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 .
Disposition of Claims
Claims 1-70 as filed on July 27, 2023 are presently pending, and are subject to examination on merits.
Claim Objections
Claim 15 is objected to because of the following informalities: the word or phrase “method of claim1 14” appears to be a typo, it is presumed the intent was to recite “method of claim 14”. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “medical insert” (claim 57) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the specification should be amended to reflect issued Patent No(s). associated with the prior filed application(s).
Appropriate correction is required.
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 1-70 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 1-70, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 and 50 recites the broad recitation "penetrating radiation", and the claim also recites "x-rays, gamma rays or electrons" which is the narrower statement of the limitation (see e.g., specification page 123, 3rd full paragraph “penetrating radiation (x-rays, electrons, gammas, infrared, microwave)”. Claim 51 recites the broad recitation "penetrating radiation", and the claim also recites "conformal x-rays or ebeam source" which is the narrower statement of the limitation (see e.g., specification page 123, 3rd full paragraph “penetrating radiation (x-rays, electrons, gammas, infrared, microwave)”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 recites the limitation "said x-rays, gamma rays or electrons" in line 7-8. There is insufficient antecedent basis for this limitation in the claim, the claims does not previously set forth x-rays, gamma rays or electrons.
Claim 50 recites the limitation “…directs penetrating radiation palliative radiation …” it is unclear whether this recitation refers to penetrating palliative radiation in the alternative or in combination, thus rendering the claim indefinite.
Claims 2-49 and 61-70 are likewise rejected, because they include all limitations and deficiencies thereof of claim 1 or 51.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6, 8, 12-18, 20-32 and 39-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Applicant cited Vo-Dinh et al., US 2011/0021970 A1 (“Vo-Dinh”).
Regarding claim 1, Vo-Dinh discloses a method for imaging or treating a disease in a human or animal body, comprising: infusing a diseased site with a photoactivatable drug and a pharmaceutical carrier including one or more phosphors which are capable of emitting ultraviolet or visible light into the body and which provide x-ray contrast (e.g. see [0201], [0205], [0341] and [0362]); irradiating the diseased site with penetrating radiation an initiation energy source to thereby initiate emission of said ultraviolet or visible light into the body (e.g. see [0223] and [0363]); and at least one of 1) producing images of the diseased site (e.g. see [0174], [0487], [0583], and [0585]) or 2) controlling a dose of said penetrating radiation (x-rays, gamma rays, or electrons) to the diseased site for production of said ultraviolet or visible light at the diseased site to activate the photoactivatable drug (e.g. see [0369])
Regarding claim 3, Vo-Dinh discloses the phosphors comprise: a first plurality of energy-converting particles in the medium which, upon radiation from the x-ray source, radiate at a first energy lower than the x-ray source; and a second plurality of energy-converting particles which, upon radiation from the x-ray source, radiate at a second energy lower than the x-ray source (e.g. see [0201], [0204]).
Regarding claim 4, Vo-Dinh discloses a combination of the first and second plurality of energy-converting particles comprises a weighted composition, and emission from the weighted composition activates the photoactivatable drug (e.g. see [0201], [0204]).
Regarding claim 5, Vo-Dinh discloses emission overlaps an absorption spectrum of the photoactivatable drug (e.g. see [0201], [0204], [0383]).
Regarding claim 6, Vo-Dinh discloses the phosphors are injected nearby the diseased site for illumination of the photoactivatable drug to treat the diseased site (e.g. see [0341], claims 73,210,311 and/or 341).
Regarding claim 8, Vo-Dinh discloses a source for an externally applied electric field or a magnetic field distribution which concentrates the phosphors at the diseased site (e.g. see [0203], [0234-0235] concentrating a magnetic energy modulation particle in a tumor site using conventional techniques in a presence of a magnetic field).
Regarding claim 12, Vo-Dinh discloses the phosphors comprise at least one of: phosphor particles; ionic doped phosphor particles; single crystal or poly-crystalline powders; single crystal or poly-crystalline monoliths; scintillator particles; a metallic shell encapsulating at least a fraction of a surface of the phosphors; a semiconductor shell encapsulating at least a fraction of a surface of the phosphors; and an insulator shell encapsulating at least a fraction of a surface of the phosphors; and phosphors of a distributed particle size (e.g. see [0234] [0571]).
Regarding claim 13, Vo-Dinh discloses the metallic shell comprises a plasmonic shell configured to enhance at least one of said absorption or said emission (e.g. see [0478]).
