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 .
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.
Claims 1, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al (WO 2020231405 A1, hereinafter Peterson).
Regarding Claim 1, Peterson discloses an applicator (Element 10, Fig. 1) for inserting a sensor (Element 250, Fig. 37) for measuring biometric information into skin of a user, the applicator comprising:
an applicator body (Elements 20 and 40, Fig. 1) to which a base unit comprising a base unit housing (Element 170, Fig. 4) and an adhesive portion (Element 14, Fig. 1B) provided at the base unit housing (“The non-adhesive side of the single-sided adhesive pad 14 is bonded to lower housing bottom 172 (shown in Fig. 22) of a sensor lower housing 170 by welding”, [0148]) to be attachable to the skin of the user (“The user simply removes the ready-to-use subcutaneous sensor applicator 10 from its packaging, removes the adhesive tape cover 12 from the adhesive tape 14 on the bottom of the applicator housing 20 exposing the adhesive that is aligned with the proximal external body flange portion 27, positions the subcutaneous sensor applicator in a pre-selected location onto the user’s skin or the skin of a patient, and pushes the deployment button assembly 40”, [0148]) is separatably coupled (“which sensor lower housing 170 is released from the applicator housing 21 when the sensor applicator system is deployed”, [0151]);
a locking hook (Element 30, Fig. 15; Element 130, Fig. 58) tiltably coupled to the applicator body (See Fig. 58; “Applicator housing 21 also includes an inwardly-facing applicator housing retaining arms 30 formed in the applicator circumferential wall 25 where the applicator housing retaining arm 30 extend at a predefined angle from the applicator circumferential wall 25 into the applicator housing chamber 28 and terminate adjacent the open proximal body end 24”, [0157]) to be engaged with the base unit housing to maintain the base unit coupled to the applicator body (See Fig. 49); and
an insertion unit (Elements 110, 140, 149, Fig. 4; “The pre-loaded insertion assembly 100 includes an insertion assembly housing 1 10, a needle assembly 140, a biasing element 149 and an electro sensor assembly 220”, [0150]) installed to the applicator body (“…the system is preassembled, pre-loaded and ready to use [and] no assembly of any portion of the system is required by the user before placement of the system on the skin of a patient…”, [0060]) to insert the sensor into the skin of the user by moving a sensor unit (See Fig. 36) comprising the sensor (Element 250, Fig. 36) and a sensor unit housing (Element 200, Fig. 4), to which the sensor is mounted (See Figs. 36-37), from a first position, which is away from the base unit (See Fig. 49; the sensor assembly is not lowered), to a second position where the sensor unit housing is coupled to the base unit housing (See Fig. 57; the sensor assembly has fully lowered),
wherein the insertion unit comprises a shuttle (Element 114, Fig, 23) configured to move with the sensor unit from the first position (See Fig. 49) to the second position (See Fig. 57), and the shuttle is configured to tilt the locking hook in a direction to be disengaged from the base unit housing by contacting the locking hook at the second position (“In this view, closed housing proximal end 1 14 had made contact with inwardly-facing applicator housing retaining arm 30 and, at its furthest most travel, has completely pushed retaining arm 30 away from sensor lower housing 170, which releases the now formed sensor module 160 from the applicator module 15”, [00179], Fig. 58).
Regarding Claim 4, Peterson discloses the applicator according to claim 2, wherein the hook portion is engaged with the base unit housing in a way that at least a part of the hook portion is inserted into a housing groove (Element 178, Fig. 50B; “This view also shows inwardly-facing applicator housing retaining arm 30 coupled to lower housing locking recess 178 to retain sensor lower housing 170 to application housing 21”, [0177]) formed on one side of the base unit housing (See Figs. 19-20).
Regarding Claim 7, Peterson discloses an applicator assembly (See Fig. 1) comprising:
an applicator body (Elements 20 and 40, Fig. 1);
a sensor unit (See Fig. 36) including a sensor (Element 250, Fig. 36) and a sensor unit housing (Element 200, Fig. 4) to which the sensor is mounted (See Figs. 36-37);
a base unit including a base unit housing (Element 170, Fig. 4) and an adhesive portion (Element 14, Fig. 1B) provided at the base unit housing (“The non-adhesive side of the single-sided adhesive pad 14 is bonded to lower housing bottom 172 (shown in Fig. 22) of a sensor lower housing 170 by welding”, [0148]) to be attachable to skin of a user (“The user simply removes the ready-to-use subcutaneous sensor applicator 10 from its packaging, removes the adhesive tape cover 12 from the adhesive tape 14 on the bottom of the applicator housing 20 exposing the adhesive that is aligned with the proximal external body flange portion 27, positions the subcutaneous sensor applicator in a pre-selected location onto the user’s skin or the skin of a patient, and pushes the deployment button assembly 40”, [0148]), the base unit separatably coupled to the applicator body (“which sensor lower housing 170 is released from the applicator housing 21 when the sensor applicator system is deployed”, [0151]) by being spaced apart from the sensor unit (See Fig. 48);
a locking hook (Element 30, Fig. 15; Element 130, Fig. 58) tiltably coupled to the applicator body (See Fig. 58; “Applicator housing 21 also includes an inwardly-facing applicator housing retaining arms 30 formed in the applicator circumferential wall 25 where the applicator housing retaining arm 30 extend at a predefined angle from the applicator circumferential wall 25 into the applicator housing chamber 28 and terminate adjacent the open proximal body end 24”, [0157]) to be engaged with the base unit housing to maintain the base unit to be coupled to the applicator body (See Fig. 49);
and an insertion unit (Elements 110, 140, 149, Fig. 4; “The pre-loaded insertion assembly 100 includes an insertion assembly housing 1 10, a needle assembly 140, a biasing element 149 and an electro sensor assembly 220”, [0150]) installed to the applicator body (“…the system is preassembled, pre-loaded and ready to use [and] no assembly of any portion of the system is required by the user before placement of the system on the skin of a patient…”, [0060]) to insert the sensor into the skin of the user by moving the sensor unit from a first position, which is away from the base unit (See Fig. 49; the sensor assembly is not lowered), to a second position where the sensor unit housing is coupled to the base unit housing (See Fig. 57; the sensor assembly has fully lowered),
wherein the insertion unit comprises a shuttle (Element 114, Fig, 23) configured to move with the sensor unit from the first position (See Fig. 49) to the second position (See Fig. 57), and the shuttle is configured to tilt the locking hook in a direction to be disengaged from the base unit housing by contacting the locking hook at the second position (“In this view, closed housing proximal end 1 14 had made contact with inwardly-facing applicator housing retaining arm 30 and, at its furthest most travel, has completely pushed retaining arm 30 away from sensor lower housing 170, which releases the now formed sensor module 160 from the applicator module 15”, [00179], Fig. 58).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Gray et al (US 20180368771 A1, cited in applicant’s IDS, hereinafter Gray).
