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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18196643 and 63391938, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Examiner notes that while there is disclosure of treating a medical condition of an appendage and the appendage may be a penis as well as subjecting the penis to at least one instance of acoustic shock wave treatment, there is no such disclosure specifically of subjecting a material formation within the penis to the at least one instance of acoustic shock wave treatment nor is there any disclosure of delivering a dose of formation-mitigating treatment composition into a region of the penis at which the material formation is located. Accordingly claims 1-20 are not entitled to the benefit of the prior application(s) and the effective filing date is considered to be the filing date of the instant application, 04/04/2025.
Claim Objections
Claims 8 and 11 are objected to because of the following informalities: Claims 8 and 11 recite “plague” which should be –plaque—.
Appropriate correction is required.
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.
(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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pausch (US 20250009990 A1), hereinafter Pausch evidenced by Ein-Gal (US 20150073312 A1), hereinafter Ein-gal.
Regarding claim 1,
Pausch teaches a method of treating a medical condition in an appendage comprising:
Subjecting a material formation within the appendage at least partially causing the medical condition to at least one instance of acoustic shock wave treatment (at least claim 8 reciting applying one or more low intensity shock wave treatments before and/or after the collagenase agent injecting is completed as well as [0048] which discloses low intensity shock wave treatment may be applied to the affected areas of the hands and/or feet to soften the cords and/or nodules. Examiner note the low intensity shockwaves are pulsed acoustic waves as evidenced by Ein-Gal [0008] incorporated by reference for the purpose of disclosing low intensity shockwave treatment); and
After performing said subjecting, delivering a dose of formation-mitigating treatment composition into a region of the appendage at which the material formation is located (at least claim 1 which discloses injecting a therapeutically effective amount of collagenase into the patient’s anatomy, claim 8 which recites applying one or more low intensity shock wave treatments before the collagenase agent injecting is complete, and [0044] which discloses Step 214 comprises further actuation of the therapeutic agent syringe plunger 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20).
Examiner notes that while the disclosure is directed to the hand/feet, the claims are directed to a method of treating Dypuytren’s disease and/or Ledderhose’s disease and/or Peyronies disease and [0013] discloses Peyronie’s disease results in curvature of the penis caused by plaque buildup and/or development of scar tissue in the tunica albugina, thus in the case of treating Peyronies, examiner notes that the appendage is the penis.
Regarding claim 2,
Pausch further discloses wherein said delivering includes delivering at least a portion of the dose of formation-mitigating treatment composition directly into the material formation ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that in the case of treating peyronies the dose is delivered directly into the collagen/calcification of the site of the scar tissue)
Regarding claim 3,
Pausch further discloses wherein:
The formation-mitigating treatment composition comprises an enzyme ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen); and
The material formation comprises a material having molecular bonds broken by the enzyme ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that the collagen/calcification of the site of the scar tissue has molecular bonds broken by the enzyme (i.e. the collagenase/xiaflex))
Regarding claim 4,
Pausch further discloses wherein:
The material formation comprises collagen ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone); and
The formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding claim 5,
Pausch further discloses wherein the formation-mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
.
Regarding claim 6,
Pausch further discloses wherein the medical condition is Peyronie’s disease (Claim 1 recites a method of treating Peyronies disease); and
The formation mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
Regarding claim 7,
Pausch further discloses wherein said delivering includes delivering at least a portion of the dose of formation-mitigating treatment composition directly into the material formation ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses As the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease))
Regarding claim 8
Pausch further discloses said subjecting includes subjecting the material to a plurality of treatments of acoustic shock waves prior to said delivering ([0048] which discloses One or more of the shockwave treatments may be provided and is done before the exemplary collagenase, or related pharmaceutical composition injected);
The material formation comprises a collagen containing plaque ([0013] which discloses Peyronie's disease may also be likened to Dupuytren's disease and results in a curvature of the penis caused by plaque buildup and/or development of scar tissue in the tunica albuginea. The plaque and scar tissue do not stretch as well as normal tissue, causing a curvature of the penis. The normal tunica albuginea is composed of elastin fibers and collagen. The site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified); and
At least a portion of the collagen containing plaque exhibits calcification ([0013] which discloses the site of the scare tissue from Peyronie’s disease is composed of collagen that can become calcified).
