DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 17 April 2026 wherein Claims 1, 4 – 7, and 15 – 23 are amended, Claims 2, 3, 8, and 9 are cancelled, and no claims are added. Therefore Claims 1, 4 – 7, 15 – 23 are currently pending.
The Applicant’s amendments to the Specification dated 17 April 2026 and Remarks dated 17 April 2026 has been fully considered. These amendments to the Specification and Remarks have overcome each Specification and Drawing Objection set forth in the Non-Final Rejection dated 22 January 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore each Specification and Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 17 April 2026 has been fully considered. These amendments to the Claims has overcome each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 20 – 21, filed 17 April 2026, with respect to the rejection(s) of independent claim 1 and its dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang (US 2019/0175819 A1), Mueller-Pathle (US 2017/0043090 A1), Sanderson et al. (US 4,722,726 A), Grant et al. (US 2019/0321260 A1), and Cirelli et al. (US 4,886,499 A).
Applicant's arguments, see pages 17 – 19, filed 17 April 2026 have been fully considered but they are not persuasive.
The Applicant alleges that the feature “the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir” of Claim 1 is not disclosed by the cited references. See pages 16 – 17 of the Remarks dated 17 April 2026. The Applicant further alleges that one of the cited references, Grant et al. (US 2019/0321260 A1), does not mention the relationship of the volume of the syringe and the volume of the reservoir. See page 18 of the Remarks dated 17 April 2026. Finally, the Applicant alleges that the cited references do not teach the function of the feature “the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir” contained in Claim 1. See page 19 of the Remarks dated 17 April 2026. The Examiner respectfully disagrees.
Claim 1 is properly rejected under 35 U.S.C. § 103 over Yang (US 2019/0175819 A1), Mueller-Pathle (US 2017/0043090 A1), Sanderson et al. (US 4,722,726 A), Grant et al. (US 2019/0321260 A1), and Cirelli et al. (US 4,886,499 A) because the feature “the volume of the filling module [being] 1 mL – 2 mL greater than the volume of the reservoir” and this feature’s functionality is taught by the cited references.
Sanderson et al. is relied upon to teach the functionality of the feature while Grant et al is relied upon to teach the volume of the filing module being 1 mL – 2 mL greater than the volume of the reservoir. See pages 10 – 11 and 13 – 14 of the Non-Final Rejection. Sanderson teaches that the filling module (the syringe) is deliberately designed to be greater than a volume of the drug to be infused, the volume of the filling module is greater than the volume of the reservoir, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module. See Col. 8, lines 31 – 55 of Sanderson.
The only teaching absent from the teaching of Sanderson is the volume of the filling module being 1 mL – 2 mL greater than the volume of the reservoir. Grant rectifies this deficiency by teaching that it is well known in the prior art to have a filling module (a syringe) with a volume that is 1 mL – 2 mL greater than the volume of the reservoir. See [0251] and [0537] of Grant.
A person having ordinary skill in the art upon completing a fair reading of the disclosures of Sanderson and Grant would come to the determination that the combination of the references teaches the feature “a volume of the filling module is deliberately designed to be greater than a volume of the drug to be infused, and an excess space in the filing module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module, wherein the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir” and its respective functionality. Furthermore Sanderson and Grant provide rationales on why a person having ordinary skill in the art would want these features and respective functionality. Sanderson teaches that the filling module may be used to prime a drug delivery device by removing air from the reservoir and allowing the reservoir to be completely filled. See Col. 8, lines 31 – 55 of Sanderson. Grant further teaches the volume difference of 1 mL – 2 mL between the volume of the filling module and the volume of the reservoir is beneficial because it allows for a physician to completely fill the volume of the reservoir with the drug from the volume of the filling module and that this amount corresponds to a multiple day supply of the drug for the patient. See [0251] of Grant.
