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 .
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 1-8, 11-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US11771447. Although the claims at issue are not identical, they are not patentably distinct from each other because:
19540800
US11771447
1) A method for preventing or treating Delayed Graft Function (DGF) following a transplant procedure by treating a transplanted organ or tissue with acoustic energy following the transplantation and/or graft procedure.
1. A method for preventing an onset of formation of renal fibrosis in a human or animal body for individuals suffering from cancer and as part of a cancer treatment protocol, the method comprising applying a low energy shockwave treatment protocol over a treatment area of at least a kidney of the human or animal body prior to applying a cancer treatment protocol selected from chemotherapy, biological therapy, cell therapy, or stem cell therapy, and wherein said treatment area having or expected to have acute tissue trauma
2) The method of claim 1 wherein applying the acoustic energy over a treatment area comprising at least a portion of the transplanted organ or tissue within a 24 hour period following the transplantation.
c) wherein said low energy shockwave treatment protocol is initiated within either a 48 hour window or at least one week prior to the cancer treatment protocol.
3) The method of claim 1 wherein the acoustic energy is applied at least two hours following the end of the transplant procedure.
c) wherein said low energy shockwave treatment protocol is initiated within either a 48 hour window or at least one week prior to the cancer treatment protocol.
4) The method of claim 1 wherein the acoustic energy is applied within a 24 hour period following initial indications of DGF.
c) wherein said low energy shockwave treatment protocol is initiated within either a 48 hour window or at least one week prior to the cancer treatment protocol.
5) The method of claim 1 wherein the acoustic energy applied is provided in form of low energy shockwave treatment having shockwave parameters including: an energy density from about 0.02 up to about 0.3 mJ/mm2, at a frequency of about 2Hz; and a) wherein the treatment protocol applies up to 5000 shockwaves over at least a portion of the transplanted organ or tissue, the treatment is characterized in that up to about 5000 low energy shockwaves are delivered to the at least a portion of the transplanted organ or tissue.
a) the low energy shockwave treatment protocol having shockwave parameters including: an energy density from 0.02 and up to 0.2 milliJoules per millimeter squared (mJ/mm2), at a frequency of 2 Hertz (Hz);
b) wherein the low energy shockwave treatment protocol applies a number of low energy shockwaves, wherein the number of applied shockwaves is up to 5000 shockwaves, over at least a portion of the treatment area, and wherein the low energy shockwaves are delivered to the treatment area triggering a cascade of bio-molecular activity involving at least one bio-molecular factor
6) The method of claim 1 wherein the acoustic source of energy is in the form of ultrasound waves having at least one parameter selected from: a) frequency of 0.4 to 3 MHz; or b) Energy density of 100 to 800 mW/cm2 SATA; or, c) 10 to 44 % duty cycle; or d) treatment exposure time for at least 0.5 minutes and up to 10 minute per treatment area.
a) the low energy shockwave treatment protocol having shockwave parameters including: an energy density from 0.02 and up to 0.2 milliJoules per millimeter squared (mJ/mm2), at a frequency of 2 Hertz (Hz);
7) The method of claim 1 wherein the transplanted organ or tissue is selected from at least one of: kidney, liver, heart, lung, graft, vascular graft, skin graft, or a combination thereof.
A method for preventing an onset of formation of renal fibrosis in a human or animal body for individuals suffering from cancer and as part of a cancer treatment protocol, the method comprising applying a low energy shockwave treatment protocol over a treatment area of at least a kidney of the human or animal body prior to applying a cancer treatment protocol selected from chemotherapy, biological therapy, cell therapy, or stem cell therapy, and wherein said treatment area having or expected to have acute tissue trauma,
8) The method of claim 7 wherein the treatment site comprising the transplanted organ or tissue is divided into a plurality of small treatment zones, wherein each treatment zone is provided with at least 100 shockwaves and up to about 500 shockwaves.
2. The method of claim 1 wherein said treatment area is divided into a plurality of small treatment zones, wherein each treatment zone is provided with at least 100 shockwaves and up to 500 shockwaves.
9) The method of claim 1 wherein the acoustic energy source is a combination of ultrasound wave and shockwaves.
N/A
10) The method of claim 1 wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue.
