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 Objections
Claim 13 is objected to because of the following informalities: in line 3, the term “and edge portion…” should instead read “an edge portion…” Appropriate correction is required.
Claim 15 is objected to because of the following informalities: in line 2, the term “before the forming…” should instead read “before forming…” 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.
Claims 1, 2 and 4-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claim 1 recites the limitation "the minute volume change" in the final lines. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is indefinite because it is unclear how it is possible to “decreas[e] a gas volume occupied by the gas continuous from the end part to an inside of the flow channel”. The end part of the flow channel and the inside of the flow channel are directly connected, as the end part is a subsection of the flow channel, and so there is no intervening volume from which gas may be decreased. It is unclear what gas volume is being decreased before forming the gas-liquid interface.
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Claims 2, 4 and 6-18 are rejected as being dependent on indefinite claims 1 and 5.
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.
Claims 1, 2, 4, 11, 12, 16-19 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moriyama (US 20220170826)1.
With respect to claims 1 and 19, Moriyama discloses a device and method for manipulating an organism. A flow channel (Figure 2C:220) having an end part is immersed in a liquid (Figure 2C:240) containing the organism. A gas-liquid interface manipulator (Figure 2A:250) is used to create an air bubble (Figure 2C:211) at the end part characterized by gas-liquid interface configured to manipulate the organism (Figure 5A:510). See Figs. 5A-5C and paragraphs [0045]-[0056]. The gas-liquid interface manipulator releases gas into the liquid from the end part to create and maintain the gas-liquid interface by providing a restoring force to act against minute volume changes.
With respect to claim 2, Jordan and Ivanov disclose the combination as described above. Jordan and Ivanov each teach that the gas-liquid interface of the bubble is formed by releasing a gas from the end part.
With respect to claim 2, Moriyama discloses the method as described above. Moriyama teaches that the gas-liquid interface of the bubble is formed by releasing a gas from the end part. Cells are collected by sucking the gas into the end part. See Figs. 5A-5C.
With respect to claims 4 and 21, Moriyama discloses the apparatus and method described above. The gas volumes of the bubbles formed by Moriyama satisfy the claimed relationship with respect to the radius of the end part of the flow channel.
With respect to claims 11 and 12, Moriyama discloses the method as described above. The Moriyama flow channel has an end part characterized by a corner having a contact angle of approximately 90°.
With respect to claims 16-18, Moriyama discloses the method as described above as described above. As previously discussed, Moriyama teaches a method in which changes in pressure are detected to control delivery of gas through the flow channel when forming the bubble using a pump, a syringe, or the like.
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, 2, 4, 11, 12, 15-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan “Interactions Between Animal Cells and Gas Bubbles…” (cited in the 9/4/2025 IDS) in view of Ivanov (US 20090133480).
With respect to claims 1 and 19, Jordan discloses a method and apparatus for manipulating an organism. Jordan shows how a bubble having a gas-liquid interface is formed at the end part of a flow channel when the end partis immersed in a liquid containing the organism. This is taught in the “Cell-Bubble Interactions” section on page 446 and “Direct Examination of Interaction of Bubbles with Cells” on pages 450-452.
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Organisms are manipulated when they are brought into contact with the bubble.
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Although Jordan requires a gas-liquid interface manipulator (i.e., 10 microliter micropipette attached to a micromanipulator) to produce the bubble, Jordan does not expressly state that the manipulator is configured to release a gas from the end part to provide a restoring force to act against minute volume changes.
Ivanov discloses a manipulation method for forming a bubble characterized by a gas-liquid interface using a flow channel immersed in a liquid. See Figs. 2-4. Ivanov states teaches that a gas-liquid interface manipulator in the form of a motorized syringe (Figure 1:6) operated by a controller (Figure 1:10,11) in communication with a pressure detector (Figure 1:12). The pressure detector provides information regarding a pressure difference across the gas-liquid interface in order to determine when gas should be released to maintain bubble shape and provide a restoring force. This is taught in paragraphs [0006]-[0014].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the gas-liquid manipulator of Jordan is used to provide a restoring force against minute volume change. Those of ordinary skill would have understood the benefit of controlling and/or limiting the expansion of the air bubble so that it stabilizes on the end of the flow channel. Ivanov teaches that this may be accomplished by regulating operation of the micropipette based on pressure differential information obtained by the sensor. Those of ordinary skill would have recognized that the bubble generated by Jordan should not break due to overexpansion when it is being used to manipulate and transport cells.
With respect to claim 2, Jordan and Ivanov disclose the combination as described above. Jordan and Ivanov each teach that the gas-liquid interface of the bubble is formed by releasing a gas from the end part.
With respect to claims 4 and 21, Jordan and Ivanov disclose the combination as described above. The gas volumes of the bubbles formed by Jordan and Ivanov satisfy the claimed relationship with respect to the radius of the end part of the flow channel.
