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
This application is a National Stage entry of PCT/JP2021/012922, filed 03/26/2021, and claims foreign priority to JP2020-057561, filed 03/27/2020.
Claims Status
Receipt of Remarks/Amendments filed on 5/22/2026 is acknowledged. Claims 9-38 are currently pending. Claims 17-18, 27-28 and 37-38 have been withdrawn. Accordingly, claims 9-16, 19-26, 29-36 are currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 5/22/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on application number 17916642 and 18694587 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New/Maintained Claim Rejection(s)/Objection(s)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-16, 19-26, 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Yip et al. (Molecular Pharmaceutics, Vol. 4, No. 2, 2006)(cited in IDS) in view of Baskaran et al. (Biomater. Res. Vol. 22, art. no. 25, 2018)(cited in IDS) and Doronina et al. (US 8,288,352 B2; Oct. 16, 2012).
Yip throughout the reference teaches Targeted delivery and enhanced cytotoxicity of cetuximab-saporin by photochemical internalization (PCI) in EGFR positive cancer cells.
Regarding claims 9, 19, 29, Yip teaches a method for killing tumor cells by targeting EGFR expressing cancer cells (tumor cells) with the model immunotoxin cetuximab-saporin using PCI (photochemical internalization) as a drug delivery method. This reads on allowing a conjugate of a substance (cetuximab) and a cytotoxin (saporin) to come into contact with the tumor cells. PCI is based on the principle of photodynamic therapy (PDT), which is approved for different cancers. PCI technology is based on the activation by light of photosensitizers. Specifically, Yip teaches the therapeutically approved cetuximab, which is a chimeric humanized murine mAb recognizing the epidermal growth factor receptor (EGFR), was linked to the type I ribosome-inactivating protein saporin. PCI of cetuximab saporin was established as a proof-of-concept in three different EGFR-positive human cancer cell lines (colorectal, HCT-116; prostate, DU-145; and epidermis, A-431). The cetuximab-saporin binds specifically to EGFR-positive cells. Yip specifically teaches HCT-116, DU-145, A-431 cells were incubated with TPPS2a (photosensitizer) for PDT only or, for the PCI experiments, coincubated with increasing concentrations of cetuximab-saporin. Cells were subsequently exposed to increasing doses of LumiSource light. This PCI protocol is referred to as “light after” PCI. Illuminations of cells were performed by using LumiSource. Yip teaches that PDT is dependent on three components, all of which are crucial to accomplish successful therapeutic outcome: (1) Light of wavelengths that correspond to the absorption properties of a (2) photosensitizer (PS). After light activation, the PS (photosensitizer) utilizes the absorbed energy in (3) oxygen dependent reactions to form reactive oxygen species (ROS). Yip teaches that efficient penetration of light requires wavelengths for photoactivation above about 600 nm and that the photosensitizer must be excited at wavelengths below about 850 nm. The therapeutic wavelength window is therefore usually defined as 600-800 nm. Thus, Yip teaches irradiating the tumor cells with a wavelength as the third/last step which reads on the third/last step recited in claims 9, 19, 29. Yip concludes that PCI of the immunotoxin cetuximab-saporin was demonstrated to be an effective and specific anti-cancer cell therapy and Yip proposes that PCI concept introduces a unique triple cytotoxicity with 1) cetuximab, 2) PDT, and 3) saporin. Photosensitizer for PDT employs TPPS2a. (see e.g., Abstract; Introduction; Experimental Section; Results and Discussion; Conclusion; Entire document).
Regarding claims 10, 11, 15, 16, 20, 21, 25, 26, 30, 31, 35, 36, as discussed supra, Yip teaches cetuximab in combination with saporin, which read on these claims.
Regarding claims 12, 22, 32, as discussed supra, Yip teaches a method for killing tumor cells by targeting EGFR expressing cancer cells (tumor cells).
Regarding claims 13, 23, 33, as discussed supra, Yip teaches three different EGFR-positive human cancer cell lines (colorectal, HCT-116; prostate, DU-145; and epidermis, A-431).
Regarding claims 14, 24, 34, as discussed supra, Yip teaches that efficient penetration of light requires wavelengths for photoactivation above about 600 nm and that the photosensitizer must be excited at wavelengths below about 850 nm. The therapeutic wavelength window is therefore usually defined as 600-800 nm.
