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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s): utilizing at least one implant (as per claim 1), the at least one implant comprises a wire, and wherein securing the position of the at least one fold comprises suturing the duodenum wall using the wire (as per claim 13), the at least one implant comprises a biological glue, and wherein securing the position of the at least one fold comprises gluing the first surface of the duodenum wall to the second surface of the duodenum wall (as per claim 14), and the at least one implant comprises a locking mechanism, the locking mechanism comprising two lockable portions, and wherein securing the position of the at least one fold comprises: securing a first lockable portion of the locking mechanism to the first surface of the duodenum wall; securing a second lockable portion of the locking mechanism to the second surface of the duodenum wall; and locking the first lockable portion with the second lockable portion (as per claim 15).
In the present figures, no implant(s) is/are shown securing the fold(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claims 14 and 15 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.
Claims 14 and 15 recite the limitation "the second surface of the duodenum wall". There is insufficient antecedent basis for this limitation in the claims. Claim 1 has only introduced a second portion of the first surface. It is unclear in claims 14 and 15 if the limitation is referring to 1) a newly introduced second surface of the duodenum wall, or if it is referring to 2) the second portion of the first surface. These features are further not shown in any figures to indicate what Applicant has intended for claims 14 and 15 to encompass.
Claim Rejections - 35 USC § 102
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) 1-5, 7, 8, 10, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krueger et al (US 2010/0160933).
Krueger et al discloses the following limitations:
Claim 1. A method (Figs. 7-12) for shortening a duodenum (16) of a subject, the method comprising:
manipulating a first surface (inner surface 26 or outer surface 32, depending on the dependent claim below) of the duodenum wall (16) such that a first portion (see annotated figure below – wherein when the first surface is interpreted as the inner surface 26 as in interpretation 1 below of the annotated figure, the first portion is the right inner wall of pouch-cuff 72; wherein when the first surface is interpreted as the outer surface 32 as in interpretation 2 below of the second annotated figure, the first portion is left wall of the fold) of the first surface of the duodenum wall is layered (via folding) onto a second portion (see annotated figure below - wherein when the first surface is interpreted as the inner surface 26 as in interpretation 1 below of the annotated figure, the second portion is the left inner wall of pouch-cuff 72; wherein when the first surface is interpreted as the outer surface 32 as in interpretation 2 below of the second annotated figure, the second portion is the right wall of the fold) of the first surface of the duodenum wall, thereby creating at least one fold (see annotated figure below, a fold exists on the bottom of the pouch-cuff 72 in interpretation 1 and another fold exists on the top of the pouch-cuff 72 in interpretation 2 below) in the first surface of the duodenum wall ([0082]; the folding is illustrated from the unfolded configuration in Fig. 8, to the folded configuration in Fig. 9); and
securing, utilizing at least one implant (supporting member 70, suture 88’, anchor 92 as described in [0083]-[0086] and/or tissue glues as described in [0100] depending on the dependent claim below), the position of the at least one fold in relation to a surrounding surface of the duodenum wall, thereby shortening the duodenum of the subject (the modified duodenum 16” in Fig. 9 is shortened as a result of a portion of the original duodenum 16 being folded into pouch-cuff 72 as seen between the transition of Figs. 8-9, supporting member 70 and anchor 92 are each positioned at the folds to hold the fold in place, additionally suture 88’ can be stitched through the duodenal tissue of the fold and through supporting member 70 to secure the fold in place as described in [0082]-[0086]. Tissue glues can further be applied to secure the duodenal walls in this folded configuration as described in [0100]).
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Claim 2. The method according to claim 1, wherein the first surface of the duodenum wall comprises at least a portion of an inner surface of the duodenum wall (see interpretation 1 in the first annotated figure above in claim 1).
Claim 3. The method according to claim 1, wherein the first surface of the duodenum wall comprises at least a portion of an outer surface of the duodenum wall (see interpretation 2 in the second annotated figure above in claim 1).
Claim 4. The method according to claim 1, further comprising controlling the tension of the duodenum wall by changing the size of the fold ([0083]; “anchor 92 may optionally be diametrically adjusted and can be moved along a length of the circumferential pouch-cuff 72 to permit the circumferential pouch-cuff to be of different lengths and volumes”; changing the length or volume of the pouch-cuff 72 effectively changes the size of the fold and thereby encompasses the claimed language).
Claim 5. The method according to claim 1, further comprising creating a plurality of folds (see annotated figures from claim 1, wherein there is a fold on the bottom of the pouch-cuff 72 and another fold on the top of the pouch-cuff 72).
