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 .
Claims 1, 7, 9-10, 17, 21-23, 25-27, 31, 34-35, 40 and 47-55 are pending.
Claims 2-6, 8, 11-16, 18-20, 24, 28-30, 32-33, 36-39, and 41-46 are cancelled.
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, 7, 9, 10, 17, 21-23, 25-27, 31, 34-35, 40, and 47-55 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 30 of copending Application No. 17/637,924 in view of LESNIAK (US 2019/0060490).
17/637,924 claims A dendrimer-targeting agent conjugate, comprising: a) a dendrimer comprising i) a core unit (C); and ii) three to five generations of building units (BU), each building unit being a lysine residue having two amino nitrogen atoms for bonding to a subsequent generation of building units and an acyl group for bonding to a previous generation of building units or the core unit;, and wherein the core unit is covalently attached to at least two building units via amide linkages (claim 1). The composition further comprises a HER2 targeting agent which is a single domain antibody having a molecular weight from 10_kDa to 16 kDa covalently linked to the dendrimer by a spacer group (claim 1), wherein the spacer group comprises a PEG group (claim 30) and a hydrophilic polymeric group that is covalently linked to surface building units of the dendrimer, wherein the hydrophilic polymeric group is selected from the group consisting of polyethylene glycol (PEG) (claim 1). Wherein the core unit comprises the structure:
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.
Note, the lysine recited ininstant claim 1 is the broad genus of the modified lysine species described in the above copending application and therefor reads on the insant claim.
The application does not teach one or more first terminal groups attached to an outermost building unit of the dendrimer, wherein the first terminal group comprises a complexation group for complexing a radionuclide.
LESNIAK teaches a PAMAM dendrimer that has a radiometal chelating moiety that comprises a radiometal suitable for treating or imaging (page 1, paragraph 0006).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a radiometal chelating moiety. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for imaging, and reasonably would have expected success because both references are in the same field of endeavor, such as dendrimers for therapeutic purposes.
This is a provisional nonstatutory double patenting rejection.
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 1, 7, 10, 17, 21, 23, 25-27, 31, 34, 40, 47-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2) in view of WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.) and GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.).
Regarding claim 1 and 52-53, BOYDE teaches a dendrimer with a core, such as BHALys (column 8, paragraph 1), which reads on a core unit of
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that has lysine building units (column 8, paragraph 2), which reads on a building unit of
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. The dendrimer can have 2 building units of lysine and 3 generations of building units (column 8, paragraphs 2-3), which reads on where the dendrimer has two generations of building unit ad the core unit is attached to at least two building units. The dendrimer further has a polyethylene glycol (PEG) that is used to attach a targeting moiety such as an antibody (column 12, paragraph 4 and column 14, paragraph 6). PEG can also be used as a second terminal group to prolong the half-life of the composition (column 21, paragraph 3).
Additional disclosure: The composition is designed to help treat cancer (column 26, paragraph 5). PAMAM is an alternative core unit to BHALys.
BOYDE does not teach using a single domain antibody or complexing a radionucleotide.
Regarding claim 1, 7 and 10, WU teaches using a HER2 single domain antibody, also called a HER2 nanobody, to target breast cancer (abstract and page 366, paragraph 2). Nanobodies are better than antibodies because they have a small size that increases tumor penetration (Page 366, paragraph 2). Nanobodies are approximately 12.5 to 15 kDa (Page 366, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a HER2 nanobody. The person of ordinary skill in the art would have been motivated to make those modifications, because nanobodies are better than antibodies because they have a small size that increases tumor penetration, and reasonably would have expected success because the references are in the same field of endeavor, such as pharmaceutical compositions to treat cancer and BOYDE teaches that an antibody can be conjugated to PEG for cancer targeting purposes.
