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 .
Receipt is acknowledged of IDS filed on 08/21/2026.
Claims 1 has been amended.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21, 24-25, 27 and 30-31 are pending.
Claims 2, 4, 5, 7, 8, 12, 13, 15, 16, 18, 20, 22, 23, 26, 28, and 29 are cancelled.
Claims 25, 27 and 30-31 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 3, 6, 9-11, 14, 17, 19, 21 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/379,726 (reference application) in view of APRIKYAN (US 2018/0223260 A1) and WANG (Functionalizable Amine-based Polymer Nanoparticles. NIH Public Access. 2015.). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites, a pharmaceutical composition comprising, a magnetic nanoparticle comprising an iron oxide core, a dextran coating functionalized with a number of surface amine groups from about 30 to 150 (claim 32). The amine groups are used to attach one or more oligonucleotides (claim 32).
The copending application does not teach crosslinking dextran with epichlorohydrin or the ratio of ferric and ferrous chloride used.
APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200). The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264), which is common in the art to synthesize iron oxide nanoparticles. The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate crosslinking dextran with epichlorohydrin. The person of ordinary skill in the art would have been motivated to make those modifications, because epichlorohydrin is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface, and reasonably would have expected success because the references are in the same field of endeavor, such as iron oxide nanoparticles that are coated in dextran and functionalized with amines.
APRIKYAN does teach that the size of the nanoparticle affects its properties, but does not explicitly state that it affects the amount of amine groups.
WANG teaches that the size of the nanoparticles affects the amount of amine groups that can attach, specifically the smaller surface area of larger nanoparticles will lead to decreased availability of surface functionalities (page 4, paragraph 3).
The reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride 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 amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Additionally the size of the nanoparticle can affect the amount of amine groups added. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
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). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12 and 14 of copending Application No. 18/035,174 (reference application) in view of APRIKYAN (US 2018/0223260 A1) and WANG (Functionalizable Amine-based Polymer Nanoparticles. NIH Public Access. 2015.). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending application recites, a therapeutic nanoparticle (claim 1), specifically an iron oxide nanoparticle (claim 12), comprising a dextran coating (claim 14), and amine group functionalization (claim 2). The amines are used to conjugate therapeutic and diagnostic molecules (claim 2). The nanoparticle further comprises a radiolabel and a chelator (claim 1).
The copending application does not teach crosslinking dextran with epichlorohydrin or the ratio of ferric and ferrous chloride used.
APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200). The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264), which is common in the art to synthesize iron oxide nanoparticles. The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate crosslinking dextran with epichlorohydrin. The person of ordinary skill in the art would have been motivated to make those modifications, because epichlorohydrin is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface, and reasonably would have expected success because the references are in the same field of endeavor, such as iron oxide nanoparticles that are coated in dextran and functionalized with amines.
APRIKYAN does teach that the size of the nanoparticle affects its properties, but does not explicitly state that it affects the amount of amine groups.
WANG teaches that the size of the nanoparticles affects the amount of amine groups that can attach, specifically the smaller surface area of larger nanoparticles will lead to decreased availability of surface functionalities (page 4, paragraph 3).
The reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride 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 amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Additionally the size of the nanoparticle can affect the amount of amine groups added. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
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). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 3, 6, 11, 14, 17, 19, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over APRIKYAN (US 2018/0223260 A1) in view of WANG (Functionalizable Amine-based Polymer Nanoparticles. NIH Public Access. 2015.).
Regarding claim 1, APRIKYAN teaches an iron oxide nanoparticle that are coated with dextran (page 20, paragraph 0191). and further modified with amine groups (page 17, paragraph 0155) coated with dextran (page 20, paragraph 0191). The nanoparticle is prepared by crosslinking the dextran with epichlorohydrin, which is used as a crosslinking agent and helps the amine groups to be attached to the dextran surface (page 20, paragraphs 0191 and 0200). The iron oxide core is made using ferric chloride and ferrous chloride (page 26, paragraph 0264). The size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride.