(see e.g., Abstract; Introduction; Experimental Section; Results and Discussion; Conclusion; Entire document).
The teachings of Yip et al. have been set forth above. As discussed supra, Yip teaches photosensitizer for PDT employs TPPS2a, which is used in combination with cetuximab and saporin. Yip does not teach Talaporfin sodium, Porfimer sodium or Verteporfin in combination with cetuximab and saporin as required in the instant claims. As such, Yip also does not teach the wavelength effective for activating these agents. However, Baskaran cures these deficiencies.
Baskaran throughout the reference teaches clinical development of photodynamic agents and therapeutic applications. Photodynamic therapy (PDT) is photo-treatment of malignant or benign diseases using photosensitizing agents, light, and oxygen which generates cytotoxic reactive oxygens and induces tumour regressions. Baskaran discloses that second generation photosensitizers such as Visudyne (verteporfin), Photofrin (Porfimer sodium) and Laserphyrin (Talaporfin sodium) have been approved clinically and induce tumor regressions. Baskaran teaches Laserphyrin (Talaporfin sodium) is irradiated superficially with laser at wavelength of 664 nm and Photofrin (porfimer sodium) at wavelength of 630 nm. (see e.g., Abstract; Table 1; Laserphyrin section; Photofin section; Entire document).
Yip et al. does not expressly teach the order of when the conjugate of a substance (cetuximab) and cytotoxin (saporin), and the photosensitizer come into contact with the tumor cells. However, Doronina cures this deficiency.
Doronina teaches antibody drug conjugate (cetuximab) to kill/inhibit tumor cells in the treatment of cancer which include administering antibody drug conjugate and a chemotherapeutic agent such verteporfin. The conjugate drug can be administered concurrently with the chemotherapeutic agent or the chemotherapeutic agent can be administered prior or subsequent to administration of a conjugate drug. (see e.g., abstract; background section; claims; col. 56-58; entire document). This reads on the order of steps recited in claims 9, 19 and 29.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Yip, Baskaran and Doronina and include Talaporfin sodium, Porfimer sodium or Verteporfin in combination with cetuximab and saporin instead of TPPS2a in the method of Yip as taught by Baskaran. Baskaran discloses that second generation photosensitizers such as Visudyne (verteporfin), Photofrin (Porfimer sodium) and Laserphyrin (Talaporfin sodium) have been approved clinically and induce tumor regressions. As such, the PDT inducing photosensitizer (e.g., verteporfin, talaporfin and porfimer) are photosensitizers commonly used in the art, and thus, one skilled in the art would have been motivated to replace TPPS2a of Yip with the photosensitizers taught by Baskaran. Further, regarding the wavelength effective for activation, Baskaran teaches Laserphyrin (Talaporfin sodium) is irradiated superficially with laser at wavelength of 664 nm and Photofrin (porfimer sodium) at wavelength of 630 nm. Yip teaches that efficient penetration of light requires wavelengths for photoactivation above about 600 nm and that the photosensitizer must be excited at wavelengths below about 850 nm. The therapeutic wavelength window is therefore usually defined as 600-800 nm. Thus, it would have been obvious to one skilled in the art to determine and optimize the wavelength needed for effective activation of the photosensitizers.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Yip, Baskaran and Doronina and determine the order of when the conjugate of a substance (cetuximab) and cytotoxin (saporin), and the photosensitizer come into contact with the tumor cells. As discussed supra, Doronina teaches antibody drug conjugate (cetuximab) to kill/inhibit tumor cells in the treatment of cancer which include administering antibody drug conjugate and a chemotherapeutic agent such verteporfin. The conjugate drug can be administered concurrently with the chemotherapeutic agent or the chemotherapeutic agent can be administered prior or subsequent to administration of a conjugate drug. Thus, absence any evidence of unexpected effect, it would have been obvious to one skilled in the art to allow the photosensitizers (e.g. talaporfin) to come into contact with the tumor cells concurrently, prior to, or after cetuximab and saporin come into contact with the tumor cells. Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Argument
Applicant argued that it would not have been obvious to modify Yip and replace TPPS2a as a photosensitizer taught by Yip with Talaporfin, Porfimer or Verteporfin as a photosensitizer taught by Baskaran. It would not have been obvious to use a photosensitizer known to be used in PDT (as in Baskaran) in a process of PCI (as in Yip and the instant claims). Applicant argue that in PCI, it is necessary to retain the photosensitizer on the endosome/lysosome membrane. Yip also teaches that for PCI it is necessary to use a photosensitizer which localizes in endo-lysosomal compartments. It was argued that talaporfin sodium taught by Baskaran is known to not accumulate on endosomal or cell membranes due to its physical properties, but rather to be distributed in the cytoplasm.
