DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121,365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551,32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 13/540396, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of US Application No. 13/540396 does not provide support for the claim language “independent of changing the rotational speed of the motor drive”. While the disclosure does provide support for the claim language of an actuator “configured to provide a variable reciprocation speed of the inner sleeve within a full reciprocation stroke of the inner sleeve” it is silent regarding the rotational speed of the motor drive. There is no mention of a rotational speed of the motor drive within the disclosure much less whether the rotational speed changes or remains the same. In light of the lack of adequate support or enablement at least claims 10-11 have been given the filing date of July 27, 2017.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 16/691,992 which has now matured into a patent the paragraph should be updated with the issued patent number. Appropriate correction is required.
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.
Claims 1-19 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 1 recites “axially reciprocates the shaft to cause linear reciprocation” it is unclear whether “the shaft” is referring to the “an elongate shaft” of the handle or the “a shaft” of the actuator, clarification is required. Claims 2-19 directly or indirectly depend from claim 1 and are also rejected to for the reasons stated above regarding claim 1.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of U.S. Patent No. 9,737,362. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 9,737,362. recite a tissue resecting device with a handle, elongated shaft with an outer sleeve and a reciprocating inner sleeve, a motor drive and an actuator within an arcuate slot engaging a pin in the handle to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve with the only differences being that the claims within the instant application recite the rotational motion of the motor drive rotates the actuator to cause linear reciprocation, however the structure disclosed within claim 27 of U.S. Patent No. 9,737,362 with the pin engaging the arcuate slot of the actuator and the motor drive would provide such movement, see claim chart below.
Instant Application
U.S. Patent No. 9,737,362
Analysis
1. (Original) A tissue resecting device, comprising:
a handle; an elongate shaft extending from the handle, the elongate shaft including an outer sleeve and a reciprocating inner resecting sleeve disposed in the outer sleeve, wherein such reciprocation of the inner resecting sleeve moves a distal end of the inner resecting sleeve across a tissue- receiving window of the outer sleeve between window-open and window-closed positions;
a motor drive in the handle; and
an actuator in the handle coupled between the motor drive and the inner resecting sleeve to convert rotational motion from the motor drive to linear reciprocation motion of the inner resecting sleeve relative to the outer sleeve for reciprocating the inner resecting sleeve;
27. A tissue resecting probe comprising: a handle; an elongate shaft extending from the handle, the elongate shaft including: an outer sleeve having a tissue-receiving window; and an inner sleeve disposed in the outer sleeve; a motor drive in the handle; an actuator in the handle coupled between the motor drive and a pin fixed relative to the inner sleeve to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve relative to the outer sleeve; wherein the actuator includes an arcuate slot engaging the pin; wherein the arcuate slot is configured to provide a variable reciprocation speed of the inner sleeve within a full reciprocation stroke; wherein the full reciprocation stroke includes an extending stroke in which the inner sleeve moves from a window-open position to a window-closed position and a retracting stroke in which the inner sleeve moves from the window-closed position to the window-open position.
both the claims in the instant application and those within U.S. Patent No. 9,737,362. recite a tissue resecting device with a handle, elongated shaft with an outer sleeve and a reciprocating inner sleeve, a motor drive and an actuator within an arcuate slot engaging a pin in the handle to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve with the only differences being that the claims within the instant application recite the rotational motion of the motor drive rotates the actuator to cause linear reciprocation, however the structure disclosed within claim 27 of U.S. Patent No. 9,737,362 with the pin engaging the arcuate slot of the actuator and the motor drive would provide such movement.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,256,987. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 12,256,987 recite a tissue resecting device with a handle, elongated shaft with an outer sleeve and a reciprocating inner sleeve, a motor drive and an actuator with an arcuate slot in the handle to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve with the only differences being that the claims within the instant application do not recite a coupling arm spaced apart from the actuator, i.e. the claims within the instant application are generic to the species claims recited within U.S. Patent No. 12,256,987, see claim chart below. The entire scope of the claims in the instant application falls within the scope of the claims within U.S. Patent No. 12,256,987. The species claims in U.S. Patent No. 12,256,987 fully anticipate the claimed genus in the instant application, therefore a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus, see MPEP 804.
Instant Application
U.S. Patent No. 12,256,987
Analysis
1. A tissue resecting device comprising: a handle; an elongate shaft extending from the handle, the elongate shaft including an outer sleeve and a reciprocating inner resecting sleeve disposed in the outer sleeve, wherein linear reciprocation of the inner resecting sleeve moves a distal end of the inner resecting sleeve across a tissue-receiving window of the outer sleeve between window-open and window- closed positions; a motor drive in the handle; and an actuator in the handle coupled between the motor drive and the inner resecting sleeve to convert rotational motion from the motor drive to linear reciprocation motion of the inner resecting sleeve relative to the outer sleeve for reciprocating the inner resecting sleeve; wherein the actuator includes an actuator body, a shaft extending distally from the actuator body, and a pin disposed within an arcuate slot of the actuator body; wherein rotational motion from the motor drive rotates the actuator body to thereby axially reciprocate the shaft to cause linear reciprocation of the inner resecting sleeve relative to the outer sleeve.
