DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 15-36 are objected to because of the following informalities:
Claim 15, line 5, “an” should be inserted before “ethylene vinyl alcohol layer”.
Claim 29, line 5, “an” should be inserted before “ethylene vinyl alcohol layer”.
Appropriate correction is required.
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.
Claims 15-17, 21, and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,102,547 (Brister). Although the claims at issue are not identical, they are not patentably distinct from each other because Brister claims:
15. A method for fabricating a composite wall for use in an intragastric balloon system, comprising:
providing a polyethylene terephthalate layer coated with a silicon dioxide layer (claim 3) having a thickness of from about 100 Å to about 800 Å (claim 1);
providing a trilayer system comprising ethylene vinyl alcohol layer sandwiched between polyethylene layers (claim 4); and
adhesively bonding the silicon dioxide layer to one of the polyethylene layers (claim 4), whereby a composite wall structure configured to maintain a CO.sub.2 leak rate of less than or equal to 40 cc/m.sup.2/day at 37° C. is obtained (claim 1).
16. Brister claims the invention substantially as claimed as discussed above but is silent regarding the thickness of the composite wall structure such that it does not claim it being 2.5 mil or less. 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 claim of Brister to have the thickness of the composite wall structure be 2.5 mil or less 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 SPQ 232 (1984). In the instant case, the device of Brister would not operate differently with the claimed wall structure since both are intragastric balloons thereby functioning appropriately having the claimed value. Further, applicant places no criticality on the range claimed (see “In an embodiment…” at P0024).
17. The ethylene vinyl alcohol layer is bonded to the polyethylene layers via tie layers (Claim 4).
21. Brister claims the invention substantially as claimed as discussed above but is silent regarding the thickness of the silicon dioxide layer such that it does not claim it being of from about 200 Å to about 500 Å. 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 claim of Brister to have the thickness of the silicon dioxide layer be of from about 200 Å to about 500 Å 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 SPQ 232 (1984). In the instant case, the device of Brister would not operate differently with the claimed wall structure since both are intragastric balloons thereby functioning appropriately having the claimed value. Further, applicant places no criticality on the range claimed (see “preferably” at P0203).
29. A method for fabricating a composite wall for use in an intragastric balloon system, comprising:
providing a polyethylene terephthalate layer coated with a silicon dioxide layer (claim 3) having a thickness of from about 100 Å to about 800 Å (claim 1);
providing a trilayer system comprising ethylene vinyl alcohol layer sandwiched between polyethylene layers (claim 4); and
laminating (e.g., by adhesive bonding) the silicon dioxide layer to one of the polyethylene layers (claim 4), whereby a composite wall structure configured to maintain a CO.sub.2 leak rate of less than or equal to 40 cc/m.sup.2/day at 37° C. is obtained (claim 1).
30. Brister claims the invention substantially as claimed as discussed above but is silent regarding the thickness of the composite wall structure such that it does not claim it being 2.5 mil or less. 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 claim of Brister to have the thickness of the composite wall structure be 2.5 mil or less 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 SPQ 232 (1984). In the instant case, the device of Brister would not operate differently with the claimed wall structure since both are intragastric balloons thereby functioning appropriately having the claimed value. Further, applicant places no criticality on the range claimed (see “In an embodiment…” at P0024).
Conclusion
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771