With respect to claims 11 and 12, Jordan and Ivanov disclose the combination as described above. The Jordan and Ivanov flow channels each have an end part characterized by a corner having a contact angle of approximately 90°.
With respect to claim 15, Jordan and Ivanov disclose the combination as described above. Jordan further teaches that a surfactant is added to decrease a surface tension of the liquid with the gas before forming the gas-liquid interface.
With respect to claims 16-18, Jordan and Ivanov disclose the combination as described above. As previously discussed, Ivanov teaches a method in which changes in pressure are detected using a sensor 12 to control delivery of gas through the flow channel when forming the bubble.
Claims 10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan “Interactions Between Animal Cells and Gas Bubbles…” (cited in the 9/4/2025 IDS) in view of Ivanov (US 20090133480) as applied to claim 1, and further in view of Ando (US 20170203290).
Jordan and Ivanov disclose the combination as described above, however do not appear to show a flow channel having a protruding portion, a stepped portion and/or first and second diameters.
Ando discloses a flow channel (Figure 1A:102) configured to dispense and manipulate cells. Ando shows that the flow channel may be fabricated according to a variety of different shapes and sizes. For example, the flow channel may include a large flow channel diameter portion (Figure 1A:114) and a small flow channel diameter portion (Figure 1A:112). See also Fig. 8. Ando additionally teaches that the flow channel may include an end part having a portion (Figure 8:134) that protrudes inwardly to create a stepped portion (Figure 8:133).
Before the effective filing date of the claimed invention, it would have been obvious to modify the shape of the Jordan flow channel to create a protruding portion, a stepped portion and/or first and second diameters. Ando teaches that these features affect dispensing and aspirating fluid according to known principles (“the outer diameter of straight pipe section 112 may be configured to be reduced toward the leading end. Due to this, liquid exhaustion at the time of sucking and discharging a liquid is improved”). Ando shows how a flow channel having protrusions and a varied diameter improves cell collection and manipulation (“protrusion 134 may be provided to the inner wall of straight pipe section 112 so as to make the inner diameter of the part where the inner diameter is the narrowest because of protrusion 134 to be 200 μm. It is possible to effectively break the cells to have a diameter of 100 to 200 μm, which is an optimal colony diameter when culturing a colony of human iPS cells owing to protrusion 134”).
Claims 10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama (US 20220170826) as applied to claim 1, and further in view of Ando (US 20170203290).
Moriyama discloses the method as described above, however does not appear to show a flow channel having a protruding portion, a stepped portion and/or first and second diameters.
Ando discloses a flow channel (Figure 1A:102) configured to dispense and manipulate cells. Ando shows that the flow channel may be fabricated according to a variety of different shapes and sizes. For example, the flow channel may include a large flow channel diameter portion (Figure 1A:114) and a small flow channel diameter portion (Figure 1A:112). See also Fig. 8. Ando additionally teaches that the flow channel may include an end part having a portion (Figure 8:134) that protrudes inwardly to create a stepped portion (Figure 8:133).
Before the effective filing date of the claimed invention, it would have been obvious to modify the shape of the Moriyama flow channel to create a protruding portion, a stepped portion and/or first and second diameters. Ando teaches that these features affect dispensing and aspirating fluid according to known principles (“the outer diameter of straight pipe section 112 may be configured to be reduced toward the leading end. Due to this, liquid exhaustion at the time of sucking and discharging a liquid is improved”). Ando shows how a flow channel having protrusions and a varied diameter improves cell collection and manipulation (“protrusion 134 may be provided to the inner wall of straight pipe section 112 so as to make the inner diameter of the part where the inner diameter is the narrowest because of protrusion 134 to be 200 μm. It is possible to effectively break the cells to have a diameter of 100 to 200 μm, which is an optimal colony diameter when culturing a colony of human iPS cells owing to protrusion 134”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Pat. No. 12,504,3532.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims set forth in U.S. Pat. No. 12,504,353 include limitations drawn to
A manipulation method of an organism comprising:
forming a gas-liquid interface, in which a restoring force acts against minute interface movement, in a flow channel or at an end part of the flow channel, with the end part immersed in a liquid in which an organism is immersed; and
manipulating the organism by using the gas-liquid interface,
wherein the forming the gas-liquid interface includes releasing a gas from the end part and maintaining the gas-liquid interface, in which the restoring force acts against the minute volume change, at the end part
and
An organism manipulation device for manipulating an organism, comprising:
a flow channel having an end part immersed in a liquid in which the organism is immersed; and
a gas-liquid interface manipulator which forms a gas-liquid interface in which a restoring force acts against minute interface movement in the flow channel or at the end part and manipulates the organism by the gas-liquid interface,
wherein the gas-liquid interface manipulator releases a gas into the liquid from the end part and maintains the gas-liquid interface, in which a restoring force acts against a minute volume change, at the end part.
