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 Objections
Claim 2 is objected to because of the following informalities: typo. “futher” in line 1 should be amended to recite “further”. Appropriate correction is required.
Claim 12 is objected to because the claim recites “the exhaust unit exhausts air from a space between the cover and the body part before the plasma generation unit generates the plasma after the cover is attached to the body part” and thus appears to recite steps of a method in an apparatus claim. It is recommended that Applicant amend the claim to recite “the exhaust unit is configured to exhaust air…” to overcome this objection.
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.
Claims 1, 10-16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 11-19 of U.S. Patent No. 11,786,745 (‘745 patent) in view of Morfill et al. (US 2012/0046602) (hereinafter Morfill).
Regarding claim 1, claim 1 of the ‘745 patent discloses a plasma treatment apparatus comprising: a cover configured to be attached to a body part; a plasma generation unit configured to generate plasma and provide the plasma to the cover; a gas supply unit configured to supply a source gas for generating the plasma to the plasma generation unit; an exhaust unit configured to exhaust an exhaust gas from the cover (ll. 1-9).
Claim 1 of the ‘745 patent does not disclose a spacing part disposed on a portion of the cover facing the body part, the spacing part being configured to maintain spacing between the cover and the body part.
Morfill, however, teaches a plasma applicator for treatment of living tissue and wounds (Abstract) including a spacing part disposed on a portion of the cover facing the body part, the spacing part being configured to maintain spacing between the cover and the body part (Fig. 1A, padding 7 maintains spacing between cover 4 and wound 2; para. 64: “The sealing cover 4 encloses a cavity between the wound 2 and the sealing cover 4, wherein the cavity is filled with a gas-permeable and porous padding 7”). Morfill additionally teaches a spacing part in the form of a rigid strut 23 arranged in the cavity thereby preventing the compression of the padding 7 in the case of low pressure in the cavity (Fig. 5; para. 87). Examiner submits that, in view of the evidence above, the padding 7 and/or the rigid strut 23 are interpreted as the claimed spacing part disposed on a portion of the cover facing the body part, the spacing part being configured to maintain spacing between the cover and the body part.
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify claim 1 of the ‘745 patent to include a spacing part disposed on a portion of the cover facing the body part, the spacing part being configured to maintain spacing between the cover and the body part by adopting the padding and/or the rigid strut taught by Morfill. Making this modification would be useful for enclosing a cavity between the wound and the sealing cover with porous padding, as well as preventing compression in the case of low pressure in the cavity with a rigid strut, as taught by Morfill.
Regarding claim 10, claim 7 of the ‘745 patent discloses a medicine applied to at least part of one surface of the cover that faces the body part.
Regarding claim 11, claim 11 of the ‘745 patent discloses the exhaust unit exhausts air from a space between the cover and the body part before the plasma generation unit generates the plasma after the cover is attached to the body part.
Regarding claim 12, claim 1 of the ‘745 patent discloses a by-product removal unit configured to remove a by-product from the exhaust gas (ll. 10-11).
Regarding claim 13, claim 1 of the ‘745 patent discloses a sensor unit configured to detect whether the body part is sealed by the cover (ll. 12-13).
Regarding claim 14, claim 12 of the ‘745 patent discloses the sensor unit includes at least one contact sensor provided on a boundary surface of the cover that makes contact with the body part and configured to detect whether the boundary surface and the body part are brought into contact with, or separated from, each other.
Regarding claim 15, claim 1 of the ‘745 patent discloses a controller unit configured to control the plasma generation unit, depending on whether the body part is sealed or not (ll. 14-16).
Regarding claim 16, claim 13 of the ‘745 patent discloses the controller stops an operation of the plasma generation unit when the boundary surface and the body part are separated from each other.
Regarding claim 18, claim 14 of the ‘745 patent discloses the controller restarts the operation of the plasma generation unit when the boundary surface and the body part are brought into contact with each other again.
Regarding claim 19, claims 15-16 of the ‘745 patent discloses the exhaust unit includes a variable suction pump configured to take in the exhaust gas from a space between the cover part and the body part, the variable suction pump being variable in suction pressure, wherein when the boundary surface and the body part are separated from each other, the controller raises the suction pressure of the variable suction pump and stops an operation of the variable suction pump after preset time passes, and wherein the controller restarts the operation of the variable suction pump when the boundary surface and the body part are brought into contact with each other again.
Regarding claim 20, claims 17-19 of the ‘745 patent discloses the cover is configured such that a supply hole through which the cover receives the plasma from the plasma generation unit or receives air from the gas supply unit has a larger area than an exhaust hole through which the exhaust gas is discharged to the exhaust unit, and wherein the cover further comprises an exhaust hole adjustment unit configured to hide or open part of the exhaust hole to adjust the area of the exhaust hole, wherein when the boundary surface and the body part are separated from each other, the controller controls the exhaust hole adjustment unit to open part of the exhaust hole to increase the area of the exhaust hole, and wherein when the boundary surface and the body part are brought into contact with each other again, the controller controls the exhaust hole adjustment unit to hide part of the exhaust hole to decrease the area of the exhaust hole.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2 and 14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 2, the claim recites “the sealing part being brought into close contact with the body part” in ll. 2-3. Such positive recitation of the sealing part being in contact with the body part directs the claim to a human organism. It is recommended that Applicant amend the claim to recite the human organism passively in order to overcome this rejection, i.e., “the sealing part configured to be brought into close contact with the body part”.