Regarding claim 9,
Pausch further discloses wherein the formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding claim 10,
Pausch further discloses wherein the formation mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
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.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pausch as evidenced by Eingal in view of Warlick et al. (US 20240024704 A1), hereinafter Warlick.
Regarding claim 11,
Pausch teaches a method of treating a medical condition in an appendage comprising:
Subjecting a material formation within the appendage at least partially causing the medical condition to at least one instance of acoustic shock wave treatment (at least claim 8 reciting applying one or more low intensity shock wave treatments before and/or after the collagenase agent injecting is completed as well as [0048] which discloses low intensity shock wave treatment may be applied to the affected areas of the hands and/or feet to soften the cords and/or nodules. Examiner note the low intensity shockwaves are pulsed acoustic waves as evidenced by Ein-Gal [0008] incorporated by reference for the purpose of disclosing low intensity shockwave treatment), wherein the material formation comprises a collagen-containing plaque ([0013] which discloses Peyronie's disease may also be likened to Dupuytren's disease and results in a curvature of the penis caused by plaque buildup and/or development of scar tissue in the tunica albuginea. The plaque and scar tissue do not stretch as well as normal tissue, causing a curvature of the penis. The normal tunica albuginea is composed of elastin fibers and collagen. The site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified); and at least a portion of the collagen containing plaque exhibits calcification ([0013] which discloses the site of the scar tissue from Peyronie’s disease is composed of collagen that can become calcified);
wherein each of said instances of subjecting includes:
placing an acoustic shock wave applicator (evidenced by Ein-gal fig. 1A/1B (20) and corresponding disclosure in at least [0020]) on a surface of a penis and causing acoustic shock waves to be transmitted from the shock wave applicator into the penis ([0022] which discloses the organ interface member 20 is positioned so as to direct the shockwaves generally upwards with respect to the support surface 14) by activating an acoustic shock wave generator or source coupled to the acoustic shock wave applicator ([0022] which discloses control the operation of the shockwave generating device 16); and
After performing said subjecting, delivering a dose of formation-mitigating treatment composition into a region of the appendage at which the material formation is located (at least claim 1 which discloses injecting a therapeutically effective amount of collagenase into the patient’s anatomy, claim 8 which recites applying one or more low intensity shock wave treatments before the collagenase agent injecting is complete, and [0044] which discloses Step 214 comprises further actuation of the therapeutic agent syringe plunger 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20).
Examiner notes that while the disclosure is directed to the hand/feet, the claims are directed to a method of treating Dypuytren’s disease and/or Ledderhose’s disease and/or Peyronies disease and [0013] discloses Peyronie’s disease results in curvature of the penis caused by plaque buildup and/or development of scar tissue in the tunica albugina, thus in the case of treating Peyronies, examiner notes that the appendage is the penis.
Pausch fails to explicitly teach wherein said placing the acoustic shock wave applicator includes manually retaining the acoustic shock wave applicator in contact with skin of the penis; placing a gaseous filled membrane at a location on an opposite surface of the penis relative to a location of the acoustic shock wave applicator, wherein the gaseous filled membrane is integral with a mitten or a glove, wherein the gaseous filled membrane is on a palm side of the mitten or the glove, and wherein said placing the gaseous filled membrane includes donning the mitten or the glove and holding the penis in contact with the palm side of the mitten or the glove; and wherein the acoustic shock waves impinge upon the gaseous filled membrane, thereby reflecting at least a portion of the acoustic shock waves back into the penis.
