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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 objected to because of the following informalities:
Line 1-2 recites “further comprising”. Examiner suggests replacing “further comprising” with “further comprising:” to put the claim in clearer form.
Line 4 recites “the user”. There is insufficient antecedent basis for the limitation in this claim. Claim 1 introduces “a user’s body”. Examiner suggests amending line 4 of claim 2 to replace “the user” with “the user’s body” OR amending line 2-3 of claim 1 to replace “a user’s body” with “a body of a user”.
Claim 6 objected to because of the following informalities:
Line 4 recites “and is connected to the sensor frame”. Examiner suggests removing the term “is” to put the claim in clearer grammatical form.
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 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.
In regard to claim 1,
Line 6-7 recites “a base portion on which the reservoir portion, the needle portion, and the driving portion are installed”. Line 4-5 recites “a reservoir portion configured to accommodate a medical liquid and receiver power from a driving portion”. The driving portion is not positively required in line 4-5. Line 6-7 however appears to positively require the driving portion. It is unclear if the driving portion is positively required by the claims and if the driving portion is a component of the liquid medicine injection apparatus. For examination purposes Examiner construes the driving portion to be positively required in line 6-7, but not line 4-5. Examiner suggests clearly introducing a driving portion after introducing a needle portion, and amending line 4-5 to replace “a driving portion” with “the driving portion” if the driving portion is introduced before the reservoir portion.
Examiner notes claims 2-10 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 7,
Line 1-2 recites “the pin portion and the sensor cover are each provided in plurality”. It is unclear what is meant by this. As shown in figure 7, two sensor covers 168 are provided, however a single sensor cover is on each side of the sensor body. Additionally, a singular pin portion and sensor cover are introduced in claim 6, which claim 7 depends on. It is unclear if “the pin portion and the sensor cover are each provided in plurality” requires the pin portion of claim 6 to be one or more pin portions and the sensor cover in claim 6 to be one or more sensor covers. For examination purposes Examiner construes one or more pin portions and a first sensor cover and a second sensor cover to be required. Examiner suggests amending claim 6 to replace “a pin portion” in line 4 of claim 6 with “one or more pin portions”, amending claim 6 to replace “a sensor cover” in line 5 of claim 6 with “a first sensor cover”, amending claim 6 to replace “the pin portion” in line 5 of claim 6 with “the one or more pin portions”, and amending claim 7 to replace “the pin portion and the sensor cover are each provided in plurality and are disposed on both sides of the sensor body” in line 1-3 of claim 7 with “the one or more pin portions is a plurality of pin portions disposed on a first side of the sensor body and a second side of the sensor body, wherein the first sensor cover is disposed on the first side of the sensor body and a second sensor cover is disposed on the second side of the sensor body”.
In regard to claim 8,
Line 1-2 recites “a circuit portion electrically connected to the driving portion”. Claim 8 depends on claim 1. As noted above, it is unclear if the driving portion is positively required in claim 1. It is therefore unclear if the driving portion is positively required to be connected to the circuit portion as claimed in claim 8. For examination purposes Examiner construes the driving portion to be positively required in claim 8. Examiner suggests addressing the 112 issue with claim 1 above.
Examiner notes claims 9-10 are similarly rejected by virtue of their dependency on claim 8.
In regard to claim 9,
Line 5-6 recites “configured to fix positions of the reservoir portion, the needle portion, and the driving portion”. It is unclear if line 5-6 is claiming multiple positions of the reservoir portion, the needle portion, and the driving portion or if the positions refer to a position of each of the reservoir portion, the needle portion, and the driving portion. For examination purposes Examiner construes “configured to fix positions of the reservoir portion, the needle portion, and the driving portion” to be “configured to fix a position of the reservoir portion, the needle portion, and the driving portion”. Examiner suggests replacing “configured to fix positions of the reservoir portion, the needle portion, and the driving portion” in line 5-6 of claim 9 with “configured to fix a position of the reservoir portion, the needle portion, and the driving portion”.
Examiner notes claim 10 is similarly rejected by virtue of its dependency on claim 9.
In regard to claim 10,
Line 4-5 recites “a second circuit connected to the first circuit and disposed on an outer peripheral surface of the second base extending from the first base toward the cover portion”. It is unclear what structure extends from the first base toward the cover portion. It is unclear if the outer peripheral surface or the second circuit extends from the first base toward the cover portion. For examination purposes Examiner construes the outer peripheral surface to extend from the first base toward the cover portion. Examiner suggests replacing “a second circuit connected to the first circuit and disposed on an outer peripheral surface of the second base extending from the first base toward the cover portion” with “a second circuit connected to the first circuit and disposed on an outer peripheral surface of the second base, the outer peripheral surface extending from the first base toward the cover portion”.
