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 .
Specification
The use of the terms “Nicolet” and “Axio Scope A1”, which is a trade name or a mark used in commerce, has been noted in this application. See specification page 7. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 – 3, 7 – 8, and 10 – 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2 – 3, 7 – 8, and 10 – 11, the phrase "preferably" in the claim renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of whether the limitation after the “preferably,” is required or not. Therefore, given the uncertainty around the limitations after the “preferably,” claims 2 – 3, 7 – 8, and 10 – 11 are rejected under 35 U.S.C. 112(b).
Moreover, in claim 3, the phrase "for example" in line 2 of the claim renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of whether the limitation after the “for example,” is required or not. Therefore, given the uncertainty around the limitations after the “for example,” claim 3 is rejected under 35 U.S.C. 112(b).
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.
Claims 1 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. US 4727064 to Pitha (Pitha’064) in view of Thünemann ((1997), Immobilization of Retinoic Acid by Cationic Polyelectrolytes, Langmuir, 13, 6040 – 6046).
Regarding claims 1 – 11, Pitha’064 teaches a method of converting drug compositions which themselves are crystalline and of low solubility into intrinsically amorphous complexes with improved pharmaceutical properties. See column 1 lines 49 – 52. Specifically, Pitha’064 teaches a composition comprising all trans retinoic acid ethanolamine salt with 1 % ethanolamine and 40 % hydroxypropyl-β-cyclodextrin. See column 3 Table 1. See claim 1 limitation for a complex comprising retinoic acid and an alcohol amine. See claim 2 limitation for a complex where the alcohol amine compound is ethanolamine. See claim 9 limitation for a composition comprising retinoic acid-alcohol amine complex according to claim 1. Moreover, Pitha’064 teaches that the preparation of mixtures of cyclodextrin derivatives which are intrinsically amorphous, water-soluble, and capable of forming inclusion complexes with drugs which are in turn effectively solubilized into aqueous media. See column 2 lines 39 – 43. See claim 4 limitation for the complex of claim 1 which is in a liquid form at room temperature.
However, the prior art of Pitha’064 fails to teach the complex according to claim 1, characterized in that molar ratio of said alcohol amine compound to the retinoic acid is (1-100):1. See claim 3 limitation. Moreover, Pitha’064 fails to teach the complex according to claim 1, the retinoic acid can exist partially or wholly in anionic form, and the alcohol amine compound can exist partially or wholly in cationic form. See claims 5 – 7. Furthermore, Pitha’064 fails to teach a method of preparing the complex according to claim 1, comprising the steps of: reacting the retinoic acid with the alcohol amine compound. See claim 8 limitation. And Pitha’064 fails to teach a method for treating skin diseases and non-skin tumors comprising administering the complex according to claim 1 or the composition according to claim 9. See claims 10 – 11 limitations.
Nevertheless, Thünemann teaches that lipophilic hormones, such as retinoic acid, steroids, thyroid hormone, and vitaminD3, function by interacting with ligand-activated transcription factors comprising the steroid/nuclear receptor superfamily. See page 6040 column 1 paragraph 1. Thünemann teaches that retinoic acid has great potential as a pharmacological agent; with a use as a therapy of serious cases of acne, and skin rejuvenation therapy. See page 6040 column 1 paragraph 2. See claims 10 – 11 limitations for a method for treating skin diseases and non-skin tumors comprising administering the complex according to claim 1 or the composition according to claim 9. Moreover, Thünemann teaches the complexation of retinoic acid with cationic polyelectrolytes. See page 6040 column 1 paragraph 3. Furthermore, Thünemann teaches that the all-trans retinoic acid has the structure of
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. See page 6041 column 1 Figure 1. See claims 5 and 6 limitations for the complex according to claim 1 where the retinoic acid can exist partially or wholly in an anion form. Likewise, Thünemann teaches that the polyelectrolyte, which contain protonated amines, can have the structures of
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. See page 6041 column 1 Figure 2. Moreover, Thünemann teaches that the complexation of retinoic acid with cationic polyelectrolytes was formed by reacting retinoic acid with a 0.01 % solution of polyelectrolyte was added dropwise while stirring until no further precipitation was observed with a subsequent filtration step to remove excess retinoic acid and salt. See page 6041 column 2 paragraph 2.