Regarding claim 14, Vo-Dinh discloses the phosphors comprise particles having a dielectric core (e.g. see [0416]).
Regarding claim 15, Vo-Dinh discloses the phosphors comprise a metallic shell at least partially covering said dielectric core and comprises at least one of Au, Ag, Cu, Ni, Pt, Pd, Co, Ru, Rh, or a combination thereof (e.g. see [0460-461]).
Regarding claim 16, Vo-Dinh discloses the phosphors comprise at least one of Y203; ZnS; ZnSe;MgS; CaS; Mn, Er ZnSe; Mn, Er MgS; Mn, Er CaS; Mn, Er ZnS; Mn,Yb ZnSe; MnYb MgS;CaWO4, YaTO4, YaTO4:Nb, BaSO4:Eu, La2O2S:Tb, BaSi2O;:Pb, NaI(Tl), CsI(Tl), CsI(Na), Csl(pure), CsF, KI(TI), Lil(Eu), BaF2, CaF, CaF2(Eu), ZnS(Ag), CaWO4, CdWO4, YAG(Ce) (Y3AlO1z(Ce)), BGO bismuth germanate, GSO gadolinium oxyorthosilicate, LSO lutetium oxyorthosilicate, LaCI(Ce), LaBr;(Ce), LaPO4; Ce, Tb (doped), and Zn2SiO4:Mn with Mn doped between 0.05-10% (e.g. see [0460-0461).
Regarding claim 17, Vo-Dinh discloses the phosphors comprise at least one of down conversion or up conversion media, and combinations and agglomerations thereof with or without plasmonic agents (e.g. see [0378], [0413-0414]).
Regarding claim 18, Vo-Dinh discloses the one or more devices administer the photoactivatable drug in accordance to a volume of the diseased site (e.g. see [0062], [0203] dosage dependent due to toxicity, and will therefore depend in a volume of the diseases site, [0214] therapeutic effective amount would depend on the volume of the diseased tissue).
Regarding claim 20, Vo-Dinh discloses the photoactivatable drug comprises a psoralen compound mixed with the phosphors (e.g. see [0217]).
Regarding claim 21, Vo-Dinh discloses the photoactivatable drug is selected from psoralens, pyrene cholesteryloleate, acridine, porphyrin, fluorescein, rhodamine, 16-diazorcortisone, ethidium, transition metal complexes of bleomycin, transition metal complexes of deglycobleomycin organoplatinum complexes, alloxazines, vitamin Ks, vitamin L, vitamin metabolites, vitamin precursors, naphthoquinones, naphthalenes, naphthols and derivatives thereof having planar molecular conformations, porphorinporphyrins, dyes and phenothiazine derivatives, coumarins, quinolones, quinones, and anthroquinones (e.g. see [0217]).
Regarding claim 22, Vo-Dinh discloses the photoactivatable drug comprises a psoralen, a coumarin, a porphyrin or a derivative thereof (e.g. see [0217]).
Regarding claim 23, Vo-Dinh discloses the photoactivatable drug comprises s 8-MOP, TMP, or AMT (e.g. see [0291]).
Regarding claim 24, Vo-Dinh discloses the photoactivatable drug comprises one selected from 7,8-dimethyl-10-ribityl, isoalloxazine, 7,8,10-trimethylisoalloxazine, 7,8-dimethylalloxazine, isoalloxazine-adenine dinucleotide, alloxazine mononucleotide, aluminum (III) phthalocyanine tetrasulonate, hematophorphyrin, and phthadocyanine (e.g. see [0217]).
Regarding claim 25, Vo-Dinh discloses the photoactivatable drug is coupled to a carrier that is capable of binding to a receptor at the diseased site (e.g. see [0202], [0203]).
Regarding claim 26, Vo-Dinh discloses the carrier is one selected from insulin, interleukin, thymopoietin or transferrin (e.g. see [0286]).
Regarding claim 27, Vo-Dinh discloses the receptor is one selected from nucleic acids of nucleated cells, antigenic sites on nucleated cells, or epitopes (e.g. see [0287]).
Regarding claim 28, Vo-Dinh discloses the photoactivatable drug has an affinity for a tumor at the diseased site (e.g. see [0286], [0299]).
Regarding claim 29, Vo-Dinh discloses the photoactivatable drug is capable of being absorbed by a tumor at the diseased site (e.g. see [0484]).
Regarding claim 30, Vo-Dinh discloses the photoactivatable drug is a DNA intercalator or a halogenated derivative thereof (e.g. see [0299] and/or claim 219).
