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 . 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.
Priority
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 provisional applications, U.S. Provisional Application No. 62/538,517 and U.S. Provisional Application No. 62/437,617, fail 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. More specifically, these provisional applications fail to disclose a system comprising ‘multiple cartridge portions’ (note claims 35-40). The disclosure of all of the prior-filed applications, fail 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. More specifically, these applications fail to disclose a system comprising ‘a controller tied to needle movement feedback’ (note claims 33 and 42).
The Examiner notes that support for claims 35-40 has been found in U.S. Patent Application No. 15/851,333. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 12/21/2017, this being the filing date of U.S. Application No. 15/851,333. The Examiner notes that support for claims 33 and 42 has only been found in the instant application. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 8/20/2024, this being the filing date of the instant application.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related application. That is, the parent application is referenced as a U.S. application even though it has issued as a patent. The paragraph should be amended to include the appropriate patent number.
Claim Objections
Claim 41 is objected to because of the following informalities: in line 12, “comprising” should be replaced with -comprises-. 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 33 and 42 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 33 recites the limitation "a threshold value" in line 3. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 42 recites the limitation "a measured movement" in line 2. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 42 recites the limitation "a threshold value" in lines 3-4. The antecedent basis for this limitation is confusing, since it has already been recited.
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.
Claim(s) 24, 30, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang, U.S. 2016/0128576 (hereinafter Chiang) in view of Frankhouser, U.S. 8,870,865 (hereinafter Frankhouser).
Regarding claim 24, Chiang discloses (note figs. 2, 3, 6, and 7) a system comprising: a handle portion (2) having a lumen and a coil (‘52’ – note paragraph 30) configured to generate a magnetic field; and a ‘cartridge portion’ capable of being ‘removably inserted’ into the lumen of the handle portion, wherein the cartridge portion includes: a shaft (32) capable of being inserted into a urethra; a needle (31) disposed in the shaft that is capable of delivering vapor; and a magnet (‘51’ – note paragraph 30) fixedly coupled to the needle; wherein a flow of current through the coil is configured to move the magnet distally to deploy the needle (note paragraph 41). However, Chiang fails to explicitly disclose that in an assembled configuration in which the cartridge portion has been inserted into the lumen of the handle portion and the needle is in a retracted configuration, the magnet is aligned with the coil. Frankhouser teaches (note fig. 20a) a similar system comprising a handle portion (910; includes coil ‘902’) and a cartridge portion (composed of magnet ‘904’, shaft ‘906’, and needle ‘912/914/20’), wherein in an assembled configuration in which the cartridge portion has been inserted into the lumen of the handle portion and the needle is in a retracted configuration, the magnet (904) is aligned with the coil (902). It is well known in the art that these different magnetic actuator configurations (having different magnet-coil orientations) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Chiang so that the magnet is aligned with the coil when the device is assembled and the needle is retracted (as taught by Frankhouser). This is because this modification would have merely comprised a simple substitution of interchangeable magnetic actuator configurations in order to produce a predictable result (see MPEP 2143). It should also be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 30, Chiang discloses (see above) a system wherein the flow of current is a first flow of current, and wherein a second flow of current, in an opposite direction to the first flow of current, is necessarily configured to retract the vapor delivery needle.
Regarding claim 34, Chiang discloses (see above) a system wherein the flow of current may necessarily be selected by a user to customize a distance the vapor delivery needle travels (note paragraph 46).
Claim(s) 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Frankhouser as applied to claims 24, 30, and 34 above, and further in view of Cucin, U.S. 2011/0306950 (hereinafter Cucin).
Regarding claims 25-29, Chiang discloses (see above) a system comprising an extendable/retractable needle and a magnetic actuator, wherein this actuator comprises an outer coil and an inner magnet (coupled to the needle). However, Chiang fails to explicitly disclose a magnetic actuator comprising multiple coils configured to generate different magnetic fields, wherein these coils comprise a proximal pushing coil and a distal pulling coil. Cucin teaches (note figs. 6A-B) a similar system comprising a magnetic actuator having multiple coils configured to generate different magnetic fields, wherein these coils comprise a proximal pushing coil and a distal pulling coil. It is well known in the art that these different magnetic actuator configurations (i.e., coil-magnet arrangements) are widely considered to be interchangeable, as can be seen by the different embodiments of Cucin (note figs. 3B, 5A-E, and 6A-B). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system of Chiang to comprise a magnetic actuator having the claimed coil-magnet arrangement (as taught by Cucin). This is because this modification would have merely comprised a simple substitution of interchangeable magnetic actuator configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Frankhouser as applied to claims 24, 30, and 34 above, and further in view of Hyoun, U.S. 2012/0190987 (hereinafter Hyoun) and Cucin.
