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 election filed on July 7th, 2026.
Claims 18-20 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Claims 1-17 in the reply filed on July 7th, 2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(1) because they
are unclear/poor quality with low resolution. 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant
is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
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 11-17 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 11 recites “a user-wearable infusion pump” on line 4 rending the claim indefinite because it is unclear whether it is referring to the same user-wearable infusion pump introduced in the preamble on line 1. Claims 13-15 similarly recite “a user-wearable infusion pump” and Examiner recommends amending the claims to recite “the user-wearable infusion pump”. Appropriate action is required.
All remaining claims are rejected by virtue of dependency on the rejected independent
claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 7-9, 11-12, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cook et al. (US 20190351134 A1, herein, Cook).
Regarding claim 1, Cook discloses a user-wearable infusion pump system (Examiner relies on patch pump 200 which incorporates components from embodiments depicted Figs.1A-2F, see Para [0025]), comprising:
a user-wearable infusion pump (patch pump 100 – Fig.1A) configured to contain a medicament (“the pump can include a drive unit and a disposable cartridge containing a medicament with the drive unit configured to cause the pump to deliver the medicament in the cartridge to the user”, see para [0006]);
a pump holder (surface 207 – Fig.2B) configured to releasably hold the user-wearable infusion pump (“a surface 207 sized to accommodate the pump 202”, see para [0025]) and including an adhesive patch (adhesive patch 108 – Fig.1A) configured to retain the pump holder on a body of a user (“an adhesive patch configured to be attached to the user's body”, see para [0006]), the pump holder comprising:
a frame base (retention frame 106 – Fig.1A) comprising a flexible material (“retention frame 106 can comprise any flexible and fatigue-resistant material”, see para [0021]) and having an outer perimeter having a shape generally matching a shape of a perimeter of the user-wearable infusion pump (retention frame in Fig.1D); and
a plurality of pump retention features comprising a rigid material (“pump 102 includes a cartridge 116 and a drive unit 118 …. the drive unit and cartridge can be comprised of, for example, polypropylene, polycarbonate COC…”, see para [0023]).
Regarding claim 2, Cook discloses the user-wearable infusion pump system (patch pump 100 – Fig.1A) of claim 1, wherein the pump retention features comprising a rigid material include one or more retention walls extending upwardly from the outer perimeter of the frame base (walls of retention frame - Fig.1A).
Regarding claim 7, Cook discloses the user-wearable infusion pump (patch pump 100 – Fig.1A) of claim 1, wherein the pump retention features comprising a rigid material include a cannula module (cannula 130 – Fig.1F) configured to receive a cannula inserted (cartridge cannula 132 – Fig.1F) therethrough.
Regarding claim 8, Cook discloses the user-wearable infusion pump (patch pump 100 – Fig.1A) of claim 7, wherein the cannula module (cannula 130 – Fig.1F) is configured to interface with a cannula interface of the user-wearable infusion pump to fluidly connect an outlet of the user-wearable infusion pump with the cannula (“cartridge also includes an opening 128 in a bottom of the cartridge that is aligned with the sealing membrane 112 of the retention frame 106, thereby aligning a cartridge cannula 132 with cannula 130 of the attachment portion 104”, see para [0023], Fig.1F).
Regarding claim 9, Cook discloses the user-wearable infusion pump (patch pump 100 – Fig.1A) of claim 1, wherein the rigid material is selected from the set consisting of polycarbonate, polypropylene and acrylonitrile butadiene styrene (“pump 102 includes a cartridge 116 and a drive unit 118 …. the drive unit and cartridge can be comprised of, for example, polypropylene, polycarbonate COC…”, see para [0023]).
Regarding claim 11, Cook discloses a pump holder for a user-wearable infusion pump (patch pump 100 – Fig.1A), comprising:
an adhesive patch (adhesive patch 108 – Fig.1A) configured to retain the pump holder on a body of a user (“an adhesive patch configured to be attached to the user's body”, see para [0006]);
a frame base (retention frame 106 – Fig.1A) comprising a flexible material (“retention frame 106 can comprise any flexible and fatigue-resistant material”, see para [0021]) and having an outer perimeter having a shape generally matching a shape of a perimeter of a user-wearable infusion pump (retention frame in Fig.1D); and
a plurality of pump retention features comprising a rigid material (“pump 102 includes a cartridge 116 and a drive unit 118 …. the drive unit and cartridge can be comprised of, for example, polypropylene, polycarbonate COC…”, see para [0023]).
