DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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
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 complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 &119(e) 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. 15/177188 & 62/173874 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.
Accordingly, the claims are given the benefit date of 6/10/2015.
Specification
The disclosure is objected to because of the following informalities: update Par. [0001] with appropriate priority information.
Appropriate correction is required.
Claim Objections
Claim 32 is objected to because of the following informalities: amend “an electrical signal” to -the electrical signal- in ll. 3. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: amend “a cold plasma” to -the cold plasma- in ll. 4. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “within a urethra of the patient” to -within the anatomical passage, wherein the anatomical passage is a urethra of the patient- in ll. 2. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-24 & 26-27 & 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229) and Shaw et al. (3,434,476).
Concerning claims 21-22, as illustrated in Fig. 7, Wandke et al. disclose an internal cold plasma system (Fig. 7) comprising:
an applicator configured to be disposed within a cavity of a patient and to produce a cold plasma only between an outer surface of the applicator and a surface of the patient, wherein the applicator is configured to be navigated through an anatomical passage of the patient into the cavity of the patient, wherein the applicator comprises a flexible conduit configured to enable the applicator to conform to different cavities on different patients (flexible hollow fiber 1/5 may have an internal diameter of 0.5-2000 m, a wall thickness of 10-2000 m, a flexible active surface and an effective active length that may extend to several meters such that it can be applied in difficult situations such as cavities or internal applications, thereby making it capable of being disposed within a urethra of various patients, hollow fiber 1/5 generates plasma 2 only between the outer surface of the hollow fiber 1/5 formed by dielectric 3 and the surface O; [0010], [0015], [0019-0020], [0024-0026], [0054], [0057]. Or, in the alternative, Delaney discloses a system comprising a cold plasma system (1) having catheter (7) that is configured to be navigated through an anatomical passage of the patient into a cavity, the anatomical structure including a urethra. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. such that the catheter is configured to be navigated through an anatomical passage of the patient into the urethra such that it is configured to be disposed within the urethra of the patient and configured to conform to different patients in order to provide the benefit of treating targeted hollow anatomical structures as taught by Delaney ([0024-0026]),
wherein the flexible conduit has a first passage extending between a first end and a second end (space formed by dielectric 3 filled with ionized gas or an electrically conductive fluid such as aqueous saline solution extends between first and second ends; [0026]), wherein the first passage contains a conductive fluid (aqueous saline solution; [0026]),
wherein the flexible conduit is defined by a wall made of a dielectric material (dielectric 3 forms walls; [0057]), and wherein the dielectric material is configured to enable an electrical signal to build charge inside the flexible conduit (dielectric 3 enables electrical signal to build charge inside the flexible conduit such that plasma 2 is formed; [0052], [0057]).
Wandke et al. or Wandke et al. in view of Delaney fail to disclose wherein the applicator further comprises a second conduit having a second passage, wherein the second passage is configured to function as a dielectric by carrying a conductive material or being empty. However, Shaw et al. disclose a plasma system comprising an applicator comprising a conduit comprising two conduits with two respective passages (16 & 19/21/18/17A), wherein the second passage is configured to function as a dielectric by carrying a conductive material or being empty. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. or Wandke et al. in view of Delaney such that the applicator further comprises a second conduit having a second passage, wherein the second passage is configured to function as a dielectric by carrying a conductive material or being empty in order to provide the benefit of cooling the first passage or directing the plasma discharge or coagulating tissue with an additional fluid (e.g., cryogen) as taught by Shaw et al. (Col. 6-7, ll. 26-15, Col. 7-8, ll. 63-5, Col. 8, ll. 10-30, Col. 9, ll. 55-67; Fig. 1-2 & 4)
Concerning claim 23, Wandke et al. disclose the dielectric material (3) of the wall of the flexible conduit is configured to enable the electrical signal to build the charge inside the flexible conduit until a sufficient amount of charge builds whereupon the electrical signal crosses through the wall between the first end and the second end and produces the cold plasma from fluid within a gap (18) between the wall and the surface (O) of the patient ([0052], [0057], Claim 1).
