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 Objections
Claim 10 is objected to because of the following informalities:
Regarding claim 10, line 1, space appears to be added to recite “claim 1” instead of “claim1”.
Appropriate correction is required.
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.
Claims 1, 8, 9, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590).
Regarding claim 1, Yodfat discloses a half-press-free drug infusion device (figure 17a with embodiment shown in figure 15a), comprising:
a reservoir 220, configured to accommodate a drug (contents inside element 220) to be infused, provided with a piston 112 and a screw 614;
a driving wheel 608, connected with the screw 614, driving the screw to push the piston forward by rotation (paragraph 0142, lines 16-24);
an infusion needle unit (see “NU” in figure 15a below), including an infusion needle 6 and an infusion needle holder (portion that holds element 6 in place in element 310), wherein the infusion needle holder is used to keep the infusion needle in place, when the infusion needle unit (see “NU” in figure 15a below) is at an intermediate position (position where element “NU” is present), the infusion needle 6 is communicated with the reservoir 220;
an adhesive patch 30 (paragraph 0128, lines 5-8, “an adhesive layer”), for attaching the half-press-free drug infusion device to a skin surface but is silent regarding a security base, arranged on a bottom of the adhesive patch, provided with an infusion needle accommodating part, which is waterproof and breathable.
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However, Kalt teaches a design of an IV clamp (figure 1) comprising a security base 15, arranged on a bottom of the adhesive patch (column 3, lines 27-32, “adhesive”, see figure 3 where element 15 is located on bottom surface of element 13 wherein element 13 represents window but is part of element 12), provided with an infusion needle accommodating part (hole in element 15 from where needle can be inserted), which is waterproof and breathable (column 3, lines 34-37) for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
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 device of Yodfat to incorporate a security base, arranged on a bottom of the adhesive patch, provided with an infusion needle accommodating part, which is waterproof and breathable as taught by Kalt for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
Regarding claim 8, Yodfat is silent regarding wherein a thickness of the security base is uniform.
However, Kalt teaches wherein a thickness of the security base 15 is uniform for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
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 device of Yodfat to incorporate wherein a thickness of the security base is uniform as taught by Kalt for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
Regarding claim 9, Yodfat discloses the adhesive patch includes at least one layer of tape (paragraph 0128, lines 5-8, “an adhesive layer”) but is silent regarding a protective film, the protective film is fixed around an outer contour of the at least one layer of the tape.
However, Kalt teaches a protective film 25 (figure 2), the protective film 25 is fixed around an outer contour of the at least one layer of the tape (see figures 1 and 2, column 3, lines 30-32) for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
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 device of Yodfat to incorporate a protective film, the protective film is fixed around an outer contour of the at least one layer of the tape as taught by Kalt for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
Regarding claim 12, Yodfat and Kalt are silent regarding a Rockwell hardness of the protective film is higher than a Rockwell hardness of the tape. The instant disclosure describes the parameter of a Rockwell hardness of the protective film is higher than a Rockwell hardness of the tape as being merely preferable, and does not describe a Rockwell hardness of the protective film is higher than a Rockwell hardness of the tape as contributing any unexpected results to the system. As such, parameters such as a Rockwell hardness are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of a Rockwell hardness of the protective film is higher than a Rockwell hardness of the tape would be dependent on the actual application of the skin patch drug infusion device and, thus would be a design choice based on the actual application.
Regarding claim 14, Yodfat is silent regarding wherein the security base is provided with a through hole.
However, Kalt teaches wherein the security base 15 is provided with a through hole (hole through which needle passes) for the purpose of allowing the needle to pass through (figure 4).
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 device of Yodfat to incorporate wherein the security base is provided with a through hole as taught by Kalt for the purpose of allowing the needle to pass through (figure 4).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590) and further in view of O’Neil et al. (US 2003/0109775 A1).
Regarding claim 10, Yodfat/Kalt (hereinafter referred as “modified Yodfat”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Yodfat is silent regarding wherein the adhesive patch includes at least two layers of tape.
