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
The amendment filed 01/20/26 has been entered. Claims 1-6, 9, 11-13, 23, 25, and 30-36 are in the original/ previously presented form. Claims 7-8, 10, 14-22, 24, 26-29 are cancelled. Claim 37 is newly presented. Thus, claims 1-6, 9, 11-13, 23, 25, and 30-37 remain pending in the application. There were no objections or 112 rejections previously applied in the non-final rejection mailed 10/20/25. Therefore, there are no objections or 112 rejections withstanding.
Because Applicant has not argued otherwise, the 112f claim interpretation applied to claims 4-5 as set forth in the Non-Final office action mailed 01/02/25 on pages 3-6 is maintained (see Claim interpretation section provided again below for immediate reference).
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.
Regarding claim 4, lines 2-3 recite “the dosing mechanism further comprises an opposite end being provided with a manual injection control means”. Therefore, claim 4 is being interpreted under 112f due to the three-prong test:
Prong A: ‘means’ is recited
Prong B: means is modified by implied functional language because the recited ‘means’ achieves the function of “manual injection control”
Prong C: the function “manual injection control” is not provided with sufficient structure for how manual injection control is achieved by the device
Thus, the examiner examined the specification for the BRI of ‘manual injection control means’. Noteworthy portions of the specification include at least [0014], [0037] and FIG. 1 with injection control means 32, where the ‘means’ is a button. Therefore, the examiner will interpret “manual injection control means” as recited in claim 4 to be a control button or equivalents.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: the manual injection control means in claim 5. Claim 5 is not being interpreted under 112f because claim 5 recites sufficient structure for the ‘manual injection control means’ (the manual injection control means comprises a control button).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
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 1-3, 12-13, 23, 25-26, and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Damiano et al. (U.S. PGPUB No. 2019/0344009), hereinafter Damiano, in view of Hsu (U.S. Patent No. 6,773,416).
Regarding claim 1, Damiano discloses Regarding claim 1, Damiano discloses a delivery system comprising:
a cartridge (530, see FIG. 5A) storing a liquid (see [0111]: pushrod used to fill cartridge 530 with medicament); and
a dosing mechanism (see FIGs. 3A-B) configured to connect to the cartridge (530, see [0111]: after filling cartridge, cartridge is loaded into pump housing as shown in FIGS. 3A-B) and to dispense a predetermined amount of the liquid from said cartridge (530, see [0004]: pump delivers medicament to patient and therefore is ‘configured to’ dispense a predetermined amount of liquid from cartridge);
wherein:
the cartridge (530, see FIG. 5A) is non-reversibly transformable (see [0111]: after cartridge is filled, pushrod 590 would be removed such as by threaded connection or breakable joint. A breakable joint would be non-reversible because components are, see [0116]: disconnected and discarded after filling. In the case of a breakable joint, the components would be discarded and NOT reused.) from a filling configuration (as shown in FIG.5B), in which the liquid can be drawn into the cartridge (see [0111]: pushrod 590 used to fill cartridge with medicament at point of care), to a dispensing configuration (see FIG. 5C and [0111]: after being filled, cartridge loaded into pump housing as shown in FIG. 3A-B to deliver medicament), in which the liquid can only be dispensed from the cartridge (see [0099]: pump works with prefilled cartridges and thus only dispenses medicament once loaded with cartridge and does not fill the cartridges. See [0111] filling of cartridge at point of care uses system of FIG. 5A, see [0186]: filling at point of care as in FIGs. 5A-C and ALL OTHER CARTRIDGES are prefilled. Thus, filling of this device occurs only in those two scenarios—FIG. 5A-C or prefilled cartridges-- and is not completed by pump);
the cartridge (530, see FIG. 5A) comprises a container (see outlined shape forming cartridge 530) and a piston (550) arranged inside the container (see FIG. 5A pointing to piston 550 inside of container), wherein motion of the piston (550) is used to draw the liquid into the container (see [0111]: piston 550 withdrawn into and back out of reservoir to fill container) as well as dispense the liquid out from the container (see [0119]: piston 550 attached to drive nut of device to distribute medicament), wherein the cartridge (530) is connectable to (as shown in FIG. 5B and described in [0111]: plunger rod 590 provided to cartridge by breakable joint) a piston rod (590) which is manually maneuverable (see [0111]: push rod used to fill cartridge by pulling piston 550 out and back and therefore is manually maneuverable), the piston rod (590) being releasably connected to (as shown in FIG. 5A and described in [0111]: plunger rod provided by breakable joint) the piston (550);
the piston rod (590) is connected to (see [0111]: pushrod 590 connected to piston 550 and used to fill cartridge with medicament at point of care) the piston (550) when the cartridge (530) is in the filling configuration (as seen in FIG. 5B);
the piston rod (590) is disconnected from (See also [0111],[0116]: plunger rod discarded after filling and then the cartridge is loaded to dosing mechanism) the piston (550) when the cartridge (530) is in the dispensing configuration (as shown in FIGs. 3A-B, piston rod 590 is removed/ not a part of the system); and
the piston rod (590) is
configured to be released from the piston (550) after the cartridge (530) is filled with the liquid (as shown in FIG. 5C and described in [0111] and [0116]).
Damiano further discloses that the piston rod/ piston coupling could be connected by a number of means including a “snug-fit” or “snap-fit” coupling (see [0097]).