1. A tissue resecting device, comprising: a handle; an elongate shaft extending from the handle, the elongate shaft including an outer sleeve and a reciprocating inner resecting sleeve disposed in the outer sleeve, wherein such reciprocation of the inner resecting sleeve moves a distal end of the inner resecting sleeve across a tissue-receiving window of the outer sleeve between window-open and window-closed positions; a motor drive in the handle; an actuator in the handle coupled between the motor drive and the inner resecting sleeve to convert rotational motion from the motor drive to linear reciprocation motion of the inner resecting sleeve relative to the outer sleeve for reciprocating the inner resecting sleeve; and a drive shaft coupled to the actuator; wherein the actuator converts rotational motion from the motor drive to linear reciprocation motion of the drive shaft such that the drive shaft translates axially relative to the handle; wherein linear reciprocation motion of the drive shaft is transferred to the inner resecting sleeve via a coupling arm spaced apart from the actuator; wherein the inner resecting sleeve extends proximal of the actuator and reciprocates relative thereto.
Both the claims in the instant application and those within U.S. Patent No. 12,256,987 recite a tissue resecting device with a handle, elongated shaft with an outer sleeve and a reciprocating inner sleeve, a motor drive and an actuator with an arcuate slot in the handle to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve with the only differences being that the claims within the instant application do not recite a coupling arm spaced apart from the actuator, i.e. the claims within the instant application are generic to the species claims recited within U.S. Patent No. 12,256,987.
2. The tissue resecting device of claim 1, wherein the inner resecting sleeve extends proximal of the actuator body and axially reciprocates relative thereto.
1. A tissue resecting device, comprising: a handle; an elongate…wherein the inner resecting sleeve extends proximal of the actuator and reciprocates relative thereto.
Fully anticipated
3. The tissue resecting device of claim 1, wherein the inner resecting sleeve is positioned parallel to and laterally offset from a central longitudinal axis of the motor drive.
2. The tissue resecting device of claim 1, wherein the inner resecting sleeve is positioned parallel to and laterally offset from a central longitudinal axis of the drive shaft.
Fully anticipated
4. The tissue resecting device of claim 3, wherein the motor drive is positioned coaxially with the actuator.
3. The tissue resecting device of claim 2, wherein the drive shaft is positioned coaxially with the actuator.
Fully anticipated
5. The tissue resecting device of claim 1, further comprising a heat exchanger disposed within the handle.
4. The tissue resecting device of claim 1, further comprising a heat exchanger disposed within the handle.
Fully anticipated
6. The tissue resecting device of claim 5, wherein the inner resecting sleeve extends proximally within the handle to the heat exchanger.
5. The tissue resecting device of claim 4, wherein the inner resecting sleeve extends proximally within the handle to the heat exchanger.
Fully anticipated
7. The tissue resecting device of claim 6, wherein the heat exchanger is configured to use fluid extracted through the inner resecting sleeve to cool the motor drive.
6. The tissue resecting device of claim 5, wherein the heat exchanger is configured to use fluid extracted through the inner resecting sleeve to cool the motor drive.
Fully anticipated
8. The tissue resecting device of claim 6, wherein the inner resecting sleeve extends through the heat exchanger.
7. The tissue resecting device of claim 5, wherein the inner resecting sleeve extends through the heat exchanger.
Fully anticipated
9. The tissue resecting device of claim 1, wherein a full reciprocation stroke includes an extending stroke in which the inner resecting sleeve moves from the window-open position to the window-closed position and a retracting stroke in which the inner resecting sleeve moves from the window-closed position to the window-open position.
8. The tissue resecting device of claim 1, wherein a full reciprocation stroke includes an extending stroke in which the inner resecting sleeve moves from the window-open position to the window-closed position and a retracting stroke in which the inner resecting sleeve moves from the window-open position to the window-closed position.
Fully anticipated
10. The tissue resecting device of claim 9, wherein the actuator is configured to vary a reciprocation speed of the inner resecting sleeve within one full reciprocation stroke of the inner resecting sleeve independent of changing rotational speed of the motor drive.
9. The tissue resecting device of claim 8, wherein the actuator is configured to vary a reciprocation speed of the inner resecting sleeve within one full reciprocation stroke of the inner resecting sleeve independent of changing rotational speed of the motor drive.
Fully anticipated
11. The tissue resecting device of claim 10, wherein the inner resecting sleeve has a faster speed during the retracting stroke and a slower speed during the extending stroke.
10. The tissue resecting device of claim 9, wherein the inner resecting sleeve has a faster speed during the retracting stroke and a slower speed during the extending stroke.
