Title of Invention	A FATTY ACID SALT COMPOSITION
Abstract	The present invention provides a Fatty acid salt particles having a size distribution wherein the particles are from about 1 to about 1,000 microns in diameter, use of the particles in pharmaceutical compositions, as well as method and using the particles and composition.

Full Text

IN RE THE INTERNATIONAL APPLICATION OF Applicant: NOBEX CORPORATION Serial No.: PCT/US2004/026403 Filing Date: 13 August 2004 Attorney Docket: 014811-310.115WO Title: MICRO-PARTICLE FATTY ACID SALT SOLID DOSAGE FORMULATIONS FOR POLYPEPTIDE THERAPEUTIC AGENTS European Patent Office D-80298 Munich Germany AMENDMENT AND REMARKS PURSUANT TO PCT ARTICLE 34 Sir: Please substitute pages 22-28 attached herewith for original pages 22-28. Please consider the amendments contained in the substitute sheets as well as the remarks below in the International Preliminary Examination to be conducted pursuant to the Demand filed herewith. RESPONSE TO REMARKS OF THE INTERNATIONAL SEARCHING AUTHORITY: The Examiner has stated that a copy of the claimed priority document has not been fur¬nished, therefore making it impossible to validate die priority claim. A copy of the "Notification Concerning Submission or Transmittal of Priority Document" issued on 7 October 2004 by the In¬ternational Bureau confirming receipt of the priority document on 27 September 2004. It is be¬lieved that the Examiner has made an error and that validation of the priority date should be made. The Examiner has cited published US application no. US2002/187536 (hereinafter Dl), is¬sued U.S. Patent No. 4,439,420 (hereinafter D2), U.S. Patent No. 3,957,662 (hereinafter D3), jour¬nal publication entitled "Studies on the promoting effects of medium chain fatty acid salts on the nasal absorption of insulin" (hereinafter D4) against the present application, and U.S. Patent No. 6,610,653 (hereinafter D5). Claim 1 has been revised as follows: 1. A fatty acid salt composition comprising fatty acid salt particles having a size distribution wherein the particles are from about 1 to about 1,000 microns in diameter, wherein the fatty acid salt comprises a fatty acid component selected from the group consisting of butyric acid, caoroic acid, caprvlic acid, capric acid, lauric acid, mvristic acid, palmitic acid. palmitoleic acid, oleic acid, linoleic acid, aloha-linolenic acid, gamma- linolenic acid, arachidic acid, gadoleic acid, arachidonic acid. EPA, be- henic acid, erucic acid. DHA. and lienoceric acid. TRII\598756vl 1 The modification recites a specific group of fatty acids, which excludes the stearates described in the cited references. Claim 11, which was objected to for lack of inventive step has been revised to render it an inde¬pendent claim: 11. A fatty acid salt composition comprising fatty acid salt particles having The fatty aoid salt composition of olaim 1 whoroin tho portioloa have a an average particle size distribution of from about 5 to about 500 microns in diameter. Claim 11 recites particle sizes that are outiside the range of the particle sizes described in the ref¬erences. Claims 12-19 have been revised to depend directly or indirectly to claim 11, and further distin¬guish the claimed invention by reciting particle sizes outside the range of the particle sizes de¬scribed in the cited references: 12. The fatty acid salt composition of claim 4-U wherein the particles have a size distribution an average particle size of1 from about 20 to about 80 microns in diameter. 13. The fatty acid salt composition of claim 2 H wherein the particles have a size distribution from about 5 to about 500 miorona in diameter at least about 30% of the particles are from about 1 to about 1,000 microns in di¬ameter. 14. The fatty acid salt composition of claim 2 13 wherein the particles have a aizo diotribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 15. The fatty acid salt composition of claim $ H wherein the partiolos have a sizo distribution from about 5 to about 500 miorona in diamotor at least about 40% of the particles are from about 1 to about 1.000 microns in di¬ameter. 16. The fatty acid salt composition of claim 3-15 wherein the particles have a aizo distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 17. The fatty acid salt composition of claim 4 1_1 wherein the partiolea have a aizo diotribution from about 5 to about 500 miorona in diamotor at least about 50% of the particles are from about 1 to about 1.000 microns in di¬ameter. 