Damiano is silent to the piston rod configured to be “automatically” released.
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) storing a liquid (L, see col. 3 lines 50-54: liquid medicine L); the cartridge (2) comprises a container (21) and a piston (42) arranged inside the container (see col. 3 lines 1-9: piston 42 within container 21), wherein the cartridge (2) is connectable to (as shown in FIG. 9 and described in col. 3 lines 35-50) a piston rod (41) which is manually maneuverable (i.e. see col. 4 lines 9-10: the piston rod can be pulled backward), the piston rod (41) being releasably connected to (see releasable connection from FIG. 12 to FIG. 13. Releasable connection provided by flexible arms 41a,b) the piston (42) such that the piston rod (41) is configured to be automatically released (see col. 4 lines 7-18: piston rod arms are released by structures of container) from the piston (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection between radially flexible components of the piston rod engaging the button of the piston as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving the piston rod configured to be “automatically” released.
Regarding claim 2, the modified system of Damiano teaches the delivery system according to claim 1, and Damiano further discloses wherein the cartridge (530, see FIG. 5C) is connectable to the dosing mechanism (see [0111]: cartridge loaded onto pump housing such as shown in FIGs. 3A-B) only (see [0111]: cartridge loaded AFTER being filled and disconnected from plunger rod and [0083], [0097]: cartridge has geometric/ other design features for mating, see [0099-0100]: onto infusion system. Thus, cartridge in filling configuration at in FIG.5B could NOT be connectable into pump housing that requires mated features ONLY on cartridge.) when the cartridge (530) is in the dispensing configuration (as in FIG. 5C as loaded into Figs. 3A-B).
Regarding claim 3, the modified system of Damiano teaches the delivery system according to claim 1, and Damiano further discloses wherein the dosing mechanism has a first end (670 at distal side/ same side as tubing 301 as shown in FIG. 3A) to which the cartridge (530) is connected (see [0089], [0100]: cartridge inserted into pump receptacle/ chamber 670).
Regarding claim 12, the modified system of Damiano teaches the delivery system according to claim 1, and Damiano further discloses wherein the cartridge (530, see FIG. 5B) is provided with a needle adaptor (596) at one end thereof (see [0111]: needle and needle adaptor provided to pierce septum of medicament vial for filling cartridge).
Regarding claim 13, the modified system of Damiano teaches the delivery system of claim 1, and Damiano further discloses wherein the cartridge (530, see FIG. 5B) is in the form of a disposable syringe (see FIG. 5A and [0116]: components of FIG. 5B disconnected and discarded==disposable after filling. In the case of a breakable joint, the components would be discarded and NOT reused. After components are discarded, only the cartridge remains such as in FIG. 5C for loading into dosing mechanism).
Regarding claim 23, the modified system of Damiano teaches the delivery system of claim 1, and Damiano further discloses wherein the piston rod (590, see FIG. 5B) is connected to (see FIG. 5B and described in [0111]: plunger rod 590 connected to piston 550 by breakable joint) the piston (550), but Damiano is silent to the connection being “by means of a plurality of resilient arms”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2), a piston (42), and a piston rod (41), wherein the piston rod (41) is connected to the piston (42) by means of a plurality of resilient arms (41a,b: see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection by means of a plurality of resilient arms as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving the connection being “by means of a plurality of resilient arms.”
Regarding claim 25, the modified system of Damiano teaches the delivery system according to claim 23, but Damiano is silent to “wherein: the arms are biased outwards but flexible inwards such that the arms fit inside the container of the cartridge.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) comprising a container (21), a piston (42), and a piston rod (41), wherein the piston rod (41) is connected to the piston (42) by means of a plurality of resilient arms (41a,b: see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”), wherein: the arms (41a,b) are biased outwards (see in FIG. 13 where arms are located at a radially “outward” position compared to that when disposed within the container. Thus, when no compressive force is applied as in FIG.13, the arms return to “biased” outward position) but flexible inwards (such as under compressive force as shown in FIG. 12 or described in col 3 lines 35-50 during insertion of piston rod) such that the arms (41a,b) fit inside (see FIG. 9) the container (21) of the cartridge (2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection by means of a plurality of resilient arms that are biased outwards but flexible inwards as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving “wherein: the arms are biased outwards but flexible inwards such that the arms fit inside the container of the cartridge.”
Regarding claim 26, the modified system of Damiano teaches the delivery system of claim 25, but Damiano is silent to “wherein: the arms are configured to grip a button when the arms are arranged inside the container; and/or the arms are configured to release the button when the arms are arranged outside the container.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) comprising a container (21), a piston (42), and a piston rod (41), wherein the piston rod (41) is connected to the piston (42) by means of a plurality of resilient arms (41a,b: see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”), wherein: the arms (41a,b) are configured to grip (see col. 3 lines 15-50: arms are radially compressed into button components and therefore “grip” the button under a compressive friction force) a button (42a-d) when the arms (41,b) are arranged inside (see FIG. 9) the container (21); and/or the arms (41a,b) are configured to release the button (42a-d) when the arms (41a,b) are arranged outside (see FIG. 13 and col. lines ) the container (21).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection by means of a plurality of resilient arms that are configured to grip a button inside the container and release a button when arranged outside the container as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving “wherein: the arms are configured to grip a button when the arms are arranged inside the container; and/or the arms are configured to release the button when the arms are arranged outside the container.”