In view of the aforementioned rationale, the Applicant’s arguments related to the cited references not teaching the feature “the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir” and its related functionality is unpersuasive. Nonetheless, as set forth above, the Applicant’s additional argument, see pages 20 – 21, filed 17 April 2026, with respect to the rejection(s) of independent claim 1 and its dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang (US 2019/0175819 A1), Mueller-Pathle (US 2017/0043090 A1), Sanderson et al. (US 4,722,726 A), Grant et al. (US 2019/0321260 A1), and Cirelli et al. (US 4,886,499 A).
Claim Objections
Claims 15 and 20 are objected to because of the following informalities:
Claim 15 recites “The drug filling method of the skin patch drug infusion system of claim 1.” The Examiner suggests amending this to recite “[[The]] A drug filling method of the skin patch drug infusion system of claim 1” to create antecedent basis for the drug filling method.
Claim 20 recites “The drug filling method of the skin patch drug infusion system of claim 1.” The Examiner suggests amending this to recite “[[The]] A drug filling method of the skin patch drug infusion system of claim 1” to create antecedent basis for the drug filling method.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 4 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 2019/0175819 A1), Mueller-Pathle (US 2017/0043090 A1), Sanderson et al. (US 4,722,726 A) (hereinafter referred to as “Sanderson”), Grant et al. (US 2019/0321260 A1) (hereinafter referred to as “Grant”), and Cirelli et al. (US 4,886,499 A) (hereinafter referred to as “Cirelli”).
Yang, Mueller-Pathle, Sanderson, and Grant are each previously cited in the Notice of References Cited form dated 22 January 2026.
With regards to claim 1, Yang discloses (see Figs. 1 – 11) a skin patch drug infusion system (see Fig. 7a and [0044] “delivery system”), comprising:
an infusion mechanism module (see Fig. 8C), wherein the infusion mechanism module includes:
a reservoir (6) (see [0044]), for accommodating a drug to be infused (see [0048] “drug fluid goes from a syringe to a reservoir”), and provided with a drug inlet (see at 101 in Fig. 7b and [0048]), a drug outlet (see at 103 in Fig. 7a and [0045]), and a piston (see [0049] “a piston in the reservoir”);
an infusion needle (see Fig. 8A and [0051] “the U-shape needle”), wherein one end of the infusion needle (51) (see [0049]) is communicated with the drug outlet of the reservoir (see [0049] and Fig. 7b), and an other end of the infusion needle (52) (see [0049]) is inserted subcutaneously implanting drug infusion (see [0002] “subcutaneous tissue”, [0003] and [0049]); and
a driving unit that moves the piston (see [0049] “a piston in the reservoir which is not illustrated in the drawings is pushed by a drive unit of the portable delivery device”);
a control mechanism module (see [0049] “a drive unit of the portable delivery device”), worked collaboratively with the infusion mechanism module to regulate drug infusion (see [0049]);
a filling module (see [0049] “When a reservoir needs to be filled, use a needle of a syringe containing the drug fluid needed to penetrate the silicone key 101, so the drug fluid goes into the chamber with triple connections 10 from the syringe through the silicone key 101 as shown in FIG. 7 and goes into the reservoir through the silicone key 102 as shown in FIG. 6” wherein the syringe is the filling module), for filling the drug to be infused into the reservoir via the drug inlet.
However Yang is silent with regards to the following:
an adhesive patch, for attaching the infusion mechanism module and/or the control mechanism module to a skin surface; and
wherein a volume of the filling module is deliberatively designed to be greater than a volume of the drug to be infused, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module,
wherein the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir,
wherein the infusion mechanism module and the control mechanism module are detachable to each other, the control mechanism module is reusable and the driving unit of the infusion mechanism module is disposable.
Nonetheless Mueller-Pathle, which is within the analogous art of filling device for drug delivery devices (see abstract and title), teaches an adhesive patch (105) (see [0129] and Fig. 1), for attaching the infusion mechanism module (101) (see [0128]) and/or the control mechanism module (103)(see [0128]) to a skin surface (100) (see [0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the skin patch drug infusion system of Yang in view of a teaching of Mueller-Pathle such that the skin patch drug infusion system further comprises an adhesive patch, for attaching the infusion mechanism module and/or the control mechanism module to a skin surface. One of ordinary skill in the art would have been motivated to make this modification because Mueller-Pathle teaches that the adhesive tape fixes the skin patch drug infusion system to the patient’s body (see [0129] of Mueller-Pathle).
