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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites an “emitting tube assembly configured to drive a slider to emit a sensor to a human body through an elastic force and pull back the slider through the elastic force to enable the slider to be rapidly separated from the sensor”. There is no support in the specification for the slider being pulled back to rapidly separate from the sensor. Furthermore, in paragraph [00138] of the provided specification it is stated that “the slider 150 does not rebound under an elastic force of the emitting spring 120”, which is the opposite of what claim 1 is teaching. For purposes of examination the claim is being interpreted as “an emitting tube assembly configured to drive a slider to emit a sensor to a human body through an elastic force”.
Claims 1-10 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.
The term “rapidly” in claim 1 is a relative term which renders the claim indefinite. The term “rapidly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 2 recites the limitation " a slider". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same slider that is already claimed in claim 1. It is recommended the claim be amended to say “the slider”.
Claim 2 states that “the slider is clamped with the needle stand and is capable of rotating relative to the needle stand” and “the slider is also clamped with the sensor”. It is unclear what is meant by clamped within this context. It is unclear what structure of these elements is doing the clamping. For purposes of examination clamped is being defined as “attached to”. The same issue is present in claims 3-5, 7, and 10.
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Antonio (US 20210378560 A1).
In regards to claim 1 Antonio teaches an auxiliary implantation device for a biosensor, comprising:
an emitting tube assembly (Fig. 14 sensor inserter 104) configured to drive a slider to emit a sensor to a human body through an elastic force ([0080] sensor carrier 212 is a slider);
a battery assembly configured to secure the sensor and supply power to the whole device ([0063] battery 142);
and an emitter assembly assembled with the battery assembly, electrically connected with the sensor, and transmitting a monitoring signal of the sensor to wireless terminal equipment ([0069] antenna 108).
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) 2-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 20210378560 A1) as applied to claim 1, in view of Jeon (US 20230011504 A1) further in view of Chae (US 20200178899 A1).
In regards to claim 2 Antonio teaches the auxiliary implantation device for a biosensor according to claim 1, wherein the emitting tube assembly comprises:
an ejecting tube (Fig. 14 plunger 200),
an emitting spring (Fig. 14 insertion spring 202),
a needle stand (Fig. 14 needle retractor 204),
a needle withdrawal spring (Fig.14 retraction spring 206),
and the slider (Fig. 14 sensor carrier 212),
wherein both the needle stand and the slider are positioned inside the ejecting tube and slide up and down along the ejecting tube ([0080] [0082]), the slider is in contact with the needle stand ([0087]), the slider is also in contact with the sensor ([0087]), and a vertically extending end of the sensor is sleeved with the needle at a bottom of the needle stand (Fig. 14 needle 222 extends through sensor);
the emitting spring is positioned between the ejecting tube and the needle stand, an upper end of the emitting spring is abutted against a top of the ejecting tube, a lower end of the emitting spring is abutted against the slider, and the emitting spring is configured to drive the needle stand and the slider to eject along the ejecting tube ([0080]);
and a top of the needle withdrawal spring is abutted against a top end of the needle stand, a bottom of the needle withdrawal spring is abutted against the slider, and the needle withdrawal spring is configured to drive the needle stand to rebound ([0082]).
Antonio teaches an annular projection that couples the needle stand to the slider and moves outwardly to release the needle stand from the slider ([0087]).
Antonio fails to teach an inserter wherein the slider is clamped with the needle stand and is capable of rotating relative to the needle stand, and the needle withdrawal spring is positioned inside the needle stand. Jeon teaches an outer sleeve that rotates to release an inward needle stand via a projection on the needle stand ([0211]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to replace the annular projection needle stand decoupling method of Antonio with the one of Jeon by having the slider rotate to release a protrusion on the needle stand. Doing so would merely be a simple substitution of one known (needle stand release method) for another to obtain predictable results.
Antonio in view of Jeon fails to teach an inserter wherein the needle withdrawal spring is positioned inside the needle stand. Chae teaches the needle withdrawal spring is positioned inside the needle stand (Fig.6 needle withdrawing body 400 has walls that surround the needle withdrawing elastic spring S2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to modify the needle stand of Antionio in view of Jeon to surround the spring like the device of Chae. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of positioning the spring in the needle stand.
In regards to claim 3 modified Antonio teaches the auxiliary implantation device for a biosensor according to claim 2. Modified Antonio fails to teach a device wherein the ejecting tube comprises an ejecting tube body and an ejecting fastener positioned on the ejecting tube body, and when the slider is not in an ejecting state, the ejecting fastener is clamped with the slider. Chae teaches an injector wherein the ejecting tube comprises an ejecting tube body and an ejecting fastener positioned on the ejecting tube body, and when the slider is not in an ejecting state, the ejecting fastener is clamped with the slider ([0097] Stepped portions is an ejecting fastener which clamps ejecting tube in place by pressing against elastic hooks of plunger). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to modify the housing and slider of modified Antonio to include the ejecting fastener and elastic hooks of Chae. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of keeping the plunger in the non-deployed position until it is ready to be used.