1 The language "a size distribution" has been revised to recite "an average particle size" to comport with the language of the last sentence of the second full paragraph of page 7 of the specification. TRll\59875«vl 2 18. The fatty acid salt composition of claim 4 17 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 19. The fatty acid salt composition of claim 5 U. wherein the partiolos have a size distribution from about 5 to about 500 miorons in diameter at least about 60% of the particles are from about 1 to about 1.000 microns in di¬ameter. 20. The fatty acid salt composition of claim $ 19 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 21. The fatty acid salt composition of claim 6 H_ wherein the partiolos have a Gize distribution from about 5 to about 500 miorons in diameter at least about 70% of the particles are from about 1 to about 1.000 microns in di¬ameter. 22. The fatty acid salt composition of claim € 21 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 23. The fatty acid salt composition of claim 7 11 wherein tho partiolos have a size distribution from about 5 to about 500 microtia in diameter at least about 80% of the particles are from about 1 to about 1.000 microns in di¬ameter. 24. The fatty acid salt composition of claim ? 23 wherein the particles have a Gizo distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 25. The fatty acid salt composition of claim 8 H wherein tho partiolc3 have a size distribution from about 5 to about 500 miorons in diameter at least about 90% of the particles are from about 1 to about 1.000 microns in di¬ameter. 26. The fatty acid salt composition of claim 8 25 wherein the particles have a siao distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 27. The fatty acid salt composition of claim 9-1_1 wherein tho particles have a size distribution from about 5 to about 500 miorons in diameterjitjeast about 95% of the particles are from about 1 to about 1.000 microns in di¬ameter. 28. The fatty acid salt composition of claim 9 27 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 29. The fatty acid salt composition of claim 40 J_1 wherein tho particles have a sizo distribution from about 5 to about 500 miorono in diameter at least about 99% of the particles are from about 1 to about 1.000 microns in di¬ameter. 30. The fatty acid salt composition of claim 40 29 wherein die particles have a oize diotribution an average particle size of from about 20 to about 80 microns in diameter. Claims 31-36 have been revised to recite that the pharmaceutical composition is a "solid oral dos¬age form," as follows: 31. A pharmaceutical composition comprising in a solid oral dosage form2: (a) the fatty acid salt composition of claims 1, and (b) a biologically active agent. 32. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 5, and (b) a biologically active agent. 33. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 10, and (b) a biologically active agent. 34. A pharmaceutical composition comprising in a solid oral dosage form: (a) die fatty acid salt composition of claims 11, and (b) a biologically active agent 35. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 15, and (b) a biologically active agent 36. A pharmaceutical composition comprising in a solid oral dosage form: (a) die fatty acid salt composition of claims 20, and (b) a biologically active agent This limitation excludes D4 which relates only to nasal delivery. In fact, D4 teaches away from the oral delivery of proteins and peptides: "It is well known that the hormone [insulin] is poorly absorbed after oral ad¬ministration because of its degradation by gastrointestinal proteases and its poor permeability through gastrointestinal mucosa due to its high molecular weight"1 D4 then proceeds to propose an altrenative route of administration for insulin - the nasal route - and proposes sodium cap rate, sodium caprylate and sodium laurate as promoters of absorption af¬ter nasal administration. As stated by the authors, "In die present study, we investigated the pro¬moting effect of medium chain fatty acid sodium salts on nasal absorption of insulin in rats."4 Nothing in D4 teaches or suggests the use of fatty acid salts in the size range claimed by the appli¬cants in the preparation of a "solid oral dosage form." Further, it is noted that none of Dl, D2 or D3 mention the use of fatty acid salts for delivery of proteins or peptides, much less the use of fatty acid salts of die size ranges recited by the appli¬cants for the oral delivery of proteins and peptides. One of skill in die art would not simply as¬sume that these small molecule formulations would also be useful in the oral delivery of proteins and peptides, as evidenced by die fact the D4 teaches away from the oral delivery of proteins and peptides. New claims 75-78 have been added further emphasizing die oral delivery aspect of the invention by reciting that the pharmaceutical composition is provided