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 § 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.
Claim(s) 1-3, 5, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PGPub 2011/046456 (Hoerdum).
In Re claim 1 Hoerdum discloses a subcutaneous indwelling needle assembly (1), comprising a base and a needle assembly; the needle assembly comprises a puncture needle holder (52 in Figure 9), a puncture needle (53 in Figure 9), an indwelling needle holder (7 in Figure 11), and a soft indwelling needle (22 in Figure 11); a base comprises a baseplate (1 in Figure 5C) for applying on a surface of skin; the baseplate comprises a first surface and a second surface provided oppositely; the base is provided with a perforation hole (12B in Figure 5A and Figure 11) penetrating the first surface and the second surface; on the first surface, an indwelling needle fixing protrusion (3 in Figure 11, Paragraph 54) for insertion of the indwelling needle holder is formed by protruding along a periphery of the perforation hole, the indwelling needle fixing protrusion is provide with a first restricting part (23A in Figure 11); an exterior wall of the indwelling needle holder is provided with a second restricting part (23 in Figure 11); the first restricting part and the second restricting part, which match each other, are collectively a rotation-stopping mechanism; and the first restricting part and the second restricting part are cooperatively mounted to restrict a relative rotation of the indwelling needle holder with respect to the indwelling needle fixing protrusion when the indwelling needle holder is inserted into the indwelling needle fixing protrusion (Paragraphs 93 and 98).
In Re claim 2 Hoerdum discloses a snap fit (between parts 23 and 23A).
In Re claim 3 Hoerdum discloses an interaction between a slot and a buckle (slot below 23A and element 23 in Figure 11).
In Re claim 5 Hoerdum discloses a retainment plate which interacts with elastic retainment buckles formed as an axial restricting part (23 and 23A in Figure 11).
In Re claim 6 Hoerdum discloses the retainment buckles abutted against the retainment plate when the indwelling needle holder is inserted (23 and 23A in Figure 11).
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PGPub 2007/0191772 (Wojcik).
In Re claim 1 Wojcik discloses a subcutaneous indwelling needle assembly (1 in Figure 1), comprising a base and a needle assembly; the needle assembly comprises a puncture needle holder (38 in Figure 2), a puncture needle (50 in Figure 2), an indwelling needle holder (80 in Figure 2), and a soft indwelling needle (2 in Figure 2); a base comprises a baseplate (10 in Figure 2) for applying on a surface of skin; the baseplate comprises a first surface and a second surface provided oppositely; the base is provided with a perforation hole (14 in Figure 3) penetrating the first surface and the second surface; on the first surface, an indwelling needle fixing protrusion (15 in Figure 2) for insertion of the indwelling needle holder is formed by protruding along a periphery of the perforation hole, the indwelling needle fixing protrusion is provide with a first restricting part (26 in Figure 2); an exterior wall of the indwelling needle holder is provided with a second restricting part (25 in Figure 2); the first restricting part and the second restricting part, which match each other, are collectively a rotation-stopping mechanism; and the first restricting part and the second restricting part are cooperatively mounted to restrict a relative rotation of the indwelling needle holder with respect to the indwelling needle fixing protrusion when the indwelling needle holder is inserted into the indwelling needle fixing protrusion (Paragraph 37).
In Re claim 2 Wojcik discloses a snap fit (Paragraph 37)
In Re claim 3 Wojcik discloses an interaction between a slot and a buckle (25 and 26 in Figure 2).
In Re claim 4 Wojcik discloses a plurality of first restricting parts evenly distributed at an edge of the indwelling needle fixing protrusion (shown in Figure 2).
In Re claim 5 Wojcik discloses a retainment plate which interacts with elastic retainment buckles formed as an axial restricting part (matching notches in Paragraph 50, element 54 in Figure 2).
In Re claim 6 Wojcik discloses the retainment buckles abutted against the retainment plate when the indwelling needle holder is inserted (matching notches in Paragraph 50, element 54 in Figure 2).
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) 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US PGPub Wojcik
In Re claims 7-9 Wojcik discloses many limitations but fails to disclose a snap fit and rotation restricting relationship between restricting parts located on the exterior wall of the indwelling needle holder and the puncture needle holder. As discussed above, Wojcik discloses restricting parts between the indwelling needle holder and indwelling needle fixing protrusion.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the Wojcik apparatus by forming the puncture needle holder and the indwelling needle holder to have a snap fit and rotation restricted relationship, in order to secure the puncture needle holder to the indwelling needle holder during use.
In Re claim 10 Wojcik discloses many limitations but fails to disclose the second surface comprising first and second annular protrusions. The use of retaining structures such as the claimed annular protrusions to fix a medical device relative to a patient was old and well known in the art at the effective filing date of the invention. Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the Wojcik apparatus by adding annular protrusions, in order to secure the baseplate relative to a patient who is receiving an injection.
In Re claim 11 it would have been an obvious matter of design choice to form the perforation hole at any location in the base plate, in order to provide the desired positioning of the injection site on the patient.
In Re claim 12 Wojcik discloses many limitations but fails to disclose positioning holes.
The use of positioning holes interacting with a set of positioning protrusions to provide a precises relative positioning of components of an apparatus was old and well known in this and many arts at the effective filing date of the invention. Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to manufacture the Wojcik apparatus with positioning holes, in order to permit a user to more accurately join the components of the Wojcik device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US PGPub 2006/0253076 discloses an injection device having an indwelling needle and a puncturing needle which are fixed to a base plate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON KAROL NIESZ whose telephone number is (571)270-3920. The examiner can normally be reached M-F 9-5 EST.
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, Craig Schneider can be reached at 571 272 3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON K NIESZ/Primary Examiner, Art Unit 3753
Prosecution Insights