except

宣誓供述書の書き方について(2):米国(Part 2)

[例2] この例においては、[例1]のように宣誓供述書の供述内容を別紙のExhibit(甲号証又は乙号証)とはしていません。また、発明者以外によって署名された例です。

内容としては、医療装置(変形爪の矯正装置)に関する二次的考慮事項(商業的成功など)に関して提出したものです。(米国出願の中間処理において弊所が実際に提出したものに基づいていますが、固有名詞・用語・数値などは適宜変更してあります。)

(商業的成功に関する宣誓供述書の書式の1例)

IN THE U.S. PATENT AND TRADEMARK OFFICE

Applicant:Taro YAMADA
Serial No.:XX/XXX,XXX
Filed:XXXX, 20XX
For:APPARATUS FOR CORRECTING AN INGROWN NAIL
Art Unit:3772
Examiner:Dan HICKS

 



DECLARATION UNDER 37 C.F.R. 1.132

 

    I, Goro Kimura, a Japanese citizen residing at XXXX, Tokyo, Japan, declare and say: 
    I was graduated from the Faculty of Medicine, XXX University in March 2005.
    In April 2005, I entered XYZ Clinic where I have been practicing the treatment of hallux valgus and ingrown nails.
    I am well familiar with the present case.
    I read and understood the Office Action dated XXXX, 2011 and references cited therein. I have carried out treatments of ingrown nails with the apparatus disclosed in claim 1 of the present application at XYZ Clinic following the instructions given by Mr. Taro Yamada who is the director of the clinic and is the inventor of the present application. Some of the results of the treatments are as reported in the website of XYZ Clinic at http://www.adcdefg-hijk.com.
    In the website, three cases of treatments are reported.  The treatments were performed using an apparatus as shown in Fig. A attached hereto.  As can be seen from Fig. A, the apparatus falls within the scope of claim 1 of the present application.
    As to the three cases (cases 1 to 3), the nails before and after the treatments are shown in Figs. B, C and D attached hereto, which are also shown at the above-mentioned website of XYZ Clinic.  In each of the tree treatments, the apparatus as shown in Fig. A was used as mentioned above.  Further, the reagents and operations in cases 1 to 3 were substantially the same as recited in Example 1 of the present application (paragraphs [00XX] to [00XX] of the specification of the present application) except that the inclination angle A of the lifting members, the lifting intervals and the nail correcting force were slightly varied depending on the characteristics of the ingrown nails of the patients.  As reported in the website of XYZ Clinic, the details of cases 1 to 3 are as follows.

Case 1:
Patient's gender and age:
    A female in her 30's.

Patient's background: 
    The patient wished to avoid a painful treatment because she had heard her acquaintance's report about having received a very painful operation for correcting an ingrown nail at another hospital which seemed to have been carried out without anesthesia.  The patient came to XYZ Clinic because she was attracted by the painless treatment of this clinic.

Results:
    The ingrown nail was corrected as shown in Fig. B by a single treatment which took about only 30 minutes.  The patient was satisfied with the results of the treatment because the ingrown nail had been corrected without feeling any pain during and after the treatment.

Case 2:
Patient's gender and age:
 
    A female in her 40's.

Patient's background: 
    The patient had a previous experience of nail-correction using a wire device which is to be hooked to the edges of the ingrown sides of the nail and is designed to lift the ingrown sides by pulling the hooked portions of the wire toward the center of the nail.
    However, she needed to go to the hospital so frequently that it became troublesome to her. As a result, the patient stopped going to the hospital before the completion of the nail correction.
    The patient also had a previous experience of nail-correction using a correction plate which is to be adhered on the surface of an ingrown nail and lifts the ingrown sides of the nail by the spring force of the plate, but the plate came off from the nail soon.

Results: 
    The ingrown nail was corrected as shown in Fig. C by performing twice an approx. 30-minute treatment, and the patient was pleased with the result.

Case 3:
Patient's gender and age: 
    A female in her 50's.

Patient's background: 
    Previously, the patient had her ingrown nail corrected by treatment using a wire device similar to that used by the patient of case 2, which treatment lasted about 18 months. However, the ingrown nail recurred after the termination of the treatment.

