DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1, 3, 4, 6, 8-11, 13, 16-19, 22-24, drawn to a sensing apparatus; and species A 1, B 1, C 1 and D 1, in the reply filed on 02/12/2026 is acknowledged.
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: configured to [...] in claims 1, 10, 16-18 and 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 4, 6, 8-11, 13, 16-19, 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 10, 16-18 and 22-24 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Regarding claims 1, 10, 16-18 and 23, the phrase “configured to” renders the claims indefinite because it is unclear what structural configurations are being claimed. Claims 1, 10, 22 and 24 are similarly unclear reciting the word “coupleable” because it is unclear whether the applicant is trying to claim a structure or a function. Further, Claims 1, 10, 16-18 and 22-24 are unclear whether the limitation(s) following the phrase “configured to” and/or the word “coupleable” are part of the claimed invention. For example, claim 1 is unclear how the part of the wall comprising a printed circuit board substrate comprising an electrode is structurally configured that the electrode is able to transmit a signal to the biological sample, and how the electrode is structurally ‘being coupleable’ (capability or function of the electrode itself?) to a sensing control unit located outside the chamber. Further, it is unclear if the “sensing control unit located outside the chamber” is part of the claimed invention.
Regarding claims 1, 10, the phrase “coupleable to a sensing control unit located outside the chamber” renders the claims indefinite because the claims include elements not actually disclosed, thereby rendering the scope of the claims unascertainable.
Regarding claim 24, the phrase “coupleable with another sensing apparatus” renders the claim indefinite because the claim includes elements not actually disclosed, thereby rendering the scope of the claim unascertainable.
Claim 1 recites the limitation "the part of the wall" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 is unclear reciting “at least part of a wall of the chamber comprising a printed circuit board substrate; the part of the wall comprising a printed circuit board substrate”. Is the applicant intending to claim two different printed circuit substrates located at the same part of the chamber? Is “the part of the wall” referring to the “at least part of a wall”?
Claim 3 recites the limitation "the substrate" in L2. There is insufficient antecedent basis for this limitation in the claim. It is unclear which substrate in claim 1 is being referred.
The term “biocompatible” in claim 3 is a relative term which renders the claim indefinite. The term “biocompatible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 4 recites the limitation "at least one wall of the chamber" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the conductive channel surface" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "at least one wall of the chamber" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is unclear reciting “at least part of a wall of the second chamber comprising a printed circuit board substrate; and the part of the wall of the second chamber comprising a printed circuit board substrate”. Is the applicant intending to claim two different printed circuit substrates located at the same part of the second chamber? Is “the part of the wall” referring to the “at least part of a wall”?
Claim 11 recites the limitation "a wall [...] a wall" in L2-L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is unclear reciting “the printed circuit board substrate comprising the at least part of a wall of the chamber and the printed circuit board substrate comprising the at least part of a wall of the second chamber” because preceding claims recite the at least part of the wall of the chamber comprises the printed circuit board substrate and the at least part of the wall of the second chamber comprises the printed circuit board substrate. Consequently, it is unclear what is being claimed.
Claim 13 recites the limitation "the printed circuit board substate" in L3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which printed circuit board substrate in claim 1 is being referred.
Claim 13 recites the limitation "a wall" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "channel" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation “configured to [...]” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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, 3, 4, 6, 8-11, 13, 16-19, 22-24 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Collins (US 2021/0055283 A1).
Regarding claim 1, Collins teaches:
1. A sensing apparatus comprising:
a chamber (e.g., wells ¶ 0266+ & Figs. 27-29+) configured to receive a biological sample (¶ 0261+);
at least part of a wall of the chamber comprising a printed circuit board substrate (e.g., top PCB with amplifier array and DAQ, ¶ 0092; intermediate PCB with extended connectors, ¶ 0277);
the part of the wall comprising the printed circuit board substrate comprising an electrode (e.g., microelectrode array/multi electrode array) capable of transmitting a signal (see ¶ 0271-0277 for example); and
a channel (see e.g., 1503, 2001, 2002, 2104, 2202, 2302, 2503, 3207, 4901, 4902+) in communication with the chamber (see Figs. 15, 20-28, 31-41, 47-49+ for example), the channel being dimensioned to allow the biological sample to extend through the channel (see ¶ 0264-0273 for example), the channel comprising a conductive surface (e.g., electrical leads and contact pads ¶ 0276-0277) capable of transmitting a signal (see ¶ 0271-0277 for example).