Regarding claim 30, Damiano discloses method for providing a delivery system, comprising:
a first step of providing a cartridge (530, see FIG. 5A and see [0111]: cartridge 530 is provided as prefilled or empty as in FIG. 5A-C when filling from medicament vial (not shown) takes place at point of care), the cartridge (530, see FIG. 5A) comprising a container (see outlined shape forming cartridge 530) and a piston (550) arranged inside the container (see FIG. 5A pointing to piston 550 inside of container), wherein motion of the piston (550) is used to draw a liquid into the container (see [0111]: piston 550 withdrawn into and back out of reservoir to fill container) as well as dispense the liquid out from the container (see [0119]: piston 550 attached to drive nut of device to distribute medicament), wherein the cartridge (530) is connectable to (as shown in FIG. 5B and described in [0111]: plunger rod 590 provided to cartridge by breakable joint) a piston rod (590) which is manually maneuverable (see [0111]: push rod used to fill cartridge by pulling piston 550 out and back and therefore is manually maneuverable), the piston rod (590) being releasably connected to (as shown in FIG. 5A and described in [0111]: plunger rod provided by breakable joint) the piston (550);
a second step of filling the cartridge with a certain amount of liquid (see [0111]: after assembling with needle assembly, pushrod fills cartridge from medicament vial--not shown);
a third step of transforming the cartridge (see [0111]: after cartridge is filled, pushrod 590 would be removed such as by threaded connection or breakable joint. Thus, the cartridge is ‘transformed’ and can no longer be filled such as shown in FIG. 5C.) from a filling configuration (as in FIG. 5B) to a dispensing configuration (see [0111]: after the cartridge is filled, it is loaded into pump housing, such as in FIGs. 3A-B. pump delivers/ dispenses medicament, see [0004]); wherein:
the piston rod (590) is connected to (see [0111]: pushrod 590 connected to piston 550 and used to fill cartridge with medicament at point of care) the piston (550) when the cartridge (530) is in the filling configuration (as seen in FIG. 5B);
the piston rod (590) is disconnected from (See also [0111],[0116]: plunger rod discarded after filling and then the cartridge is loaded to dosing mechanism) the piston (550) when the cartridge (530) is in the dispensing configuration (as shown in FIGs. 3A-B, piston rod 590 is removed/ not a part of the system); and
the piston rod (590) is
configured to be released from the piston (550) after the cartridge (530) is filled with the liquid (as shown in FIG. 5C and described in [0111] and [0116]); and
a step of connecting the cartridge to a dosing mechanism (see [0111]: after cartridge is filled, it is attached to pump housing).
Damiano further discloses that the piston rod/ piston coupling could be connected by a number of means including a “snug-fit” or “snap-fit” coupling (see [0097]).
Damiano is silent to the piston rod configured to be “automatically” released.
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) storing a liquid (L, see col. 3 lines 50-54: liquid medicine L); the cartridge (2) comprises a container (21) and a piston (42) arranged inside the container (see col. 3 lines 1-9: piston 42 within container 21), wherein the cartridge (2) is connectable to (as shown in FIG. 9 and described in col. 3 lines 35-50) a piston rod (41) which is manually maneuverable (i.e. see col. 4 lines 9-10: the piston rod can be pulled backward), the piston rod (41) being releasably connected to (see releasable connection from FIG. 12 to FIG. 13. Releasable connection provided by flexible arms 41a,b) the piston (42) such that the piston rod (41) is configured to be automatically released (see col. 4 lines 7-18: piston rod arms are released by structures of container) from the piston (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection between radially flexible components of the piston rod engaging the button of the piston as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving the piston rod configured to be “automatically” released.
Regarding claim 31, the modified system of Damiano teaches the delivery system according to claim 1, and Damiano further discloses wherein the cartridge (530, see FIG. 5C) is non- reversibly transformed at an end of a filling with the liquid (see [0111]: after cartridge is filled, pushrod 590 would be removed such as by threaded connection or breakable joint. A breakable joint would be non-reversible because components are, see [0116]: disconnected and discarded after filling. In the case of a breakable joint, the components would be discarded and NOT reused.).
Regarding claim 32, the modified system of Damiano teaches the delivery system of claim 25, but Damiano is silent to “wherein each arm comprises a flexible zone of reduced radial thickness relative the remaining portion of the arm.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) comprising a container (21), a piston (42), and a piston rod (41), wherein the piston rod (41) is connected to the piston (42) by means of a plurality of resilient arms (41a,b: see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”), wherein each arm (41a,b) comprises a flexible zone (see arms bending in FIG. 12 at “flexible zone” of reduced radial thickness) of reduced radial thickness relative the remaining portion of the arm (see ‘Modified FIG. 7’ below).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection by means of a plurality of resilient arms, wherein each arm comprises a flexible zone of reduced radial thickness as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving “wherein each arm comprises a flexible zone of reduced radial thickness relative the remaining portion of the arm.”
