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 .
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 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamagishi (US 2020/0016135).
Yamaghishi disclosed a composition comprising choline, magnesium chloride, and HEPES buffer; paragraph [0787]. It would have been understood by one of ordinary skill in the art that this was an aqueous composition, and therefore contained water.
It is noted that phosphorylcholine is encompassed by the structure described in Formula I of claim 1; specifically, phosphorylcholine has the structure:
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This is Formula I where R1 is saturated C2 aliphatic (specifically, alkyl) and R2 is hydrogen.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (US 8,603,769, IDS ref) in view of Jia (US 7,892,811, IDS ref).
Feng disclosed a method for isolating intact, viable microorganisms from blood cultures, comprising adding a choline-containing solution, lysing the blood cells, isolating the viable microorganism, and performing downstream analysis of the isolated microorganism (abstract).
Feng disclosed (column 3, line 46): “Without being bound by a particular theory, it is believed that the choline-containing solution inhibits, prevents, and/or mitigates autolysis of the microorganism, particularly S. pneumonia in the presence of lysis buffer…In addition, the choline-containing solution may also mitigate lysis of the microorganism(s) caused by the detergents used to lyse the blood cells in a PBC [positive blood culture] sample.”
Regarding claim 1, Feng disclosed (column 3, line 43): “In another embodiment, the choline-containing solution comprises phosphorylcholine.” It is noted that phosphorylcholine is encompassed by the structure described in Formula I of claim 1; specifically, phosphorylcholine has the structure:
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This is Formula I where R1 is saturated C2 aliphatic (specifically, alkyl) and R2 is hydrogen.
Feng also disclosed (column 3, lines 61-63): “The choline-containing solution can be prepared with the choline and suitable diluents known to those skilled in the art, such as water, buffers, and combinations thereof, etc.”
Regarding claim 2, Feng disclosed adding this to blood culture samples (abstract; blood cultures comprise blood). Feng further disclosed (column 4, lines 53-56): “In yet another embodiment, the choline-containing solution is added after the sample has been determined to contain at least one microorganism but prior to the addition of lysis buffer.”
Regarding claim 3, Feng disclosed (column 4, line 4): “There is no limit to the final concentration of choline when combined with the sample. In one embodiment, the final concentration of choline when combined with the sample is greater than or equal to about 0.25% by volume, preferably greater than or equal to about 1% by volume. In another embodiment the final concentration of choline when combined with the sample is in the range of about 0.25% by volume to about 10% by volume, preferably about 1% by volume to about 5% by volume. In another embodiment, the final concentration of choline when combined with the sample is 1.8% by volume. In yet another embodiment the final concentration of choline when combined with the sample is 4% by volume. Again, the concentration of choline in combination with the sample in the context of a particular application is readily determined by the skilled person.”
Feng also disclosed (column 4, lines 1-3): “In one embodiment, the concentration of choline in the choline-containing solution is up to about 20% by volume.”
To go from 20% choline (in the choline-containing solution) to 10% choline (in the mixture of the choline-containing solution with sample) would require 1 part choline-containing solution and 1 part sample, or 50% sample. A 4% choline final concentration would require 1 part choline-containing solution and 4 parts sample (80% sample). Therefore, the claimed range to blood to composition of claim 1 recited in claim 3 overlaps the range disclosed in Feng.
Regarding claim 4, Feng disclosed (column 4, lines 53-56): “In yet another embodiment, the choline-containing solution is added after the sample has been determined to contain at least one microorganism but prior to the addition of lysis buffer.”
Feng did not disclose magnesium in the composition as recited in claim 1.
Jia disclosed (column 4, line 25): “Addition of concentrations of magnesium of about 1 mM, or other similar metals can be used to stabilize the bacterial cell wall to further control lysis, until the freeze-thaw step.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to add magnesium to the choline-containing solution of Feng because Jia disclosed that magnesium could be used to stabilize the bacterial cell wall to prevent lysis. Since Feng’s composition was also for the purpose of preventing bacterial cell lysis. Therefore, it would have been obvious to combine these components since they are directed to the same purpose; see MPEP 2144.06.
Allowable Subject Matter
Claims 5-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or provide a rationale to combine the composition as recited in claim 1 with an anion exchanger.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681