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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 29 March 2026 is acknowledged.
Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 March 2026
Claim Objections
Claims are objected to because of the following informalities:
Cl.2 and 9: “the tray defining” is believed to be in error for --the tray to define--
Cl.3 and 10: “extend across” is believed to be in error for --extends across--
Cl.5: “between film” is believed to be in error for --between the film--
Cl.6: “film joined” is believed to be in error for --film is joined--
Cl.8: “housing configured” is believed to be in error for --housing is configured--
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 2-3, 5, and 8-12 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 pre-AIA the applicant regards as the invention.
Regarding Claim 2, the recitation(s) “the first enclosure includes a tray” renders the claim indefinite because it is unclear whether the tray is part of first enclosure or a separate element.
Similarly, claim 8, recites “the first enclosure includes an inner wall and a tray along the inner wall”, which is unclear whether the tray, the first enclosure, and the inner wall, are all separate elements or whether one or more of them are subcomponents of the other.
Regarding claim 5, “between film” is unclear because “between” requires two elements (i.e. between A and B) and only one (film) is recited.
Dependent Claims 3 and 9-12 are also rejected for relying on at least one rejected claim above.
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.
Claim(s) 1-2, 5-9, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chappel 9901678.
Regarding Claim 1, Chappel teaches a device (Fig 1) for delivering medication to a user (Title, Abstract, col.1 ll.12-15), the device comprising:
first and second enclosures (2, 3) that together form a housing of the device (Fig 1), the housing configured to house a reservoir (6; or between 1 and 3) for storing the medication (e.g. insulin, col.1 ll.12-13),
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wherein the first enclosure includes an inner wall (Fig 2a above) of the housing; and
a film (1) joined to the inner wall of the first enclosure (by thermoforming or heat soldering; col.1 ll.26-30), wherein the film and the inner wall of the first enclosure are configured to form walls of the reservoir for storing the medication (Fig 2a shows reservoir between 1 and 3 in the filled configuration).
Regarding claim 2, Chappel teaches all the limitations of the claimed invention as discussed above.
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Chappel further teaches the first enclosure incudes a tray (Fig 1; annular tray portion including inner wall - just as Applicant’s tray includes the inner wall - , cavity, ledge, and opening) having a cavity (Fig 1 above) and a ledge (Fig 1 above) that extends around a periphery of the tray defining an opening (Fig 1 above) that communicates with the cavity (Fig 1 above).
Regarding claim 5, Chappel teaches all the limitations of the claimed invention as discussed above. Chappel further teaches the film is formed against the inner wall of the first enclosure thereby removing any air that may be trapped between film but enabling the film to expand as the medication fills the reservoir (Figs 2a-b; col.9 ll.43-62).
Regarding claim 6, Chappel teaches all the limitations of the claimed invention as discussed above. Chappel further teaches the film joined to the inner wall of the first enclosure by bonding (by thermoforming or heat soldering; col.1 ll.26-30).
Regarding claim 7, Chappel teaches all the limitations of the claimed invention as discussed above. Chappel further teaches the medication is insulin (col.1 ll.12-13).
Regarding claim 8, Chappel teaches a device (Fig 1) for delivering medication to a user (Title, Abstract, col.1 ll.12-15), the device comprising:
first and second enclosures (2, 3) that together form a housing of the device (Fig 1);
a reservoir (6; or between 1 and 3) integrated into the housing configured to store the medication (e.g. insulin, col.1 ll.12-13);
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wherein the first enclosure includes an inner wall (Fig 1 above) and a tray (Fig 1 above) along the inner wall of the first enclosure (Fig 1); and
a film (1) joined to the tray (by thermoforming or heat soldering; col.1 ll.26-30), wherein the film and the tray are configured to form walls of the reservoir (Fig 2a shows reservoir between 1 and 3 in filled configuration).
Regarding claim 9, Chappel teaches all the limitations of the claimed invention as discussed above.
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Chappel further teaches the tray includes a cavity and a ledge that extends around a periphery of the tray defining an opening that communicates with the cavity (Fig 1 above).