However, O’Neil teaches a design of stacked adhesive sensor comprising the adhesive patch includes at least two layers of tape (paragraphs 0023, 0026, “adhesive layers”, “stacks of adhesive layers”, indicate the presence of at least two layers of tape) for the purpose enabling repositioning the device as needed or if the device was positioned incorrectly in first try (paragraph 0026, lines 5-9).
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 adhesive patch of modified Yodfat to incorporate at least two layers of tape as taught by modified Yodfat for the purpose enabling repositioning the device as needed or if the device was positioned incorrectly in first try (paragraph 0026, lines 5-9).
Regarding claim 11, modified Yodfat discloses the claimed invention substantially as claimed, as set forth above in claim 1. Yodfat is silent regarding wherein the adhesive patch further includes at least one layer of protective film.
However, Kalt teaches wherein the adhesive patch further includes at least one layer of protective film 25 for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
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 adhesive patch of Yodfat to incorporate wherein the adhesive patch further includes at least one layer of protective film as taught by Kalt for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590) and further in view of Augustine (US 2012/0238901 A1).
Regarding claim 13, modified Yodfat discloses the claimed invention substantially as claimed, as set forth above in claim 1. Yodfat further discloses the adhesive patch includes a tape (paragraph 0128, lines 5-8, “an adhesive layer”) but is silent regarding a release paper.
However, Kalt teaches a release paper 25 (figure 2) for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
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 device of Yodfat to incorporate a release paper as taught by Kalt for the purpose of extending and protecting the adhesive surface until the device is used (column 3, lines 30-32).
Modified Yodfat is silent regarding a surface of the tape is provided with dense ventilation holes.
However, Augustine teaches a design of a medical device (figure 3B) affixed to a skin surface comprising a surface of the tape 208 is provided with dense ventilation holes 214 (figure 12) for the purpose of preventing bubble by allowing trapped air to escape (paragraph 0072).
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 adhesive of modified Yodfat to incorporate a surface of the tape is provided with dense ventilation holes as taught by Augustine for the purpose of preventing bubble by allowing trapped air to escape (paragraph 0072).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590) and further in view of Smith (US 2019/0015585 A1).
Regarding claim 16, modified Yodfat discloses the claimed invention substantially as claimed, as set forth above in claim 1. Yodfat further discloses further comprising an infusion mechanism module (module formed by elements 30, 200) and a control mechanism module 100, the drug reservoir 220, and the infusion needle unit (see “NU” in figure 15a above) are arranged on the infusion mechanism module but is silent regarding the drive wheel arranged on the infusion mechanism module.
However, Smith teaches a design of an ambulatory infusion pump (figure 2) comprising drive wheel 332 arranged on the infusion mechanism module 300 (figure 1A) for the purpose of using a well-known alternative arrangement configuration to include the drive wheel into the disposable part (paragraph 0051, 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 arrangement of the drive wheel of modified Yodfat to include the drive wheel in the infusion mechanism module as taught by Smith for the purpose of using a well-known alternative arrangement configuration to include the drive wheel into the disposable part (paragraph 0051, lines 9-15).
Regarding claim 17, modified Yodfat discloses the claimed invention substantially as claimed, as set forth above in claim 1. Yodfat further discloses wherein the infusion mechanism module 30, 200 and the control mechanism module 100 are detachable (paragraph 0132, lines 1-4, elements 100 and 200 can be separated from each other) from each other and the control mechanism module is reusable (paragraph 0123, lines 8-12).
Claim(s) 1 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2019/0015585 A1) in view of Kalt (US 4,966,590) and further in view of Yodfat et al. (US 2010/0292651 A1).
Regarding claim 1, Smith discloses a half-press-free drug infusion device (figure 5c), comprising:
a reservoir 336, configured to accommodate a drug to be infused, provided with a piston 335 and a screw 334;
a driving wheel 332, connected with the screw 334, driving the screw 334 to push the piston forward by rotation (paragraph 0070, lines 1-8); an adhesive patch (paragraph 0070, lines 10-12, “adhesive backing”), for attaching the half-press-free drug infusion device to a skin surface but is silent regarding an infusion needle unit, including an infusion needle and an infusion needle holder, wherein the infusion needle holder is used to keep the infusion needle in place when the infusion needle is at an intermediate position, the infusion needle is communicated with the reservoir.
