Attachment 6b_isa237_instructions.pdf

Attachment 6 1

Attachment 6 - Instructions on Completing Form PCT/ISA/237

This form is used to provide the Written Opinion of the international Searching Authority

(Written Opinion). The Contractor should carefully review Chapters 9-14 and 17 of the PCT

International Search and Preliminary Examination Guidelines (hereafter referred to as PCT ISPE

Guidelines) posted on the Internet at http://www.wipo.int/pct/en/texts/gdlines.htm for detailed information on preparing the Written Opinion of the International Searching Authority.

237-1 Enter the name and address of the agent, common representative or special correspondence address.

This information is found in Box No IV of the PCT Request (PCT/RO/101 form), hereafter referred to as the PCT Request, shown in data field 7. The agent’s name will be indicated as “LAST NAME, First name Middle Initial (if applicable)” in data field 7. The contractor will enter the name in field 237-1 as “First Name Middle Initial (if applicable) Last Name” on the form.

For example, if the name is indicated in data field 7 as SMITH, John J., it would be entered in field 237-1 as” John J. Smith”.

If nothing is listed in data field 7 in Box No IV of the PCT Request, enter the name and address of the first applicant with “US” or “United States of America” listed as the “State (that is, country) of nationality” or the “State (that is, country) of residence”. Start with data field 5, checking specifically in data field 5a and data field 5b for the “US” indication, and continuing with data field 6,specifically checking data field 6a and data field 6b, followed by data field 8, specifically checking data field 8a and data field 8b, data field 9, specifically checking data field 9a and data field 9b, etc.

For a non-US origin international application, that is, an international application which has an international application number that does not begin with “PCT/US”, enter the name and address listed in data field 7 in Box No IV of the PCT Request. If that space is blank, enter the name and address of the applicant listed in Box No II of the PCT Request in data field 5.

237-2 Leave this field blank.

237-3 Enter the applicant's or agent's file reference.

The file reference is found on the PCT Request in data field 3. If nothing is indicated in data field 3, leave this space blank.

237-4 Enter the international application number exactly as indicated on the PCT

Request in data field 1.

The Contractor will enter the international application number in item 237-4 on subsequent sheets of this form as well.

237-5 Enter the international filing date exactly as it appears on the PCT Request in http://www.wipo.int/pct/en/texts/gdlines.htm

Attachment 6 2 data field 2.

237-6 . For international applications filed prior to 01 April 2007, enter the earliest priority date claimed as long as the international application was filed within the priority period. For international applications filed on or after 01 April 2007, enter the earliest priority date claimed as long as the international application was filed within the priority period or within 2 months from the expiration of the priority period. The priority period is defined as the period of 12 months from the filing date of the priority application. The day of filing of the priority application is not included in that period. For an application filed on 03 April 2006, the priority period expires on 03 April 2007. If the period expires on a day that the receiving Office (Office where the international application is filed) is closed for business, the period will expire on the next business day. For international applications filed in the USPTO, if the expiration of the period falls on a Saturday, Sunday or a day that the USPTO was closed for business (that is, a federal holiday within the District of Columbia), the period will expire on the next subsequent day in which the USPTO is open for business. A list of federal holidays is posted on the Internet at http://www.opm.gov/fedhol/.

The priority claims are found in Box No. VI of the PCT Request in data fields

12a – 12c. Note that additional priority claims will be indicated on the Supplemental Box as a continuation of Box No. VI in data field 12d.

237-7 Enter the classification of the claimed inventions in the application according to current International Patent Classification (IPC) and the US Classification. The Contractor should enter the same IPC and US Classification that was entered in item 210-47. See section C.4.4.1. of the Statement of Work for further information on classification.

237-8 Enter the applicant's name exactly as it appears in Box No. II of the PCT Request in data field 5.

237-9 This box is pre-marked with an “X”. No further action is necessary.

The Contractor will complete item 237-20 or items 237-21a and 237-21b in “Box No I Basis of this opinion.” Instructions for completing those boxes are provided later in this document.

237-10 Enter an “X” in this box where any of the following conditions exist:

(1) priority is claimed to a foreign priority application or to an international application filed in other than the US Receiving Office;

(2) the filing date of the priority application is more than one year before the international filing date;

(3) the priority application is directed to an invention that is unrelated to the PCT application. The Contractor can only make this determination where a copy of the priority application has been provided. Where a copy of the priority application is not provided, the Contractor will consider the priority claim to be valid.

