DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claims 2-21 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,758,300.
Claim 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,758,300 in view of Truckai et al (2002/0022870). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘300 patent teach the claims of the application except for actuating an inflation source to further expand the energy-delivery surface in the uterine cavity in a direction transverse to the lateral direction. Truckai et al teaches an analogous method for performing endometrial ablation comprising actuating an inflation source (40) to further expand the energy-delivery surface in the uterine cavity in a direction transverse to the lateral direction (paragraphs 0065, 0083, 0085, 0087 and 0094-0098; Figures 8-11). Truckai et al teaches that the distal end would be inflated by introduction of an inflation medium such as air into the balloons (52) via a port similar to port 38 using an apparatus similar to the suction/insufflation apparatus 40 (paragraph 0087). Truckai et al teaches that the balloons (52) are a potential addition to the structure of the 12 (paragraphs 0085 and 0087). Furthermore, Truckai et al teaches that carbon dioxide gas is introduced into the tube 17 via the port 38 (paragraph 0094; Figure 6) and then expands the distal end as shown in Figures 9-10 as discussed in paragraph 0095. Paragraph 0099 discusses that after the positioning is determined to be proper the insufflation is terminated, which means that immediately after the metal frame is expanded the inflation source is still being actuated to further expand the energy-delivery surface in the uterine cavity in a direction transverse to the lateral direction. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method for performing endometrial ablation, as taught by the ‘300 patent, to actuate an inflation source to further expand the energy-delivery surface in the uterine cavity in a direction transverse to the lateral direction, as taught by Truckai et al, in order to add structural integrity to the electrode carrying means when it is deployed within the body (paragraph 0085) and to achieve good contact with the endometrium (paragraphs 0094-0098; Figures 8-11).
Claim Rejections - 35 USC § 112
Claim 5 is 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.
Claim 5 recites the limitation "in a first plane" in line 2 and “in a direction generally transverse to the first plane” in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “in a lateral direction” in line 5 of claim two and “in a direction transverse to the lateral direction” in line 7 of claim two. It is not clear if claim 5 is claiming additional directions or if they are referring to the newly amended directions.
Claim Rejections - 35 USC § 102
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:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-9, 13, 16-19 and 21 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Truckai et al (2002/0022870).
Referring to claims 2-4, 16 and 21, Truckai et al teaches a method for performing endometrial ablation, comprising: introducing a probe working end into a patient's uterine cavity (paragraph 0079; Figures 6 and 7), the working end comprising a compliant energy-delivery surface (12) (paragraphs 0064-0067; Figures 1-11 and 20)
and an expandable-contractible metal frame (15/19) moveable from a linear configuration to an expanded triangular shape and having one or more spring elements (15/19) (paragraphs 0059-0060, 0081-0082 and 0086; Figures 1-11); actuating the expandable-contractible metal frame (15/19) from its linear configuration to its expanded triangular shape in order to expand the energy-delivery surface (12) within the uterine cavity in a lateral direction (paragraphs 0059-0060, 0079, 0081-0082, 0086 and 0094-0098; Figures 6-11); actuating an inflation source (40) to further expand the energy-delivery surface (12 using balloons 52) in the uterine cavity in a direction transverse to the lateral direction (paragraphs 0065, 0081-0085, 0087 and 0094-0098; Figures 5A-11 and 20) and delivering energy from or through the energy-delivery surface (12) to cause endometrial ablation (paragraphs 0067-0071 and 0094-0106).
Referring to claim 5, Truckai et al teaches wherein the expandable-contractible metal frame (15/19) expands the compliant energy-delivery surface (12) in a first plane and the inflation expands the compliant energy-delivery surface (12) in a direction generally transverse to the first plane (paragraphs 0065, 0079, 0081-0083, 0085, 0087 and 0094-0098; Figures 5A-11 and 20).
Referring to claims 6 and 17, Truckai et al teaches wherein the energy is delivered by at least one electrode (14) carried by the compliant energy-delivery surface (12) (paragraph 0057, 0085 and 0101; Figures 1-19C).
Referring to claims 7 and 18, Truckai et al teaches wherein the energy is delivered by bipolar electrodes (14) carried by the compliant energy-delivery surface (paragraph 0057).
Referring to claims 8 and 19, Truckai et al teaches wherein the energy is delivered by conductive heating the compliant energy-delivery surface (paragraphs 0067-0077 and 0105).
Referring to claim 9, Truckai et al teaches wherein the inflation source (40) delivers an inflation pressure to the working end of at least 20 mmHg (paragraph 0093).
Referring to claim 13, Truckai et al teaches wherein the compliant energy-delivery surface (12) is expanded in one stage by the expandable-contractible metal frame (15/19) and in a separate stage by the inflation source (40) (paragraphs 0065, 0081-0085, 0087 and 0094-0098; Figures 5A-11 and 20). It is noted that the claim only requires that these stages are separate but does not claim which stage occurs first.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 10-12, 14-15 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Truckai et al (2002/0022870) as applied to claims 2 and 16 above, and further in view of Stern et al (6,041,260).
Referring to claims 10 and 20, Truckai et al teaches wherein the working end comprises an inflation chamber (52) wherein a circulating gas stream within the inflation chamber is maintained at least 20 mmHg above ambient pressure (paragraphs 0065, 0081-0085, 0087 and 0108), however fails to expressly teach an inflation chamber surrounded by a thin wall elastomeric membrane. Stern teaches an endometrial ablation method that utilizes an elastomer for member 14 for the purpose of effecting contact with the endometrial lining to be destroyed (abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the inflation chamber, as taught by Truckai et al, to be surrounded by a thin walled elastomeric membrane, as taught by Stern et al, in order to effect contact with the endometrial lining to be destroyed (abstract).
Referring to claims 11 and 12, the modified Truckai reference teaches wherein the compliant energy-delivery surface (12) circumscribes the inflation chamber (52) and wherein the compliant energy-delivery surface (12) further circumscribes the expandable-contractible metal frame (15/19) (paragraphs 0065, 0079, 0081-0082, 0087 and 0094-00108; Figures 1-11).
Referring to claim 14, the modified Truckai reference teaches the compliant energy-delivery surface comprises a thin-walled elastomer (Col. 5, lines 9-30 of Stern). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the inflation chamber, as taught by Truckai et al, to be surrounded by a thin walled elastomeric membrane, as taught by Stern et al, in order to effect contact with the endometrial lining to be destroyed (abstract).
Referring to claim 15, the modified Truckai reference teaches discloses the claimed invention except for that the elastomer is silicone. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the elastomer to be silicone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
New grounds of rejection have been made, however applicant's arguments filed February 13, 2026 have been fully considered but they are not persuasive. Truckai et al teaches that the energy-delivery surface (12) can further include a pair of inflatable balloons (52) as shown in Figure 20 (paragraph 0087) and states that “it is most desirable for the electrodes 14 on the surface of the electrode carrying means 12 to be held in contact with the interior surface of the organ to be ablated, the electrode carrying means 12 may be provide to have additional components inside it that add structural integrity to the electrode carrying means when it is deployed within the body” (paragraph 0085). Therefore, Truckai et al teaches actuating the expandable-contractible metal frame (15/19) from its linear configuration to its expanded triangular shape in order to expand the energy-delivery surface (12) within the uterine cavity in a lateral direction (paragraphs 0059-0060, 0079, 0081-0082, 0086 and 0094-0098; Figures 6-11) and actuating an inflation source (40) to further expand the energy-delivery surface (12 using balloons 52) in the uterine cavity in a direction transverse to the lateral direction
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794
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