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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCTCN2021070207, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not disclose an in-position detection module.
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: 211. 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.
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.
Claim(s) 1, 4, 7-9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes et al. (US 2007/0073235 A1) in view of Hanson et al. (US 2019/0282756 A1).
With regard to claims 1, 4, and 7-9, Estes et al. teach a skin patch drug infusion device, comprising: a control mechanism module (Fig. 4 100), provided with multiple first electrical contacts (Fig. 4 149) and a first physical component exposed from a surface (Fig. 4 118a/b); an infusion mechanism module (Figs. 4 and 8 200), comprising a case (Fig. 4 210), and provided with multiple second electrical contacts (Fig. 8 249) and an in-position detection module exposed from a surface of the case, wherein the in-position detection module includes a second physical component (Fig. 8 218a/b), when the control mechanism module and the infusion mechanism module are assembled with each other, the first electrical contacts and the second electrical contacts squeezed to electrically connect with each other ([0042]); and an adhesive patch, for attaching the infusion mechanism module and the control mechanism module to a skin surface (not shown [0038], [0040]); wherein a case of the infusion mechanism module includes an upper case and a lower case, the lower case is provided with an outward extending portion, a block is provided on an edge of the outward extending portion, when the control mechanism module is assembled on the outward extending portion, the block is located beside the control mechanism module to prevent the control mechanism module from detaching the infusion mechanism module (see Reference Figures 1 and 2 below for two different interpretations). Estes et al. teach members 118a/b and 218 a/b may be magnets but do not disclose generating an in-position signal or using a threshold to send an alarm. However, Hanson et al. teach using a magnetic component and magnetic sensor to determine if two housing portions are properly aligned and using a visual/audible/tactile signal to show proper attachment in response to threshold values (exemplary Fig. 12 magnets 104, 106, [0157], exemplary Fig. 16 sensor 205 magnet 206, [0194], [0196], [0247], [0022], [0199], [0200]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an in-position detection system with magnet, sensor, and alarm in Estes et al. as Hanson et al. teach this is beneficial to ensure proper alignment for correct use.
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With regard to claim 11, see [0032].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes et al. (US 2007/0073235 A1) and Hanson et al. (US 2019/0282756 A1) as applied to claim 1 above, and further in view of Tong et al. (WO 2019/23077 A1), Aoyagi et al. (US 2012/0189796 A1), and Cantor et al. (US 2014/0243788 A1).
With regard to claim 12, Estes et al. teach an adhesive patch may be used but do not disclose details of such a patch. However, Tong et al. teach and adhesive patch which includes a release liner over and around the outer edge of an adhesive patch to cover the adhesive before use (Fig. 4 adhesive 16, liner 18). Further, Aoyagi et al. teach a release liner may be made from PET ([0089]). Additionally, Cantor et al. teach the patch may be made from a polypropylene backing coated with adhesive ([0059], 110 with adhesive 112, Fig. 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an adhesive patch with a polypropylene backing and PET release liner in Estes et al. as Tong teach such to be an art effective configuration for attachment and Aoyagi et al. and Cantor et al. teach such materials to be suitable and would yield the same predictable result. The materials as rejected are the same as disclosed by Applicant so they are expected to have the same rockwell hardness properties. It would have been additionally obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use materials with such a rockwell hardness because Applicant has not disclosed that such a hardness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with patch as provided as it yields the same predictable result of protecting adhesive prior to use and allowing attachment to a patient.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In light of the amendments the considerations of the control mechanism module and infusion mechanism module are switched. The components now considered include the claimed elements.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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