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 .
Status of Application
Applicant’s amendments of claim(s) 1-17 in the reply filed on 06/22/2023 is acknowledged.
Claims 1-17 are under examination.
Drawings
The drawings are objected to because of the following reasons:
Fig. 3
Fig. 5(f) does not clearly show which curve belongs to which dye.
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: Germany is misspelled in Table E5 for Reagent M-MLV reverse transcriptase.
Appropriate correction is required.
Claim Objections
Claim 8 is objected to because of the following informalities: aryloxy is misspelled as "arlyoxy". Appropriate correction is required.
Claim Interpretation
Claims 1-12 recites the phrases “for use” and “for the use”. These phrases are interpreted as intended use. These phrases are interpreted to limit to any polymer, lipid, and polymethine dye that can be used for the uses of each read on these claims. Therefore, any prior art which has any polymer, lipid, and polymethine dye capable of this use, reads on these claims.
Claim Rejections - 35 USC § 112
Claim 8 is 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 claim 8, section d. recites the phrase "such as" which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-7, 10-13, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer, M.; et al. (US 9,795,688 B2, cited in the IDS filed on 09/06/2023).
Bauer M.; et al. (hereafter referred to as Bauer) is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV).
As to claim 1, Bauer teaches a nanostructured delivery system comprising at least one polymer and/or at least one lipid and at least one polymethine dye (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 2, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 3, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 4, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 5, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 6, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 7, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
As to claim 10, Bauer teaches the polymethine dye is selected from the group consisting of DY-630, DY-636, DY-647, DY-648, DY-730, DY-750, DY-778, and DY-780 (col 5, lines 48-57; claim 4).
As to claim 11, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4) containing at least one active pharmaceutical ingredient (col 8, lines 31-38; claim 7).
As to claim 12, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4) containing at least one active pharmaceutical ingredient (col 8, lines 31-38; claim 7).
As to claim 13, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4) with suitable excipients and additives (col 10, lines 19-22).
As to claim 17, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4). As to the use, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
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.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer, M.; et al. (US 9,795,688 B2, cited in the IDS filed on 09/06/2023).
The teachings of Bauer are incorporated and it is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV). However, the teachings of Bauer do not expressly teach claims 8 and 9.
As to claim 8, Bauer teaches general structures I, IA, II, IIA, III, IIIA (col 4, general structures I-IV; claim 1); n is 0-10 which overlaps with the claimed n is 1-3 (col 4, lines 44-45; claim 1); R1-R19 as hydrogen, one or more alkyl, tert-alkyl, cycloalkyl, the “alkyl” and “cycloalkyl” radicals also include olefinic structures) or aryl, carboxyaryl, dicarboxyaryl, heteroaryl or heterocycloaliphatic radicals, alkyloxy, alkylmercapto, aryloxy, arylmercapto, heteroaryloxy, heteroarylmercapto, a hydroxyl, nitro or others (col 4, lines 46-57; claim 1); at least one of the R1-R19 substituents has a solubilizing and/or ionizable or ionized substituted such as SO3-, which determines the hydrophilic properties of these polymethine dyes, wherein this substituent may also be bound to the polymethine dye by a spacer group (col 4, lines 58-64; claim 1); at least one of the R1-R19 substituents has a reactive group (linker) such as isocyanates, wherein this substituent may also be bound to the polymethine dye by a spacer group (col 4, lines 65-67 and col 5, lines 1-7; claim 1); the aromatic, or other spacer groups consists of structural elements (col 5, lines 8-16; claim 1); R7-R9 substituents and R17-R18 may also be present 2-5x and may be the same or different (col 5, lines 17-19; claim 1); and R15-R16 and/or R5-R6 may form an additional alicyclic or heterocyclic ring system (claim 1, col 22, lines 3-5).
Since the prior art included each element claimed, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements, a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person or ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 9, Bauer teaches use of polymethine dyes at physiological pH values (col 10, lines 45-49) and Bauer teaches polymethine dyes fitting at least one molecular descriptor where the number of oxygen and nitrogen atoms is between 4 and 20 (Sheet 8, Figure 8, DY-680).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 9,795,688 B2, cited in the IDS filed on 09/06/2023) as applied to claims 1-7, 10-13, and 17 above, and further in view of Schnermann, M. J.; et al. (US 10,561,729 B2).
