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 .
This action is in response to Applicant’s amendments filed 06/01/2026.
Claims 1, 2, 8, 9, and 11 are currently amended.
Claims 5 and 21-104 are cancelled.
Claims 1-4 and 6-20 are being examined in this Office Action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/2026 has been entered.
Claim Objections
Claims 11-20 are objected to because of the following informalities:
Claim 11 recites the limitation “wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservative from the insulin medication.” This should read “wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of the preservative from the insulin medication”.
All remaining claims are objected to by virtue of being dependent on an objected claim.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12214159 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an insulin delivery system with an absorbent element and would infringe upon one another were they both to pass to issuance. Every limitation in the application under examination claims is recited in the conflicting references, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Instant Application
U.S. 12214159 B2
An insulin delivery system comprising:
a reservoir configured to hold an insulin medication therein;
an infusion hub;
tubing fluidically connecting the insulin reservoir and the infusion hub;
a cannula configured to deliver the insulin medication to a patient; and
an absorbent element positioned within the delivery system and in fluidic contact with the insulin medication, the absorbent element configured to absorb and store a preservative from the insulin medication, wherein the absorbent element is further configured to selectively release the preservative into the insulin medication after storing the preservative to maintain a concentration of the preservative in the insulin medication.
An insulin delivery system comprising:
a reservoir configured to hold an insulin medication therein;
an infusion hub;
tubing connecting the insulin reservoir and the infusion hub;
a cannula configured to deliver the insulin medication to a patient; and
a filter configured to capture particulates from the insulin medication prior to delivery of the insulin to the patient, wherein the filter comprises an internal coil within the cannula.
The insulin delivery system of claim 1, further comprising an absorbent element positioned within the delivery system and in fluidic contact with the insulin medication, the absorbent element configured to absorb and store preservatives from the insulin medication.
The insulin delivery system of claim 7, wherein the absorbent is further configured to release preservatives to the insulin medication after storing the preservatives.
The limitation of "to maintain a concentration of the preservative in the insulin" is considered to be an inherent feature of the absorbent element, as the absorbent element would be able to maintain the concentration of the preservative in use within the insulin medication. Therefore, it would have been obvious that the absorbent element could maintain that level of concentration of preservatives for a user.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 19/000073 in view of Demaria et al. (US 2019/0054233 A1).
This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an insulin delivery system with an absorbent element and would infringe upon one another were they both to pass to issuance. Every limitation in the application under examination claims is recited in the conflicting references, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Instant Application
Co pending Application US 19/000073
An insulin delivery system comprising:
a reservoir configured to hold an insulin medication therein;
an infusion hub;
tubing fluidically connecting the insulin reservoir and the infusion hub;
a cannula configured to deliver the insulin medication to a patient; and
an absorbent element positioned within the delivery system and in fluidic contact with the insulin medication, the absorbent element configured to absorb and store a preservative from the insulin medication, wherein the absorbent element is further configured to selectively release the preservative into the insulin medication after storing the preservative to maintain a concentration of the preservative in the insulin medication.
An insulin delivery system comprising: a reservoir configured to hold an insulin medication therein;
an infusion hub;
tubing fluidically connecting the insulin reservoir and the infusion hub;
a cannula configured to deliver the insulin medication to a patient; and
an absorbent element positioned within the delivery system and in fluidic contact with the insulin medication, the absorbent element configured to absorb and store preservatives from the insulin medication
6. The insulin delivery system of claim 1, wherein the absorbent element is configured to maintain the preservative concentration at a point of delivery to the patient at a concentration that minimizes local toxicity while maintaining insulin in a stable hexameric state.
Claim 1 of the instant application differs from claim 6 of co pending application 19/000073 in that it recites the limitation "the absorbent element is further configured to selectively release the preservative into the insulin medication". However, Demaria et al. teaches a sorbent material (240) comprised of EVOH, silicone, a low-density polymer or nylon (Paragraphs [0038]-[0041]) configured to collect phenolic excipients within insulin medications Paragraph [0007]. The sorbent material, due to its material properties, is capable of releasing a concentration of preservatives back into the insulin medication, dependent on the concentration of preservatives within the insulin medication.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the insulin infusion system disclosed by the reference application wherein the absorbent element is further configured to selectively release the preservative into the insulin medication as taught by Demaria et al. to allow a user to extend the wear time of an insulin delivery system.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Demaria et al. (Pub. No. US 20190054233 A1, herein Demaria).
