DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on May 28, 2026. Claims 1 and 4-5 are pending in the application.
Status of Objections and Rejections
The rejection of claim 3 is obviated by Applicant’s cancellation. Other rejections under 35 U.S.C. § 103 from the previous office action are maintained.
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.
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:
"a fluorescence measurer" in claim 1.
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. The specification discloses the fluorescence measuring unit 102 is a device that measures fluorescence induced in the capillary array 103 by irradiation of excitation light, and is, for example, a CCD camera (PGpub ¶16).
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inaba (US 2004/0119011) in view of Kumazaki (JP 2007/322218, machine translation used for citation).
Regarding claims 1 and 4, Inaba teaches an electrophoresis device (Fig. 1; ¶19: an electrophoresis device), comprising:
a capillary array (Fig. 1; ¶36: capillary array 1; Fig. 6; ¶43: capillaries 21) including a planar arrangement of capillaries used for electrophoresis (Fig. 6) of a sample (Fig. 1; ¶36: an electrode (sample inlet end) 2; the sample DNA solution);
an excitation light source (Fig. 3A; ¶41: a laser beam emitted by a laser 29) that applies excitation light along an arrangement direction of the capillaries (Fig. 3A; the laser beam 25, 26 passing through the fluorescence detection portion 24 of capillaries 21); and
a fluorescence measurer (Fig. 5: ¶43: CCD 46) that measures fluorescence induced from the capillary array (Fig. 1: an irradiation area 8; ¶36: causing the fluorescent dye molecules to emit light; measuring the emissions to determine a base sequence and a base length of the DNA),
the electrophoresis device, further comprising:
a reference member (Fig. 6: array holder 54 and the planar substrate 20) on which the capillary array is fixedly arranged (Fig. 6: capillaries 21 arranged on the planar substrate 20; also see Fig. 12A-B; ¶30: the capillary array fixed on a planar glass substrate); and
a capillary mounting stand (Fig. 6: the right part with the mounting reference surface 52) having a window (Fig. 6) arranged so that a center thereof coincides with an optical axis of the excitation light emitted along the arrangement direction of the capillaries (Fig. 6: the optical axis of laser beam 25, 26 is vertical; the arrangement direction of the capillaries 21 is also vertical), the capillary mounting stand being abutted against the reference member (when the capillary array fixing means push the left portion into the right portion, the right portion would be abutted against the planar substrate 20),
wherein
the reference member has a step including an upper surface where the capillaries are arranged (Fig. 6: the right surface of the planar substrate 20) and a lower surface (Fig. 6: the right surface of the array holder 54).
Inaba does not disclose the lower surface of the reference member in contact with the capillary mounting stand or an absolute value |S - (R + A)| of a difference between a distance S from a contact surface of the capillary mounting stand to an optical axis of the excitation light, the contact surface being to be in contact with the reference member, and a sum (R + A) of half R of an outer diameter of the capillary and the step is less than or equal to a predetermined threshold (claim 1) or wherein the threshold is zero (claim 4).
However, Kumazaki teaches a capillary electrophoresis apparatus (¶1) in which the capillary array 1 within the detection portion 118 using the main body portion 191 and the lid portion 192 so that the screw SF is passing through the through hole 1927 of the lid portion 192 and is fastened and fixed to the screw hole 1910 of the main body portion 191 (Fig. 5; ¶41). When mounting, the packing PA1 of the lid portion 192 is pressed against the main body portion 191 so that the main body portion 191 and the lid portion 192 are fixed to each other substantially without a gap (Fig. 5(c); ¶41). The first through-hole 1918 and the second through-hole 1919 constitute the optical path of the laser L which passes the capillaries (Fig. 5; ¶41).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inaba by substituting its left portion of the mounting structure with the lid portion 192 as taught by Kumazaki. Since the lid portion has a step including an upper surface which is capable of arranging the capillary array thereon and a lower surface which is capable of being pressed against the contact surface of the main body, the mounting would fix the main body portion and the lid portion to each other substantially without a gap (Kumazaki, Fig. 5(c); ¶41). The additional screws SF would able to fix the main body and the lid more securely for mounting the capillary array. Thus, it would be obvious to the one of ordinary skill in the art to combine Inaba and Kumazaki to arrive the recited subject matter, i.e., using the left portion of the mounting structure of Kumazaki (Fig. 5(b)) having fixed capillary array (Inaba, Fig. 6). Further, as annotate in Fig. 5(c) of Kumazaki, the distance from the contact surface of the main body portion 191 and the lid portion 192 to the optical axis (Fig. 5(c): L) is the sum of the step depth, i.e., A, and the radius of the capillary when they are tightly fixed against each other. In that situation, the absolute value |S - (R + A)| would be equal to zero, as a threshold. Here,, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 5, the designation “wherein the capillary array is integrated with the reference member, and is replaced together with the reference member” is product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed electrophoresis device and the one of the prior art.
Alternatively, the use of a one piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice. Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983). Thus, it would be obvious to one of ordinary skill in the art to make integral of multiple components into one unity and it would not add more patentable weight to the claim. 2144.04 (V)(B).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues the amended placeholder “measurer” does not invoke 35 U.S.C. § 112(f) (Response, p. 4, para. 2). Examiner disagrees. The new placeholder is merely defined by its function, but not structure. Thus, it would be interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Applicant argues Inaba does not teach capillaries arranged on a reference surface by citing Inaba ¶¶15, 44 (p. 5, para. 1). This argument is unpersuasive. Inaba explicitly discloses that the capillaries are fixed on the planar glass substrate (see Fig. 6, 12B). The capillary holding surface of the capillary array holding substrate is read as the reference surface (e.g., Fig. 6, 12B: the right surface of the left portion), not the surface 52 of the right portion as argued by Applicant (Response, p. 6, para. 1). Thus, Inaba teaches a reference member (Fig. 6, 12B: the left portion) on which the capillary array is fixedly arranged on the reference surface, and there is nothing to be cured by Kumazaki.
Conclusion
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 extension fee 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 CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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