DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 13 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 13, the limitation “a single continuous strand to resilient wire material” renders the claim indefinite as it is unclear what “to,” which is interpreted as a function word suggesting actual or figurative movement toward a place, person, or thing, does not make sense in this context. For examination purposes, “to” is interpreted as “of” as paragraph 27 of the originally filed specification states that “arms may comprise a single continuous strand of resilient wire material.”
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2-5, 12, 14, and 21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Delaney (US 4,182,332), disclosed in the IDS of May 10, 2024.
Regarding claim 2, Delaney discloses a collection device for fecal discharge (see Figs. 1-6), comprising: an annular expandable component (see Fig. 2) comprising arms 24, 26, 28, 30 connected in an undulating pattern (see Fig. 6) around a lumen 32 of the annular expandable component, wherein, when the annular expandable component is deployed, the arms impel the annular expandable component from a compressed configuration (see Fig. 4) toward an expanded configuration (see Fig. 5), wherein the annular expandable component is configured to exert an outwardly directed radial pressure against rectal walls upon deployment within a rectum (see col. 5, lines 21-24); and a transit component 36 coupled to the annular expandable component and arranged to direct the fecal discharge from within the annular expandable component out of the rectum (see Fig. 5).
Regarding claim 3, Delaney discloses the annular expandable component is configured to exert the outwardly directed radial pressure in a manner that retains the annular expandable component within the rectum (see Fig. 5; col. 5, lines 21-24 and lines 29-44 describing keeping the device in place until stool is received in the bag and then later removing the bag and stool via withdrawal of the device).
Regarding claim 4, Delaney discloses the transit component is coupled to a proximal end of the annular expandable component (see Fig. 5).
Regarding claim 5, Delaney discloses the undulating pattern includes alternating peaks and troughs (see Fig. 5, tips 25, 27, 29, 31 are peaks with troughs in between them).
Regarding claim 12, Delaney discloses the annular expandable component includes a housing sheath 14 that overlays at least one of an inner or outer contour of the annular expandable component (see Fig. 4).
Regarding claim 14, Delaney discloses a collection device (see Figs. 1-6) for fecal discharge, comprising: an annular expandable component (see Fig. 2) comprising arms 24, 26, 28, 30 connected in an undulating pattern around a lumen 32 of the annular expandable component (see Fig. 6), wherein, when the annular expandable component is deployed, the arms impel the annular expandable component from a compressed configuration (see Fig. 4) toward an expanded configuration (see Fig. 5), wherein the annular expandable component is configured to exert an outwardly directed radial pressure against rectal walls upon deployment within a rectum (see col. 5, lines 21-24), wherein the annular expandable component includes a housing sheath 14 that overlays at least one of an inner or outer contour of the annular expandable component (see Fig. 4); and a transit component 36 coupled to the annular expandable component and arranged to direct the fecal discharge from within the annular expandable component out of the rectum (see Fig. 5).
Regarding claim 21, Delaney further discloses the arms circumscribe a substantially circular contour for the annular expandable component (see Figs. 4-6).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 6-10 and 16-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delaney in view of Shuffield (US 4,516,578), disclosed in the IDS of May 10, 2024.
Regarding claim 6, Delaney discloses the limitations of claim 2 but does not disclose the device further comprising a filament coupled to the annular expandable component and configured to collapse the annular expandable component into the compressed configuration.
Shuffield discloses a rectal device with an annular component (see Fig. 1), with the lip of a ring 15 of the device attached to a cord/filament 19 and related handle/ring at end of filament (see Fig. 1) for facilitating removal of the device (see Fig. 1; col. 5, lines 47-53). It would have been obvious to a person having ordinary skill in the art before the time of invention to have the device further comprise a filament coupled to the annular expandable component, as disclosed by Shuffield, to predictably help with removal of the device, as adding such a filament and handle as that disclosed by Shuffield would be easier to fully grasp and pull for those with mobility issues than simply base member 22. Additionally, due to the shape of the arms and their flexibility, the arms would collapse in a similar manner as to that shown in Fig. 4 due to the narrow anus entryway (see Fig. 5) as it is removed from the body, therefore collapsing the annular expandable component into the compressed configuration.
Regarding claim 7, Delaney and Shuffield disclose the limitations of claim 6 and the device disclosed would further have the annular expandable component configured to collapse when the filament is pulled proximally away from the anus, as that direction would be pulled for removal from the body (see Shuffield, Fig. 1 and Delaney, Fig. 5).
Regarding claim 8, Delaney and Shuffield disclose the limitations of claim 6 and the filament would extend proximally beyond the annular expandable component, similar to the configuration shown in Fig. 1 of Shuffield.
Regarding claim 9, Delaney and Shuffield disclose the limitations of claim 6 and Shuffield further discloses the filament is coupled to a handle/ring (see Fig. 1).
Regarding claim 10, Delaney and Shuffield disclose the limitations of claim 6 and further disclose the filament provides an inwardly directed radial force to the annular expandable component sufficient to cause the annular expandable component to collapse into the compressed configuration (see Delaney, Fig. 5, inward force radial force of rectum provided to upper portion of the annular expandable component as the filament is pulled proximally, and therefore would cause/provide the collapse into the compressed configuration like that shown in Fig. 4).
Regarding claim 16, Delaney discloses the limitations of claim 14 but does not disclose the device further comprising a filament coupled to the annular expandable component and configured to collapse the annular expandable component into the compressed configuration.