in a solid oral dosage form that is a tablet5 (claim 75 and 77, which depend from claim 1) or a capsule6 (claim 76 and 78, which de¬pend from claim 11). The Examiner did not identify support in the cited references for the rejection of claims 37-45. Consequently, the applicants respectfully request the Examiner to withdraw the rejections of these claims. Claims 46-74 all depend from claim 31 and are novel and inventive for the reasons discussed above, in addition to die specific limitations of these claims. Thus, for example, the cited refer¬ences do not teach or suggest the use of medium chain fatty acids having the particle sizes claimed by the applicants in a solid oral dosage form (see claims 46 and 47). Nor do die cited references further teach die use of use of medium chain fatty acids having the particle sizes claimed by the applicants in a solid oral dosage form with a biologicallally active agent comprising a conjugated, pegylated or unconjugated polypeptide drug or prodrug (see claims 48-52). Further, die cited references do not teach or suggest the use of a formulation as recited in claim 31 with the specific calcitonin drugs recited in claims S3-SS or the specific insulin drugs recited in claims 56-62. Further, the cited references do not teach the specific molecular weight limitations of the drug, as recited in claims 63-65. It is noted that the treatment method claims (66-68) were not examined; however, these claims are retained in the application for examination in those countries in which such claims are allowable. Finally, the cited references do not teach or suggest tablets having the specific dissolution rates re¬cited in claims 69-74. In conclusion, the objections raised by the Examiner in die Written Opinion are overcome by the amendments and arguments presented herein, and the Examiner is respectfully requested to issue a clean International Preliminary Examination Report. IN RE THE INTERNATIONAL APPLICATION OF Applicant: NOBEX CORPORATION Serial No.: PCT/US2004/026403 Filing Date: 13 August 2004 Attorney Docket: 014811-310.115WO Title: MICRO-PARTICLE FATTY ACID SALT SOLID DOSAGE FORMULATIONS FOR POLYPEPTIDE THERAPEUTIC AGENTS European Patent Office D-80298 Munich Germany AMENDMENT AND REMARKS PURSUANT TO PCT ARTICLE 34 Sir: Please substitute pages 22-28 attached herewith for original pages 22-28. Please consider the amendments contained in the substitute sheets as well as the remarks below in the International Preliminary Examination to be conducted pursuant to the Demand filed herewith. RESPONSE TO REMARKS OF THE INTERNATIONAL SEARCHING AUTHORITY: The Examiner has stated that a copy of the claimed priority document has not been fur¬nished, therefore making it impossible to validate the priority claim. A copy of the "Notification Concerning Submission or Transmittal of Priority Document" issued on 7 October 2004 by the In¬ternational Bureau confirming receipt of the priority document on 27 September 2004. It is be¬lieved that the Examiner has made an error and that validation of die priority date should be made. The Examiner has cited published US application no. US2002/187536 (hereinafter Dl), is¬sued U.S. Patent No. 4,439,420 (hereinafter D2), U.S. Patent No. 3,957,662 (hereinafter D3), jour¬nal publication entitied "Studies on the promoting effects of medium chain fatty acid salts on the nasal absorption of insulin" (hereinafter D4) against the present application, and U.S. Patent No. 6,610,653 (hereinafter D5). Claim 1 has been revised as follows: 1. A fatty acid salt composition comprising fatty acid salt particles having a size distribution wherein the particles are from about 1 to about 1,000 microns in diameter, wherein die fattv acid salt comprises a fattv acid component selected from the group consisting of butyric acid, caproic acid, caorvlic acid capric acid lauric acid, mvristic acid, palmitic acid, palmitoleic acid, oleic acid, linoleic acid, alpha-linolenic acid, gamma- linolenic acid, arachidic acid, gadoleic acid arachidonic acid. EPA, be- henic acid, erucic acid. DHA. and lienoceric acid. The modification recites a specific group of fatty acids, which excludes the stearates described in the cited references. Claim 11, which was objected to for lack of inventive step has been revised to render it an inde¬pendent claim: 11. A fatty acid salt composition comprjgjnp fatty acid salt particles having The fatty aoid salt oompooition of olaim 1 whoroin the partioloa have a an average particle size distribution of from about 5 to about 500 microns in diameter. Claim 11 recites particle sizes that are outiside die range of the particle sizes described in the ref¬erences. Claims 12-19 have been revised to depend directly or indirectly to claim 11, and further distin¬guish the claimed invention by reciting particle sizes outside the range of the particle sizes de¬scribed in the cited references: 12. The fatty acid salt composition of claim 4- U. wherein die particles have a size distribution an average particle size of* from about 20 to about 80 microns in diameter. 