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 .
Claims 1 and 4-17 are presented for examination.
The claims will be examined to the extent that they read on apolipoprotein E and not a functional variant. If the originally filed claims were directed to an apolipoprotein E or a functional variant they would have been subjected to a restriction requirement.
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.
Claim 4 is 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.
Claim 4 recites the limitation "0.2:1 to 2.5:1" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent on claim 4 are also rejected, since they have all the limitations of claim 4.
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.
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.
Claim(s) 1 and 4-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (US 20070243136) in view of Kim et al. (KR 20110039798) and further in view of Valanti et al. (Current and Emerging Reconstituted HDL-apo A-I and HDL-apo E Approaches to Treat Atherosclerosis), Frangione et al. (US 20070010435) and Dasseux et al. (US 20060217312 submitted by the applicant).
Regarding claim 1, Fisher teaches a contrast agent conjugated to a component of high density lipoprotein, which comprises a phospholipid and an apolipoprotein other than apo B. See Para [0012] and claim 1. Fisher teaches that apolipoprotein is selected from the group consisting of an apolipoprotein A-I, A-II, A-IV, C-I, C-II, C-III and E. See claim 21. The use reconstituted HDL is taught in Para [0060]. Fisher makes clear that a reconstituted high density lipoprotein (rHDL) comprising a phospholipid and apolipoprotein E is old and well known. Fisher does not teach the ration of phospholipid to apolipoprotein being 0.5:1 to 1.5:1 or 0.2:1 to 2.5:1. Dasseux teaches charged lipoprotein complexes that include as one component a negatively charged phospholipid that is expected to impart the complexes with improved therapeutic properties. See the abstract. Desseux teaches that the charged lipoprotein complexes comprise a lipid:apolipoprotein molar ratio ranging from about 2:1 to about 200:1. The 2:1 is within the range of claim 4 ratio and very close to the upper limit of claims 1 and 5. It would have been obvious to a person skilled in the art to use the claimed phospholipid: apolipoprotein ratios, motivated by the teachings of Dasseux, which teaches the ratios within the scope or very close to the claimed proportions.
Regarding claims 4-6, Fisher does not specifically teach the weight ratio of phospholipid and apolipoprotein E in the rHDL. Kim teaches a method for producing high density lipoprotein nanoparticles using phospholipids, apolipoproteins and poorly soluble drugs. See the background and claim 1. Kim teaches the phospholipids, poorly soluble drugs, solvents and apolipoproteins are used in a weight ratio of 2 to 4: 0.05 to 0.2: 2 to 4: 1. See claim 6. The proportions of Kim encompass or overlap with the claimed proportions. Furthermore, the determination of optimum proportions and amount are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant's attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court states that "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claims 7-9, Fisher teaches the concentration 15mg/kg or 45 mg/kg of rHDL for the treatment
of a patients Fisher teaches that those of skill in the art will be able to vary the amount administered
depending on the size and weight of the patient. See Para [0099]. Depending on the patients' weight
the amount of rHDL in Fisher can be within the scope, overlapping or encompassing the claimed
concentrations in claims 7-9.
Regarding claim 10, Fisher does not teach the use of apo Ell or Apo Elll. However, Valanti et al. teach
the advantages of rHDL apoE3 in protecting against atherosclerosis. See page 4 and conclusion.
Regarding claim 11, Fisher does not teach rHDL comprising the combination of apolipoprotein E and apo
A1. However, Valanti teaches the combination of HDL apo A1 and HDL apo E for treating atherosclerosis. See the abstract.
Regarding claim 12, Fisher teaches the use of Apo A1 in a reconstituted high density lipoprotein. See
claim 21. Fisher teaches other Apo lipoproteins than A1, but they are used in alternative to apo A1.
Regarding claim 13, Fisher does not teach the use of HDL apolipoprotein E4. Fisher does not also teach
apo Ell or apo EIII as claimed in claim 10. However, Valanti et al. teach the use of apolipoprotein EIII in
rHDL. See page 4 and conclusion.
Regarding claim 14, Fisher teaches rHDL, wherein the phospholipid is phosphatidyl choline
phosphatidylethanolamine, which are within the scope of phospholipids of claim 14. See claim 11.
Regarding Claim 15, Fisher teaches the use of excipients in rHDL particles. See Para [0100].
Regarding claims 16 and 17, Fisher teaches rHDL comprising apolipoprotein E and a phospholipid. Frangione et
al. teach that apolipoprotein E is selected from apolipoprotein E1, apolipoprotein E2, apolipoprotein E3 and apolipoprotein E4. See claim 9. Therefore, the use of rHDL having apolipoprotein E taught by Fisher, encompasses apolipoprotein E2 and E3 in the absence of evidence to the contrary. Regarding claim 31, Fisher teaches a contrast agent conjugated to a component of high density lipoprotein, which comprises a phospholipid and an apolipoprotein other than apo B. See Para [0012] and claim 1. Fisher teaches that apolipoprotein is selected from the group consisting of an apolipoprotein A-I, A-II, A-IV, C-I, C-II, C-III and E. See claim 21. The use reconstituted HDL is taught in Para [0060]. Fisher makes clear that a reconstituted high density lipoprotein (rHDL) comprising a phospholipid and apolipoprotein E is old and well known.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his response argues that “Applicant submits that the claimed ratios of amended claim 1, i.e., "0.5:1 to 1.5:1" do not overlap with the proportions of phospholipids to apolipoproteins disclosed by Kim. Specifically, Kim teaches that phospholipids and apolipoproteins are used in a weight ratio of 2 to 4: 1; therefore, Kim teaches phospholipids and apolipoproteins in a weight ratio of 2:1, 3:1, or 4:1. All of the weight ratios disclosed by Kim require at least 2 times the amount of phospholipids to apolipoproteins; in contrast, the claimed proportion of phospholipids to apolipoprotein E or a functional variant thereof of amended claim 1 allows a maximum of 1.5 times the amount of phospholipids to apolipoprotein E or a functional variant thereof. Therefore, the proportions of Kim do not encompass or overlap with the claimed proportions of claim 1.
Furthermore, based on the teachings of Kim, Applicant submits that one of skill in the art would not have been able to determine the claimed weight ratio of phospholipids to apolipoprotein E or a functional variant thereof in amended claim 1, since Kim does not teach a weight ratio of phospholipids to apolipoproteins less than 2:1. As such, one of skill in the art would not have looked at Kim when determining the weight ratio of phospholipids to apolipoprotein E or a functional variant thereof of 0.5:1 to 1.5:1.”. It is the examiner’s position that the teaching of 2:1 by Kim is within the range of 0.2:1 to 2.5:1 as claimed in claim 4 and very close to the upper range 1.5:1 to claims 1 and 5. Additionally, Dasseux teaches that the ratio of phospholipid to apoliprotein can be as little as 2:1, which reads on the ratios the instant application or it is very close to it.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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