Regarding claim 17, APRIKYAN teaches the nanoparticle has core crystal diameter of 5 nm (page 14, paragraph 0128) and hydrodynamic diameter of 15 nm (paragraph 0132).
Regarding claim 21, APRIKYAN teaches that a nucleic acid is also attached to the nanoparticle (page 20, claim 0192).
Regarding claim 24, APRIKYAN teaches the composition is designed to be administered in a solution (page 51, paragraph 0496 and page 23, paragraph 0234), which reads on pharmaceutically acceptable carrier or dilutant.
Additional disclosures: APRIKYAN teaches that the size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles (page 15, paragraph 0135). The amines are used to conjugate bioactive molecules for therapeutic purposes (page 20, paragraph 0192 and 0197).
APRIKYAN does teach that the size of the nanoparticle affects its properties, but does not explicitly state that it affects the amount of amine groups.
WANG teaches that the size of the nanoparticles affects the amount of amine groups that can attach, specifically the smaller surface area of larger nanoparticles will lead to decreased availability of surface functionalities (page 4, paragraph 3).
The reference does not specifically teach the amount of amine groups as claimed by the Applicant. The amount of amine groups 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 amount of amine groups in order to best achieve desired results, such as having the appropriate amount of amine groups to achieve the therapeutic function desired. Since the bioactive molecule attaches to the amine groups, the amount of therapeutic agents added is dependent upon the amount of amine groups present on the nanoparticle. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of amine groups would have been obvious at the time of Applicant’s invention.
Regarding claims 1, 3, 6, 11, 14, the reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride 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 amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Additionally the size of the nanoparticle can affect the amount of amine groups added. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
Regarding claim 19, APRIKYAN teaches that dextran molecular weight can be optimized through ultrafiltration (Page 23, paragraph 0228), the dextran molecular weight affects the size of the nanoparticle (Page 23, paragraph 0231-0232). The reference does not specifically teach the dextran molecular weight as claimed by the Applicant. The dextran molecular weight 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 dextran molecular weight in order to best achieve desired results, such as having the proper sized nanoparticle for drug delivery. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dextran molecular weight would have been obvious at the time of Applicant’s invention.
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). This is in regards to the instant recitation of “ wherein the nanoparticle composition is prepared by a process comprising: crosslinking dextran with epichlorohydrin and controlling the number of the one or more surface amine groups by varying a concentration of ferric chloride and a concentration of ferrous chloride used during synthesis of the iron oxide core, wherein when the ferric chloride to ferrous chloride ratio is about 50% wt:50% wt, the number of the one or more surface amine groups ranges from about 60 to about 90, and wherein when the ferric chloride to ferrous chloride ratio is about 100% wt:0% wt, the number of the one or more surface amine groups ranges from about 246 to about 500.”.
Claims 1, 3, 6, 9-11, 14, 17, 19, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over APRIKYAN (US 2018/0223260 A1) and WANG (Functionalizable Amine-based Polymer Nanoparticles. NIH Public Access. 2015.) in view of NIKITIN (Ultrasensitive detection enabled by nonlinear magnetization of nanomagnetic labels. Royal Society of Chemistry. 2018).
APRIKYAN and WANG teach Applicant’s invention as discussed above. APRIKYAN further teaches the nanoparticle can be used for imaging (page 35, paragraph 0368).
APRIKYAN and WANG do not teach the nonlinearity index as claimed by Applicant.
Regarding claims 9-11, NIKITIN teaches that nanomaterials with a high nonlinearity of magnetization, which reads on nonlinearity index, improves the detectability limits of magnetic tags which allows for detection in deep organs of the human body (Page 11643, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a nonlinearity index. The person of ordinary skill in the art would have been motivated to make those modifications, because the nonlinearity of nanomaterials improves the detectability in deep organs of the human body, and reasonably would have expected success because both references are in the same field of endeavor such as magnetic iron nanoparticles used for imaging.