If item 237-10 is marked, the Contractor will complete items 237-31 to 237-33, as appropriate. Instructions for completing those boxes are provided later in this document.

http://www.opm.gov/fedhol/

Attachment 6 3

237-11 Enter an “X” in this box if the Written Opinion includes a statement that one claim or more claims has not been examined with regard to the novelty, inventive step or industrial applicability.

The Contractor will mark this box where item 210-12 is marked on Form 210. If item 237-11 is marked, the Contractor will complete items 237-34 through 237- 54, as appropriate. Instructions for completing those boxes are provided later in this document.

237-12 Enter an “X” in this box if the Written Opinion includes statement that unity of invention is lacking.

The Contractor will mark this box where item 210-13 was marked on Form 210.

If item 237-12 is marked, the Contractor will complete items 237-55 to 237-66, as appropriate. Instructions for completing those boxes are provided later in this document.

237-13 Enter an “X” in this box if the Written Opinion includes a statement with regard to novelty, inventive step, and industrial applicability.

Where at least one claim has been searched, the written opinion will include reasoned statements with regard to the novelty, inventive step, and industrial applicability. The Contractor will consult Chapters 12, 13 and 14 of the PCT ISPE Guidelines for information on novelty, inventive step and industrial applicability and Paragraphs 17.40-17.42 of Chapter 17 for instructions on making such statements. If item 237-13 is marked, the Contractor will complete items 237-67 through 237-73. Instructions for completing those boxes are provided later in this document.

237-14 Enter an “X” in this box if the Written Opinion includes a citation of certain documents which cannot be applied against the claimed inventions because they were published after the international filing date but have a filing date or priority date before the international filing date.

If item 237-14 is marked, the Contractor will complete items 237-74a through 237-74d and 237-75a through 237-75c, as appropriate. Instructions for completing those boxes are provided later in this document.

237-15 Enter an “X” in this box if the Written Opinion includes a statement of certain defects in the application.

Where defects in the form or contents of the international application have been found, this item will be marked. The Contractor will review Paragraph 17.47 of the PCT ISPE Guidelines for information on this point. If item 237-15 is marked, the Contractor will complete item 237-76. Instructions for completing those boxes are provided later in this document.

237-16 Enter an “X” in this box if the Written Opinion includes a statement of certain observations on the application.

This box will be marked where observations on the clarity of the claims, Attachment 6 4 description, and drawings or on the question whether the claims are fully supported by the description are made. The Contractor will review Paragraph

17.48 of the PCT ISPE Guidelines for more information. If item 237-16 is marked, the Contractor will complete item 237-77. Instructions for completing those boxes are provided later in this document.

237-17a Field will be populated by USPTO.

237-17b Field will be populated by USPTO.

237-17c Field will be populated by USPTO.

237-18 Enter the date of completion of this form.

237-19 Leave this field blank.

Box No I Basis of this opinion

237-20 Enter an “X” in this box where the opinion is on the basis of the international application in the language in which it was filed.

If the international application begins with “PCT/US”, the application must have been filed in English. In this situation, the Contractor will enter an “X” in this box.

The USPTO acts as an ISA for several foreign patent Offices under the condition that either the international application was filed in English or that an English language translation of the international application is supplied to the ISA/US. If the international application number does not begin with “PCT/US”, the

Contractor will look at data field 18 on the PCT Request to determine the language of filing. If the international application was filed in English, the

Contractor will enter an “X” in this box. If the international application was filed in a language other than English, the Contractor will not mark this box and will proceed to item 237-21a and 237-21b.

237-21a Enter an “X” where the international application was filed in a language other than English.

237-21b Enter “English” where the international application was filed in a language of other than English but where an English translation has been provided to the ISA.

237-21-1 Enter an “X” where the opinion has been established taking into account a rectification of an obvious mistake which has been authorized by the Receiving

Office or International Searching Authority. To determine if a rectification has been authorized, review the file to see if Forms PCT/RO/109 and/or PCT/ISA/217 are present. If neither form is present, do not check this box. If either of these forms is present, review the form(s) to see if item 1 is marked indicating that a request for rectification has been authorized. If item 1 is marked, enter an “X” in

Attachment 6 5 this box. Furthermore, where a rectification has been authorized, at least one sheet of the international application will be marked “Rectified Sheet” in the bottom margin. Enter an “X” anytime the corresponding box (210-10-1) on form

PCT/ISA/210 is marked.