Regarding claim 33, the modified system of Damiano teaches the delivery system of claim 25, but Damiano is silent to “wherein: the arms are configured to grip a button when the arms are arranged inside the container; and the arms are configured to release the button when the arms are arranged outside the container.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) comprising a container (21), a piston (42), and a piston rod (41), wherein the piston rod (41) is connected to the piston (42) by means of a plurality of resilient arms (41a,b: see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”), wherein: the arms (41a,b) are configured to grip (see col. 3 lines 15-50: arms are radially compressed into button components and therefore “grip” the button under a compressive friction force) a button (42a-d) when the arms (41,b) are arranged inside (see FIG. 9) the container (21); and the arms (41a,b) are configured to release the button (42a-d) when the arms (41a,b) are arranged outside (see FIG. 13 and col. lines ) the container (21).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection by means of a plurality of resilient arms that are configured to grip a button inside the container and release a button when arranged outside the container as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving “wherein: the arms are configured to grip a button when the arms are arranged inside the container; and the arms are configured to release the button when the arms are arranged outside the container.”
Regarding claim 34, the modified system of Damiano teaches the delivery system of claim 1, and Damiano discloses wherein the piston rod (590, see FIG. 5B) is configured to be released (by breakable joint) from the piston (550) only after the cartridge (530) is filled with the liquid (see [0111]: Pushrod is attached to piston to fill the cartridge. After cartridge is filled at point of care, pushrod 590 would be removed such as by threaded connection or breakable joint. Therefore, the piston rod is configured to be manually released from the piston by breakable joint only after the cartridge is filled) but Damiano is silent to the piston rod is configured to be automatically” released from the piston.
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) storing a liquid (L, see col. 3 lines 50-54: liquid medicine L); the cartridge (2) comprises a container (21) and a piston (42) arranged inside the container (see col. 3 lines 1-9: piston 42 within container 21), wherein the cartridge (2) is connectable to (as shown in FIG. 9 and described in col. 3 lines 35-50) a piston rod (41) which is manually maneuverable (i.e. see col. 4 lines 9-10: the piston rod can be pulled backward), the piston rod (41) being releasably connected to (see releasable connection from FIG. 12 to FIG. 13. Releasable connection provided by flexible arms 41a,b) the piston (42) such that the piston rod (41) is configured to be automatically released (see col. 4 lines 7-18: piston rod arms are released by structures of container) from the piston (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection between radially flexible components of the piston rod engaging the button of the piston as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving the piston rod configured to be “automatically” released.
Claims 4-6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Damiano in view of Hsu as applied to claims 3 and 1 above, and further in view of Pedersen et al. (U.S. PGPUB No. 2019/0192782), hereinafter Pedersen.
Regarding claim 4, the modified system of Damiano teaches the delivery system of claim 3, and Damiano further discloses wherein the dosing mechanism (see FIG. 3A-B) further comprises an opposite end (proximal end/ end closest to numeral 651 in FIG. 3A). Lastly, Damiano discloses that the features and components of the device could be applied in the form an injection pen (see [0187]), but Damiano is silent to the opposite end of the dosing mechanism “being provided with a manual injection control means.”
However, Pedersen teaches a delivery system (see FIG. 1B) with a cartridge (113) storing a liquid (see [0040]: drug filled transparent cartridge 113) and a dosing mechanism (101, see [0040]: housing has drug expelling mechanism==dosing mechanism) configured to connect (see connection to cartridge 113 in Fig. 2 and described in [0040]) to the cartridge (113), wherein the dosing mechanism (101) has a first end (125) to which the cartridge (113) is connected (see [0043] cartridge 113 held within 110 that connects to 101 via protrusion 111) and an opposite end (towards numeral 190 in Fig. 1B) being provided with a manual injection means (see [0040]: dose of drug expelled when button 190 is actuated. Thus, button is manually activated.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the delivery system comprising a cartridge and a dosing mechanism disclosed in Damiano in the form of an injection pen with a manual injection means as taught by Pedersen for the purpose of allowing the user to control the dose via the manual injection means (see Pedersen [0040]), instead of providing the dose automatically (such as in the infusion pump of Damiano), thus achieving the opposite end of the dosing mechanism “being provided with a manual injection control means.”
Regarding claim 5, the modified system of Damiano teaches the delivery system according to claim 4, and Damiano further discloses that the features and components of the device could be applied in the form an injection pen (see [0187]), but is silent to “wherein the manual injection control means comprises a control button”.
However, Pedersen teaches a delivery system (see FIG. 1B) with a dosing mechanism (101, see [0040]: housing has drug expelling mechanism==dosing mechanism), wherein the dosing mechanism is provided with a manual injection means (see [0040]: dose of drug expelled when button 190 is actuated. Thus, button is manually activated.), wherein the manual injection control means comprises a control button (190, see [0040]: 190 is a button).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the delivery system comprising a cartridge and a dosing mechanism disclosed in Damiano in the form of an injection pen with a control button as taught by Pedersen for the purpose of allowing the user to control the dose via the manual injection means (see Pedersen [0040]), instead of providing the dose automatically (such as in the infusion pump of Damiano), thus achieving “wherein the manual injection control means comprises a control button”.
Regarding claim 6, the modified system of Damiano teaches the delivery system according to claim 1, wherein the dosing mechanism (see FIG. 3A) is configured to control dispensing of a specific volume of the liquid from the cartridge (530, see FIG.5C and [0004]: pump delivers medicament from cartridge reservoirs and is therefore ‘configured to’ control dispensing of a specific volume of liquid from the cartridge), but is silent to “the specific volume being less than a total volume of the liquid stored inside the cartridge, wherein the specific volume is adjustable”.
