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 with traverse of group I in the reply filed on 05/19/2026 is acknowledged. Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Applicant disagrees with the restriction requirement mailed 03/26/2026. Applicant traverses on grounds that the requirement has not adequately explained why the claimed inventions, considered as a whole, fail to share the same or corresponding special technical feature.
Examiner recognizes that the same corresponding technical feature is common to the groups. MPEP 1850 (II) states, in part:
Lack of unity of invention may be directly evident "a priori," i.e., before considering the claims in relation to any prior art, or may only become apparent "a posteriori," i.e., after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.
Examiner’s citation of art establishes that the common technical feature does not make over the art. As the technical feature does not define over the art, unity of invention is lacking.
Claim Status
Claims 1-11 are pending with claims 1-10 being examined, claim 11 is deemed withdraw.
Claim Objections
Claim 2 is objected to because of the following informalities:
In line 4, “as an upper surface” should read –at an upper surface--.
Claim 7 is objected to because of the following informalities:
In line 3, “in a pack” should read –on a pack--.
In line 5, “in a pack” should read –on a pack--.
Claim 10 is objected because of the following informalities:
Applicant does not disclose the measurement items of the first reagent and the second reagent are different.
Appropriate correction is required.
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)(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)(1) as being anticipated by Sugiyama (JP 2017090356 A; hereinafter “Sugiyama”).
Regarding claim 1, Sugiyama teaches an automatic analyzer (Sugiyama; fig. 1. 1) that analyzes a sample using reagents according to a predetermined analysis item (Sugiyama; [0010] “analyzer analyzes the sample using a colorimetric analysis method”), the automatic analyzer comprising:
a reagent storage (Sugiyama; fig. 6) that stores reagent packs containing the reagents (Sugiyama; [0040] “reagents contained in containers 34c”),
wherein the reagent storage includes:
a first holding unit configured to hold only a first reagent pack (Sugiyama; fig. 6. 56); containing a first reagent among the reagents (Sugiyama; [0026] “first reagent from the reagent storage unit”);
a second holding unit configured to hold only a second reagent pack (Sugiyama; fig. 6. 34a); containing a second reagent that is different from the first reagent (Sugiyama; [0027] “second reagent from the reagent storage unit”); and
a third holding unit (Sugiyama; fig. 6. 34, 56 and [0032] “reagent containers 34 can be grouped together in same container storage rack 56”) configured to hold both the first reagent pack and the second reagent pack (Sugiyama; fig. 6. 34, 56).
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 (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 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.
Claims 2-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama (JP 2017090356 A; hereinafter “Sugiyama”) in view of Fukushi et al. (US 20210263058 A1; hereinafter “Fukushi”) and Shiyouken (JP 20122137329 A; hereinafter “Shiyouken”).
Regarding claim 2, Sugiyama teaches the automatic analyzer according to claim 1 (see above), wherein the first reagent pack is formed to be longer in a vertical direction (Sugiyama; fig. 6. 34c, 56 and [0037] “containers 34a are smaller”),
the first holding unit forms a first hole (Sugiyama; fig. 6. 56 and fig. 5. 54, 62), the second holding unit forms a second hole (Sugiyama; fig. 6. 56, fig. 5. 62 and [0037] “storage rack 56 has a shape in which multiple storage sections 62”), and the third holding unit forms a third hole. The third holding unit being grouped with the first unit 56 was discussed in claim 1 above, therefore the first holding unit hole also serves as the third holding unit hole; and
the third hole has a first region and a second region, which is on an upper side of the first region in the vertical direction and has a diameter larger than that of the first region (Sugiyama. Fig. 6. 56, 34c and [0037] Sugiyama teaches the first hole can serve as a third hole since it accommodates the first and second reagent packs. Sugiyama also teaches second container 34 are smaller than 56).
Sugiyama fails to teach the first and second reagent packs are formed in a rectangular parallelepiped shape with an aspiration port for sucking reagents as an upper surface.