Where no nucleotide and/or amino acid sequence is disclosed or where such sequence is disclosed but is not necessary to the claimed invention, proceed to the instructions for Box No II Priority that follow item 237-30 in this document.

Where any nucleotide and/or amino acid sequence is disclosed in an international application, the international application should include a sequence listing forming part of the international application (previously referred to as the “written form”) complying with the standard provide for in Annex C of the PCT Administrative Instructions. The sequence listing forming part of the international application must be filed in paper where the international application is filed in paper. The sequence listing forming part of the international application can be filed in pdf or txt format where the international application is filed electronically. The international application must also be accompanied by a sequence listing not forming part of the international application for the purpose of the international search. The sequence listing not forming part of the international application (previously referred to as the “CRF” or “search copy”) must be provided in txt format in compliance with Annex C of the PCT Administrative Instructions. The USPTO will provide the Contractor with any sequence listings filed with the international application.

The USPTO will issue an Invitation to Furnish a Sequence Listing (Form

PCT/ISA/225) where nucleotide and/or amino acid sequences are disclosed in the international application but where a sequence listing not forming part of the international application (the “CRF” or “search copy”) has not been furnished or where the copy provided does not comply with Annex C of the PCT Administrative Instructions.

A copy of applicant’s response to Form PCT/ISA/255 will be placed in the file before the file is sent to the Contractor. Any subsequently filed sequence listing does not form part of the international application. Applicant is required to furnish a statement that any subsequently provided sequence listing does not go beyond the application as filed and is identical to any previously filed sequence listing.

237-22 This data field has been deleted in the July 2009 version.

237-23 This data field has been deleted in the July 2009 version.

237-24 Enter an “X” if the sequence listing was filed in paper. Where the sequence listing was filed in paper, a pdf version will be present with the international application number stamped at the top. Also, data field 16a-p of the Request will indicate if a paper version of the sequence listing was filed with the international application.

Attachment 6 6

237-25 Enter an “X” if the sequence listing was filed in electronic form. Where there is a pdf version of the sequence listing without the application number stamped at the top and/or where there is a txt version of the sequence listing, the sequence listing was filed in electronic form. Data fields 16d-p, 16a-e, 16b-e and/or 16d-e will be marked where a sequence listing in electronic form was filed with the international application.

237-26 Enter an “X” in this box if the sequence listing was contained in the international application as filed.

237-27 Enter an “X” if the sequence listing in electronic form was filed with the international application. Data fields 16d-p, 16a-e, 16b-e and/or 16d-e will be marked where a sequence listing in electronic form was filed with the international application.

237-28 Enter an “X” if a sequence listing in txt format was provided after the international filing date and/or in response to Form PCT/ISA/225.

237-29 Enter an “X” if the applicant made the required statements that: (1) where multiple copies were furnished, that the subsequent or additional copies are identical to that in the application as filed or to each other, and/or (2) where a copy is subsequently filed, that it does not go beyond the disclosure as filed.

237-30 Enter any additional comments necessary to explain matters concerning the nucleotide and/or amino acid sequence(s) used to carry out the opinion.

Box No. II Priority

This part of the opinion is not relevant if the international application does not claim priority. Furthermore, where priority is claimed, but the citations in the international search report were all published prior to the earliest priority date, it is not necessary to consider whether or not the priority claim is valid. Therefore, unless the international search report cites pertinent references as “X,P” or “Y,P”, Box No. II should be left blank and the Contractor should move on to Box No. III.

Where the international search report includes citations categorized as “X,P” or

“Y,P”, the validity of the priority claim needs to be investigated. In general, the validity investigation will only occur with respect to US priority applications. If the priority claim in question is to an application filed in a country or region other than the US, the applicant will be notified via item 237-31 that the validity has not been investigated for the purpose of preparing this opinion because the priority application was not readily available and that all claims will be given the benefit of the earliest priority date.