Concerning claim 24, Shaw et al. further disclose the second conduit surrounds the flexible conduit, and the second passage (19/18/21/17A) is disposed between the flexible conduit and the second conduit (Fig. 1 & 3-4).
Concerning claim 26, Wandke et al. disclose an electrode (black box labeled 12 connected to power 13) that rests within the first passage (Fig. 7).
Concerning claim 27, Wandke et al. disclose the first end of the flexible conduit (3) comprises a tapered end that facilitates insertion into the cavity of the patient (Fig. 7).
Concerning claim 31, Wandke et al. disclose the applicator is configured to use the conductive fluid to carry the electrical signal that generates the cold plasma ([0057]; Fig. 7).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229) and Shaw et al. (3,434,476), as applied to claim 21, in further view of Fridman et al. (2009/0054896).
Concerning claim 28, Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. fail to disclose a plurality of spacers configured to separate a cold plasma-generating surface of the flexible conduit from the surface of the patient. However, Fridman et al. disclose a plasma system (500) comprising an applicator (406) comprising a spacer (504) configured to separate a cold plasma-generating surface (502) of a flexible conduit from the surface of the patient. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. to further comprise a spacer configured to separate a cold plasma-generating surface of the flexible conduit from the surface of the patient in order to provide the benefit of keeping the apparatus from contacting tissue as taught by Fridman et al. ([0030]; Fig. 2-3 & 5). Wandke et al. in view of Shaw et al. and Fridman et al./Wandke et al. in view of Delaney, Shaw et al. and Fridman et al. fail to the spacer comprising a plurality of spacers. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Wandke et al. in view of Shaw et al. and Fridman et al./Wandke et al. in view of Delaney, Shaw et al. and Fridman et al. such that the spacer comprises a plurality of spacers, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. See also In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229) and Shaw et al. (3,434,476), as applied to claim 21, in further view of Kim et al. (6,099,523) or Lam (2012/0289954).
Concerning claim 29, Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. fail to disclose a controller configured to produce the electrical signal that forms the cold plasma with the applicator from fluid within a gap between the outer surface of the applicator and the surface of the patient. However, Kim et al. disclose a system (Fig. 1-2) comprising an internal cold plasma system comprising a device (Fig. 1) and a controller (36) configured to produce an electrical signal that forms cold plasma (9) with the device from a fluid (7) (Col. 3-4, ll. 66-39, Col. 5, ll. 9-37; Fig. 1). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. to further comprise a controller configured to produce the electrical signal that forms the cold plasma with the applicator from fluid within a gap between the outer surface of the applicator and the surface of the patient in order to provide the benefit of regulating the electrical signal as taught by Kim et al. (Col. 4, ll. 40-49). In the alternative, Lam discloses a system (Fig. 1) comprising an internal plasma system (Fig. 1) comprising catheter (110) and a controller (140) configured to produce an electrical signal that forms plasma (116) with the catheter from a fluid (131) ([0078], [0081], [0084]; Fig. 1). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. to further comprise a controller configured to produce the electrical signal that forms the cold plasma with the applicator from fluid within a gap between the outer surface of the applicator and the surface of the patient in order to provide the benefit of regulating the electrical signal and monitoring progress as taught by Kim et al. (Col. 4, ll. 40-49) ([0091], [0093]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229) and Shaw et al. (3,434,476), as applied to claim 22, in further view of McGovern et al. (6,517,534).
Concerning claim 30, Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. fail to disclose the flexible conduit comprises an inflatable portion, wherein the inflatable portion is configured to block retraction and enable secure placement of the catheter after insertion into the urethra of the patient. However, McGovern et al. disclose a system comprising an applicator (201) comprising a conduit and an inflatable portion (210), wherein the inflatable portion (201) is configured to block retraction and enable secure placement of the catheter (201) after insertion into the urethra of the patient. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney and Shaw et al. such that the flexible conduit comprises an inflatable portion, wherein the inflatable portion is configured to block retraction and enable secure placement of the catheter after insertion into the urethra of the patient in order to provide the benefit of enabling the catheter to be fixed in a desired position relative to the prostate and urethra as taught by McGovern et al. (Col. 5, ll. 49-67, Col. 14, ll. 29-40; Fig. 5)
Claim(s) 32 & 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229), Shaw et al. (3,434,476) and Kim et al. (6,099,523), as applied to claim 29.