Regarding claim 12, Cook discloses the pump holder (patch pump 100 – Fig.1A) of claim 11, wherein the pump retention features comprising a rigid material include one or more retention walls extending upwardly from the outer perimeter of the frame base (walls of retention frame 100 - Fig.1A).
Regarding claim 15, Cook discloses the pump holder (patch pump 100 – Fig.1A) of claim 11, wherein the pump retention features comprising a rigid material include a cannula module (cannula 130 – Fig.1F) configured to receive a cannula inserted (cartridge cannula 132 – Fig.1F) therethrough, the cannula module configured to interface with a cannula interface of a user-wearable infusion pump to fluidly connect an outlet of the user-wearable infusion pump with the cannula (“cartridge also includes an opening 128 in a bottom of the cartridge that is aligned with the sealing membrane 112 of the retention frame 106, thereby aligning a cartridge cannula 132 with cannula 130 of the attachment portion 104”, see para [0023], Fig.1F).
Regarding claim 16, Cook discloses the pump holder (patch pump 100 – Fig.1A) of claim 11, wherein the rigid material is selected from the set consisting of polycarbonate, polypropylene and acrylonitrile butadiene styrene (“pump 102 includes a cartridge 116 and a drive unit 118 …. the drive unit and cartridge can be comprised of, for example, polypropylene, polycarbonate COC…”, see para [0023]).
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.
Claims 3-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cook.
Regarding claim 3, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100, 200 – Fig.1A) of claim 1, as recited above.
The embodiments do not appear to expressly disclose wherein the pump retention features comprising a rigid material include one or more guide rails extending upwardly from the frame base interior of the outer perimeter of the frame base.
However, the embodiments of Cook as depicted in Figs.4A-4F disclose wherein the pump retention features comprising a rigid material include one or more guide rails (rail 407 – Fig.4A) extending upwardly from the frame base interior of the outer perimeter of the frame base.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.4A-4F to disclose the pump retention feature comprising one or more guide rails (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Regarding claim 4, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100, 200 – Fig.1A) of claim 3, as recited above.
The embodiments do not appear to expressly disclose wherein the one or more guide rails are configured to interface with a corresponding recess on the user-wearable infusion pump to aid in proper alignment of the user-wearable infusion pump on the pump holder.
However, the embodiments of Cook as depicted in Figs.4A-4F disclose wherein the one or more guide rails are configured to interface with a corresponding recess on the user-wearable infusion pump to aid in proper alignment of the user-wearable infusion pump on the pump holder (“rail 407 terminates at the sealing membrane 412 to properly align the pump 402 with the sealing membrane 412. As can be seen in FIG. 4F, both the cartridge 416 and the drive unit 418 can include slots 417, 419 that mate with rail 407”, see para [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.4A-4F so that the guide rails are configured to interface with a corresponding recess on the user-wearable infusion pump (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Regarding claim 5, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100, 200 – Fig.1A) of claim 1, as recited above.
The embodiments do not appear to expressly disclose wherein the pump retention features comprising a rigid material include a locking projection extending upwardly from the outer perimeter of the frame base.
However, the embodiments of Cook as depicted in Figs.8A-8F disclose wherein the pump retention features comprising a rigid material include a locking projection (snap portion 815 – Fig.8A) extending upwardly from the outer perimeter of the frame base.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.8A-8F to disclose the pump retention feature comprising a locking projection (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Regarding claim 6, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100 – Fig.1A) of claim 1, as recited above.
The embodiments do not appear to expressly disclose, wherein the locking projection is configured to interface with a switch on the user-wearable infusion pump that can slide between locked and unlocked positions to releasably lock the user-wearable infusion pump on the pump holder.
However, the embodiments of Cook as depicted in Figs.8A-8F disclose wherein the locking projection (snap portion 815 – Fig.8A) is configured to interface with a switch on the user-wearable infusion pump that can slide between locked and unlocked positions to releasably lock the user-wearable infusion pump on the pump holder (“the snap portion 815 is initially pushed away from the pump 802 and then snaps into place when aligned with the recess 839 to cause an audible clicking or snapping sound that provides an indication to the user that the pump 802 is properly mated to the attachment portion 806”, see para [0032], Fig.8E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.8A-8F to disclose the pump retention feature comprising a locking projection configured to interface with a switch on a user-wearable infusion pump that can slide between locked and unlocked positions (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Regarding claim 13, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100, 200 – Fig.1A) of claim 11, as recited above.