Results: 
    The ingrown nail was corrected as shown in Fig. D by a single approx. 30-minute treatment.  During and after the treatment, the patient did not feel any pain nor uncomfortable feeling.

    Finally, it should be added that almost all of the 900 patients having received this treatment so far were very satisfied with the results.

    From the above, it is apparent that the apparatus of the present invention surely enables the correction of an ingrown nail within a very short period of time, 1.e., within about 30 minutes to about 1 hour, with a very simple operation and without causing any pain nor uncomfortable feeling to the patent.
    Thus, the apparatus of the present invention has realized a surprisingly easy and effective treatment which is far more advantageous than the conventional surgical removal method which is complicated, cumbersome and is accompanied by pain during or after the surgery and risk of microbial infection, and the conventional treatments using various correction devices or apparatuses which are in many cases not so effective and require very long treatment periods.

    The undersigned petitioner declares that all statements made herein of his own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the application or any patent issuing thereon.

Date:

(宣誓者の署名)
Goro Kimura

タグ:

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医療分野の知的財産について

今回は、最近、環太平洋戦略経済連携協定(TPP)絡みで話題になることが多い医療分野の知的財産について少々お話致します。TPPが日本の知的財産に与える影響については未だ明確なことは分かりませんので、ここでは議論致しませんが、話題を理解する上で役に立つかも知れない情報についてお話します。

医療行為について:

Trips第27条には、加盟国は「人又は動物の治療のための診断方法、治療方法及び外科的方法」を特許の対象から除外することができると定められています。

人間に対する医療行為(手術、治療又は診断する方法)については、米国やオーストラリアなどのごく少数の国を除いて、特許保護の対象として認められていません。日本、欧州、中国、韓国などにおいては、現在のところ、人間に対する医療行為に関する特許は取れません。

一方、TPP案(2012年5月)の8.2条には、以下のように規定されています。

「各当事国は、以下の発明について特許の対象とする事を認めなければならない:
a. 植物及び動物、並びに
b.  人又は動物の治療のための診断方法、治療方法及び外科的方法。」

因みに、米国では医療行為に関する特許を取得することは可能ですが、医師に対しては特許権を行使することは出来ません。しかし、全く権利行使が不可能という訳ではなく、以下のような場合に権利行使出来る可能性があります:

- 医薬の投与方法の特許を侵害する行為は、医師であっても免責されない可能性がある。

- 製薬企業が医師に医薬を提供する行為も間接侵害(寄与侵害)に該当する可能性がある。

- バイオテクノロジー特許を侵害する行為は、医師であっても免責されない。

日本でも医療行為を特許保護の対象に含めるべきかという点は以前から議論されておりますが、ごく限られた例外を除いて今までのところ実現には至っておりません。

韓国においても米国とのFTA締結に伴い、2012年特許法が改正され、特許出願に関する所謂「グレース・ピリオド」が米国と同様に1年間に変更されましたが、医療行為は特許の対象外のままです。日本も、医療行為を特許の対象と認めることに同意することはないように思われますが、はたしてどうなるでしょうか。

動物に対する医療行為について:

人間に対する医療行為(手術、治療又は診断する方法)だけでなく、動物に対する医療行為についても、特許保護が認められていない国があります。

参考までに、各国における「医療分野における方法」(医療行為や準医療行為)の特許保護可能性の概要を下記表に示します。

 

各国における「医療分野における方法」(医療行為や準医療行為)の特許保護可能性の概要

 

手術方法

治療方法

診断方法

測定方法

動物に対する 医療行為

米国1)

O

O

O

O

O

オーストラリア2)

O

O

O

O

O

日本

×

×

×

3)

O

EP

×

×

4-1)

4-2)

ヒトについてと同様

カナダ

×

×

5)

5)

ヒトについてと同様

ニュージーランド

×

×

6)

6)

O

韓国

×

×

×

7)

O

中国

×

×

×

8)

ヒトについてと同様

台湾

×

×

9-1)

9-2)

ヒトについてと同様

マレーシア

×

×

10-1)

10-2)

