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 .
Information Disclosure Statement
The information disclosure statement filed on 07/02/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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 6 and 13 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 claims 6 and 13, the term “preferably” renders the claim unclear. Specifically, it is unclear as to whether the claims require the recited preference or not. In order to further advance prosecution, Examiner is interpreting the claims as not requiring the recited preferences. Examiner suggests amending the claims to positively recite the preferred limitations in order to help overcome this rejection.
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.
Claim 16 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory
categories of invention and thus fail as eligible subject matter. Claim 16 characterizes the invention
as a “A computer program product”. A broadest reasonable interpretation of this language typically covers forms of non-transitory tangible media and transitory propagating signals per se, which are not patentable under 35 U.S.C. 101. Claims that cover both statutory and non-statutory embodiments under the broadest reasonable interpretation of the claims when read in light of the specification and in view of one skilled in the art, embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The claims are considered to be broad enough to cover a transitory propagating signal that carries a programmed instruction set. The specification discloses that “a computer program product, such as a data carrier, e.g. a non-transitory data carrier, or data stream, may contain machine readable instructions” [0116]. This text does not exclude a transitory propagating signal. Furthermore, even when claims are directed to one of the four statutory categories of invention, the claims must not be wholly directed to subject matter encompassing a judicially recognized exception without a particular practical application. In the instant case, in addition to failing to fall within one of the four statutory categories of invention, the claims recite only instructions, i.e. an algorithm that is not limited to a particular practical application. It is suggested to add “non-transitory” to the claim body to
distinguish over non-statutory subject matter.
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 1-9, 11, and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,208,278. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of U.S. Patent No. 12,208,278.
Instant Application 18/984614
US Patent No. 12,208,278
Claim 1
An illumination system for photodynamic therapy,
Claim 1
An illumination system for photodynamic therapy,
the illumination system comprising an illumination source, which is configured to emit an electromagnetic radiation to illuminate a target surface during operation, and
the illumination system comprising an illumination source, which is configured to emit an electromagnetic radiation to illuminate a target surface during operation, and
an electronic control unit,
an electronic control unit,
wherein the illumination source is configured such that the intensity of the electromagnetic radiation emitted by the illumination source can be varied,
wherein the illumination source is configured such that the intensity of the electromagnetic radiation emitted by the illumination source can be varied,
wherein the electronic control unit is operatively connected to the illumination source and configured to control operation of the illumination source according to an illumination protocol during an illumination session performed with the illumination system, and
wherein the electronic control unit is operatively connected to the illumination source and configured to control operation of the illumination source according to an illumination protocol during an illumination session performed with the illumination system, and
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes, the modes comprising:
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes, the modes comprising:
a) a first mode, wherein, in the first mode, the electronic control unit controls operation of the illumination source such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval, and
a) a first mode, wherein, in the first mode, the electronic control unit controls operation of the illumination source such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval,
b) a third mode, wherein, in the third mode, the electronic control unit controls operation of the illumination source such that the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval,
a third mode, wherein, in the third mode, the electronic control unit controls operation of the illumination source such that the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval,
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases, or
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases, or
wherein, in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases.
wherein, in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases.
Claim 15
A method for operating an illumination source,
Claim 12
A method for operating an illumination source,
wherein the illumination source is operated according to an illumination protocol during an illumination session performed with the illumination system, and
wherein the illumination source is operated according to an illumination protocol during an illumination session performed with the illumination system, and
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes, the modes comprising:
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes, the modes comprising:
a) a first mode, wherein, in the first mode, the illumination source is operated such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval, and
a) a first mode, wherein, in the first mode, the illumination source is operated such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval,
b) a third mode, wherein, in the third mode, the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval,
a third mode, wherein, in the third mode, the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval,
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases, or
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases, or
wherein, in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases.
wherein in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases.
Dependent claims 2-9, 11, and 13-21 of application no. 18/984614 are also anticipated by claims 1-11 and 13-19 of US Patent No. 12,208,278.
