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 .
Response to Arguments/Amendments
Applicant’s arguments with respect to claims 1-13 filed 8/5/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
The claim amendments dated 8/5/2026 have overcome the rejection under 35 U.S.C. 112(b) presented in the prior Office Action. However, the amendments to the claims warrant a new rejection under 35 U.S.C. 112(b) discussed below.
The claim and specification amendments dated 8/5/2026 have overcome the objection to the claims, specification, and drawings presented in the prior Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 5/18/2026 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“an inserting member…configured to accommodate the well array” in claim 3, lines 3 and 4;
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is 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 14 recites the limitation "the sample" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Oleksandrov et al. (US 2019/0329254 A1) (hereinafter referred to as Oleksandrov, presented in IDS filed 5/18/2026) in view of Lim et al. (US 2016/0271604 A1) (hereinafter referred to as Lim, presented in IDS filed 12/22/2023).
Regarding claim 1, Oleksandrov discloses an in vitro diagnostic chip (abstract) having multiple levels of hydrophilicity ([0066], hydrophilic coating layer on well array), comprising:
a well array comprising a plurality of wells (Fig. 2, well array 140); and
a coating layer coated on the well array ([0066]).
Oleksandrov does not disclose or teach wherein the coating layer has different hydrophilicity in the different regions.
However, Lim in the analogous art of devices for PCR teaches it is known in the art to form a coating layer with different hydrophilicity in different regions of a well array. Lim teaches that a patterned coating with both hydrophilic and hydrophobic properties facilitates loading of liquid in reaction sites on well array (Fig. 1B, [0060] and [0097]-[0098]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating layer of Oleksandrov’s well array to have different hydrophilicity in different regions to facilitate loading of liquid in the well array, as taught by Lim.
Regarding claim 2, the prior art combination teaches the in vitro diagnostic chip of claim 1.
Lim of the prior art combination discloses wherein the multi-hydrophilic coating layer has higher hydrophilicity in the central region of the well array as compared to the peripheral region of the well array (Fig. 1B, [0060] and [0097]-[0098]).
Regarding claim 3, the prior art combination teaches in vitro diagnostic chip of claim 1, further comprising:
a chip housing (Oleksander: Fig. 2, bottom case 120); and
an inserting member (Oleksander: Figs. 2 and 7, microfluidic chamber 130), wherein the inserting member is accommodated in the chip housing and configured to accommodate the well array (Figs. 2 and 7).
Regarding claim 4, the prior art combination teaches the in vitro diagnostic chip of claim 3, wherein the inserting member comprises silicone (Oleksander: [0063] discloses PDMS).
Regarding claim 12, the prior art combination teaches the in vitro diagnostic chip of claim 3, further comprising films configured to cover the well array, wherein the films comprise an emission film (Oleksandrov: [0091] color filter, [0085]-[0086] discuss emission filter).
The limitation “configured to cover the well array” is directed toward the intended manner of operating the claimed film and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art emission film would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 13, the prior art combination teaches the in vitro diagnostic chip of claim 3, further comprising a well cover configured to cover the well array (Oleksandrov: Fig. 2, upper case 110).
Regarding claim 14, the prior art combination teaches the in vitro diagnostic chip of claim 1.
The limitation “wherein portions of the sample flow from central regions of the well array to peripheral regions of the well array” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Oleksandrov in view of Lim as applied to claim 3 above, and further in view of Carrano et al. (US 2017/0209865 A1) (hereinafter referred to as Carrano, see PTO-892).
Regarding claim 5, the prior art combination teaches the in vitro diagnostic chip of claim 3.
The prior art combination does not disclose or teach side portions of the chip housing or the inserting member with pinching holes, groves, or protrusions.
However, Carrano in the analogous art diagnostic cartridges teaches it is known in the art to form a housing, i.e., a chip housing, with actuation posts formed at a side portion, i.e., pinching protrusions, and a substrate, i.e., an inserting member, with alignment holes formed at a side portion, i.e., pinching holes or pinching grooves (Figs. 2 and 8B, actuator posts 207 and alignment holes 560, 561, 563, 565). Carrano teaches that the actuator posts and alignment holes facilitate the alignment of the substrate with the housing ([0040] and [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination chip housing and inserting member with pinching holes, grooves, or protrusions in the manner claimed in claim 5 for the purpose of aligning the inserting member within the chip housing, as taught by Carrano. The ordinarily skilled artisan would be motivated to mitigate user error or to improve internal stability.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Oleksandrov in view of Lim as applied to claim 2 above, and further in view of Handique (US 2009/0130719 A1) (see PTO-892).
Regarding claim 11, the prior art combination teaches the in vitro diagnostic chip of claim 2.
The prior art combination does not disclose or teach an EEPROM.
However, Handique in the analogous art of microfluidic cartridges teaches it is known in the art to use an EEPROM to store assay information ([0323]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination diagnostic chip to further comprise an EEPROM for the purpose of storing assay information, as taught by Handique.
Although the prior art combination does not disclose or teach the EEPROM accommodated in the chip housing, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the EEPROM in the chip housing because such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the EEPROM would perform the same function regardless of location.
The limitation “configured to store data for chip history management” is directed toward the intended manner of operating the claimed EEPROM and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art EEPROM would be fully capable of achieving every claimed intended use because the prior art EEPROM is capable of storing data, as discussed above.
Allowable Subject Matter
Claims 6-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, Oleksandrov and Lim provide the closest prior art as discussed above. Oleksandrov in view of Lim teach the in vitro diagnostic chip as claimed in claim 3. The prior art combination does not fairly disclose or teach wherein the inserting member is coupled to an upper surface of the chip housing through a bottom surface of the inserting member, and wherein an upper surface of the inserting member comprises a receiving groove to accommodate the well array within the claim environment.
Claims 7-10 contain allowable subject matter because of their dependency on claim 6.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kojima et al. (US 2013/0102062 A1) drawn to a microchip for PCR utilizing a hydrophilic layer
Niemeyer et al. (US 2017/0157641 A1) drawn to a microfluidic chip utilizing combination of hydrophobic and hydrophilic materials to fill measurement regions.
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 ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
