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 .
Status of Claims
This office action is in response to Applicant’s Request for Continued Examination filed on 11 August 2026.
Claims 1 – 26 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 2026 has been entered.
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, the following features must be shown or the features canceled from the claims. No new matter should be entered.
“at least one snap connector” – claims 1, 10, and 18
“mechanical stop” – claims 1, 10, and 18
“a needle” in the limitation, “a needle insertion mechanism configured to insert a needle into a user” – claims 1 and 18. Figure 1 shows a needle 145 that pierces a stopper 215 but does not show a needle that inserts into a user.
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.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
This application includes claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations 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 limitations are:
“a needle insertion mechanism” in claims 1, 10, and 18.
“a drive mechanism” in claims 1, 10, and 18.
“a drive holder assembly” in claims 1, 10, and 18.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the claim limitation, “a needle insertion mechanism”, the claim limitation is being interpreted to cover the corresponding structure described in the specification in paragraph [0025] (i.e., a mechanical spring-based mechanism, an electric motor and a gear mechanism, and a gas or fluid pressure operated mechanism having either a reservoir of pressurized gas or a chemical system in which two or more chemicals are mixed together to produce gas or fluid pressure) as performing the claimed function, and equivalents thereof.
Regarding the claim limitation, “a drive mechanism”, the claim limitation is being interpreted to cover the corresponding structure described in the specification in paragraph [0033] (i.e., one or more springs, drive screws and motors), as performing the claimed function, and equivalents thereof.
Regarding the claim limitation, “a drive holder assembly”, the claim limitation is being interpreted to cover the corresponding structure described in the specification in paragraph [0045] (i.e., at least one snap fit connector and/or at least one mechanical stop), as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Claim Objections
Claims 8 and 24 – 25 are objected because of the following informalities:
Regarding claims 8 and 25, the limitation, “a needle insertion mechanism”, should read, “the needle insertion mechanism”.
Regarding claim 24, the limitation, “a drive mechanism”, should read, “the drive mechanism”.
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 is incorrect, any correction of the statutory basis 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 10 – 11 and 14 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 11,266,777 B2), in view of Cabiri (US 9,572,926 B2).
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Regarding claim 10, Gibson discloses a method of assembling a medicament delivery device, comprising:
selecting an external housing (12, fig. 1A) including a substantially rigid body with a top cover (12A, fig. 1A) and a bottom cover (12B, fig. 1A), the bottom cover defining a cavity (Figures 1A and 1C shows an upper housing 12A and a lower housing 12B wherein figure 75B shows the lower housing 12B defining a cavity);
selecting a moveable medicament container sled (390, fig. 2A. Col. 28, ll. 33 – 51 describes a medicament/drug container 50 attached to a movable guide 390 wherein the medicament/drug container 50 attached to the movable guide 390 is capable of translating towards the fluid pathway connector) and a needle insertion mechanism (200, fig. 1B) configured to insert a needle (214, fig. 11A) into a user (Col. 37, ll. 52 – 59);
placing the moveable medicament container sled and the needle insertion mechanism within a cavity of the bottom cover of the external housing (Figures 1B, 2A shows both the movable guide 390 and the insertion mechanism 200 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that these two components would be placed in the cavity of the lower housing 12B);
positioning a drive holder assembly (130, fig. 13) and a medicament container (50, fig. 1B) in engagement with the medicament container sled (Col. 28, ll. 33 – 51 describes an embodiment having a medicament/drug container 50 attached to a movable guide 390 wherein the medicament/drug container 50 via the movable guide 390 is capable of translating towards the fluid pathway connector);
positioning a drive mechanism (122, fig. 13) proximate a plunger (60, fig. 13) of the medicament container in an energized state within the drive holder assembly (Figure 14A shows biasing members 122 within a drive housing 130 wherein col. 46, ll. 57 – 59 describes the biasing members 122 are set into the drive housing in an initial energized state), the drive holder assembly retaining the drive mechanism by at least one snap-fit connector or mechanical stop (Col. 46, ll. 59 – 62 describes the biasing members 122 maintained in an energized state between the internal features of the drive housing 130 and an interface surface 110C of a piston 110. Figure 14A shows these internal features of the drive housing 130 to be a ledge/mechanical stop and sidewalls upon which the biasing members 112 are retained/held in place in the drive housing 130. Thus, the examiner deems these internal features (i.e., the ledge/ mechanical stop and sidewalls) of the drive housing 8130 as the claimed “mechanical stop” upon which the biasing members 122 are retained/held in place in the drive housing 112 and assists in maintaining the biasing members 122 in an energized state); and
closing the external housing by placing the top cover over the bottom cover (As shown in figures 1A, 1C).