Priority claims are made in Box No VI of the PCT request. Applicants can claim priority to national applications, regional applications or international

Attachment 6 7 applications. Where priority is claimed to a national application, either the two-letter country code or the name of the national Office will be indicated in data fields 12b, 13b, 14b, 15b, etc., of the PCT Request. Applications filed in the

USPTO are indicated as “US” or “United States of America” in those data fields.

Where priority is claimed to a patent application that was filed in a regional patent

Office, for example, the European Patent Office, the two-letter country code for that regional Office will be indicated in data fields 12c, 13c, 14c , 15c, etc. of the

PCT Request. Where priority is claimed to an international application that was filed in a receiving Office, the two-letter country code for that receiving Office will be indicated in data fields 12d, 13d, 14d , 15d, etc. of the PCT Request.

International applications filed in the US Receiving Office are indicated as “US”, “RO/US” or “United States of America” in these data fields.

The first step in determining the validity of a priority claim is an analysis of the filing date of the international application relative to the filing date of the priority application. Where multiple priorities are claimed, this analysis will be performed with respect to each priority claim that pre-dates the “X,P” or “Y,P” citation. Measuring from the filing date of each priority application, determine whether or not the international application was filed within the priority period.

See item 237-6 for a definition of priority period. For international applications filed on or after 01 April 2007, determine if the international application was filed within the priority period or with 2 months of the expiration of the priority period.

If the international application was not field within these prescribed times, that particular priority claim is invalid, an “X” will be placed in item 237-32, and the

“X,P” or “Y,P” citation may be applied in Box No. V of the opinion. Where the priority claim is found to be valid with respect to filing dates, the validity is then investigated with respect to support. The claims in the international application and the full disclosure of the priority application should be reviewed to determine if any one claim in the international application is fully supported by the priority application. If none of the claims of the international application are fully supported by the priority application, the priority claim is invalid, an “X” will be placed in item 237-32, and the “X,P” or “Y,P” citation may be applied in Box No.

V of the opinion. Even though these tests may result in a priority claim being considered valid, it may still be possible to apply a citation (reference) listed as

“X,P” or “Y,P” in Box No. V to defeat novelty or inventive step. Note that even though the priority claim may be determined to be valid, any particular claim in the international application may contain subject matter not found in the priority application. In this instance, the claim in question would only be entitled to the international filing date and the “X,P” or “Y,P” citation can be applied.

237-31 The Contractor will look at data fields 12b-12d, 13b-13d, 14b-14d, 15b-15d on the PCT Request to determine if any of the priority claims are to applications that were not filed in the USPTO or not filed in the US Receiving Office. Enter an

“X” where priority is claimed to an application that was not filed in the USPTO as a national Office or receiving Office. When this box is marked, the

Contractor will also enter form paragraph #1 in item 237-33 as indicated below.

Attachment 6 8

Any citations listed as “X,P” or “Y,P” in the international search report will NOT be applied in Box No. V since all claims will be given the benefit of the earliest priority date.

237-32 Enter an “X” where the priority claim to an earlier application filed in the US is found invalid based on the validity tests described above. Where this box is marked, the Contractor will provide an explanation for this conclusion in item

237-33.

The USPTO will provide copies of US priority documents identified by application number in data fields 12a, 13a, 14a, 15a, etc. Where multiple priorities are claimed and less than all the priority claims are found invalid, insert form paragraph #2 in item 237-33. For each priority claim found to be invalid, the contractor will insert for paragraph #3 or form paragraph #4, as appropriate, in item 237-33.

237-33 Where item 237-31 is marked above, the Contractor will enter the following form paragraph in this field:

Form Paragraph #1

In the event a copy of the non-US filed priority document is not furnished to this Authority because the applicant fails to comply with PCT Rule 17.1 or the document is not available to this Authority from a digital library, the applicant is invited to provide this Authority with a copy of said document. The applicant is also invited to provide a translation of said document into English (if the document is not in English) within two months from the date of mailing of this written opinion. If this Authority is not provided with a copy of said non-US filed priority document and the applicant fails to comply with PCT Rule 17.1 and the priority document is not available to this Authority from a digital library and/or an English translation of said document, if it is not in English, is not provided to this

Authority within the time period set forth above or by the time this

Authority begins to draw up any written opinion (WO) of the International

Preliminary Examining Authority (IPEA) or the International Preliminary

Report on Patentability (IPRP) of the IPEA, any said WO or IPRP of the

IPEA may be established as if the priority had not been claimed.

