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 .
Response to Amendment
This office action is responsive to the amendment filed on 04/17/2026. As directed by the amendment: claim 1 has been amended. Claims 3 and 8 are cancelled.
Thus, claims 1, 2, 4-7 & 9-15 are pending in this application.
Response to Arguments
Applicant's arguments filed on 04/17/2026 have been fully considered but they are not persuasive.
With regards to the arguments that Nemoto in view of Halbich does not teach or suggest "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, 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, and wherein the body and the first and second clamp members are integrally co-formed with each other", examiner respectfully disagrees.
In response to the argument that the sides of the adapter are not movable relative to each other, examiner acknowledges that Nemoto et al fail to explicitly teach that said clamp members are moveable but relies on Halbich to make said clamps members moveable since they are made of plastic and can be made moveable using high flexible plastics for easy reshaping which would eliminate the necessity to replace said adapter each time a difference size of cartridge is used.
The applicant further argues that said clamp members do not exhibit a biasing force against cylinder 210 but rather the movable members 411 are the features that retain the cylinder 210. It is the opinion of the examiner that the movable members 411 are used to hold the flange in place for better retaining of said cylinder adapter into injector 100, this doesn’t prevent said clamp member to exhibit a biasing force against cylinder 210.
In response to the arguments that “One of skill in the art, when considering the entire disclosure of Nemoto, would not modify the profile of the sides of the adapter body 401 of Nemoto to be movable because doing so would change the shape of the outer profile of the adapter body 401 such that it would no longer (1) match the size of the recess 114 and the size of the largest liquid syringe 200 nor (2) conform to and be held by the recess 114 of the injector 100”, examiner respectfully disagrees. Nemoto et al disclose in para 0009 in order to allow the liquid injector to hold a various types of liquid syringes having various shapes, the recess defined in the upper surface of the main injector body is shaped to be able to receive the cylinder of the liquid syringe having the maximum size. 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 or in other words the injector body doesn’t need an adapter when using a liquid syringe having the maximum size but requires different adapters for syringes having sizes other than the maximum size (see para 0043) without changing the injector body. Thus, instead of replacing the adapter with another adapter each time a different size syringe is used, one of the ordinary skill in the art would to be motivated to only use one adapter and makes it moveable to accommodate different sizes cartridge to minimize time consuming of changing adapter during usage.
With regards to the arguments that Nemoto in view of Halbich does not teach or suggest "a needle actuator assembly received within the housing, the needle actuator assembly comprising a patient needle configured to pierce a patient's skin," as recited by independent claim 7, examiner respectfully disagrees.
In response to the arguments that the liquid injection system 1000 of Nemoto is indirectly connected to the patient via an extension tube, and Nemoto is completely silent to a needle within the housing of the injection head 110 that pierces the patient's skin, examiner assembly Nemoto is completely silent to a needle within the housing of the injection head 110, it is noted that the features upon which applicant relies (i.e., a needle within the housing of the injection head 110) are not recited in the rejected claim(s). The claim limitations does not require a needle be within the needle actuator assembly that is within the housing. The medication of the injector of Nemoto et al is injected to skin via extension connected to 212.
Thus, the rejections 1, 2, 4-7 & 9-15 are maintained.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 is dependent on claim 8 which is cancelled. For purpose of examination, claim 15 will be interpreted as being dependent on claim 7.
Appropriate correction is required.
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, 2, 4-7 & 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), wherein the first and second clamp members are configured to exhibit a biasing force against a cartridge after engagement therewith (para 0043 and 0048, fig 1b), wherein the body and the first and second clamp members are integrally co-formed with each other (see annotated figure below).
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 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).
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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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