However, Pedersen teaches a delivery system (see FIG. 1B) with a dosing mechanism (101, see [0040]: housing has drug expelling mechanism==dosing mechanism), wherein the dosing mechanism (101) is configured to control dispensing of a specific volume of the liquid (see [0040]: housing 101 includes dose setting member 180 for manual setting of desired dose) from the cartridge (113), the specific volume being less than a total volume of the liquid stored inside the cartridge (see [0052]: user cannot set does larger than what is left in cartridge), wherein the specific volume is adjustable (see [0065]: incremental rotation of dose setting member 180 corresponds to size of dose).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the delivery system comprising a cartridge and a dosing mechanism disclosed in Damiano in the form of an injection pen configured to control dispensing of a specific volume of liquid as taught by Pedersen for the purpose of allowing the user to set and control the dose (see Pedersen [0009]), thus achieving “the specific volume being less than a total volume of the liquid stored inside the cartridge, wherein the specific volume is adjustable”.
Regarding claim 9, the modified system of Damiano teaches the delivery system according to claim 6, but Damiano is silent to “wherein the dosing mechanism comprises a quantity control device being configured to adjust the specific volume being dispensed from the cartridge, wherein the quantity control device is provided as a turn knob.”
However, Pedersen teaches a delivery system (see FIG. 1B) with a dosing mechanism (101, see [0040]: housing has drug expelling mechanism==dosing mechanism), wherein the dosing mechanism (101) comprises a quantity control device (180) being configured to adjust the specific volume being dispensed (see [0049-0050]: 180 turned to set dose and [0056]: incremental rotation of dose setting member 180 corresponds to size of dose) from the cartridge (113), wherein the quantity control device (180) is provided as a turn knob (see [0045]: user-operated dial member 180 and [0049]: 180 is turned to set dose. Thus, 180 is reasonably a ‘turn knob’).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the delivery system comprising a cartridge and a dosing mechanism disclosed in Damiano in the form of an injection pen including a quantity control device provided as a turn knob as taught by Pedersen for the purpose of allowing the user to set and control the dose (see Pedersen [0009]), thus achieving “wherein the dosing mechanism comprises a quantity control device being configured to adjust the specific volume being dispensed from the cartridge, wherein the quantity control device is provided as a turn knob.”
Regarding claim 11, the modified system of Damiano teaches the delivery system according to claim 1, but is silent to “wherein the dosing mechanism further comprises a visual indicator.”
However, Pedersen teaches a delivery system (see FIG. 1B) with a dosing mechanism (101, see [0040]: housing has drug expelling mechanism==dosing mechanism), wherein the dosing mechanism (101) further comprises a visual indicator (102, see Fig. 1A and [0040]: display window 102).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the delivery system comprising a cartridge and a dosing mechanism disclosed in Damiano in the form of an injection pen including a visual indicator as taught by Pedersen for the purpose of numerically displaying the set dose to the user (see Pedersen [0049]), thus achieving “wherein the dosing mechanism further comprises a visual indicator.”
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Damiano (U.S. PGPUB No. 2019/0344009) in view of Hsu (U.S. Patent No. 6,773,416), Edwards (U.S. PGPUB No. 2017/0340424), and Mews et al. (U.S. PGPUB No. 2017/0274148), hereinafter Mews.
Regarding claim 35, Damiano discloses a delivery system comprising:
a cartridge (530, see FIG. 5A) comprising:
an elongate body (see elongated barrel forming 530) having at least one wall defining a container cavity (see ‘Modified FIG. 5A’ below);
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a piston (550) slidably disposed within the container cavity (see [0111]: plunger 550 moves into and out of cartridge), the piston comprising a button (552, see FIG. 5C and [0111]: “insert” 552 of piston for coupling with “insert” 561 of piston rod 590. See FIG.2A with insert 560 for visual clarity) at a proximal end thereof (as shown in FIG. 5C), and
a piston rod (590) comprising an unloaded configuration (see [0111]: at point of care, piston rod 590 inserted into empty cartridge and threaded to button. Distal most location of piston rod/button==unloaded configuration where medication reservoir is empty) and a loaded configuration (see [0111]: pushrod used to fill cartridge by pulling button all the way back. Proximal-most location of piston rod/button==loaded configuration where the medication reservoir is full); and
a dosing mechanism (see FIGs. 3A-B) comprising an open ended tube (670, see FIG. 3A and [0095]) having a first end (proximal end of receptacle toward numeral 651 in FIG. 3A) and a second end (distal end of receptacle 670 toward numeral 2130 opposite the first end (see FIG. 3A), the second end being open to receive the elongate body and the piston of the cartridge in the loaded configuration therein (see [0095] & [0101]: cartridges such as in FIGs.5A-C are loaded into receptacles 670. See also [0111]: after filling, cartridge loaded onto dosing mechanism. The cartridge includes the piston and therefore both the cartridge body and the piston are loaded therein).
Damiano further discloses that the piston rod/ piston coupling could be connected by a number of means including a “snug-fit” or “snap-fit” coupling (see [0097]).
