Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed on 13 August 2025 has been entered. Claims 1, 3, 8, and 12 are amended. Claims 1-15 are pending. The amended claims and arguments have overcome the objection set forth in the previous office action. Therefore, the objection is hereby withdrawn.
Applicant's arguments with respect to the rejection(s) of 1-4 and 6-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Searle et al. (US 2011/0054285 Al) have been fully considered but they are not persuasive.
Applicant has contended that Searle does not teach a flexible top housing and a flexible base since Seale relies on cut-outs 402 for flexibility (para. 0054). The examiner does not agree. The amended claims do not distinguish over the flexibility of Seale’s housing. If Applicant’s invention may flexible in a different way, but the amended claims do not require any specific form of flexibility. The cut-outs providing flexibility would read on amended claims.
Applicant has contended that neither Searle or Berenson teaches a flexible top housing formed of a group of partially overlapping plates because the fish scale pattern of Berenson is applicable only to the base and not the top housing as presently claimed.
The Examiner does not agree. Berenson teaches the top housing, or cover 150, comprise microstructure arrays 156A-156D (para. 0190) which comprise fish-scales (para. 0203) which are partially overlapping plates (para. 0254). It would be obvious to apply the teachings of Berenson to Searle to arrive at partially overlapping plates for the top housing, see rejection below.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Searle et al. (hereafter Searle – US 20110054285) in view of Berenson et al. (hereafter Berenson – US 20210252256).
Claim 1 recites “a wearable injection device.” Searle teaches such a wearable injection device, as will be shown.
Searle teaches (Figs. 1-4) a wearable injection device comprising:
a housing (402, 404, see Fig. 4 and para. 0045) comprising a flexible body (para. 0045: any suitable material for providing a thin flexible housing for the components of medical device 100 may be used); comprising: a flexible base 404; and a flexible top housing 402 (flexible due to recesses 402b, see para. 0054).
a reservoir (106) comprising:
a flexible outer wall (Fig. 2, see para. 0064) with an inner volume (para. 0064); and
at least one port (para. 0064) in fluid communication with the inner volume (fill port for filling the reservoir);
a pump mechanism (114) configured to dispense a medicament from the wearable injection device (para. 0039);
an injection mechanism (108) in fluid communication with the inner volume of the reservoir (para. 0039); and
a metering mechanism (116) configured to control a dosage of the medicament dispensed from the wearable injection device (para. 0039).
However, Searle does not teach the flexible top housing comprising a group of partially overlapping plates.
Berenson teaches (Figs. 1-3) a wearable injection device (10) comprising a top housing, or cover 150, comprising microstructure arrays 156A-156D (para. 0190) which comprise fish-scales (para. 0203) which are partially overlapping plates (para. 0254).
Berenson further teaches having the plates arranged in fish scale-like pattern is suitable for grabbing onto or piercing into tissue, e.g., skin (para. 0157) and can provide consistent and uniform tension eliminating the risk of too loose or too tight attachment to the skin (para. 0072).
It would have been obvious for a person having ordinary skill in the art to apply the teachings of Berenson to the wearable injection device of Searle to have the flexible top housing comprising a group of partially overlapping plates arranged in fish scale-like pattern, as both references and Applicant’s invention are directed to wearable injection devices. Doing so would result in improved attachment to the skin, as recognized by Berenson.
Regarding Claim 2, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the medicament is diabetes medication, comprising one of a human insulin, a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analogue, a GLP-1 receptor agonists, a GLP-1 analogue or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or any mixture thereof (see para. 0039).
Regarding Claim 3, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein each of the plates is flexibly connected to at least one other plate, to a flexible substrate, or to a flexible base of the housing (Fig. 4 shows plates connected to together).
Regarding Claim 4, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the plates are made of a rigid or a semi-rigid material (para. 0045).
Regarding Claim 5, Searle teaches (Figs. 1-4) the wearable injection device of claim 3, wherein the plates are arranged in fish scale-like pattern (microstructure fish scales 30, see para. 0157, para. 0254).
Regarding Claim 6, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the flexible body of the housing comprises one of silicone, polyurethane rubber, thermoplastic elastomer, or neoprene foam (para. 0045, PVC is a thermoplastic elastomer).
Regarding Claim 7, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the housing further comprises a flexible base (lower cover 204).
Regarding Claim 8, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 7, wherein the flexible base comprises a flexible sheet (210) and an adhesive coating on at least a portion of the flexible sheet (see para. 0045).
Regarding Claim 9, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the injection mechanism comprises a cannula and a cannula insertion system.
Regarding Claim 10, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the metering mechanism further comprises: a receiving means (par. 0062, communication transceiver); a processor (para. 0061); sensors (para. 0062); and communication means (par. 0062, communication transceiver) connecting the metering mechanism with the pump mechanism and the injection mechanism (para. 062).
Regarding Claim 11, Searle, as modified above, teaches (Figs. 1-4) the wearable injection device of claim 1, wherein the metering mechanism further comprises a flexible circuit board and a soft or flexible battery (para. 0063).
Claim 12 recites “a method of delivering medicament.” Searle teaches such a method, as will be shown. Claim 12 recites a wearable injection device having the same features of Claim 1 which are rejected for the same reasons.
Searle, as modified above, teaches (Figs. 1-4) a method of delivering medicament comprising:
attaching a wearable injection device (100) to a user (see para. 0039), the wearable injection device comprising the same features of Claim 1 (see rejection above);
attaching a wearable injection device to a user (para. 0039),
powering the wearable injection device (para. 0039); sending a signal to the metering mechanism (para. 0039); and dispensing a medicament at a programmable dosage and frequency (para. 0039).
Regarding Claim 13, Searle, as modified above, teaches (Figs. 1-4) the method of claim 12, wherein the method further comprises bending or compressing the wearable injection device without permanently affecting the performance and function of the wearable injection device (para. 0047, wearable injection device is protected).
Regarding Claim 14, Searle, as modified above, teaches (Figs. 1-4) the method of claim 12, wherein sending a signal to the metering mechanism comprises touching the wearable injection device or sending a signal through a separate device by wireless means, such as radio frequency, near-field communication, or Bluetooth (para. 0042).
Regarding Claim 15, Searle, as modified above, teaches (Figs. 1-4) the method of claim 12, wherein dispensing the medicament comprises dispensing diabetes medication, comprising one of a human insulin, a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analogue, a GLP-1 receptor agonists, a GLP-1 analogue or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or any mixture thereof (para. 0039).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BUI whose telephone number is (571) 272-0685. The examiner can normally be reached on 7:30 AM - 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Courtney Heinle can be reached on (571) 270-3508. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANDREW THANH BUI/Examiner, Art Unit 3745
/COURTNEY D HEINLE/Supervisory Patent Examiner, Art Unit 3745