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 statements (IDSs) submitted on 05/31/24 and 12/17/24 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 05/31/24 has been entered. Claims 1-2 and 4-10 have been amended. Claim 3 is in the original/ previously presented form. Claims 11-20 are newly presented. Thus, claims 1-20 remain pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“the drive pusher is provided on the insertion part;” such as in at least claim 6. The drive pusher is not provided with a reference numeral (see applicant disclosure in at least [0039]) and is not shown anywhere on the drawings. Therefore, the drive pusher being provided “on” the insertion part is not properly depicted. To overcome this drawing objection, Applicant could amend the specification to include a reference numeral for the drive pusher and subsequently place the corresponding numeral on the drawings, such as in FIG. 6.
“wherein the second shell comprises a top cover with a bottom opening and a bottom cover covering the bottom opening of the top cover, and an accommodating chamber is formed within the top cover for containing a controlling member of the controlling device” of at least claim 9. The top cover, bottom cover, bottom opening, and accommodating chamber are not depicted in the drawings.
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 3 and 12 are objected to because of the following informalities:
Claim 3 lines 1-2 read “wherein any one of the first buckle and the second buckle” and should likely read “wherein any one of the plurality of first buckles and the plurality of second buckles” to align with the language as previously introduced in claim 2 from which claim 3 is interpreted to depend (see 112b rejection below)
Claim 12 lines 1-2 read “wherein any one of the first buckle and the second buckle” and should likely read “wherein any one of the plurality of first buckles and the plurality of second buckles” to align with the language as previously introduced in claim 11 from which claim 12 is interpreted to depend (see 112b rejection below)
Appropriate correction is required.
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 3 and 4-20 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 3 recites the limitation "the first buckle and the second buckle" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1, which does not provide antecedent basis for any “buckle” structure. For purposes of examination, the examiner interprets that claim 3 depend from claim 2 that provides proper antecedent basis for a plurality of “first buckles” and a plurality of “second buckles”.
Regarding claim 4, lines 11-12 recite “the mounting part is used to detachably fix a main engine unit…”. However, it is unclear to the examiner whether the “a main engine unit” recited in lines 11-12 is the same or different “main engine unit” as recited in line 2 of claim 4. According to Applicant disclosure, it appears there is only one main engine unit (3, see Fig. 4 and [0033]). Therefore, for purposes of examination, the examiner interprets lines of claim 4 to read “the mounting part is used to detachably fix [[a]] the main engine unit…”.
Due to claim dependency, claims 5-20 are subsequently rejected under 112b unless otherwise noted below.
Claim 12 recites the limitation "the first buckle and the second buckle" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 depends from claim 4, which does not provide antecedent basis for any “buckle” structure. For purposes of examination, the examiner interprets that claim 12 depend from claim 11 that provides proper antecedent basis for a plurality of “first buckles” and a plurality of “second buckles”.
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.
(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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yodfat et al. (U.S. PGPUB No. 2014/0052055), hereinafter Yodfat.
Regarding claim 1, Yodfat discloses
a balanced indwelling needle assembly (20, see FIG. 2C and [0204]), comprising a baseplate (baseplate 37, see FIG. 6a, is part of cradle unit 20 in FIG. 2C) and a vertical indwelling needle (cannula 406, see FIG. 6c and [0208] & [0211]: 406 is part of the cannula unit 400 as seen in FIG. 2C) provided in a central preset area (31, see FIG. 7a and [0208]: 31 away from edges of baseplate and is located at center of circular well 30. Therefore 31 is central preset area of well 30) of the baseplate (37); a side of the baseplate is an applying surface (see Fig. 7a and [0208] & [0212] with adhesive layer 26 on applying surface side/ patient side/downward side of baseplate. See also the modified figure titled ‘Modified FIG. 7b(left) and 12c(right)’ below for clarity)
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and an opposite side (“upward” side of baseplate, see FIG. 7b) of the baseplate (37) is a mounting surface (upward side includes latches 22/24);
the vertical indwelling needle (406) is formed with (see FIG. 6a-c and [0208-0211]: cannula unit has the needle 406 disposed within cannula 404. 406 for piercing skin and 404 stays in body) an indwelling needle catheter (404) extending vertically away from the applying surface (applying surface is patient side/ tissue side and needle and cannula extend vertically away to pierce skin as seen in Fig. 6a-c); the applying surface is formed with an adhesive layer (26) for being fixed onto a surface of a patient's skin (see fig. 7a and [0208] & [0212] with adhesive layer 26 on applying surface side/ patient side/downward side of baseplate);
the vertical indwelling needle (406) is formed with (see [0208-0209] & [0213]: cannula unit inserted into well 30 and thus the needle 406 is ‘formed with’ connector 30) a fluid inlet connector (30) on the mounting surface (see Fig. 7b), the fluid inlet connector (31) being in communication with (see Fig. 12c-d and [0208]) a top inlet (210) of an indwelling needle tube (230); the mounting surface is formed with a mounting part (22/24, see FIG. 7b and [0213]); the mounting part (22/24) is used to detachably fix (see FIG. 12c-e and [0213]: 22/24 enable connection and disconnection with dispensing unit) a main engine unit (10, see FIG. 7b and multiple components of 10—200/100 shown in FIG. 2c and described briefly in [0204]) of a medicine infusion system (see [0202]) on the mounting surface (as seen in FIG. 2c and 12c); and when the main engine unit is mounted and fixed on the mounting surface (as seen in FIG. 12c), the fluid inlet connector (30) is in sealed communication (see [0208]: latches 32/34 on connector 30 secure dispensing unit 10 and [0226]: fluidly sealed via septum) with a medicine delivery connector (connector lumen 250) of a medicine delivery device (see [0204]) of the main engine unit (10).
Regarding claim 2, Yodfat discloses the balanced indwelling needle assembly according to claim 1, and Yodfat further discloses wherein the mounting part (22/24, see FIG. 7b and [0213]) is a plurality of first buckles (22/24 are latches, see [0208] & [0226], aligning with latch structure as disclosed in the current Application in Figs. 1-3 and [0036]: snap-fit latch) formed around the mounting surface (seen best in Fig. 7b and described in [0213]), and the main engine unit (10) is provided with a plurality of second buckles (12/14, see Fig. 12c) correspondingly snap-fitted (see [0226]: groove 12/14 snap fit to latch 22/24, aligning with Applicant disclosure in [0036] of the current application disclosing second buckle as snap-fit slot) with the first buckles (22/24).
Regarding claim 3, Yodfat discloses the balanced indwelling needle assembly according to claim [[1]] 2, and Yodfat further discloses wherein any one of the first buckle (22/24, see Fig. 7b and [0208] & [0226]) and the second buckle (12/14, see Fig. 12c) is an elastic (see [0208] & [0226]: snap-fit connection able to decouple/recouple and thus is inherently “elastic”) snap latch (22/24, see [0208] & [0226]: 22/24 described as latches for snap-fit), and the other (12/14) is a snap-fit slot (see [0226]: 12/14 described as snap-fit grooves==slot).