Now, while Thünemann fails to specifically teach an alcohol amine compound of formula (II) as recited in claim 7; the relatively skill of one of ordinary skill in the medicinal chemistry arts is relatively high being that of a Ph. D or Pharm. D. Accordingly, it would have been within the purview of such artisan that is order to complex with the negatively charged retinoic acid the alcohol amine must exist in a positive form. Thus, it would be obvious to such artisan that the positive charge of the alcohol amine must be on the N atom since the O atom is more electronegative and less willing to accept hold a positive charge. Hence it would have been within the purview of one such artisan to substitute the polyelectrolytes for an alcohol amine to form a compound that can exist partially or wholly in a cationic form with the structure of formula II. See claims 5 and 6 limitations for the complex according to claim 1 where the retinoic acid can exist partially or wholly in an anion form.
With regards to claim 3 limitations for the molar ratio of the alcohol amine compound to the retinoic acid being (1-100) : 1; as taught above, Pitha’064 teaches a composition comprising all trans retinoic acid ethanolamine salt with 1 % ethanolamine. Moreover, Thünemann teaches that the complexation of retinoic acid with cationic polyelectrolytes was formed by reacting retinoic acid with a 0.01 % solution of polyelectrolyte was added dropwise while stirring until no further precipitation was observed with a subsequent filtration step to remove excess retinoic acid and salt. Accordingly, given that the relatively skill level of one of ordinary skill in the medicinal chemistry arts is relatively high being that of a Ph. D or Pharm. D; it would have been within the purview of such artisan that is order to modify the method of Thünemann, that is to substitute the cationic polyelectrolytes for the cationic ethanolamine of Patha’064. Moreover, give that the complex is formed it would have been obvious to one of ordinary skill in the art to have a molar ratio of the alcohol amine compound to the retinoic acid being (1-100) : 1.
Moreover, in regard to claim 8 limitation for a method for the preparation of the complex, by reacting retinoic acid with the alcohol amine compound; as taught above, Thünemann teaches that the complexation of retinoic acid with cationic polyelectrolytes was formed by reacting retinoic acid with a 0.01 % solution of polyelectrolyte was added dropwise while stirring until no further precipitation was observed. Accordingly, given that the relatively skill level of one of ordinary skill in the medicinal chemistry arts is relatively high being that of a Ph. D or Pharm. D; it would have been within the purview of such artisan that is order to modify the method of Thünemann, that is to substitute the cationic polyelectrolytes for the cationic ethanolamine of Pitha’064.
Therefore, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application for the composition of Pitha’064 that contains retinoic acid and the alcohol amine ethanolamine to exist in view of Thünemann that is for the retinoic acid exists in [A-] form and if the alcohol amine compound exists in [B+] form. Moreover, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application to prepare the composition of Pitha’064 that contains retinoic acid and the alcohol amine ethanolamine in view of Thünemann where the retinoic acid is reacted with the alcohol amine compound instead of a polyelectrolyte to obtain the complex. One of ordinary skill in the art would have been motivated to make this modification and had a reasonable expectation of success because it would have been within the purview of such artisan that to substitute the cationic polyelectrolytes for the cationic ethanolamine of Pitha’064.
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 – 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 19/133083 to Hu et. al. (Hu’083) in view of US Patent No. US 4727064 to Pitha (Pitha’064) and Thünemann ((1997), Immobilization of Retinoic Acid by Cationic Polyelectrolytes, Langmuir, 13, 6040 – 6046) as evidenced by National Center for Biotechnology Information (NCBI). PubChem Database. Retinoic Acid, CID=444795, https://web.archive.org/web/20191213092342/https://pubchem.ncbi.nlm.nih.gov/compound/444795 (accessed on Dec. 13, 2019).
Hu’083 recite a composition, comprising the components of: (a) a tretinoin-alcoholamine compound complex; (b) a gel matrix; and ( c) an oil phase component; wherein the tretinoin-alcoholamine compound complex is composed of tretinoin and an alcoholamine compound. See reference claim 1. As evidenced by NCBI, tretinoin is an alternative chemical name for retinoic acid. See NCBI reference page 1. Thus Hu’083 recite a composition comprising a retinoic acid alcohol amine compound. See examined claims 1 and 9. Moreover, Hu’083 recite the composition of reference claim 1 where the alcoholamine is represented by formula I:
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. See reference claim 2. See examined claim 2. Furthermore, Hu’083 recite additional components of the composition. See reference claims 3 – 9, and 11 – 17. Hu’083 recite the composition of (reference) claim 2 where a mole ratio of the alcoholamine compound to the treatinoin ranges from 1 : 1 to 100 : 1. See reference claim 13. See examined claim 3. Additionally, Hu’083 recite a method for treating a skin disease comprising administering the composition in reference claim 1. See reference claims 10, 18, and 20. See examined claims 10 – 11.