Warlick teaches placing an acoustic shock wave applicator on a surface of the penis,
wherein said placing the acoustic shock wave applicator (at least fig. 9 (43) and corresponding disclosure in at least [0059] and [0047] which discloses a hand-held applicator shock wave head and [0058] which discloses the technician is holding the applicator 43 in one hand and the other hand is extending along the shaft of the penis,) includes manually retaining the acoustic shock wave applicator in contact with skin of the penis (at least fig. 9 (100) and corresponding disclosure in at least [0059])(See at least fig. 9);
placing a gaseous filled membrane at a location on an opposite surface of the penis relative to a location of the acoustic shock wave applicator (at least fig. 9 (300) and corresponding disclosure at least [0049] and at least fig. 13 (412) and corresponding disclosure in at least [0051])
wherein the gaseous filled membrane (412) is integral with a mitten or a glove (at least figs. 13/14 (400 or 402) and corresponding disclosure in at least [0051]), wherein the gaseous filled membrane is on a palm side of the mitten or the glove ([0051] which discloses gaseous filled membrane 412 on the palm side of the glove 400 or mitten 402), and wherein said placing the gaseous filled membrane includes donning the mitten or the glove and holding the penis in contact with the palm side of the mitten or the glove ([0051] which discloses the gaseous filled membrane is pressed against the appendage using the technicians hand the gaseous filled membrane 412 is in direct contact with the surface of the appendage 100 being held and [0052] which discloses Surface 414 that contacts the appendage 100 to be treated is shown opposite the technician hand receiving area 420);
and causing acoustic shock waves to be transmitted from the acoustic shock wave applicator into the penis by activating an acoustic shock wave generator or source (at least fig. 4 (1) and corresponding disclosure in at least [0047]) coupled to the acoustic shock wave applicator (43) wherein the acoustic shock waves impinge upon the gaseous filled membrane, thereby reflecting at least a portion of the acoustic shock waves back into the penis ([0055] which discloses the shock waves 200 upon exiting and impinging the membrane 412 or balloon 300, were redirected and reflected back into the tissue of the appendage 100 being treated and claim 1 which recites activating an acoustic shock wave generator or source to emit acoustic shock waves from an acoustic shock wave applicator; and wherein the acoustic shock wave is transmitted from the acoustic shock wave applicator through the surface sending the emitted acoustic shock waves into the tissue of the appendage and exiting the opposite surface of the appendage to the gaseous filled membrane where a reflection of the acoustic shock wave occurs sending reflected acoustic shock waves back through the appendage;).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Pausch to include placing the acoustic shock wave applicator, placing the gaseous filled membrane, and causing acoustic shock waves to be transmitted as taught by Warlick in order to provide an improved method of treating the penis (Warlick Abstract). Such a modification would improve the absorption of the shock waves by redirecting the exiting waves reflecting them back into the treated appendage (Warlick [0002]) such that a compressive force is transmitted back into the tissue to stimulate the cells with a reduced tensile component that can improve the effectiveness of the acoustic shock waves (Warlick [0057]).
Regarding claim 12,
Pausch further teaches wherein said delivering includes delivering at least a portion of the dose of formation-mitigating treatment composition directly into the material formation ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that in the case of treating peyronies the dose is delivered directly into the collagen/calcification of the site of the scar tissue).
Regarding claim 13,
Pausch further discloses wherein:
The formation-mitigating treatment composition comprises an enzyme ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen); and
The material formation comprises a material having molecular bonds broken by the enzyme ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that the collagen/calcification of the site of the scar tissue has molecular bonds broken by the enzyme (i.e. the collagenase/Xiaflex))
Regarding claim 14,
Pausch further teaches wherein the formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding claim 15,
Pausch further teaches wherein the medical condition is Peyronie’s disease (Claim 1 recites a method of treating Peyronies disease); and
The formation mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
Regarding claim 16,
Pausch further teaches further comprising:
Determining a location of the material formation ([0010] which discloses individual injection site locations marked at regular intervals along the affected region of the palm of the patient's hand and [0042] which discloses the exemplary treatment method 200 may be initiated by optionally marking injection targets or sites on the patient's anatomy at step 201. Examiner thus notes that in marking injection targets/sites (e.g. sites along the affected region), the location of the material formation is necessarily determined)
Pausch, as modified, further teaches placing includes positioning the acoustic shock wave applicator for directing the acoustic shock waves toward the material formation (examiner notes that positioning the acoustic shock wave applicator of Warlick is necessarily for directing the acoustic shock waves toward the material formation in order to treat the medical condition (i.e. peyronies) accordingly)
Regarding claim 17,
Pausch, as modified, teaches the elements of claim 11 as previously stated.
Warlick, as applied to claim 11 above, further teaches wherein:
the gaseous filled membrane has an internal chamber filled with air, nitrogen or other inert gas;
and the gaseous filled membrane has an elastomeric conformable exterior surface that conforms to the shape of the surface of the penis when holding the penis in contact with the palm side of the mitten or the glove.