In response, as acknowledged by the applicant, Yip discloses that PCI is based on the principles of photodynamic therapy (PDT) (page 244, left column). As acknowledged by applicant in the remarks and disclosed by Yip and Baskaran, both PCI and PDT use photosensitizers that generate active radicals or singlet oxygen. As discussed supra, Baskaran discloses that second generation photosensitizers such as Visudyne (verteporfin), Photofrin (Porfimer sodium) and Laserphyrin (Talaporfin sodium) have been approved clinically and induce tumor regressions. As such, the PDT inducing photosensitizer (e.g., verteporfin, talaporfin and porfimer) are photosensitizers commonly used in the art, and thus, one skilled in the art would have been motivated to replace TPPS2a of Yip with the photosensitizers taught by Baskaran for killing tumor cells. As mentioned above, Yip discloses that PCI is based on the principles of photodynamic therapy and both PCI and PDT use photosensitizers that generate active radicals or singlet oxygen, therefore it would have been obvious to use the photosensitizers (e.g. Talaporfin) which were known to be used in photodynamic therapy, absence any evidence to the contrary.
Regarding applicant’s argument that Yip teaches for PCI it is necessary to use a photosensitizer which localizes in endo-lysosomal compartments and that talaporfin sodium taught by Baskaran is known to not accumulate on endosomal or cell membranes due to its physical properties, but rather to be distributed in the cytoplasm, the examiner argues that firstly the applicant have not provided any factual evidence that talaporfin sodium does not accumulate on endosomal or cell membranes. “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). In particular, Therrien et al. (International Journal of Molecular Sciences, 2019, 20, 3339) discloses that a porphyrin sodium salt, used in PDT for treatment of cancer, is Talaporfin sodium, used as a photosensitizer in PDT. The intracellular localization of Talaporfin after administration of FLS cells showed accumulation in lysosomes. The ability of porphyrins to accumulate in lysosomal and endosomal membranes can be exploited to inhibit or enhance intracellular signaling pathways. (page 8 and 10). Therefore, the art suggests that talaporfin does accumulate in endosome/lysosome and applicant’s argument that Talaporfin does not accumulate in endosome/lysosome, without any evidence, is not persuasive at this time.
Applicant further argued that systemic administration of the PCI dye AIPcS2a is associated with significant side effects. Applicant appear to argued that the method of the claimed application show absence of side effects and significant tumor suppressing effect. Applicant pointed to Komatsu et al. and Sonokawa et al. for these findings argued by the applicant. (see pages 14-16 of remarks).
In response, the examiner argues that the data presented in Komatsu et al., Sonokawa et al., and on page 15 of remarks does not appear to be a comparison to the closest prior art. See MPEP 716.02. Particularly, as discussed supra, Yip teaches a method for killing tumor cells by targeting EGFR expressing cancer cells (tumor cells) with the model immunotoxin cetuximab-saporin using PCI (photochemical internalization) as a drug delivery method. TPPS2a is used as the photosensitizer. Yip concludes that PCI of the immunotoxin cetuximab-saporin was demonstrated to be an effective and specific anti-cancer cell therapy. As mentioned above, the difference between the instant claims and Yip is that Yip teaches TPPS2a as the photosensitizer rather than Talaporfin, Porfimer or Verteporfin. The data presented on page 15 of remarks appears to use ALPcS2a and an immunotoxin as comparative example, however, this is not a comparison to the closest prior art because there is no mention of use of cetuximab or saporin as the immunotoxin and the data on page 15 uses ALPcS2a rather than TPPS2a disclosed by Yip. Also, for the experimental data (claimed method), the applicant refer to Sonokawa et al. and it is unclear whether the comparison is a single variable comparison. For example, it is unclear whether light radiation was applied for the same amount of time in both instances. The examiner respectfully requests applicant clearly explain and point out the issues mentioned above.