13. The fatty acid salt composition of claim 2 U. wherein the portioleo have a size distribution from about 5 to about 500 microns in diameter at least about 30% of the particles are from about 1 to about 1.000 microns in di¬ameter. 14. The fatty acid salt composition of claim 2 13 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 15. The fatty acid salt composition of claim £ 11 wherein tho portioleo havo a aizo distribution from obout 5 to about 500 miorona in diameter at least about 40% of die particles are from about 1 to about 1.000 microns in di¬ameter. 16. The fatty acid salt composition of claim 3-15 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 17. The fatty acid salt composition of claim 4 JU wherein the particles have a aizo diotribution from about 5 to about 500 miorona in diamotor at least about 50% of the particles are from about 1 to about 1.000 microns in di¬ameter. 18. The fatty acid salt composition of claim 417 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 19. The fatty acid salt composition of claim S11 wherein the partioleo havo a sizo distribution from about-5 to about 500 miorons in diameter at least about 60% of the particles are from about 1 to about 1.000 microns in di¬ameter. 20. The fatty acid salt composition of claim # 19 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 21. The fatty acid salt composition of claim 611 wherein tho partiolos have a aizo distribution from about S to about 500 miorono in diameter at least about 70% of the particles are from about 1 to about 1.000 microns in di¬ameter. 22. The fatty acid salt composition of claim 6 21 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 23. The fatty acid salt composition of claim ? U. wherein tho partiolos have a sizo distribution from about 5 to about 500 miorono in diameter at least about 80% of the particles are from about 1 to about 1.000 microns in di¬ameter. 24. The fatty acid salt composition of claim 7 23 wherein the particles have a sizo distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 25. The fatty acid salt composition of claim 8 11 wherein tho partioloo have a ciao diatribution from about 5 to about 500 miorono in diameter at least about 90% of the particles are from about 1 to about 1.000 microns in di¬ameter. 26. The fatty acid salt composition of claim 8 25 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 27. The fatty acid salt composition of claim 911 wherein tho partioloo have a size distribution from about 5 to about 500 miorons in diameter at least about 95% of the particles are from about 1 to about 1.000 microns in di¬ameter. 28. The fatty acid salt composition of claim 9 27 wherein the particles have a size distribution an average particle size of from about 20 to about 80 mi¬crons in diameter. 29. The fatty acid salt composition of claim 11 wherein tho portioleo havo a size distribution from about 5 to about 500-miorono in diameter at least about 99% of the particles are from about 1 to about 1.000 microns in di¬ameter. 30. The fatty acid salt composition of claim 40 29 wherein the particles have a sigo diotribution an average particle size of from about 20 to about 80 microns in diameter. Claims 31-36 have been revised to recite that the pharmaceutical composition is a "solid oral dos¬age form," as follows: 31. A pharmaceutical composition comprising in a solid oral dosage form2: (a) the fatty acid salt composition of claims 1, and (b) a biologically active agent 32. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 5, and (b) a biologically active agent 33. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 10, and (b) a biologically active agent 34. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 11, and (b) a biologically active agent. 35. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 15, and (b) a biologically active agent 36. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 20, and (b) a biologically active agent. This limitation excludes D4 which relates only to nasal delivery. In fact, D4 teaches away from the oral delivery of proteins and peptides: "It is well known that the hormone [insulin] is poorly absorbed after oral ad¬ministration because of its degradation by gastrointestinal proteases and its poor permeability through gastrointestinal mucosa due to its high molecular weight"3 D4 then proceeds to propose an altrenative route of administration for insulin - the nasal route - and proposes sodium caprate, sodium caprylate and sodium laurate as promoters of absorption af¬ter nasal administration. As stated by the authors, "In the present study, we investigated the pro¬moting effect of medium chain fatty acid sodium salts on nasal absorption of insulin in rats."4 Nothing in D4 teaches or suggests the use of fatty acid salts in the size range claimed by the appli¬cants in the preparation of a "solid oral dosage form." Further, it is noted that none of Dl, D2 or D3 mention the use of fatty acid salts for delivery of proteins or peptides, much less die use of fatty acid salts of the size ranges recited by the appli¬cants for the oral delivery of proteins and peptides. One of skill in the art would not simply as¬sume that these small molecule formulations would also be useful in the oral delivery of proteins and peptides, as evidenced by the fact die D4 teaches away from the oral delivery of proteins and peptides. New claims 75-78 have been added further emphasizing the oral delivery aspect of the invention by reciting that the pharmaceutical composition is provided in a solid oral dosage form that is a tablet (claim 75 and 77, which depend from claim 1) or a capsule4 (claim 76 and 78, which de¬pend from claim 11). The Examiner did not identify support in the cited references for the rejection of claims 37-45. Consequently, the applicants respectfully request the Examiner to withdraw the rejections of these claims. Claims 46-74 all depend from claim 31 and are novef and inventive for the reasons discussed above, in addition to die specific limitations of these claims. Thus, for example, the cited refer¬ences do not teach or suggest the use of medium chain fatty acids having the particle sizes claimed by the applicants in a solid oral dosage form (see claims 46 and 47). Nor do die cited references farther teach die use of use of medium chain fatty acids having the particle sizes claimed by the applicants in a solid oral dosage form with a biologicallally active agent comprising a conjugated, pegylated or unconjugated polypeptide drug or prodrug (see claims 48-52). Further, the cited references do not teach or suggest the use of a formulation as recited in claim 31 with the specific calcitonin drugs recited in claims 53-55 or the specific insulin drugs recited in claims 56-62. Further, die cited references do not teach the specific molecular weight limitations of the drug, as recited in claims 63-65. It is noted that die treatment method claims (66-68) were not examined; however, these claims are retained in the application for examination in those countries in which such claims are allowable. Finally, the cited references do not teach or suggest tablets having (he specific dissolution rates re¬cited in claims 69-74. In conclusion, the objections raised by the Examiner in the Written Opinion are overcome by the amendments and arguments presented herein, and the Examiner is respectfully requested to issue a clean International Preliminary Examination Report THE CLAIMS We claim: 1. A fatty acid salt composition comprising fatty acid salt particles having a size distribution wherein the particles are from about 1 to about 1,000 microns in diameter, wherein the fatty acid salt comprises a fatty acid component selected from the group consisting of butyric acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, palmitoleic acid, oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidic acid, gadoleic acid, arachidonic acid, EPA, behenic acid, erucic acid, DHA, and lignoceric acid. 2. The fatty acid salt composition of claim 1, wherein at least about 30% of the particles are from about 1 to about 1,000 microns in diameter. 3. The fatty acid salt composition of claim 1, wherein at least about 40% of the particles are from about 1 to about 1,000 microns in diameter. 4. The fatty acid salt composition of claim 1, wherein at least about 50% of the particles are from about 1 to about 1,000 microns in diameter. 5. The fatty acid salt composition of claim 1, wherein at least about 60% of the particles are from about 1 to about 1,000 microns in diameter. 6. The fatty acid salt composition of claim 1, wherein at least about 70% of the particles are from about 1 to about 1,000 microns in diameter. 7. The fatty acid salt composition of claim 1, wherein at least about 80% of the particles are from about 1 to about 1,000 microns in diameter. 8. The fatty acid salt composition of claim 1, wherein at least about 90% of the particles are from about 1 to about 1,000 microns in diameter. 9. The fatty acid salt composition of claim 1, wherein at least about 93% of die particles are from about 1 to about 1,000 microns in diameter. 