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 .
Election/Restrictions
Applicant’s election with traverse of Group 1 (claims 1,2,5-10, and 17-26), Species 1: carbohydrate, and Species 2: saponin is acknowledged.
Claims 27 and 33 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
linking claim. Election was made with traverse in the reply filed on April 6, 2026.
Applicant traverses the requirement citing 1.475(b)(4), which states that an application containing claims to the categories of invention for a process and an apparatus designed for carrying out the process will be considered to have unity of invention.
However, the same special technical feature of a separating material in a tube, is taught by Mace et al., (US10436768B2; published 2019-10-08) therefore the feature does not make a contribution over the prior art and unity of invention is lacking.
Applicant traverses the requirement citing 37 C.F.R. 1.141(a) on the grounds that a reasonable number of species within a claimed genus may be claimed when at least one genus claim encompassing all of the species is patentable. However, there are presently no patentable claims. The examiner will consider rejoinder in the presence of an allowable generic claim.
The requirement(s) for restriction, as detailed previously, is still deemed proper and is therefore made FINAL.
The restriction requirement Species 2, as set forth in the office action mailed on, February 4, 2026 has been reconsidered and is hereby withdrawn. In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 7 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 7 recites “ a step or continuous density gradient”. The term is deemed unclear since the Specification does not provide a definition of what would meet the criteria, and is subjective and fails to provide boundaries for determining “a step” versus “continuous density gradient”. The Specification merely states: “This separating material can form a gradient, such as a step or continuous gradient.” The Specification does not distinguish between a step and a continuous gradient, and a person of ordinary skill in the art would not understand how the ‘step’ is distinguished from the continuous gradient in a tube. The separation created between phases and/or layers by the viscous material is not delineated and/or isolated into discreet steps; therefore, it is unclear how one would identify a ‘step’ versus a continuous gradient, in a viscous material within a tube.
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.
Claim(s) 1-2, 5-10, and 17-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mace, C.R. et al., (US10436768B2; published 2019-10-08).
Regarding claims 1, 5, and 6 Mace et al., discloses separating material, in a tube (column 19-20, lines 50-67 and lines 5-16), using tubes containing polyethylene glycol (PEG)-Ficoll which are used for blood collection (claims 5 and 6) (column 11, lines 53-59); samples are introduced to the multi-phase system (MPS) by pipette, injection, and other methods (column 18, lines 18-22). The biological sample interacts with a MPS composed of phase(s) corresponding to density (column14, lines 12-33) in which each phase has an upper and lower boundary (column 14, lines 34-35). Samples are centrifuged and cells migrate and separate into the material(s) of the phases (column 14, lines 55-68). Figure 10 illustrates mammalian cells separated in the MPS, including 50% as a ‘captured percentage’ relative to density (sheet 10) in a lower phase (column 7, paragraph 21-25). Separation of material results in an enriched population of biological cells as illustrated in Figure 6 for red blood cells infected with Plasmodium falciparum, where 6% of infected cells were concentrated at the interface between polymer layers (column 23, lines 30-44) and data from Figure 7 shows healthy versus parasitized erythrocytes isolated from the MPS (column 7, lines 45- 56); desired agent(s) are extracted using methods of separation from the phase(s) (column 19-20, lines 50-67 and 1-16).
Regarding claim 2, Mace et al., discloses biological samples that are bodily fluid (blood) and E.coli cultured from blood samples of patients (column 24, Example 4).
Regarding claim 7, Mace et al., disclosed a continuous density gradient, where there are one or more or two or more phases, sequentially (column 3, lines 16-32).
Regarding claims 8 and 9, Mace et al., discloses phase components that are polymer (column 27, claim 1b), carbohydrates, including poly sucrose in buffered solutions (column 28, claim 15) and/or media(s) (column 8, lines 45-57).
Regarding claim 10, Mace et al., discloses a tube centrifuged at 13,000 x g for 4 minutes to concentrate E.coli using the MPS (column 24, Example 4).
Regarding claims 17, 18, and 19 Mace et al., discloses the use of sodium dodecyl sulfate (SDS) and other surfactants in the MPS as a phase, in which one or more phases cause cells to lyse and the analyte of interest is recovered from the cell lysate (column 28, claim 10 and 15).
Regarding claims 20, 21, and 22 Mace et al., disclose the use of injection and the use of a pump and switch among other methods to introduce a sample to the MPS (column 18, lines 18-22).
Claim 23 depends from claim 22 and claim 22 recites in the alternative, a stopcock or automated pump and switch. Therefore, claim 23 is anticipated by Mace et al., since Mace et al., discloses the automated pump and switch and the stopcock is recited in the alternative in claim 22.
Regarding claim 24, Mace et al., disclose a method of further processing samples (column 20, lines 1-16), isolate organisms and/or living cells (column 20, lines 17-28), and analysis methods based on cell types and/or organisms (column 20, lines 29-67).
Regarding claim 25, Mace et al., discloses the use of antibiotics with components of a phase (column 4, lines 36-40), in a kit to assess biological analyte(s) (column 4, lines 41-42).
Regarding claim 26, Mace et al., discloses degassing of the MPS to remove residual amounts of gas, including oxygen, to minimize compromising samples and to avoid oxidation of samples (column 11, lines 48-52).
Conclusion
No claims are deemed allowable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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