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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on April 20th, 2026. Claims 1-32, 60, and 61 are pending. Claims 19-32 are withdrawn from consideration. Claims 33-59 are canceled.
Specification
The amendments filed April 20th, 2026 and September 11th, 2025 are objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The added recitation to “[i]n some aspects, biochemical cartridge 200 can further include one or more additional ports or portals to a reaction chamber region of the cartridge” is not supported by the disclosure. *(reaction lanes of an electrode configuration 260 appear to have basis as in fig. 23B, but noting that the reaction lanes themselves are not numerically identified)*
Applicant cites page 43 of the specification of related provisional application 62/329,591 as providing support, however, no such support is found. Page 43 is drawn to a figure titled “HRM Actuation Prototype” that highlights the elements “optical post mount,” “spring preload adjustment,” “spring stack,” “consumable interface,” and “motor retainer.”
This does not provide basis for the above-cited amendment to the specification.
Further, the specification of the instant application makes mention of “Power input port 128,” “USB port 128,” “loading port 218,” “CAN port 614,” and “USB port 650” (see pars.[0081,0096,0119,0120] of Applicant’s pre-grant publication US 2021/0311042), but these do not coincide with the added disclosure cited above. It is also notable that the alternative language of “portal” is not found in the specification. It is further noted that the specification is absent discussion to a “reaction chamber” nor “reaction chamber region” as provided herein (Examiner notes that par.[0020] describes a gap between the top and bottom substrates may be an assay chamber).
Applicant is required to cancel the new matter in the reply to this Office Action.
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:
1) Biochemical testing module as in cl. 1.
2) Newborn screening mobile application as in cl. 15.
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.
1) Unclear from the disclosure. *Further clarification is required* see below under 35 USC 112 b/2nd.
2) Unclear from the disclosure. *Further clarification is required* see below under 35 USC 112 b/2nd.
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 1-18, 60 and 61 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.
The metes and bounds of the sought point-of-birth testing system are indefinitely defined herein.
Herein, as amended, Applicant has provided some structural and functional connection among elements of the testing system, however, the metes and bounds remain indefinitely defined as there remain gaps in the structural/functional constitution of elements of the system so as to set forth clear metes and bounds to the sought operative embodiment.
The metes and bounds of the system are indefinitely defined with respect to the cartridge and its sample input well to receive sample fluid and the structural/functional communication afforded with the horizontal reservoir module that provides for sealing and releasing sample processing fluid therein.
The claims are drawn to functionality of “sample processing” in relation to the sample fluid and the sample processing fluid, however, the claimed cartridge is without a communicative relationship between the sample input well and the horizontal reservoir module that respectively provide the sample fluid and sample processing fluid.
The amended recitation that the sample input well having a loading port does not provide such structural/functional relationship to the subsequently-claimed horizontal reservoir module and gap between top and bottom substrates forming a reaction region.
For example, what is the fluid communication afforded from the sample input well and its loading port to the horizontal reservoir module and the gap/reaction chamber region to afford such “sample processing based…on the sample fluid…the sample processing fluid?”
Additionally, the amendment to the foil take-up reel on the biochemical cartridge is indefinitely understood as the base discussion is drawn to “the biochemical cartridge comprising…” in which such a recitation to the reel being “on the biochemical cartridge” is indefinitely understood as it is self-referencing.
From Applicant’s disclosure, it appears that a digital microfluidic arrangement is provided cooperatively between the cartridge and the point-of-birth instrument in which an electrode configuration is provided at the bottom substrate of the cartridge and interfaces with the circuit board of the point-of-birth instrument (see pars.[0102-0104], figs. 23a/b, for example). Examiner notes that there is no particular discussion to the relative movement of the sample fluid to/through the sample processing fluid as a consequence of particularly-actuated electrical contacts.
It is further noted that the specification provides that, alternatively, the biochemical cartridge may comprise a flow cell (par.[0105], fig. 26). However, it is not clear what physical, fluidic connections (i.e. channels/conduits) are defined in such an embodiment wherein the cartridge is a flow cell so as to fluidically communicate the input well with the horizontal reservoir module to allow for desired interaction of the sample fluid and sample processing fluid.
Clarification is required in providing the structural/functional elements to the cartridge that afford either one of the offered embodiments in the specification (digital microfluidics and flow cell) that afford fluidic communication for sample processing with the sample fluid and sample processing fluid.
Further, with respect to the amendments to the circuit board to “control operations…”, without provided operation(s) to various elements of the testing system, it is unclear what is being affected by the circuit board concordant therewith.
Applicant is invited to clarify and recite those operation(s) correlated with various element(s) of the system to which that circuit board may thereby control.
Further, as discussed above, “Biochemical testing module cl. 1” provides a computer-implemented means-plus-function recitation, wherein the written description fails to disclose the algorithm(s) for performing the claimed specific computer functions for biochemical testing.
See MPEP 2181, Section II, B:
For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer-implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.” EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general purpose computer.” EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer-implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714
To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. § 112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.)) An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or “in any other manner that provides sufficient structure.” Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
Applicant’s specification is devoid of the algorithm(s) required for performing biochemical testing.
The “biochemical testing module” is generically and prophetically discussed in pars.[0013,0079] of Applicant’s pre-grant publication US 2021/0311042, but is without the particulars thereto in providing for the particular functionality of biochemical testing. Examiner further notes the general discussion in pars. [0011,0027,0030,0139,0151] to a newborn screening application, software application, point-of-birth application, newborn screening (NBS) desktop/mobile application, however, the discussion itself is generic and to the application’s nominal usage. The disclosure is absent any particular discussion to the algorithm(s) utilized therein which afford such interfacing and operating of the point-of-birth instrument by the newborn screening application.
Further, the functions in the claims go beyond a general purpose computer and are not coextensive with the computer as defined in the MPEP passages cited above. Therefore, the claims are indefinite and rejected under 35 USC 112b/2nd.
It is further seen that the biochemical testing module is indefinitely set forth with its structural/functional relationship within the confines of the system.
Likewise, as in claim 15, the recitation to “newborn screening mobile application” remains to be drawn to computer-implemented means-plus-function recitation to the specific functionality of “newborn screening”, and wherein the software/algorithms thereto are not provided in the disclosure. A user interface alone does not suffice in providing for a “newborn screening mobile application” as a user interface does not provide for “newborn screening” functionality.
Allowable Subject Matter
Claims 1-18, 60, and 61 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest, as best understood herein, a point-of-birth testing system for newborn screening, as particularly recited therein that includes a housing with a circuit board for controlling operations of the instrument biochemical testing module, a biochemical testing module and smart display, a biochemical cartridge as claimed that includes a horizontal reservoir module comprising a foil strip sealing the sample processing fluid inside, and a foil take-up reel for peeling the foil strip to release the sample processing fluid.
Response to Arguments
With regards to the objection to the drawings/specification, Applicant asserts that amendments herein to the specification that find support at least in the corresponding provisional application such as at page 43.
Examiner asserts that such amendments to the specification are drawn to new matter in the disclosure.
From above in the body of the action –
The amendments filed April 20th, 2026 and September 11th, 2025 are objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The added recitation to “[i]n some aspects, biochemical cartridge 200 can further include one or more additional ports or portals to a reaction chamber region of the cartridge” is not supported by the disclosure. *(reaction lanes of an electrode configuration 260 appear to have basis as in fig. 23B, but noting that the reaction lanes themselves are not numerically identified)*
Applicant cites page 43 of the specification of related provisional application 62/329,591 as providing support, however, no such support is found. Page 43 is drawn to a figure titled “HRM Actuation Prototype” that highlights the elements “optical post mount,” “spring preload adjustment,” “spring stack,” “consumable interface,” and “motor retainer.”
This does not provide basis for the above-cited amendment to the specification.
Further, the specification of the instant application makes mention of “Power input port 128,” “USB port 128,” “loading port 218,” “CAN port 614,” and “USB port 650” (see pars.[0081,0096,0119,0120] of Applicant’s pre-grant publication US 2021/0311042), but these do not coincide with the added disclosure cited above. It is also notable that the alternative language of “portal” is not found in the specification. It is further noted that the specification is absent discussion to a “reaction chamber” nor “reaction chamber region” as provided herein (Examiner notes that par.[0020] describes a gap between the top and bottom substrates may be an assay chamber).
Applicant is required to cancel the new matter in the reply to this Office Action.
With regards to the Claim Interpretation under 35 USC 112 f/6th, Applicant traverses the interpretation.
Applicant asserts that the recitation has been amended to “a biochemical testing module,” wherein a 112F interpretation should be withdrawn as the claim does not use the word “means” and “a biochemical testing module” is not a generic placeholder but rather a term that would be understood by persons of ordinary skill in the art to have a sufficiently definite structure, and the term is not modified by functional language.
Examiner asserts that the recitation remains to present a generic placeholder in that of “module” alongside functionality to that of “biochemical testing” without reciting sufficient structure to perform the recited function of “biochemical testing” and the generic placeholder to “module” is not preceded by a structural modifier. *(Conversely, for example, Examiner notes that “horizontal reservoir module comprising sample processing fluid…” as recited herein has not been treated under 112 f/6th as “module” has been preceded by a structural modifier in reservoir that suffices for the functionality of having/holding the fluid).
Examiner further refers Applicant to MPEP 2181 I(A) wherein “module” is particularly called out as a non-structural generic placeholder.
Examiner further notes that Applicant’s general offering that “biochemical testing module” would have a sufficient definite meaning and particularly in light of the specification and figures is wholly unpersuasive as it is drawn to a conclusory remark with substantive evidence thereto and discussion to particular structure.
Further, Applicant’s following remark that the term “biochemical testing module” describes a recognized component in diagnostics instrumentation – a discrete hardware assembly designed to perform biochemical analysis is also unpersuasive as setting forth a discrete hardware assembly is not particular structure and itself is drawn to a generic placeholder in “assembly.”
Examiner further notes that Applicant’s discussion that the “biochemical testing module” is a discrete hardware assembly designed to perform biochemical analysis also confirms that that the recitation “biochemical testing module” does recite functionality as previously indicated by the Examiner and contradicts Applicant’s assertion with respect to element (3) and the recitation purportedly not providing functional language.
Similar discussion is had with respect to the 35 USC 112 F/6th interpretation of “newborn screening mobile application.”
Applicant asserts that “mobile application” is widely understood in the art as a software program designed to run on mobile devices such as smartphones and tablets.
Examiner assert that “mobile application” is a generic placeholder (this is likewise seen with respect to “software” and the like) appended with the functionality of “newborn screening.”
Herein, and as discussed below, the “structure” that is not provided to the claim recitation (and also not clearly provided as in 35 USC 112 b/2nd) is the algorithm(s), particular programming that provides for such a “mobile application” and its functionality to “newborn screening.”
Further, a “user interface” alone does not suffice in providing a “mobile application” and this is further seen through Applicant’s own discussion in which a user interface is not a software program designed to run on mobile devices and does not afford the “newborn screening” functionality.
As discussed above in the concordant rejection under 35 USC 112b/2nd, this recitation is drawn to a computer-implemented 112 f/6th recitation, in which –
See MPEP 2181, Section II, B:
For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer-implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.” EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general purpose computer.” EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer-implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714
To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. § 112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.)) An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or “in any other manner that provides sufficient structure.” Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
This is likewise seen with respect to the “biochemical testing module” as previously discussed in the action mailed on October 20th, 2025.
Examiner notes that in the case of “biochemical testing module” the claimed “module” and its structure for biochemical testing may be to a combination of physical infrastructure therefor as well as particular programming therefor. At present, and as seen through the prior and above-discussed rejection of the claims under 35 USC 112 b/2nd, neither part of the “structure” to the module for biochemical testing is definitely provided. This is further seen in its overall relationship within the system being indefinitely set forth as it is not recited with connection to element(s) of the system.
With regards to claims 1-18, 60, and 61 under 35 USC 112 b/2nd, Examiner acknowledges Applicant’s remarks with respect to the rejection and the amendments made herein and directs Applicant above to the body of the action wherein the rejection is maintained and further discussion is provided to the present response.
Examiner further notes that with respect to “biochemical testing module,” removal of the phrase “that includes a process for testing assays” does not suffice to remedy the issue of indefiniteness.
As discussed above, the recitation “biochemical testing module” remains drawn to interpretation under 35 USC 112 F/6th, and wherein such recitation is drawn to a computer-implemented 112F/6th recitation that is concordantly rejected under 35 USC 112 b/2nd for those reasons discussed above and in the body of the action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Handique et al. (US 2007/0292941) discloses an integrated system for processing microfluidic samples that includes a microfluidic cartridge having reservoirs sealed by pierceable blisters wherein the cartridge is loaded into to a housing for processing and detection of analytes thereof the sample and the system includes a display for results thereof and software to interface with uses for conducting analysis or analyzing results, which is relevant to Applicant’s field of endeavor.
Lowe et al. (US 2013/0309778) discloses an assay device and reader wherein the reader may include electrical circuitry and software to allow the reader to be programmed to carry out one or more different assays, and wherein the reader accepts an assay cartridge, which is relevant to Applicant’s field of endeavor.
Kayyem et al. (US 2016/0129437) discloses an instrument and cartridge for performing assays in a closed sample preparation and reaction system employing electrowetting fluid manipulation, and wherein the cartridge includes chambers sealed by pierceable blisters that are pierced by a compression mechanism for selective releasing reagent or buffer for the assays, which is relevant to Applicant’s field of endeavor.
THIS ACTION IS MADE FINAL. 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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, Charles Capozzi can be reached at 571-270-3638. 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.
/NEIL N TURK/ Primary Examiner, Art Unit 1798
Prosecution Insights