N/A
11) The method of claim 1 wherein the treatment is applied immediately following the transplant procedures within a timeframe of from 2 hours and up to about 72 hours following the organ transplant procedure.
c) wherein said low energy shockwave treatment protocol is initiated within either a 48 hour window or at least one week prior to the cancer treatment protocol.
12) The method of claim 1 provided wherein the source of the transplanted organ or tissue is harvested from a deceased donor.
1. A method for preventing an onset of formation of renal fibrosis in a human or animal body for individuals suffering from cancer and as part of a cancer treatment protocol, the method comprising applying a low energy shockwave treatment protocol over a treatment area of at least a kidney of the human or animal body prior to applying a cancer treatment protocol selected from chemotherapy, biological therapy, cell therapy, or stem cell therapy, and wherein said treatment area having or expected to have acute tissue trauma,
13) The method of claim 12 provided to revive vasculature of the harvested organ.
1. A method for preventing an onset of formation of renal fibrosis in a human or animal body for individuals suffering from cancer and as part of a cancer treatment protocol, the method comprising applying a low energy shockwave treatment protocol over a treatment area of at least a kidney of the human or animal body prior to applying a cancer treatment protocol selected from chemotherapy, biological therapy, cell therapy, or stem cell therapy, and wherein said treatment area having or expected to have acute tissue trauma,
14) The method of claim 13 provided to revive collateral blood vessels of harvested organ.
1. A method for preventing an onset of formation of renal fibrosis in a human or animal body for individuals suffering from cancer and as part of a cancer treatment protocol, the method comprising applying a low energy shockwave treatment protocol over a treatment area of at least a kidney of the human or animal body prior to applying a cancer treatment protocol selected from chemotherapy, biological therapy, cell therapy, or stem cell therapy, and wherein said treatment area having or expected to have acute tissue trauma,
15) The method of claim 1 wherein the acoustic energy is applied at least once a day for a period of up to at least 21 days following transplantation.
N/A
16) The method of claim 1 wherein the treatment is provided in up to three individual treatment sessions per day.
N/A
17) The method of claim 1 wherein the acoustic energy is administered to the transplanted organ or tissue over at least one treatment area and/or at least one or more treatment zones defined about the organ or tissue.
2. The method of claim 1 wherein said treatment area is divided into a plurality of small treatment zones, wherein each treatment zone is provided with at least 100 shockwaves and up to 500 shockwaves.
18) The method of claim 14 wherein the treatment area, comprising the transplanted organ or tissue, may be divided into a plurality of individual treatment zones and/or focal zones.
2. The method of claim 1 wherein said treatment area is divided into a plurality of small treatment zones, wherein each treatment zone is provided with at least 100 shockwaves and up to 500 shockwaves.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US11771447 in view of Cioanta et al. (US20250157616, hereafter Cioanta).
Regarding claim 9, the claims of US11771447 discloses all of the limitations of claim 1 as discussed above.
The claims of US11771447 do not disclose wherein the acoustic energy source is a combination of ultrasound wave and shockwaves.
In an analogous energy treatment system for tissue field of endeavor Cioanta discloses wherein an acoustic energy source is a combination of ultrasound wave and shockwaves(Cioanta, Para 260; “FIG. 8A is a schematic representation of an energy combination applicator that simultaneously delivers shockwaves and non-contact ultrasound transmitted via a mist solution to the targeted region, according to one embodiment of the present invention”) (Cioanta, Para 407; “The combined effects of the shockwaves/pressure waves 18 and of the non-contact ultrasound waves 86 that are transmitted via ultrasound transmission mist solution field pattern 85 will enhance and expedite the healing of the wound/lesion/tissue condition 19, which is beneficial for a successful medical treatment and thus becomes more financially viable and less time consuming for both the patients and the medical personnel”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of US11771447 wherein the acoustic energy source is a combination of ultrasound wave and shockwaves in order to enhance and expedite the healing of the wound/lesion/tissue condition in a more financially viable and less time consuming manner as taught by Cioanta (Cioanta, Para 407).
Claims 10 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US11771447 in view of US20210153885.
Regarding claim 10, the claims of US11771447 discloses all of the limitations of claim 1 as discussed above.
The claims of US11771447 do not disclose wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue.
In an analogous acoustic treatment field of endeavor Spector discloses all of the
wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue (Spector, Para 32; “each active treatment session includes up to about 5000 low energy shockwaves that are administered over a treatment area”).
