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 status
Claims 1-14 and 18-20 are pending following the Reply filed 07/02/2026. Claims 15-17 have been cancelled. Claim 1 and 14 have been amended without introducing new matter. Claims 18-20 remain withdrawn. Claims 1-14 are presently considered.
Withdrawn
Any rejection or objection to claims 15-17 is moot because the claims have been cancelled.
The objection to claim 14 is withdrawn in light of the amendments.
Claim Interpretation
Claim 1 has been amended to recite “A scalable, high throughput microfluidic potency assay device”. As discussed in the previous Office Action (see Non-Final Rejection filed 03/03/2026 at Claim Interpretation), the “assay” of claim 1 was interpreted to be directed to a product, and inventions of this statutory category are patentably defined by their recited structure. While the recitation of an “assay device” has literal support in the specification (see pg. 17, lines 20-27) and appears to provide better clarity regarding the nature of the invention, this amendment does not change the examiner’s interpretation of the claim. In addition, the recitation of the device being “scalable, high throughput” in the preamble is directed to the functional capabilities of the device and does not effectively serve to limit the structure of the claimed product beyond the structure that is already recited in the body of the claim.
Claim 1 also recites the limitation “wherein the device comprises means for detecting one or more cytokines in the sample or samples obtained from the cell culture”. Here, the phrase “means for detecting” invokes interpretation under 35 U.S.C. 112(f), as discussed further below.
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.
In the instant case, claim 1 recites the limitation, “wherein the device comprises means for detecting one or more cytokines in the sample or samples obtained from the cell culture”. Here, the claim recites a “means for” performing a recited function (“detecting”), while the recited “means” is not further modified by any structure, material, or acts for performing the claimed function. Therefore, this limitation is being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112(b)
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 1-14 is/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.
Claim 1 recites the limitation “wherein a pump is used to continually perfuse media through the assay device” which renders the claim indefinite, because it is directed to a method step of using the claimed product. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b), because it creates confusion as to when direct infringement occurs. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). This ambiguity arises because it is unclear whether infringement occurs when one creates the system or when one uses said system. See MPEP 2173.05(p). Furthermore, it is unclear whether the recited “pump” is made to be part of the device itself, because it could also be provided by the user when performing the method step.
Suggestion to obviate the rejection: Applicant may, for example, amend the limitation above to recite: “wherein the assay device comprises a pump for continuously perfusing media through the assay device”. In the interest of compact prosecution, the claim is interpreted accordingly.
Claim 1 also recites the limitation "the samples or samples" in line 6 and the limitation “the cell culture” in line 7. There is insufficient antecedent basis for these limitations in the claim.
Suggestion to obviate the rejection: Applicant may, for example, consider amending “living cells” (in line 2) to recite “a cell culture comprising living cells”; and further amending “in the sample or samples” (in line 6) to recite “in a sample or samples”. However, Applicant should also take into consideration the rejection of the parent limitation below when amending the claim. See the interpretation of the parent limitation below for further discussion.
The claim limitation “wherein the device comprises means for detecting one or more cytokines in the sample or samples obtained from the cell culture” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
In the instant case, the specification appears to disclose potential structures and/or acts of varying scope that may be related but are not clearly linked to the recited function. For example, the specification recites:
“obtaining one or more liquid samples from the cell culture; and detecting one or more markers in the sample or samples obtained from the cell culture” (see pg. 20, lines 14-16) and “the marker, or analyte… can be a… cytokine” (see pg. 20, lines 18-22);
“[t]he media effluent is easily accessible from the collection syringe, and cell secretome analysis can be nondestructively and temporally performed. This technology was envisioned to be readily incorporated as an in-line assay of current cell therapy manufacturing practices for stepwise potency evaluation” (see pg. 24, lines 11-14); and
“[after] continuous perfusion of IFN-γ supplemented media… secretome analysis was performed on collected media effluent via Luminex assay and cells were recovered following hydrogel degradation and analyzed by flow cytometry” (see pg. 25, lines 16-19).