Regarding claim 4, Yodfat discloses
A paste-type medicine infusion system (see [0027], [0208], and [0212]: device adhered to skin by way of adhesive layer 26), comprising a balanced indwelling needle assembly (20, see FIG. 2C and [0204]) and a main engine unit (10), wherein the balanced indwelling needle assembly comprises a baseplate (baseplate 37, see FIG. 6a, is part of cradle unit 20 in FIG. 2C) and a vertical indwelling needle (cannula 406, see FIG. 6c and [0208] & [0211]: 406 is part of the cannula unit 400 as seen in FIG. 2C) provided in a central preset area (31, see FIG. 7a and [0208]: 31 away from edges of baseplate and is located at center of circular well 30. Therefore 31 is central preset area of well 30) of the baseplate (37); a side of the baseplate is an applying surface (see Fig. 7a and [0208] & [0212] with adhesive layer 26 on applying surface side/ patient side/downward side of baseplate. See also the modified figure titled ‘Modified FIG. 7b(left) and 12c(right)’ below for clarity)
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and an opposite side (“upward” side of baseplate, see FIG. 7b) of the baseplate (37) is a mounting surface (upward side includes latches 22/24);
the vertical indwelling needle (406) is formed with (see FIG. 6a-c and [0208-0211]: cannula unit has the needle 406 disposed within cannula 404. 406 for piercing skin and 404 stays in body) an indwelling needle catheter (404) extending vertically away from the applying surface (applying surface is patient side/ tissue side and needle and cannula extend vertically away to pierce skin as seen in Fig. 6a-c); the applying surface is formed with an adhesive layer (26) for being fixed onto a surface of a patient's skin (see fig. 7a and [0208] & [0212] with adhesive layer 26 on applying surface side/ patient side/downward side of baseplate);
the vertical indwelling needle (406) is formed with (see [0208-0209] & [0213]: cannula unit inserted into well 30 and thus the needle 406 is ‘formed with’ connector 30) a fluid inlet connector (30) on the mounting surface (see Fig. 7b), the fluid inlet connector (30) being communicated with (see Fig. 12c-d and [0208]) a top inlet (210) of an indwelling needle tube (230); the mounting surface is formed with a mounting part (22/24, see FIG. 7b and [0213]); the mounting part (22/24) is used to detachably fix (see FIG. 12c-e and [0213]: 22/24 enable connection and disconnection with dispensing unit) [[a]] the main engine unit (10, see FIG. 7b and multiple components of 10—200/100 shown in FIG. 2c and described briefly in [0204]) of a medicine infusion system (see [0202]) on the mounting surface (as seen in FIG. 2c and 12c), the fluid inlet connector (30) is in sealed communication (see [0208]: latches 32/34 on connector 30 secure dispensing unit 10 and [0226]: fluidly sealed via septum) with a medicine delivery connector (connector lumen 250) of a medicine delivery device (see [0204]) of the main engine unit (10).
Regarding claim 5, Yodfat discloses the paste-type medicine infusion system according to claim 4, and Yodfat further discloses wherein the main engine unit (10, see FIG.11b) comprises a medicine delivery device (see [0221-0222]: engine unit contains a piston, aligning with as much as is disclosed for Applicant’s “medicine delivery device” of the current Application such as in [0039]) and a controlling device (130) for controlling a medicine dispensing amount of the medicine delivery device (see [0221]); the medicine delivery device (see [0221]) is integrated into a first shell (200, see Fig. 11b/2c and [0222] & [0224]), and the controlling device (100, see Fig. 11b/2c and [0222]) is integrated into a second shell (100, see Fig. 11b/2c and [0222-0223]); the first shell (200) is formed with an insertion slot (see ‘Modified FIGs. 48a-b’ below, [0286-0287] & [0322]),
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and the second shell (100) is formed with an insertion part (see ‘Modified FIGs. 48a-b’ above and [0286-0287] & [0322]) inserted to fit into the insertion slot (see arrow in FIG. 40a and [0286-0287] & [0322]); a direction (see directional arrow in FIG. 40a) of insertion fit between the insertion part (see ‘Modified FIGs. 48a-b’ above) and the insertion slot (see ‘Modified FIGs. 48a-b’ above) is parallel to (as indicated by horizontal arrow in Fig. 40a) the mounting surface (upper side of baseplate, see Fig. 7b) of the baseplate (37) of the balanced indwelling needle assembly (20); and when the insertion part (see ‘Modified FIGs. 48a-b’ above) is inserted into the insertion slot (see ‘Modified FIGs. 48a-b’ above), the controlling device (130) controls the medicine dispensing amount of the medicine delivery device (see [0221]).