Regarding claim 14, the claim recites, “a boundary surface of the cover that makes contact with the body part”. Such positive recitation of boundary surface being in contact with the body part directs the claim to a human organism. It is recommended that Applicant amend the claim to recite the human organism passively in order to overcome this rejection, i.e., “a boundary surface of the cover that is configured to make contact with the body part”.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 10-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morfill et al. (US 2012/0046602) (hereinafter Morfill).
Regarding claim 1, Morfill discloses a plasma treatment apparatus (Abstract; Figs. 1A, 2, & 5) comprising: a cover configured to be attached to a body part (cover 4); a plasma generation unit configured to generate plasma and provide the plasma to the cover (HV generator 18 with cable 19, electrode 8, electrical contact 9); a gas supply unit configured to supply a source gas for generating the plasma to the plasma generation unit (gas source 12 with conduit 13, inlet valve 14, gas inlet 10); an exhaust unit configured to exhaust an exhaust gas from the cover (suction pump 15 with conduit 17, outlet valve 16, gas outlet 11); and a spacing part disposed on a portion of the cover facing the body part, the spacing part being configured to maintain spacing between the cover and the body part (padding 7; Fig. 5, rigid strut 23; see double patenting rejection above with respect to teachings of Morfill).
Regarding claim 2, Morfill discloses a sealing part disposed at an edge of the cover, the sealing part being brought into close contact with the body part to seal a space between the cover and the body part (Fig. 1A, adhesive 6 on border strip 5; para. 63: “the sealing cover 4 comprises an adhesive boarder strip 5 which is coated with an adhesive 6 for adhering the boarder strip 5 of the sealing cover 4 to the skin of the patient 3 surrounding the wound 2”).
Regarding claim 3, Morfill discloses the cover includes a pad manufactured in advance to cover a wound (Abstract; Figs. 1A, 2, 5, show that cover 4 includes padding 7 and covers a wound 2).
Regarding claim 10, Morfill discloses a medicine is applied to at least part of one surface of the cover that faces the body part (para. 26: “it is also possible to functionalise the sealing cover by coating or impregnating the sealing cover with a substance which is improving the plasma generation and/or which has a medical effect, particularly a sterilizing effect. Therefore, the sealing cover can be coated or impregnated with a bactericide, a fungicide and/or an antiviral substance”).
Regarding claim 11, Morfill discloses the exhaust unit exhausts air from a space between the cover and the body part before the plasma generation unit generates the plasma after the cover is attached to the body part (Fig. 3, S5 exhausting air out of cavity occurs before S8 (treating wound with plasma) and after S1 (adhering cover to wound)).
Regarding claim 13, Morfill discloses a sensor unit configured to detect whether the body part is sealed by the cover (Fig. 1A, pressure sensor 21).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Morfill in view of Van Wyk et al. (US 2008/0208189) (hereinafter Van Wyk).
Regarding claim 12, Morfill does not disclose a by-product removal unit configured to remove a by-product from the exhaust gas.
Van Wyk, however, teaches devices for thermal tissue treatment (Abstract) with plasma (para. 130) and that gas ventilation and liquid circulation, aspiration and irrigation may be used for cooling and/or removing byproducts and/or debris (para. 133, last sentence).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Morfill to include a by-product removal unit configured to remove a by-product from the exhaust gas via the techniques of Van Wyk above. Making this modification would be useful for cooling and/or removing byproducts and/or debris, as taught by Van Wyk.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Morfill in view of Heikenfield et al. (US 2015/0112164) (hereinafter Heikenfield).
Regarding claim 14, Morfill does not disclose the sensor unit comprises at least one contact sensor provided on a boundary surface of the cover that makes contact with the body part and configured to detect whether the boundary surface and the body part are brought into contact with, or separated from, each other.
Heikenfield, however, teaches a pad for sweat stimulation and biosensing (Abstract) including an electrical sensor associated with said sweat stimulation pad, said sensor adapted to detect direct or indirect contact between said pad and skin, which permits deactivation of said pad (claim 8). If stimulation electrode/pad contact to the skin is inadequate, this can be detected as an increase in impedance and that pad can be deactivated for purpose of skin safety and/or inadequate stimulation (para. 36, with reference to Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Morfill such that the sensor unit comprises at least one contact sensor provided on a boundary surface of the cover that makes contact with the body part and configured to detect whether the boundary surface and the body part are brought into contact with, or separated from, each other. Making this modification would be useful for detecting inadequate skin contact and then deactivating the pad for skin safety, as taught by Heikenfield.
Allowable Subject Matter
Claims 4-9 and 15-20 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: In the closest prior art, Morfill does not teach or suggest the gas supply unit comprises a fan unit configured to generate an air flow from a first space between the opposite electrodes to a second space between the cover and the body part (claim 4), in combination with other limitations; a controller configured to control the plasma generation unit, depending on whether the body part is sealed or not (claim 15).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim (KR 101568380) discloses a skin treatment apparatus using plasma (Abstract).
Watson et al. (US 2013/0071286) discloses cold plasma sterilization devices (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anant A Gupta whose telephone number is (571)272-8088. The examiner can normally be reached Mon-Fri 9 am - 5 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.G./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796