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 .
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 24, 25, and 29-33 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 24 recites the limitation "the source" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation should be amended to recite “a source” or if the claim should be dependent on claim 22. For examination purposes, the claim is interpreted to be dependent on claim 22.
Claim 25 recites the limitation "the source" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation should be amended to recite “a source” or if the claim should be dependent on claim 22. For examination purposes, the claim is interpreted to be dependent on claim 22.
Claim 29 recites the limitation "the tubular member" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation should be amended to recite “a tubular member” or if the limitation should be amended to recite “the fluid transfer portion”. For examination purposes, the limitation is interpreted to mean “the fluid transfer portion”.
Claim 31 recites the limitation "the source" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation should be amended to recite “a source” or if the claim should be dependent on claim 29. For examination purposes, the claim is interpreted to be dependent on claim 29.
Claim 32 recites the limitation "the source" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation should be amended to recite “a source” or if the claim should be dependent on claim 29. For examination purposes, the claim is interpreted to be dependent on claim 29.
Regarding claim 33, the claim recites the annular member forms “a cavity” in line 1. It is unclear if this cavity is the same cavity formed by the capture portion in claim 28 or a different cavity. For examination purposes, the limitation is interpreted to be the same cavity recited in claim 28.
Claim 30 is also rejected by virtue of being dependent on claim 29.
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.
Claim(s) 21-26, 28-33, and 35-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Canada (US 20120116329).
Regarding claim 21, Canada discloses a system for managing fluid transfer with respect a bodily region (device 1 in fig. 4), comprising:
a hydrophilic member having a unitary structure (foam 9 in fig. 4; paragraph 5 discloses the foam is polyurethane which is hydrophilic);
an annular member disposed about the hydrophilic member and configured to engage the bodily region (part 2 in fig. 4 is shown to be positioned annularly about foam 9); and
a tubular member partially disposed within the hydrophilic member (section 5 in fig. 4) and configured to transfer fluid relative to the hydrophilic member (paragraph 25 discloses producing a vacuum which would suction fluid relative to foam 9).
Regarding claim 28, Canada discloses a system for managing fluid transfer with respect to a bodily region (fig. 4), comprising:
a hydrophilic member configured to conformingly engage the bodily region (foam 9 in fig. 4; paragraph 5 discloses polyurethane foam which is hydrophilic and would be capable of conforming to a body portion), wherein the hydrophilic member includes a unitary structure (fig. 4 shows a unitary piece of foam); and
an annular member including a capture portion (part 2 in fig. 4) and a fluid transfer portion (section 5 in fig. 4), the capture portion forming a cavity to partially receive the hydrophilic member to provide flow relative to the cavity (fig. 4 shows part 2 as concave and forming a cavity about foam 9 which would allow fluid to be suctioned relative to the cavity).
Regarding claims 22 and 29, Canada discloses a source configured to apply suction to the tubular member (paragraph 25 discloses “a pump”).
Regarding claims 23 and 30, Canada discloses a source tubing connecting the tubular member and the source (suction tube 4 in fig. 4; paragraph 25).
Regarding claims 24 and 31, Canada discloses the source is configured to apply suction to the tubular member to transfer fluid with respect to the hydrophilic member (paragraph 25). Regarding claims 25 and 32, Canada discloses the source is configured to remove fluid from the hydrophilic member (paragraph 5 discloses the vacuum pump removing fluid extracted from the wound which would flow from the wound through foam 9).
Regarding claims 26 and 33, Canada discloses the annular member forms a cavity and the hydrophilic member is configured to be at least partially received in the cavity (fig. 4 shows the foam 9 received in a cavity formed by concave part 2).
Regarding claim 35, Canada discloses a method for managing fluid transfer with respect to a bodily portion (paragraph 5 discloses extracting fluid from a wound), the method comprising:
providing a hydrophilic member having a unitary structure (foam 9 in fig. 4; paragraph 5 discloses a polyurethane foam which is hydrophilic);
providing an annular member (part 2 and union 6 form the “annular member” in fig. 4) including a capture portion (part 2 in fig. 4) and a fluid transfer portion (union 6 in fig. 4); and
providing a tubular member partially disposed within the hydrophilic member (section 5 in fig. 4) and configured to transfer fluid relative to the hydrophilic member (paragraph 25 discloses generating suction).
