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 Claims
As directed by the amendment filed on 3 December 2025: claim(s) 1, 18, and 19 has been amended. Thus, Claims 1-7 and 16-19 are presently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-2, 5-6, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marco et al. (US 20090182424 A1) in view of Schauer et al. (US 20130331642 A1) and further in view of Cully et al. (US 20080255594 A1).
Regarding Claim 1, Marco discloses a gastrointestinal device (see Abstract) comprising a disintegrable sleeve (represented at least by the implants 180(b) shown in FIG. 14 and 240 in FIG. 20A) comprising a proximal end and a distal end (see FIG. 14 & 20A),
wherein the disintegrable sleeve ("180(b)) shows several structural members"; [0092]; FIG. 13) comprises a plurality of non-erodible segments ("panels or sheets may be constructed in such a way that they are … not bioerodible"; [0093]; FIG. 14) connected by one or more erodible portions ("circumferential structural members (182) and longitudinal structural members (184)"; [0092]; FIG. 14),
whereupon erosion of the one or more erodible portions, the plurality of non-erodible segments separates ("sheets or panels may be constructed in such a way that they have selectively erodible pathways that allow the structure to maintain its effective shape in the stomach and then to degenerate into smaller portions"; [0093]),
wherein the plurality of non-erodible segments comprise of expanded polytetrafluoroethylene (“ePTFE” [0177]), the one or more erodible portions comprise of poly(lactic-co-glycolic acid) (“biodegradable copolymer comprises a lactic acid and glycolic acid copolymers sometimes referred to as poly(dl-lactic-co-glycolic acid) (PLG)” [0174]-[0175]).
Marco fails to specify the plurality of non-erodible segments comprise of a copolymer of expanded polytetrafluoroethylene and fluorinated ethylene-propylene. However, Schauer teaches a preformed gastric band comprising of a flexible substrate and a plurality of band members ([0006]) wherein the plurality of non-erodible segments (“substrate 14” [0034]) comprise of a copolymer of expanded polytetrafluoroethylene and fluorinated ethylene-propylene (“expanded PTFE (ePTFE)”, “fluorinated ethylene propylene”, “and/or copolymers thereof” [0034]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Marco with Schauer’s teaching to suitably control the “the absorption or degradation rate of the material” ([0034]).
Marco/Schauer fails to specify the one or more erodible portions have a thickness that is at least 30% less than the non-erodible segments of the sleeve. However, the courts have held that a change in form, proportions, or degree "will not sustain a patent" (Smith v. Nichols, 88 U.S. 112, 118-19 (1874) and "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." (In re Williams, 36 F.2d 436, 438 (CCPA 1929) (MPEP 2144.05). The instant Specification fails to present any critically on the proportion as claimed (Specification pg. 7 ln. 20-35). Furthermore, 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 SPQ 232 (1984). In the instant case, the device of Marco/Schauer/Cully would not operate differently with the claimed proportions. Therefore, it would have been obvious to modify the device of Marco/Schauer/Cully to have the proportion as claimed to suitably “allow step-wise removal” of the implant in “a controlled manner” ([0096]) and to optimize the device so that the “dimensions allow the implant, when properly collapsed, to be swallowed by a patient” ([0132]).
Marco/Schauer fails to specify an anchoring system configured for securing the sleeve to a patient's pylorus, wherein the disintegrable sleeve is configured to fit within a patient's duodenum and carry fluid from the proximal end to the distal end. However, Cully teaches a gastrointestinal sleeve having different properties along its length (see Abstract) comprising an anchoring system ("anchoring component"; [0058]) configured for securing the sleeve to a patient's pylorus ("anchoring component is used to at least partially fix the device inside a portion of the gastrointestinal tract, e.g., before, across, or after the pylorus"; [0058]),
wherein the disintegrable sleeve is configured to fit within a patient's duodenum ("apparatus includes a first anchoring component sized to be located in a patient's duodenum and a first sleeve attached to and extending from the first anchoring component"; [0046]) and carry fluid from the proximal end to the distal end (“sleeve is a conduit for transporting ingested materials, e.g., pre-digested food, chyme, gastrointestinal material and fluids found in the stomach, and the like”; [0039]).
Therefore, it would have been obvious to modify the Marco/Schauer device as taught by Cully, to securely anchor the sleeve in a therapeutically optimal location in the gastrointestinal tract ([0058]) “to permit at least partial isolation of ingested and/or gastrointestinal fluids, such as, bile and pancreatic juices, from at least portions of the gastrointestinal tract” ([0039]).
Regarding Claim 2, Marco discloses the plurality of non-erodible segments is aligned along a longitudinal axis (see FIG. 14).
Regarding Claim 5, Marco discloses the one or more erodible portions are strips that run perpendicularly to the longitudinally aligned non-erodible segments (see FIG. 20A).