The reference does not specifically teach a non-linearity index as claimed by the Applicant. The non-linearity index 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 non-linearity index in order to best achieve desired results, such improving the detectability in deep organs of the human body. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of a non-linearity index would have been obvious at the time of Applicant’s invention.
Response to Arguments
Applicant argues, Aprikyan does not recognize the number of surface amine groups per nanoparticle as a result controlled by ferric chloride and ferrous chloride during synthesis of the iron oxide core. Applicant respectfully submits that Aprikyan's discussion of surfactant-to-metal-complex ratio and core size is different from Applicant's claimed ferric/ferrous chloride control of surface amine count on a dextran coating. Aprikyan's general teaching that amine groups may be used to attach biologically active molecules, including nucleic acids, does not supply a teaching or suggestion to obtain either of the claimed surface amine count windows.
The examiner does not find the argument persuasive because as discussed above, APRIKYAN does teach that the size of the nanoparticle affects its properties, but does not explicitly state that it affects the amount of amine groups. However, WANG teaches that the size of the nanoparticles affects the amount of amine groups that can attach, specifically the smaller surface area of larger nanoparticles will lead to decreased availability of surface functionalities (page 4, paragraph 3).
Additionally, as discussed above, 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)
Applicant argues, the instant application confirms that the claimed features are not merely routine optimizations of a known Aprikyan parameter. Applicant respectfully directs the Examiner's attention to Example 4, which describes quantifying amine content using SPDP conjugation and P2T detection.
The examiner does not find the argument persuasive 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, as described above, APRIKYAN teaches the size of the nanoparticle core depends on the molar ratio of the metal complex (page 17, paragraph 0156), such as the ratio of ferric chloride and ferrous chloride. APRIKYAN does teach that the size of the nanoparticle affects its properties, but does not explicitly state that it affects the amount of amine groups.
WANG teaches that the size of the nanoparticles affects the amount of amine groups that can attach, specifically the smaller surface area of larger nanoparticles will lead to decreased availability of surface functionalities (page 4, paragraph 3).
As can be seen, the prior art teaches changing the molar ratio of ferric chloride and ferrous chloride affects the size of the nanoparticle and in turn the amount of amine groups that can be attached. The claimed unexpected results are an advantage predictable from the prior art.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Additionally, as discussed above, 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)
Applicant argues, claim 1 requires a dextran-coated iron oxide nanoparticle having a specified number of surface amine groups, namely a number in a range selected from about 60 to about 90 and about 246 to about 500. Aprikyan has not been shown to disclose or render obvious a dextran coated iron oxide nanoparticle having those measured surface amine populations. Nor has Aprikyan been shown to recognize that ferric chloride and ferrous chloride concentrations used during synthesis of the iron oxide core control the number of surface amine groups on the dextran coating. Thus, the rejection has not established that Aprikyan's product is the same as, or obvious from, the claimed product.
The examiner does not find the argument persuasive because as discussed above, as discussed above, although the reference does not specifically teach the ratio, weight percent or grams of ferric chloride and ferrous chloride as claimed by the Applicant. The amount of ferrous and ferric chloride 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 amount of ferrous and ferric chloride in order to best achieve desired results, such as the ideal size of nanoparticle. The size of the nanoparticle can affect the physical, optical, and electronic characteristics of nanoparticles and the size of the nanoparticle is controlled by the molar ratio of ferric and ferrous chloride. Additionally, the size of the nanoparticle can affect the amount of amine groups added. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of ferrous and ferric chloride would have been obvious at the time of Applicant’s invention.
The reference does not specifically teach the amount of amine groups as claimed by the Applicant. The amount of amine groups 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 amount of amine groups in order to best achieve desired results, such as having the appropriate amount of amine groups to achieve the therapeutic function desired. Since the bioactive molecule attaches to the amine groups, the amount of therapeutic agents added is dependent upon the amount of amine groups present on the nanoparticle. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of amine groups would have been obvious at the time of Applicant’s invention.
Additionally, as discussed above, 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)
Conclusion
No claims are allowable.
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 /JAKE M VU/Primary Examiner, Art Unit 1618
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