A person having ordinary skill in the art would understand that Spector achieves the recited effect because the specification of the instant application discloses that applying low energy shockwaves accomplishes the recited effect (Pg 4, lines 10-18; “the low energy shockwave treatment is provided to at least a portion of an implanted organ to treat DGF provides both an immediate effect comprising vasodilation after administration of acoustic energy”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of US11771447 wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue in order to improve function of the treatment portion of the human or animal body as taught by Spector (Spector, Abstract).
Regarding claim 16, the claims of US11771447 discloses all of the limitations of claim 1 as discussed above.
The claims of US11771447 do not disclose wherein the treatment is provided in up to three individual treatment sessions per day.
In an analogous acoustic treatment field of endeavor Spector discloses all of the
wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue day (Spector, Para 132-133; “the number of active treatment sessions may be provided from about 1 session up to about 18 sessions. Optionally 12 active treatments may be provided during the treatment protocol according to the present invention. Optionally number of active treatment session may for example be 1, or 2, or 3, or 4 or 5 or 6, or 7 or 8 or 9 or 10 or 11, or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or so sessions”) (Spector, Para 125; “The optional treatment protocol shown calls for two active treatment sessions per week during weeks 1, 2, 3, 7, 8, and 9, while no treatment is provided during weeks 4-6. Optionally the treatment protocol may comprise up to four active treatment session per week”).
A person having ordinary skill in the art would understand that Spector achieves the recited effect because the specification of the instant application discloses that applying low energy shockwaves accomplishes the recited effect (Pg 4, lines 10-18; “the low energy shockwave treatment is provided to at least a portion of an implanted organ to treat DGF provides both an immediate effect comprising vasodilation after administration of acoustic energy”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of US11771447 wherein the treatment is provided in up to three individual treatment sessions per day in order to improve function of the treatment portion of the human or animal body as taught by Spector (Spector, Abstract).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US11771447 in view of Zhang (US20250082541).
The claims of US11771447 do not disclose wherein the acoustic energy is applied at least once a day for a period of up to at least 21 days following transplantation.
In an analogous energy treatment system for tissue field of endeavor Zhang discloses wherein acoustic energy (Zhang, Para 30; “Energy waves that can be generated and utilized by the present invention include optical waves or electromagnetic waves such as infrared waves; sound waves including infrasonic waves, acoustic waves and ultrasonic waves”) is applied at least once a day for a period of up to at least 21 days following an unhealthy condition (Zhang, Para 182; “said one or more therapeutically effective doses are 5 to 200 watt hours per day for a treatment period of about 3 days to 90 days”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of US11771447 do not disclose wherein the acoustic energy is applied at least once a day for a period of up to at least 21 days following transplantation in order to maintain or improve general health, or alleviate or treat diseases and/or conditions as taught by Zhang (Zhang, Para 190).
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 5-6, 8, and 11 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.
Regarding claim 5, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what energy densities would be about 0.02 to about 0.3, what frequencies are about 2Hz, and what number of shockwaves is about 5000.
Regarding claim 6, the abbreviation SATA should be defined before it is used. Since no definition is provided within the specification, it is unclear what the abbreviation means. Clarification is required.
Regarding claim 8, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what energy densities would be about 500 shockwaves.
Regarding claim 11, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what energy densities would be about 72 hours.
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.
(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.
(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.
Claims 1-3, 5-8, 10-11, and 16-17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Spector et al. (US20210153885, hereafter Spector).
Regarding claim 1, Spector discloses a method for preventing or treating Delayed Graft Function (DGF) following a transplant procedure by treating a transplanted organ or tissue with acoustic energy (Spector, Para 18; “The present invention overcomes the deficiencies of the background by providing a method for treating a human or animal body with low energy extracorporeal shockwaves so as to control the cascade of biomolecular activity involving a plurality of biomolecular factors”) (Spector, Para 4; “A shockwave is a form of acoustic energy resulting from phenomena that create a sudden intense change in pressure for example an explosion or lightning.”) following (Spector, Para 33; “the low energy shockwave treatment session are provided […] after […] an acute trauma event.”)the transplantation and/or graft procedure (Spector, Para 43; “Optionally, the acute trauma and/or acute tissue trauma event and/or invasive medical intervention may for example include but is not limited to […] removal of tissue (“ectomy”), cancer treatment, transplant the like or any combination thereof.”) (Spector, Para 83; “The human or animal body or portion thereof refers to any part, cell, tissue, system, or organ having in-vivo origin, in-vitro origin, as a result of a transplant, the like or any combination thereof.”) (Spector, Para 44; “In embodiments the treatment according to the present invention may be provided for alleviating fibrosis as part of treatment for a medical condition selected from the group consisting of […] surgical procedures, transplants or the like”).