Gibson does not explicitly disclose securing a housing drive cap over a rear portion of the drive mechanism.
However, Cabiri, in the same field of endeavor teaches securing a housing drive cap (14, fig. 2) over a rear portion (22, fig. 2) of a drive mechanism (18, fig. 4).
Cabiri is evidence that securing the housing drive cap over the rear portion of the drive mechanism were known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling the medicament delivery device of Gibson with securing the housing drive cap over the rear portion of the drive mechanism, as taught by Cabiri. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling the medicament delivery device of Gibson with securing the housing drive cap over a rear portion of the drive mechanism, as taught by Cabiri, in order to provide a door in the medicament delivery device main body to insert the medicament container so that the medicament container can be assembled to the medicament delivery device main body at a location different form that of the manufacturing facility that manufactures the medicament delivery device main body – for example, the manufacturing and filling facility of the medicament container. This multiple facility strategy provides benefits in resilience, customer proximity, scalability, and specialized production.
Regarding claim 11, Gibson, as modified by Cabiri, discloses the invention as recited in claim 10.
Gibson discloses the placing the medicament container in engagement with the medicament container sled includes forming an aseptic region (The region between a first film 2318 and second film 2322, fig. 52B) between a cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and the fluid path (via piercing member 2316A,B) (Please note, col. 82, ll. 19 – 24 describes that the drug delivery device of figs 1 – 47, 74, 75, and 77 – 91B can incorporate the embodiments of the fluid pathway connector of figs. 48 – 56 and 76A – 76C).
Regarding claim 14, Gibson, as modified by Cabiri, discloses the invention as recited in claim 11.
Gibson discloses the forming the aseptic region between the cap of the medicament container and the fluid path includes forming a first sterile barrier (2322, fig. 52B) over the cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and a second sterile barrier (2318, fig. 52B) over a piercing member (2316A,B, fig. 52B) of the fluid path.
Regarding claim 15, Gibson, as modified by Cabiri, discloses the invention as recited in claim 14.
Gibson discloses the first sterile barrier (2322, fig. 52B) and the second sterile barrier (2318, fig. 52B) each comprise a film (Col. 85, l. 6).
Regarding claim 16, Gibson, as modified by Cabiri, discloses the invention as recited in claim 10.
Gibson discloses placing a needle insertion mechanism (200, fig. 1B) within the external housing (12, fig. 1A, 1C).
Regarding claim 17, Gibson, as modified by Cabiri, discloses the invention as recited in claim 16.
Gibson discloses connecting the needle insertion mechanism (200, fig. 1B) with the fluid path (300, fig. 1B) (Col. 26, l. 66 – col. 27, l. 2).
Claims 18 – 23 and 25 – 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 11,266,777 B2), in view of Buchi (US 12,115,345 B2).