The skin patch drug infusion system of Yang modified in view of a teaching of Mueller-Pathle will hereinafter be referred to as the skin patch drug infusion system of Yang and Mueller-Pathle.
Neither Yang nor Mueller-Pathle explicitly teaches the following:
wherein a volume of the filling module is deliberatively designed to be greater than a volume of the drug to be infused, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module,
wherein the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir,
wherein the infusion mechanism module and the control mechanism module are detachable to each other, the control mechanism module is reusable and the driving unit of the infusion mechanism module is disposable.
Nonetheless Sanderson, which is within the analogous art of drug delivery devices (see abstract and title), teaches a volume of the filling module is deliberatively designed to be greater than a volume of the drug to be infused, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module (Col. 8, lines 31 – 55 “syringe or other suitable drug delivery means is filled with a volume of drug solution somewhat larger than the volume of the lower cavity, and the needle of the syringe is forced through the serum stopper 5 into the tube 2. The syringe plunger is drawn back to aspirate air from the lower chamber 10, then the drug solution is forcibly transferred through the needle into the tube 2. This process of air aspiration and transfer of solution is repeated until the drug solution in the device completely fills lower cavity 10”) (Based on this disclosure the filling module/syringe is deliberately designed to be greater than a volume of the drug to be infused, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path because the syringe plunger is drawn back to aspirate air from the lower cavity and then fill the lower cavity with the drug. Therefore, the syringe has an excess space in order to hold the aspirated air prior to filling the cavity with the drug.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the volume of the filling module of the skin patch drug infusion system of Yang and Mueller-Pathle in view of a teaching of Sanderson such that a volume of the filling module is deliberatively designed to be greater than a volume of the drug to be infused, and an excess space in the filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module. One of ordinary skill in the art would have been motivated to make this modification because Sanderson teaches that a filling module may be used to prime a drug delivery device thereby removing air from the reservoir and allowing the reservoir to be completely filled (see Col.8, lines 31 – 55 of Sanderson). Furthermore, priming a medical device improves patient safety by reducing the chances of an air embolism and increasing the accuracy of medication delivery.
The skin patch drug infusion system of Yang and Mueller-Pathle modified in view of a teaching of Sanderson will hereinafter be referred to as the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson.
However none of Yang, Mueller-Pathle, or Sanderson teaches
wherein the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir,
wherein the infusion mechanism module and the control mechanism module are detachable to each other, the control mechanism module is reusable and the driving unit of the infusion mechanism module is disposable.
Nonetheless Grant, which is within the analogous art of apparatus, systems, and methods for fluid delivery (see abstract and title), teaches (see Fig. 4) the volume of the filling module (see [0537] “Any syringe known in the art may be used, however, in the exemplary embodiments, any syringe having a size and shape to be accommodated by the filling aid 3004 may be used, including, but not limited to, a 3 cc/mL TERUMO SYRINGE without needle, made by TERUMO Europe, Belgium, together with a Becton Dickinson 26G1/2 PRECISIONGLIDE Needle, made by Becton Dickinson & Co., Franklin Lakes, N.J.” wherein the syringe is the filling module and a 3 cc/mL TERUMO SYRINGE has a maximum volume of 3 mL) is 1 mL – 2 mL greater than the volume of the reservoir (118) (see [0251] “reservoir 118 may hold about 1.00 to 3.00 ml of insulin”) (When the syringe comprises a volume of 3 mL while the reservoir being a volume of 1.00 – 2.00 mL then the volume of the syringe is 1 – 2 mL greater than the volume of the reservoir).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson in view of a teaching of Grant such that the volume of the filling module is 1 mL – 2 mL greater than the volume of the reservoir. One of ordinary skill in the art would have been motivated to make this modification because Grant teaches this volume for a reservoir corresponds to approximately a three day supply of insulin (see [0251] of Grant). Therefore, a person having ordinary skill in the art would recognize that a reservoir being 1 mL – 2 mL provides for approximately a one to two day supply of insulin while the volume of the filling module/syringe allows for the refilling of the reservoir in its entirety.
