members, and the second connection interface are integrally formed with each other (see annotated figure above).
Regarding claim 14, Nemoto et al in view of Halbich disclose the cartridge adapter of claim 1, wherein the connection interface of the body is configured to extend substantially fully within the recess inside the housing-of a drug delivery device (para 0052- a rear portion of the lower surface is retained with recess 114).
Regarding claim 15, Nemoto et al in view of Halbich disclose the drug delivery device of claim 8, wherein the second connection interface of the body is configured to extend substantially fully within the recess inside the housing of the drug delivery device (para 0052- a rear portion of the lower surface is retained with recess 114).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 11/12/2025, with respect to the rejection(s) of claim(s) 1-7, 9-13 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nemoto et al in view of Halbich.
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/ Examiner, Art Unit 3783