Regarding claim 6, Yodfat discloses the paste-type medicine infusion system according to claim 5, and Yodfat further discloses wherein the medicine delivery device is provided with a piston (110, see FIG. 11b) for adjusting the medicine dispensing amount (see [0221-0222]); the piston (110) is provided in the insertion slot (see ‘Modified FIGs. 48a-b’ above, FIG. 11b, and [0224]); the controlling device (130) is provided with a drive pusher (186 of driving mechanism 120, see FIG. 11b and [0221]: 120 includes motor and gears, which see [0265] drive threaded cylinder 286, see Fig. 38); the drive pusher (186) is provided on (on an inside surface of) the insertion part (see FIG. 38, 39, 42b and ‘Modified FIGs. 48a-b’ above); and when the insertion part is inserted into the insertion slot, the drive pusher drives the piston to move and to adjust the medicine dispensing amount (see [0248] & [0265-0266]).
Regarding claim 7, Yodfat discloses the paste-type medicine infusion system according to claim 5, and Yodfat further discloses wherein the insertion slot and the insertion part (see ‘Modified FIGs. 48a-b’ above) are fixed by a snap fit (see [0322]: such as latches 261/262 of insertion slot and grooves 161/162 on insertion part).
Regarding claim 8, Yodfat discloses the paste-type medicine infusion system according to claim 5, and Yodfat further discloses wherein the insertion part is formed with an avoiding groove (see cutout area as seen in ‘Modified FIG. 48b’ below)
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for avoiding the medicine delivery connector of the medicine delivery device (device has the groove and therefore the groove is capable of performing the function of “avoiding” any structure of the device such as the medicine delivery connector in accordance with as much as is disclosed by Applicant in FIG. 6 and [0041] of the current Application’s PGPUB).
Regarding claim 9, Yodfat discloses the paste-type medicine infusion system according to claim 5, and Yodfat further discloses wherein the second shell (100, see Fig. 30a-b) comprises a top cover (102, see [0271-0272]) with a bottom opening (opening where 181 is inserted) and a bottom cover (181) covering the bottom opening (see [0272]) of the top cover (102), and an accommodating chamber (see [0271-0272]) is formed within the top cover (102) for containing a controlling member of the controlling device (see Fig. 31: 130 contained within chassis 181).
Regarding claim 10, Yodfat discloses the paste-type medicine infusion system according to claim 5, and Yodfat further discloses wherein a side (chasis 281 of shell 200, see FIG. 14b) of the first shell (200) away from the insertion slot (281 disposed away from edge of slot, see fig. 48a) is also provided with a battery mounting groove (see [0230-0231]: groove cutout of chasis for battery 240 in FIG. 14b).
Regarding claim 11, Yodfat discloses the paste-type medicine infusion system according to claim 4, and Yodfat further discloses wherein the mounting part (22/24, see FIG. 7b and [0213]) is a plurality of first buckles (22/24 are latches, see [0208] & [0226], aligning with latch structure as disclosed in the current Application in Figs. 1-3 and [0036]: snap-fit latch) formed around the mounting surface (seen best in Fig. 7b and described in [0213]), and the main engine unit (10) is provided with a plurality of second buckles (12/14, see Fig. 12c) correspondingly snap-fitted (see [0226]: groove 12/14 snap fit to latch 22/24, aligning with Applicant disclosure in [0036] of the current application disclosing second buckle as snap-fit slot) with the first buckles (22/24).
Regarding claim 12, Yodfat discloses the paste-type medicine infusion system according to claim [[4]] 11, and Yodfat further discloses wherein any one of the first buckle (22/24, see Fig. 7b and [0208] & [0226]) and the second buckle (12/14, see Fig. 12c) is an elastic (see [0208] & [0226]: snap-fit connection able to decouple/recouple and thus is inherently “elastic”) snap latch (22/24, see [0208] & [0226]: 22/24 described as latches for snap-fit), and the other (12/14) is a snap-fit slot (see [0226]: 12/14 described as snap-fit grooves==slot).