GUO teaches a dendrimer-targeting agent conjugate comprising: PAMAM-OH G4 with 64 terminal hydroxyl groups, which has a core unit and building units (Page 8326, paragraph 6 and Figure 1). The dendrimer has a targeting agent, TRC105, which is a monoclinal antibody used for targeting tumors, that is attached to the dendrimer by the spacer group PEG (figure 1 and page 8324, paragraph 3). The dendrimer has a first terminal group, NOTA, which is a macrocyclic chelator for 64Cu (figure 1 and page 8324, paragraph 3), which reads on one or more first terminal groups attached to an outermost building unit of the dendrimer, wherein the first terminal group comprises a complexation group for complexing a radionuclide. The radiolabel allowed for imaging to be performed using PET (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a complexation group for a radionucleotide. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for PET imaging to be performed which can give an image to show where the cancer is located, and reasonably would have expected success because the references are in the same field of endeavor, such as dendrimer pharmaceutical compositions to treat cancer and PAMAM is an alternative to BHALys according to BOYDE.
Regarding claim 17 and 23, there is no evidence on the record that the reaction to form the covalent linkage between the targeting agent and the spacer group affects the final product. Note, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 21 and 31, BOYDE teaches using PEG570, which has 10 ethyleneoxy repeat units and a molecular weight of 570 Da (table 3 and example 3). BOYDE does not explicitly teach using PEG570 as a spacer molecule, however It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate it as a spacer molecule. The person of ordinary skill in the art would have been motivated to make those modifications, because and reasonably would have expected success because BOYDE teaches using a PEG as a spacer molecule and also lists multiple PEGs, such as PEG570 that can be used in the composition in general.
Regarding claim 25-27 and 47, GUO teaches the dendrimer has a first terminal group, NOTA, which is a macrocyclic chelator for 64Cu (figure 1 and page 8324, paragraph 3),
Regarding claim 34, BOYDE teaches dendrimer can have 2 building units of lysine (column 8, paragraphs 2-3),
Regarding claim 40, BOYDE teaches the composition can comprise a pharmaceutically acceptable excipient (column 16, paragraph 3).
Regarding claim 48-49, BOYDE teaches that the composition can have an active agent to treat cancer, such as Taxol, which is a taxane, for breast cancer (column 44, paragraph 5). The taxol is attached via a linker (column 48, paragraph 1). The terminal groups are attached to the composition via the building unit recited above (column 8), which ends in nitrogens, therefor this read on one or more third terminal groups attached to a nitrogen atom of a surface building unit via a linker, wherein the third terminal group comprises the residue of an anticancer agent.
Regarding claim 50, BOYDE further teaches that irinotecan, which is a topoisomerase inhibitor, can also be used as the anticancer agent (column 20, paragraph 9). BOYDE does not have an explicit example of using irinotecan however, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate irinotecan. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because mannitol and irinotecan are functional equivalents of anticancer agents commonly used in the pharmaceutical industry.
Claims 1, 7, 9, 10, 17, 21, 23, 25-27, 31, 34, 40, 47-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2), WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.) and GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.) in view of PROMEGA (Plasmid and Protein Quantitation. Promega Corporation. 2010.).
BOYDE, WU and GUO teach Applicant’s invention as discussed above.
Regarding claim 9, BOYDE, WU and GUO do not teach that the targeting agent has fewer than 120 amino acid residues.
Regarding claim 9, PROMEGA teaches antibodies are specific proteins made of amino acids and the amount of amino acids directly correlates to the proteins molecular weight. PROMEGA further teaches that the average molecular weight of an amino acid is 110 Daltons.
The reference does not specifically teach having a targeting agent with fewer than 120 amino acid residues as claimed by the Applicant. The amount of amino acid residues is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amino acid residues in order to best achieve desired results, such as having a small enough size for increased tumor penetration which is taught in WU, since the amount of amino acid residues correlates to the molecular weight. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of amount of amino acid residues would have been obvious at the time of Applicant’s invention. Furthermore, WU teaches that nanobodies are roughly 12.5 kDa and using the average molecular weight of an amino acid (as shown in PROMEGA), this would roughly equate to 114 amino acid residues.
Claims 1, 7, 9, 10, 17, 21-23, 25-27, 31, 34, 40, 47-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2), WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.), GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.) and PROMEGA (Plasmid and Protein Quantitation. Promega Corporation. 2010.) in view of KUBETZKO (ScFv PEGylation and Multimerization for Tumor Targeting).
BOYDE, WU, GUO and PROMEGA teach Applicant’s invention as discussed above.
Regarding claim 22, BOYDE, WU, GUO and PROMEGA do not teach linking the spacer group at the C-terminus of the antibody/targeting agent.
