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 .
Election/Restrictions
Applicant’s election of Species B in the reply filed on February 2, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2, 3, 5, and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.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 February 2, 2026.
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.
Specification
The disclosure is objected to because of the following informalities:
Pg. 7 line 6: 150 should be 120
P6. 22 second full paragraph: 222comprises needs a space
Appropriate correction is required.
Drawings
The drawings are objected to because the numbering in Fig. 12b does not appear to correspond to the disclosure. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 514, 301, 323, 313, 3221, 4231, 52311/b, 4221a/b, and 523. 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.
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: 101b. 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 § 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 9 and 10 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 9 recites a case of the infusion mechanism module includes and upper and lower case and that the second electrical contact and detection modules are provided on a convex portion of the upper case. However, the second electrical contacts and in-position detection module are not part of the infusion mechanism module, they are recited as part of the control mechanism module. For purposes of Examination this is considered as referring to the case of the control mechanism module.
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, and 7-11 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, 7, and 8, Estes et al. teach a skin patch drug infusion device, comprising: an infusion 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); a control 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]). 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.
With regard to claims 9 and 10, see Reference Figure 1 below.
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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.
Double Patenting
Claims 1 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 7 of copending Application No. 18269959 in view of Tong et al. (WO 2019/23077 A1). Claim 7 of the copending application teaches all limitations except for an adhesive 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). 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 as Tong et al. teach such to be an art effective configuration for attachment.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mounce et al. (US 2008/0077081 A1) and Yodfat (US 2010/0137790 A1) tach in position detection modules.
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.
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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