Further, as discussed supra, Yip teaches targeted delivery and enhanced cytotoxicity of cetuximab-saporin by photochemical internalization (PCI) in EGFR positive cancer cells. Yip teaches killing tumor cells by targeting EGFR expressing cancer cells (tumor cells) with the model immunotoxin cetuximab-saporin using PCI (photochemical internalization) as a drug delivery method. TPPS2a is used as the photosensitizer. Yip concludes that PCI of the immunotoxin cetuximab-saporin was demonstrated to be an effective and specific anti-cancer cell therapy. Baskaran teaches that second generation photosensitizer (e.g. talaporfin) have improved tissue selectivity. The second-generation PS are fulfilled with several serious drawbacks using first generation PS. First generation PS are not very specific to cancer cells and tend to accumulate in normal tissues as well. First generation PS are not clear rapidly from the human body and it has lack of sensitivity. The second-generation PS are effective and technically superior than first generation PS. (see page 3, right column). Baskaran teaches that second generation photosensitizer (e.g. talaporfin) have improved tissue selectivity (e.g., less accumulation in normal tissue/cell) and thus one would expect this to lead to less side effects as normal tissue cells would not be targeted. Thus, applicant’s argument of there being fewer side effects with sodium talaporfin does not appear to be an unexpected effect.
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.
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Claims 9-16, 19-26, 29-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/694,632 (US20250000998A1) in view of Yip et al. (Molecular Pharmaceutics, Vol. 4, No. 2, 2006)(cited in IDS), Baskaran et al. (Biomater. Res. Vol. 22, art. no. 25, 2018)(cited in IDS) and Doronina et al. (US 8,288,352 B2; Oct. 16, 2012).
‘632 teaches a method for killing tumor cells comprising (1) allowing a conjugate of a substance that binds to a target substance on the surface of tumor cells and a cytotoxin to come into contact with the tumor cells, and (2) allowing talaporfin sodium, porfimer sodium or verteporfin to come into contact with the tumor cells after (1), and (3) irradiating the tumor cells with a wavelength effective for activating talaporfin, porfimer or verteporfin after (2), so as to kill the cells. The substance that binds to a target is an antibody and cytotoxin is saporin. The tumor cells express EGFR, wherein the tumor cells are cancer cells of head and neck cancer, lung cancer and other cancers which are recited in instant claims. The wavelength effective for activating talaporfin, porfimer or verteporfin is 600 to 800 nm.
‘632 does not expressly teach the antibody (conjugate substance) is cetuximab, the wavelength is specifically 650 nm and the order of administration recited in claims 19 and 29. However, Yip, Baskaran and Doronina cure these deficiencies.
The teachings of Yip, Baskaran and Doronina set forth above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘632 with Yip, Baskaran and Doronina and include cetuximab as the antibody because Yip also teaches a medicament and method of killing tumor cells wherein the conjugate drug is an antibody and specifically cetuximab is used in combination with saporin. It would have been obvious to use the antibody such as cetuximab because it is also taught to be useful in treating or killing tumor cells. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Further, regarding the wavelength effective for activation, Baskaran teaches Laserphyrin (Talaporfin sodium) is irradiated superficially with laser at wavelength of 664 nm and Photofrin (porfimer sodium) at wavelength of 630 nm. Yip teaches that efficient penetration of light requires wavelengths for photoactivation above about 600 nm and that the photosensitizer must be excited at wavelengths below about 850 nm. The therapeutic wavelength window is therefore usually defined as 600-800 nm. Thus, it would have been obvious to one skilled in the art to determine and optimize the wavelength needed for effective activation of the photosensitizers.
As discussed supra, Doronina teaches antibody drug conjugate (cetuximab) to kill/inhibit tumor cells in the treatment of cancer which include administering antibody drug conjugate and a chemotherapeutic agent such verteporfin. The conjugate drug can be administered concurrently with the chemotherapeutic agent or the chemotherapeutic agent can be administered prior or subsequent to administration of a conjugate drug. Thus, absence any evidence of unexpected effect, it would have been obvious to one skilled in the art to allow the photosensitizers (e.g. talaporfin) to come into contact with the tumor cells concurrently, prior to, or after cetuximab and saporin come into contact with the tumor cells. Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Claims 9-16, 19-26, 29-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/012,050 (US20230242554A1) in view of Yip et al. (Molecular Pharmaceutics, Vol. 4, No. 2, 2006)(cited in IDS), Baskaran et al. (Biomater. Res. Vol. 22, art. no. 25, 2018)(cited in IDS) and Doronina et al. (US 8,288,352 B2; Oct. 16, 2012).
