BERKELEY LIGHTS, INC.

UNITED STATES PATENT AND TRADEMARK OFFICE

UNITED STATES DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS P.O. Box 1450

Alexandria, Virginia 22313-1450 www.uspto.gov

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.

15/135,252 04/21/2016 Keith J. Breinlinger BL001162-US 3378 132633 7590 08/04/2025 EXAMINER

Vista IP Law Group/Bruker Cellular Analysis, Inc.

100 Spectrum Center Drive

HASSAN, LIBAN M

Suite 900

Irvine, CA 92618

ART UNIT PAPER NUMBER

1799

NOTIFICATION DATE DELIVERY MODE

08/04/2025 ELECTRONIC

Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es):

Docketing.bnano@bruker.com

ctn@viplawgroup.com

mjb@viplawgroup.com

PTOL-90A (Rev. 04/07)

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UNITED STATES PATENT AND TRADEMARK OFFICE

____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

____________

Ex parte KEITH J. BREINLINGER, RUSSELL A. NEWSTROM, J. TANNER NEVILL, JASON M. MCEWEN, and DAVID A. WEISBACH ____________

Appeal 2024-002783

Application 15/135,252

Technology Center 1700

____________

Before DONNA M. PRAISS, N. WHITNEY WILSON, and CHRISTOPHER C. KENNEDY, Administrative Patent Judges. KENNEDY, Administrative Patent Judge.

DECISION ON APPEAL

The Appellant¹appeals under 35 U.S.C. § 134(a) the Examiner's decision rejecting claims 1, 3, 4, 6, 10, 18, 21, 22, 24, 28-33, 35, 52-60, 62, and 63. We have jurisdiction under 35 U.S.C. § 6(b).

We AFFIRM.

BACKGROUND

The subject matter on appeal relates to culturing stations for biologic cells contained in a microfluidic device. E.g., Spec. ¶ 2; Claim 1. Claim 1 is reproduced below from page 35 (Claims Appendix) of the Appeal Brief:

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Appeal 2024-002783 Application 15/135,252

1. A culturing station for culturing biological cells contained in a microfluidic device, the culturing station comprising:

a plurality of mounting interfaces, each mounting interface being thermally conductive and dimensioned and configured for having a microfluidic device detachably mounted directly thereon;

a plurality of attachment mechanisms, each attachment mechanism being associated with a corresponding one of the mounting interfaces, and comprising a microfluidic device cover configured to at least partially enclose a microfluidic device mounted on the corresponding mounting interface; a thermal regulation system comprising a plurality of heating elements, each heating element being thermally coupled with, and configured for controlling a temperature of, a corresponding one of the mounting interfaces; and a media perfusion system including a plurality of pumps and a plurality of perfusion lines, each pump being associated with a corresponding one of the mounting interfaces, and having an input fluidically connected to a source of culturing media and an output, each perfusion line being associated with a corresponding one of the mounting interfaces and with a corresponding one of the pumps, wherein a proximal end of each perfusion line is fluidly connected to the output of the corresponding pump, a distal end of each perfusion line is coupled to the microfluidic device cover associated with the corresponding mounting interface and configured to be fluidly connected via a fluid tight connection to a fluid ingress port of the microfluidic device mounted on the corresponding mounting interface as the respective microfluidic device cover at least partially encloses the microfluidic device.

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Appeal 2024-002783 Application 15/135,252

REJECTIONS ON APPEAL

ANALYSIS

After review of the cited evidence in the appeal record and the opposing positions of the Appellant and the Examiner, we determine that the Appellant has not identified reversible error in Rejections 2-7. Accordingly, we affirm those rejections for reasons set forth below, in the Final Action dated May 11, 2023, and in the Examiner's Answer dated March 29, 2024. However, for reasons set forth below, we reverse Rejection 1.

2 US 2013/0048089 A1, published Feb. 28, 2013.

3 US 7,358,078 B2, issued Apr. 15, 2008.

4 US 2009/0155908 A1, published June 18, 2009.

5 EP 2397224 A1, published Dec. 21, 2011.

6 US 2007/0196237 A1, published Aug. 23, 2007.

7 US 2007/0048863 A1, published Mar. 1, 2007.

8 US 2014/0045186 A1, published Feb. 13, 2014.

9 US 2005/0158787 A1, published July 21, 2005.

10 WO 2013/086505 A1, published June 13, 2013.

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Appeal 2024-002783 Application 15/135,252 Rejection 1

The Examiner determines that claim 62 is indefinite due to the recitation, "further comprising at least one of the microfluidic devices, each of the at least one microfluidic device mounted on a corresponding one of the mounting interfaces." Final Act. 3. The Examiner states, "[t]he claim recites 'at least one of the microfluidic devices' and then recites 'each of the at least one microfluidic device.' It is not clear as to which microfluidic devices are being referred to by the limitation 'each of the at least one microfluidic device.'" Id.

