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 .
Allowable Subject Matter
Claims 7, 10, 11, 13, and 14 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The ‘sensor mechanism’ limitations of claim(s) 2-3 and 19-20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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
Claim(s) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-20 of U.S. Patent No. 12089948. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
Claim(s) 1 and 18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 20 of U.S. Patent No. 10213151. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 8 is/are 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 pre-AIA the applicant regards as the invention.
For claim(s) 8, the body of the claim(s) recites
“the controller is configured to provide a notification that the uterus is perforated to thereby characterize if the flow rate of the fluid flow does not drop below the predetermined minimum threshold level over the predetermined time interval after initiation of the fluid flow”
It is not clear, in the context of the claim(s), how the phrase ‘to thereby characterize if’ modifies the subsequent language in the claim(s) and as such the claim(s) as a whole is not clear. The scope of the claim is unclear enough that a determination of any applicable prior art cannot be made until the issues of clarity are resolved.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-6 and 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US 20130310705 A1) in view of Freed (US 20100228239 A1).
For claim(s) 1 and 18, Toth teaches
an elongated probe [110] configured for trans-cervical introduction to a uterine cavity;
an energy applicator [150] for ablating uterine tissue in uterus, the energy applicator positioned at a distal end of the elongated probe, the energy applicator including a flexible polymeric membrane defining an interior chamber; [¶41]
and a first flow channel extending along the flexible polymeric membrane distal of a proximal end of the flexible polymeric membrane to a first distal outlet opening to an exterior of the flexible polymeric membrane;
a second flow channel extending along the flexible polymeric membrane distal of the proximal end of the flexible polymeric membrane to a second distal outlet opening to the exterior of the flexible polymeric membrane;
a pressurized fluid source [140A] adapted to deliver a fluid flow through the flow channel to exit the at least one distal outlet when the energy applicator is positioned in the uterine cavity;
and a controller [135] configured to monitor at least one fluid flow parameter of the fluid flow.
Toth fails to teach first and second flow channels and outlets extending distal of the proximal end of the membrane.
Freed teaches a uterine ablation device [abstract, ¶34 use for delivering fluid] having fluid delivery through first and second distal flow channels and outlets [Fig. 8 protrusions 402 with flow channels therebetween; Fig. 4-5 channels 400] which extend distal of a proximal end of, and are open to, an exterior of a polymeric membrane [50 in Fig(s). 5]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Toth to incorporate the first and second channels and outlets of Freed in order to ensure delivery of the fluid to the target anatomy (i.e., the uterus) during the procedure. As motivated by Freed ¶34.
For claim(s) 2, Toth teaches The system of claim 1,
wherein the controller is coupled to a sensor mechanism configured to monitor the at least one fluid flow parameter. [flow assessment to determined perforation in ¶¶62-67]
For claim(s) 3, Toth teaches The system of claim 2,
wherein the sensor mechanism is selected from the group of a flow rate meter, a pressure sensor and a flow volume meter. [¶49]
For claim(s) 4, Toth teaches The system of claim 1,
wherein the controller is configured to control a flow rate of the fluid flow at a rate of between 0.01 slpm and 1.0 slpm. [¶63]
For claim(s) 5, Toth teaches The system of claim 4,
wherein the controller is configured to determine if the flow rate of the fluid flow drops below a predetermined minimum threshold level over a predetermined time interval after initiation of the fluid flow. [¶63]
For claim(s) 6, Toth teaches The system of claim 5,
wherein the predetermined time interval is between 1 second and 20 seconds. [near the beginning of ¶63 - overlapping range of 1-60 s or 5-30s]
For claim(s) 12, Toth teaches The system of claim 1,
wherein the energy applicator is triangular-shaped in an expanded configuration. [Fig(s). 2]
For claim(s) 15, Toth teaches The system of claim 1,
wherein the at least one distal outlet is located at a distal tip of the flexible polymeric membrane. [202 in Fig(s). 5]
For claim(s) 16, Toth teaches The system of claim 1,
wherein the fluid flow comprises CO2. [¶59]
For claim(s) 17, Toth teaches The system of claim 1,
wherein the elongate probe includes a cervical seal [225] configured to prevent fluid leakage outwardly from the uterine cavity.
For claim(s) 19, Toth teaches The system of claim 18,
wherein the controller is coupled to a sensor mechanism configured to monitor the at least one fluid flow parameter. [¶49]
For claim(s) 20, Toth teaches The system of claim 19,
wherein the sensor mechanism is selected from the group of a flow rate meter, a pressure sensor and a flow volume meter. [¶49]
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Sampson (US 20030191412 A1).
For claim(s) 9, Toth fails to teach the controller providing a perforation notification.
Sampson teaches a uterine perforation detection system [abstract] including a controller that alerts to a uterine perforation if a pressure drops below a threshold for a time. [¶12 ¶35 ¶38]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the controller of Toth to incorporate the alerting of Sampson in order to aid in determining whether a patient’s uterus is perforated. As motivated by Sampson ¶12 ¶35 ¶38.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
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