ヒトについてと同様

インド

×

×

11-1)

11-2)

ヒトについてと同様

インドネシア

×

×

×

×

×

注1)(米国) 医師・医療機関の特許侵害に対して部分的な免責規定がある。即ち、米国特許法第287条の第(c)項(いわゆる「免責規定」)により、(1)医師が侵害に該当する医療行為を実施した場合は、差止請求権・損害賠償請求権などの規定は該医師又は該医療行為に関与する関連医療機関には適用されない。(2)ただし、該「医療行為」とは、身体に対する医療的又は外科的処置を施すことをいうが、次に挙げる行為は含まないものとする。(i) 特許された装置、製造物または組成物の侵害的使用、(ii) 組成物の使用に関する特許の侵害的実施、及び (iii) バイオテクノロジー特許を侵害するプロセスの実施。

注2)(オーストラリア) 医師・医療機関の特許侵害に対して免責規定は無い。

注3)(日本) 手術工程・治療工程を含まず、また医療目的で判断する工程を含まない、人体に対する測定方法は、特許対象である。また、検体の分析・測定方法は特許対象である。(審査基準 第Ⅱ部 第1章 産業上利用することができる発明、2.1.1参照)

注4-1)(EP) 検体を用いた診断方法は特許対象である(EPO Guidelines for Examination, G-II, 4.2.1参照)。

注4-2)(EP) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(EPO Guidelines for Examination, G-II, 4.2.1参照)。

注5)(カナダ) 手術又は治療の工程を含まない人体に対する診断方法は特許対象である(カナダ国知財庁の特許審査ガイドラインによる)。

注6)(ニュージーランド) 手術工程を含まない人体に対する診断方法は特許対象である(ニュージーランド国知財庁の特許審査ガイドラインによる)。

注7)(韓国) 人体に直接的でかつ一時的でない影響を与える工程を含まない限り、人体に対する測定方法(臨床的判断を含まない)は特許対象である(韓国知財庁の特許審査ガイドラインによる)。

注8)(中国) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である。また、診断プロセスに至らない検体の分析・測定方法は特許対象である。(中国知財庁の特許審査ガイドラインによる)

注9-1)(台湾) 検体を用いた診断方法は特許対象である(台湾国知財庁の特許審査ガイドラインによる)。

注9-2)(台湾) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(台湾知財庁の特許審査ガイドラインによる)。

注10-1)(マレーシア) 検体を用いた診断方法は特許対象である(マレーシア国知財庁の特許審査ガイドラインによる)。

注10-2)(マレーシア) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(マレーシア国知財庁の特許審査ガイドラインによる)。

注11-1)(インド) 検体を用いた診断方法は特許対象である(インド国知財庁の特許審査ガイドラインによる)。

注11-2)(インド) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(インド国知財庁の特許審査ガイドラインによる)。

医薬品の特許期間とジェネリック医薬品:

現在、日本において特許の存続期間は出願から20年であり、医薬品の場合、最大で5年間の延長が認められます。特許が有効に存在している間は、第三者は特許権者の許可なく発明を実施することは出来ません。即ち、第三者は、許可無く、特許された医薬品を製造・販売することは出来ません。

しかし特許期間が満了すると、第三者が、特許権者の許可無く発明を実施できるようになります。医薬品の場合、先発医薬品が認可を受けていれば、簡単な審査で特許製品と同様の医薬品の認可が下ります。研究開発費などはかかっていないわけですので通常、先発医薬品よりも安価に提供され、そのような医薬品を通常「ジェネリック医薬品」と称します。

更に、TRIPS(知的所有権の貿易関連の側面に関する協定)においては、ジェネリック医薬品製薬会社が既存の医薬品の臨床データを、薬剤認可を受ける際に利用することを許容しています。臨床データの取得は、時間と費用がかかるため、臨床データが不要であることはジェネリック医薬品の価格低下に大きく寄与しています。

また、近年、2010~2012年頃にかけて、大型医薬品(ブロックバスター)の特許が一斉に切れるという所謂「2010年問題」が話題になっています。ジェネリック大国である中国・インドなどが、この機を大きなビジネスチャンスと考えています。

タグ:

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Exceptions to Lack of Novelty of Invention

Q1. We understand that Japan has a grace period for avoiding certain public disclosures from constituting prior art against a Japanese application.  How long is this grace period?