Regarding Claim 1, Demaria discloses an insulin delivery system (Fig. 2) comprising:
a reservoir configured to hold an insulin medication therein (“At its first, proximal end 212, device 200 includes a reservoir connector 220 configured to couple with an insulin reservoir (not shown)” – Paragraph [0032]);
an infusion hub (230);
tubing fluidically connecting the insulin reservoir and the infusion hub (222);
a cannula configured to deliver the insulin medication to a patient (234); and
an absorbent element (240, Paragraph [0035]) positioned within the delivery system and in
fluidic contact with the insulin medication (Fig. 2, Paragraph [0035]), the absorbent element configured to absorb and store a preservative from the insulin medication (Paragraph [0035]), wherein the absorbent element is further configured to selectively release the preservative after storing the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication (Demaria discloses “a sorbent material configured to collect phenolic excipients … from the insulin formulation by sorption, such as adsorption and/or absorption” and that “The sorbent material may be positioned along a fluid pathway specifically designed to increase and/or extend exposure between the insulin formulation and the sorbent material” – Paragraph [0007], Examiner interprets that since the sorbent material is designed to increase and/or extend exposure
between the insulin formulation and the sorbent material, after absorbing a concentration of m-
cresol, for example, 80% as referenced in Paragraph [0036], the sorbent material would be able to
continuously release preservatives back into the insulin medication to perform the same function.)
Examiner is interpreting the limitation “configured to selectively release the preservative after storing the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication” as intended use. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Examiner interprets the sorbent element disclosed by Demaria to be capable of preforming the limitation of selectively releasing the preservative after storing the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication since it is composed of same material as the claimed invention and functions in the same manner to maintain a concentration of the same preservative as claimed.
Furthermore, in a differing embodiment, Demaria teaches of a dispersive infusion catheter (234’) which may be designed to deliver the insulin formulation, and any phenolic excipients, in a more diffuse manner over a greater volume (Paragraph [0061]).
Therefore, it would be obvious to one of ordinary skill in the art to modify the insulin delivery system disclosed by Demaria wherein the absorbent element is further configured to selectively release the preservative after storing the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication so that insulin may be delivered in a more diffusive manner over a greater volume to minimize local impact within the subcutaneous tissue (Demaria, Paragraph [0061]).
Regarding Claim 3, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element comprises EVOH, silicone, a low-density polymer and nylon (Paragraphs [0038]-[0041]).
Regarding Claim 4, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element comprises a preservative capacity greater than a maximum concentration of
preservative in the insulin medication (“sorbent material 240 may be capable of collecting over 5%
10%, 15%, 20%, 25%, or 30% of the m-cresol initially present in the insulation formulation. In certain
embodiments, sorbent material 240 may be capable of collecting over 60%, 65%, 70%, 75%, or 80% of
the m-cresol after the 1-hour exposure time. The sorption may also increase as the surface area
and/or volume of sorbent material 240 increases” - Paragraph [0036]).
For examination purposes, examiner interprets the maximum concentration of preservatives of
the insulin medication to be less than 80%.
Regarding Claim 6, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element is configured to maintain a preservative concentration at the point of delivery to the patient (Paragraph [0043]) at a concentration that minimizes local toxicity (sorption is impacted by
both surface area and volume, Paragraph [0064], in the first example the sorbent material is shown to
collect roughly 0.63 mg/mL (19%) of m-cresol leaving about 2.67 mg/mL of m-cresol within the insulin
formulation prior to delivery, Paragraph [0064], this is greater than 1.25 mg/mL as referenced in
applicant’s specification) while maintaining insulin in a stable hexameric state (“This arrangement may
preserve the integrity and stability of the insulin formulation and minimize risk of insulin precipitation
and fluid path occlusion” – Paragraph [0043]).
Regarding Claim 7, Demaria discloses the insulin delivery system of claim 6, wherein the absorbent element is configured to maintain the preservative concentration at a concentration of
greater than about 1.25 mg/mL (sorption is impacted by both surface area and volume, Paragraph
[0064], in the first example the sorbent material is shown to collect roughly 0.63mg/mL (19%) of m-
cresol leaving about 2.67 mg/mL of m-cresol within the insulin formulation prior to delivery,
Paragraph [0064]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 10-14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demaria in view of Yodfat et al. (Pub. No. US 20100174239 A1, herein Yodfat).
Regarding Claim 2, Demaria discloses the insulin delivery system of claim 1.
Demaria does not expressly disclose further comprising an impermeable backing layer adjacent
to the absorbent element and configured to maintain the preservative within the absorbent element.
Yodfat teaches an impermeable backing layer (31) adjacent to the absorbent element (Fig. 4)
and configured to maintain the preservatives within the absorbent element (Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the applicant’s claimed invention to modify the absorbent element disclosed by Demaria to
have an impermeable backing layer adjacent to the absorbent element and configured to maintain the
preservative within the absorbent element as taught by Yodfat in order to ensure the preservatives are
maintained within the system (Yodfat, Paragraph [0046]).
Regarding Claim 10, Demaria discloses the insulin delivery system of claim 1.
Modified Demaria does not expressly disclose wherein the absorbent element comprises an interior layer of the tubing.