Regarding claim 18,
Pausch further teaches the material formation comprises collagen ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone); and
The formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding claim 19,
Pausch, as modified, teaches the elements of claim 11 as previously stated. Warlick, as applied to claim 11 above, further teaches wherein:
the mitten or the glove includes a first layer of material (at least figs. 12-13 (410 and 408 and/or 400) and corresponding disclosure in at least [0052]) defining a palm region of the glove and at least partially defining a hand-receiving space thereof (at least figs. 12-13 (420) and corresponding disclosure in at least [0052]) ;
the mitten or the glove includes a second layer of material (at least figs. 12-13 (414) and correspond disclosure in at least [0052]) attached to the first layer of material (410/400) to define an interior space (at least figs. 12-13 (418) and corresponding disclosure in at least [0052]) between the first (410/400) and second layers (414) of material
and the interior space (418) has the gaseous filled membrane (412) therein (see at least fig. 13)
Regarding claim 20,
Pausch, as modified, teaches the elements of claim 19 as previously stated. Warlick, as applied to claim 19 above, further teaches wherein:
the gaseous filled membrane (412) is engaged with an exterior surface of the first layer of material (see at least fig. 13);
the interior space defined by the first and second layers of material is filled with a fluid that reflects the acoustic shock waves ([0052] which discloses internal area 418 filled with a fluid 416).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10, and 14 of U.S. Patent No. 12303721 in view of Pausch.
Regarding instant claims 1 and 11,
Reference claim 1 recites
A method of treating an appendage of a patient, comprises the steps of:
placing an acoustic shock wave applicator on a surface of the appendage, wherein said placing the acoustic shock wave applicator includes manually retaining the acoustic shock wave applicator in contact with skin of the appendage;
placing a gaseous filled membrane at a location on an opposite surface of the appendage relative to a location of the acoustic shock wave applicator, wherein the gaseous filled membrane is integral with a mitten or a glove, wherein the gaseous filled membrane is on a palm side of the mitten or the glove, and wherein said placing the gaseous filled membrane includes donning the mitten or the glove and holding the appendage in contact with the palm side of the mitten or the glove,
causing one or more acoustic shock waves to be transmitted from the acoustic shock wave applicator through the appendage by activating an acoustic shock wave generator or source coupled to the acoustic shock wave applicator, wherein the one or more acoustic shock waves impinge upon the gaseous filled membrane, thereby reflecting the one or more of the acoustic shock waves back into the appendage
where such causing of one or more acoustic shock waves subjects the appendage to at least one instant of acoustic shock wave treatment
Reference claim 1 fails to explicitly recite treating a medical condition in a penis, subjecting a material formation within the penis at least partially causing the medical condition and after performing said subjecting wherein the material formation comprises a collagen-containing plaque, wherein at least a portion of the collagen-containing plaque exhibits calcification, delivering a dose of formation-mitigating treatment composition into a region of the penis at which the material formation is located.
Pausch teaches the cited elements as noted above.
It would have been obvious to a person having ordinary skill in the art before the effective filing date/date of the invention to have modified Reference claim 1 to include the cited features as taught by Pausch in order to provide treatment for peyronies. Such a modification would further enhance the treatment of the appendage by providing additional treatment steps after the shock waves to disrupt any scar tissue or collagen/calcification thereof (Pausch [0041])
Regarding instant claim 2 and claim 12,
Pausch, as applied to instant claims 1 and 11 above, further teaches wherein said delivering includes delivering at least a portion of the dose of formation-mitigating treatment composition directly into the material formation ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that in the case of treating peyronies the dose is delivered directly into the collagen/calcification of the site of the scar tissue).
Regarding instant claims 3 and 13,
Pausch, as applied to instant claims 1 and 11 further teaches wherein:
The formation-mitigating treatment composition comprises an enzyme ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen); and
The material formation comprises a material having molecular bonds broken by the enzyme ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone. Examiner notes that the collagen/calcification of the site of the scar tissue has molecular bonds broken by the enzyme (i.e. the collagenase/xiaflex))
Regarding instant claims 4 and 14,
Pausch, as applied to instant claims 1 and 11 above, further teaches wherein:
The material formation comprises collagen ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone); and
The formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding instant claim 5,
Pausch, as applied to instant claim 5, further teaches wherein the formation-mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of Xiaflex as the collagenase and [0009] which discloses Xiaflex has the generic name collagenase clostridium histolyticum).