The embodiments do not appear to expressly disclose wherein the pump retention features comprising a rigid material include one or more guide rails extending upwardly from the frame base interior of the outer perimeter of the frame base, the one or more guide rails configured to interface with a corresponding recess on a user-wearable infusion pump to aid in proper alignment of the user- wearable infusion pump on the pump holder.
However, the embodiments of Cook as depicted in Figs.4A-4F disclose wherein the pump retention features comprising a rigid material include one or more guide rails (rail 407 – Fig.4A) extending upwardly from the frame base interior of the outer perimeter of the frame base (“retention frame 406 can be provided with tabs that mate with recesses in pump 402, similar to any of the previous embodiments”, see para [0028], Fig.1A), the one or more guide rails configured to interface with a corresponding recess on a user-wearable infusion pump to aid in proper alignment of the user- wearable infusion pump on the pump holder (“rail 407 terminates at the sealing membrane 412 to properly align the pump 402 with the sealing membrane 412. As can be seen in FIG. 4F, both the cartridge 416 and the drive unit 418 can include slots 417, 419 that mate with rail 407”, see para [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.4A-4F to disclose the pump retention feature comprising one or more guide rails configured to interface with a corresponding recess on a user-wearable infusion pump (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Regarding claim 14, the embodiments of Cook as depicted in Figs.1A-2F disclose the user-wearable infusion pump system (patch pump 100 – Fig.1A) of claim 1, as recited above.
The embodiments do not appear to expressly disclose wherein the pump retention features comprising a rigid material include a locking projection extending upwardly from the outer perimeter of the frame base, the locking projection configured to interface with a switch on a user-wearable infusion pump that can slide between locked and unlocked positions to releasably lock the user- wearable infusion pump on the pump holder.
However, the embodiments of Cook as depicted in Figs.8A-8F disclose wherein the pump retention features comprising a rigid material include a locking projection (snap portion 815 – Fig.8A) extending upwardly from the outer perimeter of the frame base, the locking projection configured to interface with a switch on a user-wearable infusion pump that can slide between locked and unlocked positions to releasably lock the user- wearable infusion pump on the pump holder (the snap portion 815 is initially pushed away from the pump 802 and then snaps into place when aligned with the recess 839 to cause an audible clicking or snapping sound that provides an indication to the user that the pump 802 is properly mated to the attachment portion 806”, see para [0032], Fig.8E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments depicted in Figs.1A-2F with the embodiments depicted in Figs.8A-8F to disclose the pump retention feature comprising a locking projection configured to interface with a switch on a user-wearable infusion pump that can slide between locked and unlocked positions (“the embodiments herein are specifically described…singly or in combination with one another”, see para [0035]).
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Moberg et al. (US 20080097381 A1, herein. Moberg).
Regarding claim 10, Cook discloses the user-wearable infusion pump (patch pump 100 – Fig.1A) of claim 1, as recited above.
Cook does not appear to expressly disclose wherein the flexible material is selected from the set consisting of silicone, thermoplastic elastomer and thermoplastic polyurethane.
Moberg teaches wherein the flexible material is selected from the set consisting of silicone, thermoplastic elastomer and thermoplastic polyurethane (“base 21 of the disposable housing portion 20 may be made of a relatively flexible material, such as a flexible silicone, plastic, rubber, synthetic rubber or the like”, see para [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Moberg with the disclosure
of Cook so that silicone, thermoplastic elastomer and thermoplastic polyurethane may be used as the flexible material in order to further provide “a greater level of patient-user comfort may be achieved when the base is secured to the patient-user's skin” (Moberg para [0085]).
Regarding claim 17, Cook discloses the pump holder (patch pump 100 – Fig.1A) of claim 11, as recited above.
Cook does not appear to expressly disclose wherein the flexible material is selected from the set consisting of silicone, thermoplastic elastomer and thermoplastic polyurethane.
Moberg teaches wherein the flexible material is selected from the set consisting of silicone, thermoplastic elastomer and thermoplastic polyurethane (“base 21 of the disposable housing portion 20 may be made of a relatively flexible material, such as a flexible silicone, plastic, rubber, synthetic rubber or the like”, see para [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Moberg with the disclosure
of Cook so that silicone, thermoplastic elastomer and thermoplastic polyurethane may be used as the flexible material in order to further provide “a greater level of patient-user comfort may be achieved when the base is secured to the patient-user's skin” (Moberg para [0085]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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