DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. 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.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
4. Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Marsella U.S. 2007/0066990 (herein referred to as “Marsella”).
5. Regarding Claim 1, Marsella teaches a system for endometrial ablation (para 0014), comprising:
a. an elongated shaft (Fig. 1, ref num 108);
b. an expandable RF ablation device disposed at a distal end of the elongate shaft (Fig. 2, ref num 150, 152), the expandable RF ablation device configured to be deployed into a uterine cavity (Fig. 2, ref num 104), the RF ablation device comprising:
b.1 an elongated cervical seal carried by the elongated shaft (Fig. 2, ref num 150);
b.2 wherein the cervical seal is configured to convert from an axially extended configuration to provide a reduced cross-section for insertion in a cervical canal to a radially expanded configuration for sealing the cervical canal (para 0021, “the cervical seal 150 comprises a flexible element 152 designed so that, when compressed longitudinally, the flexible element 152 expands radially to increase the effectiveness of the seal against the cervix 102”; also see Figs. 3a, 3b); and
b.3 an inflation source coupled to the cervical seal for expanding the cervical seal after insertion in the cervical canal (para 0028, “the inflatable element 256 is connected to a source of inflation fluid via a conduit 254. The source of inflating fluid (not shown) may include, for example, a simple hand-syringe, a compressor, a pump, a pressure storage device, or any other means”; Marsella teaches multiple embodiments may be modified or combined with one another, para 0015, 0033).
Double Patenting
6. 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).
7. 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).
8. 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.
9. 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.
10. Claim(s) 1-20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 3-19 of U.S. Patent No. 12,207,844 (herein referred to as “Patent ‘844”) and in view of Marsella U.S. 2007/0066990 (herein referred to as “Marsella”). Patent ‘844 teaches a cervical seal configured to convert from an axially extended configuration for insertion in a cervical canal to a radially expanded configuration for sealing the cervical canal, the cervical seal comprises a plurality of ridges. However, Patent ‘844 fails to explicitly teach an elongated shaft and an expandable RF ablation device at the distal end of the elongated shaft. It is noted that Patent ‘844 teaches a distal balloon that could read on the expandable device disposed at a distal end of the device. However, Marsella teaches an elongated shaft and an expandable RF ablation device at the distal end of the elongated shaft (Fig. 1, ref num 108, Fig. 2, ref num 150,152). This provides a means of delivering the cervical seal to the cervical canal for sealing the area (para 0005). Therefore, the combination of Patent ‘844 and the prior art Marsella would produce the same expected result of a device with an elongated shaft and expandable RF ablation device at the distal end, as this provides the means to deliver the cervical seal to the target area for sealing.
11. Claim(s) 1-20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-7 of U.S. Patent No. 10,588,689 (herein referred to as “Patent ‘689”) and in view of Marsella U.S. 2007/0066990 (herein referred to as “Marsella”). Patent ‘689 teaches an elongated shaft and a cervical seal configured to convert from an axially extended configuration for insertion in a cervical canal to a radially expanded configuration for sealing the cervical canal, the cervical seal comprises a plurality of ridges. However, Patent ‘689 fails to explicitly teach an expandable RF ablation device at the distal end of the elongated shaft. It is noted that Patent ‘689 teaches a distal balloon that could read on the expandable device disposed at a distal end of the device. However, Marsella teaches an expandable RF ablation device at the distal end of the elongated shaft (Fig. 2, ref num 150,152). This provides a means of delivering the cervical seal to the cervical canal for sealing the area (para 0005). Therefore, the combination of Patent ‘689 and the prior art Marsella would produce the same expected result of a device with an elongated shaft and expandable RF ablation device at the distal end, as this provides the means to deliver the cervical seal to the target area for sealing.
12. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,585,712. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent and the instant application recite the same basic device for sealing a uterine cavity of a patient, such that the instant application discusses such device that includes all of the structural features recited in the reference patent. For example, the instant application recites an elongated shaft and an expandable ablation device comprising a cervical seal, which can be found in Claim(s) 1 and 9 of the reference patent. Both the instant application and reference patent recite nearly identical independent claims in regards to the rest of the claim language. Therefore, the reference patent anticipates the instant application.
13. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 8, 9, and 13 of U.S. Patent No. 8,926,629. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent anticipate the claims of the instant application. Here, the more specific patent claims encompass the broader instant application claims. For example, Claim 1 of the instant application discusses a generic device/system comprising an elongated shaft, an expandable RF ablation device, and an elongated cervical seal, which is a broader recitation compared to the limitations outlined in the reference patent. Following the rationale in In re Goodman cited in the preceding paragraph, wherein the applicant has once been granted a patent containing a claim for the specific narrow invention, the applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Allowable Subject Matter
14. Claims 2-20 contain allowable subject matter. The prior art of record does not disclose or fairly suggest either singly or combination the claimed system for endometrial ablation comprising a cervical seal with a plurality of annular ridges configured for engaging tissue surrounding the cervical canal. This language is similarly recited in previously allowed applications found within the same family as the present application, and therefore, follows the same reasons for finding allowable subject matter as these previous applications (see applications 18/407,835; 16/783,987; 15/422,800; 14/560,221; 13/270,942).
15. Claims 2-18 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.
Conclusion
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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