Yodfat teaches that an absorbent element comprises an interior layer of tubing (Fig. 4, “an inner
layer of polyolefin, such as for example polyethylene, polypropylene, or the like” – Paragraph [0033]).
Polyolefin being an example of a low-density polymer used as the absorbent element.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
Demaria so that the absorbent element comprises an interior layer of the tubing as taught by Yodfat, so that the absorbent element is protected by a barrier layer (Yodfat, Paragraph [0047]).
Regarding Claim 11, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 10, wherein at least a portion of the insulin delivery system includes a barrier layer (Yodfat, "an outer layer of PVC" - Paragraph [0033]) configured to prevent migration of preservative from the insulin medication (Yodfat, "an outer layer that is substantially impermeable to both liquid and vapor phases of at least the preservative compound and/or water." -Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
Demaria wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservative from the insulin medication so that the insulin delivery system is better able to prevent migration of preservatives outside of the tubing (Yodfat, Paragraph [[0046]).
Regarding Claim 12, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11 wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of the multi-layer tubing (Yodfat, Fig. 4, Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
Demaria wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of
a layer of the multi-layer tubing as taught by Yodfat, the motivation being to coat the tubing with PVC
(Yodfat, Paragraph [0033]) which can act as the barrier material in the multi-layered tubing.
Regarding Claim 13, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11, wherein the tubing is a multi-layer tubing, and wherein the barrier layer forms an entire layer of the multi-layer tubing (Yodfat, Fig. 4, Paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
Demaria wherein the tubing is a multi-layered tubing, and wherein the barrier layer forms an entire
layer of the multi-layer tubing as taught by Yodfat, the motivation being to coat the tubing with PVC
(Yodfat, Paragraph [0033]) which can act as the barrier material in the multi-layered tubing.
Regarding Claim 14, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11, wherein the tubing comprises the barrier layer (Yodfat, Paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant's claimed invention to modify the insulin delivery system disclosed by Demaria wherein the tubing comprises the barrier layer as taught by Yodfat so that the tubing prevents the migration of preservatives from the insulin medication (Yodfat, Paragraph [0046]).
Regarding Claim 17, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11, wherein the barrier layer comprises PTFE, organic or inorganic plasma-deposited
coatings (e.g. PTFE, PVC, Halogenated siloxanes, silicon suboxides), or parylene (Yodfat, Paragraphs [0033] and [0046]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
Demaria wherein the barrier layer comprises organic or inorganic plasma-deposited coatings (e.g. PTFE,
PVC, Halogenated siloxanes, silicon suboxides) as taught by Yodfat so that the barrier layer is better able
to prevent migration of preservatives from the insulin medication (Yodfat, Paragraph [0046]).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demaria.
Regarding Claim 8, Demaria discloses insulin delivery system of claim 6.
Demaria does not expressly disclose wherein the absorbent element is configured to maintain the preservative concentration at a concentration of 1.15-1.75 mg/mL. However, Paragraph
[0065] shows examples that teach preservation concentrations in absorbent materials and Paragraph
[0066] teaches that absorption results are impacted by both surface area and volume of the absorbent
element.
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the
invention to find the specific surface area and volume wherein the absorbent element is configured to
maintain the preservative concentration at a concentration of 1.15-1.75 mg/mL, since it has been
held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum
or workable ranges involves only routine skill within the art. In re Aller, 105 USPQ 233.
Regarding Claim 9, Demaria discloses the insulin delivery system of claim 6.
Modified Demaria does not expressly disclose wherein the absorbent element is configured to maintain the preservative concentration at a concentration of 1.25-1.50 mg/mL. However, Paragraph
[0065] shows examples that teach preservation concentrations in absorbent materials and Paragraph
[0066] teaches that absorption results are impacted by both surface area and volume of the absorbent
element.
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the
invention to find the specific surface area and volume wherein the absorbent element is configured to
maintain the preservative concentration at a concentration of 1.25-1.50 mg/mL, since it has been
held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum
or workable ranges involves only routine skill within the art. In re Aller, 105 USPQ 233.
Claim(s) 15, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Demaria in view of Yodfat, further in view of Dillon et al. (Pub. No. US 2017/0224877 A1, herein Dillon).
Regarding Claim 15, modified Demaria in view of Yodfat discloses the insulin delivery system of
claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer
comprises a coating on the tubing.
Dillon teaches wherein the barrier layer (“vapor deposition”- Paragraph [0014], “polyether
block amide” – Paragraph [0013]) comprises a coating on the tubing (Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
modified Demaria in view of Yodfat wherein the barrier layer comprises a coating on the tubing as
taught by Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 16, modified Demaria in view of Yodfat discloses the insulin delivery system of
claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer
comprises an inner layer of the tubing.