In regards to claim 10 modified Antonio teaches the auxiliary implantation device for a biosensor according to claim 2. Modified Antonio fails to teach a device wherein an assembly groove through which the sensor passes is formed at a bottom of the slider, and an assembly clamping strip through which the sensor is clamped protrudes from the side wall of the assembly groove. Chae teaches a device wherein an assembly groove through which a sensor passes is formed at a bottom of the slider, and an assembly clamping strip through which the sensor is clamped protrudes from the side wall of the assembly groove ([0102] The sensor fixing hooks 330 can engage with the sensor module 20, inserted into the sensor receptacle 301). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to modify the housing and slider of modified Antonio to include a sensor receptacle the sensor fixing hooks of Chae. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of attaching the sensor to the insertion device.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 20210378560 A1), in view of Jeon (US 20230011504 A1) of in view of Chae (US 20200178899 A1) as applied to claim 2, further in view of Peterson (US 20160058474 A1).
In regards to claim 7 modified Antonio teaches the auxiliary implantation device for a biosensor according to claim 2. Modified Antonio fails to teach a device wherein a protruding strip for clamping and securing the ejecting tube protrudes from a lower end of the ejecting tube body, an arc-shaped groove running through from top to bottom is formed in a battery upper cover of the battery assembly, a protruding strip for clamping and securing the upper cover protrudes from the arc-shaped groove, and the protruding strip for clamping and securing the upper cover is clamped with the protruding strip for clamping and securing the ejecting tube. Peterson teaches a device wherein a protruding strip for clamping and securing the ejecting tube protrudes from a lower end of the ejecting tube body, an arc-shaped groove running through from top to bottom is formed in a battery upper cover of the battery assembly, a protruding strip for clamping and securing the upper cover protrudes from the arc-shaped groove, and the protruding strip for clamping and securing the upper cover is clamped with the protruding strip for clamping and securing the ejecting tube ([0132 “Housing body 202 also includes a locking mechanism 205 (e.g., resilient tab, clip, protrusion, etc.) that engages sensor housing 206”, see annotated Fig. 23 below. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to modify the housing and sensor of modified Antonio to include the protruding strips and groove of Peterson. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of attaching the sensor to the insertion device. It would have also been obvious to make the groove arc-shaped. Doing so would be a mere change of shape MPEP 2144.04.III.
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Annotated Peterson Fig. 23
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 20210378560 A1), in view of Jeon (US 20230011504 A1) of in view of Chae (US 20200178899 A1) as applied to claim 2, further in view of Donnay (US 20120303043 A1).
In regards to claim 8 modified Antonio teaches the auxiliary implantation device for a biosensor according to claim 2. Modified Antonio fails to teach a device wherein a guide post extending downwards is disposed at a top of the ejecting tube body, a guide slot running through from top to bottom is formed at a top of the needle stand, and the guide post extends into the guide slot, so that the needle stand slides up and down along the guide post. Donnay teaches a device wherein a guide post extending downwards is disposed at a top of the ejecting tube body, a guide slot running through from top to bottom is formed at a top of the needle stand, and the guide post extends into the guide slot, so that the needle stand slides up and down along the guide post ([0142] Housing may further include sharp carrier guide rail 2714 (guide post) which interfaces with rail guides 2718 (guide slot) located on sharp carrier). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the clamed invention to modify the housing and needle stand of modified Antonio to include the guide post and slot of Donnay. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the needle to slide up and down relative to the housing.
Examiner’s Note
In regards to claims 4-6, none of the prior art teaches or suggests, either alone or in combination, a device comprising an ejecting fastener that comprises a pressing part and a hooking part that are positioned at two opposite ends, wherein the pressing part is suspended relative to an ejecting tube body, and a hooking part is clamped with a slider, in combination with the other claimed elements.
In regards to claim 9, none of the prior art teaches or suggests, either alone or in combination, a device comprising a lower end of a needle stand body provided with an opening, a center post extending downwards disposed at a top end inside a needle stand body, a needle stand inner protrusion disposed at a bottom of the center post, and a slider inner clamping block corresponding to the needle stand inner protrusion is disposed inside a slider, in combination with the other claimed elements.
Claims 4-6, and 9 contain no prior art rejections, however they are not in condition for allowance due to their rejections under 35 U.S.C. 112(b).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791