A1.  The grace period defined under Article 30 of the Japanese patent law (Exceptions to Lack of Novelty of Invention) is 6 months from the date of public disclosure.

Q2. What type of disclosures is capable of taking advantage of the Exceptions to Lack of Novelty of Invention in Japan?

A2.  According to current Article 30 of the Japanese patent law (effective as of April 1, 2012), virtually any disclosure, including “inventions made public at meetings and seminars, which are not academic conference designated by the Commissioner of the Patent Office, inventions made public on TV and radio, and inventions made public through sales”, are covered by the Exceptions to Lack of Novelty of Invention.  However, a patent publication is not a non-prejudicial disclosure.

Q3. Is the grace period applicable to scientific articles published on the web? 

A3.  The 6-month grace period is also applicable to electronic publications of scientific articles.  When a scientific article is published in the form of an electronic publication in advance to the publication in print, the 6-month grace period will start from the date of the electronic publication.  This rule applies not only to a free electronic publication, but also to an electronic publication which requires registered membership and/or purchase of the publication for accessing the electronic publication.

Q4. An invention has been published as a scientific article and a basic patent application has been filed in the US within 6 months from the publication of the scientific article.  Already 10 months have passed from the publication of the scientific article, but is it still possible to enjoy the benefit of the Japanese 6-month grace period by filing a Japanese patent application claiming the Paris convention priority from the basic US application filed within 6 months from the publication date? 

A4.  No.  Claiming of the Paris convention priority does not allow the filing date in Japan to date back for the purpose of grace period.  In other words, when a basic application is filed in other country within 6 months from the date of public disclosure, and a Japanese patent application claiming the convention priority from the basic application is filed after the expiration of the 6-months grace period, the Japanese patent application cannot enjoy the benefit of the grace period.

For receiving the benefit of the 6-month grace period in Japan, the Applicant must file within the 6-month grace period either one of the following applications:

   (1) Japanese national patent application*, or

   (2) PCT application designating Japan as one of the designated states. 

* Either a Japanese patent application or a PCT application claiming the convention priority from this Japanese patent application can be filed after the expiration of the grace period and still enjoy the benefit of the grace period.

Q5. What are the steps necessary for obtaining the benefit of the Japanese 6-month grace period?  

A5.  Necessary steps are explained separately for Japanese national patent application and PCT application.

Japanese national patent application:

A patent application is filed simultaneously with a Request for Grace Period within 6 months from the date of public disclosure.  Alternatively, the Request may be omitted by stating such effect in the patent application.

Next, a Document Verifying the Request, which is signed by all applicants, is filed within 30 days from the filing date of the patent application.  Filing of a specific evidence material (such as a copy of the scientific article disclosing the invention) is not required, but it is most advisable to file the evidence material with the Document.

PCT application designating Japan:

When a PCT application designating Japan as one of the designated states is filed within the 6 month grace period, such a PCT application will obtain the benefit of the grace period even when the PCT application enters the Japanese national phase after the expiration of the grace period (i.e., within non-extensible 30 month deadline).  In this case, both the Request for Grace Period and the Document Verifying the Request are filed within 30 days from the entry into the Japanese national phase. 

[Filing of the Request for Grace Period can be omitted when “Declaration as to Non-Prejudicial Disclosures or Exceptions to Lack of Novelty” (PCT Rule 4.17(v), 26ter.1) is made at the international stage.]

The Document Verifying the Request can be prepared at our end and forwarded for execution by the applicant(s). 

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Appeal against the Decision for Rejection

Q1. We understand that an Appeal can be filed against the Decision for Rejection.  What are the steps necessary for filing an Appeal?

A1.  Firstly, a Notice of Appeal, which is a formal document requesting the initiation of Appeal Proceedings, is filed by the deadline which is three months (for Applicants residing in Japan) or four months (for foreign Applicants) from the dispatch date of the Decision for Rejection. 

