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 .
Status of the Claims
Claims 1-33 are pending in the application, with claims 1, 2, 4, 6, 15, 18, and 27 amended and new claims 31-33 added. Claims 1-5 and 31-33 are under consideration and claims 6-30 are withdrawn (See Restriction Election by Original Presentation below).
The claim objection to claim 2 is withdrawn in view of the amendments to claim 2.
Election by Original Presentation: Claim Amendments After Restriction Requirement
Applicant's election without traverse of Group I claims 1-5 in the 10/27/25 Response to Restriction is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Therefore, the subject matter of non-elected: Group II (claims 6-17) and Group III (claims 18-30) is therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. It is noted that Applicants have amended non-elected claims 6-30 to be dependent upon claim 1, but where non-elected claims 6-30 are claiming withdrawn subject matter. Accordingly, since the subject matter of claims 6-30 is non-elected, claims 6-30 are withdrawn from consideration. See MPEP 818.02(a) and 821.03.
A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Allowable Subject Matter
Claims 32-33 are objected to, but would be allowable if amended to incorporate all of the limitations of claim 1 from which they depend. The closest prior art of record is Bonadio, which fails to teach or fairly suggest wherein: (claim 32) the outer ring comprises a split ring configuration; OR (claim 33) the inner ring is deformable to a figure of 9 and returns to an un-deformed state after being deformed. It would not have been obvious to one of skill before the effective filing date to modify the inner or outer rings of Bonadio to include the limitations of claims 32 or 33, and one of skill would not be motivated to do so, where Bonadio fails to teach or fairly suggest these limitation, and does not provide any motivation to do so.
Response to Arguments
Applicants amendments and arguments have been fully considered, but are not persuasive. The amendments to claim 1 (but see 112(a) rejection below) are still taught by Bonadio, where Bonadio teaches an outer ring 4/51/10 (proximal O-ring 4 held by guide member 51 and ring 4 mounted to valve/seal 10 [0124],ll.7-8 for location externally of the wound opening; Fig.1; [0118]; [0128], e.g., a stoma as a wound opening) having a noncircular cross section that can be prevented from unrolling the flexible polymer sleeve (See 112(a) rejection above) (where valve portion of proximal ring/member is made of gelatinous elastomer, which would necessary provide at least some de minimus non-circular cross-section that could act to provide some de minimus prevention from unrolling of the flexible polymer sleeve, as recited below [0012],ll.4-6). Accordingly, the rejections of claims 1-5 are maintained.
Claim Objections
The claims are objected to for the following informalities:
In claim 33, line 2, “returns returns” should be “returns”; Appropriate correction is suggested. See MPEP 608.01(m).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 1 is rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite the new limitation of: “an outer ring having a non-circular cross section that can be inverted to fold over the flexible polymer sleeve” The only specification and figure support appears to be at page 4, line 33, to page 5, line 5, which describes the following:
“(Figure 3)
The device is a flexible, elastic generally cylindrical sleeve 11 with two rings attached made of flexible, or malleable or semi-rigid plastic or polymer. An inner ring 12 is located within the lumen of the stoma and lodges in the sub-fascial space. The outer ring 13 is rolled upon itself 10 so shortening the length of the sleeve membrane 11. The outer ring is prevented from "unrolling" by a "split ring" configuration having a non-circular cross-section area similar to a figure of 8. The membrane may be transparent or opaque, non-elastic or elastic.”
Further, the term “inverted” is not used with the term ring, but is only used to provide that the inner ring is smaller than the outer ring so that the sleeve has an inverted configuration (i.e., p.5,ll.33; p.12,ll.31).
Accordingly, amended claim 1 lacks written description in the specification, such that the meaning of these terms in the claims are not ascertainable by reference to the description. Applicant is required to amend the claims, or to make appropriate amendment to the description, to provide clear support or antecedent basis for these terms appearing in the claims provided, and where no new matter is introduced. For purposes of examination, this term will be interpreted to mean “an outer ring having a non-circular cross section that can be prevented from unrolling
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)(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 1-4 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Bonadio (US 2014/0303443 A1).