Form paragraph #2

The following priority claims have been found invalid: <identify each invalid priority claim by application number, filing date and country of filing>.

Attachment 6 9

Form paragraph #3

The priority claim to < identify invalid priority claim by application number, filing date and country of filing> is found to be invalid because the international application was not filed within the priority period as defined by PCT Rule 2.4 or, for international applications filed on or after

01 April 2007, within 2 months of the expiration of the priority period.

Form paragraph #4

The priority claim to < identify invalid priority claim by application number, filing date and country of filing> is found to be invalid because none of the claims in the international application are fully supported by the earlier application.

Box No. III Non-establishment of opinion with regard to novelty, inventive step and industrial applicability

237-34 Enter an “X” in this box if all the claims were found unsearchable with regard to novelty, inventive step, and industrial applicability.

This box will be marked only where Form 203 was prepared because all of the claims were found to be unsearchable.

237-35 Enter an “X” in this box where only certain claims were found unsearchable with regard to the novelty, inventive step, and industrial applicability.

This box will be marked only where item 210-12 on Form 210 was marked. A claim may be unsearchable for any of the following reasons:

A claim may be unsearchable for any of the following reasons:

1) the claim is directed to subject matter that the USPTO would not search in a US patent application. See MPEP sections 706.03(a), 1843.02, 2105 and 2106 and Chapter 9 of the PCT ISPE Guidelines, especially paragraphs 9.01-9.16, A9.07[1] and A9.15[1].

2) the claim is so poorly supported by the disclosure that no meaningful search can be made. See MPEP section 1843.03. For example, a claim is directed to a specific amino acid or nucleotide acid sequence but applicant did not provide a computer readable form of that sequence after receiving an invitation to do so;

3) the claim is so unclear as to render it unintelligible. See MPEP section

1843.03;

4) the claim is an improper multiple dependent claim. A multiple dependent claim is improper under PCT Rule 6.4(a) if it depends from another multiple dependent claim or if it is not written in the alternative. See MPEP section

Attachment 6 10

608.01(n) subsection A for examples of acceptable multiple dependent claim wording and subsection B for examples of unacceptable multiple dependent claim wording.

237-36 Enter the claim numbers that will not be examined because they were not searched for one of the reasons set forth above.

237-37 Enter an “X” in this box where claims will not be examined because they relate to subject matter that the US will not search and examine as specified in MPEP sections 706.03(a), 2105 and 2106.

This box will be marked where item 210-33a on Form 210 was marked or where any of items 203-8a through 203-8m on Form 203 were marked.

237-38 Enter the claim number that will not be examined because they relate to certain specified subject matter.

Where Form 203 was issued, enter the claim numbers that were not searched because they relate to certain specified subject matter. If item 210-33a was marked, the claim numbers will be the same as indicated in item 210-33b on

Form 210.

237-39 Enter the reason why those claims will not be examined.

Where Form 203 was issued or where item 210-33a was marked, enter the reason why those claims were not examined. The Contractor should copy the reason indicated in item 210-33c.

237-40 Enter an “X” in this box where the description, claims or drawings or where specific claims which are so unclear that no meaningful opinion could be formed.

The Contractor will mark this box where Form 203 was prepared and item 203-9 was marked or where item 210-34a was marked because the description, claims or drawings are so unclear that no meaningful opinion could be formed or 210-

35a is marked.

237-41 Enter the claim number that will not be examined because they are so unclear that no meaningful opinion could be formed.

Where Form 203 was issued, the Contractor will enter the claim numbers that were not searched because they were so unclear that no meaningful opinion could be forms. Where item 210-34a was marked, the Contractor will enter the claim numbers indicated in item 210-34b on Form 210. Where item 210-35a was marked, the Contractor will enter the claim numbers indicated in item 210-35b on

Form 210.

237-42 Enter the reasons why the description, claims or drawings are so unclear that no

Attachment 6 11 meaningful opinion could be formed.

Where Form 203 was issued, the Contractor will enter the reasons why the description, claims or drawings are considered so unclear that no meaningful opinion could be forms. Where item 210-34a was marked, the Contractor will enter the reasons why the description, claims or drawings or where specific claims are held to be so unclear that no meaningful opinion could be formed. Where item 210-35a was marked, the Contractor will indicate that the claims are not drafted in accordance with the second and third sentences of Rule 64.4(a).