Regarding instant claims 6 and 15,
Pausch, as applied to instant claims 1 and 11, further teaches wherein the medical condition is Peyronie’s disease (Claim 1 recites a method of treating Peyronies disease); and
The formation mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
Regarding instant claim 7,
Pausch, as applied to instant claim 6, further teaches wherein said delivering includes delivering at least a portion of the dose of formation-mitigating treatment composition directly into the material formation ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses As the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease))
Regarding instant claim 8,
Pausch, as applied to instant claim 1 above, further teaches said subjecting includes subjecting the material to a plurality of treatments of acoustic shock waves prior to said delivering ([0048] which discloses One or more of the shockwave treatments may be provided and is done before the exemplary collagenase, or related pharmaceutical composition injected);
The material formation comprises a collagen containing plaque ([0013] which discloses Peyronie's disease may also be likened to Dupuytren's disease and results in a curvature of the penis caused by plaque buildup and/or development of scar tissue in the tunica albuginea. The plaque and scar tissue do not stretch as well as normal tissue, causing a curvature of the penis. The normal tunica albuginea is composed of elastin fibers and collagen. The site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified); and
At least a portion of the collagen containing plaque exhibits calcification ([0013] which discloses the site of the scar tissue from Peyronie’s disease is composed of collagen that can become calcified).
Regarding claim 9,
Pausch, as applied to instant claim 8 above, further teaches wherein the formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding claim 10,
Pausch, as applied to instant claim 9 above, further teaches wherein the formation mitigating treatment composition comprises collagenase Clostridium Histolyticum ([0039]-[0040] disclosing the use of xiaflex as the collagenase and [0009] which discloses Xiaflex® has the generic name collagenase clostridium hisolyticum).
Regarding instant claim 16,
Pausch further teaches determining a location of the material formation ([0010] which discloses individual injection site locations marked at regular intervals along the affected region of the palm of the patient's hand and [0042] which discloses the exemplary treatment method 200 may be initiated by optionally marking injection targets or sites on the patient's anatomy at step 201. Examiner thus notes that in marking injection targets/sites (e.g. sites along the affected region), the location of the material formation is necessarily determined) and examiner notes that modified reference 1 includes positioning the acoustic shock wave applicator which is for directing the acoustic shock waves toward the material formation.
Regarding instant claim 17,
Reference claim 3 recites the elements of claim 17.
Regarding instant claim 18,
Pausch, as applied to instant claim 11 above, further teaches wherein:
The material formation comprises collagen ([0044] which discloses 32 to inject a therapeutic amount of the exemplary collagenase into the patient's cord and/or nodules via the injection needles 20 and [0004] which discloses as the thickening progresses, lumps or nodules may form under the skin, or long thick cords of tissue may form that extend from the palm to the fingers and [0005] which discloses such as collagen nodules of the feet (Ledderhose's disease) and [0013] which discloses the site of scar tissue from Peyronie's disease is composed mostly of collagen that can become calcified and, in extreme cases, harden to the thickness of bone); and
The formation-mitigating treatment composition breaks molecular bonds of the collagen ([0039]-[0040] disclosing the use of Xiaflex as the collagenase and [0009] which discloses collagenase is an enzyme with the ability to digest collagen).
Regarding instant claim 19,
Reference claim 10 recites the elements of instant claim 19.
Regarding instant claim 20,
Reference claim 14 recites the elements of instant claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Morganstern et al. (US 11602540 B2) teaches subjecting a material formation in a penis to at least one acoustic wave shock treatment (at least fig. 6 (112) and corresponding disclosure in at least Col. 4 lines 1-20) and delivering a dose of formation-mitigating treatment composition into a region of the penis at which the material formation is located (at least fig. 6 (118 and/or 116) and corresponding disclosure in at least Col. 4 line 50-Col. 5 line 10) and additionally teaches after carboxy therapy subsequently administering by injection a therapeutically effective dose of collagenase clostridium histolyticum into the penile plaque deposit (claim 17) and additionally teaches determining a location of the material formation at least fig. 8A (802) and corresponding disclosure in at least Col. 6 lines 55-58)
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797