However, Fukushi teaches the analogous art of an automatic analyzer (Fukushi; Title) that includes first and second reagent packs (Fukushi; fig. 5B. 4 and [0036] “reagent bottle 4”) wherein the first reagent pack and the second reagent pack are formed in a rectangular parallelepiped shape (Fukushi; fig. 4. 4) with an aspiration port for sucking reagents as an upper surface (Fukushi; [0036] “on the top surface of reagent containers an opening is provided”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Sugiyama’s first and second reagent packs to be formed in a rectangular parallelepiped shape with an aspiration port for sucking reagents as an upper surface, as taught by Fukushi, because Fukushi teaches an automatic analyzer (Fukushi; Title) that includes first and second reagent packs (Fukushi; fig. 5B. 4 and [0036] ”reagent bottle 4”) wherein the first reagent pack and the second reagent pack are formed in a rectangular parallelepiped shape (Fukushi; fig. 4. 4) with an aspiration port for sucking reagents as an upper surface (Fukushi; [0036] “on the top surface of reagent containers an opening is provided”).
The modification allows consistent positioning and alignment of the reagent packs since the reagent bottle holding portion and the rectangular parallelepiped reagent bottle are since the reagent bottle holding portion and the rectangular parallelepiped reagent bottle are shape matched (Fukushi; [0037]).
i
Sugiyama fails to teach the first reagent pack is shorter in a horizontal direction than that of the second reagent pack with the aspiration port as the upper surface.
However, Shiyouken teaches the analogous art of an analyzer (Shiyouken; Title) that includes a first reagent pack (Shiyouken; fig. 3. 19b) and second reagent pack (Shiyouken;. 3. 19a), wherein the first reagent pack is shorter in a horizontal direction than that of the second reagent (Shiyouken; fig. 3. 19a, 19b).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Sugiyama’s first reagent pack to be shorter in a horizontal direction than that of the second reagent pack as taught by Shiyouken because Shiyouken teaches an analyzer (Shiyouken; Title) that includes a first reagent pack (Shiyouken; fig. 3. 19b) and second reagent pack (Shiyouken;. 3. 19a), wherein the first reagent pack is shorter in a horizontal direction than that of the second reagent pack (Shiyouken; fig. 3. 19a, 19b).
The modification allows to have reagent containers of different sizes (Shiyouken; [0028]).
Regarding claim 3, Sugiyama teaches the automatic analyzer according to claim 2 (see above), wherein: a holding unit of the reagent packs is disposed in a double ring in the reagent storage (Sugiyama; fig. 6. 34a, 56); and only the second holding unit is disposed on an inner peripheral side (Sugiyama; fig. 6. 34a).
Regarding claim 4, Sugiyama teaches the automatic analyzer according to claim 3 (see above), wherein the first holding unit and the third holding unit are alternately disposed on an outer peripheral side (Sugiyama; fig. 6. 34c, 56 illustrates alternate configuration).
Regarding claim 5, Sugiyama teaches the automatic analyzer according to claim 2 (see above), wherein the first region and the second region (Sugiyama; fig. 5. 54 (60,61), and [0037] “the rack body 61 on outer storage rack 56 stores containers 34a of the third holding unit”) of the third holding unit (Sugiyama; fig. 5. 54, and [0056] “storage rack 54 stores third holding unit 56”) are designed such that when the first reagent pack or the second reagent pack is held in the third hole, a height of an upper surface of a vessel is the same for the first reagent pack and the second reagent pack (Sugiyama; fig. 6. 34c, 56).
Regarding claim 6, Sugiyama teaches the automatic analyzer according to claim 5 (see above), wherein the first reagent pack and the second reagent pack have different cold insulation temperatures (Sugiyama; [0038]). Sugiyama teaches only controlling temperature of containers 34 (second reagent pack), therefore, it is implicit that first reagent container and second reagent container would have different cold insulation temperatures.