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.
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.
Claims 1-3, 5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Windmiller (U.S. PG publication 20200297997) further in view of Yodfat (U.S. PG publication 20140094746).
In regard to claim 1,
Windmiller discloses a Liquid medicine injection apparatus (figure 20 and 21, item 2000; paragraph [0074]) comprising:
a needle portion (figure 21, item 803’) having one or more needle bodies (see figure 21) configured to be injected into a user's body (paragraph [0063]);
a reservoir portion (space within item 800’ which holds a medical liquid; paragraph [0074]) configured to accommodate a medical liquid (paragraph [0074], and [0114]-[0115]) and receive power from a driving portion to deliver the medical liquid to the needle portion (Examiner notes “configured to accommodate a medical liquid and receive power from a driving portion to deliver the medical liquid to the needle portion” is a functional limitation. The reservoir portion is fully capable of the recited function due to its structure as supported by paragraph [0074] and [0114]-[0115]. Examiner notes the driving portion is not positively required by the claim);
a base portion (housing of item 800’ and item 2030; see figure 20 and 21) on which the reservoir portion and the needle portion are installed (see figure 21 and paragraph [0074] and [0114]-[0115] wherein the reservoir portion and the needle portion are installed on housing of item 800’);
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a cover portion (see figure 21 above) covering the base portion (see figure 21); and
a sensor portion (figure 21, item 20’) configured to measure blood sugar (paragraph [0091]),
wherein, in the cover portion, an insertion groove (figure 20, item 2020) which has one side open and has a preset depth is formed (see figure 20), and
the sensor portion is insertable into the insertion groove (see figure 21) and is spatially separable from the base portion (see figure 21).
Windmiller is silent as to a base portion on which the driving portion is installed.
Yodfat teaches a base portion (housing of item 1005 in figure 2) on which the reservoir portion (reservoir; paragraph [0114]), the needle portion (figure 2, item 66), and the driving portion (driving mechanism; paragraph [0114]) are installed (paragraph [0114]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Windmiller to substitute the base portion of Windmiller for a base portion on which the driving portion is installed, as taught by Yodfat, because the substitution is a simple substitution that would yield the same predictable result of enabling fluid delivery (paragraph [0074] of Windmiller and paragraph [0114] of Yodfat). Furthermore, Windmiller discloses modifications can be made (paragraph [0126] of Windmiller).
In regard to claim 2,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 1, further comprising
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an attachment portion (see figure 20 above of Windmiller) connected to the base portion and the sensor portion (see figure 21 of Windmiller) and attachable to the user (paragraph [0115] of Windmiller; Examiner notes “attachable to the user” is functional limitation. The attachment portion is fully capable of the recited function due to its structure and as supported by paragraph [0115] of Windmiller).
In regard to claim 3,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 2, wherein the attachment portion comprises:
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a first attachment member (see figure 20 of Windmiller above) connected to one side of the base portion (see figure 21 of Windmiller); and
a second attachment member (see figure 20 of Windmiller above) that is a separate component from the first attachment member (see figure 20 above of Windmiller) and is connected to one side of the sensor portion (see figure 21 of Windmiller).
Windmiller is silent as to a second attachment member formed as a separate component from the first attachment member.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the second attachment member as a separate component from the first attachment member, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
In regard to claim 5,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 1, wherein the sensor portion comprises:
a sensor frame (outer housing of 20’) that is insertable into the insertion groove (see figure 21 of Windmiller); and
a sensor module (components of the sensor other than the outer housing. See components described in paragraph [0101] of Windmiller: circuit board, circuit board cover, front panel, the back plate, and needles 150 of Windmiller) installed in the sensor frame (paragraph [0101] of Windmiller) and comprising a sensor needle (see figure 21 of Windmiller).
In regard to claim 8,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 1, further comprising a circuit portion (circuit board in item 20’ of Windmiller and figure 20, item 2040 of Windmiller; paragraph [0101]; of Windmiller) electrically connected to the driving portion (see figure 20 of Windmiller wherein the circuit portion is connected to the driving portion via the connection line 2030 of Windmiller).