Instant Application 18/984614
US Patent No. 12,208,278
Claim 2
Claim 2
Claim 3
Claim 1
Claim 4
Claim 3
Claim 5
Claim 4
Claim 6
Claim 5
Claim 7
Claim 6
Claim 8
Claim 7
Claim 9
Claim 8
Claim 11
Claim 9
Claim 13
Claim 10
Claim 14
Claim 11
Claim 16
Claim 13
Claim 17
Claim 14
Claim 18
Claim 15
Claim 19
Claim 16
Claim 20
Claim 17
Claim 21
Claims 18-19
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-8, 11, 13, 15-16, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas-Benedict (US 2005/0024853) hereinafter Thomas.
Regarding claim 1, Thomas discloses an illumination system for photodynamic therapy ([0012] light delivery wrap system 11), the illumination system comprising an illumination source (assembly 15), which is configured to emit an electromagnetic radiation to illuminate a target surface during operation ([0012] assembly 15 of generators of electromagnetic radiation in the form of light), and
an electronic control unit ([0012] electrical power source 13 that delivers controllable power),
wherein the illumination source is configured such that the intensity of the electromagnetic radiation emitted by the illumination source can be varied ([0039] light intensity patterns represented in Figs. 15-17),
wherein the electronic control unit is operatively connected to the illumination source and configured to control operation of the illumination source according to an illumination protocol during an illumination session performed with the illumination system ([0012] electrical power source 13 that delivers controllable power), and
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes ([0041] in Fig. 17, the light intensity rises to a first maximum, optionally continues at or near that level for a first selected illumination time interval, falls to a first lower value, goes to 0 for a dark field time interval, rises to a second maximum value, optionally continues at that level for a second selected illumination time interval, falls to a second lower value, then goes to 0), the modes comprising:
a) a first mode (see annotated Fig. 17), wherein, in the first mode, the electronic control unit controls operation of the illumination source such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval ([0041] light intensity I(t;i;j) rises to a first maximum value I(max; 1)), and
b) a third mode (see annotated Fig. 17), wherein, in the third mode, the electronic control unit controls operation of the illumination source such that the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value),
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Annotated Fig. 17: The first mode is encircled and the third mode is outlined by a box
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value), or
wherein, in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value).
Regarding claim 3, Thomas discloses a second mode (see annotated Fig. 17),
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Annotated Fig. 17: The first mode is outlined by a solid box, the second mode is encircled, and the third mode is outlined by a dashed box
wherein, in the second mode, the electronic control unit controls operation of the illumination source such that the intensity of the electromagnetic radiation emitted by the illumination source is constant or substantially constant for a second mode time interval ([0041] the light intensity optionally continues at or near that level for a first selected illumination time interval of length).
Regarding claim 4, Thomas discloses wherein the illumination source is operated in the second mode after the first mode and/or before the third mode during the illumination session (annotated Fig. 17 shows the second mode occurring after the first mode and before the third mode; [0041] the light intensity rises to a first maximum (first mode), optionally continues at or near that level for a first selected illumination time interval (second mode), falls to a first lower value, goes to 0 for a dark field time interval, rises to a second maximum value, optionally continues at that level for a second selected illumination time interval, falls to a second lower value, then goes to 0 (third mode)).
Regarding claim 5, Thomas discloses wherein the beginning of the operation of the illumination source in the first mode defines the start of the illumination session and the end of the operation of the illumination source in the third mode defines the end of the illumination session ([0039] Fig. 17 shows a light pattern; [0041] light intensity rises to a first maximum, continues at that level, drops to zero, rises again, and then goes to 0; Examiner notes that Fig. 17 shows a start and end of the light pattern containing the three modes).
Regarding claim 6, Thomas discloses wherein every mode selected from the first mode, the second mode, and the third mode of operation of the illumination source occurs once, preferably only once, during the illumination session (annotated Fig. 17 shows every mode occurring once).
Regarding claim 7, Thomas discloses wherein the electromagnetic radiation has a peak wavelength in the visible spectral range, e.g. in the red, green, yellow, or blue spectral range ([0012] system 11 includes an electrical power source 13 that delivers controllable power to an assembly 15 of generators of electromagnetic radiation in the form of light in the visible and near infrared ranges).