Further, any amendment  (if any) must be filed simultaneously with the filing of the Notice of Appeal.  (In the case of patent applications filed on or before March 31, 2007, divisional applications can be filed only simultaneously with the filing of the Notice of Appeal.  In the case of parent patent applications filed on or after April 1, 2007, divisional applications can be filed either before, simultaneously with or after the filing of the Notice of Appeal as long as it is before the expiration of the above-mentioned deadline for filing the Notice of Appeal.)  With respect to the amendment, please note that there is a restriction to the permissible claim amendments.  Please see section “Restriction to Permissible Claim Amendments after Final Rejection” for more details.

Next, any arguments, reference materials and/or experimental reports are filed as an Appeal Brief (i.e., Reasons for Appeal).  The Appeal Brief can be filed either simultaneously with the Notice of Appeal or after the filing of the Notice of Appeal.  When the Appeal Brief is not filed with the Notice of Appeal, the due date for filing the Appeal Brief will be set by the Japan Patent Office, and it is usually about 2 months from the filing date of the Notice of Appeal.

Q2. Is it possible to obtain any extension of deadline for filing the Notice of Appeal or the Appeal Brief?

A2.  No.  The deadlines for filing a Notice of Appeal and an Appeal Brief are non-extensible

Q3. Is it possible to submit new experimental data in the appeal stage?

A3.  Yes.  Any experimental data can be filed together with the Appeal Brief except that effectiveness of data may vary depending on the purpose of the data.

Submission of data for demonstrating novelty and/or inventive step of an invention over prior art is effective if the data itself is appropriate for this purpose; whereas data submitted at the appeal stage cannot compensate for the lack of enabling disclosure or lack of support in the specification, and such data are usually dismissed as late filed.

The Japanese patent system does not allow for applicants to establish the enabling disclosure requirement and/or supporting disclosure requirement through later-filed evidence. That is, these requirements must be satisfied by the patent application as filed, and later-filed data for making up the deficiency in this respect will not be admitted by the JPO.

Q4. Is there an opportunity to file additional amendments and/or divisional applications after the filing of the Notice of Appeal?

A4.  Concerning additional amendments after the filing of the Notice of Appeal, such additional amendments are admissible only when the applicant responds to a Notice of Rejection which may or may not be issued in the appeal stage.   That is, the applicant may not be given any opportunity to file an amendment after the filing of the Notice of Appeal.  Therefore, it is safer to consider that the time of filing of the Notice of Appeal is substantially the last chance to file amendments.

On the other hand, as mentioned in A1 above, in the case of patent applications filed on or after April 1, 2007, divisional applications may be filed even after the filing of the Notice of Appeal as long as it is before the expiration of the deadline for filing the Notice, i.e., three months (for Applicants residing in Japan) or four months (for foreign Applicants) from the dispatch date of the Decision for Rejection.

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Design Registration

Q1. If a design application is to be filed in Japan claiming Convention Priority based on a non-Japanese application, is the priority period one year as in patent applications? 

A1.  No. For filing design applications in Japan claiming Convention priority, the priority period is for six (6) months, instead of one year, from the filing of the priority application.  Even if you have a design "patent" application filed at the USPTO, the priority period is 6 months for filing a Japanese patent application with a valid priority claim based on the degisn "patent" application filed in the US.  

You also have to be careful when filing a patent application in Japan claiming priority from both a patent application and a design application.  That is, for example, if you filed in your country a patent application on May 1, 2012 and a design application on October 30, 2012 and are now considering filing a patent application on May 1, 2013 in Japan claiming priority from both of the above-mentioned patent application and design application filed in your country, this date “May 1, 2013” is within one-year priority period based on the patent application but is after the expiration of six-month priority period (October 30, 2012 + 6 months = April 40, 2013) based on the design application.  Therefore, the priority claim based on the design application is not valid.  

Q2. I am planning to file a design patent application in Japan claiming priority from a US design patent application.  What are the major differences in practice between the United States and Japan that require particular attention?

A2.  Firstly, unlike the “design patent” in the United States which is one type of patents and is basically dealt with under the patent law, Japan has a design law separate from a patent law. 