However, Hu’083 fails to recite whether the retinoic acid exists in [A-] form and if the alcohol amine compound exists in [B+] form. See examined claims 6 – 7. Moreover, Hu’083 fails to recite a preparation method for complex. See examined claim 8.
Nevertheless, the teachings of Pitha’064 and Thünemann as they relate to the prior art rejections of examined claims 1 – 11, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application for the composition of Hu’083 that contains retinoic acid and the alcohol amine to exist in view of Thünemann that is for the retinoic acid exists in [A-] form and if the alcohol amine compound exists in [B+] form. Moreover, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application for the composition of Hu’083 that contains retinoic acid and the alcohol amine to be prepared in view of Pitha’064 and Thünemann where the retinoic acid is reacted with the alcohol amine compound instead of a polyelectrolyte to obtain the complex. One of ordinary skill in the art would have been motivated to make this modification and had a reasonable expectation of success because it would have been within the purview of such artisan that to substitute the cationic polyelectrolytes for the cationic ethanolamine of Pitha’064.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 19 of copending Application No. 19/666630 to Hu et.al. (Hu’630) in view of US Patent No. US 4727064 to Pitha (Pitha’064) and Thünemann ((1997), Immobilization of Retinoic Acid by Cationic Polyelectrolytes, Langmuir, 13, 6040 – 6046) as evidenced by National Center for Biotechnology Information (NCBI). PubChem Database. Retinoic Acid, CID=444795, https://web.archive.org/web/20191213092342/https://pubchem.ncbi.nlm.nih.gov/compound/444795 (accessed on Dec. 13, 2019).
Hu’630 recite a composition, comprising: a first component comprising tranexamic acid or a pharmaceutically acceptable salt thereof; and a second component comprising a tretinoin-alcoholamine complex or a tretinoin-fatty amine complex; wherein the tretinoin-alcoholamine complex is composed of tretinoin and an alcohol amine compound; and the tretinoin-fatty amine complex is composed of tretinoin and a fatty amine compound. See reference claim 1. As evidenced by NCBI, tretinoin is an alternative chemical name for retinoic acid. See NCBI reference page 1. Thus Hu’630 recite a composition comprising a retinoic acid alcohol amine compound. See examined claims 1 and 9. Hu’630 recite the composition of (reference) claim 1 where a mole ratio of the alcoholamine compound to the treatinoin ranges from (1-100): , and where the alcoholamine is represented by formula I:
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.See reference claims 3 – 4. See examined claims 2 – 3. Furthermore, Hu’630 recite additional components of the composition. See reference claims 5 – 17. Additionally, Hu’630 recite a method for treating a skin disease comprising administering the composition in reference claim 1. See reference claim 18. See examined claims 10 – 11. Moreover, Hu’630 recite a preparation method for the composition of (reference) claim 1 comprising the steps of preparing an oil phase containing the tretinoin-alcoholamine complex or the tretinoin-fatty amine complex; and mixing by adding the aqueous phase into the oil phase, and subjecting a resulting mixture to emulsification and homogenization to obtain the composition. See reference claim 19.
However, Hu’630 fails to recite whether the retinoic acid exists in [A-] form and if the alcohol amine compound exists in [B+] form. See examined claims 6 – 7. Moreover, Hu’630 fails to recite a preparation method for complex. See examined claim 8.
Nevertheless, the teachings of Pitha’064 and Thünemann as they relate to the prior art rejections of examined claims 1 – 11, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application for the composition of Hu’630 that contains retinoic acid and the alcohol amine to exist in view of Thünemann that is for the retinoic acid exists in [A-] form and if the alcohol amine compound exists in [B+] form. Moreover, it would have been obvious to one of ordinary skill in that art before the effective filing date of the examined application for the composition of Hu’630 that contains retinoic acid and the alcohol amine to be prepared in view of Pitha’064 and Thünemann where the retinoic acid is reacted with the alcohol amine compound instead of a polyelectrolyte to obtain the complex. One of ordinary skill in the art would have been motivated to make this modification and had a reasonable expectation of success because it would have been within the purview of such artisan that to substitute the cationic polyelectrolytes for the cationic ethanolamine of Pitha’064.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1 – 11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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