Regarding claim 2, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein applying the acoustic energy over a treatment area comprising at least a portion of the transplanted organ or tissue within a 24 hour period following the transplantation (Spector, Para 33; “the treatment is provided within a 24 hour window from the occurrence of the acute trauma event”).
Regarding claim 3, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the acoustic energy is applied at least two hours following the end of the transplant procedure (Spector, Para 29; “an active treatment period comprises a three week period of bi-weekly treatments and an optional a rest period comprising a three week period that is devoid of low energy shockwave treatments”).
Regarding claim 5, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the acoustic energy applied is provided in form of low energy shockwave treatment (Spector, Para 32; “each active treatment session includes up to about 5000 low energy shockwaves that are administered over a treatment area”) having shockwave parameters including: an energy density from about 0.02 up to about 0.3 mJ/mm2 (Spector, Para 52; “The shockwave intensity may be provided from about 0.02 mJ/mm2 to about 0.2 mJ/mm2. Optionally and preferably shockwave intensity may be provided from about 0.09 mJ/mm2 to about 0.11 mJ/mm2. Optionally and more preferably shockwave intensity may be provided at about 0.1 mJ/mm2”), at a frequency of about 2Hz (Spector, Para 55; “Optionally shockwave frequency may be provided from about 1 Hz to about 6 Hz. Optionally and preferably a shockwave frequency may be provided at about 2-4 Hz. Optionally and preferably a shockwave frequency may be provided at about 2 Hz”); and a) wherein the treatment protocol applies up to 5000 shockwaves over at least a portion of the transplanted organ or tissue, the treatment is characterized in that up to about 5000 low energy shockwaves are delivered to the at least a portion of the transplanted organ or tissue (Spector, Para 32; “each active treatment session includes up to about 5000 low energy shockwaves that are administered over a treatment area”).
Regarding claim 6, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the acoustic source of energy is in the form of ultrasound waves having at least one parameter selected from: a) frequency of 0.4 to 3 MHz (Spector, Para 55; “Optionally shockwave frequency may be provided from about 1 Hz to about 6 Hz. Optionally and preferably a shockwave frequency may be provided at about 2-4 Hz. Optionally and preferably a shockwave frequency may be provided at about 2 Hz”).
Regarding claim 7, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the transplanted organ or tissue is selected from at least one of: kidney, liver, heart, lung, graft, vascular graft, skin graft, or a combination thereof (Spector, Para 45; “In embodiment the treatment according to the present invention may be provided for […] maintaining function of any cell, tissue or organ of the human or animal anatomy, for example including but not limited to heart, lung, kidney, liver, gall bladder, pancreas, spleen, stomach, intestine, gastrointestinal tract, lymphatic system, skeletal muscles, smooth muscles, cardiovascular system, urinary bladder, skin, female reproductive system, uterus, ovaries, fallopian tubes, cervix, male reproductive system, penis, vas deferens, testicles, prostate, or any portion, cell, tissue or functional group of the human or animal anatomy.”) (Spector, Para 43; “Optionally, the acute trauma and/or acute tissue trauma event and/or invasive medical intervention may for example include but is not limited to […] removal of tissue (“ectomy”), cancer treatment, transplant the like or any combination thereof.”) (Spector, Para 83; “The human or animal body or portion thereof refers to any part, cell, tissue, system, or organ having in-vivo origin, in-vitro origin, as a result of a transplant, the like or any combination thereof.”) (Spector, Para 44; “In embodiments the treatment according to the present invention may be provided for alleviating fibrosis as part of treatment for a medical condition selected from the group consisting of […] surgical procedures, transplants or the like”).
Regarding claim 8, Spector discloses all of the limitations of claim 7 above.