Regarding claim 12, Chappel teaches all the limitations of the claimed invention as discussed above. Chappel further teaches the medication is insulin (col.1 ll.12-13).
Claim(s) 1-3, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 8298183.
Regarding claim 1, Menot teaches a device (Fig 2) for delivering medication to a user (Abstract), the device comprising:
first and second enclosures (19, 20) that together form a housing of the device (Fig 2), the housing configured to house a reservoir (between 3 and 1) for storing the medication (e.g. insulin, col.1 ll.5-8),
wherein the first enclosure (either enclosure 20 or 21 could be interpreted as including the wall 1) includes an inner wall (surface of 1 defining cavity 2) of the housing (Fig 2); and
a film (3) joined to the inner wall of the first enclosure (col.2 ll.19-27), wherein the film and the inner wall of the first enclosure are configured to form walls of the reservoir for storing the medication (Fig 2).
Regarding claim 2, Menot teaches all the limitations of the claimed invention as discussed above, Menot further teaches the first enclosure incudes a tray (1) having a cavity (2) and a ledge (between 20, 21) that extends around a periphery of the tray (Figs 2-4) defining an opening (that is closed by film 3 when film 3 is attached to 1) that communicates with the cavity (Figs 2-4).
Regarding claim 3, Menot teaches all the limitations of the claimed invention as discussed above, Menot further teaches the tray is rectangular (Figs 3-4) and extends across the full width of the inner wall of the first enclosure (Figs 2-4).
Regarding claim 8, Menot teaches a device (Fig 2) for delivering medication to a user (Abstract), the device comprising:
first and second enclosures (19, 20) that together form a housing of the device (Fig 2);
a reservoir (between 3 and 1) integrated into the housing configured to store the medication (e.g., insulin, col.1 ll.5-8);
wherein the first enclosure includes an inner wall (either enclosure 20 or 21 could be interpreted as including the tray 1 having an inner wall that is the surface defining the cavity 2) and a tray (1) along the inner wall of the first enclosure (1 defining the inner wall; Figs 2-4); and
a film (3) joined to the tray (col.2 ll.19-27), wherein the film and the tray are configured to form walls of the reservoir (Fig 2).
Regarding claim 10, Menot teaches all the limitations of the claimed invention as discussed above, Menot further teaches the tray is rectangular and extend across the full width of the inner wall of the first enclosure (Figs 2-4).
Claim(s) 1, 4, 8, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bianchi 11266567.
Regarding claim 1, Bianchi teaches a device (Fig 3) for delivering medication to a user (for insulin infusion pumping; Title, Abstract, Col.1 ll.16-60), the device comprising:
first and second enclosures (2, 6) that together form a housing of the device (Figs 1, 3), the housing configured to house a reservoir (between 1 and 2) for storing the medication (e.g. insulin; col.1 ll.64-end),
wherein the first enclosure includes an inner wall of the housing (surface of 2 facing 1); and
a film (1) joined to the inner wall of the first enclosure (by welding; col.2 l.65-end), wherein the film and the inner wall of the first enclosure are configured to form walls of the reservoir for storing the medication (col.2 l.65 - col.3 l.11).
Regarding claim 8, Binachi teaches a device (Fig 3) for delivering medication to a user (for insulin infusion pumping; Title, Abstract, Col.1 ll.16-60), the device comprising:
first and second enclosures (2, 6) that together form a housing of the device (Figs 1, 3);
a reservoir (between 1 and 2) integrated into the housing configured to store the medication (e.g., insulin, col.1 ll.64-end);
wherein the first enclosure includes an inner wall (surface of 2 facing film 1) and a tray (portion of 2 forming the reservoir with film 1) along the inner wall of the first enclosure (2 defining the inner wall; Figs 1-3); and
a film (1) joined to the tray (by welding; col.2 l.65-end), wherein the film and the tray are configured to form walls of the reservoir (col.2 l.65 - col.3 l.11).
Regarding claims 4 and 11, Binachi teaches all the limitations of the claimed invention as discussed above. Bianchi further teaches the film is plastic (col.2 ll.25-27).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741
Prosecution Insights