The skin patch infusion system of Yang, Mueller-Pathle, and Sanderson modified in view of a teaching of Grant will hereinafter be referred to as the skin patch infusion system of Yang, Mueller-Pathle, Sanderson and Grant.
However, none of Yang, Mueller-Pathle, Sanderson or Grant teaches:
wherein the infusion mechanism module and the control mechanism module are detachable to each other, the control mechanism module is reusable and the driving unit of the infusion mechanism module is disposable.
Nonetheless Cirelli, which is within the analogous art of portable injection appliances (see abstract and title), teaches wherein the infusion mechanism module (42) (see Col. 6, lines 45 – 61) and the control mechanism module (43) (see Col. 6, lines 65 – 67) are detachable to each other (see Col. 6, lines 32 – 37), the control mechanism module is reusable (see Col. 6, lines 65 – 67 “reusable part 43”) and the driving unit (45) (see Col. 6, lines 45 – 61 “The disposable part 42 also comprises pump means 45”) of the infusion mechanism module is disposable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module and the control mechanism module of the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, and Grant in view of a teaching of Cirelli such that wherein the infusion mechanism module and the control mechanism module are detachable to each other, the control mechanism module is reusable and the driving unit of the infusion mechanism module is disposable. One of ordinary skill in the art would have been motivated to make this modification because reusable medical device parts provide significant benefits such as cost savings and environmental advantages by reducing waste. See Col. 6, line 38 – Col. 7, line 3 of Cirelli.
The skin patch infusion system of Yang, Mueller-Pathle, Sanderson and Grant modified in view of a teaching of Cirelli will hereinafter be referred to as the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli.
With regards to claim 4, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches the claimed invention of Claim 1 and the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli further teaches wherein the reservoir volume is 1 mL – 5 mL (see the rejection of Claim 1 above wherein the reservoir is modified to have a volume of 1 mL – 2 mL).
With regards to claim 5, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches the claimed invention of Claim 4 and the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli further teaches wherein the volume of the reservoir is 1 mL – 2 mL (see the rejection of Claim 1 above wherein the reservoir is modified to have a volume of 1 mL – 2 mL).
With regards to claim 6, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches the claimed invention of claim 1, however, Yang is silent with regards to the volume of the filling module is at least 20% greater than the volume of the reservoir
Nonetheless Grant, which is within the analogous art of apparatus, systems, and methods for fluid delivery (see abstract and title), teaches (see Fig. 4) the volume of the filling module (see [0537] “Any syringe known in the art may be used, however, in the exemplary embodiments, any syringe having a size and shape to be accommodated by the filling aid 3004 may be used, including, but not limited to, a 3 cc/mL TERUMO SYRINGE without needle, made by TERUMO Europe, Belgium, together with a Becton Dickinson 26G1/2 PRECISIONGLIDE Needle, made by Becton Dickinson & Co., Franklin Lakes, N.J.” wherein the syringe is the filling module and a 3 cc/mL TERUMO SYRINGE has a maximum volume of 3 mL) is at least 20% greater than the volume of the reservoir (118) (see [0251] “reservoir 118 may hold about 1.00 to 3.00 ml of insulin”) (When the syringe comprises a volume of 3.00 mL while the reservoir being a volume of 1.00 – 2.00 mL then the volume of the filling module is at least 20% greater than the volume of the reservoir).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli in view of a further teaching of Grant such that the volume of the filling module is at least 20% greater than the volume of the reservoir. One of ordinary skill in the art would have been motivated to make this modification because Grant teaches this volume for a reservoir corresponds to approximately a three day supply of insulin (see [0251] of Grant). Therefore, a person having ordinary skill in the art would recognize that a reservoir being 1 mL – 2 mL provides for approximately a one to two day supply of insulin while the volume of the filling module/syringe allows for the refilling of the reservoir in its entirety.