Regarding claims 31-33, Chiang discloses (see above) a system that detects displacement of the needle and communicates with a controller (note paragraphs 13 and 35). However, Chiang fails to explicitly disclose a sensor configured to measure a second magnetic field generated by the magnet to measure a movement of the magnet (and therefore the needle). Chiang further fails to explicitly disclose that the controller is configured to compare a measured movement of the magnet to a threshold value, wherein if the measured movement is below a threshold value, the electronic controller is configured to alert a user or to cease deployment of the vapor delivery needle. Hyoun teaches a similar system comprising an inner sensor (94) configured to measure a magnetic field generated by an outer magnet (92), to measure a movement of a needle (note paragraph 134). The system of Hyoun further teaches an electronic controller configured to compare a measured movement of the needle to a threshold value (i.e., magnetic fields are compared), wherein if the measured movement is below a threshold value, the electronic controller is configured to alert a user (note paragraphs 134-135). It is well known in the art that providing a user with sensed feedback would result in increased safety and efficiency, and that these different needle movement sensor configurations are widely considered to be interchangeable. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system of Chiang to comprise the magnetic sensor of Hyoun along with a controller configured to compare a measured movement of the magnet to a threshold value, wherein if the measured movement is below a threshold value the electronic controller is configured to alert a user (as taught by Hyoun, in order to increase safety and efficiency). This is because this modification would have merely comprised a simple substitution of interchangeable needle movement sensor configurations in order to produce a predictable result (see MPEP 2143). While this combination of references still fails to expressly teach the claimed sensor-magnet configuration (i.e., an outer/reference sensor and an inner needle magnet), it should be noted that Cucin does teach this claimed configuration (note fig. 9B; paragraph 120). It is well known in the art that these different magnetic sensor configurations (having inverted orientations) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system of Chiang to comprise the claimed sensor-magnet configuration (as taught by Cucin). This is because this modification would have merely comprised a simple substitution of interchangeable magnetic sensor configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Hyoun and Cucin.
Regarding claims 41-42, Chiang discloses (note figs. 2, 3, 6, and 7) a system comprising: a handle portion (2) having a lumen and a coil (‘52’ – note paragraph 30) configured to generate a first magnetic field; and a ‘cartridge portion’ capable of being ‘removably inserted’ into the lumen of the handle portion, wherein the cartridge portion includes: a shaft (32) capable of being inserted into a urethra; a needle (31) disposed in the shaft that is capable of delivering vapor; and a magnet (‘51’ – note paragraph 30) fixedly coupled to the vapor delivery needle; wherein, in an assembled configuration in which the cartridge portion has been inserted into the lumen of the handle portion, a flow of current through the coil is configured to move the magnet distally to deploy the vapor delivery needle (note paragraph 41). While Chiang discloses detecting displacement of the needle and communicating with a controller (note paragraphs 13 and 35), Chiang fails to explicitly disclose that the handle portion comprises a sensor configured to measure a second magnetic field generated by the magnet to measure a movement of the magnet (and therefore the needle). Chiang further fails to explicitly disclose that the controller is configured to compare a measured movement of the magnet to a threshold value, wherein if the measured movement is below a threshold value, the electronic controller is configured to alert a user or to cease deployment of the vapor delivery needle. Hyoun teaches a similar system comprising an inner sensor (94) configured to measure a magnetic field generated by an outer magnet (92), to measure a movement of a needle (note paragraph 134). The system of Hyoun further teaches an electronic controller configured to compare a measured movement of the needle to a threshold value (i.e., magnetic fields are compared), wherein if the measured movement is below a threshold value, the electronic controller is configured to alert a user (note paragraphs 134-135). It is well known in the art that providing a user with sensed feedback would result in increased safety and efficiency, and that these different needle movement sensor configurations are widely considered to be interchangeable. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Chiang to comprise the magnetic sensor of Hyoun along with a controller configured to compare a measured movement of the magnet to a threshold value, wherein if the measured movement is below a threshold value the electronic controller is configured to alert a user (as taught by Hyoun, in order to increase safety and efficiency). This is because this modification would have merely comprised a simple substitution of interchangeable needle movement sensor configurations in order to produce a predictable result (see MPEP 2143). While this combination of references still fails to expressly teach the claimed sensor-magnet configuration (i.e., an outer handle sensor and an inner needle magnet), it should be noted that Cucin does teach this claimed configuration (note fig. 9B; paragraph 120). It is well known in the art that these different magnetic sensor configurations (having inverted orientations) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system of Chiang to comprise the claimed sensor-magnet configuration (as taught by Cucin). This is because this modification would have merely comprised a simple substitution of interchangeable magnetic sensor configurations in order to produce a predictable result (see MPEP 2143). It should also be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 43, Chiang discloses (see above) a system wherein the flow of current may necessarily be selected by a user to customize a distance the vapor delivery needle travels (note paragraph 46).
Allowable Subject Matter
Claims 36-40 are allowed.
Claim 35 is 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2014/0288543 (Hoey).
U.S. 2008/0214956 (Briggs).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