Spector further discloses wherein the treatment site comprising the transplanted organ or tissue is divided into a plurality of small treatment zones (Spector, Para 31; “The treatment area may be divided into a plurality of individual treatment zones and/focal zones”), wherein each treatment zone is provided with at least 100 shockwaves and up to about 500 shockwaves (Spector, Para 32; “each active treatment session may include at least 100 and up to about 500 low energy shockwaves that are administered over a single treatment focal zone”).
Regarding claim 10, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the acoustic energy provided is configured to achieve an immediate and/or short term effect of vasodilation in the tissue surrounding the transplanted organ or tissue (Spector, Para 32; “each active treatment session includes up to about 5000 low energy shockwaves that are administered over a treatment area”).
A person having ordinary skill in the art would understand that Spector achieves the recited effect because the specification of the instant application discloses that applying low energy shockwaves accomplishes the recited effect (Pg 4, lines 10-18; “the low energy shockwave treatment is provided to at least a portion of an implanted organ to treat DGF provides both an immediate effect comprising vasodilation after administration of acoustic energy”)
Regarding claim 11, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the treatment is applied immediately following the transplant procedures within a timeframe of from 2 hours and up to about 72 hours following the organ transplant procedure (Spector, Para 33; “the low energy shockwave treatment is provided within a 48 hour window from the occurrence of the acute trauma event. Optionally the treatment is provided within a 24 hour window from the occurrence of the acute trauma event”).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 16, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the treatment is provided in up to three individual treatment sessions per day (Spector, Para 132-133; “the number of active treatment sessions may be provided from about 1 session up to about 18 sessions. Optionally 12 active treatments may be provided during the treatment protocol according to the present invention. Optionally number of active treatment session may for example be 1, or 2, or 3, or 4 or 5 or 6, or 7 or 8 or 9 or 10 or 11, or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or so sessions”) (Spector, Para 125; “The optional treatment protocol shown calls for two active treatment sessions per week during weeks 1, 2, 3, 7, 8, and 9, while no treatment is provided during weeks 4-6. Optionally the treatment protocol may comprise up to four active treatment session per week”).
Regarding claim 17, Spector discloses all of the limitations of claim 1 above.
Spector further discloses wherein the acoustic energy is administered to the transplanted organ or tissue over at least one treatment area and/or at least one or more treatment zones defined about the organ or tissue (Spector, Para 31; “The treatment area may be divided into a plurality of individual treatment zones and/focal zones”) (Spector, Para 32; “each active treatment session may include at least 100 and up to about 500 low energy shockwaves that are administered over a single treatment focal zone”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Spector and Jones et al. (US20160030280, hereafter Jones).
Regarding claim 4, Spector discloses all of the limitations of claim 1 above.
Spector does not clearly and explicitly disclose wherein the acoustic energy is applied within a 24 hour period following initial indications of DGF.
In an analogous acoustic wave treatment field of endeavor Jones discloses wherein acoustic energy is applied within a 24 hour period following initial indications of a disease (Jones, Para 5; “The therapy can be applied at the onset of RLS symptoms”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Spector wherein the acoustic energy is applied within a 24 hour period following initial indications of DGF in order to allow the patient to experience relief and treatment sooner as taught by Jones (Jones, Para 21).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Spector and Cioanta et al. (US20250157616, hereafter Cioanta).
Regarding claim 9, Spector discloses all of the limitations of claim 1 above.
Spector does not clearly and explicitly disclose wherein the acoustic energy source is a combination of ultrasound wave and shockwaves.
In an analogous energy treatment system for tissue field of endeavor Cioanta discloses wherein an acoustic energy source is a combination of ultrasound wave and shockwaves(Cioanta, Para 260; “FIG. 8A is a schematic representation of an energy combination applicator that simultaneously delivers shockwaves and non-contact ultrasound transmitted via a mist solution to the targeted region, according to one embodiment of the present invention”) (Cioanta, Para 407; “The combined effects of the shockwaves/pressure waves 18 and of the non-contact ultrasound waves 86 that are transmitted via ultrasound transmission mist solution field pattern 85 will enhance and expedite the healing of the wound/lesion/tissue condition 19, which is beneficial for a successful medical treatment and thus becomes more financially viable and less time consuming for both the patients and the medical personnel”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Spector wherein the acoustic energy source is a combination of ultrasound wave and shockwaves in order to enhance and expedite the healing of the wound/lesion/tissue condition in a more financially viable and less time consuming manner as taught by Cioanta (Cioanta, Para 407).