Regarding claim 8, Sugiyama teaches the automatic analyzer according to claim 2 (see above), further comprising: an auxiliary adapter that fills a gap generated when the first reagent pack is installed on the third holding unit (Sugiyama; fig. 5. 60b, and [0038]).
Regarding claim 9, Sugiyama teaches the automatic analyzer according to according to claim 1 (see above), wherein each of the first holding unit, the second holding unit, and the third holding unit (Sugiyama; fig. 6. 60) further includes a sample auxiliary adapter for holding a sample vessel containing a sample (Sugiyama; fig. 5. 62 and [0039]).
Regarding claim 10, Sugiyama teaches the automatic analyzer according to claim 1 (see above), wherein measurement items of the first reagent and the second reagent are different.
Sugiyama; [0010] “biochemical analyzer is used to test various test items”).
It would have been obvious to include different first and second reagent measurement items in order for the automatic analyzer to perform more than one test.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama (JP 2017090356 A; hereinafter “Sugiyama”) in view of Fukushi et al. (US 20210263058 A1; hereinafter “Fukushi”) and Shiyouken (JP 20122137329 A; hereinafter “Shiyouken”) as applied to claim 4 above, and further in view of Matsumoto (US 20150355210 A1; hereinafter “Matsumoto” previous of record) and Kondou (US 20100104475 A1; hereinafter “Kondou”).
Regarding claim 7, Sugiyama teaches the automatic analyzer according to claim 4 (see above), wherein: the first reagent pack has a first tag on a side surface for storing reagent information in a pack (Sugiyama; [0017] “barcode attached to radially outer surface of container 34); a reader for reading the reagent information stored in the first tag is provided on a side surface of the reagent storage (Sugiyama; fig. 1. 22).
Sugiyama fails to teach the second reagent pack has a second tag on an upper 38 surface for storing reagent information in a pack; and a reader for reading the reagent information stored in the second tag is provided on an upper portion of the reagent storage.
However, Matsumoto teaches the analogous art of an automatic analyzer (Matsumoto; Title) that includes a second reagent pack (Matsumoto; fig. 4B. 14a) that has a second tag on an upper surface for storing reagent information in a pack, (Matsumoto; [0062] “a label describing the second reagent is attached to the second container”). Matsumoto teaches the label is attached in a predetermined position on the outer surface of the container.
Matsumoto does not explicitly teach the second tag is on an upper surface for storing reagent information in a pack.
However, it would have been obvious to place the label on an upper surface for storing reagent information in a pack in order to provide a clear space for reading the label as having the containers side by side could block the scanners visibility.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Sugiyama’s second reagent pack to have a second tag on an upper surface for storing reagent information in a pack, as taught by Matsumoto, because Matsumoto teaches an automatic analyzer (Matsumoto; Title) that includes a second reagent pack (Matsumoto; fig. 4B. 14a) that has a second tag for storing reagent information in a pack (Matsumoto; [0062]).
The modification allows to distinguish the first and second tag to prevent misidentification of the samples.
Sugiyama fails to teach the automatic analyzer includes a reader for reading the reagent information stored in the second tag is provided on an upper portion of the reagent storage.
However, Kondou teaches, in the analogous art of analyzers (Kondou; Title), a first reader that reads bar codes on a sidewall of a reagent storage (Kondou; fig. 3. 350, and [0070], and a second reader that reads bar codes provided on an upper portion of the reagent storage (Kondou; fig. 3. 3c and [0071]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Sugiyama’s analyzer to include a second reader that reads bar codes provided on an upper portion of the reagent storage, as taught by Kondou, because Kondou teaches an analyzer (Kondou; Title) that includes a first reader that reads bar codes on a sidewall of a reagent storage (Kondou; fig. 3. 350, and [0070], and a second reader that reads bar codes provided on an upper portion of the reagent storage (Kondou; fig. 3. 3c and [0071]).
The modification allows the second reader to read a second set of barcodes affixed to the test tubes (reagent storage) (Kondou; [0071]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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