10. The fatty acid salt composition of claim 1, wherein at least about 99% of the particles are from about 1 to about 1,000 microns in diameter. 11. A fatty acid salt composition comprising fatty acid salt particles having an average particle size distribution of from about 5 to about 500 microns in diameter. 12. The fatty acid salt composition of claim 11 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 13. The fatty acid salt composition of claim 11 wherein at least about 30% of the particles are from about 1 to about 1,000 microns in diameter. 14. The fatty acid salt composition of claim 13 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 15. The fatty acid salt composition of claim 11 wherein at least about 40% of the particles are from about 1 to about 1,000 microns in diameter. 16. The fatty acid salt composition of claim 15 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 17. The fatty acid salt composition of claim 11 wherein at least about 50% of the particles are from about 1 to about 1,000 microns in diameter. 18. The fatty acid salt composition of claim 17 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 19. The fatty acid salt composition of claim 11 wherein at least about 60% of the particles are from about 1 to about 1,000 microns in diameter. 20. The fatty acid salt composition of claim 19 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 21. The fatly acid salt composition of claim 11 wherein at least about 70% of the particles are from about 1 to about 1,000 microns in diameter. 22. The fatty acid salt composition of claim 21 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 23. The fatty acid salt composition of claim 11 wherein at least about 80% of the particles are from about 1 to about 1,000 microns in diameter. 24. The fatty acid salt composition of claim 23 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 25. The fatty acid salt composition of claim 11 wherein at least about 90% of the particles are from about 1 to about 1,000 microns in diameter. 26. The fatty acid salt composition of claim 25 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 27. The fatty acid salt composition of claim 11 wherein at least about 95% of the particles are from about 1 to about 1,000 microns in diameter. 28. The fatty acid salt composition of claim 27 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 29. The fatty acid salt composition of claim 11 wherein at least about 99% of the particles are from about 1 to about 1,000 microns in diameter. 30. The fatty acid salt composition of claim 29 wherein the particles have a size distribution from about 20 to about 80 microns in diameter. 31. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 1, and (b) a biologically active agent 32. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 5, and (b) a biologically active agent. 33. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 10, and (b) a biologically active agent. 34. A pharmaceutical composition comprising in a solid oral dosage form: (a) die fatty acid salt composition of claims 11, and (b) a biologically active agent 35. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 15, and (b) a biologically active agent. 36. A pharmaceutical composition comprising in a solid oral dosage form: (a) the fatty acid salt composition of claims 20, and (b) a biologically active agent 37. The pharmaceutical composition of claim 31 wherein the composition is provided as a granulation. 38. The pharmaceutical composition of claim 31 further comprising a buffer. 39. The pharmaceutical composition of claim 31 further comprising a buffer having a pH from about 5 to about 10. 40. The pharmaceutical composition of claim 31 further comprising a buffer having a pH of from greater than 7.0 to about 10.0. 41. The pharmaceutical composition of claim 31 further comprising a buffer having a pH of from greater than 7.0 to about 9.0. 42. The pharmaceutical composition of claim 31 further comprising a buffer having a pH of from about 7.6 to about 8.0. 43. The pharmaceutical composition of claim 31, wherein the fatty acid salt has a dissolution rate in pH 7.4 buffer of greater than about 50% in up to ten minutes. 44. The pharmaceutical composition of claim 31, wherein the fatty acid salt has a dissolution rate in pH 7.4 buffer of greater than about 75% in up to ten minutes. 45. The pharmaceutical composition of claim 31, wherein the fatty acid salt has a dissolution rate in pH 7.4 buffer of greater than about 100% in up to ten minutes. 