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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, 8, and 10-11 in the reply filed on 05/05/2026 is acknowledged. The traversal is on the ground(s) that March (US PGPUB 20150025483) does not teach the newly added technical features of Group I and II inventions and searching all the pending claims would not represent an undue search burden. The arguments are not found persuasive. Since Applicant amended the claims, Scalise (US PGPUB 20200046543) is applied to teach the newly added technical features (see rejection of claim 1 below). The newly added technical features do not make contribution over the prior art. Thus, Group I and II inventions lack of unity of invention. In addition, Group I and II require a different field of search (i.e. searching different classes/subclasses or employing different search queries; See MPEP 808.02). Therefore, the extra search and/or examination burden for addressing Groups I and II poses a serious burden to the examiner which makes the restriction requirement proper.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claim(s) 1-6, 8, 10-11, 13-14, 17-20, and 22 is/are pending in the application.
Claim(s) 13-14, 17-20, and 22 is/are withdrawn from consideration.
Claim(s) 1-6, 8, and 10-11 is/are examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/02/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "102" and "104" have both been used to designate “outlet of the valve 100”. 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(s) 1-6, 8, and 10-11 is/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 1 recites the limitation “a flow control formation … is configured to be located internally to an attached ostomy appliance” which is indefinite. It is unclear if the claimed “attached ostomy appliance” same or different from the “ostomy appliance” introduced in lines 1-2 of claim 1. The limitation has been examined below as if it read -- a flow control formation … is configured to be located internally to [[an attached]] the ostomy appliance --.
Claim(s) 2-6, 8, and 10-11 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
Claim 1 recites the limitation “a flow control formation, which includes a contact surface upstream of the outlet” which is indefinite. According to Abstract, Figs. 12A, and 13A of Applicant’s published application, a contact surface 320 extends away from a body 110 of a valve 100 or an outlet 104 of the valve 100 and is positioned at/near an inlet of the valve 100. Thus, the limitation has been examined below as if it read -- a flow control formation, which includes a contact surface [[upstream of]] extending away from the outlet --.
Claim(s) 2-6, 8, and 10-11 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
Claim 4 recites the limitation “… so that the first deflectable part and the second deflectable part are movable towards each other to close the flow path” which is indefinite. It is unclear if the claimed “first deflectable part” same or different from the “deflectable part” introduced in claim 3. The limitation has been examined below as if it read -- so that the [[first]] deflectable part and the second deflectable part are movable towards each other to close the flow path --.
Claim(s) 5-6, 8, and 10-11 is/are rejected as being dependent from claim 4 and therefor including all the limitation thereof.
Claim 5 recites the limitation “the first deflectable part and/or the second deflectable part are resiliently biased to an initial shape and/or position, which corresponds to the open condition” which is indefinite. It is unclear if the claimed “first deflectable part” same or different from the “deflectable part” introduced in claim 3. The limitation has been examined below as if it read -- the [[first]] deflectable part and/or the second deflectable part are resiliently biased to an initial shape and/or position, which corresponds to the open condition --.
Claim(s) 6, 8, and 10-11 is/are rejected as being dependent from claim 5 and therefor including all the limitation thereof.
Claim 6 recites the limitation “the first deflectable part and/or the second deflectable part project from the body of the valve” which is indefinite. It is unclear if the claimed “first deflectable part” same or different from the “deflectable part” introduced in claim 3. The limitation has been examined below as if it read -- the [[first]] deflectable part and/or the second deflectable part project from the body of the valve --.
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 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.
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) 1, 3-6, 8, and 10 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Scalise (US PGPUB 20200046543).
Regarding claim 1, Scalise discloses a valve for an ostomy appliance (¶0041 and 0064; Figs. 2 and 56-57) including:
a body for connection to the ostomy appliance (an outlet body 1250: ¶0064; Figs. 56-57),
an inlet and an outlet, connected by a flow path (¶0044 and 0064; see annotated Fig. 57 below),
a closure arrangement (a cap 1252: ¶0064 and Figs. 56-57) which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid cannot flow through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet (¶0009 and 0044; Figs. 56-57), and
a flow control formation (a valve 1140: ¶0064; Figs. 56-57), which includes a contact surface extending away the outlet (see annotated Fig. 57 below) and is configured to be located internally to the ostomy appliance (¶0044 and Fig. 2), and is configured to default to an open condition and has a closed condition in which the flow of liquid from the outlet is prevented or at least inhibited (¶0064).
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Regarding claim 3, Scalise further discloses the flow control formation has a deflectable part (see annotated Fig. 57 above), which is moveable to close the flow path (¶0064).
Regarding claim 4, Scalise further discloses the flow control formation further includes a second deflectable part (see annotated Fig. 57 above), so that the first deflectable part and the second deflectable part are moveable towards each other to close the flow path (¶0064).
Regarding claim 5, Scalise further discloses the deflectable part and/or the second deflectable part are resiliently biased to an initial shape and/or position, which corresponds to the open condition (¶0064).
Regarding claim 6, Scalise further discloses the deflectable part and/or the second deflectable part project from the body of the valve (¶0064 and Fig. 63).
Regarding claim 8, Scalise further discloses the contact surface contacts a portion of the ostomy appliance when the flow path is closed (¶0040; Figs. 2 and 57): interface assembly 22/1222 is disposed at an outlet 26 of the ostomy pouch 12; thus, the contact surface contacts a portion of the ostomy appliance), and/or wherein the contact surface includes a convex portion.
Regarding claim 10, Scalise further discloses the body includes a first attachment portion and a second attachment portion (see annotated Fig. 57 above), each of which extends away from the inlet (see annotated Fig. 57 above), and the contact surface extends between the first attachment portion and the second attachment portion (see annotated Fig. 57 above).
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 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.
Claim(s) 2 and 11 is/are rejected under 35 U.S.C 103 as being unpatentable over Scalise (US PGPUB 20200046543).
Regarding claim 2, Scalise in the embodiment of Figs. 56-57 does not disclose the flow control formation is movable to its closed condition via manual manipulation by a user.
In the embodiment of Fig. 63, Scalise discloses/suggests to have a valve slider 1180 at/near an open end 1176 of a valve 1170 (¶0070 and Fig. 63). Scalise further discloses the valve 1170 is actuated when a user pulls the valve slider 1180 outward or inward to move the valve 1170 in open/close condition (¶0070).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Scalise by replacing a closure arrangement with a valve slider, motivated by the desires to assist in opening and/or closing the valve, as suggested in ¶0070 and Fig. 63 of Scalise.
Regarding claim 11, Scalise in the embodiment of Figs. 56-57 does not disclose the body forms a U or V shape.
In the embodiment of Figs. 53-54, Scalise discloses/suggests the body forms a V shape (Figs. 53-54) for the benefit of assisting in actuating the valve by squeezing opposite lateral sides (¶0061).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Scalise by changing shape of the body to U shape, in order to assist in actuating the valve by squeezing opposite lateral sides, as suggested in ¶0061 and Figs. 53-54 of Scalise and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Czaplewski (USPGPUB 20240065876) discloses a valve for an ostomy appliance (Figs. 1-5 and accompanying texts).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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