With regards to claim 7, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches the claimed invention of claim 1, and Yang further teaches further including an elastic seal (101) (see [0048]) at the drug inlet (see at 101 in Fig. 7b and [0048]), which automatically seals the drug inlet to prevent the drug from leaking after the drug is filled into the reservoir (see Figs. 7A – 7B and [0048]).
Claim(s) 15 – 18 and 20 – 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, Sanderson, Grant and Cirelli as applied to claim 1 above, and further in view of Hines et al. (US 2009/0163866 A1) (hereinafter referred to as “Hines”).
Hines is cited in the Notice of References Cited form dated 22 January 2026.
With regards to claim 15, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches a drug filling method of the skin patch drug infusion system of claim 1 (see the rejection of claim 1 above) for filling the drug to be infused into the infusion mechanism module, comprising:
Step 1: wherein the volume of the filling module is deliberately designed to be greater than the volume of the drug to be infused (see the rejection of Claim 1 above and the modification in view of Sanderson);
Step 2: Inserting the filling module into the drug inlet of the infusion mechanism module and drawing the air in the fluid path of the infusion mechanism module into the filling module (see the rejection of Claim 1 above and the modification in view of Sanderson);
Step 3: Pulling out the filling module and aspirate the air (see the rejection of Claim 1 above and the modification in view of Sanderson); and
Step 4: Inserting the filling module into the drug inlet of the infusion mechanism module again and filling the drug into the reservoir of the infusion mechanism module (see the rejection of Claim 1 above and the modification in view of Sanderson).
However, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli is silent with regards to withdrawing the drug to be infused from a vial into the filling module.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches withdrawing the drug to be infused from a vial into the filling module (see [0005] “this may be accomplished with a syringe and mounted needle by first drawing an amount of air into the syringe equal to the amount of insulin that will be withdrawn from the vial. Next, the vial septum is pierced with the needle and air is injected from the syringe into the vial, thus pressurizing the vial. The desired amount of insulin is then withdrawn from the vial into the syringe and thereafter, the needle is withdrawn from the vial. Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe. The septum on the medicament delivery device is then pierced with the syringe to access the device reservoir and the insulin is injected into the reservoir.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method taught by the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli in view of a teaching of Hines such that withdrawing the drug to be infused from a vial into the filling module. One of ordinary skill in the art would have been motivated to make this modification because Yang is silent with regards to how to fill filling module. Therefore, a person having ordinary skill in the art would refer to a teaching of Hines such that the drug to be infused from a vial into the filling module (see [0005] of Hines).
The method taught by the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli modified in view of a teaching Hines will hereinafter be referred to as the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines.
With regards to claim 16, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 15, however, Yang is silent with regards to further including air aspirating between step 1 and step 2.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches air aspirating between step 1 and step 2 (see [0005] “ Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a further teaching of Hines such that air aspirating between step 1 and step 2. One of ordinary skill in the art would have been motivated to make this modification because Hines further teaches that the syringe/filling module can be held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then gently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe (see [0005] of Hines). This method step is beneficial because doing so lowers the risk of an air embolism occurring by reducing the introduction of air into the medical device.
With regards to claim 17, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 16, however, Yang is silent with regards to the air aspirating is performed in the vial or after the filling module being pulled out from the vial.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches the air aspirating is performed in the vial or after the filling module being pulled out from the vial (see [0005] “The desired amount of insulin is then withdrawn from the vial into the syringe and thereafter, the needle is withdrawn from the vial. Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a further teaching of Hines such that the air aspirating is performed in the vial or after the filling module being pulled out from the vial. One of ordinary skill in the art would have been motivated to make this modification because Hines further teaches that the syringe/filling module can be held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then gently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe (see [0005] of Hines). This method step is beneficial because doing so lowers the risk of an air embolism occurring by reducing the introduction of air into the medical device.
With regards to claim 18, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 15, however, Yang is silent with regards to the volume of the filling module is deliberately designed to be greater than a volume of the reservoir.