Damiano is silent to the piston rod “comprising one or more components that are flexible in a radially outward direction, wherein, when the piston and the one or more components of the piston rod are disposed within the container cavity in a unloaded configuration, the one or more components are compressed radially inward by the at least one wall of the body to engage with the button of the piston, and when the proximal end of the piston and the one or more components are drawn outside of the container cavity to a loaded configuration, the one or more components flex radially outward to disengage with the button” and the dosing mechanism first end “comprising a control button, the control button engageable with the button of the piston, wherein the control button is depressible to push the piston distally within the container cavity to dispense a predetermined amount of the liquid from the cartridge.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2) comprising: an elongate body (21) having at least one wall defining a container cavity (cylindrical region housing medicament and piston and piston rod, see ‘Modified FIG. 9’ below);
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a piston (42) slidably disposed within the container cavity (see col. 3 lines 7-8: piston rod 41 reciprocates==moves forward/back==slides the stopper within body 21), the piston (42) comprising a button (42a-d, see FIG. 5) at a proximal end thereof (as seen in FIG. 5), and
a piston rod (41) comprising one or more components (41a, 41b) that are flexible in a radially outward direction (arms are flexible from position shown in FIG. 12 to radially outward direction shown in FIG.13), wherein, when the piston (41) and the one or more components (41a, 41b) of the piston rod (41) are disposed within the container cavity (see ‘Modified FIG. 9’ above) in a unloaded configuration (such as when all the liquid is dispensed such that the piston is located most distally—liquid expelled as described in see col. 3 lines 52-54), the one or more components (41a, 41b) are compressed radially inward by the at least one wall of the body (see FIG. 13 where components 41a, 41b are larger in diameter than wall of 21. Therefore, the components 41a, 41b MUST be compressed while the components are contained within the container cavity) to engage with the button (41a-d as seen in FIG. 5) of the piston (see col. 3 lines 35-50: 41a,b compressed inwards to engage with piston 42 to secure the piston rod 41 to the piston 42), and when the one or more components (41-d) are drawn outside of the container cavity (see FIG.12-13) to a loaded configuration (such as when the piston is fully retracted as shown in FIG. 13), the one or more components (41a-d) flex radially outward to disengage with the button (see col. 4 lines 9-17: 41a, b are forced radially inward, see FIG.12, and then disengaged to position shown in FIG. 12. Therefore, 41a,b MUST flex outward after the inward force is applied to obtain radially outward position as shown in FIG.13).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection between one of more radially flexible components of the piston rod compressed by the cavity wall to engage the button of the piston as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving the piston rod “comprising one or more components that are flexible in a radially outward direction, wherein, when the piston and the one or more components of the piston rod are disposed within the container cavity in a unloaded configuration, the one or more components are compressed radially inward by the at least one wall of the body to engage with the button of the piston, and when the proximal end of the piston and the one or more components are drawn outside of the container cavity to a loaded configuration, the one or more components flex radially outward to disengage with the button.”
Damiano in view of Hsu remain silent to “when the proximal end of the piston” is “drawn outside of the container cavity to a loaded configuration” and the dosing mechanism first end “comprising a control button, the control button engageable with the button of the piston, wherein the control button is depressible to push the piston distally within the container cavity to dispense a predetermined amount of the liquid from the cartridge.”
However, Edwards teaches a delivery system (see Figure 5) comprising a cartridge (12) comprising an elongate body (see cylindrically shaped body of cartridge 12) having at least one wall defining a container cavity (see Figure 8 with wall and container cavity reservoir shown), a piston (87, see Figure 8 and [0076]), a button (52) forming the proximal end (see [0076]: piston 87 terminates at button 52) of the piston (87), and a dosing mechanism (16). Edwards teaches when the proximal end (proximal end of piston 87 terminates at button 52) of the piston (87) is drawn outside of the container cavity to a loaded configuration (such as shown in Figure 4, 5, 8 with button 52 of proximal end outside of the container cavity).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the button disclosed in Damiano to extend from the piston such that the button is drawn outside the container cavity in the loaded configuration as taught by Edwards for the purpose of facilitating the coupling to a dosing mechanism by a variety of potential coupling mechanisms (see [0069-0072]), thus achieving “when the proximal end of the piston” is “drawn outside of the container cavity to a loaded configuration””.
Damiano in view of Hsu and Edwards remain silent to the dosing mechanism first end “comprising a control button, the control button engageable with the button of the piston, wherein the control button is depressible to push the piston distally within the container cavity to dispense a predetermined amount of the liquid from the cartridge.”
