The present application is being examined under the pre-AIA first to invent provisions.
Examiner makes the following findings regarding the scope of claim language. First, according to at least paragraphs [00112]-[00113], the “magnetically active fluid” language may include a ferrofluid, paramagnetic particles, diamagnetic particles and/or magnetic particles. Second, according to at least paragraph [00101]-[00102], a “magnetically active constituent” may include one or more non-ferrous tags, one or more ferrous tags, one or more magnetic tags one or more paramagnetic tags or mixing the sample with one or more magnetically active agents such as magnetically active antibodies, aptamers, nucleic acids, ligands, or polypeptides to form the one or more magnetically active constituents. Based on these definitions, it appears that claim 1 requires the magnetically active fluid to contain some form of magnetic or magnetically influenceable constituent or particle prior to the magnetically active fluids are placed in the separation channels in substantially laminar flow with the sample fluid(s). It also appears that claim 1 requires the translocating process to occur through some form of magnetically active constituent/particle or magnetically influenceable constituent/particle. For examination purposes, examiner will treat the claim more broadly than this. For example, the “magnetically active fluid” will be treated as including a fluid that becomes magnetically active through translocation of magnetic, paramagnetic or diamagnetic particles from a sample fluid into a receiving fluid that initially did not contain particles.
The disclosure is objected to because of the following informalities: the following paragraphs in the specification contain references to applications that need to have their current status updated: Paragraph [00001] paragraph [00106], paragraph [00111], paragraph [00127], paragraph [00135], paragraph [00140], paragraph [00155], paragraph [00162], and paragraph [00167].
Appropriate correction is required.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that, for pre-AIA , the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 requires placing one or more sample fluids into one or more separation channels such that they are in substantially laminar flow with one or more magnetically active fluids. This language covers flow that is, in the language of applicant, “parallel” (paragraph [00112] in which the fluids flow in the same direction) and “anti-parallel” (paragraph [00113] in which the fluids flow in the opposite direction). The art of record shows that “parallel” of concurrent laminar adjacent flow was known and/or practiced in the art prior to the earliest filing date that applicant can claim any benefit from and thus in not a problem. However, “anti-parallel” or countercurrent laminar adjacent flow requires that the two fluids move in opposite directions. The instant disclosure uses the term but provides no detail on how “anti-parallel” laminar adjacent flow is accomplished. The scope of claim 1 covers both types of adjacent laminar flow. If the flow is to be adjacent and laminar, it requires little if any mixing occurs as the fluids flow past each other. The instant claims cover flow of any liquid past any other liquid (i.e. an aqueous fluid adjacent another aqueous fluid, and organic fluid adjacent another organic fluid, etc.). The similarity in surface tension between two aqueous fluids or between two organic fluids is such that two such fluids flowing adjacent to each other in a channel in opposite directions would rapidly mix rather than produce a laminar flow pattern. In such cases there is nothing in the instant disclosure showing that applicant had the ability to flow an aqueous fluid adjacent to another aqueous fluid or an organic fluid adjacent to another organic fluid in an “anti-parallel” manner without substantial if not complete mixing occurring. In other words, there is no evidence that applicant was in possession of a system or method of producing “anti-parallel” laminar adjacent flow between two aqueous fluids or two organic fluids. Even with an aqueous and an organic fluid, formation of an “anti-parallel” (countercurrent) laminar adjacent flow is not trivial. The cited Aota paper (Angewandte Chemie International Edition 2007) clearly shows that it requires more than simply flowing the two fluids through a channel to form the instantly claimed “anti-parallel” laminar adjacent flow. In figures 1c) countercurrent flow in a conventional macroscale device is shown as gravitational segregation involving droplets (i.e. not laminar flow, see the paragraph bridging pages 878-879). The second paragraph on page 879 of Aota teaches that in the case of liquid–liquid countercurrent microflow, the interfacial tension and viscous forces of both phases play important roles. Therefore, liquid–liquid countercurrent microflow cannot be easily established. In an ordinary microchannel, countercurrent flow cannot occur because the two phases collide (Figure 1d) and high shear stress at the liquid–liquid interface causes breakup (Figure 1e). To form countercurrent microflow, the aqueous solution must flow along one side of the channel and the organic solution must flow along the other side without breaking up. In other words, without something to counter the problems of these to forces, the instantly claimed “anti-parallel” laminar adjacent flow is not possible even with an aqueous fluid adjacent an organic fluid. The solution of Aota was a differential treatment of the two adjacent parts of the channel along the channel such that one side was hydrophilic and the other side was hydrophobic. The instant application fails to show that applicant was in possession of anything more than an idea that it might be possible to form an “anti-parallel” laminar adjacent flow. There are no details to show that applicant was in possession of the ability to produce the “anti-parallel” laminar adjacent flow at the time the instant application was filed. Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected under 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 pre-AIA the applicant regards as the invention. In claim 1, if applicant intends for the magnetically active fluid to be magnetically active before in substantially laminar flow with the sample fluid, it is not clear how the one or more magnetically active constituents are translocated from the sample fluid to the magnetically active fluid. Is formation of magnetically active constituents required in the separation channel, prior to the separation channel or are they inherently present in the sample fluid?
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) 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 1 is rejected under 35 U.S.C. 102(a) as being clearly anticipated by Kim (WO-2006/021410) in view of an English language equivalent (US 2009/00047297). In the patent publication Kim teaches a device and method for the isolation of biological particles. Figure 1 shows the device. Elements 8 and 10 of the figure are the instantly claimed magnetically active fluid (a liquid 10 which contains immunomagnetic particles 8). Elements 9 and 11-12 constitute the instantly claimed fluid sample (a mixed liquid 9 which contains various biological particles 11, 12). Page 12, line 19 to page 13, line 2 describe placing the sample fluid and the magnetically active fluid in a separation channel (5) so that they are in substantially laminar flow (see paragraphs [0031]-[0032] of the English language equivalent US 2009/00047297). Page 14, line 4 to page 16, line 11 teaches how the electromagnets 6 and 7 are used to place magnetically active particles (immunomagnetic particles 8) into contact with particles (11,12) in the sample fluid (9), form magnetically active constituents and translocate them back to the magnetically active fluid (10) (see paragraphs [0033]-[0035] of the English language equivalent US 2009/00047297). Thus claim 1 is clearly anticipated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached on 1st week Monday-Thursday, 2nd week Monday-Friday.
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/Arlen Soderquist/
Primary Examiner, Art Unit 1797
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