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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2022 and 01/26/2024 have been considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group II, Claims 11-14, in the reply filed on 04/24/2026 is acknowledged. Applicant has also added Claims 15-20, which are drawn to Group II. Thus, Group I, Claims 1-10 are withdrawn and Group II, Claims 11-20 are examined herein.
Claim Objections
Claims 11-14 are objected to because of the following informalities:
Claim 11, please amend “measuring an impedance of an intestinal organoid” to “measuring an impedance of [[an]] the intestinal organoid”; “step of filling” to “a step of filling”; “step of positioning” to “a step of positioning”; and “step of evaluating” to “a step of evaluating”.
Claim 12, please amend “evaluate using difference” to “evaluate using a difference”.
Claim 13, please amend “measuring an impedance of an intestinal organoid” to “measuring an impedance of [[an]] the intestinal organoid”; “step of filling” to “a step of filling”; “step of forming” to “a step of forming”; “step of measuring” to “a step of measuring”; “step of evaluating” to “a step of evaluating”.
Claim 14, please amend “equation 1” to “[[e]]Equation 1”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings in Figures 1 and 2 are unclear as to which tubes corresponds to the first tube, the at least three second tubes, the third tube, and the fourth tube. As the specification does not include reference numbers for the various tubes and there are no labels in either Figure 1 or Figure 2, the impedance-based organoid evaluation system in Figures 1 and 2 is unclear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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 limitations are: Claim 11, “a step of forming a negative pressure in the intestinal organoid deformation generating unit” is being interpreted under 35 U.S.C. 112(f). Prong 1: the intestinal organoid deformation generating unit (uses a generic placeholder), prong 2: forming a negative pressure (functional language), prong 3: sufficient structure for performing the function is not recited. Therefore, claim 11 invokes 112(f). The corresponding structure for performing the functions is not described in the specification.
Claim 13, “a step of forming a negative pressure in the intestinal organoid deformation generating unit” is being interpreted under 35 U.S.C. 112(f). Prong 1: the intestinal organoid deformation generating unit (uses a generic placeholder), prong 2: forming a negative pressure (functional language), prong 3: sufficient structure for performing the function is not recited. Therefore, claim 13 invokes 112(f). The corresponding structure for performing the functions is not described in the specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 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 limitations recite 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 11-20 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.
Regarding Claim 11, the limitations “the barrier integrity” in line 1 and “the second tubes” lack antecedent basis. In addition, the limitation “a step of forming a negative pressure in the intestinal organoid deformation generating unit” invokes 112(f), as outlined previously in the claim interpretation. The corresponding structure for performing the functions is not described in the specification. Therefore, the scope of Claim 11 is indefinite. Claims 12 and 15-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 11.
Regarding Claim 13, the limitations “the barrier integrity” in line 1 and “the second tubes” lack antecedent basis. The limitation “a step of forming a negative pressure in the intestinal organoid deformation generating unit” invoke 112(f), as outlined previously in the claim interpretation. The corresponding structure for performing the functions is not described in the specification. In addition, the limitation “where the negative pressure is stable” is indefinite as “stable” is a relative term. The term “stable” in claim 13 is a relative term which renders the claim indefinite. The term “stable” 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. Thus, Claim 13 is indefinite. Claims 14 and 18-20 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 13.
Regarding Claim 14, the limitations “the value of Equation 1” and “the resistance value” (in three places) lack antecedent basis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee (US 2017/0115247 A1) teaches an apparatus for measuring electrical properties of a biological sample using channels (Fig. 1a) using negative pressure [para. 0057] and electrodes [para. 0049]. Yu (US 2019/0086387 A1) teaches an apparatus for detecting a disease using a first micro-device (Fig. 2) with a substrate in the shape of a tube [para. 0030].
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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