Attachment 4b_isa210_instructions.pdf

Attachment 4 – rev 4 17 05 1

Attachment 4 - Instructions on Completing Form PCT/ISA/210

This form is used to provide the International Search Report.

210-1 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.

210-2 Enter the international application number exactly as indicated on the PCT

Request in data field 1.

The Contractor will enter the international application number on each subsequent sheet of the International Search Report in the box provided.

210-3 Enter the international filing date exactly as it appears on the PCT Request in data field 2.

210-4 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.

210-5 Enter the applicant's name exactly as it appears in Box No. II of the PCT Request in data field 5.

210-6 Leave this space blank.

210-7 Mark this box only if any non-US Patent or Patent application publication is cited in the ISR.

210-8 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.

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

Attachment 4 – rev 4 17 05 2

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 210-9 and 210-10.

210-9a Enter an “X” where the international application was filed in a language other than English.

210-9b 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.

210-10 Enter an “X” where the search report 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 this box. Furthermore, where a rectification has been authorized, at least one sheet of the international application will be marked as “Rectified Sheet” in the bottom margin.

210-11 Enter an “X” where the application contains disclosure of a nucleotide and/or amino acid sequence and the sequence is necessary to the claimed invention.

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”)

Attachment 4 – rev 4 17 05 3 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.

Where applicant does not respond to Form PCT/ISA/225 or where the response is defective, the USPTO will inform the Contractor accordingly. The Contractor will search the claimed invention to the extent possible without the use of such a sequence listing. Where claims are directed to specific sequences that cannot be searched because of the lack of a searchable sequence listing, the Contractor will mark item 210-12 and complete items 210-34a, 210-34b and 210-34c

If 210-11 is marked, the Contractor must also fill in the appropriate boxes in “Box

No I Nucleotide and/or amino acid sequence(s) (Continuation of item 1b of the first sheet)”, items 210-26 through 210-32. Instructions follow later in this document.

210-12 Enter an “X” in this box where some claims were found unsearchable.

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 International Search and Preliminary Examination Guidelines (ISPE), especially paragraphs 9.01-9.16, A9.07[1] and A9.15[1]. A copy of the ISPE is posted on the Internet at http://www.wipo.int/pct/en/texts/gdlines.htm.

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 608.01(n) subsection A for examples of acceptable multiple dependent claim http://www.wipo.int/pct/en/texts/gdlines.htm

Attachment 4 – rev 4 17 05 4 wording and subsection B for examples of unacceptable multiple dependent claim wording.

If this box is marked, the Contractor must also fill in items 210-33a through 210-

35b found in “Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of the first sheet)”. Instructions follow later in this document.

210-13 Enter an “X” in this box if unity of invention is lacking.

The Contractor will have previously prepared an Invitation to Pay Additional Fees

(form PCT/ISA/206).

If this box is marked, the Contractor must also complete items 210-36 through

210-44 “Box III Observations where unity of invention is lacking (Continuation of item 3 of first sheet)”. Instructions follow later in this document.

210-14 Enter an “X” if the text of the title as submitted by the applicant is approved.

The title of the invention must be short and precise, preferably 2 – 7 words but not more than 17 words. See MPEP 1821 under “Title of Invention” for more information.

210-15 Enter an “X” if the title submitted by the applicant is not approved.

210-16 If item 210-15 is marked, the Contractor will enter an acceptable title in the space provided. See instructions for field 210-14.

210-17 Enter an “X” if the text of the abstract is acceptable.

The abstract is a concise summary of the disclosure, not more than 150 words in length.

210-18 Enter an “X” if the abstract is not acceptable.

If this box is marked, the Contractor will also complete item 210-46. A new abstract will be established if the abstract is more than 150 words in length; or if no abstract is present in the international application.

210-19 Enter the figure number of drawing to be printed with the abstract.

The Contractor will decide which drawing figure best characterizes the invention.

The figure to be published should not have excessive text, e.g., a flow chart should not be selected.