Regarding claim 31, Vo-Dinh discloses the initiation energy source delivers a controlled radiation dose to the phosphors for activation of the photoactivatable drug (e.g. see [0369]).
Regarding claim 32, Vo-Dinh discloses the controlled radiation dose causes an auto-vaccine effect in the human or animal body (e.g. see [0371] and/or claim 218).
Regarding claim 39, Vo-Dinh discloses simultaneously provide 1) a controlled radiation dose for activation of the photoactivatable drug and 2) an image-forming beam; or rotationally direct the controlled radiation dose about a rotational axis to minimize radiation loading at a surface of the human or animal body (e.g. see [0105] [0273] [0369]).
Regarding claim 40, Vo-Dinh discloses the initiation source further comprises an infrared source and the phosphors up-convert infrared radiation from the infrared source into at least one of visible or ultraviolet light (e.g. see [0272] [0385] [0415] [0492]).
Regarding claim 41, Vo-Dinh discloses a source of at least one of visible light, infrared light, or microwave radiation for irradiation of the diseased site (e.g. see [0189]).
Regarding claim 42, Vo-Dinh discloses said source of the visible light, infrared light, or microwave radiation produces supplemental radiation which mediates, initiates or enhances treatment of the diseased site or provides diagnostic radiation for analysis the diseased site (e.g. see [0189]).
Regarding claim 43, Vo-Dinh discloses the initiation energy source directs radiation to at least one of a tumor or a malignancy (e.g. see [0203]).
Regarding claim 44, Vo-Dinh discloses the initiation energy source directs radiation to at least one of a eukaryotic cell, a prokaryotic cell, a subcellular structure, an extracellular structure, a virus or prion, a cellular tissue, a cell membrane, a nuclear membrane, cell nucleus, nucleic acid, mitochondria, ribosome, or other cellular organelle (e.g. see [0199], [0229]).
Regarding claim 45, Vo-Dinh discloses the initiation energy source directs said radiation to the diseased site in a pulsed manner having an on and off time (e.g. see [0013] [0272]).
Regarding claim 46, Vo-Dinh discloses the initiation energy source directs said radiation to a tumor or a malignancy in a pulsed manner having an on and off time (e.g. see [0013] [0272]).
Regarding claim 47, Vo-Dinh discloses the initiation energy source directs said radiation to the diseased site such that the on time activates the phosphor and the off time is long enough for decay of phosphor light emission (e.g. see [0013] [0272]).
Regarding claim 48, Vo-Dinh discloses the initiation energy source directs said radiation to the diseased site according to a predetermined radiation protocol such that a predetermined change occurs in the diseased site (e.g. see [0095], [0189], [0298], [0304]).
Regarding claim 49, Vo-Dinh discloses said predetermined change at least one of 1) affects a prion, viral, bacterial, fungal, or parasitic infection, 2) comprises at least one of one of tissue regeneration, inflammation relief, pain relief, immune system fortification, or 3) comprises at least changes in cell membrane permeability, up-regulation and down-regulation of adenosine triphosphate and nitric oxide (e.g. see [0199], claims 100, 104, 105, 107).
Regarding claim 50, Vo-Dinh discloses a system for imaging or treating a disease in a human or animal body (e.g. see [0003], [0094], [0197], [0296]), comprising:
a pharmaceutical carrier including one or more phosphors which are capable of emitting ultraviolet or visible light into the body (e.g. see [0095-0096], [0106], [0201], [0239]) and which provide imaging contrast (e.g. see [0201], 0484]);
one or more devices which infuse a diseased site with a photoactivatable drug and the pharmaceutical carrier (see e.g. [0203], [0319], [0331]);
an initiation energy source comprising a source of radiation which direct penetrating and/or palliative radiation to the diseased site to provide symptomatic relief (see e.g. [0012], [0095], [0188-0189], [0195], treatment of a condition such as chronic pain would result with symptomatic relief) to thereby initiate emission of said ultraviolet or visible light into the body (e.g. see [0095-0096], [0201], [0239]); and
a processor programmed to at least one of 1) produce images of the diseased site or 2) control a dose of the penetrating radiation to the diseased site (e.g. see [0095], [0223], [0369], [0373]) for production of said ultraviolet or visible light at the diseased site to activate the photoactivatable drug (e.g. see [0201], [0239]).
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 2 is rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 1 above, and further in view of Applicant cited Bourke et al., WO 2013009688 A1 (“Bourke”).