237-43 Enter an “X” in this box where claims are so inadequately supported by the description that no meaningful opinion could be formed.

Where Form 203 was prepared and item 203-13 was marked, the Contractor will mark this box.

237-44 Enter the claim number that will not be examined because they are so inadequately supported that no meaningful opinion could be formed.

The Contractor will enter the claim numbers that apply.

237-45 Enter the reasons why the claims indicated in item 237-44 are considered so inadequately supported by the description that no meaningful opinion could be formed.

Where Form 203 was prepared and item 203-13 was marked or where item 210-

34a was marked, the Contractor will indicate the reasons why those claims are considered to be inadequately supported to the extent that no meaningful opinion could be formed.

237-46 Enter an “X” in this box where no search report was established for one or more claims.

237-47 List the claim number for which no international search report was established.

Where Form 203 was prepared, list all the claim numbers in item 237-47. Where only certain claims were not searched, enter the claim numbers listed in items

210-33b, 210-34b and 210-35b. Claim numbers will only be listed once.

Items 237-48 to 237-54 are only applicable to an international application that contains disclosure of nucleotide and/or amino acid sequences. Skip these items where no such sequences are disclosed and proceed to item 237-55.

237-48 Enter an “X” if the sequence listing has not been furnished or does not comply with the standard provided for in Annex C of the Administrative Instructions.

Attachment 6 12

237-49 Do not mark this box.

237-50 Enter an “X” if a sequence listing in txt format complying with Annex C has not been furnished.

237-51 Do not mark this box.

237-52 This data field has been deleted in the July 2009 version. .

237-53 This data field has been deleted in the July 2009 version.

237-54 Mark this box if additional comments are necessary to explain items 237-48 to

237-50 and enter the explanation in item 237-78.

Box No. IV Lack of unity of invention

237-55 Enter an “X” where applicant was invited to pay additional search fees because unity of invention was lacking.

The USPTO will notify the Contractor of applicant’s response to Form 206. The notification by the USPTO will be in writing and will include an indication where the applicant paid the additional fees under protest. If applicant did not respond to Form 206 within the time limit, the USPTO will notify the Contractor in writing that no response to Form 206 was received.

237-56 Enter an “X” where applicant paid additional fees for the search of additional inventions without protest.

237-57 Enter an “X” where applicant paid additional fees under protest.

237-58 Do not mark this box.

237-59 Enter an “X” where applicant did not pay additional fees.

237- 60 Do not mark this box.

This box will only be marked where after the USPTO has reviewed the PCT application, the application is returned to the Contractor because unity of invention is lacking but the Contractor failed to prepare a Form 206.

237-61 Do not mark this box.

237-62 Enter an “X” in the box to indicate that unity of invention is lacking.

237-63 Enter a detailed explanation setting forth the groups of inventions and the

Attachment 6 13 reasoning for that finding in the space provided.

The Contractor can copy this information from item 210-36 on Form 210.

237-64 If a Form 206 was mailed to the applicant, enter an “X” to indicate that an opinion has been established for all claims in the application, that is, where applicant paid for the search of all additional inventions. If no Form 206 was mailed to the applicant, do not mark this box.

237-65 Enter an “X” in this box to indicate that an opinion has been established for less an all the claimed inventions, that is, where applicant did not pay for all additional inventions.

237-66 Enter the claim numbers for which a written opinion has been established.

Box No. V Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step or industrial applicability; citations and explanations supporting such statement

Claims listed in item 237-36 are not addressed in items 237-67 through 237-73. If item

237-65 is marked, only the claims listed in item 237-66 are addressed in items 237-67 through 237-73. Claims held to be unsearchable and claims for which additional fees were not paid are not included in this section.

237-67 Enter the claim numbers that have novelty.

237-68 Enter the claim numbers that do not have novelty.

All claims subject to examination should appear in either item 237-65 or 237-66.

237-69 Enter the claim numbers that have an inventive step (that is, are non-obvious).

237-70 Enter the claim numbers that do not have an inventive step.

All claims listed in item 237-68 as not having novelty should be included here because claims that do not have novelty, inherently do not have an inventive step.

All claims subject to examination should appear in either item 237-69 or 237-70.