However, Mews teaches a delivery system (see Fig. 1B) comprising a cartridge (120, see [0031]) with an elongate body (see cylindrical shape of cartridge 120) and a piston (see [0031]: cartridge has piston) and a dosing mechanism (101, see [0031]: 101 has integrated drug expelling mechanism). Mews further teaches the dosing mechanism (101) comprising an open ended (see [0031]: open end holds cartridge holder 110 + cartridge 120) tube (see tubular shape of 101) having a first end (rightward/proximal end) comprising a control button (190) and a second end (leftward/distal end) opposite the first end (rightward/proximal end), the second end (leftward/distal end) being open to receive the elongate body and the piston of the cartridge in a loaded configuration therein (see [0031]: distal/ open end of 101 holds cartridge—including piston-- and cartridge holder), the control button (190) engageable with a button (a proximal end of piston) of the piston (see [0031]: control button 190 delivers dose via actuation of piston and therefore meets the claim limitation as much as is disclosed by Applicant such as in [0037-0038] of Applicant disclosure), wherein the control button (190) is depressible to push (see [0031]: button is actuated and [0005]: pushable buttons known in the art) the piston distally within the container cavity to dispense a predetermined amount of the liquid from the cartridge (see [0031]: dose is set and delivered by driving piston).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dosing mechanism for loading the cartridge thereon disclosed in Damiano to be an injection pen dosing mechanism for loading a cartridge thereon and comprising a depressible control button as taught by Mews for the purpose of allowing a user to manually set and deliver the dose (see [0031]), instead of having the dose automatically delivered such as by an infusion pump dosing mechanism of Damiano, thus achieving the dosing mechanism first end “comprising a control button, the control button engageable with the button of the piston, wherein the control button is depressible to push the piston distally within the container cavity to dispense a predetermined amount of the liquid from the cartridge.”
Regarding claim 36, the modified system of Damiano teaches the delivery system according to claim 35, but Damiano is silent to “wherein the one or more components of the piston rod comprise a plurality of arms.”
However, Hsu teaches a delivery system (see FIG. 9) comprising: a cartridge (2), a piston (42), and a piston rod (41) comprising one or more components (41a, 41b) that are flexible in a radially outward direction (arms are flexible from position shown in FIG. 12 to radially outward direction shown in FIG.13), wherein the one or more components (41a,b) of the piston rod (41) comprise a plurality of arms (see FIG. 9 and col. 3 lines 15-23: 41a,b described as radially and longitudinally extending to a front side== “arms”).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston rod/ piston connection disclosed in Damiano to be formed by a connection between one of more radially flexible arms of the piston rod compressed by the cavity wall to engage the button of the piston as taught by Hsu for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe (see col.1 lines 60-64), thus achieving “wherein the one or more components of the piston rod comprise a plurality of arms.”
Regarding claim 37, the modified system of Damiano teaches the delivery system according to claim 35, and Damiano further discloses wherein the button (552, see FIG. 5C and [0111]: “insert” 552 for coupling with “insert” 561 of piston rod 590. See FIG.2A with insert 560 of piston for visual clarity) comprises a disc (see disc shape of insert 560 best seen in FIG. 2A. Button must be disc shaped to be disposed within cylindrical cartridge barrel) that is centrally disposed at a proximal end (see [0111], [0116-0117], and FIG. 2A for best visual) of the piston (550).
Response to Arguments
Applicant's arguments filed 01/20/26 have been fully considered but they are not persuasive.
On pages 8-11, Applicant submits that the combination of Damiano in view of Hsu is improper and therefore the 35 U.S.C. § 103 claim rejections under Damiano in view of Hsu should be withdrawn. The examiner disagrees and maintains the rejections.
Specifically, on page 11, Applicant submits that a person of ordinary skill in the art would not be motivated to combine Damiano in view of Hsu because Damiano disconnects the piston/piston rod connection after filling of the syringe. Meanwhile, Hsu disconnects the piston/ piston rod connection after the cartridge is emptied. Thus, Applicant seems to argue that that because Damiano and Hsu disconnect the piston/piston rods at different functional timeframes, a combination of Damiano in view of Hsu cannot be made. The examiner disagrees. Damiano teaches the piston/piston rod connection in FIG. 5A-B and further discloses that the piston/piston rod connection can be connected by a number of means (see [0097] as cited in the claim rejections above and in the claim rejections of the non-final office action mailed 10/20/25). Hsu teaches a piston/piston rod connection that automatically disconnects. Thus, a person of ordinary skill in the art would look to Hsu as having an alternative piston/piston rod connection beneficial to Damiano because Hsu has an automatically disconnected connection, regardless of when that disconnection occurs. Therefore, the examiner maintains the rejections and specifically notes MPEP § 2123.I and MPEP § 2143.01.II. First, MPEP § 2123.I states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”. Damiano suggests modifying the piston/piston rod connection mechanism. Hsu teaches a specific modification of the mechanism that obtains an automatic disconnection. Thus, the art reasonably suggests to one of ordinary skill in the art to modify Damiano’s connection with Hsu’s for the purpose of obtaining an automatic release between the components. Next, MPEP § 2143.01.II notes that, although prior art teachings may have conflicts (i.e.: when the piston/ piston rod disconnection occurs), the disclosures may still be combined when the references would not have “deterred one of ordinary skill in the art from using” the teachings. Nothing in Damiano or Hsu would deter a person of ordinary skill in the art from modifying the piston/piston rod connection mechanism. Therefore, the examiner was not persuaded by this argument and has maintained the rejections.
Next, on pages 11-12, Applicant submits that the combination of Damiano in view of Hsu relies on improper hindsight reasoning and only relies on motivation from the current application alone. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner disagrees with Applicant’s suggestion that motivation was only gleaned from Applicant disclosure. In the combinations of Damiano in view of Hsu, such as at least the claim rejection of claim 1 on page 10 of the non-final office action mailed 10/20/25, the examiner relies on motivation for the modification of Damiano in view of Hsu “for the purpose of enabling the piston rod to be automatically disconnected from the piston after use of the syringe”. The examiner cited col. 1 lines 60-64 of Hsu to support this motivation. Col 1 lines 60-64 of Hsu read “The present invention has been accomplished under the circumstances in view. It is the main object of the present invention to provide a safety hypodermic syringe, which enables the plunger to be automatically disconnected from the stopper after the service of the syringe…” Therefore, the knowledge of using the piston/ piston rod connection of Hsu to obtain an automatically disconnectable mechanism “within the level of ordinary skill at the time the claimed invention was made”, such as at least by the disclosure of Hsu in col 1 lines 60-64. Therefore, the examiner was not persuaded by this argument and maintains the claim rejections.