Regarding claim 2, Vo-Dinh discloses the method of claim 1 as discussed above, but does not explicitly disclose wherein the initiation energy source comprises an x-ray source configured to generate x-rays from a peak applied cathode voltage at or below 300 kVp, at or below 200 kVp, at or below 120 kVp, at or below 105 kVp, at or below 80 kVp, at or below 70 kVp, at or below 60 kVp, at or below 50 kVp, at or below 40 kVp, at or below 30 kVp, at or below 20 kVp, at or below 10 kVp, or at or below 5 kVp.
Bourke discloses wherein an initiation energy source comprises an x-ray source configured to generate x-rays from a peak applied cathode voltage at or below 105 kVp to emit a lower energy than the x-ray source to interact with a medium or with at least one photoactivatable agent in the medium ([abstract]). In view of these teaching, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to modify the method of Vo-Dinh to include generation of x-rays from a peak applied cathode voltage at or below 105 kVp, because Bourke teaches that x-rays from a peak applied cathode voltage at or below 105 kVp is suitable for emitting x-ray suitable to interact with analogous medium or with photoactivable agent in the medium, for light stimulation within the medium.
Claim 7 is rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 6 above as evidenced by Nord et al., US 20110200170 A1 (“Nord”), and further in view of Yadav et al. US 6716525 B1 (“Yadav”)or in the alternative, in view of Nord and Yadav.
Regarding claim 7, Vo-Ding as evidenced by or in view of Nord does not explicitly disclose wherein the phosphors injected nearby the diseased site comprise a mixture of micron-size and nanometer-size particles. Yadav discloses wherein phosphors comprise a mixture of micron-size and nanometer-size particles (Col. 19: lines 4-13, 18-30 - phosphor mixture comprising phosphor carrier particles with a size range of 50 nm to 25 microns and dispersed phosphor particles with ·a size range of 1-100 nanometers;). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention to modify the method of Vo-Dinh, to include a mixture of micron size and nanometer-size particles as taught by Yadav, so as to improve phosphor stability and light emitting efficiency and to reduce costs (Yadav Col 1: line 66 to Col. 2: line 7).
Claim 9 is rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 1 above as evidenced by Nord et al., US 20110200170 A1 (“Nord”), and further in view of Kim et al. US 20090310742 A1 or in the alternative, in view of Nord and Kim.
Regarding claim 9, Vo-Dinh as evidenced by or in view of Nord does not explicitly disclose wherein the initiation energy source comprise an x-ray or high energy electron source utilizing carbon nanotubes as a source of electrons. However, Vo-Dinh does disclose in [0373] “In preferred embodiments, the initiation energy source may be a linear accelerator equipped … One example of such linear accelerators is the SmartBeam™ IMRT (intensity modulated radiation therapy) system from Varian medical systems” an IMRT system as evidenced by Nord [0022] comprise tungsten filaments). Kim discloses initiation energy source comprise an x-ray or high energy electron source utilizing carbon nanotubes as a source of electrons ([abstract]) and wherein tungsten filament are art recognized alternative to carbon nanotube ([0021]). Inasmuch as Kim disclose tungsten filaments and carbon nanotubes as art recognized alternatives, it would have been obvious to one of ordinary skill in the exercise art at the time of filing the claimed invention to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982).
In the alternative, even in the event that it is argued that the initiation energy source in Vo-Dinh in [0373] does not comprise tungsten filaments, which is not conceded here, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the initiation energy source of Vo-Dinh with the initiation energy source of Nord, as expressly suggested by Vo-Dinh in [0373] to predictably direct initiation energy to the diseases tissue in Vo-Dinh, to arrive at the claimed invention as this is the same exact system that Vo-Dinh suggest. And, inasmuch as Kim disclose tungsten filaments and carbon nanotubes as art recognized alternatives, it would have been obvious to one of ordinary skill in the exercise art at the time of filing the claimed invention to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982).
Claims 10-11 are rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 1 above and further in view of Applicant cited Koyakutty et al. US 20120184495 A1 (“Koyakutty”).
Regarding claims 10-11, Vo-Dinh discloses the method of claim as discussed above, but does not disclose assembling said images of the diseased site into tomographic views of the diseased site, wherein assembling comprises assembling images of a tumor or malignancy. Koyakutty discloses assembling images of a diseased site into tomographic views of the diseased site wherein assembling comprises assembling images of a tumor or a malignancy (e.g. see [0068], [0071] actual imaging coordinates of a diseased site of a body are revealed by computed tomography of a tumor paragraph). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to modify the method of Vo-Dinh, to include a assembling images of the diseased site into tomographic views that comprise a tumor, as disclosed by Koyakutty, to guide radiation therapy with accurate and aligned images to selectively destroy diseased tissues without damaging adjacent healthy tissues, improving therapeutic efficacy for certain forms of cancers (Koyakutty [0002], [0059], [0068]).