Regarding claim 8, Thomas discloses wherein the target surface is arranged at a target location relative to the illumination source during the illumination session ([0013] each radiation generator is spaced apart from the body component 19 by at least a selected threshold distance), and
wherein the illumination system is configured to irradiate the target surface with a predetermined radiation dose during the illumination session ([0044] an accumulated energy density range of 2.5 Joules/cm.sup.2. to 20 Joules/cm.sup.2.).
Regarding claim 11, Thomas discloses wherein the radiation dose is greater than or equal to 8 J/cm2 and less than or equal to 12 J/cm2 when the target surface is arranged at the target location relative to the illumination source during the illumination session ([0044] an accumulated energy density range of 2.5 Joules/cm.sup.2. to 20 Joules/cm.sup.2.).
Regarding claim 13, Thomas discloses wherein the distance between the radiation exit surface of the illumination source and the target location is between 1 cm and 20 cm, preferably between 5 cm and 8 cm ([0013] A suitable threshold distance is d(thr)=1-10 cm).
Regarding claim 15, Thomas discloses a method for operating an illumination source, wherein the illumination source is operated according to an illumination protocol during an illumination session performed with the illumination system ([0012] system 11 includes an electrical power source 13 that delivers controllable power to an assembly 15 of generators of electromagnetic radiation in the form of light; [0039] Fig. 17 shows a light intensity pattern), and
wherein the illumination protocol comprises instructions to operate the illumination source during the illumination session in a plurality of different modes ([0041] in Fig. 17, the light intensity rises to a first maximum, optionally continues at or near that level for a first selected illumination time interval, falls to a first lower value, goes to 0 for a dark field time interval, rises to a second maximum value, optionally continues at that level for a second selected illumination time interval, falls to a second lower value, then goes to 0), the modes comprising:
a) a first mode (see annotated Fig. 17), wherein, in the first mode, the electronic control unit controls operation of the illumination source such that the intensity of the electromagnetic radiation emitted by the illumination source is increased continuously or quasi-continuously from a base intensity B to a target intensity T within a first mode time interval ([0041] light intensity I(t;i;j) rises to a first maximum value I(max; 1)), and
b) a third mode (see annotated Fig. 17), wherein, in the third mode, the electronic control unit controls operation of the illumination source such that the illumination source is operated such that darker phases and illumination phases alternate for a third mode time interval ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value),
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Annotated Fig. 17: The first mode is encircled and the third mode is outlined by a box
wherein the intensity of the electromagnetic radiation emitted by the illumination source is lower in the darker phases than in the illumination phases ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value), or
wherein, in the darker phases the illumination source does not emit electromagnetic radiation whereas the illumination source emits electromagnetic radiation in the illumination phases ([0041] light intensity falls to a first lower value, then goes to 0 for a dark field interval, and then rises to a second maximum value).
Regarding claim 16, Thomas discloses a computer program product, such as a data carrier, e.g. a non-transitory data carrier, or data stream, the computer program product containing machine readable instructions which, in particular when loaded in and/or executed by a computer system, e.g. by an electronic control unit thereof, cause an illumination source to be operated according to the method of claim 15 ([0045] At least one of the control panel 151 and the driver module 153 includes a computer to process information and/or commands needed to provide appropriate light wavelengths in the appropriate time intervals according to the invention).
Regarding claim 21, Thomas discloses wherein the first mode time interval, the second mode time interval, and/or the third mode time interval is greater than or equal to 1 min and less than or equal to 10 min, or
wherein the duration of one darker phase and/or of one illumination phase is greater than 15 s and less than or equal to 4 min, or
wherein the first mode time interval and the second mode time interval are longer than the duration of a single darker phase and a single illumination phase, or
wherein the second mode time interval is shorter than the first mode time interval, or
wherein a bearing surface (light delivery wrap mechanism 16) is positioned such that the target surface is arranged at a target location (threshold distance) relative to the illumination source during the illumination session ([0013] light delivery wrap mechanism 16 that is configured to contact and wrap around a selected body component 19, a group of two or more adjacent body components or the whole body, so that each radiation generator is spaced apart from the body component 19 by at least a selected threshold distance).