Regarding Claim 2, Peterson discloses the applicator according to claim 1, wherein the locking hook comprises: a pivot portion (See the proximal end of element 30 that attached to the rest of the apparatus , Fig. 58), a hook portion (See the distal portion of element 30, Fig. 58) connected to one side of the pivot portion (See Fig. 58) to be engaged with the base unit housing (See Fig. 50B), and wherein the locking hook is installed to be rotatable around the pivot portion as a rotation center (See Fig. 58; the dashed and solid outlines of element 130 show that element 130 rotates around its proximal end).
Peterson discloses the claimed invention except for expressly disclosing a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle. However, Gray, which is directed towards the same field of invention, teaches a locking hook (Elements 7372a-7372b, Fig. 73), wherein the locking hook comprises various levers, arms, rods, or other structural elements (“Wearable retention elements 7372a, 7372b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. In some embodiments, wearable retention elements 7372a, 7372b may extend around rather than through holder 7124”, [0351]). The examiner notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).Therefore, one of ordinary skill in the art could have added a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle through routine experimentation as suggested by Gray. In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson as suggested by Gray such that the locking hook comprises a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle, because Gray teaches that any structure capable of a retaining function can be used in a locking hook and one of ordinary skill in the art could have substituted one known part for another, or added an additional element to the locking hook.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Gray, and further in view of Chae et al (KR 20200014002 A, cited in applicant’s IDS, hereinafter Chae; an attached machine translation was relied upon for this rejection).
Regarding Claim 3, modified Peterson discloses the applicator according to claim 2. Modified Peterson discloses the claimed invention except for expressly disclosing wherein the applicator body comprises a supporting portion configured to limit a tilting angle of the locking hook by supporting the lever portion when the locking hook is tilted to be disengaged from the base unit housing. However, Chae teaches a supporting portion configured to limit a tilting angle of the locking hook by supporting the lever portion when the locking hook is tilted to be disengaged from the base unit housing (See Fig. 16, bottom figure; element 102 limits the tilting angle of element 330 when element 330 is disengaged from element 5112). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the supporting portion of Chae to the applicator of Peterson, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Chae.
Regarding Claim 5, modified Peterson discloses the applicator according to claim 1. Modified Peterson discloses the claimed invention except for expressly disclosing wherein the applicator body includes an elastic arm configured to bias the locking hook to be engaged with the base unit housing by contacting one side of the locking hook. However, Chae teaches wherein the applicator body includes an elastic arm (S1, Fig. 16) configured to bias the locking hook to be engaged with the base unit housing by contacting one side of the locking hook (See Fig. 16; “…the sensor fixing hook 330 is attached to the body as shown in FIG. 15 when the plunger body 300 is positioned in the first position. The body attachment unit 20 is elastically supported in an inward direction to be engaged with the engagement coupling groove 5112 of the unit 20”, page 9 of the attached machine translation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson in view of Chae because this would secure the applicator components during transportation and prevent any accidental movements.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Chae, and further in view of Gray.
Regarding Claim 6, modified Peterson discloses the applicator according to claim 5, wherein the locking hook comprises: a pivot portion (See the proximal end of element 30 that attached to the rest of the apparatus , Fig. 58) and a hook portion (See the distal portion of element 30, Fig. 58) connected to one side of the pivot portion (See Fig. 58) to be engaged with the base unit housing (See Fig. 50B). Modified Peterson discloses the claimed invention except for expressly disclosing the locking hook comprising: a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle, and a rod protruding from another side of the pivot portion, and wherein the elastic arm is provided to contact the rod. However, Gray, which is directed towards the same field of invention, teaches a locking hook (Elements 7372a-7372b, Fig. 73), wherein the locking hook comprises various levers, arms, rods, or other structural elements (“Wearable retention elements 7372a, 7372b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. In some embodiments, wearable retention elements 7372a, 7372b may extend around rather than through holder 7124”, [0351]). The examiner notes he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).Therefore, one of ordinary skill in the art could have added a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle, and a rod protruding from another side of the pivot portion, and wherein the elastic arm is provided to contact the rod through routine experimentation as suggested by Gray. In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson as suggested by Gray such that the locking hook comprises a lever portion protruding in a direction of intersecting with the pivot portion to be contactable with the shuttle, and a rod protruding from another side of the pivot portion, and wherein the elastic arm is provided to contact the rod, because Gray teaches that any structure capable of a retaining function can be used in a locking hook and one of ordinary skill in the art could have substituted one known part for another, or added an additional element to the locking hook.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Halac et al (US 20170188910 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791