Claim 19 is rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 18 above and further in view of Applicant cited references of Bourke and Wollowitz et al. US 6218100 B1 (“Wollowitz”).
Regarding claim 19, Vo-Dinh does not disclose wherein an amount of the phosphors in the pharmaceutical carrier ranges from 0.1 to 0.66 milligrams of phosphor per cm3 of the volume of the diseased site, and a concentration of the photoactivatable drug in the pharmaceutical carrier ranges from 10 microgram/ml to 50 microgram/ml.
In regards to amount of phosphor, Bourke discloses wherein an amount of phosphors in a pharmaceutical carrier ranges from 0.1 to 0.66 milligrams of phosphor per cm3 of a volume of a diseased site (a phosphor loading of 0.1 to 0.18 milligrams of phosphor per cm3 at a targeted site; page 14, fifth paragraph; page 19, seventh paragraph). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to modify the method of Vo-Dinh, to include 0.1 to 0.66 milligrams of phosphor per cm3, as disclosed by Bourke, to have sufficient phosphor concentration for energy modulation without exposing cells to toxic phosphor concentrations (Bourke; page 2, first paragraph; page 35, first-second paragraphs).
In regards to concentration of the photoactivatable drug in the pharmaceutical carrier, Wollowitz discloses wherein a concentration of a photoactivatable drug in a pharmaceutical carrier ranges from 10 microgram/ml to 50 microgram/ml (a psoralen at a concentration of 10 microgram/ml can be used to treat cancer; column 58, lines 53-63). In view of this, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to modify the method of Vo-Dinh, to include 10 microgram/ml of a photoactivatable drug, as disclosed by Wollowitz, because psoralen is toxic at a concentration of 10 microgram/ml (Wollowitz; column 58, lines 53-63), and thus controlled activation would be beneficial.
Claims 33 and 35-36 are rejected under 35 U.S.C. 103 as obvious over Vo-Dinh as applied to claim 1 above and further in view of Applicant cited O’Brien et al. US 20040062754 A1 (“O’Brien”).
Regarding claims 33, 35 and 36, Vo-Dinh does not explicitly disclose the method of claim 1 further comprising controlling the penetrating radiation during a booster treatment repeated on a periodic basis after an initial treatment of the diseased site and wherein the booster treatment produces psoralen-modified cancer cells or X-ray modified cancer cells, or wherein the booster treatment produces radiation damaged cancer cells.
O’Brien discloses wherein penetrating radiation of an x-ray or high energy source during a booster treatment is repeated on a periodic basis after an initial treatment of a diseased site (e.g. see [0022], [0029], [0036]), wherein the booster treatment produces psoralen-modified cancer cells (see e.g. [0011], [0021], [0029] photoactivated psoralen alters treated leukocytes by crosslinking thymidine bases in a DNA helix, preventing normal transcription) or wherein the booster treatment produces radiation damaged cancer cells (e.g. see [0001], [0022], [0024], [0036] - infected cells are damaged after exposure to ultraviolet radiation). In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the method of Vo-Dinh to include repeated (i.e., controlled) booster treatments, so as to improve clinical outcomes in patients with chronic diseases as taught by O’Brien in [0003] an [0009], and produce psoralen-modified cancer cells or radiation damaged cancer cells via the booster treatment, to increase patient’s immune response to a diseased cell population in a clinical beneficial way as taught by O’Brien in [0001] and [0029].
Claim 34 is rejected under 35 U.S.C. 103 as obvious over Vo-Dinh n view of O’Brien as applied to claim 33 above, and further in view of Applicant cited Hallahan et al. EP 0986401 B1A1 (“Hallahan”).
Regarding claim 34, Vo-Dinh in view of O’Brien does not explicitly disclose wherein, in the booster treatment, at least one of phosphor concentration, photoactivatable drug concentration, and the radiation dose is increased by a factor of at least two times, five times, or ten times respective initial values.
Hallahan discloses wherein, in a booster treatment, radiation dose is increased by a factor of at least two times, five times, or ten times initial values (subjects were treated with repeated doses of radiation, increasing from 2 Gy to 10 Gy (five times increase); paragraph [0231]). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to modify the method of Vo-Dinh in view of O’Brien, to include increased booster radiation dose, as disclose by Hallahan, to trigger a radiation-mediated inflammatory response against a tumor while alleviating radiation-related damage to normal tissue as taught by Hallahan in [0018], [0222]).
