DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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. The amendment seeking to introduce “at least one controller configured to perform” a combination of steps (a), (b), (c1) and/or (c2) introduces new matter. Support for “at least one controller” cannot be found in the written description, and a controller is not depicted in the Figures. At best, the specification describes a drug feed management unit in paragraph [0112] and a position control unit in paragraph [0107]. The drug feed management unit is used to introduce a drug into the storage part, and the position control unit is used to locate the light irradiation unit. Neither of these units is a controller configured to perform the claimed combination of steps (a), (b), (c1) and/or (c2). The remarks filed 06 August 2026 did not indicate where support for the amendment may be found, and it is believed that the amendment is indeed not supported by the original specification.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Arai (WO 2016136273) in view of Iannotti (WO 2021257760) and Miltenyi (US 20110003380).
With respect to claim 1, Arai discloses a sample sorting system comprising a container, a sorting part (Figure 9:30), a storage part and a first liquid container. Arai indicates that the sorting part includes a first filter module (Figure 9:60a) that separates a mixture of solids (Figure 9:54) smaller in size than target bioparticles (Figure 9:61). The sorting part includes a second filter module (Figure 9:60b) that separates a mixture of solids (Figure 9:5) larger in size than the target bioparticles. At least one reagent container is used to label target bioparticles (“examples of the carrier material include beads labeled with antibodies and the like”). In the Fig. 9 embodiment, a blood sample is fractionated using deterministic lateral displacement, such that target epithelial tumor cells 61 are separated from platelets 54 in the first filter module 60a, and target epithelial tumor cells 61 (“we attempted to isolate the epithelial tumor cells present in the blood of cancer-bearing patients with higher accuracy”) are separated from leukocytes 52 in the second filter module 60b. The leukocytes 52 are bound to antibody-labelled beads 62 to form a complex 5 that is greater in size than the target epithelial tumor cells 61. This is described in Example 4. Accordingly, steps (a), (b) and (c2) are met.
Although it is implied, Arai, however, does not expressly state that container, sorting part, storage part, first liquid container and chamber are airtightly connected using a flow channel. Arai does not appear to teach that the sorting part includes a chamber used to temporarily hold a liquid.
Iannotti discloses a sample sorting system comprising a container (Figure 1B:51a-c), a sorting part having a first module (Figure 1B:71) and a second module (Figure 1B:78), a reagent container (Figure 1B:74), a storage part (Figure 1B:61a-c), and a chamber (Figure 1B:76) used to temporarily hold a sample, particle, reagent, liquid, or a mixture thereof. These units are airtightly connected using a flow channel system (Figure 1B:31, 70, 73, 77, 32). This is described in paragraphs [0051]-[0055]. A controller is used to regulate fluid flow between the container, first module, second module, reagent container, storage part and chamber. See paragraph [0078].
Miltenyi discloses a sample sorting system comprising a container (Figure 2:80,81,82), a sorting part having a first module (Figure 2:30) and a second module (Figure 2:40), a reagent container (Figure 5:114), and a storage part (Figure 2:83,84,85). These units are airtightly connected using a flow channel system (“the invention further relates to an integrated cell processing instrument…”). This is shown in Fig. 2 and described in paragraphs [0113]-[0133]. A controller is used to regulate fluid flow between the container, first module, second module, reagent container, storage part and chamber (“the system may be controlled by a computer program that can be executed on a computer”).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Arai system includes a temporary storage chamber, an airtight network of flow channels, and a controller configured to regulate flow through the sorting part. Iannotti and Miltenyi teach that airtight and integrated fluidic systems are beneficial because they are ready to use and prevent contamination. Iannotti states in paragraph [0071] that “[l]ine 31a, 31b, 32, 70, 73, 77, 80 is preferably a closed and sealed line to prevent the introduction of air or gas into the fluid which it conveys”). Iannotti further indicates that the provision of a temporary fluid holding chamber is advantageous because it may perform a wide variety of functions, such as mixing, labelling and reagent addition. A mere duplication of parts (here, the introduction of an additional generic chamber) that produces a cumulative, minimal or otherwise predictable effect is considered to be prima facie obvious. See MPEP 2144.04.