Nonetheless Sanderson, which is within the analogous art of drug delivery devices (see abstract and title), teaches the volume of the filling module is deliberatively designed to be greater than a volume of the reservoir (Col. 8, lines 31 – 55 “syringe or other suitable drug delivery means is filled with a volume of drug solution somewhat larger than the volume of the lower cavity, and the needle of the syringe is forced through the serum stopper 5 into the tube 2. The syringe plunger is drawn back to aspirate air from the lower chamber 10, then the drug solution is forcibly transferred through the needle into the tube 2. This process of air aspiration and transfer of solution is repeated until the drug solution in the device completely fills lower cavity 10”) (Based on this disclosure the filling module/syringe is deliberately designed to be greater than a volume of the reservoir in order to hold the aspirated air and then fill the lower cavity with the drug.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the volume of the filling module and the volume of the reservoir of the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a further teaching of Sanderson such that the volume of the filling module is deliberatively designed to be greater than a volume of the reservoir. One of ordinary skill in the art would have been motivated to make this modification because Sanderson teaches that a filling module may be used to prime a drug delivery device thereby removing air from the reservoir and allowing the reservoir to be completely filled (see Col.8, lines 31 – 55 of Sanderson). Furthermore, priming a medical device improves patient safety by reducing the chances of an air embolism and increasing the accuracy of medication delivery.
With regards to claim 20, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli teaches a drug filling method of the skin patch drug infusion system of claim 1 (see the rejection of claim 1 above) for filling the drug to be infused into the infusion mechanism module, comprising:
Step 2: Inserting the filling module into the drug inlet of the infusion mechanism module and filling the drug into the reservoir (see the rejection of Claim 1 above wherein at least Sanderson teaches this limitation);
Step 3: Pulling a push-pull rod of the filling module and drawing out the air in the fluid path of the infusion mechanism module (see the rejection of Claim 1 above wherein at least Sanderson teaches this limitation).
However, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli is silent with regards to:
Step 1: Withdrawing the drug to be infused from a vial into the filling module.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches Step 1: withdrawing the drug to be infused from a vial into the filling module (see [0005] “this may be accomplished with a syringe and mounted needle by first drawing an amount of air into the syringe equal to the amount of insulin that will be withdrawn from the vial. Next, the vial septum is pierced with the needle and air is injected from the syringe into the vial, thus pressurizing the vial. The desired amount of insulin is then withdrawn from the vial into the syringe and thereafter, the needle is withdrawn from the vial. Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe. The septum on the medicament delivery device is then pierced with the syringe to access the device reservoir and the insulin is injected into the reservoir.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method taught by the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant and Cirelli in view of a teaching of Hines such that the method comprises Step 1: withdrawing the drug to be infused from a vial into the filling module. One of ordinary skill in the art would have been motivated to make this modification because Yang is silent with regards to how to fill filling module. Therefore, a person having ordinary skill in the art would refer to a teaching of Hines such that the drug to be infused from a vial into the filling module (see [0005] of Hines).
The method taught by the skin patch infusion system of Yang, Mueller-Pathle, Sanderson, Grant, and Cirelli modified in view of a teaching Hines will hereinafter be referred to as the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines.
With regards to claim 21, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 20, however, Yang is silent with regards to further including air aspirating between step 1 and step 2.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches air aspirating between step 1 and step 2 (see [0005] “ Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a further teaching of Hines such that air aspirating between step 1 and step 2. One of ordinary skill in the art would have been motivated to make this modification because Hines further teaches that the syringe/filling module can be held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then gently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe (see [0005] of Hines). This method step is beneficial because doing so lowers the risk of an air embolism occurring by reducing the introduction of air into the medical device.
With regards to claim 22, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 21, however, Yang is silent with regards to the air aspirating is performed in the vial or after the filling module being pulled out from the vial.