Regarding Claim 6, Marco discloses the one or more erodible portions are strips that run substantially non-perpendicularly to the longitudinally aligned non-erodible segments (see FIG. 14).
Regarding Claim 19, Marco fails to specify the disintearable sleeve comprises from 5 to 40 segments. However, Cully teaches a gastrointestinal sleeve having different properties along its length (see Abstract) comprising 5 to 40 segments (“six equal or non-equal sleeve segments” [0075]). Therefore, it would have been obvious to modify Marco’s device as taught by Cully “allow a physician to release a portion of the sleeve thereby permitting in-situ length adjustment” ([0075]).
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marco/Schauer/Cully et al. in view of Stopek et al. (US 20100010519 A1).
Regarding Claim 3, Marco discloses each of the plurality of non-erodible segments forming a annular shape (see FIG. 14) but fails to specify each of the plurality of non-erodible segments are annular. However, Stopek teaches a sleeve (“sheath”) comprising at least one biodegradable portion and at least one non-biodegradable portion ([0014]) for use in the body’s gastrointestinal system ([0029]) wherein each of the plurality of the non-erodible segment is annular ("sheath is tubular-shaped"; [0050]; FIG. 5). Therefore, it would have been obvious to modify Marco/Schauer/Cully’s device as taught by Stopek, to suit the desired “method of use and patient anatomy” ([0045]).
Regarding Claim 7, Marco discloses the one or more erodible portions ([0092]; FIG. 14) but fails to specify the proportion wherein the one or more erodible portions have a longitudinal width that is no more than 10% than that of the non-erodible segments of the sleeve. However, Stopek teaches a sleeve (“sheath”) comprising at least one biodegradable portion and at least one non-biodegradable portion ([0014]) for use in the body’s gastrointestinal system ([0029]) wherein the one or more erodible portions have a longitudinal width that is no more than 10% than that of the non-erodible segments of the sleeve ("majority of the total length of the sheath is non-biodegradable"; [0051]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Marco/Schauer/Cully’s device as taught by Stopek, to suitably control degradation profile and times and “mitigate inflammation and encapsulation” ([0044]).
Claim(s) 4 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marco/Schauer/Cully et al. in view of Dann et al. (US 20070010866 A1).
Regarding Claim 4, Marco discloses the one or more erodible portions are configured to erode but fails to specify the one or more erodible portions are configured to erode in a distal-to-proximal direction. However, Dann teaches devices and methods for attachment of a gastrointestinal bypass sleeve (see Abstract) comprising “a series of segments that biodegrade sequentially” ([0107]) wherein the one or more erodible portions are configured to erode in a distal-to-proximal direction ("first portion on the distal end of the sleeve may degrade first, followed some time later by a second intermediate portion and a third proximal portion"; [0107]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Marco/Schauer/Cully’s device as taught by Dann, to “allow a gradual change of therapy over time” and “allow for a safe mode of degradation and elimination” without any danger of bowel obstruction ([0107]).
Regarding Claim 16, Marco fails to specify the sleeve is at least 30 cm in length. However, Dann teaches devices and methods for attachment of a gastrointestinal bypass sleeve (see Abstract) comprising “a series of segments that biodegrade sequentially” ([0107]) wherein the sleeve is at least 30 cm in length ("gastrointestinal sleeve 100 is preferably approximately 60-180 cm in length"; [0104]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Marco/Schauer/Cully’s device as taught by Dann, to suitably “reduce the absorption of nutrients” “depending upon the desired clinical outcome” ([0104]).
Regarding Claim 17, Marco discloses the gastrointestinal device of claim 1 but fails to specify a method of implanting the gastrointestinal device of claim 1, the method comprising securing the device to a surface proximal to or within the duodenum of the patient. However, Dann teaches devices and methods for attachment of a gastrointestinal bypass sleeve (see Abstract) comprising “a series of segments that biodegrade sequentially” ([0107]) wherein the method comprises securing the device to a surface proximal to or within the duodenum of the patient ("distal end of the bypass tube may be positioned … in the patient's duodenum"; [0020]). Therefore, it would have been obvious to modify Marco/Schauer/Cully’s method as taught by Dann, to suitably anchor the implant to the target site within the body ([0062]).
Regarding Claim 18, Marco discloses a method of treating a metabolic disorder using the gastrointestinal device of claim 1 but fails to specify the method comprising securing the device to a surface proximal to or within the duodenum of the patient. However, Dann teaches devices and methods for attachment of a gastrointestinal bypass sleeve (see Abstract) comprising “a series of segments that biodegrade sequentially” ([0107]) wherein the method comprises securing the device to a surface proximal to or within the duodenum of the patient ("distal end of the bypass tube may be positioned … in the patient's duodenum"; [0020]). Therefore, it would have been obvious to modify Marco/Schauer/Cully’s method as taught by Dann, to suitably anchor the implant to the target site within the body ([0062]).
Conclusion
Applicant's amendment 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781