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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/3/2024 has been considered by the examiner.
Claim Objection
Claims 1 and 5 are objected to because of the following informalities:
Claim 1: please amend “ one piece or more capillary” to -- one [[piece]] or more capillary--; “within the capillary” to -- within the capillary array--
Claim 5: please amend “the load header side of the detection unit” to -- [[the]] a load header side of the detection unit--.
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.
Claim 1, “a detection unit … detecting a sample electrophoresed within the capillary”, is being interpreted under 35 U.S.C. 112(f) . Prong 1: a detection unit (uses the generic placeholder), prong 2: detecting a sample electrophoresed within the capillary (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). The corresponding structure for performing the functions is described in the specification such as Fig.4 illustrating a configuration of the detection unit 116 [para. 0034] in PG-Pub.
Claim 1, “a protection unit … allows an inner surface of the holder to depart from the detection unit”, is being interpreted under 35 U.S.C. 112(f) . Prong 1: a protection unit (uses the generic placeholder), prong 2: allows an inner surface of the holder to depart from the detection unit (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). Although the specification discloses: “Therefore, the base convex portion 221 of the present embodiment also exerts a role of allowing the inner surface of the array holder 105 to depart from the detection unit 116 (particularly the silicon substrate 212) when the detection unit 116 is to be fit to the array holder 105” in [para. 0055] in PG-Pub, the specification does not clearly link the protection unit to the particular structure of 221 (protection portions). Thus, the corresponding structure of a protection unit for performing the functions is NOT described in the specification.
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 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1, claim 1 recites “a protection unit … allows an inner surface of the holder to depart from the detection unit”, which invoke 112(f) and the specification does not provide the corresponding structure of the protection unit for performing the functions above. Therefore, the scope of claim 1 is indefinite. Claims 2-7 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 3, claim 3 recites “the back side”, which lacks antecedent basis. Furthermore, it is unclear if it refers to a back side of the protection unit or a back side of the rail. Therefore, the scope of claim 3 is indefinite. Claims 4-5 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 3.
Regarding claim 6, claim 6 recites “further comprising … a protection unit formed in the holder abuts on a rail formed in the plate”. It is unclear if “a protection unit” is the same as or different than “the protection unit” recited in claim 1. It is unclear if there are two protection units since claim 6 recites “further” comprising a protection unit. Thus, the scope of claim 6 is indefinite.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huang et al. (US20240094162A1).
Regarding claim 1, Huang teaches an electrophoresis device (a capillary electrophoresis apparatus [abstract; Figs.1 , 4, and 7; para. 0034]) including a capillary array (at least two capillary channels, and a capillary being mounted in each of the capillary channels [claim 1]; capillaries 700 are shown in Fig.1 [para. 0036]) that includes one or more capillary (see capillaries 700 in Fig.1), the capillary array including a load header arranged at one end (Figs. 4 and 10 show capillary channel inlet 130 arranged in the inlet end sealing plate 121 at the bottom of the segment clip housing 120 [para. 0083]), a capillary head arranged at the other end (Each combined channel 301 may be loaded with a capillary, and the plurality of combined channels 301 tend to gradually converge in a direction from a capillary inlet to a capillary outlet of the combining sealing body, such that a plurality of capillaries converge at the capillary outlet of the combining sealing body [para. 0070]; the combined capillaries at the outlet combination portion is deemed as the capillary head; Fig.7 shows the load header in the inlet segment clip portion 100 is arranged at the left end, and the capillary head in the outlet combination portion 300 is disposed at the right end), and a detection unit (The detection portion 200 may be configured to form an optical detection path that penetrates a detected section of the capillary by cooperating with an optical detection element [para. 0039]; the optical detection element can be removably integrated in the detection window 201 [para. 0046]) formed between the load header and the capillary head (Figs. 1, 4, and 7 show the detection portion 200 is disposed between the load header disposed in the upstream inlet segment clip portion 100 and the capillary head disposed in the downstream outlet combination portion 300) and detecting a sample electrophoresed within the capillary array (The capillary loaded in the clip body may pass through the detection window 201 to expose the detected section of the capillary from the clip body for optical detection, wherein a separated sample in the capillary passes through the detection window 201 in a direction from the sample inlet end 201a to the sample outlet end 201b. The detection window 201 may allow incident light to be guided to the detected section of the capillary from one side of the detection window 201, and allow emergent light passing through the detected section of the capillary to be collected from the other side opposite to the detection window 201 [para. 0043]), the electrophoresis device comprising:
a holder (detection portion 200 in Figs. 1 and 3) to which the detection unit is fit (the optical detection element can be removably integrated in the detection window 201 of the detection portion 200 [para. 0043, 0046]); and a protection unit (an auxiliary mounting element 400 as shown in Figs. 3-4 [para. 0047]) protruding with respect to an array surface of the capillary array (the auxiliary mounting element 400 may be inserted into the detection window 201 from one side of the detection window 201, and the auxiliary mounting element 400 may be fixed to the detection window 201 by means of snap-fit [para. 0048]; Fig. 7 shows the auxiliary mounting element 400 is vertically inserted into the detection window 201 protruding with respect to an array surface of the capillary array, wherein the capillary array is horizontally aligned in the detection window 201); wherein
when the detection unit is to be fit, the protection unit allows an inner surface of the holder to depart from the detection unit (The at least two optical detection elements may be removably mounted in the detection window 201 by means of their respective auxiliary mounting elements 400, or may be removably mounted in the detection window 201 in the mounting positions of the at least two optical detection elements on the same auxiliary mounting element 400 [0054]. Fig.4 shows the auxiliary mounting elements 400 is not inserted into the detection window 201, and Fig.7 shows the auxiliary mounting elements 400 is inserted into the detection window 201. Since the optical detection elements are on the auxiliary mounting element 400, when the detection unit is to be fit, the protection unit [auxiliary mounting elements 400] allows an inner surface of the holder to depart from the detection unit [the optical detection elements on the auxiliary mounting element 400]).