Regarding claim 18, Gibson discloses a method of assembling a medicament delivery device, comprising:
selecting a medicament delivery device main body (10, fig. 1A), comprising:
an external housing (12, fig. 1A) including a substantially rigid body with a top cover (12A, fig. 1A) and a bottom cover (12B, fig. 1A), the bottom cover defining a cavity (Figures 1A and 1C shows an upper housing 12A and a lower housing 12B wherein figure 75B shows the lower housing 12B defining a cavity);
a moveable medicament container sled (390, fig. 2A) received within the cavity of the bottom cover (Figure 1B, 2A shows the movable guide 390 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that ties component would be placed in the cavity of the lower housing 12B);
a drive holder assembly (130, fig. 13);
a needle insertion mechanism (200, fig. 1B) received within the cavity of the bottom cover (Figure 1B, 2A shows the insertion mechanism 200 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that this component would be placed in the cavity of the lower housing 12B) and configured to insert a needle (214, fig. 11A) into a user (Col. 37, ll. 52 – 59); and
a fluid path (300, fig. 1B) operable to connect a needle of the needle insertion mechanism (Col. 26, l. 66 – col. 27, l. 2) with a medicament container (50, fig. 1B);
selecting a medicament container (50, fig. 1B) and a drive mechanism (122, fig. 13); and
assembling the medicament delivery device in an energized state by placing the medicament container in the medicament container sled (Col. 28, ll. 33 – 51 describes an embodiment having a medicament/drug container 50 is attached to a movable guide 390 wherein the medicament/drug container 50 attached to the movable guide 390 is capable of translating towards the fluid pathway connector) and the drive mechanism within the drive holder assembly (Figure 14A shows biasing members 122 within a drive housing 130), the drive holder assembly retaining the drive mechanism by at least one snap-fit connector or mechanical stop (Col. 46, ll. 59 – 62 describes the biasing members 122 maintained in an energized state between the internal features of the drive housing 130 and an interface surface 110C of a piston 110. Figure 14A shows these internal features of the drive housing 130 to be a ledge/mechanical stop and sidewalls upon which the biasing members 112 are retained/held in place in the drive housing 130. Thus, the examiner deems these internal features (i.e., the ledge/ mechanical stop and sidewalls) of the drive housing 8130 as the claimed “mechanical stop” upon which the biasing members 122 are retained/held in place in the drive housing 112 and assists in maintaining the biasing members 122 in an energized state).
Gibson further discloses known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product (Col. 116, ll. 23 – 26).
The modified Gibson does not explicitly disclose assembling the medicament delivery device under sterile conditions.
However, Buchi, in the same field of endeavor, teaches assembling the medicament delivery device under sterile conditions (Figure 19b shows the medicament/drug container assembled into the medicament delivery device main body under aseptic condition).
Buchi is evidence that assembling the medicament delivery device under sterile conditions was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling a medicament delivery device of the modified Gibson with assembling the medicament delivery device under sterile conditions, as taught by Buchi. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling a medicament delivery device of the modified Gibson with assembling the medicament delivery device under sterile conditions, as taught by Buchi, in order to prevent infections and ensure patient safety. Contaminated devices can introduce harmful microorganisms, such as bacteria and viruses, directly into a patient's body, which can lead to serious health complications, prolonged illness, and even death.
Regarding claim 19, Gibson, as modified by Buchi, discloses the invention as recited in claim 18.
Gibson discloses the placing the medicament container in the medicament container sled includes forming an aseptic region (The region between a first film 2318 and second film 2322, fig. 52B) between a cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and the fluid path (via piercing member 2316A,B) (Please note, col. 82, ll. 19 – 24 describes that the drug delivery device of figs 1 – 47, 74, 75, and 77 – 91B can incorporate the embodiments of the fluid pathway connector of figs. 48 – 56 and 76A – 76C).
Regarding claim 20, Gibson, as modified by Buchi, discloses the invention as recited in claim 18.
The modified Gibson discloses sterilizing the medicament container (Gibson – 8050, fig. 69A) (Buchi – Figure 19b shows a RTF container body and a plunger of a medicament/drug container sterilized and then assembled and filled under aseptic conditions).
Regarding claim 21, Gibson, as modified by Buchi, discloses the invention as recited in claim 18.
Gibson discloses packaging the delivery device under sterile conditions (Col. 2, ll. 55 – 60).
Regarding claim 22, Gibson, as modified by Buchi, discloses the invention as recited in claim 19.
Gibson discloses the forming the aseptic region between the cap of the medicament container and the fluid path includes forming a first sterile barrier (2322, fig. 52B) over the cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and a second sterile barrier (2318, fig. 52B) over a piercing member (2316A,B, fig. 52B) of the fluid path.
Regarding claim 23, Gibson, as modified by Buchi, discloses the invention as recited in claim 22.
Gibson discloses the first sterile barrier (2322, fig. 52B) and the second sterile barrier (2318, fig. 52B) each comprise a film (Col. 85, l. 6).
Regarding claim 25, Gibson, as modified by Buchi, discloses the invention as recited in claim 18.
Gibson discloses placing the needle insertion mechanism (200, fig. 1B) within the external housing (12, fig. 1A, 1C).