Claims 37-38 are rejected under 35 U.S.C. 103 as obvious over Vo-Dinh n view of O’Brien as applied to claim 33 above, and further in view of Applicant cited Gerrans et al. US 20120259268 A1 (“Gerrans”).
Regarding claims 37 and 38, Vo-Dinh in view of O’Brien does not explicitly disclose wherein a period between booster treatments is delayed according to a tolerance level of the human or animal body for radiation-modified cells generated during the booster treatment and wherein the period between booster treatments is delayed such that no tolerance is developed for the radiation-modified cells.
Gerrans discloses wherein a period between booster treatments is delayed according to a tolerance level of the human or animal body for radiation-modified cells generated during the booster treatment (e.g. see [0007], [0074], [0079], [0083] delivering a diffusion-limited oxygenating agent to a tumor tissue (delayed period) and then radiating the tissue, to prevent development of radiation resistance (tolerance level), in a process that can be repeated (booster treatments)). In view of these teachings, it would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention to modify the method of Vo-Dinh in view of O’Brien to include delayed booster treatments according to cell radiation tolerance, as disclose by Gerrans, so as to prevent development of radiation-resistance within a tumor and achieve effective radiation treatment as taught by Gerrans in [0011], [0014], [0074]).
Claims 51, 54-56, 58-61, 64-66 and 68-70 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by Vo-Dinh as evidenced by Nord or, in the alternative, under 35 U.S.C. 103 as obvious over Vo-Dinh in view of Nord.
Regarding claim 51, Vo-Dinh discloses a system for imaging or treating a disease in a human or animal body (e.g. see [0003], [0094], [0197], [0296]), comprising:
a pharmaceutical carrier including one or more phosphors which are capable of emitting ultraviolet or visible light into the body (e.g. see [0095-0096], [0106], [0201], [0239]) and which provide imaging contrast (e.g. see [0201], 0484]);
one or more devices which infuse a diseased site with a photoactivatable drug and the pharmaceutical carrier (see e.g. [0203], [0319], [0331]);
an initiation energy source comprising a source of radiation which direct penetrating radiation to the diseased site to thereby initiate emission of said ultraviolet or visible light into the body (e.g. see [0095-0096], [0201], [0239]), wherein the initiation energy source comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site in the human or animal body ([0373] “In preferred embodiments, the initiation energy source may be a linear accelerator equipped … One example of such linear accelerators is the SmartBeam™ IMRT (intensity modulated radiation therapy) system from Varian medical systems” an IMRT system comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site e.g. as evidenced by Nord [0002], [0022]); and
a processor programmed to at least one of 1) produce images of the diseased site (generating images of the diseased area for image-guided computer control capability; e.g. see [0095], [0371], [03731] or 2) control a dose of the penetrating radiation to the diseased site (computer controller delivers a precisely calibrated beam of radiation, such as x-ray, gamma ray, or an electron beam, to a pre-selected diseased area in a subject; paragraphs [0095), [0223], [0369], [0373]) for production of said ultraviolet or visible light at the diseased site to activate the photoactivatable drug (initiation energy is converted by the energy modulation agents to emit visible or ultraviolet light and activate the activatable pharmaceutical agents to treat the area; paragraphs [0105)-[0106), [0201), [02391).
In the alternative, even in the event that it is argued that the initiation energy source disclosed in [0373] (linear accelerators is the SmartBeam™ IMRT (intensity modulated radiation therapy)) does not necessarily comprise a conformal x-ray or ebeam source shaped in conformance with the diseased site, which is not conceded here, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the initiation energy source of Vo-Dinh with the initiation energy source of Nord, as expressly suggested by Vo-Dinh in [0373] to predictably direct initiation energy to the diseases tissue in Vo-Dinh, to arrive at the claimed invention as this is the same exact system that Vo-Dinh suggest. In modified Vo-Dinh, the initiation energy source will comprise a conformal x-ray or ebeam source shaped in conformance with the diseased site as discussed in Nord in e.g., [0002] and [0022].
Regarding claim 54, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord discloses wherein the conformal x-ray or ebeam source comprises at least one of a linear array, a two dimensional array, or a three dimensional array (e.g. see Vo-Dinh [0373] “linear accelerators” define an array and/or as modified or disclosed by Nord [0022] and [0034] “multi leaf collimators” define an array).