In regard to claim 9,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 8, wherein the base portion comprises:
a first base (figure 20, item 2030 of Windmiller) connected to one side of the cover portion (see figure 20 of Windmiller) and on which the circuit portion is disposed (see figure 20 and 21 of Windmiller wherein at least item 2040 of Windmiller is disposed on the first base); and
a second base (housing of item 800’ of Windmiller) disposed on the first base (see figure 21 of Windmiller) and configured to fix positions of the reservoir portion, the needle portion, and the driving portion (Examiner notes “configured to fix positions of the reservoir portion, the needle portion, and the driving portion” is a functional limitation. Due to the reservoir portion, the needle portion, and the driving portion being located within the second base, the second base is fully capable of the recited function; see analysis of claim 1 above).
In regard to claim 10,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 9, wherein the circuit portion (circuit board in item 20’ of Windmiller and figure 20, item 2040 of Windmiller) comprises:
a first circuit (figure 20, item 2040 of Windmiller) disposed on the first base (see figure 20 of Windmiller); and
a second circuit (circuit board in item 20’ of Windmiller) connected to the first circuit (see figure 20 and 21 of Windmiller) and disposed on an outer peripheral surface of the second base extending from the first base toward the cover portion (see figure 20 and 21 of Windmiller; Examiner notes the second circuit is disposed via other components on an outer peripheral surface of the second base extending from the first base toward the cover portion ).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Windmiller (U.S. PG publication 20200297997) in view of Yodfat (U.S. PG publication 20140094746) further in view of Wieser (U.S. PG publication 20210369957).
In regard to claim 4,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 1.
Windmiller in view of Yodfat is silent as to further comprising a lever portion rotatably installed on the cover portion and configured to transmit rotational power to the needle portion.
Wieser teaches a lever portion (figure 5A, item 11) rotatably installed on the cover portion (housing 5 in figure 5A) and configured to transmit rotational power to the needle portion (see figure 5B-5C; paragraph [0053]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Windmiller in view of Yodfat to include a lever portion rotatably installed on the cover portion and configured to transmit rotational power to the needle portion, as taught by Wieser, for the purpose of ensuring safety before and after use (paragraph [0050] and [0005]-[0006] of Wieser).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Windmiller (U.S. PG publication 20200297997) in view of Yodfat (U.S. PG publication 20140094746) further in view of Brewer (U.S. PG publication 20160058939).
In regard to claim 6,
Windmiller in view of Yodfat teaches the Liquid medicine injection apparatus of claim 5, wherein the sensor module comprises:
a sensor body in which the sensor needle is formed (see figure 7C of Windmiller and figure 21 of Windmiller);
a pad portion (figure 7A, item 127 of Windmiller; see figure 7A where the pad portion contains 6 pads) connected to the sensor body and comprising a conductive material (paragraph [0103] of Windmiller); and
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a sensor cover (see figure 7A above of Windmiller and figure 7E of Windmiller wherein the sensor cover comprises the portion identified in figure 7A and bottom plate shown in figure 7E) covering the pad portion (see figure 7A and 7E of Windmiller wherein the sensor cover covers a portion of the pad portion depending on the orientation of the device) and is connected to the sensor frame (see figure 21 of Windmiller).
Windmiller in view of Yodfat is silent as to a pin portion connected to the sensor body and comprising a conductive material. Accordingly, Windmiller in view of Yodfat is also silent as to a sensor cover covering the pin portion and is connected to the sensor frame.
Brewer teaches a pin potion (paragraph [0032]) comprising a conductive material (paragraph [0032]) and that a pin portion or pad portion could all be used to achieve the same result (paragraph [0032]) and thus a pin portion and a pad portion were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a pin portion in place of the pad portion since it has been held that substituting parts of an invention involves only routine skill in the art. Examiner notes the substitution would result in a pin portion (6 pins which replace the 6 pads of Windmiller in view of Yodfat) connected to the sensor body and comprising a conductive material and a sensor cover covering the pin portion and is connected to the sensor frame.
In regard to claim 7,
Windmiller in view of Yodfat in view of Brewer teaches Liquid medicine injection apparatus of claim 6, wherein the pin portion (see analysis of claim 6 above wherein 6 pins replace the 6 pads shown in figure 7A of Windmiller) and the sensor cover are each provided in plurality (see figure 7A and 7E of Windmiller and analysis of claim 6 above) and are disposed on both sides of the sensor body (left and right side of the sensor body).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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