46. Hie pharmaceutical composition of claim 31, wherein the fatty acid salt composition comprises a medium chain fatty acid. 47. The pharmaceutical composition of claim 46, wherein the medium chain fatty acid comprises fatty acid selected from the group consisting of butyric acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidic acid, gadoleic acid, arachidonic acid, EPA, behenic acid, erucic acid, DHA, and lignoceric acid. 48. The pharmaceutical composition of claim 31 wherein the biologically active agent comprises polypeptide drug. 49. The pharmaceutical composition of claim 48 wherein the polypeptide drug comprises an unconjugated polypeptide. 50. The pharmaceutical composition of claim 48 wherein the polypeptide drug comprises a pegylated polypeptide. 51. The pharmaceutical composition of claim 48 wherein the polypeptide drug is conjugated to an oligomer. 52. The pharmaceutical composition of claim 31 wherein the biologically active agent comprises a prodrug. 53. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises native calcitonin or an unconjugated, bioactive calcitonin analog. 54. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises conjugated calcitonin. 55. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises: Cys Ser Asn Leu Ser Thr Cys Val Leu Gly Lys (NH-CXXCHzMOCHzCH^OCHj) Leu Ser Gly Glu Leu His Lys (NH-CO(CH2)7(OCH2CH2)70CH3) Leu Gin Thr Tyr Pro Arg Thr Asn Thr Gly Ser Gly Thr Pro. 56. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises native insulin or an unconjugated, bioactive insulin analog. 57. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises conjugated insulin. 58. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises: Insulin B29 Lys - (NH-C0(CH2)5(0CH2CH2)70CH3) 59. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises an insulin coupled to a modifying moiety having a structure: coupled to the insulin at a nucleophilic residue. 60. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises an insulin coupled to a modifying moiety having a structure: coupled to the insulin at a nucleophilic residue. 61. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises an insulin coupled to a modifying moiety having a structure: coupled to the insulin at a B29. TRtl\598767vl 26 Docket No. 014811-31 l.lu « Substitute Sheet 62. The pharmaceutical composition of claim 31 wherein the polypeptide drug comprises an insulin coupled to a modifying moiety having a structure: coupled to the insulin at B29. 63. The pharmaceutical composition of claim 31 wherein the polypeptide drug has a molecular weight range of from about 300 to about 10,000,000 Daltons. 64. The pharmaceutical composition of claim 31 wherein die polypeptide drug has a molecular weight range of from about 1,000 to about 50,000 Daltons. 65. The pharmaceutical composition of claim 31 wherein the polypeptide drug has a molecular weight range of from about 1,000 to about 10,000 Daltons. 66. A method of treating a subject in need thereof, comprising administering to the subject an effective amount of a formulation comprising the fatty acid salt composition of claim 1 and a biologically active agent 67. A method of treating osteoporosis in a subject in need thereof, comprising administering to die subject an effective amount of the pharmaceutical composition of claim 53. 68. A method of treating diabetes mellitus in a subject in need thereof, comprising administering to die subject an effective amount of the pharmaceutical composition of claim 56. 69. Hie pharmaceutical composition of claim 31 in die form of a tablet wherein the tablet has a dissolution rate of about 30% of the fatty acids into solution in up to ten minutes. 70. The pharmaceutical composition of claim 31 in the form of a tablet wherein the tablet has a dissolution rate of about 50% of die fatty acids into solution in up to ten minutes. 71. The pharmaceutical composition of claim 31 in die form of a tablet wherein the tablet has a dissolution rate of about 70% of the fatty acids into solution in up to ten minutes. 72. The pharmaceutical composition of claim 31 in the form of a tablet wherein the tablet has a dissolution rate of about 90% of the fatty acids into solution in up to ten minutes. 73. The pharmaceutical composition of claim 31 in the form of a tablet wherein the tablet has a dissolution rate of about 95% of the fatty acids into solution in up to ten minutes. 74. The pharmaceutical composition of claim 31 in the form of a tablet wherein the tablet has a dissolution rate of about 100% of die fatty acids into solution in up to ten minutes. TRII\598767vl 27 75. The pharmaceutical composition of claim 31 provided as a tablet 76. The pharmaceutical composition of claim 31 provided as a capsule. 77. The pharmaceutical composition of claim 34 provided as a tablet. 78. The pharmaceutical composition of claim 34 provided as a capsule.

