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 .
Priority
This application is a 371 of PCT/US2021/045963 (08/13/2021)
PCT/US2021/045963 has PRO 63/065,118 (08/13/2020).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-6, 14, 16, 41, and 81 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398).
Regarding claim 1, Limjeerajarus teaches “a Thermo-Sensitive Injectable Hydrogel as an Iloprost Delivery System for Dental Use” (Title) “that prolonged the release of iloprost for up to 5 days in vitro” (p. 396). Limjeerajarus teaches the composition also comprises PF-127 hydrogel (also known as poloxamer 407) (p. 392).
Regarding claim 2, the prior art product has substantially the same structure as the product of the claim. As per MPEP 2112.01: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 4, the prior art teaches the same composition and is silent regarding the dose, however, one of skill in the art would at once envisage (MPEP 2131.02) the same composition as a single dose appropriately formulated.
Regarding claim 5, the prior art product and the claimed product structures are the same.
Regarding claim 6, the prior art teaches a composition with a concentration of 10-6 M iloprost having a molecular weight of 360, which is approximately 12 wt%.
Regarding claim 14, PF-127 acts as a solubilizing agent and condensing agent as defined in the instant specification.
Regarding claim 16, the prior art teaches an injectable hydrogel.
Regarding claim 41, the prior art product has substantially the same structure as the product of the claim. As per MPEP 2112.01: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 81, the prior art teaches a pH which is “about” the same as defined in the instant specification ([0056]).
Claim Rejections - 35 USC § 103
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, 2, 4-8, 11-14, 16-18, 23, 28, 30, 34, 36, 40, 41, 81, 94 are rejected under 35 U.S.C. 103 as being unpatentable over Malinin et al. (US20150328232) in view of Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398).
Regarding claim 1, Malinin teaches prostacyclin analog particulate compositions (Abstract) comprising iloprost (claim 120), a lipid (claims 124-129), and formulated for subcutaneous administration (claim 137, [0018], [0122]). Malinin teaches “the present invention provides particle composition that incorporates the prostacyclin or analog thereof and the cationic compound, and provides a controlled release of the drug over time” ([0025]).
Malinin does not teach the claim element of “wherein the composition releases iloprost over a period of about 5 days to about 7 days”.
Limjeerajarus teaches “a Thermo-Sensitive Injectable Hydrogel as an Iloprost Delivery System for Dental Use” (Title) “that prolonged the release of iloprost for up to 5 days in vitro” (p. 396). Limjeerajarus teaches the composition also comprises PF-127 hydrogel (also known as poloxamer 407) (p. 392).
One of ordinary skill in the art following the teaching of Malinin would have considered other known formulations of the same compound such as taught by Limjeerajarus. One of ordinary skill in the art would have reasonably considered extending Malinin’s controlled release by utilizing elements of Limjeerajarus’ injectable hydrogel and arrive at the claimed invention. Once of ordinary skill in the art would have had a reasonable expectation of success because both prior art references are to formulations of the same active agent and administered in the same manner.
Regarding claim 2, Malinin teaches optimization of the composition to adjust the delivered active agent ([0121], [0140]-[0141], [0195]-[0196]). Thus, one of ordinary skill in the art would have considered optimization of the well-known results-effective variable and arrive at the claimed invention.
Regarding claim 4, Malinin teaches optimization of the dose for the appropriate delivery (claim 137, [0018], [0025]-[0027], [0122]). Thus, one of ordinary skill in the art would have considered optimization of the well-known results-effective variable and arrive at the claimed invention.
Regarding claim 5, Malinin teaches formulated for subcutaneous administration (claim 137, [0018], [0122]).
Regarding claim 6, Malinin teaches the composition has about 1% by weight of the active agent ([0058]-[0059], [0097]-[0099]).
Regarding claims 7-8, Malinin teaches the composition comprises phospholipids including phosphatidylcholine ([0064]-[0078]).
Regarding claims 11-12, Malinin teaches the composition comprises tocopherol/Vitamin-E ([0078]).
Regarding claim 13, Malinin teaches the composition comprises fatty acids ([0066]).
Regarding claim 14, Malinin teaches the composition comprises buffers, acidifying agent, and solubilizing agents ([0101], [0190]) routinely used in pharmaceutical formulation
Regarding claim 16, Limjeerajarus teaches a hydrogel composition.
Regarding claims 17, 23, 28, Malinin teaches the composition is an emulsion with nanometer particle sizes including liposomes (Abstract, [0090], claim 129, 147).
Regarding claim 18, Malinin teaches the composition comprises glycoprotein such as albumin ([0070]) which corresponds to the claimed peptide.
Regarding claim 30 and 34, Malinin teaches the composition comprises microspheres ([0013]) and particle sizes of about 3 to 500 microns ([0125]) which one of ordinary skill in the art would consider optimization of the particular size and arrive at the claimed invention.
Regarding claim 36, Limjeerajarus teaches a hydrogel composition which one of ordinary skill in the art would have considered along with the teaching of Malinin and arrive at the claimed invention.
Regarding claim 40, Limjeerajarus teaches a hydrogel composition but not a phospholipid gel. One of ordinary skill in the art would have considered the combined teaching of the prior art along with the teaching of Malinin to use phospholipids and arrive at the claimed invention for the same purpose.
Regarding claim 41, Malinin teaches optimization of the composition to adjust the delivered active agent ([0121], [0140]-[0141], [0195]-[0196]) and Malinin teaches optimization of the dose for the appropriate delivery (claim 137, [0018], [0025]-[0027], [0122]). Thus, one of ordinary skill in the art would have considered optimization of the well-known results-effective variable and arrive at the claimed invention.
Regarding claim 81, Limjeerajarus teaches a pH which is “about” the same as defined in the instant specification ([0056]) and one of ordinary skill in the art would have considered optimization of the pH to improve efficacy and arrive at the claimed invention.
Regarding claim 94, Malinin teaches administration of the iloprost composition to prevent infection ([0051]) and one of ordinary skill in the art would have considered utilizing the composition in the same manner to prevent other types of infections including those recited in the claim.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Malinin et al. (US20150328232) in view of Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398) as applied to claims 1, 2, 4-8, 11-14, 16-18, 23, 28, 30, 34, 36, 40, 41, 81, 94 above and further in view of Peebles (US20200009105, published 2020-01-09).
Regarding claim 15, Malinin teaches the composition comprises buffers, acidifying agent, and solubilizing agents ([0101], [0190]) routinely used in pharmaceutical formulation, but does not teach the carriers as recited in the claim.
Peebles teaches formulations of prostacyclin analogs including iloprost (claim 6) which include ingredients such as glycerol ([0093]). One of ordinary skill in the art would have considered utilizing well-known carrier such as glycerol and arrive at the claimed invention with a reasonable expectation of success.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626