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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
1110 on page 14 of the Specification dated 28 June 2023.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
10 within Fig. 1b.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 8 recites “the internal control mechanism module 100.” The Examiner suggests amending this to recite “the control mechanism module 100” to improve the claim language consistency for referring to the structure of the control mechanism module.
Page 9 recites “the control structure 100.” The Examiner suggests amending this to recite “the control mechanism module 100” to improve the claim language consistency for referring to the structure of the control mechanism module.
Page 11 of the Specification recites “control structure 101.” The Examiner suggests amending this to recite “control mechanism module 100 ” to improve the claim language consistency for referring to the structure of the control mechanism module and provide the proper reference numeral for this structure.
Page 12 recites “infusion mechanism module 100.” The Examiner suggests amending this to recite “infusion mechanism module [[100]] 110” to correct the reference numeral for the infusion mechanism module.
Page 14 recites “infusion mechanism module 100.” The Examiner suggests amending this to recite “infusion mechanism module [[100]] 110” to correct the reference numeral for the infusion mechanism module.
Page 14 recites “the drug storage unit 131…the drug storage unit 131 are in communication…from the drug storage unit 131…” The Examiner suggests amending this to recite “the reservoir 131…the reservoir 131 are in communication…from the reservoir 131…” to improve the consistency of the structure referred to by reference numeral 131.
Page 18 recites “control mechanism 100.” The Examiner suggests amending this to recite “control mechanism module 100” to improve the claim language consistency for referring to the structure of the control mechanism module.
Page 19 recites “after module 110 and control mechanism 100.” The Examiner suggests amending this to recite “after infusion mechanism module 110 and control mechanism module 100” to improve the claim language consistency for referring to the structures of the infusion mechanism module and the control mechanism module.
Appropriate correction is required.
Claim Objections
Claims 1 – 9 and 15 – 23 are objected to because of the following informalities:
Claim 1 recites “the infusion mechanism includes” and “a fluid path.” The Examiner suggests the following amendments to Claim 1 to provide proper antecedent basis for the claim limitations. The first proposed amendment clarifies that the “infusion mechanism” is referring to the “infusion mechanism module.” The second proposed amendment clarifies that the fluid path is the fluid path of the infusion mechanism module.
A skin patch drug infusion system, comprising:
an infusion mechanism module, wherein the infusion mechanism module includes:
a reservoir, for accommodating a drug to be infusion, and provided with a drug inlet and a drug outlet;
an infusion needle, wherein one end of the infusion needle is communicated with the drug outlet of the reservoir, and an other end of the infusion needle is inserted subcutaneously implanting drug infusion;
a control mechanism module, worked collaboratively with the infusion mechanism module to regulate drug infusion;
an adhesive patch, for attaching the infusion mechanism module and/or the control mechanism module to a skin surface; and
a filling module, for filling the drug to be infused into the reservoir via the drug inlet, wherein 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 filling module is used to generate negative pressure to extract air in a fluid path of the infusion mechanism module.
Claims 2 – 9 each recite “A skin patch drug infusion system.” The Examiner suggests amending each preamble of the dependent Claims to recite “[[A]] The skin patch drug infusion system” to provide proper antecedent basis for the preamble of each claim.
Claim 15 recites “A drug filling method of skin patch drug infusion system of claim 1” and “draw the air in the fluid path of the infusion mechanism module.” The Examiner suggests the following amendments to Claim 15 to provide proper antecedent basis for the claim limitations and to clarify the grammar of the claim.
A drug filling method of the skin patch drug infusion system of claim 1 for filling the drug to be infused into the infusion mechanism module, comprising:
Step 1: Withdrawing the drug to be infused from a vial into the filling module, wherein the volume of the filling module is deliberately designed to be greater than the volume of the drug to be infused;
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;
Step 3: Pulling out the filling module and aspirate the air; and
Step 4: Inserting the filling module into the drug inlet of the infusion mechanism module again and filling it into the reservoir of the infusion mechanism module.
Claims 16 – 19 each recite “A drug filling method of claim.” The Examiner suggests amending each preamble of the dependent Claims to recite “[[A]] The drug filling method of claim” to provide proper antecedent basis for the preamble of each claim.
Claim 19 recites “wherein the drug filling method is performed after or before the infusion mechanism module and control mechanism module electrically connected. The Examiner suggests amending this to recite “wherein the drug filling method is performed after or before the infusion mechanism module and control mechanism module are electrically connected” to improve the grammar and understanding of the claim.
Claim 20 recites “A drug filling method of skin patch drug infusion system of claim 1,” “fill the drug into the reservoir,” and “draw out the air in the fluid path of the infusion mechanism module.” The Examiner suggests the following amendments to Claim 20 to provide proper antecedent basis to the claim limitations and clarify the grammar of the claim.
A drug filling method of the skin patch drug infusion system of claim 1 for filling the drug to be infused into the infusion mechanism module, comprising:
Step 1: Withdrawing the drug to be infused from a vial into the filling module;
Step 2: Inserting the filling module into the drug inlet of the infusion mechanism module and filling the drug into the reservoir;
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.
Claims 21 – 23 each recite “A drug filling method of claim.” The Examiner suggests amending each preamble of the dependent Claims to recite “[[A]] The drug filling method of claim” to provide proper antecedent basis for the preamble of each claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 – 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “Step 4: Inserting the filling module into the drug inlet of the infusion mechanism module again and filling it into the reservoir of the infusion mechanism module.” It is unclear what the pronoun “it” is referring to? Does it refer to the “filling module,” “a drug” or some other component. Therefore, Claim 15 is indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 16 – 19 are dependent upon Claim 15 and are rejected under 35 U.S.C. 112(b) for the same rationale.
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, 2, and 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), and Sanderson et al. (US 4,722,726 A; hereinafter referred to as “Sanderson”)
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 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]) and a drug outlet (see at 103 in Fig. 7a and [0045]);
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]);
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.
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 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.
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 (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. 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.
With regards to claim 2, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson teaches the claimed invention of claim 1, however, Yang is silent with regards to wherein the volume of the filling module is deliberatively 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 wherein 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 volume of the filling module 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 skin patch infusion system of Yang, Mueller-Pathle, and Sanderson 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 7, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson 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) 3 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, and Sanderson as applied to claim 2 above, and further in view of Grant et al. (US 2019/0321260 A1; hereinafter referred to as “Grant”).
With regards to claim 3, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson teaches the claimed invention of claim 2, however, Yang is silent with regards to wherein the volume of the filling module is 1 mL – 2 mL 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 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.
With regards to claim 4, the skin patch infusion system of Yang, Mueller-Pathle, Sanderson and Grant teaches the claimed invention of Claim 3 and the skin patch infusion system of Yang, Mueller-Pathle, Sanderson and Grant further teaches wherein the reservoir volume is 1 mL – 5 mL (see the rejection of Claim 3 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 and Grant teaches the claimed invention of Claim 4 and the skin patch infusion system of Yang, Mueller-Pathle, Sanderson and Grant further teaches wherein the volume of the reservoir is 1 mL – 2 mL (see the rejection of Claim 3 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, and Sanderson teaches the claimed invention of claim 2, 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, and Sanderson in view of a 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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, and Sanderson as applied to claim 1 above, and further in view of Shor et al. (US 2019/0009019 A1; hereinafter referred to as “Shor”).
With regards to claim 8, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson teaches the claimed invention of claim 1, however Yang is silent with regards the infusion mechanism module and the control mechanism module are detachable to each other, and the control mechanism module is reusable.
Nonetheless Shor, which is within the analogous art of device for subcutaneous delivery of fluid medicament (see abstract and title), teaches (see Figs. 2 – 3) the infusion mechanism module (102) (see [0125]) and the control mechanism module (104) (see [0125]) are detachable to each other (see [0138]), and the control mechanism module is reusable (see Abstract “The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament 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 infusion mechanism module and control mechanism module of the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson in view of a teaching of Shor such that the infusion mechanism module and the control mechanism module are detachable to each other, and the control mechanism module is reusable. 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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, and Sanderson as applied to claim 1 above, and further in view of Searle et al. (US 2014/0052096 A1; hereinafter referred to as “Searle”).
With regards to claim 9, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson teaches the claimed invention of claim 1, however Yang is silent with regards to the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single-use.
Nonetheless Searle, which is within the analogous art of pump engines with a metering system for dispensing liquid medication (see abstract and title)¸ teaches the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single-use (see [0010] “a patch pump is an integrated device that combines most or all of the fluidic components (including the fluid reservoir and pumping mechanism) in a single housing which is adhesively attached to an infusion site” wherein the reservoir is the infusion mechanism module and the pumping mechanism is the control mechanism module).
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 skin patch infusion system of Yang, Mueller-Pathle, and Sanderson in view of a teaching of Searle such that the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single-use. One of ordinary skill in the art would have been motivated to make this modification because Searle teaches that this configuration does not require the use of separate infusion, tubing sets to supply insulin to the patient (see [0010] of Searle). Furthermore, incorporating the infusion mechanism module and control mechanism module within one housing will reduce the amount of components for the overall skin patch infusion system thereby simplifying the design.
Claim(s) 15 – 18 and 20 – 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, Mueller-Pathle, and Sanderson as applied to claim 1 above, and further in view of Hines et al. (US 2009/0163866 A1; hereinafter referred to as “Hines”).
With regards to claim 15, the skin patch infusion system of Yang, Mueller-Pathle, and Sanderson teaches a drug filling method of 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 draw 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 it 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, and Sanderson 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, and Sanderson 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, and Sanderson modified in view of a teaching Hines will hereinafter be referred to as the method of Yang, Mueller-Pathle, Sanderson and Hines.
With regards to claim 16, the method of Yang, Mueller-Pathle, Sanderson 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, 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 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, 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, 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, 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, and Sanderson teaches a drug filling method of 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 fill 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 draw 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, and Sanderson 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, and Sanderson 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, and Sanderson modified in view of a teaching Hines will hereinafter be referred to as the method of Yang, Mueller-Pathle, Sanderson and Hines.
With regards to claim 21, the method of Yang, Mueller-Pathle, Sanderson 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, 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 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, 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, 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”).
With regards to claim 19, the method of Yang, Mueller-Pathle, Sanderson, 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 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) 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, 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).
With regards to claim 23, the method of Yang, Mueller-Pathle, Sanderson, 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, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al. (US 2018/0104408 A1).
Hauswald (US 2015/0141957 A1).
Hoss (US 2011/0160696 A1).
Carter et al. (US 2011/0112484 A1).
Gillum (US 2010/0185177 A1).
Hines et al. (US 2009/0163865 A1).
Alferness et al. (US 2007/0299408 A1).
Lyde et al. (US 2005/0283123 A1).
Hauswald (US 10,086,132 B2).
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/20/2026