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470-CHENP-2006 AMENDED PAGES OF SPECIFICATION 23-08-2013.pdf

470-CHENP-2006 AMENDED CLAIMS 23-08-2013.pdf

470-CHENP-2006 CORRESPONDENCE OTHERS 15-02-2013.pdf

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470-CHENP-2006 FORM-1 23-08-2013.pdf

470-CHENP-2006 FORM-3 23-08-2013.pdf

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470-CHENP-2006 OTHER PATENT DOCUMENT 23-08-2013.pdf

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470-CHENP-2006 AMENDED CLAIMS 08-09-2014.pdf

470-CHENP-2006 AMENDED PAGES OF SPECIFICATION 06-01-2014.pdf

470-CHENP-2006 AMENDED PAGES OF SPECIFICATION 08-09-2014.pdf

470-CHENP-2006 ASSIGNMENT 17-01-2014.pdf

470-CHENP-2006 CORRESPONDENCE OTHERS 12-06-2014.pdf

470-CHENP-2006 CORRESPONDENCE OTHERS 17-01-2014.pdf

470-CHENP-2006 EXAMINATION REPORT REPLY RECEIVED 23-08-2013.pdf

470-CHENP-2006 EXAMINATION REPORT REPLY RECEIVED 06-01-2014.pdf

470-CHENP-2006 EXAMINATION REPORT REPLY RECEIVED 08-09-2014.pdf

470-CHENP-2006 FORM-1 08-09-2014.pdf

470-CHENP-2006 FORM-13 11-04-2007.pdf

470-CHENP-2006 FORM-3 06-01-2014.pdf

470-CHENP-2006 FORM-6 15-04-2009.pdf

470-CHENP-2006 OTHER PATENT DOCUMENT 17-01-2014.pdf

470-CHENP-2006 OTHERS 06-01-2014.pdf

470-CHENP-2006 POWER OF ATTORNEY 08-09-2014.pdf

470-CHENP-2006 ABSTRACT.pdf

470-CHENP-2006 ASSIGNMENT.pdf

470-CHENP-2006 CLAIMS.pdf

470-CHENP-2006 CORRESPONDENCE OTHERS.pdf

470-CHENP-2006 DESCRIPTION (COMPLETE).pdf

470-CHENP-2006 DRAWINGS.pdf

470-CHENP-2006 FORM 1.pdf

470-CHENP-2006 FORM 13.pdf

470-CHENP-2006 FORM 18.pdf

470-CHENP-2006 FORM 3.pdf

470-CHENP-2006 FORM 5.pdf

470-CHENP-2006 FORM 6.pdf

470-CHENP-2006 PCT.pdf

470-CHENP-2006 POWER OF ATTORNEY.pdf