The teachings of Bauer as applied in the previous rejection are incorporated in this rejection. Bauer is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV).
As to claim 14, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4).
Bauer does not teach adapted for inhalation.
Schnermann, M. J.; et al. (hereafter referred to as Schnermann) is drawn to polymethine dyes that can be used in targeted delivery (abstract, lines 1-7) and cancer (col 5, lines 25-26) and pharmaceutical compositions with the polymethine dyes (col 46, lines 24-30) adapted for inhalation (col 46, line 52).
Schnermann teaches a polymethine dye delivery system adapted for inhalation (col 46, line 52).
A person of ordinary skill in the art could have combined the elements as claimed by known methods of Bauer with Schnermann, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. (See MPEP 2143(I)(A).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer, M; et al. (US 9,795,688 B2, cited in the IDS filed on 09/06/2023) as applied to claims 1-7, 10-13, and 17 above, and further in view of Yang, X. et al. (WO 2011/116142 A1, cited in the IDS filed on 09/06/2023).
The teachings of Bauer as applied in the previous rejection are incorporated in this rejection. Bauer is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV).
As to claim 15, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4).
Bauer does not teach a method for targeted transport into adenocarcinoma tissue and/or cells with step comprising contacting the delivery system in vitro with the adenocarcinoma tissue and/or cells.
Yang, X.; et al. (hereafter referred to as Yang) teaches a method of using polymethine dyes delivery system (pg 2, para 2, line 1-4) for targeting and imaging cancers (title; abstract; pg 1, background, para 3, lines 1-3 and 6-7; pg 19, para 2, lines 1-6; pg 53, example 1; pg 67, example 17).
Yang teaches a method of contacting a delivery system with polymethine dye to adenocarcinoma tissue and/or cells in vitro (pg 53, example 1; pg 67, example 17).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 16, Bauer teaches the nanostructured delivery system according to claim 1 (col 1, lines 12-21; claim 1, lines 1-4).
Bauer does not teach the adenocarcinoma tissue is a prostate tissue.
Yang teaches the adenocarcinoma tissue is a prostate tissue (pg 53, example 1; pg 67, example 17).
The person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Nonstatutory 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.
Patent No. 9,795,688
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-8 of U.S. Patent No. 9,795,688 and the combined teachings of Bauer, Schnermann, and Yang as presented above. Although the claims at issue are not identical, they are not patentably distinct from each other because they are taught by conflicting claims of issued U.S. Patent No. 9,795,688.
Instant claim 1 is drawn to a nanostructured delivery system comprising at least one polymer and/or at least one lipid and at least one polymethine dye.
Conflicting claim 1 teaches a nanostructured delivery system comprising at least one polymer and/or at least one lipid and at least one polymethine dye.
Instant claim 2 is drawn to a nanostructured delivery system wherein at least one polymethine dye mediates targeted transport of the nanostructured delivery system into adenocarcinoma cells.
Conflicting claim 2 teaches the polymethine dye mediates uptake of the nanostructured delivery system into the cells of the target tissue.
Conflicting claim 2 does not teach adenocarcinoma.
However, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 3 is drawn to that adenocarcinoma comprises adenocarcinoma cells in which said gene expression alteration affects the SCLO1 gene.
Conflicting claim 6 lists tissue-specific transporters that mediate an effect on SCLO1 genes. Additionally, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 4 is drawn to adenocarcinoma cell in which said gene expression alteration affects the SCLO1B3 gene.
Conflicting claim 6 lists tissue-specific transporters that can mediate an effect on SCLO1B3 genes. Additionally, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 5 is drawn to adenocarcinoma is a gastrointestinal, lung, prostate, or breast cancer.
While the conflicting claims do not teach these cancers, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 6 is drawn to at least one polymethine dye mediates targeted transport of nanostructured delivery system into adenocarcinoma stem cells.
