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 .
CLAIM INTERPRETATION
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.
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.
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:
A “vibrating element” supported by the cervical cup, the “vibrating element” configured to initiate ureter peristalsis, which, in turn, provides feedback to the surgeon confirming contact between the cervical cup and the ureter and provides feedback to the surgeon confirming a location of the cervical cup within a uterus in claims 21, 32 and 40.
Claims 21, 32 and 40 function: ‘initiating ureter peristalsis’ and ‘providing feedback to confirm contact/location.’
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.
Claim Rejections - 35 USC § 112
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) 21-40 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “vibrating element” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim [0007, 0010, 0042] and Fig. 1 which only displays the vibrating element (163) as a dot disposed on the cervical cup. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For the purposes of art rejections, the vibrating element will be interpreted as a piezoelectric actuator, eccentric mass motor, ultrasound transducer or equivalents thereof.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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) 21 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,127,798. This is an actual NSDP rejection over U.S. Patent No. 12,127,798, which is commonly owned with the present application by Covidien LP. U.S. Patent No. 12,127,798 recites a position sensor on the cervical cup and instant claim 21 does not. A person of ordinary skill in the art would have viewed the omission of the position sensor as an obvious variant because the U.S. Patent No. 12,127,798 claim teaches confirming contact/location through ureter peristalsis feedback; a sensor provides an additional modality but is not required for the peristalsis-based confirmation (C4:L47-52). Therefore, the instant claim is not patentably distinct.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2018/0325554A1, “Prior”) in view of Erbey, II et al. (US 2017/0021129A1, “Erbey”).
Regarding claim 21, Prior discloses a uterine manipulator including a housing (20; Fig. 2), a shaft (40) extending distally from the housing, and end effector assembly (42) disposed at a distal end portion of the shaft. However, Prior does not disclose a vibrating element supported by the cervical cup that is capable of initiating ureter peristalsis which provides feedback to the surgeon confirming contact between the cervical cup and the ureter and a location of the cervical cup within a uterus.
In the same field of endeavor, ureteral devices, Erbey teaches a catheter(112) having a distal end including mechanical stimulation devices (191) that have linear or annular actuators embedded in or mounted to the sidewall of the catheter [0236; Fig. 4B]. The stimulation devices are capable of emitting low levels of vibration to actuate peristaltic muscles associated with the ureter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been motivated to include a low-level mechanical stimulator on the cervical cup to elicit physiologic feedback indicating proximity/contact with the ureter, thereby confirming instrument location and reducing risk of ureteral injury. Erbey teaches catheter-mounted vibratory actuators capable of inducing ureter peristalsis ([0236];Fig. 4B). Applying such a stimulator to Prior’s cervical cup is a predictable use of known components to achieve a known function (inducing peristalsis for feedback), with a reasonable expectation of success. See KSR, 550 U. S. at 417; MPEP 2143. With this modification, the uterine manipulator of the combination of Prior and Erbey is capable of initiating ureter peristalsis which provides feedback to the surgeon confirming contact between the cervical cup and the ureter and a location of the cervical cup within a uterus.
Claim(s) 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Prior in view of Erbey, as applied to claim 21 above, and further in view of Begg et al. (US 2021/0204910A1, “Begg”).
Regarding claims 22-24, the combination of Prior and Erbey does not disclose a plurality of position sensors arranged at a distal end portion of the cervical cup and capable of confirming the location of the cervical cup. In the same field of endeavor, medical devices used in treatment of cervix, uterus and surrounding tissue, Begg teaches a device that includes a shaft (320) having a distal end portion (424) that is used to abut with the cervix [0090-0093]. A plurality of position sensors (432, 532) are disposed on the distal end portion of the shaft in an array that is arranged circumferentially around a distal face portion and on the distal-facing portion (470) [0092-0093]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the distal end portion of the cervical cup of the combination of Prior and Erbey which abuts with the cervix, with the plurality of position sensors, as taught by Begg, to complement and confirm the peristalsis-based feedback while improving localization. The circumferential arrays on the distal face are well-suited for contact mapping of the cervix.
Claim(s) 40 are rejected under 35 U.S.C. 103 as being unpatentable over Prior in view of Erbey in view of Traina (US 2020/0253676A1).