To continue, on page 13, Applicant argues that Damiano does not disclose “a dosing mechanism comprising an open ended tube…” because 670 is a “chamber” and “not a tube (i.e., a hollow cylinder).” The examiner disagrees. FIG. 3A, as cited by the examiner, shows the receptacle 670 with a cross-section of a circle. [0095], as cited by the examiner, describes medicament vials (see definition of vial per Collins dictionary: a small, cylindrical bottle, for containing liquids) inserted into the receptacles 670. Thus, receptacle 670 has a circular cross-section and holds a cylindrical element. Therefore, the receptable 670 must have a hollow cylindrical shape, reasonably disclosing a “tube”. Thus, the examiner was not persuaded by this argument and has maintained the claim rejections.
On pages 13-15, Applicant argues that Damiano in view of Hsu fail to teach the one or more components “compressed radially inward” by the wall to engage the button of the piston. Applicant states that it is not clear in FIG. 13 that the components are compressed radially inward. However, the examiner cited many other figures for depiction of the one or more components compressed radially inward, such as “arms are flexible from position shown in FIG. 12 to radially outward direction shown in FIG.13” (see page 28 of the non-final office action mailed 10/20/25). The examiner also cited col 4 lines 9-17 (see page 29 of the non-final office action mailed 10/20/25) that teaches the arms are “inwardly forced” at least by the rear side of the barrel. Therefore, as a whole, Damiano in view of Hsu would suggest to a person of ordinary skill in the art to modify Damiano’s piston/piston rod connection to be compressed by the cavity wall to engage the button to form an automatically disconnectable mechanism (see page 29 of the non-final office action mailed 10/20/25). Again, MPEP § 2123.I states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”. Damiano suggests modifying the piston/piston rod connection mechanism. Hsu teaches a specific modification of the mechanism that uses a cavity wall to compress arm-like structures to obtain an automatic disconnection. Thus, the art reasonably suggests to one of ordinary skill in the art to modify Damiano’s connection with Hsu’s for the purpose of obtaining an automatic release between the components. Therefore, the examiner was not persuaded by this argument and has maintained the claim rejections.
On pages 15-16, Applicant submits that the combination of Damiano in view of Hsu fails to teach the piston drawn outside the container cavity to a loaded configuration. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Edwards is used to teach the button withdrawn completely outside of the container/ beyond the proximal end of the container (see pages 30-31 of the non-final office action mailed 10/20/25). Thus, the arguments against Damiano and Hsu relative to this feature are not persuasive.
On pages 15-16, Applicant argues that a person of ordinary skill in the art could not combine the structure of the references Damiano in view of Hsu and Edwards. Applicant argues that a person of ordinary skill in the art would have “no motivation or understanding” in view of Edwards how to modify the release mechanism of Damiano in view of Hsu. The examiner disagrees. First, the modification is only to modify Damiano’s button in view of Edwards (see page 31 of the non-final office action mailed 10/20/25). Next, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Edwards provides the motivation for modifying the button disclosed in Damiano to extend from the piston such that the button is drawn outside the container as taught by Edwards for the purpose of facilitating the coupling to a dose mechanism by a variety of potential coupling mechanism (see Edwards [0069-0072] and page 31 of the non-final office action mailed 10/20/25). Lastly, in response to applicant's argument that a person of ordinary skill in the art would have no “understanding” in view of Edwards how to modify the release mechanism of Damiano, 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). Damiano discloses that other piston/piston rod connection mechanisms can be used in the device. Edwards teaches a piston with a button that protrudes beyond the proximal end of a cartridge to facilitate coupling with a piston rod. Therefore, the combined teachings would suggest to a person of ordinary skill in the art that a piston including a button design that protrudes proximally beyond the cartridge proximal end would facilitate coupling with several dosing mechanisms/ piston rod designs. A person of ordinary skill in the art would have reasonable expectation of success for modifying Damiano’s button with a proximally extending protuberance as taught in Edwards such that the button extends beyond the cartridge proximal end. A person of ordinary skill in the art would not have to bodily incorporate the exact piston button of Edwards into the piston button disclosed in Damiano. Therefore, the examiner was not persuaded by this argument and maintains the 35 U.S.C § 103 claim rejections.
Lastly, on page 16, Applicant argues that modifying the connection mechanism of Damiano in view of Hsu would destroy the principle operation of the release mechanism of Hsu. However, the modification in view of Edwards is to only modify the button of Damiano. Thus, the arguments that Hsu’s mechanism would be changed from its principle operation are moot and the examiner maintains the claim rejections.
There are no other arguments presented. Thus, the examiner maintains the 35 U.S.C. § 103 independent claim rejections as argued by Applicant and all subsequent depending claim rejections therefrom.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783