Examiner notes that the limitations of wherein the first mode time interval, the second mode time interval, and/or the third mode time interval is greater than or equal to 1 min and less than or equal to 10 min, or wherein the duration of one darker phase and/or of one illumination phase is greater than 15 s and less than or equal to 4 min, or wherein the first mode time interval and the second mode time interval are longer than the duration of a single darker phase and a single illumination phase, or wherein the second mode time interval is shorter than the first mode time interval are alternatively claimed and not positively recited. Therefore, the prior art discussed above satisfies the claim language as currently written.
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.
Claim(s) 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2005/0024853).
Regarding claim 2, Thomas discloses the system of claim 1 as discussed above, but fails to expressly disclose wherein B is greater than or equal to 0.1T and less than or equal to 0.5T. However, Thomas discloses that the light intensity rises to a first maximum value and further discloses that the first and second lower values may be the same, may differ, or may be zero [0041]. Examiner notes that at some point during the first mode, when the base intensity is increasing to the target intensity as taught by Thomas, the base intensity is greater than or equal to 0.1T and less than or equal to 0.5T (see annotated Fig. 17).
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Annotated Fig. 17: A portion of the light intensity is encircled where the intensity is greater than or equal to 0.1T and less than or equal to 0.5T for a period of time
Examiner submits that the claimed greater than or equal to 0.1T and less than or equal to 0.5T range is so close to the taught minimum value being zero that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a base intensity of 0T to have the same properties as a base intensity that is greater than or equal to 0.1T and less than or equal to 0.5T (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)). In this case it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Thomas with B being greater than or equal to 0.1T and less than or equal to 0.5T since discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Regarding claim 14, Thomas discloses wherein the duration of the entire illumination session is 5-45 min, but fails to explicitly teach wherein the duration of the entire illumination session is less than or equal to one of the following values: 20 min, 19 min, 18 min, 17 min, 16 min, 15 min, 14 min, 13 min. However, Examiner submits that the claimed less than or equal to 20 min, 19 min, 18 min, 17 min, 16 min, 15 min, 14 min, 13 min duration is so close to the taught 5-45 min duration that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a 5-45 min duration to have the same properties as a 20 min or less duration (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)). In this case, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill to modify the 5-45min duration as taught by Thomas with a duration of 20 min or less since discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Claim(s) 9, 17-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2005/0024853) in view of Lundahl et al (US 2019/0216927).
Regarding claim 9, Thomas discloses the system of claim 8 as discussed above, but fails to disclose wherein the radiation dose is greater than or equal to 30 J/cm2 and less than or equal to 45 J/cm2 when the target surface is arranged at the target location relative to the illumination source during the illumination session. However Lundahl discloses wherein the radiation dose is greater than or equal to 30 J/cm2 and less than or equal to 45 J/cm2 when the target surface is arranged at the target location relative to the illumination source during the illumination session ([0036] The red light can provide a dose of, for example, 10 to 75 J/cm.sup.2 (such as 37 J/cm.sup.2), e.g., within 10 minutes).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Thomas with the radiation dose is greater than or equal to 30 J/cm2 and less than or equal to 45 J/cm2 when the target surface is arranged at the target location relative to the illumination source during the illumination session as taught by Lundahl. Such a modification would provide the predictable results of using red light to irradiate lesions uniformly (Lundahl, [0044]).
Regarding claim 17, Thomas discloses a kit for treating a disease, in particular a skin disease, comprising: an illumination system as claimed in claim 1 configured to irradiate a region of the skin to which a substance has been applied (see rejection above), but fails to teach a pharmaceutical substance suitable to be topically applied to the skin in a region to be treated. However, Lundahl discloses a pharmaceutical substance suitable to be topically applied to the skin in a region to be treated ([0003] topical composition (e.g., a topical solution or emulsion) containing ALA ).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the kit as taught by Thomas with a pharmaceutical substance suitable to be topically applied to the skin in a region to be treated as taught by Lundahl. Such a modification would provide the predictable results of administering a photoactivatable agent that, once activated, can selectively locate, destroy, or alter the target tissue while, at the same time, causing at most only mild and reversible damage to other tissues in the treatment area (Lundahl, [0003]).