Therefore, in Japan, an application for registration of a design is referred to as “design application”, not “design patent application” as in the United States.  

More importantly, this difference in legal system leads to some significant differences in design registration practice between the US and Japan representative examples of which are enumerated below.

Difference 1)  “Single design per application” system in Japan

It is understood that the US system allows an applicant to pursue two or more designs (embodiments) of a single inventive concept in a single design patent application.  This, however, is not the case in Japan.  According to the Japanese practice, each design application may include only a single design of single shape.

Therefore, in Japan, when a single priority application includes multiple designs, it is necessary to either:

-  file separate design applications with respect to the different designs, or

-  file an application including different designs and later file a divisional application(s).

In this connection, however, it should be noted that it is not allowed to file a divisional application on a “partial” design from a “whole” design application and vice versa.  Concerning the “partial” and “whole” designs, explanations are made below.

Further, there is an exception to the "single design per application" system, and the Japan's Design Law provides "related design" system for covering a plurality of similar designs.

1-1) Exception to the “single design per application” rule

The Japan’s Design Law exceptionally allows for discrete objects to be claimed in a single application if common sense indicates that such discrete objects are usually sold as a “set”, as in the case of, for example, a 3-piece set including a knife, fork and spoon. 

1-2) Related design applications

In the case where the priority US application contains a plurality of different but similar designs (e.g., minor variations of a certain design), such similar designs may be covered by utilizing the related design system in Japan.  Specifically, the similar designs can be covered by filing a principal design application and filing a related design application(s) by one day prior to the publication of the principal design. 

The design registered as the related design can be enforced independently of the registered principal design and other registered related design(s).  That is, a related design right can cover even a design similar to that related design, which, however, is not similar to the principal design. 

For covering such similar designs under the related design regime, it is possible to either:

-  file a principal design application and also file a related design application(s) simultaneously with the principal application or later (by one day prior to the publication of the principal design at the latest), or

-  file general design applications on the similar designs, and later amend the general applications into a principal design application and a related design application(s).

The JPO may find that the designs are not similar enough to be eligible for registration under the related design regime but there is no need to be so nervous about this point.  If the JPO denies the similarity, the JPO will issue an office action requesting the applicant to stop relying on the related design system and change the applications to normal applications.

 

Finally, the right of a registered related design is independent from the right of a registered principal design but there are the following exceptions.

1.   Synchronized protection term: 

The protection term for both of a registered principal design and a registered related design is 20 years from the registration date of the principal design.  This point, however, is substantially immaterial in the present case because the two applications will probably be registered almost simultaneously.  Further, the registered related design can be maintained even if the principal design is allowed to lapse due to non-payment of maintenance fee, and vice versa.   

 2.   Restriction of transfer of rights and licensing: 

The right of a registered related design cannot be transferred or licensed independently from the registered principal design.  That is, for transfer of design rights to a third party by assignment etc., the principal and related designs must be simultaneously transferred together to the same entity.  Further, also for licensing, the principal and related designs must be licensed simultaneously to the same entity.

 

Difference 2)  Partial Design System

The Japan’s Design Law has a “partial design system” which allows registration of parts of shapes or forms with distinct characteristics.  

The US system also provides a similar practice where dotted lines can be used to indicate non-claimed parts.  There is, however, one important difference.  That is, the Japan’s system requires that a partial design application should be filed with a clear indication that the application claims a partial design.  In the absence of such indication, the application will be recognized as claiming a whole design. 

Once filed with the indication of a partial design application, it is in principle not allowed to amend the application into a whole design application and vice versa.  Similarly, a divisional application on a partial design cannot be filed from a whole design application and vice versa. 

Therefore, if it is important to cover both of whole and partial designs, it is recommended to file both a whole design application and a partial design application.

 

Of course, there are many other differences between US and Japanese practices; however, the above differences are believed to be the main differences which require particular attention when filing a design application in Japan claiminig priority from a US design patent application.

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Quick Cost Estimate for PCT national phase

If you like to have a quick estimate of cost for national phase entry of already published PCT application in Japan, please simply fill in the following items here, and send it:

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