Claim Rejections - 35 USC § 103
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Huang, as applied to claim 1 above, and in view of Yamazaki et al. (US20060096863A1).
PNG
media_image1.png
312
710
media_image1.png
Greyscale
Regarding claim 2, Huang teaches the electrophoresis device according to claim 1, further comprising:
a plate (see “plate” in annotated Fig.4 in Huang; Fig.7 also shows the plate arranged beneath the capillary) that supports a part of the capillary array including the detection unit (Fig.7 shows the plate of the detection portion 200 arranged beneath the capillary supports a part of the capillary array including the detection unit; the auxiliary mounting element 400 may be fixed to the detection window 201 by means of threaded connection [para. 0048]).
Huang further teaches wherein the auxiliary mounting element 400 may be fixed to the detection window 201 by means of threaded connection; and the auxiliary mounting element 400 may be fixed to the detection window 201 by means of snap-fit [para. 0048].
Huang is silent to wherein the protection unit (the auxiliary mounting element 400) formed in the plate abuts on a rail formed in the holder.
Yamazaki teaches a multi-capillary electrophoresis apparatus (abstract), and further teaches easily install and uninstall a load header 27 from a thermostat oven 3 by sliding like rails (Fig. 9a-9b and [para. 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 thread connection between the auxiliary mounting element 400 and the detection window 201 in Huang to rail connection by providing a rail formed in the detection window such that the auxiliary mounting element can be installed to and uninstalled from the detection window by sliding like rails, as taught by Yamazaki, since it would allow to easily install and uninstall the part (auxiliary mounting element) by sliding like rails [para. 0098 in Yamazaki]. Applying a known technique (connecting two parts of an electrophoresis device by sliding like rails as taught by Yamazaki) to a known device (electrophoresis apparatus of Huang) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(D)). With the above modification, the auxiliary mounting element 400 formed in the plate abuts on a rail formed in the holder.
Regarding claim 6, Huang teaches the electrophoresis device according to claim 1, further comprising:
a plate (see “plate” in annotated Fig.4 in Huang; Fig.7 also shows the plate arranged beneath the capillary) that supports a part of the capillary array including the detection unit (Fig.7 shows the plate of the detection portion 200 arranged beneath the capillary supports a part of the capillary array including the detection unit; the auxiliary mounting element 400 may be fixed to the detection window 201 by means of threaded connection [para. 0048]).
Huang further teaches wherein the auxiliary mounting element 400 may be fixed to the detection window 201 by means of threaded connection; and the auxiliary mounting element 400 may be fixed to the detection window 201 by means of snap-fit [para. 0048].
Huang is silent to wherein the protection unit (the auxiliary mounting element 400) formed in the holder on a rail formed in the plate.
Yamazaki teaches a multi-capillary electrophoresis apparatus (abstract), and further teaches easily install and uninstall a load header 27 from a thermostat oven 3 by sliding like rails (Fig. 9a-9b and [para. 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 thread connection between the auxiliary mounting element 400 and the plate of the detection window 201 in Huang to rail connection by providing a rail formed in the plate such that the auxiliary mounting element can be installed to and uninstalled from the detection window by sliding like rails, as taught by Yamazaki, since it would allow to easily install and uninstall the part (auxiliary mounting element) by sliding like rails [para. 0098 in Yamazaki]. Applying a known technique (connecting two parts of an electrophoresis device by sliding like rails as taught by Yamazaki) to a known device (electrophoresis apparatus of Huang) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(D)). With the above modification, the auxiliary mounting element 400 formed in the holder abuts on a rail formed in the plate.
Allowable Subject Matter
Claims 3-5 and 7 would be allowable if they are 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.
Regarding claim 3, the prior art of the record does not teach and/or suggest
at the time of fitting the detection unit, the protection unit moves to the back side after sliding along a front side of the rail.
Regarding claim 4, the prior art of the record does not teach and/or suggest
a slide direction dead end portion of the rail inclines.
Regarding claim 5, the prior art of the record does not teach and/or suggest a distance between the protection unit and a center of the detection unit is longer than a distance between the slide direction dead end portion of the rail and a center of a window portion formed in the holder, and a distance between the protection unit and an end portion on the load header side of the detection unit is shorter than a distance between the slide direction dead end portion of the rail and an end portion located away from the rail of the window portion.
Regarding claim 7, the prior art of the record does not teach and/or suggest the protection unit is positioned to face a corner portion of the detection unit, and a distance from an array surface of the capillary array to a distal end of the protection unit is longer than a distance from the array surface of the capillary array to a surface of the detection unit.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Ma et al. (CN210269705U) teaches an all-in-one clip capillary electrophoresis apparatus. Goodale et al. (US 5417925A) teaches a capillary and capillary retaining system. Shimizu et al. (US20010040095A1) teaches a capillary electrophoresis apparatus. Ugai et al. (US20060219559A1) teaches a capillary electrophoresis apparatus. Furukawa et al. (US20070062814A1) teaches capillary array and electrophoresis apparatus. Shoji et al. (US20090183990A1) teaches a capillary electrophoresis apparatus. Lim et al. (US20200232943A1) teaches a capillary electrophoresis apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 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, Luan V. Van can be reached on (571) 272-8521. 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.
/SHIZHI QIAN/Examiner, Art Unit 1795