Shuffield discloses a rectal device with an annular component (see Fig. 1), with the lip of a ring 15 of the device attached to a cord/filament 19 and related handle/ring at end of filament (see Fig. 1) for facilitating removal of the device (see Fig. 1; col. 5, lines 47-53). It would have been obvious to a person having ordinary skill in the art before the time of invention to have the device further comprise a filament coupled to the annular expandable component, as disclosed by Shuffield, to predictably help with removal of the device, as adding such a filament and handle as that disclosed by Shuffield would be easier to fully grasp and pull for those with mobility issues than simply base member 22. Additionally, due to the shape of the arms and their flexibility, the arms would collapse in a similar manner as to that shown in Fig. 4 due to the narrow anus entryway (see Fig. 5) as it is removed from the body, therefore collapsing the annular expandable component into the compressed configuration.
Regarding claim 17, Delaney and Shuffield disclose the limitations of claim 16 and the device disclosed would further have the annular expandable component configured to collapse when the filament is pulled proximally away from the anus, as that direction would be pulled for removal from the body (see Shuffield, Fig. 1 and Delaney, Fig. 5).
Regarding claim 18, Delaney and Shuffield disclose the limitations of claim 16 and the filament would extend proximally beyond the annular expandable component, similar to the configuration shown in Fig. 1 of Shuffield.
Regarding claim 19, Delaney and Shuffield disclose the limitations of claim 16 and Shuffield further discloses the filament is coupled to a handle/ring (see Fig. 1).
Regarding claim 20, Delaney and Shuffield disclose the limitations of claim 16 and further disclose the filament provides an inwardly directed radial force to the annular expandable component sufficient to cause the annular expandable component to collapse into the compressed configuration (see Delaney, Fig. 5, inward force radial force of rectum provided to upper portion of the annular expandable component as the filament is pulled proximally, and therefore would cause/provide the collapse into the compressed configuration like that shown in Fig. 4).
Claims 11 and 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delaney in view of Vargas (US 2010/0049224).
Regarding claim 11, Delaney discloses the limitations of claim 2 but does not specifically disclose the outwardly directed radial pressure generated by the arms is less than a pressure exerted by the rectal walls during peristaltic contractions.
Vargas discloses an outflow restrictor 701 for the intestines, which the rectum is part of, that is compliant such that it compresses radially when the pyloric sphincter closes and expands radially when the pyloric sphincter opens (see par. 58), such that the compliance of the restrictor may be tuned to allow chyme to exit the stomach at greater or lesser peristaltic pressure. Therefore, Vargas discloses that the compliance and therefore the radial pressure of a lumen within the intestines affects the allowability of matter to exit through the lumen affected by peristaltic contractions, and therefore the radial pressure therefore would need to be optimized to allow matter to exit via the lumen. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the arms as it involves only adjusting the dimension, compliance and related radial pressure, disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the radial pressure generated by the arms to be less than a pressure exerted by the rectal walls during peristaltic contractions as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15, Delaney discloses the limitations of claim 14 but does not specifically disclose the outwardly directed radial pressure generated by the arms is less than a pressure exerted by the rectal walls during peristaltic contractions.
Vargas discloses an outflow restrictor 701 for the intestines, which the rectum is part of, that is compliant such that it compresses radially when the pyloric sphincter closes and expands radially when the pyloric sphincter opens (see par. 58), such that the compliance of the restrictor may be tuned to allow chyme to exit the stomach at greater or lesser peristaltic pressure. Therefore, Vargas discloses that the compliance and therefore the radial pressure of a lumen within the intestines affects the allowability of matter to exit through the lumen affected by peristaltic contractions, and therefore the radial pressure therefore would need to be optimized to allow matter to exit via the lumen. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the arms as it involves only adjusting the dimension, compliance and related radial pressure, disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the radial pressure generated by the arms to be less than a pressure exerted by the rectal walls during peristaltic contractions as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-12, 14-15, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 11-12 of U.S. Patent No. 11,944,763, hereinafter ‘763, and disclosed in the IDS of May 10, 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of ‘763 disclose the following identified claims of the current application:
Application claim
2
3
4
5
6
7
8
‘763 claim
1
1
1
1
4
5
5
Application claim
9
10
11
12
14
15
21
‘763 claim
5
4
11
12
12
12
12
Claims 2-11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 10 of U.S. Patent No. 10,953,200, hereinafter ‘200, and disclosed in the IDS of May 10, 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of ‘763 disclose the following identified claims of the current application:
Application claim
2
3
4
5
6
7
8
‘200 claim
1
1
1
1
1
1
1
Application claim
9
10
11
13
‘200 claim
10
1
1
4
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 18 of U.S. Patent No. 8,840,594, hereinafter ‘594, and disclosed in the IDS of May 10, 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of ‘763 disclose the following identified claims of the current application:
Application claim
2
3
4
5
6
7
8
‘594 claim
1
1
1
1
18
18
18
Application claim
9
10
11
12
13
14
15
‘594 claim
18
18
14
1
4
1
1
Application claim
16
17
18
19
20
21
‘594 claim
18
18
18
18
18
3
Examiner Comment
No prior art was found to reject claim 13 above under 35 USC 102 or 35 USC 103. The closest prior art found was Delaney, which does not disclose the single continuous strand of resilient wire material. In Delaney, the arms are flanges adapted to exert pressure on the inner wall of the rectum while also helping to keep the neck portion of the bag retained against the inner wall of the rectum (see Fig. 5; col. 2, lines 38-43) and one of ordinary skill in the art would not be motivated to modify such flanges disclosed by Delaney to make them comprise a single continuous strand of resilient wire material, as this would change the design of the flanges such that they could not fulfill their intended purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781