Claims 12-14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Spector and Anaghavi et al. (WO2008148062, hereafter Anaghavi).
Regarding claim 12, Spector discloses all of the limitations of claim 1 above.
Spector does not clearly and explicitly disclose wherein the source of the transplanted organ or tissue is harvested from a deceased donor.
In an analogous treatment of transplanted tissues field of endeavor Anaghavi discloses wherein a source of a transplanted organ or tissue is harvested from a deceased donor (Anaghavi, Para 159; “Donor tissue can be living or deceased.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Spector wherein the source of the transplanted organ or tissue is harvested from a deceased donor as taught by Anaghavi in order to increase the number of organs available for transplant and therefore save lives.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 13, Spector as modified by Anaghavi above discloses all of the limitations of claim 12 above.
Spector further discloses performing to the method provided to revive vasculature of the harvested organ (Spector, Para 14; “Shockwaves have been used in medicine as a noninvasive means for treating a variety of anomalies such as […] revascularization, angiogenesis are well known and described in medical literature”) (Spector, Para 45; “In embodiment the treatment according to the present invention may be provided […] for maintaining function of any cell, tissue or organ of the human or animal anatomy, for example including but not limited to […] cardiovascular system”) (Spector, Para 105-119; “Most preferably the low energy shockwaves 110 to the treatment area 15 provide for treating fibrosis by enabling to control the biomolecular activity and/or signalizing pathway and/or cascade of biomolecular activity […] the cascade of molecular activity may further involve at least one or more of the following regulatory factors selected from the group consisting of: vascular endothelial growth factor (VEGF)”).
Regarding claim 14, Spector as modified by Anaghavi above discloses all of the limitations of claim 13 above.
Spector further discloses performing to the method provided to revive collateral blood vessels of harvested organ (Spector, Para 14; “Shockwaves have been used in medicine as a noninvasive means for treating a variety of anomalies such as […] revascularization, angiogenesis are well known and described in medical literature”) (Spector, Para 45; “In embodiment the treatment according to the present invention may be provided […] for maintaining function of any cell, tissue or organ of the human or animal anatomy, for example including but not limited to […] cardiovascular system”) (Spector, Para 105-119; “Most preferably the low energy shockwaves 110 to the treatment area 15 provide for treating fibrosis by enabling to control the biomolecular activity and/or signalizing pathway and/or cascade of biomolecular activity […] the cascade of molecular activity may further involve at least one or more of the following regulatory factors selected from the group consisting of: vascular endothelial growth factor (VEGF)”).
Regarding claim 18, Spector as modified by Anaghavi above discloses all of the limitations of claim 14 above.
Spector further discloses wherein the treatment area, comprising the transplanted organ or tissue, may be divided into a plurality of individual treatment zones and/or focal zones (Spector, Para 31; “The treatment area may be divided into a plurality of individual treatment zones and/focal zones”) (Spector, Para 32; “each active treatment session may include at least 100 and up to about 500 low energy shockwaves that are administered over a single treatment focal zone”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Spector and Zhang (US20250082541).
Regarding claim 15, Spector discloses all of the limitations of claim 1 above.
Spector does not clearly and explicitly disclose wherein the acoustic energy is applied at least once a day for a period of up to at least 21 days following transplantation.
In an analogous energy treatment system for tissue field of endeavor Zhang discloses wherein acoustic energy (Zhang, Para 30; “Energy waves that can be generated and utilized by the present invention include optical waves or electromagnetic waves such as infrared waves; sound waves including infrasonic waves, acoustic waves and ultrasonic waves”) is applied at least once a day for a period of up to at least 21 days following an unhealthy condition (Zhang, Para 182; “said one or more therapeutically effective doses are 5 to 200 watt hours per day for a treatment period of about 3 days to 90 days”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Spector wherein the acoustic energy is applied at least once a day for a period of up to at least 21 days following transplantation in order to maintain or improve general health, or alleviate or treat diseases and/or conditions as taught by Zhang (Zhang, Para 190).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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, Pascal Bui-Pho can be reached at (571) 272-2714. 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.
/JOHN D LI/Primary Examiner, Art Unit 3798
Prosecution Insights