Regarding claim 26, Gibson, as modified by Buchi, discloses the invention as recited in claim 25.
Gibson discloses connecting the needle insertion mechanism (200, fig. 1B) with the fluid path (300, fig. 1B) (Col. 26, l. 66 – col. 27, l. 2).
Claims 1 – 9 and 12 – 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 11,266,777 B2), in view of Cabiri (US 9,572,926 B2), in further view of Buchi (US 12,115,345 B2).
Regarding claim 1, Gibson discloses a method of assembling a medicament delivery device, comprising:
selecting a medicament delivery device main body (10, fig. 1A, 1C), comprising:
an external housing (12, fig. 1A, 1C) including a substantially rigid body with a top cover (12A, fig. 1A) and a bottom cover (12B, fig. 1A), the bottom cover defining a cavity (Figures 1A and 1C shows an upper housing 12A and a lower housing 12B wherein figure 75B shows the lower housing 12B defining a cavity);
a moveable medicament container sled (390, fig. 2A) received within the cavity of the bottom cover (Figure 1B, 2A shows the movable guide 390 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that ties component would be placed in the cavity of the lower housing 12B);
a drive holder assembly (130, fig. 13);
a needle insertion mechanism (200, fig. 1B) received within the cavity of the bottom cover (Figure 1B, 2A shows the insertion mechanism 200 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that this component would be placed in the cavity of the lower housing 12B) and configured to insert a needle (214, fig. 11A) into a user (Col. 37, ll. 52 – 59); and
a fluid path (300, fig. 1B) operable to connect the needle of the needle insertion mechanism with a medicament container (50, fig. 1B) (Col. 26, l. 66 – col. 27, l. 2);
selecting the medicament container including a container body (58, fig. 13) and a plunger (60, fig. 13);
selecting a drive mechanism (122, fig. 13); and
setting the drive mechanism in an energized state within the drive holder assembly (Figure 14A shows biasing members 122 within a drive housing 130 wherein col. 46, ll. 57 – 59 describes the biasing members 122 are set into the drive housing in an initial energized state) wherein setting the drive mechanism in the energized state includes retaining the drive mechanism in the drive holder assembly by at least one snap-fit connector or mechanical stop of the drive holder assembly (Col. 46, ll. 59 – 62 describes the biasing members 122 maintained in an energized state between the internal features of the drive housing 130 and an interface surface 110C of a piston 110. Figure 14A shows these internal features of the drive housing 130 to be a ledge/mechanical stop and sidewalls upon which the biasing members 112 are retained/held in place in the drive housing 130. Thus, the examiner deems these internal features (i.e., the ledge/ mechanical stop and sidewalls) of the drive housing 8130 as the claimed “mechanical stop” upon which the biasing members 122 are retained/held in place in the drive housing 112 and assists in maintaining the biasing members 122 in an energized state);
Gibson does not disclose selecting a housing drive cap.
However, Cabiri, in the same field of endeavor, teaches selecting a housing drive cap (14, fig. 2).
Cabiri is evidence that selecting a housing drive cap was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling a medicament delivery device of Gibson with selecting a housing drive cap, as taught by Cabiri. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling a medicament delivery device of Gibson with selecting a housing drive cap, as taught by Cabiri, so that a medicament container can be assembled to a medicament delivery device main body at a location different from that of the manufacturing facility that manufactures the medicament delivery device main body – for example, the manufacturing and filling facility of the medicament container. This multiple facility strategy provides benefits in resilience, customer proximity, scalability, and specialized production.
Gibson further discloses known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product (Col. 116, ll. 23 – 26).
The modified Gibson does not explicitly disclose sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap; sterilizing the medicament container; and under sterile conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled. However, Buchi, in the same field of endeavor, teaches sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap (Col. 18, ll. 61 – 67 describes the fluidic pack and the container casing may be manufactured in a first manufacturing facility and sterilized, preferably using gamma sterilization, wherein col. 18, ll. 19 – 33 describes the fluidic pack as comprising a pumping system 8 wherein the examiner deems the pumping system 8 equivalent to the claimed, “the drive mechanism”; and the container casing as a container casing 38 and all other casing parts wherein the examiner deems container casing 38 and all other casing parts equivalent to the claimed, “the medicament delivery device main body and the housing drive cap” since the housing drive cap in the modified Gibson is a casing part of the medicament delivery device main body of the modified Gibson); sterilizing the medicament container (Figure 19b shows a RTF container body and a plunger of a medicament/drug container sterilized and then assembled and filled under aseptic conditions); and under sterile conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled (Figure 19b shows the medicament/drug container assembled into the medicament delivery device main body having the housing drive cap and drive mechanism under aseptic conditions).