First, it is not sufficiently clear whether the above passages of the specification are linked to the claimed function of “detecting one or more cytokines”, but they appear to be related to the obtaining of a liquid sample in order to perform analysis, which appears to include detecting cytokines. However, even if this were the case, it could be interpreted that (1) the “means” comprises a human action of obtaining the sample from the device for transferring to another device, (2) the “means” comprises a collection syringe, or (3) the “means” requires an in-line detection component. Not only do these interpretations carry different scopes, but the examiner cannot identify which, if any, of these structures, materials or acts correspond to the “means for detecting” recited in the claim. 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.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
In the interest of compact prosecution, the limitation of “wherein the device comprises means for detecting one or more cytokines in the sample or samples obtained from the cell culture” is presently interpreted as “wherein the device comprises an outlet channel for obtaining one or more cytokines”. This limitation appears to be supported by Applicant’s disclosure (see pg. 4, lines 15-18; FIG. 3) and reasonably provides the minimal structure required to collect a sample (i.e., effluent) for the detection of cytokines.
Claims 2-14 are rejected for depending from an indefinite claim and for failing to obviate the basis for the rejection of the claim from which they depend.
Claim 13 also recites the limitation "the liquid media" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Suggestion to obviate the rejection: Applicant may, for example, amend this limitation to recite “the media”. In the interest of compact prosecution, the claim is interpreted accordingly. Applicant may alternatively amend claim 1 (e.g., to recite “a liquid media”) to provide antecedent basis for claim 13.
Claim 14 also recites the limitation "the closed system" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Suggestion to obviate the rejection: Applicant may, for example, amend this limitation to recite “the sealed system”. In the interest of compact prosecution, the claim is interpreted accordingly.
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)(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) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams, et al. (Enabling Mesenchymal Stromal Cell Immunomodulatory Analysis using Scalable Platforms. Integr Biol (Camb). Pubmed. 01 April 2019; 11(4): 154-162; cited in the IDS filed 10/30/2023 at Cite No. 2), hereafter, “Williams”.
Regarding claim 1, Williams discloses a microfluidic device designed to demonstrate the feasibility of using microfluidics for high throughput potency testing (pg. 4, para. 5). Williams teaches that the platform was designed to demonstrate the feasibility of evaluating the response of human mesenchymal stromal cells (hMSCs) cultured in hydrogels to factors, such as inflammatory stimuli, in a high-throughput and scalable manner (see Abstract; pg. 8, para. 2). Williams teaches the hMSCs are encapsulated in synthetic polyethylene glycol (PEG)-based hydrogels in a scalable tissue-on-a-chip platform (see pg. 3, para. 1; pg. 5, para. 3), wherein the hMSCs are those that were screened for colony forming units, cell growth, and differentiation (see pg. 3, para. 3), and hence, are “living cells”.
Regarding the limitation, “wherein the hydrogel is incorporated into a sealed system”, Williams discloses that a hole was punched through polydimethylsiloxane (PDMS), generating a channel through which inflammatory stimuli could be perfused, and the hole was then filled with PEG-4MAL hydrogel containing hMSCs and enclosed via a plasma-bonded glass coverslip (see pg. 4, para. 3). It should be noted that this is the same bonding technique for obtaining a “sealed” system disclosed in the instant specification (see instant specification at pg. 32, lines 27-32).
Williams discloses that the channel filled with PEG-4MAL hydrogel was perfused with growth media containing inflammatory stimuli, IFN-gamma and TNF-alpha (see pg. 8, para. 4). Further, Williams teaches that IFN-gamma is an important licensing cytokine at sites of inflammation (see pg. 3, para. 2).
Regarding the limitation of “a pump”, Figure 2 of Williams’ disclosure illustrates the use of a syringe to perfuse media through the channel:
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As the syringe is a mechanical device that moves fluids using pressure, it reasonably meets the limitation of a “pump”. Furthermore, the instant specification states, “a pump is used to continually perfuse media through the assay device. This can be done, for example, with a peristaltic or fixed displacement/syringe pump” (see instant specification at pg. 17, lines 26-28).
Regarding the limitation of a “means for detecting”, as discussed under 35 U.S.C. 112(b), this limitation is interpreted as the device comprising an outlet channel for obtaining one or more cytokines. Figure 1 of Williams’ disclosure illustrates the device comprising both an inlet for perfusing media and an outlet for collecting effluent containing secreted cytokines:
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In Summary, Williams teaches a microfluidic potency assay device (a microfluidic device based on an assay platform for potency analysis) comprising living cells (hMSCs), wherein the cells are encapsulated in a synthetic hydrogel (PEG-4MAL), and further wherein the hydrogel is incorporated into a sealed system (PDMS channel with plasma-bonded glass coverslip) which is perfused with media using an attached pump (syringe), wherein the device comprises an outlet channel for obtaining one or more cytokines (effluent with secreted cytokines).
Regarding claim 2, Williams teaches the hMSCs have differentiation capacities (see pg. 2, para. 2) and were screened for differentiation prior to being used in the platform (see pg. 3, para. 3). Hence, the cells (hMSCs) of Williams are “differentiating cells”.
Regarding claim 3, Williams teaches the differentiating cells are human mesenchymal stromal cells (hMSCs), as discussed above.
Regarding claim 4, Williams teaches the synthetic hydrogel comprises PEG-4MAL, as discussed above.
Regarding claim 5, Williams teaches the hydrogels used for hMSC culture were prepared by combining the cross-linkers VPM and dithiothreitol (DTT) to provide a crosslinking solution, which was mixed with the PEG-4MAL/RGD solution (hydrogel) and hMSCs (see pg. 4, para. 2). The cross-linker, “VPM”, meets the limitation of a “protease-degradable peptide” in view of instant claim 6.
Regarding claim 6, Williams teaches the hydrogel is mixed with the cross-linker, VPM, as discussed above.
Regarding claim 7, Williams discloses VPM as “GCRDVPMS↓MRGGDRCG” (see pg. 4, para. 2), which is identical to GCRDVPMSMRGGDRCG (instant SEQ ID NO: 1).
Regarding claim 8, Williams teaches the hydrogels used for hMSC culture were prepared by combining the cross-linkers VPM and dithiothreitol (DTT) to provide a crosslinking solution, which was mixed with the PEG-4MAL/RGD solution and hMSCs, as discussed above. The cross-linker, “dithiothreitol (DTT)” meets the limitation of a dithiolated molecule in view of instant claim 9.
Regarding claim 9, Williams teaches the dithiolated molecule comprises dithiothreitol (DTT), as discussed above.
Regarding claim 10, Williams teaches the hydrogels were prepared by adding the hMSCs to a solution comprising PEG-4MAL and the adhesive peptide GRGDSPC (RGD), which was then combined with the crosslinkers (see pg. 4, para. 2).
Regarding claim 11, Williams teaches the adhesive peptide comprises RGD, as discussed above.
Regarding claim 12, Williams discloses RGD as GRGDSPC, which is identical to GRGDSPC (instant SEQ ID NO: 2), as discussed above.
Regarding claim 13, Williams teaches the hydrogel is perfused with a medium containing IFN-gamma and TNF-alpha, as discussed above.
Regarding claim 14, Williams teaches the sealed system is comprised of silicone polydimethylsiloxane (PDMS), as discussed regarding claim 1.
Response to Arguments
Regarding the rejections under 35 U.S.C. 102, Applicant argues that claim 1, as amended, is directed to a dedicated, validated predictive diagnostic system configured and used to generate a potency readout suitable for cell-therapy product characterization and prediction of clinical efficacy, including donor-to-donor variability. In contrast, Williams is expressly framed as an engineering “proof-of-concept” study focusing on feasibility and scalability of culturing hMSCs in PEG-based hydrogels in a microfluidic device. Williams repeatedly emphasizes feasibility of using 3D PEG-hydrogel microfluidic culture for “scalable” analysis and “high-throughput” evaluation of hMSC responses, but Williams neither designs nor validates a potency assay that predicts in vivo therapeutic performance or donor-specific clinical efficacy. Williams does not establish, or even propose, a defined potency readout linked to clinically relevant functional outcomes or in vivo therapeutic responses.
Applicant’s arguments have been fully considered but they are not persuasive.
First, Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 1. When reading the preamble in the context of the entire claim, the recitation of the “scalable, high throughput” capabilities of the claimed device does not effectively serve to limit the structure of the claimed product beyond the structure that is already recited in the body of the claim. Here, the claim is directed to a device which is recited as comprising the same structures as the prior art device, which is disclosed by Williams as being capable of high-throughput and scalable operation. Applicant’s argument fails to address which recited structure(s) result in a functional difference over the prior art device, or explain how these structure(s) are absent in the prior art reference.
Furthermore, Applicant appears to acknowledge that Williams expressly teaches scalability and high-throughput to be goals of the microfluidic platform, while disparaging Williams for not teaching this platform to have been “validated” for the same purposes of Applicant’s invention. A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). Here, Williams adequately describes the prior art device possessing the same structures that are recited in the claims.
Regarding the argument that “Williams does not establish, or even propose, a defined potency readout linked to clinically relevant functional outcomes or in vivo therapeutic response”, 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. Furthermore, it should be noted that the features upon which applicant relies (i.e., “defined potency readout”, “cell-therapy product characterization”, “prediction of clinical efficacy”, “donor-to-donor variability”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Applicant’s arguments fail to address how these capabilities arise from the structure of the claimed product, let alone how these features amount to a structural difference compared to the prior art of Williams.
Applicant further argues that even if certain structural features overlap, Williams fails to disclose the claimed "microfluidic potency assay" as understood in Applicant's specification: an integrated assay system whose design and outputs have been functionally validated as predictive of hMSC immunomodulatory potency and clinical-like efficacy, not merely an in vitro engineering platform for observing cell responses. A reference that discloses a device for general in vitro characterization but does not teach or suggest that the device constitutes a validated potency assay cannot anticipate a claim that is directed to such a potency assay, particularly where, as here, the Examiner has expressly recognized that "potency" and "potency analyses" carry functional significance in the art.
Applicant’s arguments have been fully considered but they are not persuasive.
Regarding the argument that Applicant’s specification describes “an integrated assay system whose design and outputs have been functionally validated”, this argument is not persuasive for at least the same reasons discussed above. Furthermore, it is unclear if the intended meaning of this argument is that the structures of claim 1 are considered to be “integrated” merely because they are attached to one another, or whether Applicant believes one may envisage from the specification a more comprehensive system of components. In either case, there is not enough structural detail recited in the claim itself for the examiner to construe the claimed invention to be any more “integrated” than the platform described in Williams’ disclosure. Applicant is reminded that limitations from the specification are not read into the claims.
Regarding Applicant’s argument that Williams teaches “a device for general in vitro characterization”, this argument again attempts to distinguish the claimed invention by its intended use, rather than specifically pointing out structural differences. Applicant is reminded that a reference may be directed to an entirely different problem than the one addressed by the inventor, yet the reference is still anticipatory if it explicitly discloses every limitation recited in the claims. See MPEP 2131.05. However, it should be noted that Williams is clearly directed to providing a device (see pg. 4, para. 3) based on a microfluidic platform (see pg. 3, para. 1) intended for testing the potency of hMSC-based therapies, based on the hMSC secretion of cytokines, for clinical applications (see pg. 2, Introduction, paras. 1-3). Williams explicitly states that such potency assays are intended to be predictive of in vivo effects (see pg. 2, Introduction, para. 3; pg. 9, para. 2). Therefore, Applicant’s argument that Williams’ teachings are limited to “general in vitro characterization” is not a reasonable conclusion.
Finally, Applicant’s statement that “the Examiner has expressly recognized that ‘potency’ and ‘potency analyses’ carry functional significance in the art”, this argument is unclear. For one, Applicant fails to specifically point out where the Examiner has "expressly recognized" this significance and moreover fails to explain how this significance relates to the facts of the rejection under 35 U.S.C. 102. Furthermore, the examiner maintains that the claimed product is primarily limited by its structure, not its function or intended use. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP 2114(II).
Applicant further argues that the claimed assay maps on-chip hMSC secretory responses directly against functional hMSC-mediated immune cell suppression, establishing a mechanistic link between on-chip readouts and the therapeutic mechanism of action relevant to clinical immunomodulation. By contrast, Williams' "outputs" are limited to general phenotypic changes and cytokine secretion profiles of hMSCs cultured in 3D versus 2D environments under defined inflammatory gradients. Williams does not perform co-culture experiments, demonstrate the prediction of immune suppression potency, or correlate microfluidic readouts for cell-therapy product characterization. The Examiner characterizes Williams as teaching "a microfluidic platform for analyzing the response of human mesenchymal stromal cells (hMSCs) to factors such as inflammatory stimuli for potential use in potency analyses." However, "potential use in potency analyses" is speculative and forward-looking without any actual potency assay design, calibration, or validation in Williams. Williams stops at demonstration of differential cytokine secretion and phenotype under various microenvironmental conditions; it does not establish whether those differences correspond to increased or decreased functional immunomodulatory potency in a clinically relevant context.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation. As before, Applicant’s argument does not identify any structures in the claimed product which are responsible for the capabilities of the claimed assay device, and fails to recognize that the intended use of the device does not distinguish it from the prior art when the prior art teaches every structural limitation recited in the claim. It is not persuasive to argue that two identical products are somehow different, based only on the fact that the prior art device was not subjected to the same level of testing to demonstrate its capabilities. These differences must be captured by the structural limitations recited in the claim in order to distinguish the claimed invention from the prior art under 35 U.S.C. 102.
Applicant further argues that the claimed assay is expressly configured and validated such that secretory outputs (e.g., defined cytokine signatures under controlled microfluidic stimuli) are quantitatively correlated with downstream functional readouts of immune cell suppression, thereby enabling the assay to serve as a predictive diagnostic for hMSC therapeutic performance. Williams does not disclose this required functional linkage or mechanism-of-action-based validation and therefore cannot anticipate the claimed subject matter.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant fails to specifically point out what configurations are “expressly” recited in the claims that give rise to the alleged difference in functional capabilities of the claimed assay. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Applicant is also reminded that proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation, and claims to an apparatus cover what the device is, not what it does.
Applicant further argues that the Examiner relies on structural identity between Williams' microfluidic system and the claimed assay, concluding that Williams "teaches a microfluidic potency assay (microfluidic platform for potency analysis) comprising living cells ... encapsulated in a synthetic hydro gel ... incorporated into a closed system ... perfused with media containing disease-relevant chemical stimuli." This characterization again overlooks a critical conceptual and functional distinction between the two works: Williams is limited to in vitro characterization of cell behavior in a 3D microfluidic environment, whereas Applicant's invention is purpose-built to bridge in vitro assay readouts to in vivo physiological and therapeutic performance.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that 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. Applicant’s arguments fail to provide any objective evidence to show that there is a structural difference presented in the claims that result in the claimed device having a “functional distinction” from the device disclosed by Williams.
Applicant further argues that the anticipation analysis in the Office Action appears to treat claim 1 as if it were limited purely to static structural elements (microfluidic channel, PEG hydrogel, encapsulated hMSCs, perfused inflammatory media), and then maps each structural element to Williams. Applicant respectfully submits that this construction is overly narrow and inconsistent with the claim language read in light of the specification. Williams fails to disclose the claimed invention "as a whole" and therefore cannot anticipate under 35 U.S.C. § 102(a)(1).
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). It should be noted further that even if the prior art device performs all the functions recited in the claim, the prior art cannot anticipate the claim if there is any structural difference. In re Donaldson, 16 F.3d 1189, 1193, 29 USPQ2d 1845, 1848 (Fed. Cir. 1994) (emphasis added). See MPEP 2114.
Therefore, the treatment of a claimed device based on its “static structural elements” is consistent with the patent examining procedure set forth in the MPEP. MPEP 2114 clearly establishes that a claimed device can be anticipated based solely on the structure of the prior art device, whereas the disclosed functions of said prior art device cannot anticipate when there is any structural difference. If the examiner finds the disclosure of a prior art device having the same structure as that which is claimed, the burden shifts to the applicant to prove that the prior art device is not capable of performing the recited function. See MPEP 2114(I).
Furthermore, Applicant fails to specifically point out which limitations have been allegedly subjected to an “overly narrow” or “inconsistent” interpretation by the examiner. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In other words, if there are any features having support in the specification which would distinguish the claimed invention from the prior art, it would be improper for the examiner to assume these features to be present in the claimed invention unless they are actually recited in the claims.
Conclusion
No claims are allowed.
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 DENNIS ARMATO whose telephone number is (703)756-5348. The examiner can normally be reached Mon-Fri 11:00am-7:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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