With respect to claim 2, Arai, Iannotti and Miltenyi disclose the combination as described above. As previously discussed, Arai indicates that labeling is performed by binding detectable antibodies to beads (“an anti-CD45 antibody-labeled bead having a particle size of 30 μm carrying a monoclonal antibody against human CD45 (anti-CD45 antibody) as a target capture molecule for blood of a cancer-bearing patient”).
With respect to claims 3 and 4, Arai, Iannotti and Miltenyi disclose the combination as described above. As stated above, Arai expressly teaches in Example 4 the steps (a), (b) and (c2). Arai indicates that a complex 5 is formed by reacting reagents (e.g., antibodies) and the beads and then binding leukocytes. Particles (antibodies, leukocytes) bound to the beads are thereby removed during (c2) at the second filter module. Arai and Iannotti each teach multiple (first, second, etc.) reagent containers. Arai teaches alternative embodiments (see Example 1), in which the target epithelial tumor cells 51 are bound to the beads 55 and isolated during separation at the sorting unit. Iannotti also discusses the creation of capture complexes by binding target biological material using first, second, third, etc. binding entities. Iannotti further indicates that capture complexes are selectively released from binding entities using a cleaving entity. This is discussed in paragraphs [0020]-[0030].
With respect to claim 5, Arai, Iannotti and Miltenyi disclose the combination as described above. Arai indicates that the first filter module is a microchannel comprising first and second outlets for separated components. Similarly, the second filter module is a microchannel comprising first and second outlets for separated components.
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With respect to claim 6, Arai, Iannotti and Miltenyi disclose the combination as described above. Arai, Iannotti and Miltenyi each discuss labeling using fluorescent markers. See, for example, paragraph [0079] of Iannotti (“target biological materials may initially be simultaneously labeled with…fluorescently labeled reagents, such as fluorescently labeled binding entities and/or fluorescent dyes, for analysis and sorting”).
With respect to claims 7 and 8, Arai, Iannotti and Miltenyi disclose the combination as described above. Arai, Iannotti and Miltenyi each teach adjusting and liquid introduction steps. Furthermore, apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
Response to Arguments
Applicant's arguments filed 06 August 2026 have been fully considered but they are not persuasive.
Applicant states that Arai does not describe the performance of any of steps (a), (b), (c1) or (c2), but does not provide any further elaboration to explain this assertion. In response, it is noted that Arai expressly teaches at least steps (a), (b) and (c2). In the Fig. 9 embodiment, a blood sample is fractionated using deterministic lateral displacement, such that target epithelial tumor cells 61 are separated from platelets 54 in the first filter module 60a, and target epithelial tumor cells 61 (“we attempted to isolate the epithelial tumor cells present in the blood of cancer-bearing patients with higher accuracy”) are separated from leukocytes 52 in the second filter module 60b. The leukocytes 52 are bound to antibody-labelled beads 62 to form a complex 5 that is greater in size than the target epithelial tumor cells 61. This is described in Example 4. Accordingly, steps (a), (b) and (c2) are met.
Arai indicates that a complex 5 is formed by reacting reagents (e.g., antibodies) and the beads and then binding leukocytes. Particles (antibodies, leukocytes) bound to the beads are thereby removed during (c2) at the second filter module. Arai and Iannotti each teach multiple (first, second, etc.) reagent containers. Arai teaches alternative embodiments (see Example 1), in which the target epithelial tumor cells 51 are bound to the beads 55 and isolated during separation at the sorting unit. Iannotti also discusses the creation of capture complexes by binding target biological material using first, second, third, etc. binding entities. Iannotti further indicates that capture complexes are selectively released from binding entities using a cleaving entity. This is discussed in paragraphs [0020]-[0030].
Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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