However, Yodfat teaches an infusion needle unit (see “NU” in figure 15a above), including an infusion needle 6 and an infusion needle holder (portion that holds element 6 in place in element 310), wherein the infusion needle holder is used to keep the infusion needle in place, when the infusion needle unit (see “NU” in figure 15a above) is at an intermediate position (position where element “NU” is present), the infusion needle 6 is communicated with the reservoir 220 for the purpose of allowing the fluid to be injected into the desired site of interest (paragraph 0139).
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 device of Smith to incorporate an infusion needle unit, including an infusion needle and an infusion needle holder, wherein the infusion needle holder is used to keep the infusion needle in place when the infusion needle is at an intermediate position, the infusion needle is communicated with the reservoir as taught by Yodfat for the purpose of allowing the fluid to be injected into the desired site of interest (paragraph 0139).
Smith is silent regarding a security base, arranged on a bottom of the adhesive patch, provided with an infusion needle accommodating part, which is waterproof and breathable.
However, Kalt teaches a design of an IV clamp (figure 1) comprising a security base 15, arranged on a bottom of the adhesive patch (column 3, lines 27-32, “adhesive”, see figure 3 where element 15 is located on bottom surface of element 13 wherein element 13 represents window but is part of element 12), provided with an infusion needle accommodating part (hole in element 15 from where needle can be inserted), which is waterproof and breathable (column 3, lines 34-37) for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
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 device of Yodfat to incorporate a security base, arranged on a bottom of the adhesive patch, provided with an infusion needle accommodating part, which is waterproof and breathable as taught by Kalt for the purpose of sealing and protecting the skin puncture by the needle (column 3, lines 42-45).
Regarding claim 16, Smith discloses further comprising an infusion mechanism module 300 and a control mechanism module 200, the drug reservoir 336, the drive wheel 332 are arranged on the infusion mechanism module 300 but is silent regarding the infusion needle unit is arranged on the infusion mechanism module.
However, Yodfat discloses the infusion needle unit (see “NU” in figure 15a above) is arranged on the infusion mechanism module 30 for the purpose of allowing the separation of the infusion mechanism module from the other component thereby allowing to take necessary steps as needed (paragraph 0126, lines 5-7).
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 device of Smith to incorporate the infusion needle unit arranged on the infusion mechanism module as taught by Yodfat for the purpose of allowing the separation of the infusion mechanism module from the other component thereby allowing to take necessary steps as needed (paragraph 0126, lines 5-7).
Regarding claim 17, Smith discloses wherein the infusion mechanism module 300 and the control mechanism module 200 are detachable (paragraph 0078, lines 8-11) to each other and the control mechanism module 200 is reusable (paragraph 0065).
Regarding claim 18, Smith discloses wherein the infusion mechanism module 300 and the control mechanism module 200 are electrically connected by an electrical contact (paragraph 0074, lines 16-23).
Regarding claim 19, Smith discloses wherein the infusion mechanism module 300 and the control mechanism module 200 are disposed in one housing 350, discarded together after a single use (after single use, element 350 along with elements 300 and 200 could be discarded).
Allowable Subject Matter
Claims 2-7, 15 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590), is silent regarding wherein the security base includes an elastic seal, a waterproof and breathable membrane and a security base body in combination with other claimed limitations of claim 2.
Claims 3-5 and 20 being dependent on claim 2 are also indicated allowable.
The closest prior art of record, Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590), is silent regarding wherein the security base is a hollow elastic sealing member, at least one side of the hallow elastic sealing member is provided with a plurality of dense micro-holes in combination with other claimed limitations of claim 6.
The closest prior art of record, Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590), is silent regarding wherein a thickness of the security base is gradually decreased from an end close to one end of the adhesive patch to a middle part of the adhesive patch, and forms a plane with an other end of the adhesive patch in combination with other claimed limitations of claim 7.
The closest prior art of record, Yodfat et al. (US 2010/0292651 A1) in view of Kalt (US 4,966,590), is silent regarding wherein the through hole is tapered in combination with other claimed limitations of claim 15.
Conclusion
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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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