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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 9, 10, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR20180079917A) in view of Handique et al. (WO2019046307).
Regarding Claim 1, Lee teaches the following:
A microfluidic platform 100 (a microfluidic platform). The platform being for reproduction of cells is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The microfluidic platform of Lee would be capable of the reproduction of cells and therefore meets the claim limitation.
One central area in which fluid is introduced through the inlet (feeding channel) of the inlet portion (at least one central area for receiving a solution in the at least one central area wherein the at least one central area comprises at least one first feeding channel for feeding the solution)(para 51 and Fig. 2, below)
Two side areas provided mutually on opposite sides of the at least one central area, each one having at least one second feeding channel for feeding a material (see Fig. 2, below)
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The height of a side area is greater than the height of the one central area (see Fig. 1, below)
A solution being fed into the central area would reach the side areas by way of flow of the solution and absent evidence to the contrary, would end its progress due to the surface tension and capillary effect. It appears Applicant is claiming that the liquid ending its progress due to the surface tension and capillary effect is due to the structure claimed. Given the structure of Lee meets the structure as claimed, it would also end the liquids progress due to surface tension and capillary effect.
In the alternative, assuming arguendo, these limitations are process limitations and provide no further structural limitations to the apparatus claim.
Lee does not teach the central area is treated with poly-D-lysine (PDL).
Handique teaches a system for isolating and analyzing cells (Abstract). Handique further teaches a functional surface coating on the internal surface of a well and that functional surface coating can be poly-D-lysine (para 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lee with the surface coating of poly-D-lysine as taught by Handique. One would have been motivated to make this modification as it would allow the surface to physically retain and/or manipulate the captured content such as the cells (para 64).
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Regarding Claim 2, Lee in view of Handique teaches all of the limitations of Claim 1 (see above). Lee further teaches the central area to have at least one protrusion (see below).
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Regarding Claim 3, Lee in view of Handique teaches all of the limitations of Claim 1 (see above). Lee further teaches one of the at least two side areas to comprise a plurality of pockets (see Fig. 2, below).
The plurality of pockets being for reproduction of tumor spheroids is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The pocket of Lee would be capable of the reproduction of tumor spheroids and therefor meets the claim.
Regarding Claims 9, 19, and 20, Lee in view of Handique teaches all of the limitations of Claim 1, 2 and 3, respectively (see above).
Lee in view of Handique does not explicitly teach that the microfluidic platform is produced with a hot pressing or an injection molding method. However, this is a process limitation in a product/apparatus claim. The patentability of a product is independent of how it was made. "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding Claim 10, Lee in view of Handique teaches all of the limitations of Claim 2 (see above). Lee further teaches one of the at least two side areas to comprise a plurality of pockets (see Fig. 2, above).
The plurality of pockets being for reproduction of tumor spheroids is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The pocket of Lee would be capable of the reproduction of tumor spheroids and therefor meets the claim.
Claims 4, 5, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR20180079917A) in view of Handique et al. (WO2019046307) and further in view of Daniele (WO2020056320A2).
Regarding Claim 4, Lee in view of Handique teaches all of the limitations of Claim 1 (see above). Lee in view of Handique does not teach the central area to have a solution containing one, several or all of collagen, fibrin, or gelatin.
Daniele teaches two dimensional models of tissue barriers (para 47). Daniele further teaches a solution that can flow into the flow channel (para 55) which can include gelatin (para 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central area to have a solution containing gelatin as taught by Daniele. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58).
Regarding Claim 5, Lee in view of Handique teaches all of the limitations of Claim 1 (see above). Lee in view of Handique does not teach the central area to have a solution containing at least one synthetic macromolecule.
Daniele teaches two dimensional models of tissue barriers (para 47). Daniele further teaches a solution that can flow into the flow channel (para 55) which can include gelatin-methyacrylol (GelMA) (synthetic macromolecule)(para 58). Note: Applicant’s specification, page 5, states an example of the synthetic macromolecule to be GelMA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central area to have a solution containing GelMA as taught by Daniele. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58).
Regarding Claim 11, Lee in view of Handique teaches all of the limitations of Claim 2 (see above). Lee in view of Handique does not teach the central area to have a solution containing at least one synthetic macromolecule.
Daniele teaches two dimensional models of tissue barriers (para 47). Daniele further teaches a solution that can flow into the flow channel (para 55) which can include gelatin-methyacrylol (GelMA) (synthetic macromolecule)(para 58). Note: Applicant’s specification, page 5, states an example of the synthetic macromolecule to be GelMA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central area to have a solution containing GelMA as taught by Daniele. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58).
Regarding Claim 12, Lee in view of Handique teaches all of the limitations of Claim 3 (see above). Lee does not teach the central area to have a solution containing at least one synthetic macromolecule.