With regard to limitations in claims 1, 3, 4, 6, 8, 9, 10, 16-18, 22-24 (e.g., [...] to transmit or receive a signal to the biological sample, the electrode being coupleable to a sensing control unit located outside the chamber; [...] to transmit or receive a signal to at least a portion of the biological sample extendable through the channel, the conductive channel surface being coupleable to the sensing control unit located outside the chamber [...] to transmit or receive a second chamber signal to the second biological sample the second chamber electrode being coupleable to a sensing control unit located outside the second chamber, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 3, 4, 6, 8-11, 13, 16-19, 22-24, Collins teaches:
3. The sensing apparatus according to claim 1, wherein at least one of the substrate, the chamber, the electrode, the channel, and the conductive surface comprise a material (see i.e., ¶ 0045, 0265; see also: the perfusion of fluids can be performed using a set of liquid pumps and valves which are compatible with all the liquids such as cell media, buffer, drug, solvents. ¶ 0267).
4. The sensing apparatus according to claim 1, wherein at least one wall of the chamber comprises an adhesion layer (see ¶ 0263, 0272, 0276, 0285+ for example).
6. The sensing apparatus according to claim 1, wherein the conductive surface comprises an adhesion layer (see ¶ 0263, 0272, 0276, 0285+ for example).
8. The sensing apparatus according to claim 4, wherein the adhesion layer comprises a material selected from the group consisting of: poly(lysine) (PL), poly(ornithine) (PO), poly(arginine), poly(ethylenimine) (PEI), poly-L-lysine (PLL), poly-D-lysine (PDL), poly-L-ornithine (PLO), and an extracellular cell matrix or a laminin coating (see ¶ 0263, 0272, 0276, 0285+ for example).
9. The sensing apparatus according to claim 1, wherein at least one wall of the chamber comprises a cell growth factor (see ¶ 0069 for example).
10. The sensing apparatus according to claim 1, wherein the apparatus comprises: a second chamber (e.g., wells ¶ 0266+ & Figs. 27-29+) configured to receive a second biological sample (¶ 0261+); at least part of a wall of the second chamber comprising a printed circuit board substrate (e.g., top PCB with amplifier array and DAQ, ¶ 0092; intermediate PCB with extended connectors, ¶ 0277); and the part of the wall of the second chamber comprising the printed circuit board substrate comprising a second chamber electrode (e.g., microelectrode array/multi electrode array) capable of transmitting a second chamber signal (see ¶ 0271-0277 for example), and wherein the channel connects the chamber and the second chamber (see Figs. 15, 20-28, 31-41, 47-49+ for example).
11. The sensing apparatus according to claim 10, wherein the chamber and the second chamber are on the same printed circuit board substrate (see ¶ 0277 & Figs. 59-60 for example).
13. The sensing apparatus according to claim 1, wherein the apparatus comprises: at least one further printed circuit board substrate (e.g., top PCB with amplifier array and DAQ, ¶ 0092; intermediate PCB with extended connectors, ¶ 0277) located above the printed circuit board substrate comprising the at least part of the wall of the chamber, and wherein the chamber is formed between the printed circuit board substrate and the further printed circuit board substrate (see ¶ 0277 for example).
16. The sensing apparatus according to claim 1, wherein the apparatus comprises an access port associated with the chamber, the access port being capable of allowing insertion of the biological sample into the chamber (see ¶ 0272-0273 & Figs. 58-60 for example).
17. The sensing apparatus according to claim 10, wherein the apparatus comprises: an access port associated with each chamber, each access port being capable of allowing insertion of a biological sample into the respective chamber (see ¶ 0272-0273 & Figs. 58-60 for example).
18. The sensing apparatus according to claim 17, wherein the access port is capable of allowing insertion of a biological sample into a respective chamber from an outer surface of the apparatus (see ¶ 0272-0273 & Figs. 58-60 for example).
19. The sensing apparatus according to claim 1, wherein the channel comprises a via formed on the printed circuit board substrate (see ¶ 0277, Figs. 34A, 59A, 59B, 60B for example).
22. The sensing apparatus according to claim 1, wherein the chamber and channel are in communication with each other (see Figs. 15, 20-28, 31-41, 47-49+ for example) and to a media source (see Fig. 32C & ¶ 0267 for example).
23. The sensing apparatus according to claim 22, further comprising a media circulation device (e.g., pumps) configured to circulate media through the chamber (see Fig. 32C & ¶ 0267 for example).
24. The sensing apparatus according to claim 1, wherein the channel of the sensing apparatus is capable of being coupled with another sensing apparatus (see ¶ 0058 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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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.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798