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 .
Response to Arguments
Applicant's arguments filed July 21, 2026 have been fully considered but they are not persuasive. Applicant contends that Scalise (US 20200046543 A1) does not have the requisite structure needed to perform the requisite function. However, Scalise demonstrates elliptical corrugations that protrude from the inner base material (fig. 33) having a larger outer diameter than the base diameter of the inner base member. Scalise does not expressly disclose the diameters of the corrugations but suggests such diameters in the figures, and Applicant does not demonstrate how Scalise cannot have the claimed diameters. Nor does Applicant demonstrate that the mating/engagement cap of Scalise would operate differently if the diameters were modified.
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 13-20 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 13 recites the limitation "the short direction of the core portion" and “the longitudinal direction of the core portion”. There is insufficient antecedent basis for this limitation in the claim.
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(s) 1-3, 5-6, 9, 11-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scalise et al. (US 20200046543 A1) in view of Winchell (US 4319571 A).
Regarding claim 1, Scalise discloses a medical component comprising: a mouth tool (fig. 29) that is attached to a pouch (14, fig. 4) in which excrement from a stoma is to be stored and has an opening (756 is a rendition of bag outlet 42, para. [0041, 0054]) having a tubular shape through which the excrement is discharged (fig. 29, abstract); and
a cap (752) having a core portion (portion of 752 inside opening 756, fig. 34) to be inserted into the opening (756, fig. 34), wherein
a cross-sectional shape of the opening is a substantially elliptical shape having a major diameter (A, annotated fig. 32) in a substantially horizontal direction relative to a body surface,
a cross-sectional shape of the core portion (portion of 752 inside opening 756, fig. 34) is a substantially elliptical shape having a diameter equal to or smaller than the opening (756, see fig. 34),
one or more annular corrugations (ribs on 792, para. [0054]) having a substantially elliptical shape are formed in an insertion direction on an outer wall of the core portion (figs. 30, 33).
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However, Scalise fails to expressly disclose wherein the annular corrugation is formed such that a length of a width in the substantially vertical direction relative to the body surface is longer than a length of a width in a substantially horizontal direction relative to the body surface.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the corrugations of Scalise to have a length of a width in the substantially vertical direction relative to the body surface is longer than a length of a width in a substantially horizontal direction relative to the body surface since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the corrugations of Scalise would not operate differently with the claimed proportion of the length of the widths.
Scalise also fails to disclose cross-sectional shape of the opening has a smaller diameter than the cross-sectional shape of the core portion including the annular corrugation.
Winchell discloses a similar device in the same field of endeavor wherein a cross-sectional shape of the opening has a smaller diameter than the cross-sectional shape of the core portion (column 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the opening and core portion of Scalise such that the diameter of the core portion with the corrugations is larger than the diameter of the opening than the core portion is inserted into as shown in Winchell to provide a tight secure fit (column 4 lines 11-14).
Regarding claims 2, 3, and 7, the combination of Scalise and Winchell discloses the component of claim 1. However, Scalise fails to disclose:
(Claim 2) wherein a minor diameter of the annular corrugation is formed longer than a minor diameter of the opening;
(Claim 3) wherein a major diameter of the annular corrugation is formed longer than the major diameter of the opening;
(Claim 7) wherein a major diameter of the annular corrugation is formed longer than the major diameter of the opening.
Winchell teaches a diameter of a plug that is larger than the diameter of the opening it fits into (column 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the annular corrugations and core portion of Scalise such that the diameters of the annular corrugations are larger than the diameter of the opening than the core portion is inserted into as demonstrated by the principle in Winchell to provide a tight secure fit (column 4 lines 11-14).
Regarding claim 5, the combination of Scalise and Winchell discloses the component of claim 1. Scalise further discloses wherein the mouth tool and the cap are integrally formed (fig. 29, para. [0054]).
Regarding claim 6, the combination of Scalise and Winchell discloses the component of claim 1. Scalise further discloses an excrement storage device comprising: the medical component (fig. 29) according to claim 1; and a pouch (14) in which excrement from a stoma is to be stored, wherein the pouch (14) has a discharge port (750) through which the excrement is discharged, and the medical component (fig. 29) is attached to the discharge port (750).
Regarding claim 9, the combination of Scalise and Winchell discloses the component of claim 2. Scalise further discloses wherein the mouth tool and the cap are integrally formed (fig. 29, para. [0054]).
Regarding claim 11, the combination of Scalise and Winchell discloses the component of claim 3. Scalise further discloses wherein the mouth tool and the cap are integrally formed (fig. 29, para. [0054]).