Regarding claim 36, Canada discloses providing a source (paragraph 25 discloses “a pump”) and applying suction by the source to the tubular member (paragraph 25).
Regarding claim 37, Canada discloses a source tubing connecting the tubular member and the source (suction tubing 4 in fig. 4).
Regarding claim 38, Canada discloses applying suction to the tubular member to transfer fluid with respect to the hydrophilic member (paragraph 25 discloses producing a vacuum).
Regarding claim 39, Canada discloses removing fluid from the hydrophilic member (paragraph 5 discloses storing fluid extracted from a wound which would be removed from the foam 9 and pass through tubings 4, 5, and 6).
Regarding claim 40, Canada discloses the annular member forms a cavity and the hydrophilic member is configured to be at least partially received in the cavity (fig. 4 shows part 2, which is part of the “annular member” as defined above, forming a cavity which receives foam 9).
Claim(s) 21-24, 26-31, 33-38, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riddell (US 3060935).
Regarding claim 21, Riddell discloses a system for managing fluid transfer with respect a bodily region (fig. 2), comprising:
a hydrophilic member having a unitary structure (core 12 in fig. 3 is shown to be a unitary structure; 1:61-62 discloses core 12 is made from “sponge polyurethane” indicating that it is hydrophilic);
an annular member disposed about the hydrophilic member and configured to engage the bodily region (coating 13 in figs. 2 and 3 is annular about the outer perimeter of core 12); and
a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member (tube 14 in fig. 3 extends through core 12; 1:54-57 discloses removing saliva so that fluid would transfer relative to the core 12).
Regarding claim 28, Riddell discloses a system for managing fluid transfer with respect to a bodily region (fig. 2), comprising:
a hydrophilic member configured to conformingly engage the bodily region (core 12 in fig. 2; 1:61-62 discloses core 12 is made from “sponge polyurethane” indicating that it is hydrophilic and can conform to the teeth and gum area), wherein the hydrophilic member includes a unitary structure (fig. 3); and
an annular member including a capture portion (coating 13 in fig. 2) and a fluid transfer portion (tube 14 in fig. 3), the capture portion forming a cavity to partially receive the hydrophilic member to provide flow relative to the cavity (see below, the coating 13 forms a cavity around the perimeter of the core 12).
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Regarding claims 22 and 29, Riddell discloses a source configured to apply suction to the tubular member (2:10-15 discloses “a vacuum in a dentist’s office” or “a small syringe or other hand pump”).
Regarding claims 23 and 30, Riddell discloses a source tubing connecting the tubular member and the source (suction hose 15 in fig. 2).
Regarding claims 24 and 31, Riddell discloses the source is configured to apply suction to the tubular member to transfer fluid with respect to the hydrophilic member (1:54-57 discloses drawing saliva from the mouth which would be transferred relative to the hydrophilic member; the examiner notes that the claim does not presently require that the fluid be transferred from the hydrophilic member).
Regarding claims 26 and 33, Riddell discloses the annular member forms a cavity and the hydrophilic member is configured to be at least partially received in the cavity (see cavity defined above, the coating forms a cavity around the outer perimeter of the core 12).
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Regarding claims 27 and 34, Riddell discloses the hydrophilic member includes a C-shaped structure (see dotted line below; the core 12 is C-shaped overall when viewed in plan view to fit the teeth).
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Regarding Claim 35, Riddell discloses a method for managing fluid transfer with respect to a bodily portion, the method comprising:
providing a hydrophilic member having a unitary structure (core 12 in fig. 2 and 3; 1:61-62 discloses the core is “sponge polyurethane” so that it is hydrophilic and is shown to be unitary in fig. 3);
providing an annular member including a capture portion (coating 13 in fig. 2) and a fluid transfer portion (see below; the openings in coating 13 which receive tube 14 are the “fluid transfer portion”); and
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providing a tubular member partially disposed within the hydrophilic member (tube 14 in fig. 3 extends through core 12) and configured to transfer fluid relative to the hydrophilic member (1:54-57 discloses suctioning saliva so that fluid would transfer relative to core 12).