Concerning claim 32, Wandke et al. disclose a method (method for treatment of tissue; Claim 21) comprising: positioning the applicator of the system of claim 29 within a cavity of a patient (apparatus can be applied in cavities; [0020]); producing an electrical signal (voltage is applied; [0017]); and generating a cold plasma using the electrical signal, wherein the conductive fluid conducts the electrical signal toward the patient (cold plasma beam 2 is produced via gas discharge and aimed at target object; [0015], [0051]). The modified invention of Wandke et al. in view of Shaw et al./Wandke et al. in view of Delaney, Shaw et al. and Kim et al. disclose the electrical signal produced with the controller (140) (Kim et al.: (Col. 4, ll. 40-49) ([0091], [0093]).
Concerning claim 36, Wandke et al. disclose the conductive fluid comprises saline ([0026]).
Claim 37 is rejected upon the same rationale as provided for claim 22.
Claim(s) 33 & 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wandke et al. (2011/0022043) in view of Shaw et al. (3,434,476), or, in the alternative, Wandke et al. (2011/0022043) in view of Delaney (2013/0006229), Shaw et al. (3,434,476) and Kim et al. (6,099,523), as applied to claims 32 & 37, in further view of McGovern et al. (6,517,534).
Concerning claims 33 & 39, Wandke et al. in view of Shaw et al. and Kim et al./Wandke et al. in view of Delaney, Shaw et al. and Kim et al. fail to disclose pumping a gas from a gas source to the applicator and inflating an inflatable portion of the flexible conduit to block retraction and secure the catheter within the urethra of the patient. However, McGovern et al. disclose a method comprising positioning an applicator (201) within a cavity of a patient, pumping gas (air) from a gas source to an inflatable portion (201) of the applicator and inflating an inflatable portion of the flexible conduit to block retraction and secure the catheter within the urethra of the patient, and treating the cavity tissue. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. in view of Shaw et al. and Kim et al./Wandke et al. in view of Delaney, Shaw et al. and Kim et al. such that the method comprises pumping a gas from a gas source to the applicator and inflating an inflatable portion of the flexible conduit to block retraction and secure the catheter within the urethra of the patient in order to provide the benefit of enabling the catheter to be fixed in a desired position relative to the prostate and urethra as taught by McGovern et al. (Col. 5, ll. 49-67, Col. 14, ll. 29-40, Col. 14-15, ll. 61-8; Fig. 5)
Allowable Subject Matter
Claims 25, 34-35 & 38 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, discloses (1) an internal cold plasma system comprising an applicator having a flexible conduit that surrounds a second conduit, the flexible conduit having a first passage disposed between the flexible conduit and the second conduit that contains a conductive fluid, the flexible conduit being defined by a wall made of a dielectric material; or (2) a method comprising generating cold plasma with the applicator, wherein the conductive fluid conducts the electrical signal toward the patient, wherein the conductive fluid is a conductive bodily fluid of the patient.
The closest prior is regarded as: Wandke et al. (2011/0022043) who discloses an applicator comprising a flexible conduit having a passage with a conductive fluid and being defined by a wall made of dielectric material, the applicator configured to produce a cold plasma only between an outer surface of the applicator and a surface of the patient. Since the conductive fluid contained within the first passage of Wandke et al. is enclosed within the walls of the applicator, it would not have been obvious to one of ordinary skill in the art to modify the invention of Wandke et al. such that the conductive fluid is conductive bodily fluid of the patient. Fridman et al. (2009/0054896) discloses a passage (606 or 608) within an applicator’s dielectric wall (602), but fails to disclose the passage disposed between a flexible conduit and a second conduit. Shaw et al. (3,434,476) disclose multiple passages (16/21/17A/18) between conduit walls of a plasma applicator, but fail to disclose the applicator configured to produce a cold plasma only between an outer surface of the applicator and a surface of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794