Regarding claim 12, the combination of Scalise and Winchell discloses the component of claim 4. Scalise further discloses wherein the mouth tool and the cap are integrally formed (fig. 29, para. [0054]).
Regarding claim 13, Scalise discloses a medical component comprising: a mouth tool (fig. 29) that is attached to a pouch (14, fig. 4) in which excrement from a stoma is to be stored and has an opening (756 is a rendition of bag outlet 42, para. [0041, 0054]) having a tubular shape through which the excrement is discharged (fig. 29, abstract); and
a cap (752) having a core portion (portion of 752 inside opening 756, fig. 34) to be inserted into the opening (756, fig. 34), wherein
a cross-sectional shape of the opening is a substantially elliptical shape having a major diameter (A, annotated fig. 32) in a substantially horizontal direction relative to a body surface,
a cross-sectional shape of the core portion (portion of 752 inside opening 756, fig. 34) is a substantially elliptical shape having a diameter equal to or smaller than the opening (756, see fig. 34),
one or more annular corrugations (ribs on 792, para. [0054]) having a substantially elliptical shape are formed in an insertion direction on an outer wall of the core portion (figs. 30, 33).
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However, Scalise fails to disclose the annular corrugation is formed such that the length of a width in the short direction of the core portion is longer than the length of a width in the longitudinal direction of the core portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the corrugations of Scalise to have a length of a width in the short direction of the core portion is longer than the length of a width in the longitudinal direction of the core portion since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the corrugations of Scalise would not operate differently with the claimed proportion of the length of the widths.
Scalise also fails to disclose cross-sectional shape of the opening has a smaller diameter than the cross-sectional shape of the core portion including the annular corrugation.
Winchell discloses a similar device in the same field of endeavor wherein a cross-sectional shape of the opening has a smaller diameter than the cross-sectional shape of the core portion (column 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the opening and core portion of Scalise such that the diameter of the core portion with the corrugations is larger than the diameter of the opening than the core portion is inserted into as shown in Winchell to provide a tight secure fit (column 4 lines 11-14).
Regarding claims 14 and 15, the combination of Scalise and Winchell discloses the component of claim 13. However, Scalise fails to disclose:
(Claim 14) wherein a minor diameter of the annular corrugation is formed longer than a minor diameter of the opening;
(Claim 15) wherein a major diameter of the annular corrugation is formed longer than the major diameter of the opening;
Winchell teaches a diameter of a plug that is larger than the diameter of the opening it fits into (column 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the annular corrugations and core portion of Scalise such that the diameters of the annular corrugations are larger than the diameter of the opening than the core portion is inserted into as demonstrated by the principle in Winchell to provide a tight secure fit (column 4 lines 11-14).
Regarding claim 17, the combination of Scalise and Winchell discloses an excrement storage device comprising: the medical component according to claim 13. Scalise further discloses a pouch (14) in which excrement from a stoma is to be stored, wherein the pouch (14) has a discharge port (750) through which the excrement is discharged, and the medical component (fig. 29) is attached to the discharge port (750).
Regarding claim 18, the combination of Scalise and Winchell discloses the component of claim 14. However, Scalise fails to disclose wherein a major diameter of the annular corrugation is formed longer than the major diameter of the opening.
Winchell teaches a diameter of a plug that is larger than the diameter of the opening it fits into (column 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the annular corrugations and core portion of Scalise such that the diameters of the annular corrugations are larger than the diameter of the opening than the core portion is inserted into as demonstrated by the principle in Winchell to provide a tight secure fit (column 4 lines 11-14).
Claim(s) 4, 8, 10, 16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scalise et al. (US 20200046543 A1) in view of Winchell (US 4319571 A), and in further view of Tofield (US 4676802 A).
Regarding claims 4, 8, and 10, the combination of Scalise and Winchell discloses the component of claims 1, 2, and 3. However, Scalise fails to disclose wherein the mouth tool and the cap are formed of the same resin material.
Tofield teaches a similar device in the same field of endeavor with a resin material (column 4 lines 47-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the component of Scalise to incorporate the resin material teaching of Tofield to create a tight seal from a resilient plastic resin material (column 4 lines 47-50).
Regarding claims 16 and 19-20, the combination of Scalise and Winchell discloses the component of claims 14 and 15. Scalise discloses wherein the mouth tool and the cap are integrally formed (fig. 29, para. [0054]). However, Scalise fails to disclose wherein the mouth tool and the cap are formed of the same resin material.
Tofield teaches a similar device in the same field of endeavor with a resin material (column 4 lines 47-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the component of Scalise to incorporate the resin material teaching of Tofield to create a tight seal from a resilient plastic resin material (column 4 lines 47-50).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (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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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781
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