If none of the figures is appropriate for publication, leave this space blank and proceed to item 210-23. If no drawing figures are present, skip items 210-19 to 210-23.

210-20 Enter an “X” if the figure to be published is as suggested by the applicant.

The Contractor will look at Box No. IX of the PCT Request in data field 17 for applicant’s suggested figure to be published.

Attachment 4 – rev 4 17 05 5

210-21 Enter an “X” if the figure to be published was chosen because applicant failed to suggest a figure.

210-22 Enter an “X” if the figure to be published was chosen because this figure better characterizes the invention.

210-23 Enter an “X” if none of the figures is to be published with the abstract.

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 Observations where certain claims were found unsearchable (Continuation of item 2)” in this document.

210-26 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.

210-27 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.

210-28 Enter an “X” if the sequence listing was contained in the application as filed.

210-29 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.

210-30 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.

210-31 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.

210-32 Enter any additional comments necessary to explain matters concerning the nucleotide and/or amino acid sequence(s) used to carry out the international search.

210-33a Enter an “X” if certain claims are held to be unsearchable because they relate to subject matter not required to be searched by the ISA/US.

See instructions for item 210-12.

210-33b Enter the claim numbers affected under this criterion.

Attachment 4 – rev 4 17 05 6

210-33c Enter a statement explaining why those claims are considered unsearchable.

210-34a Enter an “X” if certain claims are held to be unsearchable because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent that no meaningful international search can be carried out.

The Contractor will mark this box where the description, claims or drawings or where specific claims which are so unclear that no meaningful opinion could be formed; where claims are so inadequately supported by the description that no meaningful opinion could be formed; or where the claims are directed to specific nucleotide and/or amino acid sequences but applicant has not provided a searchable copy of the sequence listing in compliance with Annex C of the Administrative Instructions.

210-34b Enter the claim numbers affected under this criterion.

210-34c Enter a statement explaining why those claims are considered unsearchable.

210-35a Enter an “X” if certain claims are not drafted in accordance with the second and third sentences of Rule 6.4(a), that is, if they are improper multiple dependent claims.

210-35b Enter the claim numbers affected under this criterion.

210-36 When item 210-13 is marked, enter the identified groups of inventions, including claim numbers, the special technical feature of each group and the rationale for making the lack of unity of invention holding. This information can be copied from Form 206, items 206-11 and 206-12.

If the space provided is insufficient, enter the information in item 210-59 on

PCT/ISA/210 (extra sheet).

The USPTO will notify the Contractor of applicant’s response to Form 206. The notification by the USPTO will be in writing and will indicate if 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.

210-37 Enter an “X” if all additional search fees were timely paid.

210-38 Do not mark this box.

Where, after reviewing the PCT application, the USPTO determines that unity of invention is lacking but that the Contractor did not issue Form 206, this box will be marked by the USPTO.

210-39 Enter an “X” where the applicant only paid some of the additional search fees.

Attachment 4 – rev 4 17 05 7

210-40 Enter the claim numbers for all claims that were search, that is, the claims of Group I and the claims of the groups for which the additional search fees were paid.

210-41 Enter an “X” where no required additional search fees were timely paid by the applicant.

210-42 Enter the claims numbers of Group I.

210-43 Enter an “X” if the additional search fees were accompanied by the applicant’s protest.

If the applicant does not agree with the lack of unity of invention requirement set forth on Form 206, he can file a protest together with the payment of additional search fees. The Contractor will look at applicant’s response to Form 206 for the presence of a protest. If no protest accompanied the payment of additional search fees, skip this box and go to item 210-45.

210-44 Do not mark this box.

210-45 Enter an “X” if no protest accompanied the payment of additional fees.

210-46 If item 210-18 is marked, enter the reason(s) why a new abstract is established and the text of the new abstract.

The Contractor will prepare a new abstract if the abstract is not in accordance with PCT Rule 8.1(b) because it is not as concise as the disclosure permits. The abstract should not be more than 150 words in length. The Contractor will establish an abstract if none is present in the international application.