Buchi is evidence that sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap; sterilizing the medicament container; and under sterile conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled were known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling a medicament delivery device of the modified Gibson with sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap; sterilizing the medicament container; and under sterile conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled, as taught by Buchi. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling a medicament delivery device of the modified Gibson with sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap; sterilizing the medicament container; and under sterile conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled, as taught by Buchi, in order to prevent infections and ensure patient safety. Contaminated devices can introduce harmful microorganisms, such as bacteria and viruses, directly into a patient's body, which can lead to serious health complications, prolonged illness, and even death.
Regarding claim 2, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 1.
Gibson discloses the placing the medicament container in the medicament container sled includes forming an aseptic region (The region between a first film 2318 and second film 2322, fig. 52B) between a cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and the fluid path (via piercing member 2316A,B) (Please note, col. 82, ll. 19 – 24 describes that the drug delivery device of figs 1 – 47, 74, 75, and 77 – 91B can incorporate the embodiments of the fluid pathway connector of figs. 48 – 56 and 76A – 76C).
Regarding claim 3, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 1.
The modified Gibson discloses the sterilizing the medicament container includes sterilizing the container body, filling the medicament container with a sterile medicament, and closing the medicament container (Buchi – Figure 19B shows the RTF container body sterilized and moved to a Pharm Company where the RTF container body is filled and closed with a plunger to make a medicament/dug container under aseptic conditions).
Regarding claim 4, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 1.
Gibson discloses packaging the delivery device under sterile conditions (Col. 2, ll. 55 – 60).
Regarding claim 5, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 2.
Gibson discloses the forming the aseptic region between the cap of the medicament container and the fluid path includes forming a first sterile barrier (2322, fig. 52B) over the cap (3324, fig. 52B) of the medicament container (2330, fig. 52B) and a second sterile barrier (2318, fig. 52B) over a piercing member (2316A,B, fig. 52B) of the fluid path.
Regarding claim 6, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 5.
Gibson discloses the first sterile barrier (2322, fig. 52B) and the second sterile barrier (2318, fig. 52B) each comprise a film (Col. 85, l. 6).
Regarding claim 7, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 1.
The modified Gibson discloses the assembling the medicament delivery device further includes placing the drive mechanism (Gibson – 122, fig. 13) proximate the plunger (Gibson – 60, fig. 13) of the medicament container (Gibson – 50, fig. 1B), and securing the drive housing cap (Cabiri – 14, fig. 2) proximate a rear portion of the drive mechanism (Figure 2 shows the door 14 proximate to a rear portion of the activation mechanism 18, specifically coupling element 22, wherein one having ordinary skill in the art would recognize that the drive mechanism 8122 of Gibson is analogous to the activation mechanism 18 of Cabiri) close the medicament delivery device.
Regarding claim 8, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 1.
Gibson discloses placing the needle insertion mechanism (200, fig. 1B) within the external housing (12, fig. 1A, 1C).
Regarding claim 9, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 8.
Gibson discloses connecting the needle insertion mechanism (200, fig. 1B) with the fluid path (300, fig. 1B) (Col. 26, l. 66 – col. 27, l. 2).
Regarding claim 12, Gibson, as modified by Cabiri, discloses the invention as recited in claim 10.
The modified Gibson does not explicit disclose sterilizing the medicament container.
However, Buchi, in the same field of endeavor, teaches sterilizing the medicament container (Figure 19b shows a RTF container body and a plunger of a medicament/drug container sterilized and then assembled and filled under aseptic conditions).
Buchi is evidence that sterilizing the medicament container were known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling a medicament delivery device of the modified Gibson with sterilizing the medicament container, as taught by Buchi. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling a medicament delivery device of the modified Gibson with sterilizing the medicament container, as taught by Buchi, in order to prevent infections and ensure patient safety. Contaminated devices can introduce harmful microorganisms, such as bacteria and viruses, directly into a patient's body, which can lead to serious health complications, prolonged illness, and even death.
