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 .
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 tube having a cross section that varies in a longitudinal direction and the handle 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference character 7 is not shown in the drawings. 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, The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “10” has been used to designate both a pumping unit and a hand pump ball. 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. 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 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.
Claim 3 is 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 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-4, 6-7 and 9-11 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Eggert et al. (US 2016/0287428).
As to claim 1, Eggert et al. (hereinafter “Eggert”) discloses a device for repositioning a stoma prolapse, comprising:
a container (100) comprising side walls, a first end and a second end wherein the second end comprises an opening (see annotated figure 1C below), and further comprising:
a piston (210) dimensioned to travel inside the container from the first end of the container to the second end (figures 5A and 5B), and
a push device (see annotated figure 5B below) configured to move the piston from a first position to a second position close to or in contact with the second end as set forth in [0062-0063].
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584
860
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408
754
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As to claim 2, Eggert discloses a device wherein the push device comprises a rigid connection extending from the piston to a handle (230) outside the container as shown in annotated figure 5B above.
With reference to claim 3, Eggert discloses a device wherein the push device (6) is connected to an opening at the first end of the container which opening via a conduit is connected to a pumping unit for pumping a fluid as set forth in [0068].
As to claim 4, Eggert discloses a device wherein the container comprises an opening at or near the second end of the container as set forth in annotated figure 1C above.
Regarding claim 6, Eggert discloses a device wherein the device comprises a connecting surface (140) at the second end (figure 6A) configured to provide a liquid tight contact as set forth in [0057-0059].
As to claims 7 and 11, Eggert discloses a device wherein the sidewalls of the container constitute a tube having a round or oval or elliptic or polygonal cross section wherein a cross section of the tube varies in a longitudinal direction (cl.11) as shown in figure 6A.
With respect to claim 9, Eggert discloses an assembly comprising the device and a unit (130,150,120) positionable at a stoma, wherein the unit is placed inside the container as shown in figure 1K.
With reference to claim 10, Eggert discloses an assembly wherein the unit comprises an edge part (150), and a vaulted central part (120) having an opening as shown in figure 1C.
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.
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.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US 2016/0287428).
With reference to claim 5, Eggert discloses a device wherein the container comprises at least two openings (via element 160) at or near the second end of the container as shown in figure 1C.
The difference between Eggert and claim 5 is the provision that the openings have specific functions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to designate the desired function to the openings as the openings themselves are fully capable of functioning as inlet or outlet openings.
With reference to claim 8, Eggert teaches the invention substantially as claimed as set forth in the rejection of claim 1.
Eggert discloses that the container includes rigid material as set forth in [0054-0056].
The difference between Eggert and claim 8 is the explicit recitation that the rigid material is also transparent.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the rigid container of Eggert as transparent because Eggert discloses that the material may include isoprene, which is a highly transparent material, as set forth in [0056].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mulhauser et al. (hereinafter “Mulhauser”) teaches a controlled evacuation ostomy device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca 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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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781