Regarding claim 22, KUBETZKO teaches linking a PEG at the c terminus of an antibody (abstract and page 35187, paragraph 7). This is a common practice when covalently linking antibodies to spacer molecules, in particular to PEG.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate linking a PEG at the c terminus of the antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because those skilled in the art use various methods to link components together and can routinely choose which method will benefit the overall composition and its use, and reasonably would have expected success because the references are in the same field of endeavor, such as pharmaceutical compositions for the treatment of cancer that comprise pegylated antibodies.
Claims 1, 7, 9, 10, 17, 21-23, 25-27, 31, 34, 35, 40, 47-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2), WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.), GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.), PROMEGA (Plasmid and Protein Quantitation. Promega Corporation. 2010.) and KUBETZKO (ScFv PEGylation and Multimerization for Tumor Targeting) in view of OWEN (WO 2012/167309 A1).
BOYDE, WU, GUO, PROMEGA and KUBETZKO teach Applicant’s invention as discussed above.
Regarding claim 35, BOYDE, WU, GUO, PROMEGA and KUBETZKO do not teach using dipropylenetriamine as a core unit.
Regarding claim 35, OWEN teaches a dendrimer used to treat cancer (claim 40). The dendrimer can have various anticancer drugs (claim 49). The dendrimer has a core unit such as BHALys or
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(page 28 and page 30) as a core unit, the second of which reads on the core unit recited instant claim 35. The building units can be lysine (claim 17), which is the building unit recited in instant claim 1.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the core unit of
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. The person of ordinary skill in the art would have been motivated to make those modifications, because and reasonably would have expected success because this core unit and BHALys are functional equivalents of core units used in dendrimers for cancer treatment that use lysine building blocks.
Claims 1, 7, 9, 10, 17, 21-23, 25-27, 31, 34, 35, 40 and 47-53 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2), WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.), GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.), PROMEGA (Plasmid and Protein Quantitation. Promega Corporation. 2010.), KUBETZKO (ScFv PEGylation and Multimerization for Tumor Targeting) and OWEN (WO 2012/167309 A1) in view of CASTAIGNE (WO 2014/026286).
BOYDE, WU, GUO, PROMEGA, KUBETZKO and OWEN teach Applicant’s invention as discussed above. BOYDE further teaches that the composition can have an active agent to treat cancer, such as Taxol, which is a taxane for breast cancer (column 44, paragraph 5).
Regarding claim 51, BOYDE, WU, GUO, PROMEGA, KUBETZKO and OWEN do not teach using an auristatin.
Regarding claim 51, CASTAIGNE teaches a PAMAM dendrimer (page 24, paragraph 1) that is used for breast cancer therapy (abstract) and binds to HER2 (page 7, paragraph 3). Various anticancer agents are used in the composition, such as methotrexate and monomethyl auristatin E (MMAE), which is an auristatin (claim 32).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate MMAE. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because MMAE and methotrexate are functional equivalents of anticancer drugs commonly used in the pharmaceutical industry.
Claims 1, 7, 9, 10, 17, 21-23, 25-27, 31, 34, 35, 40 and 47-55 are rejected under 35 U.S.C. 103 as being unpatentable over BOYDE (US 8,703,116 B2), WU (A Single Domain–Based Anti-Her2 Antibody Has Potent Antitumor Activities. Translational Oncology. 2018.), GUO (Image guided and tumor-targeted drug delivery with radiolabeled unimolecular micelles. Biomaterials. 2013.), PROMEGA (Plasmid and Protein Quantitation. Promega Corporation. 2010.), KUBETZKO (ScFv PEGylation and Multimerization for Tumor Targeting) and OWEN (WO 2012/167309 A1) in view of CASTAIGNE (WO 2014/026286) in view of REVETS (US 2011/0028695 A1).
BOYDE, WU, GUO, PROMEGA, KUBETZKO, OWEN and CASTAIGNE teach Applicant’s invention as discussed above.
Regarding claim 54-55, BOYDE, WU, GUO, PROMEGA, KUBETZKO, OWEN and CASTAIGNE do not teach using SEQ ID 1.