Claim 7. The method according to claim 5, wherein at least two of the plurality of folds are spaced apart (Fig. 9, the two annotated folds in claim 1 are longitudinally spaced apart and do not exist at the same axial location along the duodenum).
Claim 8. The method according to claim 1, wherein the at least one fold extends circumferentially around the duodenum wall (Fig. 9 illustrates the cross section, while Fig. 10 shows the folds extending circumferentially all the way around the duodenum when the securing member 70 is retracted as described in [0082]).
Claim 10. The method according to claim 1, wherein the at least one fold is essentially parallel to a longitudinal axis of the duodenum (Fig. 9).
Claim 13. The method according to claim 1, wherein the at least one implant comprises a wire (88’), and wherein securing the position of the at least one fold comprises suturing the duodenum wall using the wire (Figs. 8, 12; [0086]).
Claim 14. The method according to claim 1, wherein the at least one implant comprises a biological glue (tissue glue), and wherein securing the position of the at least one fold comprises gluing the first surface of the duodenum wall to the second surface of the duodenum wall ([0100]; “use of tissue glues…to induce a more secure attachment with the intestinal (such as the duodenal) walls”).
Claim 15. The method according to claim 1, wherein the at least one implant comprises a locking mechanism, the locking mechanism comprising two lockable portions (70 and 88’), and wherein securing the position of the at least one fold comprises:
securing a first lockable portion (70) of the locking mechanism to the first surface (region of outer surface which is now folded inward of pouch-cuff 72 in Fig. 9) of the duodenum wall;
securing a second lockable portion (88’) of the locking mechanism to the second surface (outer surface of the pouch-cuff 72) of the duodenum wall; and
locking (via stitching) the first lockable portion with the second lockable portion (Fig. 12; [0086]).
Claim Rejections - 35 USC § 103
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krueger et al in view of Dalessandro et al (US 2005/0070929).
Claim 12. Krueger et al discloses the invention substantially as claimed above, but fails to disclose the at least one implant is composed of an absorbable material configured to absorb into the tissue of the subject. However, Krueger et al does disclose the implant as being temporary or removable and therefore not permanently required ([0070]).
In a field of similar endeavor, Dalessandro et al implants are often applied to the surface of the duodenum in surgical procedures to hold the tissue together ([0002], [0045]), wherein these implants may be nontoxic bioasborbable adhesives which are absorbed into tissue of the subject ([0033], [0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one known securing implant (implants of Krueger et al) with another (bioabsorbable adhesive of Dalessandro et al) to achieve the predictable result of holding the duodenal wall tissue together for the desired duration of time.
Allowable Subject Matter
Claims 6, 9 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the drawing objections are obviated without introducing new matter.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Krueger et al, discloses the invention substantially as claimed above.
In regards to claim 6, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed method for shortening a duodenum comprising, inter alia, at least two of the plurality of folds are abutting. The method of Krueger et al involves forming two folds (top and bottom fold defining pouch-cuff 72) as shown in Fig. 9. However, these folds are longitudinally spaced one from another and are therefore not abutting. To form abutting folds, an additional would be necessary and Krueger et al does not provide any indication as to why that would be necessary or advantageous.
In regards to claim 9, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed method for shortening a duodenum comprising, inter alia, at least two of the plurality of folds are parallel to each other. Krueger et al discloses alternative methods that involves a plurality of folds (144) being parallel to one another (Fig. 27; [0075]). However, this would does not result in a shortening of a duodenum as required by claim 1. These parallel folds are to form additional longitudinal channels as seen in Figs. 3-4 for example and do not shorten the duodenum. The method of Figs. 1-6, 27 with the parallel folds do not overlap in scope with the cited embodiment (Figs. 7-12) of the instant rejection above.
In regards to claim 11, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed method for shortening a duodenum comprising, inter alia, the at least one fold is essentially perpendicular to a longitudinal axis of the duodenum. The method of Krueger et al involves forming a fold longitudinally and therefore opposite to what is recited in claim 11. The longitudinal positioning of the channel is a result of the suture (88’) and knots (96) being positioned through the duodenal walls and the holes (94) of the supporting member (70) (Figs. 9 and 12; [0086]). It would not have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the longitudinal fold to a fold that is essentially perpendicular to the longitudinal axis of the duodenum as this would alter the stitching and securement of the fold.
Other related prior art includes Stack et al (US 2005/0247320) which teaches a method of shortening tissue by folding the tissue with a perpendicular fold (18), or parallel and abutting folds (Fig. 22A) and securing the fold with an implant (106, 2A, 94). However, this method is manipulating the stomach and esophageal tissue. There are no discussions in Stack et al related to the folding of duodenal tissue to shorten the duodenum.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771