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 .
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Withdrawn Rejection(s)
The rejection under 35 USC 112, second paragraph is withdrawn. The rejections under 35 USC 102(a)(1) over US20150157570 and Henry, 35 USC 103 for Babiychuk or Henry in view of Ebert et al, 35 USC 103 for Babiychuk or Henry in view of Ebert et al, further in view of WO 9222, and Babiychuk or Henry in view of Ebert, further in view of WO’92 are withdrawn in view of applicant’s remarks filed 02/11/2026.
New Rejections
Claim Objections
Claim 3 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 2. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1, 5 and 6 are objected to because of the following informalities: The claims alternate between using “comprising” and “consisting essentially of”. Since applicant has not defined “consisting essentially of”, applicant is advised to use comprising. Appropriate correction is required.
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 5-6 recite the limitation "the first empty liposome (a) consists essentially of cholesterol and sphingomyelin" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 sets out that the first empty liposome comprises cholesterol. Correction is requested.
Maintained Rejection
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)(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.
Claim(s) 1-3, 5-7, 9, 10, 13-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 8,906,855 (Simpkins).
. Regarding claims 1-6, Simpkins teaches a method of treating hypotension in a human at col. 1, lines 67 to col. 4, lines 1-4 and 33-34; col. 3, lines 33-35; col. 5, lines 24-33 col. 6, lines 45-48; col. 26, lines 56-64; col 27, lines 1-14. Administration through a mixture of empty liposomes is taught at col. 34, lines 45-47, 53-63; col. 6, line 1 and 16-28. A second empty liposome comprising sphingomyelin is taught at col. 5, lines 45-47 and 52-56. Simpkins teaches the amount of cholesterol and sphingomyelin at col. 3, lines 35-40; col. 4, lines 43-64; col. 5, lines 45-47, 52-56; col. 6, lines 1, 16-28; col 7, lines 4-5, 13-17. The 1:1 ratio of claim 6 is found at col. 4, lines 43-64. Therefore, the range of 45% -55% for cholesterol is clearly encompassed by the range set out at col. 6, lines 16-28. Treatment of sepsis is specifically recited at col. 22, lines 51-55.
With regard to claim 7, Simpkins teaches hypotension as defined by a measurement of less than 70 mm at col. 29, lines 49-64.
Regarding claim 9, Simpkins teaches the use of adjunctive antibiotic administration at col. 16, lines 26-28.
With regard to claim 10, the antibiotic may be administered intravenously at col. 23, lines 4-5.
Regarding claims 13-15, the composition may be administered on the form of a solution (see col. 23, lines 4-5. Administration may be over hours , days or weeks (col. 23, lines 6-10).
With regard to claim 16, the conditions related to lack of blood supply leading to hospital stay are defined at col. 5, lines 24-33.
The claims are anticipated by Simpkins.
Conclusion
Claims 8, 11, 12, and 17-22 are objected to as dependent upon a rejected base claim.
No claims are allowed.
The disclosures of US Patent Nos. 9,439,855 and 10,716,756 are viewed as very similar Simkins.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz