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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Drawings
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 an ostomy appliance and a valve. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "110a" and "11a" have both been used to designate a base. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "10" and "30" have both been used to designate a valve. 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.
Claims 8-9, 11 and 16-19 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.
Claim 8 recites the limitation "the first and second slots" in lines 1-2 and “the third and fourth slots” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 8 recites the limitation "the cage" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the same material” in line 2. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 11 and 17-19 recite a broad recitation, and the claims also recite a narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 and 13 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Kellermeyer et al. (US 4,106,507).
With reference to claim 1, Kellermeyer et al. (hereinafter “Kellermeyer”) discloses an ostomy drainage system (abstract) including an ostomy appliance and a drainage conduit (figures 2-3), the ostomy appliance including:
an internal collecting volume (13) defined by a first wall and a second wall connected together about a periphery (figure 2);
a stoma receiving opening defined in the first wall and a valve (see annotated figure 2 below) including:
a body connected to the first and second walls (see annotated figure 3 below),
an inlet and an outlet, connected by a flow path and fluidly connected to the internal collecting volume (see annotated figure 2 below); and
the drainage conduit including a connector device (23) which is connectable to the valve (figure 2), wherein the connector device has a connector body providing a passage (figure 4), and an inlet formation which widens radially outwardly relative to the connector body (see annotated figure 2 below), such that when the connector device is connected to the valve, the connector body extends from the outlet to the inlet and the inlet formation resists removal from the valve as set forth in col. 5, lines 34-43.
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As to claim 13, Kellermeyer discloses an ostomy drainage wherein the connector body includes a shoulder formation (36) that is positioned adjacent the outlet of the valve when in use as shown in figure 4.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Fenton (US 3,881,486).
With reference to claim 1, Fenton discloses an ostomy drainage system including an ostomy appliance (14) and a drainage conduit (25), the ostomy appliance including:
an internal collecting volume defined by a first wall and a second wall connected together about a periphery (col. 2, lines 3-14);
a stoma receiving opening defined in the first wall (col. 2, lines 15-22) and a valve (21) including:
a body connected to the first and second walls (col. 2, lines 39-41),
an inlet and an outlet, connected by a flow path and fluidly connected to the internal collecting volume (figures 2-3); and
the drainage conduit including a connector device which is connectable to the valve (figure 3), wherein the connector device has a connector body providing a passage (see annotated figure 3 below), and an inlet formation which widens radially outwardly relative to the connector body (i.e., inlet formation is fitted over the connector body), such that when the connector device is connected to the valve, the connector body extends from the outlet to the inlet (figure 3) and the inlet formation resists removal from the valve as set forth in col. 2, lines 35-53.
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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.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kellermeyer et al. (US 4,106,507).
With reference to claim 14, Kellermeyer teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Kellermeyer and claim 14 is the explicit recitation that the connector body is formed from a rigid material.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the connector body of Kellermeyer with a rigid material since Kellermeyer acknowledges that the connector body would not need to be flexible and may be fabricated of any material which will not react with urine or water.
Claims 2-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fenton (US 3,881,486).
With reference to claim 2, Fenton discloses the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fenton and claim 1 is the explicit recitation that the inlet formation forms part of a mucus guard member.
It would have been obvious to one of ordinary skill in the art at the time of the invention to interpret the inlet formation of Fenton as a part of a mucus guard member because Fenton discloses that the inlet formation prevents stagnation of fluids (which would encompass mucus) as set forth in col. 2, lines 47-50.
As to claim 3, see the rejection of claim 2.
Fenton teaches an ostomy drainage system wherein, when the connector device is connected to the valve, the connector body extends from the outlet to the inlet and the mucus guard member is located at the inlet and provides a cage around the inlet to inhibit the ingress of mucus as set forth in figure 3 and as discussed in col. 2, lines 47-50.
Regarding claims 4 and 5, see the rejection of claim 2.
Fenton teaches an ostomy drainage system wherein the mucus guard member includes a generally upstanding wall which, in use, projects away from the inlet of the valve and from the connector body in an annular shape (cl. 5) as shown in figure 3.
As to claims 6 and 7, see the rejection of claim 2.
Fenton teaches an ostomy drainage system wherein the mucus guard member includes a plurality, namely at least 4 (cl. 7) slots or channels (29) as shown in figure 3.
With reference to claims 8-9, see the rejection of claim 2.
Fenton teaches an ostomy drainage system wherein the first and second slots are separated by a bar of the cage and form a first pair and the third and fourth slots are separated by a second bar of the cage and form a second pair where the first pair is on an opposing (i.e., different) side of the mucus guard member to the second pair (cl. 9) as shown in annotated figure 3 below.
Alternatively, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the location of the slots as desired since it has been held that mere changes in location of an element previously disclosed in the prior art is considered to be within the level of ordinary skill in the art.
As to claims 10-12, Fenton teaches the invention substantially as claimed as set forth in the rejection of claim 2.
The difference between Fenton and claims 10-12 is the provision that the mucus guard member has a specific shape.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the shape of the mucus guard member of Fenton as desired since it has been held that mere changes size and/or shape of an element previously disclosed in the prior art is considered to be within the level of ordinary skill in the art.
With reference to claims 14-16, Fenton teaches the invention substantially as claimed as set forth in the rejection of claims 1-2.
The difference between Fenton and claims 14-16 is the explicit recitation that the connector body and the mucus guard members are formed from a rigid material, specifically the same material as required by claim 16.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the recited elements of Fenton with the same rigid material because Fenton anticipates the device including relatively stiff materials (col. 2, line 43) and the inclusion of such would prevent inadvertent collapse or folding of the device as suggested by Fenton in col. 2, lines 54-55. Providing the elements with the same rigid material provides the benefit of cost reduction and manufacturing simplicity.
As to claims 17-19, Fenton teaches the invention substantially as claimed as set forth in the rejection of claims 1-2.
The difference between Fenton and claims 17-19 is the provision that the connector body and the mucus guard member have specific dimensions resulting in a specific ratio.
It would have been obvious to one of ordinary skill in the art at the time of the invention to dimensions of the recited elements of Fenton as desired since it has been held that mere changes size and/or shape of an element previously disclosed in the prior art is considered to be within the level of ordinary skill in the art.
With reference to claim 20, Fenton teaches the invention substantially as claimed as set forth in the rejection of claims 1-2.
Fenton also teaches a connector device that provides an anchor which holds the connector device connected to the valve as set forth in col. 2, lines 35-53.
Additionally, Fenton provides an inlet formation which functions as mucus guard member as set shown in figure 3 and discussed in the rejection of claim 2.
The difference between Fenton and claim 20 is the explicit recitation that the mucus guard member prevents / reduces how much mucus travels into the passage.
It would have been obvious to one of ordinary skill in the art at the time of the invention to interpret the inlet formation of Fenton as a part of a mucus guard member which prevents / reduces how much mucus travels into the passage because Fenton discloses that the inlet formation prevents stagnation of fluids as set forth in col. 2, lines 47-50.
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.
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 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
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