Regarding claim 13, Gibson, as modified by Cabiri, as further modified by Buchi, discloses the invention as recited in claim 12.
The modified Gibson discloses the sterilizing the medicament container includes sterilizing the container body, filling the medicament container with a sterile medicament, and closing the medicament container (Buchi – Figure 19B shows the RTF container body sterilized and moved to a Pharm Company where the RTF container body is filled and closed with a plunger to make a medicament/dug container under aseptic conditions).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 11,266,777 B2), in view of Buchi (US 12,115,345 B2), in further view of Cabiri (US 9,572,926 B2),
Regarding claim 24, Gibson, as modified by Buchi, discloses the invention as recited in claim 18.
Gibson discloses the assembling the medicament delivery device further includes placing the drive mechanism (130, fig. 13) proximate the plunger (60, fig. 13) of the medicament container (50, fig. 1B).
The modified Gibson does not explicitly disclose securing a drive housing cap proximate a rear portion of the drive mechanism to close the medicament delivery device.
However, Cabiri, in the same field of endeavor, teaches securing a drive housing cap (14, fig. 2) proximate a rear portion (22, fig. 2) of a drive mechanism (18, fig. 4) to close the medicament delivery device.
Cabiri is evidence that securing a drive housing cap proximate a rear portion of the drive mechanism to close the medicament delivery device was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of assembling a medicament delivery device of the modified Gibson with securing a drive housing cap proximate a rear portion of the drive mechanism to close the medicament delivery device, as taught by Cabiri. Moreover, the one having ordinary skill in the art would have been motivated to modify the method of assembling a medicament delivery device of the modified Gibson with securing a drive housing cap proximate a rear portion of the drive mechanism to close the medicament delivery device, as taught by Cabiri, so that a medicament container can be assembled to a medicament delivery device main body at a location that different that the manufacturing facility that manufactures the medicament delivery device main body – for example, the manufacturing and filling facility of the medicament container. This multiple facility strategy provides benefits in resilience, customer proximity, scalability, and specialized production.
Response to Arguments
Applicant’s amendments and arguments, filed 2 January 2026, with respect to the rejections of claims 1 – 26 under 35 USC §103 have been fully considered but are not persuasive. Applicant argues:
First, the cited references do not disclose retaining the drive mechanism in the drive holder assembly by at least one snap-fit connector or mechanical stop, as now recited in each of independent claims 1, 10, and 18. The Examiner construed "drive holder assembly" under 35 U.S.C. § 112(f) to the corresponding structure of specification paragraph [0045] - at least one snap-fit connector and/or at least one mechanical stop (Office Action, 12). Gibson retains its biasing member 8122 in the energized state by compression and by a tether: "Compressed within the drive housing 8130, between the drug container 8050 and the proximal end of the housing 8130, are one or more drive biasing members 8122 and a piston 8110" (col. 109, 11. 34-37), and "Initially, the tether 8525 may retain the biasing member 8122 in an initial energized position" (col. 114, 11. 25- 26). Neither compression between the container and the housing nor a tether is a snap-fit connector or a mechanical stop of a drive holder assembly, and neither Cabiri nor Buchi supplies this structure. The amended independent claims therefore recite a drive-mechanism retention structure that the cited references do not disclose, and which holds the rejection to the Examiner's own § 112(f) construction; the rejections should be withdrawn on this basis.
In response to applicant’s argument that Gibson does not disclose retaining the drive mechanism in the drive holder assembly by at least one snap-fit connector or mechanical stop, as now recited in each of independent claims 1, 10, and 18, col. 46, ll. 59 – 62 of Gibson describes the biasing members 122 being maintained in an energized state between the internal features of the drive housing 130 and an interface surface 110C of a piston 110. Figure 14A shows these internal features of the drive housing 130 to be a ledge/mechanical stop and sidewalls upon which the biasing members 112 are retained/held in place in the drive housing 130. Thus, the examiner deems these internal features (i.e., the ledge/ mechanical stop and sidewalls) of the drive housing 8130 as the claimed “mechanical stop” upon which the biasing members 122 are retained/held in place in the drive housing 112 and assists in maintaining the biasing members 122 in an energized state.