Regarding claims 54-55, REVETS teaches SEQ ID 1986 which is a 2D3 HER2 targeting agent that is the same SEQ ID as SEQ ID 1 (page 44).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate SEQ ID 1986 which is a 2D3 HER2 targeting agent. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because SEQ ID 1986 and a HER2 nanobody are functional equivalents of HER2 targeting agents commonly used in the pharmaceutical industry for cancer targeting.
Response to Arguments
Applicant argues, regarding the double pat3entin rejection the claims have been significantly narrowed, including requiring specific types of chemotherapeutic agent, being an auristatin, maytansinoid, anti-microtubule agent or topoisomerase inhibitor. Applicant respectfully submits that the claims of the present application, as filed herewith, and which require a complexation group for complexing a radionuclide, are patentably distinct.
The examiner does not find the argument persuasive. As discussed above it would be obvious to add the complexation group for complexing a radionuclide to preform imaging.
Applicant argues, the claimed invention exhibits unexpected results. These data show that regardless of dendrimer generation, the single domain antibody when conjugated with dendrimer substantially improves binding towards cells. Additionally, the 04 single domain antibody-dendrimer conjugate SRS-2-304 was compared to KY-2a (Trastuzumab), with SRS-2-304 showing binding to cells which overexpress HER2 receptors at levels comparable with trastuzumab (a full-sized antibody, as noted above in relation to D4). Example 8 then goes on to demonstrates internalization of the single domain antibody dendrimer conjugate Compound 123 into the HER2-overexpressing cell lines MDA-MB-231/HER2 and SKOV-3 compared with the untargeted conjugate Compound 71. Figures 5a and 6a shows that conjugate Compound 123 is readily internalized by MDA-MB-231/HER2 and SKOV-3 cell lines. Figures 5b and 6b show that Compound 71 was not. It is clear that the single domain antibody-targeting agent-dendrimer Compound 123 shows superior tumor growth inhibition and improved probability of survival compared to both Herceptin® (trastuzumab) and Kadcyla® (trastuzumab emtansine).
The examiner does not find the argument percussive because In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980).
In the instant case, the unexpected results are all directed towards showing the improvements that are a result of using a single domain antibody-targeting agent. As discussed above, WU teaches using a HER2 single domain antibody, also called a HER2 nanobody, to target breast cancer (abstract and page 366, paragraph 2). Nanobodies are better than antibodies because they have a small size that increases tumor penetration (Page 366, paragraph 2). Nanobodies are approximately 12.5 to 15 kDa (Page 366, paragraph 2), which reads on the targeting agent recited in instant claim 1. Furthermore, REVETS teaches SEQ ID 1986 which is a 2D3 HER2 targeting agent that is the same SEQ ID as SEQ ID 1 (page 44). In summary, the recite single domain antibody is taught by the priori art and the prior art also teaches the internalization and enhanced targeting described.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Applciant argues, Castaigne does not disclose in vivo efficacy or biodistribution results for any dendrimer-targeting agent conjugates. The experimental examples in CASTAIGNE relate solely to the preparation of a peptide-mAb conjugate (anti-HER2 mAb-[MFCO-An2-(SuDoce)2]n) which contains the full-sized antibody trastuzumab, and the assessment of an anti-HER2-Angiopep-2 conjugate in an in vitro cytotoxicity assay. Accordingly, there is no expectation from Castaigne that a conjugate within the scope of the claims could and would possess the properties demonstrated, e.g. improved tumor growth inhibition compared to trastuzumab.
Examiner does not find the argument persuasive because CASTAIGNE is cited not for its targeting agent, but rather for adding monomethyl auristatin E (MMAE), which is an auristatin, which would be obvious to do as described above.
Applicant argues, There is no expectation in Owen that a dendrimer-conjugate within the scope of the amended claims would possess properties which enable it to be localized in the target tumor and not at off-target sites, or that they would have improved tumor growth inhibition compared to approved therapies such as trastuzumab/HERCEPTIN®. For example, Owen does not disclose any efficacy results for any dendrimer-targeting agent conjugates. There is also no teaching in Owen relating to radiotherapy. Again, a skilled person would not arrive at the present invention in view of Owen.
Examiner does not find the argument persuasive because OWEN is not cited for its targeting agent or efficacy.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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