Regarding claim 18, Thomas discloses a method or treating a skin disease comprising irradiating the region with an illumination source according to the method as specified in claim 15 (see above rejection of claim 15), but fails to disclose applying a pharmaceutical substance to the surface of the skin in a region which is to be treated. However, Lundahl discloses applying a pharmaceutical substance to the surface of the skin in a region which is to be treated ([0003] Photosensitization following application of a topical composition (e.g., a topical solution or emulsion) containing ALA).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Thomas with applying a pharmaceutical substance to the surface of the skin in a region which is to be treated as taught by Lundahl. Such a modification would provide the predictable results of administering a photoactivatable agent that, once activated, can selectively locate, destroy, or alter the target tissue while, at the same time, causing at most only mild and reversible damage to other tissues in the treatment area (Lundahl, [0003]).
Regarding claim 19, the modified Thomas discloses the method of claim 18 as discussed above, but fails to disclose wherein the pharmaceutical substance is a photosensitizing drug or precursor to such a drug that is excitable by radiation in the emitted spectrum. However, Lundahl discloses wherein the pharmaceutical substance is a photosensitizing drug or precursor to such a drug that is excitable by radiation in the emitted spectrum ([0003] the area in which the photoactivatable agent is administered is then exposed to visible light, which causes chemical and/or biological changes in the agent; a precursor of a photoactivatable agent is 5-aminolevulinic acid (“ALA”)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Thomas with the pharmaceutical substance is a photosensitizing drug or precursor to such a drug that is excitable by radiation in the emitted spectrum as taught by Lundahl. Such a modification would provide the predictable results of administering a photoactivatable agent that, once activated, can selectively locate, destroy, or alter the target tissue while, at the same time, causing at most only mild and reversible damage to other tissues in the treatment area (Lundahl, [0003]).
Regarding claim 20, Thomas discloses wherein the skin disease is a neoplastic skin disease like actinic keratosis, basal cell carcinoma, squamous cell carcinoma in situ, or warts, acne, wound healing disorders/chronic wounds, bacterial and/or fungal infections, inflammatory skin diseases ([0018] The wrap 41 has also been used successfully for acne reduction).
Regarding claim 22, the modified Thomas discloses the system of claim 1 as discussed above, but fails to disclose wherein the illumination protocol is configured to provide an illumination session for photodynamic therapy with 5-aminolevulinic acid with a reduced pain burden perceived by the patient and an increased efficiency due to re-oxygenation of a treated issue. However, Lundahl discloses wherein the illumination protocol is configured to provide an illumination session for photodynamic therapy with 5-aminolevulinic acid with a reduced pain burden perceived by the patient and an increased efficiency due to re-oxygenation of a treated issue ([0007] topically applying ALA to a treatment area to be treated with photodynamic therapy).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Thomas with the illumination protocol is configured to provide an illumination session for photodynamic therapy with 5-aminolevulinic acid with a reduced pain burden perceived by the patient and an increased efficiency due to re-oxygenation of a treated issue as taught by Lundahl. Such a modification would provide the predictable results of administering a photoactivatable agent that, once activated, can selectively locate, destroy, or alter the target tissue while, at the same time, causing at most only mild and reversible damage to other tissues in the treatment area (Lundahl, [0003]).
Regarding claim 23, the modified Thomas discloses the method of 18 as discussed above, but fails to disclose wherein the pharmaceutical substance comprises 5-aminolevulinic acid. However, Lundahl discloses wherein the pharmaceutical substance comprises 5-aminolevulinic acid ([0003] One example of a precursor of a photoactivatable agent is 5-aminolevulinic acid (“ALA”), which is commonly used in photodynamic therapy of actinic keratosis).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Thomas with the pharmaceutical substance comprises 5-aminolevulinic acid as taught by Lundahl. Such a modification would provide the predictable results of administering a photoactivatable agent that, once activated, can selectively locate, destroy, or alter the target tissue while, at the same time, causing at most only mild and reversible damage to other tissues in the treatment area (Lundahl, [0003]).
Conclusion
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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