While the conflicting claims do not teach targeted transport of nanostructured delivery into adenocarcinoma stem cells, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 7 is drawn to adenocarcinomatous cancer is prostate or colon cancer.
Conflicting claims do not teach adenocarcinomatous cancer is prostate or colon cancer. However, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 8 is drawn to at least one polymethine dye is a symmetrical or asymmetrical polymethine with general structures I, IA, II, IIA, III, IIIA.
Conflicting claim 1 teaches a polymethine that is a symmetrical or asymmetrical polymethine with general structures I, IA, II, IIA, III, IIIA.
Instant claim 9 is drawn to characterizing polymethine dyes at pH 7.4 with a variety of molecular descriptors.
While the conflicting claims do not teach targeted transport of nanostructured delivery into adenocarcinoma stem cells, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 10 is drawn to at least one polymethine dye is from the group DY635, DY780, DY730,DY750, DY736, DY615, DY636, DY731 , DY647P1 , DY648P1 , CY-E10 derivatives, CY5.5 derivatives, DY630, IRDye800; DY778.
Conflicting claim 4 teaches polymethine is from a group consisting of polymethine dyes that overlaps with instant claim 10. The polymethine dyes may be selected from the group consisting of DY-635, DY-680, DY-780, DY-880, DY-735, DY-835, DY-830, DY-730, DY-750, DY-850, DY-778, DY-878, DY-830, DY-730, DY-750, DY-850, DY-778, DY-878, DY-704, DY-804, DY-754, DY-854, DY-700, DY-800, ICG and DY-IRDYE 800CW.
Instant claim 11 is drawn to at least one active pharmaceutical ingredient.
Conflicting claim 3 teaches at least one active pharmaceutical ingredient.
Instant claim 12 is drawn to a list of active pharmaceuticals that may be selected.
Conflicting claim 7 teaches an overlapping list of pharmaceutical ingredients.
Instant claim 17 is drawn to a nanostructured delivery system and/or its components is detectable in adenocarcinoma tissue and/or the adenocarcinoma cell by means of fluorescence properties of at least one polymethine dye.
Conflicting claim 8 teaches fluorescence of at least one polymethine dye indicates presence of the nanostructured delivery system.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 and 6-8 of U.S. Patent No. 9,795,688 in view of Bauer (US 9,795,688 B2, cited in the IDS filed on 09/06/2023).
Bauer is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV). All arguments made above are incorporated by reference.
Instant claim 13 is drawn to a composition comprising nanostructured delivery system and further suitable excipients and additives.
While the conflicting claims do not teach suitable excipients and additives, the prior art used in the arguments above teaches suitable excipients and additives. Bauer teaches suitable excipients and additives (col 10, lines 19-22).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,795,688 in view of Schnermann, M. J.; et al. (US 10,561,729 B2).
The teachings of Bauer as applied in the previous rejection are incorporated in this rejection.
Schnermann is drawn to polymethine dyes that can be used in targeted delivery (abstract, lines 1-7) and cancer (col 5, lines 25-26) and pharmaceutical compositions with the polymethine dyes (col 46, lines 24-30) adapted for inhalation (col 46, line 52).
Instant claim 14 is drawn to a composition adapted for inhalation.
The conflicting claims do not teach a composition adapted for inhalation.
Schnermann teaches adaptation for inhalation (col 46, line 52).
A person of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Claims 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,795,688 in view of Yang, X. et al. (WO 2011/116142 A1, cited in the IDS filed on 09/06/2023).
The teachings of Bauer as applied in the previous rejection are incorporated in this rejection.
Yang teaches a method of using polymethine dyes delivery system (pg 2, para 2, line 1-4) for targeting and imaging cancers (title; abstract; pg 1, background, para 3, lines 1-3 and 6-7; pg 19, para 2, lines 1-6; pg 53, example 1; pg 67, example 17).
Instant claim 15 is drawn to a method of contacting adenocarcinoma tissue and/or cells with nanostructured delivery system.
The conflicting claims do not teach a method of contacting adenocarcinoma tissue and/or cells with nanostructured delivery system.
Yang teaches a method of contacting a delivery system with polymethine dye to adenocarcinoma tissue and/or cells in vitro (pg 53, example 1; pg 67, example 17).
A person of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Instant claim 16 is drawn to adenocarcinoma tissue is prostate tissue.
The conflicting claims do not teach adenocarcinoma tissue is prostate tissue.
Yang teaches the adenocarcinoma tissue is a prostate tissue (pg 53, example 1; pg 67, example 17).
The person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Patent No. 12,472,259
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of U.S. Patent No. 12,472,259 and the combined teachings of Bauer, Schnermann, and Yang as presented above. Although the claims at issue are not identical, they are not patentably distinct from each other because they are taught by conflicting claims of issued U.S. Patent No. 12,472,259.
Instant claim 1 is drawn to a nanostructured delivery system comprising at least one polymer and/or at least one lipid and at least one polymethine dye.
Conflicting claims 1 and 14 teach a polymethine dye and at least one polymer or at least one lipid.
Instant claim 2 is drawn to a nanostructured delivery system wherein at least one polymethine dye mediates targeted transport of the nanostructured delivery system into adenocarcinoma cells.
While the conflicting claims do not teach the polymethine dye mediating targeted transport, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 3 is drawn to adenocarcinoma which comprises adenocarcinoma cells in which said gene expression alteration affects the SCLO1 gene.
Conflicting claim 13 teaches a list of tissue specific transporters.
Additionally, the conflicting claims teach the nanostructured delivery system. And, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 4 is drawn to an adenocarcinoma cell in which said gene expression alteration affects the SCLO1B3 gene.
Conflicting claim 13 teaches a list of tissue specific transporters.
Additionally, the conflicting claims teach the nanostructured delivery sytem. And, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 5 is drawn to adenocarcinoma is a gastrointestinal, lung, prostate, or breast cancer.
While the conflicting claims do not teach these cancers, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 6 is drawn to at least one polymethine dye mediates targeted transport of nanostructured delivery system into adenocarcinoma stem cells.
While the conflicting claims do not teach targeted transport of nanostructured delivery into adenocarcinoma stem cells, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 7 is drawn to an adenocarcinomatous cancer which is prostate or colon cancer.
Conflicting claims do not teach adenocarcinomatous cancer is prostate or colon cancer. However, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Instant claim 8 is drawn to at least one polymethine dye is a symmetrical or asymmetrical polymethine with general structures I, IA, II, IIA, III, IIIA.
Conflicting claim 1 teaches the at least one polymethine dye as a symmetrical or asymmetrical polymethine with general structures I, IA, II, IIA, III, IIIA.
Instant claim 9 is drawn to characterizing polymethine dyes at pH 7.4 with a variety of molecular descriptors.
While the conflicting claims do not teach characterization with these properties, the conflicting claim 1 teaches the dyes. And, “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II).
Claims 10-13 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of U.S. Patent No. 12,472,259 in view of Bauer (US 9,795,688 B2, cited in the IDS filed on 09/06/2023).
Bauer is drawn to nanostructured delivery systems made of at least one lipid, polymer, and polymethine dye capable of delivery pharmaceutical active ingredients (title; abstract; col 1, lines 12-21; col 4, structures I-IV). All arguments made above are incorporated here.
Instant claim 10 is drawn to at least one polymethine dye is from the group DY635, DY780, DY730,DY750, DY736, DY615, DY636, DY731 , DY647P1 , DY648P1 , CY-E10 derivatives, CY5.5 derivatives, DY630, IRDye800; DY778.
Conflicting claim 1 teaches a polymethine dye.
Conflicting claims do not teach this list of polymethine dyes.
Bauer teaches polymethine is from a group consisting of polymethine dyes that overlaps with instant claim 10. The polymethine dyes may be selected from the group consisting of DY-635, DY-680, DY-780, DY-880, DY-735, DY-835, DY-830, DY-730, DY-750, DY-850, DY-778, DY-878, DY-830, DY-730, DY-750, DY-850, DY-778, DY-878, DY-704, DY-804, DY-754, DY-854, DY-700, DY-800, ICG and DY-IRDYE 800CW (claim 4).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Instant claim 11 is drawn to a nanostructured delivery system with at least one active pharmaceutical ingredient.
Conflicting claims 1 and 13-14 teach a nanostructured delivery system.
Conflicting claims do not teach at least one active pharmaceutical ingredient
Bauer teaches at least one active pharmaceutical ingredient (claim 3).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Instant claim 12 is drawn to a nanostructured delivery system with a list of active pharmaceuticals that may be selected.
Conflicting claims 1 and 13-14 teach a nanostructured delivery system.
Conflicting claims do not teach a list of active pharmaceuticals that may be selected.
Bauer teaches an overlapping list of pharmaceutical ingredients (claim 7).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Instant claim 13 is drawn to a composition comprising nanostructured delivery system and further suitable excipients and additives.
Conflicting claims 1 and 13-14 teach a nanostructured delivery system.
Conflicting claims do not teach suitable excipients and additives.
Bauer teaches suitable excipients and additives (col 10, lines 19-22).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Instant claim 17 is drawn to a nanostructured delivery system and/or its components is detectable in adenocarcinoma tissue and/or the adenocarcinoma cell by means of fluorescence properties of at least one polymethine dye.
Conflicting claims 1 and 13-14 teach a nanostructured delivery system.
Conflicting claims do not teach a nanostructured delivery system and/or its components is detectable in adenocarcinoma tissue and/or the adenocarcinoma cell by means of fluorescence properties of at least one polymethine dye.
Bauer teaches fluorescence of at least one polymethine dye indicates presence of the nanostructured delivery system (claim 8).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in the specification and claims of Bauer, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 13-14 of U.S. Patent No. 12,472,259 in view of Bauer (U.S. 9,795,688 B2, cited in the IDS filed on 09/06/2023) and Schnermann (US 10,561,729 B2).
The teachings of Bauer as applied in the previous rejections are incorporated in this rejection.
Schnermann is drawn to polymethine dyes that can be used in targeted delivery (abstract, lines 1-7) and cancer (col 5, lines 25-26) and pharmaceutical compositions with the polymethine dyes (col 46, lines 24-30) adapted for inhalation (col 46, line 52).
Instant claim 14 is drawn to a composition adapted for inhalation.
Conflicting claim 1 and 13-14 teach a nanostructured delivery system.
The conflicting claims do not teach suitable excipients and additives.
Schnermann teaches adaptation for inhalation (col 46, line 52).
A person of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Claims 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of U.S. Patent No. 12,472,259 in view of Bauer (U.S. 9,795,688 B2) and Yang, X. et al. (WO 2011/116142 A1, cited in the IDS filed on 09/06/2023).
The teachings of Bauer as applied in the previous rejection are incorporated in this rejection.
Yang teaches a method of using polymethine dyes delivery system (pg 2, para 2, line 1-4) for targeting and imaging cancers (title; abstract; pg 1, background, para 3, lines 1-3 and 6-7; pg 19, para 2, lines 1-6; pg 53, example 1; pg 67, example 17).
Instant claim 15 is drawn to a method of contacting adenocarcinoma tissue and/or cells with nanostructured delivery system.
Conflicting claim 1 and 13-14 teach a nanostructured delivery system.
The conflicting claims do not teach a method of contacting adenocarcinoma tissue and/or cells with nanostructured delivery system.
Yang teaches a method of contacting a delivery system with polymethine dye to adenocarcinoma tissue and/or cells in vitro (pg 53, example 1; pg 67, example 17).
A person of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Instant claim 16 is drawn to adenocarcinoma tissue is prostate tissue.
Conflicting claims 1 and 13-14 teach a nanostructured delivery system.
The conflicting claims do not teach adenocarcinoma tissue is prostate tissue.
Yang teaches the adenocarcinoma tissue is a prostate tissue (pg 53, example 1; pg 67, example 17).
The person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Conclusion
No claims allowed.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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