Dillon teaches wherein the barrier layer comprises an inner layer of the tubing (Paragraph
[0014]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
modified Demaria in view of Yodfat wherein the barrier layer comprises an inner layer of the tubing as
taught by Dillon so that so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 18, modified Demaria in view of Yodfat discloses the insulin delivery system of
claim 11, further comprising a barrel (Demaria, 251) connected to the cannula (Fig. 2).
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer is
positioned on at least a portion of the barrel.
Dillon teaches a coating (104) of a barrier layer that is able to be positioned on at least a portion
of the barrel (Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
modified Demaria in view of Yodfat wherein the barrier layer is positioned on at least a portion of the
barrel as taught by Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph
[0009]).
Regarding Claim 19, modified Demaria in view of Yodfat discloses the insulin delivery system of
claim 11, comprising a connector (Demaria, 224, Fig. 2).
Modified Demaria in view of Yodfat does not expressly disclose a connector comprising the
barrier layer.
Dillon teaches a coating (104) that can be applied to the connector comprising the barrier layer
(Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
modified Demaria in view of Yodfat comprising a connector comprising the barrier layer as taught by
Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 20, modified Demaria in view of Yodfat discloses the insulin delivery system of
claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer
extends through an entire fluid path of the system.
Dillon teaches wherein the barrier layer extends through an entire fluid path of the system (“the
cannula 102 is at least partially coated on its exterior surface 102a with a coating 104 that comprises
an anti-inflammatory agent. The cannula 102 is in fluid connection to the chamber, and the distal end
of the cannula 102 extends into the patient” - Paragraph [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective
filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by
modified Demaria in view of Yodfat wherein the barrier layer extends through an entire fluid path of the
system as taught by Dillon to extend the wear time of the system (Dillon, Paragraph [0009]).
Response to Arguments
Applicant’s arguments filed June 1, 2026 have been fully considered.
In regards to Applicant’s argument that
“Claims 8-9 stand 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 pre-AIA , the applicant, regards as the invention. Solely in the interest of advancing prosecution, Applicant has amended these claims herein. It is respectfully requested that these rejections be withdrawn.”
This argument is persuasive and the 35 U.S.C. 112(b) rejection for claims 8 and 9 have been withdrawn.
In regards to Applicant’s argument that
“Claims 1, 3-4, and 6-7 are rejected under 35 U.S.C. § 102 as allegedly being anticipated by U.S. Publication No. 2019/0054233 to Demaria et al. ("Demaria"). These rejections are respectfully traversed.
Although Applicant does not acquiesce and specifically disputes the positions set forth in the Office Action at least for the reasons set forth in Applicant's previous Amendment, solely in the interest of advancing prosecution Applicant has amended independent claim 1 herein to recite that the absorbent element is further configured to release the preservative into the insulin medication "after storing the preservatives" to maintain a concentration of the preservative in the insulin medication as previously claimed in dependent claim 5.”
These arguments are persuasive and the 35 U.S.C. § 102 rejection for claims 1, 3, 4, 6, and 7 has been withdrawn. However, upon further consideration. A new ground of rejection is made in view of Demaria for the following reasons:
Claim 1 recites the limitation “wherein the absorbent element is further configured to selectively release the preservative into the insulin medication after storing the preservative”.
The sorbent material 240 disclosed by Demaria include polyurethanes, nylon, EVOH, polypropylene, and silicone, Paragraphs [0038]-[0041], materials equivalent to the absorbent element of the claimed invention. Examiner is interpreting the limitation “configured to selectively release the preservative after storing the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication” as intended use. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Furthermore, the sorbent materials of Demaria are utilized to perform the same function of absorbing, and storing a preservative from the insulin medication, Paragraph [0036].
In regards to Applicant’s argument that
“Claims 8-9 stand rejected under 35 U.S.C. § 103 as being unpatentable over Demaria. Claims 2, 10-14, and 17 stand rejected as being unpatentable over Demaria in view of U.S. Publication No. 2010/0174239 to Yodfat et al. ("Yodfat"). Claims 15-16 and 18-20 stand rejected as being unpatentable over Demaria in view of Yodfat, and further in view of U.S. Publication No. 2017/0224877 to Dillon et al. ("Dillon"). These claims are allowable at least because the underlying base claim is allowable, although Applicant does not acquiesce in the positions set forth in the Office Action and specifically reserves the right to make further arguments with respect to these claims. It is therefore respectfully requested that these rejections be withdrawn.”
This argument is not persuasive for the following reasons:
Independent claim 1 stands rejected in view of Demaria. The rejection of the dependent claims is maintained as recited above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Novak et al. (Pub. No. US 20200147300 A1) is considered relevant prior art with regards to an insulin delivery system, an infusion hub, tubing fluidically connecting the insulin reservoir and the infusion hub, a reservoir configured to hold an insulin medication therein, and an absorbent material made of a low-density polymer configured to absorb and store a preservative from in insulin medication.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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