Claims 1, 2, 4-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 13, 16, 17, 20 and 23-26 of copending Application No. 18/027,816 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims set forth in copending Application No. 18/027,816 include limitations drawn to
A manipulation method of an organism comprising:
forming a gas-liquid interface, in which a restoring force acts against minute interface movement, in a flow channel or at an end part of the flow channel, with the end part immersed in a liquid in which an organism is immersed; and
manipulating the organism by using the gas-liquid interface,
wherein the forming the gas-liquid interface includes releasing a gas from the end part and maintaining the gas-liquid interface, in which the restoring force acts against the minute volume change, at the end part
and
An organism manipulation device for manipulating an organism, comprising:
a flow channel having an end part immersed in a liquid in which the organism is immersed; and
a gas-liquid interface manipulator which forms a gas-liquid interface in which a restoring force acts against minute interface movement in the flow channel or at the end part and manipulates the organism by the gas-liquid interface,
wherein the gas-liquid interface manipulator releases a gas into the liquid from the end part and maintains the gas-liquid interface, in which a restoring force acts against a minute volume change, at the end part.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-17 and 19 of copending Application No. 18/027,821 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims set forth in copending Application No. 18/027,821 include limitations drawn to
A manipulation method of an organism comprising:
forming a gas-liquid interface, in which a restoring force acts against minute interface movement, in a flow channel or at an end part of the flow channel, with the end part immersed in a liquid in which an organism is immersed; and
manipulating the organism by using the gas-liquid interface,
wherein the forming the gas-liquid interface includes releasing a gas from the end part and maintaining the gas-liquid interface, in which the restoring force acts against the minute volume change, at the end part
and
An organism manipulation device for manipulating an organism, comprising:
a flow channel having an end part immersed in a liquid in which the organism is immersed; and
a gas-liquid interface manipulator which forms a gas-liquid interface in which a restoring force acts against minute interface movement in the flow channel or at the end part and manipulates the organism by the gas-liquid interface,
wherein the gas-liquid interface manipulator releases a gas into the liquid from the end part and maintains the gas-liquid interface, in which a restoring force acts against a minute volume change, at the end part.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8-17 and 24 of copending Application No. 18/027,822 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims set forth in copending Application No. 18/027,822 include limitations drawn to
A manipulation method of an organism comprising:
forming a gas-liquid interface, in which a restoring force acts against minute interface movement, in a flow channel or at an end part of the flow channel, with the end part immersed in a liquid in which an organism is immersed; and
manipulating the organism by using the gas-liquid interface,
wherein the forming the gas-liquid interface includes releasing a gas from the end part and maintaining the gas-liquid interface, in which the restoring force acts against the minute volume change, at the end part
and
An organism manipulation device for manipulating an organism, comprising:
a flow channel having an end part immersed in a liquid in which the organism is immersed; and
a gas-liquid interface manipulator which forms a gas-liquid interface in which a restoring force acts against minute interface movement in the flow channel or at the end part and manipulates the organism by the gas-liquid interface,
wherein the gas-liquid interface manipulator releases a gas into the liquid from the end part and maintains the gas-liquid interface, in which a restoring force acts against a minute volume change, at the end part.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Yonekawa (JP 2010172231) reference uses a flow channel immersed in fluid to deliver a release liquid 30 to cells. A gas-liquid interface A (see Figs. 6C and 6D) is formed inside the flow channel to facilitate cell collection and manipulation. Yonekawa does not teach releasing a gas from the end part of the flow channel.
The Yamanishi (US 20150011930) reference teaches a flow channel configured as a bubble-spraying member configured to manipulate cells. Gas is released from the flow channel to form bubbles having gas-liquid interfaces. These bubbles are ejected from the flow channel and not maintained at an end part of the flow channel.
The Chiou (US 20150044751) reference teaches a flow channel configured to generate bubbles at an end part in order to manipulate cells. See Fig. 21. The bubble is created by releasing gas from the end part. The gas-liquid interface of the bubble is not maintained by restoring forces, but rather the bubble is intended to collapse in order to porate the cell.
The Akagi (WO 2015098919) references uses bubbles to dislodge adherent cells. The bubbles are generated by photoresponsive agent. Akagi does not teach generating and maintaining a gas-liquid interface at an end part of a flow channel immersed in a fluid.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
1 Due to non-overlapping inventorship, a rejection under 102(a)(2) is appropriate. However, it is possible that an exception under 102(b) might be available to overcome this rejection.
2 This double patenting rejection is made in the alternative to the rejection under 35 USC 102(a)(2) presented in this Office Action involving the corresponding printed publication (US 2022/0170826). In the event that the anticipation rejection is disqualified using an exception under 35 USC 102(b), this double patenting rejection will apply. See MPEP 717.02(c)