Daniele teaches two dimensional models of tissue barriers (para 47). Daniele further teaches a solution that can flow into the flow channel (para 55) which can include gelatin-methyacrylol (GelMA) (synthetic macromolecule)(para 58). Note: Applicant’s specification, page 5, states an example of the synthetic macromolecule to be GelMA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central area to have a solution containing GelMA as taught by Daniele. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58).
Regarding Claim 13, Lee in view in view of Handique and further in view of Daniele teaches all of the limitations of Claim 4 (see above). Lee in view of Handique does not teach the central area to have a solution containing at least one synthetic macromolecule.
Daniele teaches two dimensional models of tissue barriers (para 47). Daniele further teaches a solution that can flow into the flow channel (para 55) which can include gelatin-methyacrylol (GelMA) (synthetic macromolecule)(para 58). Note: Applicant’s specification, page 5, states an example of the synthetic macromolecule to be GelMA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central area to have a solution containing GelMA as taught by Daniele. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58).
Claims 9, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR20180079917A) ) in view of Handique et al. (WO2019046307) and further in view of Pavesi et al. (WO2016076795A1, cited in IDS dated 01/06/2022). This is an alternative rejection to the one above assuming arguendo about the limitations of claims 9, 19 and 20.
Regarding Claim 9, Lee in view of Handique teaches all of the limitations of Claim 1 (see above). Lee does not explicitly teach the platform to be produced with hot pressing or injection molding method.
Pavesi teaches a microfluidic platform for investigating cell-based interactions (Abstract). Pavesi further teaches the step of molding the chip is injection molding (page 4, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of injection molding to create the device of Lee. One would have been motivated to use this method as Pavesi teaches it to be a suitable way of producing a microfluidic platform and it would have resulted in an effective microfluidic chip for the production of cells.
Regarding Claim 19, Lee in view of Handique teaches all of the limitations of Claim 2 (see above). Lee does not explicitly teach the platform to be produced with hot pressing or injection molding method.
Pavesi teaches a microfluidic platform for investigating cell-based interactions (Abstract). Pavesi further teaches the step of molding the chip is injection molding (page 4, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of injection molding to create the device of Lee. One would have been motivated to use this method as Pavesi teaches it to be a suitable way of producing a microfluidic platform and it would have resulted in an effective microfluidic chip for the production of cells.
Regarding Claim 20, Lee in view of Handique teaches all of the limitations of Claim 3 (see above). Lee does not explicitly teach the platform to be produced with hot pressing or injection molding method.
Pavesi teaches a microfluidic platform for investigating cell-based interactions (Abstract). Pavesi further teaches the step of molding the chip is injection molding (page 4, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of injection molding to create the device of Lee. One would have been motivated to use this method as Pavesi teaches it to be a suitable way of producing a microfluidic platform and it would have resulted in an effective microfluidic chip for the production of cells.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
In response to applicant’s arguments that Claim 1 requires a specific geometric configuration of the side areas being higher than the central area that produces a particular fluidic behavior so that the solution advances from the central area into the side areas but then ceases movement due to the surface tension and capillary effect, Lee teaches a configuration of the side areas being higher than the central area which would produce the fluidic behavior as described, absent evidence to the contrary.
In response to applicant’s arguments that Lee does not teach at least one of the two side areas comprise a plurality of pockets, Lee does teach a side area with a plurality of pockets (see Fig. 2 on page 5 of this Office Action).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the teaching of injection molding a microfluidic device is taught by Pavesi and therefore would be obvious to be used in the creation of the microfluidic device of Lee.
Further, how the device is produce is a process limitation in a product/apparatus claim. The patentability of a product is independent of how it was made. "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
In response to applicant’s arguments that the applicant identified a problem others did not, establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967), second, the long-felt need must not have been satisfied by another before the invention by the inventor, third, the invention must in fact satisfy the long-felt need. See MPEP 716.04. Applicant has not submitted evidence recognizing the long felt need.
Further, in response to applicant's argument that Lee is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Lee’s field of endeavor, microfluidic devices containing cells, is the same field of endeavor.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, moreover that the examiner has not put the Applicant’s disclosure to the side when determining obviousness, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The device of Lee would be obvious to combine with Daniele given the knowledge within the level of ordinary skill. One would have been motivated to make this addition as it would allow the solution to have enough solids to form a scaffold and still remain porous similar to an extracellular matrix in order for cells to organize in 3D (para 58). Thus, it is the Examiner's position that the rejection is not based on hindsight, but rather is based on the motivation to combine found in the references themselves.
The remainder of applicant’s arguments are directed towards newly amended claims and have been addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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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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/J.E.L./ Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/ Supervisory Patent Examiner, Art Unit 1799