Fully anticipated
12. The tissue resecting device of claim 9, wherein the inner resecting sleeve has a dwell time in a fully extended stroke position to thereby allow negative and/or positive pressures to move tissue through the inner resecting sleeve.
11. The tissue resecting device of claim 8, wherein the inner resecting sleeve has a dwell time in a fully extended stroke position to thereby allow negative and/or positive pressures to move tissue through the inner resecting sleeve.
Fully anticipated
13. The tissue resecting device of claim 12, wherein the dwell time is at least 0.1 second.
12. The tissue resecting device of claim 11, wherein the dwell time is at least 0.1 second.
Fully anticipated
14. The tissue resecting device of claim 1, further comprising a controller for controlling reciprocation of the inner resecting sleeve.
13. The tissue resecting device of claim 1, further comprising a controller for controlling reciprocation of the inner resecting sleeve.
Fully anticipated
15. The tissue resecting device of claim 14, wherein the controller is configured for locking the inner resecting sleeve in a partially extended position between the window-open position and the window-closed position.
14. The tissue resecting device of claim 13, wherein the controller is configured for locking the inner resecting sleeve in a partially extended position between the window-open position and the window-closed position.
Fully anticipated
16. The tissue resecting device of claim 14, wherein the controller is configured for locking the inner resecting sleeve in the window-open position.
15. The tissue resecting device of claim 13, wherein the controller is configured for locking the inner resecting sleeve in the window-open position.
Fully anticipated
17. The tissue resecting device of claim 14, wherein the controller is configured for locking the inner resecting sleeve in the window-closed position.
16. The tissue resecting device of claim 13, wherein the controller is configured for locking the inner resecting sleeve in the window-closed position.
Fully anticipated
18. The tissue resecting device of claim 14, wherein a distal end of the inner resecting sleeve includes an RF electrode having a first polarity and the outer sleeve serves as a return electrode having an opposite, second polarity.
17. The tissue resecting device of claim 13, wherein a distal end of the inner resecting sleeve includes an RF electrode having a first polarity and the outer sleeve serves as a return electrode having an opposite, second polarity.
Fully anticipated
19. The tissue resecting device of claim 18, wherein the RF electrode is configured to generate plasma for resecting tissue.
18. The tissue resecting device of claim 17, wherein the RF electrode is configured to generate plasma for resecting tissue.
Fully anticipated
1. A tissue resecting device comprising: a handle; an elongate shaft extending from the handle, the elongate shaft including an outer sleeve and a reciprocating inner resecting sleeve disposed in the outer sleeve, wherein linear reciprocation of the inner resecting sleeve moves a distal end of the inner resecting sleeve across a tissue-receiving window of the outer sleeve between window-open and window- closed positions; a motor drive in the handle; and an actuator in the handle coupled between the motor drive and the inner resecting sleeve to convert rotational motion from the motor drive to linear reciprocation motion of the inner resecting sleeve relative to the outer sleeve for reciprocating the inner resecting sleeve; wherein the actuator includes an actuator body, a shaft extending distally from the actuator body, and a pin disposed within an arcuate slot of the actuator body; wherein rotational motion from the motor drive rotates the actuator body to thereby axially reciprocate the shaft to cause linear reciprocation of the inner resecting sleeve relative to the outer sleeve.
19. A tissue resecting device, comprising: a handle; an elongate shaft extending from the handle, the elongate shaft including an outer sleeve and a reciprocating inner resecting sleeve slidably disposed in the outer sleeve, wherein reciprocation of the inner resecting sleeve axially translates a distal end of the inner resecting sleeve across a tissue-receiving window of the outer sleeve between a window-open position and a window-closed position; a motor drive in the handle; an actuator in the handle coupled between the motor drive and the inner resecting sleeve to convert rotational motion from the motor drive to linear reciprocation motion of the inner resecting sleeve relative to the outer sleeve for reciprocating the inner resecting sleeve; and a drive shaft coupled to the actuator; wherein the actuator converts rotational motion from the motor drive to linear reciprocation motion of the drive shaft such that the drive shaft translates axially relative to the handle; wherein linear reciprocation motion of the drive shaft is transferred to the inner resecting sleeve via a coupling arm spaced apart from the actuator; wherein the actuator includes an arcuate slot configured to vary a reciprocation speed of the inner resecting sleeve within one full reciprocation stroke of the inner resecting sleeve; wherein the inner resecting sleeve extends proximal of the actuator and reciprocates relative thereto.
Both the claims in the instant application and those within U.S. Patent No. 12,256,987 recite a tissue resecting device with a handle, elongated shaft with an outer sleeve and a reciprocating inner sleeve, a motor drive and an actuator with an arcuate slot in the handle to convert rotational motion from the motor drive to reciprocation motion of the inner sleeve with the only differences being that the claims within the instant application do not recite a coupling arm spaced apart from the actuator, i.e. the claims within the instant application are generic to the species claims recited within U.S. Patent No. 12,256,987.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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