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As to claim 1, Bonadio discloses an endoluminal stoma channel 1 (wound retractor 1; Fig.1; [0001], [0118]-[0142], incorporated by reference, capable of being used for an endoluminal stoma channel, i.e., apparatus claims evaluated for patentability based on structure rather than function: MPEP 2114(I),(II); 2173.05(g)) comprising: an inner ring 3 (distal O-ring 3; Fig.1) that is resilient and deformable (any suitable material, e.g., a resilient elastomeric material for insertion through wound opening; [0118]);
an outer ring 4/51/10 (proximal O-ring 4 held by guide member 51 and ring 4 mounted to valve/seal 10 [0124],ll.7-8 for location externally of the wound opening; Fig.1; [0118]; [0128], e.g., a stoma as a wound opening) having a noncircular cross section that can be prevented from unrolling the flexible polymer sleeve (See 112(a) rejection above) (where valve portion of proximal ring/member is made of gelatinous elastomer, which would necessary provide at least some de minimus non-circular cross-section that could act to provide some de minimus prevention from unrolling of the flexible polymer sleeve, as recited below [0012],ll.4-6);
a flexible polymer sleeve 2 (sleeve 2 Fig.1 of pliable plastics material [0119]) connected to the inner ring 3 and the outer ring 4 (inner ring 3 and outer ring 4/51/10 connected via sleeve 2 Fig.1; [0128]) to form a flow channel (Fig.1) and comprising a biocompatible polymer (of pliable plastics material [0119]); and
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a tether 81/82/83 (tether as ribbon 81 attached at one end 82; Fig.1; [0122]) comprising a cord 81 (ribbon tie 81 Fig.4;[0140]) and a knob 83 (bead/knob 83 may be gripped; Fig.4; [0131]), wherein cord/ribbon 81 is attached to the inner ring 3 (Fig.4;[0131],ll.2-3), and the knob 83 has a position such that the cord 81 (Fig.4; [0140]) can extend along the sleeve 2 (Fig.4), in the interior or adjacent the exterior of the sleeve 2 (Fig.4 showing cord 81 adjacent to exterior of sleeve 2), past the outer ring 4/51/10 with the outer ring pulled away from the inner ring 3 such that the sleeve is taut (Fig.4,1 showing cord 81 past outer ring 51 with the sleeve 2 taut).
As to claim 2, Bonadio teaches wherein the inner ring 3 comprises a[n] elastomeric polymer (ring made of elastomeric material/plastics as polymer [0118]).
As to claim 3, Bonadio teaches wherein the outer ring 4/51/10 (Fig.1) has a larger diameter than the inner ring 3 (Fig.1 showing outer ring 51 portion having larger diameter than inner ring 3).
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As to claim 4, Bonadio teaches wherein the outer ring 4/51/10 comprises an elastomeric polymer (elastomeric sheet material of 10; [0048],ll.1-3) with non-circular cross section (of valve/seal 10 Fig.[0124],ll.7-14) that can be inverted to fold over the flexible polymer sleeve 2 Fig.1,3, as capable of being stretched over a portion of sleeve 2 Fig.1,3). 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 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 35 U.S.C. 103, 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 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 5 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bonadio.
As to claim 5, Bonadio does not specifically teach wherein the inner ring 3 and the outer ring 4/51/10 independently have diameters from 1-10 cm, and the sleeve has a length from .5 -20 cm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to provide the recited dimensions of the diameters of the inner and outer rings of Bonadio, and one of skill would have been motivated to do so, since such relative dimensions are known in the art and since finding optimum relative dimensions of the angle, depending on its intended use, is within the skill of those skilled in the art. Furthermore, the Federal Circuit 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04(IV)(A). As to new claim 31, Bonadio teaches wherein the flexible polymer sleeve 2 is connected to the inner 3 and/or outer 4 ring (sleeve fixed to outer ring 4 [0120],ll.4-5). Bonadio does not specifically teach that the inner or outer ring is connected to the sleeve through adhesive bonding or heat bonding.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to connect the sleeve to the outer ring by adhesive or heat bonding, as well known in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Applicant's amendments necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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