‘050 teaches a medicament for killing tumor cells and a method comprising allowing a compound of claim 1 and conjugate of a substance and a cytotoxin to come into contact with tumors cells, and allow killing the tumor cells by irradiating the cells with a wavelength that is effective for activating the compound. The substance is an antibody. The cytotoxin is saporin. The antibody is an antibody reacting against EGFR and the tumor cells are cancers of head and neck cancer, lung cancer, etc.
‘050 does not expressly teach the antibody (conjugate substance) is cetuximab and the photosensitizer which is talaporfin, porfimer or verteporfin, the wavelength is specifically 650 nm and the order of administration recited in instant claims. However, Yip, Baskaran and Doronina cure these deficiencies.
The teachings of Yip, Baskaran and Doronina set forth above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘050 with Yip, Baskaran and Doronina and include cetuximab as the antibody because Yip also teaches a medicament and method of killing tumor cells wherein the conjugate drug is an antibody and specifically cetuximab is used in combination with saporin. It would have been obvious to use the antibody such as cetuximab because it is also taught to be useful in treating or killing tumor cells.
Further, Baskaran discloses that second generation photosensitizers such as Visudyne (verteporfin), Photofrin (Porfimer sodium) and Laserphyrin (Talaporfin sodium) have been approved clinically and induce tumor regressions. As such, the PDT inducing photosensitizer (e.g., verteporfin, talaporfin and porfimer) are photosensitizers commonly used in the art, and thus, one skilled in the art would have been motivated to use the photosensitizers taught by Baskaran.
Further, regarding the wavelength effective for activation, Baskaran teaches Laserphyrin (Talaporfin sodium) is irradiated superficially with laser at wavelength of 664 nm and Photofrin (porfimer sodium) at wavelength of 630 nm. Yip teaches that efficient penetration of light requires wavelengths for photoactivation above about 600 nm and that the photosensitizer must be excited at wavelengths below about 850 nm. The therapeutic wavelength window is therefore usually defined as 600-800 nm. Thus, it would have been obvious to one skilled in the art to determine and optimize the wavelength needed for effective activation of the photosensitizers.
As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
As discussed supra, Doronina teaches antibody drug conjugate (cetuximab) to kill/inhibit tumor cells in the treatment of cancer which include administering antibody drug conjugate and a chemotherapeutic agent such verteporfin. The conjugate drug can be administered concurrently with the chemotherapeutic agent or the chemotherapeutic agent can be administered prior or subsequent to administration of a conjugate drug. Thus, absence any evidence of unexpected effect, it would have been obvious to one skilled in the art to allow the photosensitizers (e.g. talaporfin) to come into contact with the tumor cells concurrently, prior to, or after cetuximab and saporin come into contact with the tumor cells. Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Regarding ‘632, applicant argued pending claims are distinct for similar reasons discussed above with respect to the combination of Yip and Baskaran.
In response, applicant’s arguments regarding Yip and Baskaran have been addressed above and are not found persuasive. The arguments presented by the examiner above are incorporated herein and for the same reasons discussed above, the double patenting rejection is maintained.
Regarding ‘050, applicant argued that ‘050 claims recite the compound of formula 1, which is a photosensitizer. The examiner provides no reasoning as to why it would have been obvious to substitute the compound of formula 1 with the claimed photosensitizers.
In response, as discussed supra, Baskaran discloses that second generation photosensitizers such as Visudyne (verteporfin), Photofrin (Porfimer sodium) and Laserphyrin (Talaporfin sodium) have been approved clinically and induce tumor regressions. As such, the PDT inducing photosensitizer (e.g., verteporfin, talaporfin and porfimer) are photosensitizers commonly used in the art, and thus, one skilled in the art would have been motivated to use the photosensitizers taught by Baskaran. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (i.e. killing tumor cells), in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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