Nonetheless Hines, which is within the analogous art of infusion devices (see abstract and title), teaches the air aspirating is performed in the vial or after the filling module being pulled out from the vial (see [0005] “The desired amount of insulin is then withdrawn from the vial into the syringe and thereafter, the needle is withdrawn from the vial. Next, the syringe is held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then ently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a further teaching of Hines such that the air aspirating is performed in the vial or after the filling module being pulled out from the vial. One of ordinary skill in the art would have been motivated to make this modification because Hines further teaches that the syringe/filling module can be held in a vertical orientation to allow entrapped air to rise to the top. The syringe plunger is then gently advanced until the air has been ejected and a small amount of fluid is expressed from the syringe (see [0005] of Hines). This method step is beneficial because doing so lowers the risk of an air embolism occurring by reducing the introduction of air into the medical device.
Claim(s) 19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines as applied to claims 18 and 20 above, and further in view of Streit et al. (US 2021/0338924 A1) (hereinafter referred to as “Streit”).
Streit is cited in the Notice of References Cited form dated 22 January 2026.
With regards to claim 19, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 18, however, Yang is silent with regards to the drug filling method is performed after or before the infusion mechanism module and control mechanism module are electrically connected.
Nonetheless Streit, which is within the analogous art of modular administration appliances (see abstract and title), teaches the drug filling method is performed after or before the infusion mechanism module (200) and control mechanism module (100) are electrically connected (see [0009] “a fillable reservoir,” [0035] “The reservoir module 200 in this case may be configured as a single-use module (multi-use modules may also be possible without departing from the present disclosure)” wherein multi-use modules are modules which are refillable, and [0037] “Pump module 100 and reservoir module 200 may be connected to each other not only mechanically but also electrically when the bayonet connector is assembled.”) (Here the drug filling method is performed both before and after the infusion mechanism module and control mechanism module are electrically connected. For example, the reservoir module is full upon first electrical connection with the pump module. Upon delivering the full reservoir module dosage the reservoir module is disconnected, refilled, and then electrically and mechanical reattached to the pump module. The reservoir module and pump module can be used in this reusable manner thereby resulting in the drug filling method to be performed after and before the electrical connection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module and control mechanism module of the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a teaching of Streit such that the drug filling method is performed after or before the infusion mechanism module and control mechanism module are electrically connected. Here, the infusion mechanism module and control mechanism module would be modified to include electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because Streit teaches that the electrically connecting the infusion mechanism module with the control mechanism module can transmit control signals from the pump module to the reservoir module (see [0017] of Streit). Furthermore, the connection provides a supply of energy to the pump module from the reservoir module (see [0004] and [0017] of Streit).
With regards to claim 23, the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines teaches the claimed invention of claim 20, however, Yang is silent with regards to the drug filling method is performed before or after the infusion mechanism module and control mechanism module are electrically connected.
Nonetheless Streit, which is within the analogous art of modular administration appliances (see abstract and title), teaches the drug filling method is performed after or before the infusion mechanism module (200) and control mechanism module (100) are electrically connected (see [0009] “a fillable reservoir,” [0035] “The reservoir module 200 in this case may be configured as a single-use module (multi-use modules may also be possible without departing from the present disclosure)” wherein multi-use modules are modules which are refillable, and [0037] “Pump module 100 and reservoir module 200 may be connected to each other not only mechanically but also electrically when the bayonet connector is assembled.”) (Here the drug filling method is performed both before and after the infusion mechanism module and control mechanism module are electrically connected. For example, the reservoir module is full upon first electrical connection with the pump module. Upon delivering the full reservoir module dosage the reservoir module is disconnected, refilled, and then electrically and mechanical reattached to the pump module. The reservoir module and pump module can be used in this reusable manner thereby resulting in the drug filling method to be performed after and before the electrical connection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module and control mechanism module of the method of Yang, Mueller-Pathle, Sanderson, Grant, Cirelli, and Hines in view of a teaching of Streit such that the drug filling method is performed after or before the infusion mechanism module and control mechanism module electrically connected. Here, the infusion mechanism module and control mechanism module would be modified to include electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because Streit teaches that the electrically connecting the infusion mechanism module with the control mechanism module can transmit control signals from the pump module to the reservoir module (see [0017] of Streit). Furthermore, the connection provides a supply of energy to the pump module from the reservoir module (see [0004] and [0017] of Streit).
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/08/2026
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