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 with traverse of Invention II, Species C from Group I and Species FF of group II (claims 11-19) in the reply filed on 5/18/2026 is acknowledged. The traversal is on the ground(s) that under MPEP 803, restriction is proper only where the claimed inventions are independent or distinct and where examination of all claims would impose a serious search and/or examination burden, if the search and examination of all claims can be made without serious burden, the claims should be examined on merits. Applicant further argues that MPEP 808 requires reasons not merely a statement of conclusion, explaining why such a burden exists. Applicant further argues that identified species of Group I and Group II are not directed to unrelated technologies requiring materially different searches and searching all the species in Groups I and II would not pose an undue burden. This is not found persuasive because examiner has indicated to elect a single species to be elected from Groups I and II because each species is claiming different structures of a respective feature. According to MPEP 809.02(a), the reasons for search burden can be established by listing a reason such as “acquired a separate status in the art in view of their different classification”, “a separate status in the art due to their recognized divergent subject matter” and “a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)”. Therefore, the search burden is established.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 18 is objected to because of the following informalities:
Regarding claim 18, line 4, the recitation “a plunger” appears to be amended to recite “a plunger” to refer to “a plunger” recited in claim 18, line 2.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillespie et al. (US 10,092,690 B2).
Regarding claim 11, Gillespie teaches a syringe detection device (figure 1) for use in a flow control apparatus 10 (figure 1) for delivering fluid from a syringe 14 to a subject, the device comprising:
a syringe holder 12 for securing the syringe 14 to the flow control apparatus 10, the syringe holder 12 comprising a body (portion of element 12 that receives element 14 and holding element 242) for receiving at least a portion of the syringe 14 and a clip 52 pivotally attached to the body for retaining a barrel 46 of the syringe 14 to the syringe holder 12;
a magnet 240 (column 13, lines 26-27) at the clip; and
an angular sensor 242 attached to the body and configured to detect an angle of a magnetic field generated by the magnet, the angle of the magnetic field indicating a size of the syringe when the clip is pivoted to retain the barrel of the syringe to the syringe holder (column 13, lines 27-33).
Regarding claim 14, Gillespie teaches wherein the magnet 240 comprises a permanent magnet (element 240 is not operated with power to generate magnetic field therefore, Gillespie is implicitly teaching element 240 as a permanent magnet).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie et al. (US 10,092,690 B2) in view of Morgan et al. (US 2010/0010443 A1).
Regarding claim 12, Gillespie discloses the claimed invention substantially as claimed, as set forth above in claim 11. Gillespie appears to be disclosing wherein the magnet 240 is imbedded in the clip 52 and the angular sensor 242 is embedded in the body (as seen in figures 18 and 19, elements 240 and 242 appears to be embedded) but does not explicitly recite the magnet imbedded in the clip and the angular sensor embedded in the body even though the magnet is attached on the clip and the angular sensor is attached to the body.
However, Morgan teaches a design of an insulin reservoir detection mechanism comprising a sensor 20 (figure 4) embedded (paragraph 0018, lines 9-15) in the body (body of element 10) and magnet 22 imbedded (paragraph 0022, lines 1-3) to a body 14 for the purpose of securely attaching the sensor and magnet to the respective device parts using a well-known affixing means (paragraph 0022, lines 1-3, paragraph 0018, lines 9-15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the attachment of the magnet and the angular sensor with the respective device components of Gillespie to incorporate the magnet imbedded (in the clip) and the angular sensor embedded in the body as taught by Morgan for the purpose of securely attaching the sensor and magnet to the respective device parts using a well-known affixing means (paragraph 0022, lines 1-3, paragraph 0018, lines 9-15).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gillespie et al. (US 10,092,690 B2) in view of Shor et al. (US 2019/0009019 A1).
Regarding claim 13, Gillespie discloses the claimed invention substantially as claimed, as set forth above in claim 11. Gillespie is silent regarding wherein the angular sensor is located on a flexible printed circuit board.
However, Shor teaches a design of a device for subcutaneous delivery of fluid medicament comprising a sensor 3800 (figure 37E) located on a flexible printed circuit board (paragraph 0288, lines 1-4) for the purpose of being able to attach the sensor on a rounded surface of body (paragraph 0288, lines 4-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the attachment location of the angular sensor of Gillespie to incorporate being located on a flexible printed circuit board as taught by Shor for the purpose of being able to attach the sensor on a rounded surface of the body (paragraph 0288, lines 4-9).
Claim(s) 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pippin et al. (US 2019/0351132 A1) in view of Shigeru (WO 2007026684 A1, English translation is used to refer to the specification).
Regarding claims 15 and 17, Pippin teaches a syringe detection device (figure 1) usable with a flow control apparatus (figure 1) for delivering fluid to a subject, the device comprising:
a syringe holder 100 for removeably securing a syringe 110 thereto, the syringe holder 100 comprising a body 112 for receiving at least a portion of the syringe 110 and a flange plate 160 movably attached to the body 112 and configured to engage a flange of the syringe 110 when the syringe 110 is retained to the holder 112 (paragraph 0074);
a magnet (paragraph 0092, lines 8-9) attached to the flange plate 160; and
a sensor 886 (figure 8) attached to the body (paragraph 0094, lines 1-4). While Pippin discloses the use of magnet and magnetic field, Pippin is silent regarding the sensor being configured to detect a change in a magnetic field generated by movement of the magnet as a result of the movement of the flange plate when the flange of the syringe engages the flange plate, the change in the magnetic field indicating the presence of the syringe in the holder, wherein the sensor is a hall effect sensor.
However, Shigeru a design of an injector device (figures 8a-8c) comprising a magnet 522 attached to the flange plate 521 and a sensor (paragraph 0069, lines 9-11) attached to the body configured to detect a change in a magnetic field generated by movement of the magnet as a result of the movement of the flange plate when the flange of the syringe engages the flange plate, the change in the magnetic field indicating the presence of the syringe in the holder (paragraph 0069, lines 9-11), wherein the sensor is a hall effect sensor (paragraph 0069, lines 9-11) for the purpose of using an alternative well-known means to detect the engagement of the syringe with the syringe holder (paragraph 0069, lines 9-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the sensor of Pippin to incorporate a sensor being configured to detect a change in a magnetic field generated by movement of the magnet as a result of the movement of the flange plate when the flange of the syringe engages the flange plate, the change in the magnetic field indicating the presence of the syringe in the holder, wherein the sensor is a hall effect sensor as taught by Shirgeru for the purpose of using an alternative well-known means to detect the engagement of the syringe with the syringe holder (paragraph 0069, lines 9-11).
Regarding claim 16, Pippin discloses wherein the flange plate 160 (paragraph 0074, lines 4-6) is cantilevered from the body to facilitate movement of the flange plate relative to the body 112.
Regarding claim 18, Pippin discloses wherein the syringe holder 100 further comprises a follower 132, 400 (paragraphs 0086 and 0100) that is configured to move with a plunger of the syringe as a content of the syringe is withdrawn therefrom, wherein the follower further comprises a moveable catch 416, 417 (paragraph 0079) configured to captively engage a plunger of the syringe when the syringe is retained to the holder.
Regarding claim 19, Pippin discloses wherein the follower 132, 400 is configured to slideably move along a rail (paragraph 0100, rail could be construed as elements 520a, 520b, surface near opening into which element 132 enters or any other structure that allows sliding of elements 132, 400) of the syringe holder as the content of the syringe is withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tieck et al. (US 2017/0333620 A1): discloses the design of an infusion pump device comprising a magnetic field angle detection by the sensor to ensure the cap is fully installed within the reservoir.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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