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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 09/03/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (US PGPub. 2004/0039212) in view of Rawat ( Molecular Membrane Biology, 2003) and Babiychuck (WO 2013/0186286); as evidenced by Lim et al. (US PG Pub. 2016/0106864).
Liotta teaches the treatment of infections caused by bacteria and viruses using sphingolipids which are amphiphiles (which are known to form bilayered liposomes upon hydration as discussed below). The sphingolipids include sphingomyelin. Viruses such as HIV and influenza are taught, (see abstract, [0005-0006], [0009], [0050], [0057], [0693], [0735], [0744] and claims 3 and 23-28).
Liotta does not explicitly state that the formulation is a liposomal formulation. However, Liotta teaches on paragraph [0744] the administration as suspensions of sphingolipids in sterile water or saline. Although Liotta does not explicitly teach liposomes, since when amphiphiles such as phospholipids and sphingomyelin which are bilayer forming compounds are suspended in an aqueous medium, they form liposome as is evident from Lim et al. teaching formation of liposome from sphingomyelin, (see [0062], [0117], and [0129]).
Liotta’s formulations also do not teach use of cholesterol in sphingolipid liposomal formulations.
Rawat teaches the entry of enveloped viruses by cholesterol and phospholipids or sphingolipids by fusion process. According to Rawat, the vesicle system containing PC (lecithin), phosphatidyethanolamine PE, Sphingomyelin SM and Cholesterol fuse or rupture the virus (See the entire publication).
Babiychuck teaches the administration of empty liposomes comprising sphingomyelin and cholesterol or a mixture of empty liposomes containing cholesterol and sphingomyelin and empty liposomes containing sphingomyelin at a 1:1 ratio by weight to prevent or treat bacterial infections. The cholesterol amount in the liposomes is 30%. According to Babiychuck, cholesterol in concentrations above 30% are required for liposomes containing cholesterol and sphingomyelin to protect the monocytes (see abstract, pages 2, 7-10, 21, Fig. 3 and claims). It should also be pointed out that cholesterol is known to be a protective agent or provides stability for liposomes. As is evident from Lim et al. teaching cholesterol provides stability to the liposome, (see Lim et al. [0057]). A mixture of cholesterol-containing and cholesterol-free, sphingomyelin-only liposomes was fully protective against Streptococcus pneumoniae toxins (see Figure 6). More potent mixtures of liposomes comprise the empty sphingomyelin-only liposomes, the 1:1 cholesterol-containing sphingomyelin liposome and additional liposomes (see Figures 9-10) and (see the descriptions of figures, claims and entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the liposomal compositions containing sphingomyelin or mixture of liposomal compositions containing sphingomyelin and liposomal compositions containing sphingomyelin and cholesterol taught by Babiychuck to treat viral infections caused by HIV or influenza with a reasonable expectation of success since Liotta teaches that water suspensions of sphingolipids including sphingomyelin can be used to treat bacterial as well as antiviral infections caused by HIV or influenza and since hydration of sphingomyelin with water forms liposomes as evidenced by Lim et al. and Rawat teaches that the entry of enveloped viruses is done by cholesterol, phospholipids or sphingolipids by fusion process. Thus, the expected result will be treatment of viral infection by administering an effective amount of a single empty liposome comprising sphingomyelin or with cholesterol based on the teachings of eh references discussed above.
Applicant argues that based on Liotta ‘s teachings, liposomes will not necessarily be formed. According to Applicant, Liotta mentions the use of liposomes?® as one of the preferred carriers of the active compounds (sphingolipid derivative). In other words, those liposomes encapsulate an active compound. In contrast, the claimed liposomes are empty and do not encapsulate an active compound. According to applicant, Liotta purportedly suggests that a virus can be treated with a sphingolipid derivative, but the disclosure is broad and lacks any examples demonstrating treatment of a virus. Without empirical evidence, a person of ordinary skill would have had no expectation of success by making the Office’s suggested modifications. The number of compounds taught is very large and there are at least 507 listed compounds, based on paragraphs [0099]-[0606]. Further, the Markush structure allows for any infinite number of compounds. Liotta alleges that cancer, modification of microflora, inflammatory conditions, bacteria and even viruses can be treated with these compounds." Yet, Liotta’s sole example is for glucoronoyl-ceramide in the treatment of colon carcinogenesis. A person of ordinary skill in the art would not have expected, based on the teaching in Liotta, that any or all these compounds would be able to treat viruses. The disclosure is too broad and unsupported.
These arguments are not persuasive because Liotta was cited for the teachings of Sphingomyelin for the treatment of HIV and influenza viruses and as evidenced by Lim et al. sphingomyelin are lipids which are used to form liposomes when suspended in aqueous environment. Babiychuck et al. was cited for the teachings of using empty liposomes comprising either sphingomyelin or in combination with cholesterol as cholesterol is known to provide stability to the liposome as is evidenced by Lim et al. As discussed in the rejections above, one of ordinary skill would have been motivated to have administered the liposomal compositions containing sphingomyelin or mixture of liposomal compositions containing sphingomyelin and liposomal compositions containing sphingomyelin and cholesterol taught by Babiychuck to treat viral infections caused by HIV or influenza with a reasonable expectation of success since Liotta teaches that water suspensions of sphingolipids including sphingomyelin can be used to treat bacterial as well as antiviral infections caused by HIV or influenza and since hydration of sphingomyelin with water forms liposomes as evidenced by Lim et al. and Rawat teaches that the entry of enveloped viruses is done by cholesterol, phospholipids or sphingolipids by fusion process. The rejections is based on the combined teachings of all the three references and not just one reference by Liotta or Rawat or Babiychuck et al. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Liotta and Rawat explicitly teach that sphingomyelin is used to viral infections including enveloped viral and Babiychuck et al. provide teachings that empty sphingomyelin and cholesterol can be used to treat infections.
Action is final
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612