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 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.
Claim(s) 1-7, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (US 20180344506 A1).
Regarding Claim 1, Larsen’506 discloses an ostomy device for attachment to a base plate (see Abstract), the ostomy device comprising:
an attachment ring ("attachment ring 8" [0080]; FIG. 1B) configured for being detachably attached to the base plate ("configured to detachable attachment on the inner portion of a locking flange 52 of the base plate 6" [0080]);
a connecting element ("connecting element 10" [0080]) comprising one or more engagement portions ("engagement elements 18" [0080]) configured to be detachably attached to corresponding engagement members ("corresponding openings/apertures 42" [0080]) of the attachment ring, wherein the connecting element comprises an opening ("opening 34" [0081]; FIG. 1A) surrounded by a flange (see FIG. 3D);
a sealing member ("closing disc 12" [0081]; FIG. 1A) configured to be detachably attached to the flange ([0080]; FIG. 1A) and to seal the ostomy device against a collecting element ("collecting element 28" [0081]; FIG. 1A) extending through the opening surrounded by the flange (see FIG. 1A);
wherein the flange comprises a radially protruding protrusion ("protrusions 22" [0080]; FIG. 1A) configured to engage with an annular outer portion of the sealing member, wherein the annular outer portion is shaped to be detachably attached to the flange ("configured to be received by a corresponding aperture (or recess) in the adjacent portion 11 of the closing disc 12" [0080]; FIGs. 2A-2B).
Regarding claims 2-7 and 9-10, Larsen’506 discloses wherein the sealing member (12) comprises a wall portion ("flange 14" [0081]; FIG. 1A) defining a hole configured to receive the collecting element (see FIG. 1A);
wherein a height (H2) of the wall portion is larger than a height of the attachment ring and the connecting element stacked on top of each other and attached to one another (see FIG. 1A);
wherein the height (H2) of the wall portion is larger than a height (H1) of the annular outer portion (see FIG. 1A);
wherein a distal end of the wall portion protrudes from the annular outer portion with respect to a longitudinal axis (X) of the sealing member (see FIG. 1A);
wherein the sealing member comprises an open cap ("shield 60" [0082]; FIG. 1B) provided with an attachment structure extending along an inner wall of the open cap ("blocking element 16" [0083]; FIG. 1B), wherein the open cap is provided with an open end configured and shaped to allow a stoma to extend out of the open end of the open cap (see FIG. 1B);
wherein the sealing member comprises a planar bottom portion that is aligned with a bottom part of the attachment ring (see FIG. 1A);
wherein the connecting element comprises two opposing guiding elements extending along a periphery of a plate-shaped portion of the connecting element ("two engagement profiles 78 extending perpendicular along the longitudinal axis X of the connecting element 10" [0088]; FIG. 2A).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 20180344506 A1).
Regarding Claim 8, Larsen’506 fails to specify the sealing member comprises a grip portion protruding radially from the annular outer portion. However, Larsen’506 teaches the open cap (“shield 60”) comprises a grip portion protruding radially from the annular outer portion ("the grips 62" [0085]; FIG. 1B). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sealing member of the device to also have a grip portion protruding radially from the annular outer portion to suitably improve ease of handling (“used for handling” [0085]).
Regarding Claim 11, Larsen’506 fails to specify a protruding structure protruding from a central portion of each of the guiding elements. However, such protruding structure is a mere change in shape of the disclosed guiding elements (“engagement profiles 78”). The court has held that a change in shape is obvious in the absence of persuasive evidence that the claimed shape is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In this case, no evidence is found that the claimed shape is significant.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen’506 in view of Larsen (US 20180000628 A1).
Regarding Claim 12, Larsen’506 fails to specify several spaced apart notches provided in the periphery of the plate-shaped portion of the connecting element. However, Larsen’628 teaches a similar device (see abstract) comprising several spaced apart notches ("recesses 68" [0103]; FIG. 6B) provided in the periphery of the plate-shaped portion of the connecting element (see FIG. 6B). Therefore, it would have been obvious to modify Larsen’506 to arrive at the claimed invention to suitably aid in the alignment of the layers ([0103]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
