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 .
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.
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 16-24 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.
Regarding claim 16, the limitation “the support structure being configured to be pushed away from the attachment portion by a force exerted by a cover extension of the medicament delivery device when transitioning from a retracted position to an extended position, such that the cover extension is allowed to move to the extended position in response to the pad being removed from the injection site while the medicament delivery device is present in the attachment portion.” Applicant is claiming the pad and not a system of a pad and a medicament delivery device. It is not clear in what way the force being exerted by the cover extension further limits the structure of the pad. In accordance with the claim, if the force were exerted by a finger, a pencil or any other device, the structure of the pad would appear to be the same. Thus, this claim language is unclear in that it doesn’t appear to further limit the structure of the pad. Claims 17-24 depend from claim 16.
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 16-21, 23, 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yudelevich (US 20190160230).
Regarding claim 16, Yudelevich teaches a pad ( 924, Fig. 9) extending along an axis from a proximal end to a distal end (Fig. 9, axis is coaxial with needle 904), where the proximal end is the end of the pad adjacent to an injection site when the pad is in use (proximal end is placed on injection site, ¶138-142), the pad comprising: an attachment portion (tube holding needle retainer 901, needle retainer movers in the tube ¶143) configured to receive a medicament delivery device (901, needle retainer retains needle 904. The needle, needle retainer and a portion of the spring 905, Fig. 10, covering the needle is a medicant delivery device) , and a support structure at the proximal end of the attachment portion configured to abut against the medicament delivery device when in use and the medicament delivery device is arranged in the attachment portion 914, the support structure being configured to be pushed away from the attachment portion by a force exerted by a cover extension of the medicament delivery device (a portion of the spring 905, which is part of the medicant delivery device is the cover extension) when transitioning from a retracted position to an extended position (Fig. 9 shows the extended position), such that the cover extension is allowed to move to the extended position in response to the pad being removed from the injection site while the medicament delivery device is present in the attachment portion (The spring covers the needle 904 and hence is a cover extension. It extends to move the support structure to an extended position. When the base 924 is pulled away from injection site, the support structure 914 can pivot open as shown in Fig. 9. If the support structure is against the injection site, the support structure is in a retracted position and can’t be pushed down. Fig. 11C shows an example of the support structure in a retracted position.).
Regarding claim 17, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the support structure is at the proximal end of the pad adjacent to the injection site when the pad is in use (the support structure extends from the bottom, proximal end of the attachment structure 924).
Regarding claim 18, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the support structure is configured to allow the cover extension to penetrate through the attachment portion to beyond a plane of the proximal end of the pad (Fig. 9, The cover extension, spring 905 that covers the needle 904, extends below the bottom plane of attachment structure 924).
Regarding claim 19, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the support structure comprises at least one flexible arm attached to the pad, the at least one flexible arm being configured to flex by the force from the cover extension (The structure extending from support structure 914 that engages the cover extension 905 is a flexible arm. Any material has an ability to flex).
Regarding claim 20, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the support structure comprises a proximal injection surface configured to be separated from the attachment portion by the force exerted by the cover extension (The bottom of support structure 914 is the proximal injection surface as it is proximal to the injection site. The proximal injection surface moves away from the attachment portion and is hence separated from the attachment surface when the cover extension 905 pushes the support structure down).
Regarding claim 21, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the proximal injection surface is hinged to a side structure of the pad (Fig. 9 shows a hinged structure).
Regarding claim 23, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the proximal injection surface comprises a clip configured to hold the proximal injection surface in place prior to release by the force exerted by the cover extension.(the ledge opposite the hinge side of support structure 914 is a clip).
Regarding claim 24, Yudelevich teaches the invention as claimed and discussed above and Yudelevich further teaches the proximal injection surface is adjacent to the injection site when the pad is in use (Fig. 9, the bottom surface of the support structure 914, which is the proximal injection surface, is adjacent to the injection site, when the device in Fig. 9 is used).
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 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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yudelevich (US 20190160230) in view of Cipoletti (US 2004/0138629).
Regarding claim 22, Yudelevich teaches the invention as discussed above for claim 21. Yudelevich doesn’t teach the hinge is a living hinge.
Cipoletti teaches as a medical device including a syringe with a number of hinged attachments (Fig. 1). In ¶24, the use of living hinges is taught to simplify the manufacturing process.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the pad of Yudelevich have a living hinge, as taught by Cipoletti, in order to simplify the manufacturing process of the pad.
Allowable Subject Matter
Claim 25-30 are allowed.
The closest prior art appears to be Lavi (US 2002/0055711). Lavi doesn’t teach the attachment portion comprises a release mechanism which, upon being actuated, releases the medicament delivery device from the pad, and a release arm configured to act on the release mechanism when the pad is being removed from the injection site by transferring a force from the pad caused by the pad being deformed while being removed from the injection site to the release mechanism.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OLYNICK whose telephone number is (571)272-2355. The examiner can normally be reached M-F: 7:30 am-5 pm (ET).
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/DAVID P. OLYNICK/Primary Examiner, Art Unit 3741