We reverse the rejection for reasons given by the Appellant. See Appeal Br. 5-7; Reply Br. 1-2. The Examiner recognizes that claim 1 does not "positively recite[]" a microfluidic device. Final Act. 3. Claim 62, however, does positively recite a microfluidic device. In the context of the claim, a person of ordinary skill in the art would have understood that the language "each of the at least one microfluidic device" refers to the single microfluidic device in the instance in which only one microfluidic device is part of the culturing station, and that the language refers to each (all) of the microfluidic devices in the instance in which more than one microfluidic device is part of the culturing station.

Even if the language is somewhat unconventional, see Reply Br. 2 (acknowledging potentially "unorthodox" language), the Examiner fails to establish that a person of ordinary skill in the art would have found the term to lack adequate clarity.

Rejections 2-5

We discuss claim 1 below, which is sufficient to address all of the Appellant's arguments on appeal with respect to Rejections 2-5.

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Appeal 2024-002783 Application 15/135,252 Claim 1 recites, inter alia, "a distal end of each perfusion line is coupled to the microfluidic device cover associated with the corresponding mounting interface and configured to be fluidly connected via a fluid tight connection to a fluid ingress port of the microfluidic device." The Examiner and the Appellant agree that the microfluidic device itself is not an affirmatively recited structural component of claim 1. Of particular relevance to the issues that the Appellant raises, the Examiner finds that "the housing of the attachment mechanism" of Adey corresponds to the claimed "microfluidic device cover." Final Act. 5-7, 32-

33. As shown in Adey Figure 1, housing 12 defines an internal space 20 that accommodates a sample process insert 22. See Adey Fig. 1. Fluid input 16 allows fluid to enter the internal space 20, and fluid output 24 allows fluid to exit the internal space 20. See id. The Examiner finds that "the distal end of the perfusion line [Adey Fig. 1 element 16] is fully capable of fluidly connect[ing] via a fluid tight connection to a fluid ingress port of the microfluidic device." Final Act. 8 (emphasis added). The Examiner recognizes that Adey does not literally depict a perfusion line connected via fluid tight connection to a fluid ingress port of a microfluidic device. See id. The Examiner finds that Adey teaches that insert 22 may be a microarray or microscope slide, which suggest microfluidic devices, Final Act. 29; Ans. 5, and that a person of ordinary skill in the art would have understood that

"fluid input 16 of Adey is fully capable of connecting to a fluid connection of any insert on the mounting interface including [a] microfluidic device insert." Ans. 8.

The Examiner also finds that both Chen and Chai-Gao teach similar apparatuses that include microfluidic devices that have perfusion lines

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Appeal 2024-002783 Application 15/135,252 coupled via fluid tight connections to ingress ports. Final Act. 8-9 (Chen), 11-12 (Chai-Gao). The Examiner determines that if the subject matter of claim 1 would not have been obvious over Adey alone, that Chen and Chai- Gao teach or suggest the use of microfluidic devices and connections that encompass any subject matter missing from Adey alone. Id. The Appellant argues that "Adey does not disclose [t]he 'fluid tight connection' claim element." Appeal Br. 11 et seq. The Appellant argues that, "because the fluid input 16 [of Adey] is mounted to the side of the housing 12 . . . it would be impossible for the fluid input 16 to fluidly connect to a fluid ingress port of any microfluidic device that can be imagined." Id. at 16.

That argument fails to identify reversible error in the rejection. The Appellant does not meaningfully dispute the Examiner's finding in the Answer that Adey itself teaches or suggests microfluidic devices. E.g., Ans. 5. Adey teaches that inserts 22 may be, e.g., "microarrays . . . and the like." Adey ¶ 52. There is no dispute that a microarray either constitutes or suggests a microfluidic device. In the context of Chai-Gao, the Appellant acknowledges that a "microarray platform" corresponds to a microfluidic device. Appeal Br. 21. The Appellant also acknowledges more generally that "microfluidic devices were well known prior to the filing of Adey."

Reply Br. 12. Thus, the record supports the Examiner's determination that Adey suggests that insert 22 may be a microfluidic device. As to the recited fluid tight connection, there is no dispute that a person of ordinary skill in the art would have understood that microfluidic devices use fluid tight connections. Thus, notwithstanding Adey's reference to "an open bath-type protocol" that can be used with certain types of

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Appeal 2024-002783 Application 15/135,252 inserts 22, a person of ordinary skill in the art would have understood that fluid tight connections are used with microfluidic devices such as those of Chen and Chai-Gao. When a microfluidic device is used as the insert 22 of Adey, see, e.g., Adey Fig. 1, it would have been well within the ordinary level of skill in the art for a person of ordinary skill in the art to couple fluid input 16 to the microfluidic device with a fluid tight connection. That such would have been within the ordinary level of skill in the art is demonstrated by Adey itself. Adey teaches a wide variety of different inserts 22, but Adey does not go into specific detail describing precisely how each different type of insert 22 would be used or arranged within Adey's system. See, e.g., Adey ¶ 52; see also id. ¶ 50 (describing "various connections and fittings" that are "designed to allow a module having a given sample process to be replaced by a module having a different sample process"), ¶ 60 ("Various physical configurations of sample processing modules are contemplated in order to accommodate a wide variety of sample processes."), ¶ 65 ("A variety of configurations are contemplated . . . ."). That suggests that the appropriate use of various types of inserts was within the ordinary level of skill in the art.

On this record, we are not persuaded that Adey fails to teach or suggest the recited fluid tight connection.

But even if Adey itself did fail to teach or suggest a fluid tight connection, there is no dispute that Chen and Chai-Gao both teach fluid tight connections to microfluidic devices. See, e.g., Reply Br. 11 (acknowledging that Chen "provides fluid tight connections to the fluid ingress port and fluid egress port of the microfluidic device 20"). The Appellant's argument concerning the Examiner's reliance on Chen and Chai-Gao is that the

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Appeal 2024-002783 Application 15/135,252 proposed combination (i.e., use of a microfluidic device in Adey) "would change the principle of [Adey's] operation." Appeal Br. 19. In particular, the Appellant argues that Adey's principle of operation requires "bathing a sample process insert in a fluid," whereas Chen and Chai-Gao's principle of operation "is to flow fluid through the microfluidic devices." Id. at 22. Even if, in some sense, a bath involves a different principle of operation than fluid flow through a microfluidic device, relevant case law indicates that "principle of operation" arguments might be persuasive if the proposed change to the principle of operation negates reason to combine. E.g., Plas-Pak Indus., Inc. v. Sulzer Mixpac AG, 600 F. App'x 755, 759 (Fed. Cir. 2015) (citing In re Ratti, 270 F.2d 810, 813 (CCPA 1959) and In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012)). Adey describes water baths in the context of examples and does not purport to categorically exclude other methods of fluid introduction to a sample. See, e.g., Adey ¶¶ 60, 62, 65. Given our determination above that Adey itself suggests the use of microfluidic devices, and that there is no dispute that it was known in the art that microfluidic devices involve fluid flow that is different from a water bath, we do not agree that the proposed combination with Chen and/or Chai- Gao changes Adey's principle of operation in a way that might indicate reversible error in the Examiner's rejection.

On this record, we are not persuaded by the Appellant's arguments concerning principle of operation.

For the foregoing reasons, the appellant fails to identify reversible error in the Examiner's rejection of claim 1.

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Appeal 2024-002783 Application 15/135,252 Rejection 6

Rejection 6 concerns claim 60, which depends from claim 1 and further recites, "each attachment mechanism comprising a frame defining a mounting area for the microfluidic device mounted on the corresponding mounting interface, each of the plurality of microfluidic covers configured to be mounted to a corresponding one of the frames."

The Examiner finds that Adey discloses microfluidic device covers (i.e., housing) that "are configured to be removable and replaceable with a different microfluidic device cover." Final Act. 29. The Examiner finds that Hongo teaches a device with a plurality of mounting interfaces and attachment mechanisms, and that each of the plurality of attachment mechanism[s] includes a frame defining a mounting area of a sample holder. Id. The Examiner determines that it would have been obvious "to have modified the attachment mechanism of modified Adey with that of Hongo in order to secure a sample holder on the mounting interfaces." Id. at 29-30. The Examiner determines that the proposed modification is a "simple substitution of one known attachment mechanism for another [with] the predictable result of securing a sample holder on a mounting interface." Id. The Appellant argues that the device depicted by Hongo's Figures 42 and 43 (a cassette) "appears to resemble a microfluidic device, and thus, one of ordinary skill in the art would not substitute the housing 12 of the Adey sample processing module, which is designed to hold a microfluidic device, with the cassette 703 itself." Appeal Br. 29.

That argument is unpersuasive. The Appellant fails to establish that the device of Hongo's Figures 42 and 43 would be considered equivalent to a microfluidic device. The record supports the Examiner's determination

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Appeal 2024-002783 Application 15/135,252 that Hongo's Figures 42 and 43 depict an attachment mechanism comprising a frame 712 and a cover for a sample holder 714. That Hongo's sample holder 714 may not itself be a microfluidic device does not defeat the rejection because a person of ordinary skill in the art would have understood that Hongo's attachment mechanism could be used with other known sample holders such as those of Adey, Chen, and Chai-Gao.

The Appellant argues that even if Adey's housing were replaced with the device of Hongo's Figures 42 and 43, "the resulting apparatus would not have a separate attachment mechanism and a separate microfluidic device"

because "the substrate 714 is not a 'microfluidic device.'" Id. at 29-30. That argument is not persuasive for reasons set forth above. Namely, that Hongo's sample holder 714 may not itself be a microfluidic device does not defeat the rejection because a person of ordinary skill in the art would have understood that Hongo's attachment mechanism could be used with other known sample holders such as those of Adey, Chen, and Chai-Gao. The Appellant also argues that the Examiner "has not explained how the distal end of [the] perfusion line would be fluidly connected via a fluid tight connection to the fluid ingress port of the cassette 703 as the top cover 711 of the cassette 703 at least partially encloses the substrate [714]." Id. at

30.

In the Answer, the Examiner finds that Hongo's top cover "includes openings (722-723) for fluidly coupling the sample holder 714 (insert) to a fluid source." Ans. 14. The Appellant does not dispute that finding. In the Reply Brief, the Appellant assumes that the Examiner is interpreting the openings 723, 724 on the bottom cover 711 (see Hongo Fig. 43) as the ingress ports of the microfluidic device. That is not a

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Appeal 2024-002783 Application 15/135,252 reasonable interpretation of the rejection. The Examiner is proposing the use of known microfluidic devices, e.g., those of Chen and/or Chai-Gao, as the sample holder 714, and there is no dispute that those microfluidic devices include fluid ingress ports. As set forth above in our discussion of claim 1, it would have been within the ordinary level of skill in the art to make fluid tight connections to the ingress ports of microfluidic devices. The Appellant fails to identify reversible error in the Examiner's rejection of claim 60.

Rejection 7

Rejection 7 concerns claims 62 and 63. Claim 62 depends from claim 1 and further recites, "further comprising at least one of the microfluidic devices, each of the at least one microfluidic device mounted on a corresponding one of the mounting interfaces." Claim 63 depends from claim 62 and further recites, "wherein each of the microfluidic devices comprises an enclosure and a microfluidic circuit contained within the enclosure, wherein the fluid ingress port of the microfluidic device is in fluid communication with the microfluidic circuit contained in the respective microfluidic device." As explained above, claim 1 does not affirmatively recite the microfluidic device as part of the culturing station. Claim 62 does, and claim 62 further recites that the microfluidic device is mounted on a mounting interface. Claim 63 appears to simply define a microfluidic device in accordance with what a person of ordinary skill in the art would understand to be a microfluidic device.

The Examiner finds that Block teaches a microfluidic device having a microfluidic circuit within an enclosure, and that it would have been obvious

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Appeal 2024-002783 Application 15/135,252 to use Block's microfluidic device as the insert 22 of Adey. Final Act. 30-

31.

The Appellant misapprehends the Examiner's rejection and states that

"the Examiner proposes to modify the Adey sample processing module by substituting the housing 12 (i.e., as the claimed 'microfluidic cover') of the Adey sample processing device . . . with the microcontroller 3340/3440 [of Block]." Appeal Br. 31. The Appellant argues that a person of ordinary skill in the art would not substitute Block's microcontroller for Adey's housing 12. Id. at 32.

The Appellant's arguments are unpersuasive because the Examiner is not proposing to replace Adey's housing 12; the Examiner is merely proposing the use of a known microfluidic device as the insert 22 of Adey. As set forth above, it would have been within the ordinary level of skill in the art to make the fluid connections to the microfluidic device. The Appellant fails to identify reversible error in Rejection 7.

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Appeal 2024-002783 Application 15/135,252

CONCLUSION

In summary:

No time period for taking any subsequent action in connection with

this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.

§ 1.136(a)(1)(iv).

AFFIRMED

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