Regarding claims 40, the combination of Prior and Erbey discussed above in claim 21 discloses the claimed uterine manipulator but does not disclose at least one robot arm capable of operating a uterine manipulator and a display device configured to display images of a patient’s anatomy overlaid with images of a position of the uterine manipulator relative to the patient’s anatomy. In the same field of endeavor, uterine manipulators/robotic teleoperation, Traina teaches a robotic system including a robot arm that is capable of operating a uterine manipulator and a display device that is capable of displaying images of a patient’s anatomy overlaid with images of a position of the uterine manipulator [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the uterine manipulator of the combination of Prior and Erbey with a robotic arm and display device, as taught by Traina, to provide improved telemanipulation and situational awareness.
Claim(s) 25, 27, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Prior in view of Erbey, as applied to claim 21 above, and further in view of Haisch et al. (US 2004/0152987A1).
Regarding claims 25, 27, 28 and 31, the combination of Prior and Erbey discloses a cervical cup (Fig. 7; Prior) having a tag in the form of light emitting diodes (102) that are arranged circumferentially around a distal-end portion and distal-facing surface of the cervical cup. The tag is capable of emitting light to identify a location of the cervical cup and includes a power source capable of activating the tag in the form of a generator, outlet or external battery [0060]. However, the combination of Prior and Erbey does not disclose that the tag is fluorescent.
In the same field of endeavor, visualizing fluorescent markers, Haisch teaches an LED that emits light within the fluorescent wavelength range [0041,0046]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have replaced or augmented visible LEDs with fluorescent emitters or dyes (Haisch; [0041, 0046]), to improve contrast and localization under surgical imaging, a predictable substitution of one known illumination modality for another. Predictable results include known wavelengths and dyes. Providing fluorescence improves contrast and visibility through tissue and blood, thus enabling better localization.
Claim(s) 25, 27-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Prior and Erbey, as applied to claim 21 above, and further in view of Steger et al. (US 2020/0078109A1, “Steger”).
Regarding claims 25, 27-29 and 31, the combination of Prior and Erbey discloses a cervical cup (Fig. 7; Prior) having a tag in the form of light emitting diodes (102) that are arranged circumferentially around a distal-end portion and distal-facing surface of the cervical cup. The tag is capable of emitting light to identify a location of the cervical cup and includes a power source capable of activating the tag in the form of a generator, outlet or external battery [0060]. However, the combination of Prior and Erbey does not disclose that the tag is fluorescent.
In the same field of endeavor, visualizing fluorescent markers, Steger teaches an LED or fluorescent dye that emits light from distal facing portion (Fig. 34) [0104-0107]. The fluorescent dye provides passive illumination markers. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have replaced or augmented visible LEDs with fluorescent emitters or dyes (Steger; [0104-0107]), to improve contrast and localization under surgical imaging, a predictable substitution of one known illumination modality for another. Fluorescence improves contrast and visibility through tissue and blood, thus enabling better localization.
Claim(s) 26 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Prior, Erbey and Steger, as applied to claim 25 above, and further in view of Doyle et al. (US 2020/0229890A1, “Doyle”).
Regarding claims 26 and 30, the combination of Prior, Erbey and Steger discloses a cervical cup (Fig. 7; Prior) having a tag in the form of light emitting diodes (102; Prior) that are arranged circumferentially around a distal-end portion and distal-facing surface of the cervical cup. The tag is capable of emitting light to identify a location of the cervical cup and includes a power source capable of activating the tag in the form of a generator, outlet or external battery [0060]. However, the combination of Prior, Erbey and Steger does not disclose that the emitted light is non-visible to humans.
In the same field of endeavor, visualizing fluorescent markers, Doyle teaches a cervical cup of a uterine manipulator having near infrared fluorescent dye [0006]. The near infrared fluorescent dye is non-visible to humans and is reactively fluorescent [0006], wherein the near infrared fluorescent dye is excited by a frequency of near infrared radiation [0007]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the LEDs of the combination of Prior, Erbey and Steger with the near infrared fluorescent dye and respective power source of excitation for activation, as taught by Doyle, as this modification involves the simple substitution of one light for another for the predictable result of improving contrast and visibility through tissue and blood to enable better localization.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prior et al. (US 2019/0150983A1) discloses a uterine manipulator including a cervical cup and Vasilevsky et al. (US 4,192,294) teaches vibration means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771