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 § 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) 1-13, 15, and 31-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0256533 A1 to Roth et al. (hereinafter “Roth”).
Regarding claim 1, Roth discloses (see abstract; Figs. 1-64; and [0093]-[0186]) an endoscopic gastric apparatus (see at least [0093]) comprising: an applier (10, Fig. 1) having a distal end (42, Fig. 1) and a proximal end (50, Fig. 1), the applier including two gastric wall engagement elements (44/46) opposing one another and in cooperative arrangement (see Fig. 1) for engaging an anterior gastric wall and a posterior gastric wall (fully capable of, see [0165]-[0171]), respectively, into abutment ([0098]) and deploying one or a plurality of tissue fasteners (staples, see [0097]-[0098] and [0140]+), simultaneously or sequentially (see [0141]), operable for applying the one or the plurality of tissue fasteners to fix the anterior and posterior gastric walls together for the creation of a septum within a stomach defining an active stomach portion and a restricted stomach portion, wherein the septum allows for fluid communication between the active stomach portion and the restricted stomach portion through a pathway defined by the septum (these limitations are intended use limitations and the device of Roth is fully capable of being used in such a manner if one desired to do so (see also Figs. 35-64 and [0166]-[0186]) - note that the limitations are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) - see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Roth further discloses (claim 2) wherein the applier is secured at the distal end with a support (562) shaped and dimensioned for passage into an abdominal cavity (see [0157]); (claim 3) wherein the septum extends from a fundus to adjacent an antrum such that the pathway defined by the septum is adjacent the antrum (see the intended use form paragraph above, however, see also Figs. 35-64 and [0166]-[0186]); (claim 4) wherein each of the plurality of tissue fasteners is deployed sequentially (see [0141]); (claim 5) wherein each of the plurality of tissue fasteners is deployed simultaneously (see Fig. 22C and [0141], if there are four rows of staples but only two wedges, then it follows that at least two staples will be deployed simultaneously (especially staples which are at the same longitudinal location on the staple cartridge)); (claim 6) wherein the pathway is sized as to allow for passage of substances between the restricted stomach portion and the active stomach portion (see the intended use form paragraph above, however, see also Figs. 35-64 and [0166]-[0186]); (claim 7) wherein the one or the plurality of tissue fasteners is a staple (staples, see [0097]-[0098] and [0140]+) (claim 8) wherein a number of tissue fasteners deployed ranges from 1 to 40 (see Fig. 22C and [0141], using fewer than four rows would result in a number of staples being within the claimed range); (claim 9) wherein the endoscopic gastric apparatus comprises a first arced portion and a second arced portion at a proximal end of each of the two gastric wall engagement elements (see Fig. 30, each side of curved portion 568 defines arced portions at the proximal end of the stapler head); (claim 10) wherein the first and second arced portions are configured to enclose a spacing when the endoscopic gastric apparatus is in a closed configuration (see Figs. 30-31), the spacing operable to form the pathway defined by the septum (see intended use form paragraph above); (claim 11) wherein a first of the two gastric wall engagement elements comprises a cartridge (392) housing the one or plurality of tissue fasteners (see Figs. 20A-B and [0139]); (claim 12) wherein a second of the two gastric wall engagement elements comprises of one or a plurality of tissue fastener receiving elements (426) (see Fig. 22D and [0142]); (claim 13) wherein the one or the plurality of tissue fasteners comprises staples (414) and the one or the plurality of tissue fastener receiving elements comprises staple pockets (426) (see Figs. 20A-22D and [0139]-[0142]); (claim 15) wherein the two gastric wall engagement elements are configured to each have a length that are about equal (see Fig. 30)
Regarding claim 31, Roth discloses (see abstract; Figs. 1-64; and [0093]-[0186]) a method for treating obesity (see [0005]-[0009]), comprising: using the endoscopic gastric apparatus of claim 1 (see rejection of claim 1 above) to engage the anterior and posterior gastric walls towards each other in abutment at a location from a fundus to adjacent an antrum (see Figs. 35-42) defining an active stomach portion and a restricted stomach portion (see Figs. 41-43); and coupling the anterior and posterior gastric wall so as to secure the abutment and forming a septum (676) while retaining fluid communication between the active stomach portion and the restricted stomach portion (see Figs. 41-43 and [0166]-[0171]).
Roth further discloses (claim 32) wherein the septum is formed from the fundus to adjacent the antrum (see Fig. 43); (claim 33) wherein the fluid communication is retained through a pathway defined by the septum and a stomach wall (see Fig. 43); (claim 34) wherein coupling the anterior and posterior gastric wall includes positioning one of the two gastric wall engagement elements adjacent the anterior gastric wall and the other of the two gastric wall engagement elements adjacent the posterior gastric wall and deploying the one or more plurality of tissue fasteners (see Figs. 35-41 and [0166]-[0171]).
Regarding claim 35, Roth discloses (see abstract; Figs. 1-64; and [0093]-[0186]) a method for treating diabetes (see [0005]-[0009], Applicant's specification states that treating obesity also treats diabetes at [00061]), comprising: using the endoscopic gastric apparatus of claim 1 (see rejection of claim 1 above) to engage the anterior and posterior gastric walls towards each other in abutment at a location from a fundus to adjacent an antrum (see Figs. 35-42) defining an active stomach portion and a restricted stomach portion (see Figs. 41-43); and coupling the anterior and posterior gastric wall so as to secure the abutment and forming a septum (676) from the fundus to adjacent the antrum (see Fig. 43) while retaining fluid communication between the active stomach portion and the restricted stomach portion (see Figs. 41-43 and [0166]-[0171]).
Roth further discloses (claim 36) wherein coupling the anterior and posterior gastric wall includes positioning one of the two gastric wall engagement elements adjacent the anterior gastric wall and the other of the two gastric wall engagement elements adjacent the posterior gastric wall and deploying the one or more plurality of tissue fasteners (see Figs. 35-41 and [0166]-[0171]).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth.
Roth discloses the invention substantially as claimed as discussed above, however, with respect to claim 14, Roth fails to specifically disclose wherein the two gastric wall engagement elements are configured to each have a length that is about between 200 mm and 250 mm. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Roth's device have the claimed dimensions 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 USPQ 232 (1984).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing devices and methods for reducing the size of the stomach.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771