Regarding claim 55, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord discloses wherein said at least one of a linear array, a two dimensional array, or a three dimensional array has a shape of the diseased site (see e.g. Nord [0002] [0022]).
Regarding claim 56, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord further discloses a controller to operate said at least one of a linear array, a two dimensional array, or a three dimensional array in a controlled manner in order to control radiation exposure to the diseased site (see e.g. Nord [0002] [0022] control system for moving the controllable leaves).
Regarding claim 58, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord further discloses wherein the conformal x-ray or ebeam source comprises an x-ray source which provides x-rays to the diseased site (e.g., see Vo-Dinh [0223], [0274-0275] and/or Nord [0019-0020]).
Regarding claim 59, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord further discloses wherein the conformal x-ray or ebeam source comprises an electron beam source which provides an electron beam to the diseased site (e.g., see Vo-Dinh [0223], [0274-0275] and/or Nord [0019-0020]).
Regarding claim 60, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord further discloses wherein the conformal x-ray or ebeam source comprises a combination x-ray source which provides x-rays to the diseased site and electron beam source which provides an electron beam to the diseased site (see e.g., Vo-Dinh [0223], [0274], [0304] combination of sources).
Regarding claim 61, in regards to the limitation wherein the initiation energy source comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site in the human or animal body, see claim 51 regarding overlapping subject matter, the discussion and citation in claim 51 are equally applicable to claim 61 and will not be repeated here for brevity sake.
Regarding claims 54-66 and 66-70, see overlapping subject matter in claims 54-56 and 58-60, the discussion and citations in claims 54-56 and 58-60 are equally applicable to claims 54-66 and 66-70 and will not be repeated here for brevity sake.
Claims 52-53 and 62-63 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by Vo-Dinh as evidenced by Nord and Lemaitre et al. US 20110188637 A1 (“Lemaitre”) or, in the alternative, under 35 U.S.C. 103 as obvious over Vo-Dinh in view of Nord as applied to claim 51, and further in view of Lemaitre.
Regarding claim 52, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord further discloses wherein the conformal x-ray or ebeam source comprises a low work function electron emitter (e.g. see Nord [0022] “… individually controllable leaves, typically thin slices of tungsten, that can be moved into or out of the x-ray beam under the control of system software” tungsten is a low work function electron emitter as evidenced by Lemaitre in [0006] “The filament material is typically chosen for its ability to generate electrons through the thermionic effect … Traditionally, the filament material has been chosen to be tungsten or a tungsten derivative such as doped tungsten (i.e., tungsten with added impurities). Tungsten has a high melting point and a relatively low work function”).
In the alternative, even in the event it is argued that the conformal x-ray or ebeam source does not comprises a low work function electron emitter, which is not conceded here, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have selected a filament material that has a high melting point and a relative low work function for the source of Vo-Dinh in view of Nord, to allow the system of modified Vo-Dinh to generate higher x-ray output as suggested by Lemaitre in [0016] and because it has been held that selection of a known material based on its suitability for its intended use supports prima facie obviousness. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Regarding claim 53, Vo-Dinh as evidenced by Nord and Lemaitre or Vo-Dinh in view of Nord and Lemaitre wherein the low work function electron emitter comprises at least one of a carbon nanotube, amorphic diamond or diamond-like carbon, a thermionic material, or a photocathode (e.g. see Lemaitre [0016] tungsten is a thermionic material).
Regarding claims 62 and 63, see overlapping subject matter in claims 52 and 53, the discussion and citations in claims 52 and 53 are equally applicable to claims 62 and 63 and will not be repeated here for brevity sake.
Claims 57 and 67 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by Vo-Dinh as evidenced by Nord or, in the alternative, under 35 U.S.C. 103 as obvious over Vo-Dinh in view of Nord as applied to claim 51 or 61, and further in view of Kim.
Regarding claims 57 and 67, Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord do not explicitly disclose wherein the conformal x-ray or ebeam source comprises a medical insert or inserting the conformal x-ray or ebeam source into the human or animal body.
Kim discloses in [0012] “… medical X-ray tube system may be manufactured in the form of a pen or a pencil. The X-ray emission module may approach an inner or outer local portion of human body including inside and outside of the oral cavity to thereby emit X-rays to the approached local portion. Also, the X-ray emission module may be used for diagnoses and cancer therapy …”. In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the system and method of Vo-Dinh/Nord or VO-Dinh in view of Nord to form the x-ray tube in form a pen or pencil as taught by Kim that can be inserted into a human or animal body, to allow for diagnosis and/or cancer therapy inside the human or animal body.