Regarding claims 13 and 14, Yodfat discloses the paste-type medicine infusion system according to claims 11 and 12, respectively, and Yodfat further discloses wherein the main engine unit (10, see FIG.11b) comprises a medicine delivery device (see [0221-0222]: engine unit contains a piston, aligning with as much as is disclosed for Applicant’s “medicine delivery device” of the current Application such as in [0039]) and a controlling device (130) for controlling a medicine dispensing amount of the medicine delivery device (see [0221]); the medicine delivery device (see [0221]) is integrated into a first shell (200, see Fig. 11b/2c and [0222] & [0224]), and the controlling device (100, see Fig. 11b/2c and [0222]) is integrated into a second shell (100, see Fig. 11b/2c and [0222-0223]); the first shell (200) is formed with an insertion slot (see ‘Modified FIGs. 48a-b’ below, [0286-0287] & [0322]),
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and the second shell (100) is formed with an insertion part (see ‘Modified FIGs. 48a-b’ above and [0286-0287] & [0322]) inserted to fit into the insertion slot (see arrow in FIG. 40a and [0286-0287] & [0322]); a direction (see directional arrow in FIG. 40a) of insertion fit between the insertion part (see ‘Modified FIGs. 48a-b’ above) and the insertion slot (see ‘Modified FIGs. 48a-b’ above) is parallel to (as indicated by horizontal arrow in Fig. 40a) the mounting surface (upper side of baseplate, see Fig. 7b) of the baseplate (37) of the balanced indwelling needle assembly (20); and when the insertion part (see ‘Modified FIGs. 48a-b’ above) is inserted into the insertion slot (see ‘Modified FIGs. 48a-b’ above), the controlling device (130) controls the medicine dispensing amount of the medicine delivery device (see [0221]).
Regarding claims 15 and 16, Yodfat discloses the paste-type medicine infusion system according to claims 13 and 14, respectively, and Yodfat further discloses wherein the medicine delivery device is provided with a piston (110, see FIG. 11b) for adjusting the medicine dispensing amount (see [0221-0222]); the piston (110) is provided in the insertion slot (see ‘Modified FIGs. 48a-b’ above, FIG. 11b, and [0224]); the controlling device (130) is provided with a drive pusher (186 of driving mechanism 120, see FIG. 11b and [0221]: 120 includes motor and gears, which see [0265] drive threaded cylinder 286, see Fig. 38); the drive pusher (186) is provided on (on an inside surface of) the insertion part (see FIG. 38, 39, 42b and ‘Modified FIGs. 48a-b’ above); and when the insertion part is inserted into the insertion slot, the drive pusher drives the piston to move and to adjust the medicine dispensing amount (see [0248] & [0265-0266]).
Regarding claims 17 and 18, Yodfat discloses the paste-type medicine infusion system according to claims 13 and 14, respectively, and Yodfat further discloses wherein the insertion slot and the insertion part (see ‘Modified FIGs. 48a-b’ above) are fixed by a snap fit (see [0322]: such as latches 261/262 of insertion slot and grooves 161/162 on insertion part).
Regarding claims 19 and 20, Yodfat discloses the paste-type medicine infusion system according to claims 13 and 14, respectively, and Yodfat further discloses wherein the insertion part is formed with an avoiding groove (see cutout area as seen in ‘Modified FIG. 48b’ below)
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for avoiding the medicine delivery connector of the medicine delivery device (device has the groove and therefore the groove is capable of performing the function of “avoiding” any structure of the device such as the medicine delivery connector in accordance with as much as is disclosed by Applicant in FIG. 6 and [0041] of the current Application’s PGPUB).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights