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 September 11th, 2025. Claims 1-32, 60, and 61 are pending. Claims 19-32 are withdrawn from consideration. Claims 33-59 are canceled. Claims 60 and 61 are newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 11th, 2025 has been entered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Newly-added reference number 217 is not provided in the specification, and notably not within the amended specification as provided herein.
From the amendment on 09/11/25, does Applicant intend that the “…one or more ports or portals” are the identified elements to reference number 217?
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In the amended portion of the specification filed 09/11/25, the disclosure to “…reaction lanes of an electrode configuration…” is missing its corresponding numerical identifier of ‘260.’
Appropriate correction is required.
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 that includes a processor for testing assays 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.
As amended, Applicant has provided a parts listing to those items included in the point-of-birth instrument (housing, loading dock, circuit board, biochemical testing module). However, the metes and bounds of the point-of-birth instrument are indefinitely defined as these elements are without structural and/or functional relationships to one another so as to form the sought point-of-birth instrument for its operative embodiment.
Herein, as amended, Applicant has provided a parts listing to those items included in the biochemical cartridge, however, the elements are absent cooperative structural/functional connection so as to set forth clear metes and bounds to the operative arrangement sought.
What is the functional/structural relationship of the sample input well, horizontal reservoir module comprising processing fluid that is sealed by a foil strip, foil take-up reel, and the gap forming a reaction chamber region?
Further, as discussed above, “Biochemical testing module that includes a processor for testing assays as in 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 testing assays.
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 the testing assays.
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 testing assays. 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.
This is likewise seen in claim 15, in which 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.”
Further, as in claim 1, 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.
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.
Lastly, the metes and bounds of the cartridge are indefinitely defined as it is unclear how (structurally and/or functionally) the recited top and bottom substrate relate with the previously-recited elements above (sample input well, horizontal reservoir module, foil take-up reel).
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 biochemical cartridge as claimed comprising a sample input well, a horizontal reservoir module comprising sample processing fluid wherein the 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, and wherein the biochemical cartridge comprises a bottom substrate and a top substrate spaced from the top substrate by a gap, a portion of the gap forming a reaction chamber region for sample processing based at least in part on the sample fluid from the sample input well and the sample processing fluid, and wherein the biochemical cartridge is insertable into the loading deck to process the sample fluid of the newborn and wherein the smart display communicates results of processed sample fluid of the newborn.
Response to Arguments
With regards to the objection to the drawings, Applicant traverses the rejection and sets forth the replacement sheet including to figures 17, 18, 20, 22B, 23A, and 29A.
Examiner acknowledges these changes along with the amendments provided to the specification herein, and notes that Applicant has added numerical identifier ‘217’ to the figures, however, the accompanying amended disclosure in the specification is absent correlation of such identifier ‘217’. As discussed above, does Applicant intend that the one or more ports or portals are to be labeled with ‘217’?
Further, and as discussed above in the objection to the specification, Examiner notes that the “electrode configuration” is absent its correlated numerical identifier ‘260.’
Appropriate correction is required.
Applicant’s arguments with respect to claim(s) 1-18, 60, and 61 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As discussed above, claims 1-18, 60, and 61, as amended, are rejected under 35 USC 112 b/2nd for the reasons discussed above in the body of the action.
Conclusion
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, Jill Warden can be reached at 571 272-1267. 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