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 1-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 10,596,387 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim of the patent and corresponding claim pending differ in that the preamble of the patented claims is narrow in scope, (i.e., recites “A method of imaging and treating”) while the pending claims are of a broad scope (i.e., recites “A method of imaging or treating”. As such, the narrow patented claims anticipate the broad pending claims.
Claim 50 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48, 49 or 97 of U.S. Patent No. 11,865,359 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 50 is broad in scope and is therefore anticipated by the patented claims.
Claims 33-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9 and 30-32 of U.S. Patent No. 10,441,810 B2 or claims 79-81 of U.S. Patent No. 11, 260,129 B2 each in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord. The limitations not disclosed by the patented claims are disclosed by Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord as set forth in the rejections of claims 33-38 set forth in the prior art rejection above. The pending claims would have been obvious in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord for substantially similar rationale and would not be repeated here for brevity’s sake.
Claims 51, 54-56 and 58-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 or 50 of U.S. Patent No. 11,865,359 B2 in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord. The patented claims differs with the pending claims as the patented claims do not disclose “wherein the initiation energy source comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site” recited in independent claim 51, in combination to recitations of each of claims 54-56 and 58-60. However, these limitations are disclosed by Vo-Dinh as evidenced by, and/or in view of Nord, and would have been obvious for substantially similar rationale as set forth in claims 51, 54-56 and 58-60 as detailed above in the prior art rejections, the discussions and citations are equally applicable here and will not be repeated for brevity’s sake.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 or 58 of U.S. Patent No. 11,865,359 B2 in view of Vo-Dinh as evidenced by Nord and Lemaitre or Vo-Dinh in view of Nord and in view of Lemaitre. The patented claims differs with the pending claims as the patented claims do not disclose “wherein the initiation energy source comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site” recited in independent claim 51, in combination to recitations of each of claims 52 and 53. For the recitation in independent claim 51, this limitations is disclosed by Vo-Dinh as evidenced by, and/or in view of Nord. In regards to recitations in claim 52 and 53, it is noted that patented claims 9 and 58 disclose aspect of carbon nanotube, in regards to low function emitter this limitation is disclosed by Vo-Dinh as evidenced by, and/or in view of Nord and Lemaitre, and would have been obvious for substantially similar rationale as set forth in claims 52 and 53 as detailed in the prior art rejections above, the discussions and citations are equally applicable here and will not be repeated for brevity’s sake.
Claim 57 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 or 50 of U.S. Patent No. 11,865,359 B2 in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord and further in view of Kim. The patented claims differs with the pending claims as the patented claims do not disclose “wherein the initiation energy source comprises a conformal x-ray or ebeam source shaped in conformance with the diseased site” recited in independent claim 51, in combination to recitations of each of claim 57. For the recitation in independent claim 51, this limitations is disclosed by Vo-Dinh as evidenced by, and/or in view of Nord. In regards to recitations in claim 57 regarding medical insert, this limitation is disclosed by Vo-Dinh as evidenced by, and/or in view of Nord and further in view of Kim, and would have been obvious for substantially similar rationale as set forth in claim 57 as detailed in the prior art rejections above, the discussions and citations are equally applicable here and will not be repeated for brevity’s sake.
Claims 61, 64-66 and 68-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,596,387 B2 in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord. The patented claims differs with the pending claims as the patented claims do not recite limitations of claims 61, 64-66 and 68-70. However, these limitations are disclosed by Vo-Dinh as evidenced by, and/or in view of Nord, and would have been obvious for substantially similar rationale as set forth in claims 61, 64-66 and 68-70 as detailed above in the prior art rejections, the discussions and citations are equally applicable here and will not be repeated for brevity’s sake.
Claims 62 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,596,387 B2 in view of Vo-Dinh as evidenced by Nord and Lemaitre or Vo-Dinh in view of Nord and in view of Lemaitre. The patented claims differs with the pending claims as the patented claims do not recite limitations of claims 62 and 63. However, these limitations are disclosed by Vo-Dinh as evidenced by, and/or in view of Nord and Lemaitre, and would have been obvious for substantially similar rationale as set forth in claims 62 and 63 as detailed in the prior art rejections above, the discussions and citations are equally applicable here and will not be repeated for brevity’s sake.
Claim 67 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,596,387 B2 in view of Vo-Dinh as evidenced by Nord or Vo-Dinh in view of Nord a