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 .
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed November 13, 2023 has been entered and the references cited therein have been considered by the examiner.
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 are: controller in claims 1-17.
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.
Claims 2 and 9-16 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.
Claims 2 and 9 recite that the controller “provides the plasma” and “generates the plasma.” However, this is technically incorrect. The plasma is generated by passing a current between the electrodes. The controller does control the current to the electrodes but it technically does not provide or create plasma.
As claims 11-16 depend from claim 9, they are likewise rejected.
In addition, claim 12 recites “wherein the controller changes the number of discharge holes through a hole changing part” without affirmatively reciting the “hole changing part.” The claim also does not define how the controller changes the number of discharge holes.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9, 10 and 14-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keidar et al. (PCT Publication No. WO 2012/167089).
In regard to claims 9 and 14-16, Keidar et al. teach a cold plasma therapy system 100 comprised of a power supply 102, a controller 104, a gas source 106 and a delivery mechanism 120 (see Figs. 1-3 and para. 0019). Delivery mechanism 120 is an elongated syringe having a main body 121 with a discharge area 122 at the distal end having a narrowed neck 123 and a distal opening or nozzle 129 (see Fig. 2 and para. 0020). A central electrode 126 is located in the interior of the body 121 and the electrode 126 is entirely surrounded by insulation except at its distal end which is exposed and in contact with gas and plasma (see Fig. 2 and para. 0021). An annular outer ring electrode 128 is located about a portion of the narrow neck 123 at the outside of the syringe 120 (see Fig. 2 and para. 0022). The power supply 102 is electrically connected to the electrodes 126, 128 and provides a high voltage supply to the electrodes 126, 128 through cables 101, 103 (see Fig. 2 and para. 0022). The controller 140 regulates the voltage and frequency that is applied to the central electrode 126 and the ring electrode 128 (see para. 0022). The gas source 106 is in gas communication with the syringe 120 through a supply tube 108 that is connected to a port 107 on the side of the body 121 of syringe 120 (see Fig. 2). Gas flows through the syringe 120 and exits the syringe 120 through the neck 123 and nozzle 129 at the discharge end 122 as a jet or stream flow 150 (see Fig. 2 and para. 0023). As the gas enters the discharge area 122 and the neck 123 of the syringe 120, the electrodes 126, 128 excite the gas, thereby ionizing the gas to form a cold plasma that is then discharged out of the nozzle 129 as jet or stream flow 150 (see para. 0023). Keidar et al. teach that the syringe 120 allows the plasma to be targeted at desired cancer cells in the skin and can treat any type of cancer that is close to the skin (see para. 0024). Keidar et al. also teach an endoscopic delivery device 200 that would constitute a housing that is inserted into the skin (see Figs. 4-5 and para. 0027). Keidar et al. also teach that other suitable delivery device can be utilized other than a syringe or an endoscope (see para. 0034). In regard to claim 10, Keidar et al. teach that the body 121 is formed from glass or a rigid plastic, which are insulative (see para. 0020).
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.
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) 1-6, 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keidar et al. (PCT Publication No. WO 2012/167089).
In regard to claims 1-5 and 8, see the above rejection for claim 9. With further respect to claim 1, Keidar et al. do not specifically teach that the controller 104 controls power to the electrodes 126, 128 in a sequential fashion. However, since Keidar et al. teach that the controller 104 provides power to the electrodes 126, 128 individually (see para. 0022), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the controller 104 of Keidar et al. such that the electrodes 126, 128 are controlled in a sequential fashion in order to more precisely control the plasma jet or stream flow 150 that is created. In other words, sequential activation or control of the electrodes 126, 128 would allow for a precise plasma stream (higher or lower, more or less velocity) as the device is advanced and as the tumor is treated. It should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In regard to claims 6 and 11, Keidar et al. teach that the endoscope 210 may have a camera that facilities introduction of the tube 210 and delivery of the plasma beam 250 to the target tissue such that the controller 104 would not be activated to deliver the plasma beam 250 until the tube 210 had been inserted into the skin to a predetermined depth (otherwise the plasma beam 250 would be misplaced).
Claim(s) 7, 12, 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keidar et al. (PCT Publication No. WO 2012/167089) in view of Choi (Korean Publication No. 10-20200136118).
In regard to claim 17, see the above rejection for claim 9. With further respect to claim 17 and in regard to claims 7, 12 and 13, Keidar et al. teach a singular syringe 120 with a singular nozzle 129. However, Choi teaches a similar plasma therapy device that has a housing with a plurality of openings for plasma jets (see Figs. 2 and 4). Choi thus demonstrates that it was well known in the art to provide a plasma therapy device with a plurality of openings for plasma jets in the interest of equipping the device with the ability to more precisely direct the plasma jets for the required therapy. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Keidar et al. with multiple openings in the syringe 120 allot for multiple plasma jets in order to equip the device with ability to more precisely direct the plasma jets for the required therapy. Similarly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide a housing with multiple syringes 120 on the device of Keidar et al. again in order to equip the device with ability to more precisely direct the plasma jets for the required therapy. Furthermore, it is well settled that the duplication of parts is a design choice well within the skill of the art. See In re Harza, 274 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). With further respect to claims 7, 12 and 13, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to utilize the controller 104 of Keidar et al. to switch among the different plasma jet outlets in order to more precisely direct the plasma jets for the required therapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794