Applicant further argues:
Second, the cited references do not disclose a bottom cover defining a cavity that receives both the moveable medicament container sled and the needle insertion mechanism, as now recited. The rejection relies on Gibson FIG. 69A and on Gibson's statement that the "pump housing 8012 contains all of the device components" (col. 102, 11. 13-14). A general statement that a two-part housing "contains" the device's components, however, does not disclose the specific claimed architecture - a bottom cover that defines a cavity within which both the moveable medicament container sled and the needle insertion mechanism are received. FIG. 69A is expressly an "isometric view of the interior components" of the device; it depicts the arrangement of interior components but does not disclose the sled and the needle insertion mechanism received within a cavity defined by the bottom cover. To the contrary, Gibson describes a different assembly architecture, in which components are "pre-assembled as separate components and configured into position onto the assembly platform 8020" (col. 102, 11. 9-11) - that is, mounted onto an assembly platform, not received within a cavity of a bottom cover. Gibson's generalized "contains" statement and its platform-mounting disclosure neither teach nor suggest the claimed cavity-receipt of both the sled and the needle insertion mechanism.
In response to applicant’s argument that Gibson does not disclose a bottom cover defining a cavity that receives both the moveable medicament container sled and the needle insertion mechanism, the examiner relies on a different embodiment of Gibson that discloses an external housing 12 with a top cover 12A and a bottom cover 12B wherein the bottom cover 12B, also shown in figure 75, having a cavity. Figures 1B, 2A shows both the movable guide 390 and the insertion mechanism 200 wherein, given the lower housing 12B shown in figs. 1A, 1C, and the placement of the drug container 50 in window 18, it would be obvious to one having ordinary skill in the art that these two components would be placed in the cavity of the lower housing 12B.
Applicant further argues:
Third, the rejection assembles the claimed method from multiple, distinct Gibson embodiments joined only by assertions that one of ordinary skill "would recognize" the combination, without the articulated reasoning that MPEP § 2143 requires (Office Action, 17). The claimed moveable medicament container sled is mapped to Gibson's movable guide 390, which Gibson introduces in a different embodiment and in which Gibson teaches only that the fluid pathway connector or the drug container is "attached to a movable guide 390" (col. 28, 11. 46-50) - not the insertion mechanism. The 8000-series wearable-pump embodiment relied upon for the housing, the drive, and the needle insertion mechanism contains no movable guide 390 and no sled, and the aseptic-region dependent claims are read on yet another embodiment. Because Gibson's movable guide 390 carries the connector or the container rather than the insertion mechanism, Gibson does not teach the claimed co-location of the moveable medicament container sled and the needle insertion mechanism, and the rejection articulates no reasoned basis for combining these separate embodiments. Neither Cabiri nor Buchi cures these deficiencies of Gibson.
In response to applicant’s argument, the current rejection are based on a single embodiment of Gibson (figs. 1A-C, 2A-B, 3A-B, 4A-B, 5A-C, 6A-C, 7A-B, 8A-B, 9, 10A-C, 11A-C, 12, 13, 14A-E) thus arguments directed towards the combination of different embodiment is moot.
Applicant further argues:
Finally, the asserted motivation to combine is stated only in generic terms. The rejection's "multiple facility strategy" rationale for incorporating Cabiri's door 14, and its infection-prevention rationale for incorporating Buchi's aseptic assembly (Office Action, 117, 33, and 45), are not tied to Gibson's specific structure and do not establish a reasonable expectation of success in arriving at the specific cavity-receipt and snap-fit/mechanical-stop retention architecture now recited. A conclusion of obviousness requires articulated reasoning with a rational underpinning; the generic benefits invoked here do not supply it for the claimed combination.
To the best of the examiner’s understanding of applicant’s argument, applicant is arguing that one having ordinary skill in the art would not have a reasonable expectation of success bodily incorporating the secondary reference into the structure of the primary reference. However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID G SHUTTY whose telephone number is (571)272-3626. The examiner can normally be reached 7:30 am - 5:30 pm, Monday - Friday.
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/DAVID G SHUTTY/Examiner, Art Unit 3731
21 August 2026
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