Regarding claim 36, Riddell discloses providing a source and applying suction by the source to the tubular member (2:10-15 discloses a “vacuum in a dentist’s office” or “small syringe or other hand pump”).
Regarding claim 37, Riddell discloses a source tubing connecting the tubular member and the source (suction hose 15 in fig. 2).
Regarding claim 38, Riddell discloses applying suction to the tubular member to transfer fluid with respect to the hydrophilic member (1:54-57 discloses drawing saliva from the mouth so that fluid would transfer relative to the core 12; 2:10-15 discloses “applying suction to the saliva ejector” which would encompass applying suction to the tube 14).
Regarding claim 40, Riddell discloses the annular member forms a cavity (see below, the coating 13 forms a cavity around the outer perimeter of core 12) and the hydrophilic member is configured to be at least partially received in the cavity (fig. 2).
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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.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11744933.
Regarding claim 28, claim 1 of the issued patent claims A system for managing fluid transfer with respect to a bodily region (24:38-39), comprising:
a hydrophilic member configured to conformingly engage the bodily region (24:40-42 claims an “anchoring member” which was interpreted under 112(f) during prosecution to mean a hydrophilic foam), wherein the hydrophilic member includes a unitary structure (24:43); and
an annular member including a capture portion and a fluid transfer portion (24:44-45), the capture portion forming a cavity to partially receive the hydrophilic member to provide flow relative to the cavity (24:45-50).
Claims 21-27 and 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 18, and 19 of U.S. Patent No. 11744933 in view of Canada (see table below).
Regarding claim 21, claim 1 of the issued patent claims a system for managing fluid transfer with respect a bodily region (24:38-39), comprising:
a hydrophilic member having a unitary structure (24:40-43 claims an “anchoring member” which was interpreted under 112(f) during prosecution to mean a hydrophilic foam);
an annular member disposed about the hydrophilic member and configured to engage the bodily region (24:44-50 claims a capture portion which forms a cavity around the anchoring member so to be an “annular member”).
However, claim 1 of the ‘933 patent does not claim a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member.
Canada teaches a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member (section 5 in fig. 4). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to claim a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member, as taught by Canada, as Canada teaches that this tubular member fluidically connects the foam to suction (paragraph 25, fig. 4).
Regarding claim 35, claim 18 of the issued patent claims a method for managing fluid transfer with respect to a bodily portion, the method comprising:
providing a hydrophilic member having a unitary structure (26:18-22 claims an “anchoring member” which was interpreted under 112(f) during prosecution to mean a hydrophilic foam);
providing an annular member including a capture portion and a fluid transfer portion (26:19-26 claims the capture portion forms a cavity about the anchoring member so as to be annular).
However, the issued patent does not claim providing a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member.
Canada teaches providing a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member (section 5 in fig. 4). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to claim providing a tubular member partially disposed within the hydrophilic member and configured to transfer fluid relative to the hydrophilic member, as taught by Canada, as Canada teaches that this tubular member fluidically connects the foam to suction (paragraph 25, fig. 4).
Instant Claims
Issued Claims
Teaching
21
1
see discussion above
22
1
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
23
2
24
1
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
25
1
The issued patent does not claim that the source is configured to remove fluid from the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to remove fluid in order to remove fluid from a treatment site.
26
1
27
1
Claim 1 of the issued patent claims a "u-shaped" anchoring member. The examiner notes that "c-shape" and "u-shape" are considered equivalent shapes.
29
1
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
30
2
31
1
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
32
1
The issued patent does not claim that the source is configured to remove fluid from the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to remove fluid in order to remove fluid from a treatment site.
33
1
34
1
Claim 1 of the issued patent claims a "u-shaped" anchoring member. The examiner notes that "c-shape" and "u-shape" are considered equivalent shapes.
35
18
see discussion above
36
19
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
37
19
38
1
The issued patent does not claim that the source is configured to apply suction to the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to apply suction in order to remove fluid from a treatment site.
39
1
The issued patent does not claim that the source is configured to remove fluid from the tubular member. Canada teaches this limitation as discussed above. It would have been obvious to have modified the issued claim to have the source be configured to remove fluid in order to remove fluid from a treatment site.
40
18
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783