237-71 Enter the claim numbers that have industrial applicability.

237-72 Enter the claim numbers that do not have industrial applicability.

All claims subject to examination should appear in either item 237-71 or 237-72.

237- 73 Enter detailed explanations as to why the claims have or lack novelty, have or

Attachment 6 14 lack an inventive step, and have or lack industrial applicability using the form paragraphs below.

Only references that were made available to the public by means of written disclosure before the “relevant date” can be applied against the claims. The relevant date is either the priority date or the international filing date. Where an intervening reference has been found and a copy of the priority application is available to the Contractor, the Contractor will review the priority application to determine whether the claimed invention gets the benefit of the filing date of the priority application or whether the claimed invention is not adequately described in the priority application to enable one skilled in the art to practice the claimed invention. Note that some claims may get benefit of the filing date of the priority application because they were described in the priority application whereas other claims may be new to the PCT application. Where a copy of the priority application is not available, the priority claim will be considered valid for the purposes of issuing the written opinion. (See instructions relating to Box No. II

Priority)

Where certain claims have novelty but lack inventive step, a separate positive statement on novelty is not necessary, provided that the explanation on lack of inventive step distinctly point out what the reference teaches and what it lacks.

The following form paragraphs should be used by the Contractor for each negative or positive statement:

Claim*** [lack or lacks] novelty under PCT Article 33(2) as being anticipated by

[reference]. [Insert an explanation as to what the reference teaches that anticipates the claimed invention.]

Claim*** [lack or lacks] an inventive step under PCT Article 33(3) as being obvious over [reference]. [Insert an explanation as to what the reference teaches and what it lacks as well as why it would have been obvious to one of ordinary skill in the art to include the missing element.] obvious over [primary reference] in view of [secondary reference]. [Insert an explanation as to what the primary reference teaches and what it lacks; what the secondary reference teaches; why it would have been obvious to one of ordinary skill in the art to make the change to the primary reference, that is, the motivation for the combination of references.] obvious over the prior art as applied in the immediately preceding paragraph and further in view of [reference]. Insert an explanation as to what the primary reference teaches and what it lacks; what the secondary reference teaches; why it would have been obvious to one of ordinary skill in the art to make the change to

Attachment 6 15 the primary reference, that is, the motivation for the combination of references.]

Claim*** [lack or lacks] industrial applicability as defined by PCT Article 33(4) because [insert an explanation for the negative statement].

Claim*** [has or have] industrial applicability as defined by PCT Article 33(4) because the subject matter can be made or used in industry.

Claim*** [meet or meets] the criteria set out in PCT Article 33(2)-(3), because the prior art does not teach or fairly suggest [insert an explanation for the positive statement].

Box No VI Certain documents cited

The Contractor should refer to Paragraph 17.43 to 17.46 of the PCT ISPE Guidelines before completing this section. The Contractor will list under “Certain published documents (Rule 43bis.1 and 70.10)” any patents and published patent applications which have been found but which cannot be applied against the claims because they have publication dates after the international filing date but priority dates or filing dates prior to the international filing date. These documents cannot be used in 237-71.

237-74a Enter the application number or patent number.

237-74b Enter the publication date using a numerical day/month/year format.

237-74c Enter the filing date using a numerical day/month/year format.

237-74d Enter any priority date shown on the publication using a numerical day/month/year format.

The Contractor will list under “Non-written disclosures (Rule 43bis.1 and 70.9)” any written document made available to the public on or after the international filing date that refers to an oral disclosure, use or exhibition that occurred before the international filing date. These documents cannot be used in 237-71.

237-75a Enter the kind of non-written disclosure.

237-75b Enter the date of non-written disclosure.

237-75c Enter the publication date of a written disclosure referring to the non-written disclosure.

Box No. VII Certain defects in the international application

237-76 Enter defects of form or content in the international application, such as spelling

Attachment 6 16 errors, incorrect drawings, typographical errors, etc.

The Contractor should review Paragraph 17.47 of the PCT ISPE Guidelines before completing this section.

Box No VIII Certain observations on the international application

237-77 Enter any statement on the clarity of the claims or on whether the claims are fully supported by applicant's description.

The Contractor should review Paragraph 17.48 of the PCT ISPE Guidelines before completing this section.

Supplemental Box

237-78 Use this for any items above where additional space is necessary.