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 .
Election/Restrictions
Applicant’s election of Group I; and Species: A. 1 (i.e., a microfluidic device of claim 1); B. N/A; C. 1 (i.e., wherein the perfusion liquid is delivered to both the second microfluidic channel and the third microfluidic channel to perform perfusion of the cell-containing structure from both lateral and vertical directions, thereby facilitating diffusion and advection between the first microfluidic channel and the second microfluidic channel, and facilitating diffusion and advection between the first microfluidic channel and the third microfluidic channel); D. 1 (i.e., Fig. 1A); and E. 1 (i.e., Fig. 15A) in the reply filed on 02/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-13 and 17-19 are being examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “[...] said lateral geometrical meniscus-pinning feature being configured to resist fluid flow between said first microfluidic channel and said second microfluidic channel within said first portion of said first microfluidic channel; and [...] said vertical geometrical meniscus-pinning feature being configured to resist fluid flow between said first microfluidic channel and said third microfluidic channel within said second portion of said first microfluidic channel” in claim 1; and “[...] said lateral meniscus-pinning ridge and said vertical meniscus-pinning ridge being configured to resist fluid flow in orthogonal directions” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 17-19 are rejected under 35 U.S.C. 112(b) or 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 8, 10, 12, 13, 17 are not clear with respect to what the applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. In claim 1, the phrase geometrical meniscus-pinning feature makes the claim unclear because it is unclear whether the applicant is trying to claim a structure (i.e., geometrical dimension), or a functional feature (i.e., meniscus-pinning feature). For this reason, claim 1 and its dependent claims relating to the phrase is similarly unclear. In claims 1, 5, 8 and 13, the term configured to is unclear what structural configurations are being claimed. Claim 8 is further unclear whether the limitation(s) following the term are part of the claimed invention (i.e., a pipette tip, a fluid in the pipette tip and the first microfluidic channel).
Claim 10 is unclear reciting “[...] wherein at least one of an upper surface of said first layer and a lower surface of said second layer comprise recessed features that define, after said first layer is bonded to said second layer, said first microfluidic channel, said second microfluidic channel, and said lateral geometrical meniscus-pinning feature; said second layer further comprising at least one aperture defined such that said aperture resides above said first microfluidic channel after said first layer is bonded to said second layer; and a third layer secured to said second layer, wherein a lower surface of said third layer comprises an additional recessed feature that defines, after said third layer is bonded to said second layer, said third microfluidic channel, and wherein said aperture forms, at least in part, said vertical geometrical meniscus-pinning feature” because it is unclear whether the applicant is trying to claim a device or method of making a device.
Claim 12 is unclear whether the horizontal membrane residing between said reservoir and said third microfluidic channel is part of the claimed invention.
Claim 17 is indefinite reciting “wherein a substrate of said microfluidic device comprises a planar surface residing below said first horizontal planar region, such that said planar surface and said second horizontal planar region reside on opposite sides of said first horizontal planar region, and wherein a portion of said substrate residing between said planar surface and said first microfluidic channel is sufficiently transparent to permit microscopic imaging of at least said first microfluidic channel” because it is unclear whether the limitation(s) following the wherein clause are part of the claimed invention.
Claim limitation “configured to” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) 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.
(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.
Claim(s) 1, 5, 8, 10, 12, 13, 17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Toner et al. (US 2019/0022653 A1).
Regarding claim 1, Toner et al. teach:
1. A microfluidic device comprising:
a first microfluidic channel extending within a first horizontal planar region (see annotated Fig. 21 for example);
a second microfluidic channel extending within said first horizontal planar region, said second microfluidic channel residing laterally adjacent to said first microfluidic channel along a first portion of said first microfluidic channel such that said second microfluidic channel is in direct lateral fluid communication with said first microfluidic channel along said first portion of said first microfluidic channel (see annotated Fig. 21 for example);
a third microfluidic channel extending within a second horizontal planar region, said second horizontal planar region being vertically offset from said first horizontal planar region, said third microfluidic channel residing vertically adjacent to said first microfluidic channel along a second portion of said first microfluidic channel such that said third microfluidic channel is in direct vertical fluid communication with said first microfluidic channel along said second portion of said first microfluidic channel (see annotated Fig. 21 for example);
a lateral geometrical meniscus-pinning feature (e.g., obstacles, microposts) residing between said second microfluidic channel and said first microfluidic channel within said first portion of said first microfluidic channel (see annotated Fig. 21 for example); and
a vertical geometrical meniscus-pinning feature (e.g., obstacles, microposts) residing between said third microfluidic channel and said first microfluidic channel within said second portion of said first microfluidic channel (see annotated Fig. 21 for example).
Annotated Fig. 21 of Toner et al. (US 2019/0022653 A1)
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With regard to limitations in claims 1, 3-6, 8, 10, 11, 12, 13, 17, (e.g., [...] geometrical meniscus-pinning feature [...]; [...] to resist fluid flow between said first microfluidic channel and said second microfluidic channel within said first portion of said first microfluidic channel; [...] to resist fluid flow between said first microfluidic channel and said third microfluidic channel within said second portion of said first microfluidic channel; [...] [...] to resist fluid flow in orthogonal directions, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-13, 17-19, Toner et al. teach:
2. The microfluidic device according to claim 1 wherein said first portion of said first microfluidic channel overlaps at least in part with said second portion of said first microfluidic channel (see annotated Fig. 21 for example).
3. The microfluidic device according to claim 1 wherein at least one of said lateral geometrical meniscus-pinning feature and said vertical geometrical meniscus-pinning feature comprises an elongate meniscus-pinning edge feature extending longitudinally between said first portion of said first microfluidic channel and said second microfluidic channel (see Fig. 10 & ¶ 0099 for example).
4. The microfluidic device according to claim 3 wherein said elongate meniscus-pinning edge feature comprises a meniscus-pinning ridge (see Fig. 10 & ¶ 0099 for example).
5. The microfluidic device according to claim 1 wherein said lateral geometrical meniscus-pinning feature comprises a lateral meniscus-pinning ridge and said vertical geometrical meniscus-pinning feature comprises a vertical meniscus-pinning ridge (see Fig. 10 & ¶ 0099 for example).
6. The microfluidic device according to claim 1 wherein at least one of said lateral geometrical meniscus-pinning feature and said vertical geometrical meniscus-pinning feature comprises a plurality of microposts (see Figs. 8-9, 21 for example).
7. The microfluidic device according to claim 1 further comprising a first inlet port and a first outlet port in flow communication with said first microfluidic channel (see Figs. 7, 21 for example).
8. The microfluidic device according to claim 7 wherein said first inlet port is capable of being sealed (see Fig. 7 for example).
9. The microfluidic device according to claim 7 further comprising: a second inlet port and a second outlet port in flow communication with said second microfluidic channel (see Fig. 21 for example); and a third inlet port and a third outlet port in flow communication with said third microfluidic channel (see Fig. 21 for example); wherein said second inlet port, said second outlet port, said third inlet port and said third outlet port reside within respective microwells (see Fig. 21 for example).
10. The microfluidic device according to claim 1 further comprising: a first layer; a second layer bonded to said first layer; and a third layer secured to said second layer (see Figs. 7, 8, 18 for example).
11. The microfluidic device according to claim 10 wherein said third layer is detachably removable from said second layer (see Figs. 7, 8 for example).
12. The microfluidic device according to claim 1 further comprising a reservoir defined above at least a portion of said third microfluidic channel, said reservoir being in fluid communication with said third microfluidic channel (see Fig. 7 for example).
13. The microfluidic device according to claim 1 wherein said lateral geometrical meniscus-pinning feature is a first lateral geometrical meniscus-pinning feature, said microfluidic device further comprising: a fourth microfluidic channel extending within said first horizontal planar region, said fourth microfluidic channel residing laterally adjacent to said first microfluidic channel along a third portion of said first microfluidic channel such that said fourth microfluidic channel is in direct lateral fluid communication with said first microfluidic channel along said third portion of said first microfluidic channel, said first microfluidic channel residing between said second microfluidic channel and said fourth microfluidic channel; and a second lateral geometrical meniscus-pinning feature (e.g., obstacles, microposts) residing between said first microfluidic channel and said fourth microfluidic channel within said third portion of said first microfluidic channel (see annotated Fig. 21 for example).
17. The microfluidic device according to claim 1 wherein a substrate of said microfluidic device comprises a planar surface residing below said first horizontal planar region (see Fig. 7 for example), and said first microfluidic channel is sufficiently transparent (see ¶ 0072 for example).
18. The microfluidic device according to claim 1 wherein said first microfluidic channel comprises a gel (e.g., hydrogel), and wherein said second microfluidic channel and said third microfluidic channel are substantially absent of said gel (see ¶ 0065 for example).
19. The microfluidic device according to claim 1 wherein said second microfluidic channel and said third microfluidic channel each comprise a gel (e.g., hydrogel), and wherein said first microfluidic channel is substantially absent of said gel (see ¶ 0065 for example).
Regarding limitations recited in claim 10, which are directed to method of making the microfluidic device (e.g., wherein at least one of an upper surface of said first layer and a lower surface of said second layer comprise recessed features that define, after said first layer is bonded to said second layer, said first microfluidic channel, said second microfluidic channel, and said lateral geometrical meniscus-pinning feature, etc.) it is noted that said limitations are given little patentable weight in the product claims. Even though a product-by-process is defined by the process steps by which the product is made, determination of patentability is based on the product itself and does not depend on its method of production. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). As the court stated in Thorpe, 777 F.2d at 697, 227 USPQ at 966 (The patentability of a product does not depend on its method of production. In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969). If the product in a product-by-process claim is the same or obvious as the product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.), see MPEP 2113 and 2114.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798