210-47 Enter the classification of the application according to current International Patent

Classification, and the US Classification.

210-48 Enter the areas in which a classified search was performed. See section C.4.7. of the Request for Proposal on recordation of the search history.

210-49 Enter a concise summary from the “SEARCH HISTORY” document (see section

C.4.7. of the Request for Proposal) of the documentation searched other than minimum documentation.

210-50 Enter a concise summary from the “SEARCH HISTORY” document (see section

C.4.7. of the Request for Proposal) of the electronic databases searched and the search terms used.

210-51a, b, c Enter all prior art references considered to be pertinent in these spaces. Skip a line between each prior art reference listed.

Relevant prior art for the purposes of establishing the international search report is defined in PCT Rule 33.1 as everything which is made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations) and which is capable of being assistance in determining that the claimed invention is or is not new and that is does or does not involve an inventive step (i.e., that it is or is not obvious), provided that the making available to the public occurred prior to the international filing date.

Attachment 4 – rev 4 17 05 8

210-51a Enter the category of the first reference cited.

The Contractor will indicate the particular category of the cited document in the left column in field 210-510a as follows:

“X” is used for a document that anticipates the claimed invention or renders it obvious by itself, that is, a “stand alone” reference.

“Y” is used for a document that when combined with another document renders the claimed invention obvious.

“A” is used for a document which teaches the general state of the art but which is not considered to be of particular relevance to the claimed invention.

Where the document was published on or after the priority date but before the international filing date, in addition to “X”, “Y” or “A”, the contractor will also indicate “P”, for example, “X,P” or “Y, P” or “A, P”.

Where the document is a published patent application or patent that was published on or after the international filing date but that patent application or patent has a filing date or a priority date prior to the international filing date, in addition to “X”, “Y” or “A”, the contactor will also indicate “E”, for example, “X, E” or “Y, E” or “A, E”.

All categories of cited documents are defined on the PCT/ISA/210 form below items 210-52 and 210-53.

210-51b Enter the first relevant piece of prior art found using the format specified in WIPO

Standard ST.14 together with an indication of the pertinent parts of that prior art document.

The Contractor will cite the prior art document in the center column, using format specified in WIPO Standard ST.14. A copy of that standard is posted at the following URL http://www.wipo.int/scit/en/standards/pdf/03-14-01.pdf.

For example, US 5,902,299 A (JAYARAMAN SWAMINATHAN) 11 May 1999

(11.05.1999) column 5, line 45 – 62; figures 4-7

210-51c Enter the claim number to which that prior art document is relevant.

If one document is applied against certain claims as one category, for example, “X”, and that same document is applied against other claims as a different category, for example, “Y”, the Contractor will list the document once in item 210-51b. In item 210-51a the Contractor will list the first category, e.g., X, as described above, and will list the second category, e.g., Y, directly beneath it with a series of 3 – 4 dashes between the two categories. In 210-51c, the Contractor will list the claim numbers relevant to the first category, e.g., claims 1-5, and the claim numbers relevant to the second category beneath, e.g., claims 6-10, with a series of dashes between the two. See the example below .

X US 5,902,299 A (JAYARAMAN SWAMINATHAN) May 1999 1-5 --- 11 (11.05.1999) column 5, line 45 – 62 -----http://www.wipo.int/scit/en/standards/pdf/03-14-01.pdf

Attachment 4 – rev 4 17 05 9

Y figures 4-7 6-10

210-52 Enter an “X” if additional space is needed to list further documents and continue in item 210-58a, 210-58b and 210-58c on PCT/ISA/210 (continuation of second sheet).

210-53 Do not mark this box.

210-54 Enter the date that this form was completed.

The contractor will enter the date of completion using a “Day Month Year (DD Month YYYY)” format, e.g., 24 September 2003 (24.09.2003).

210-55 Leave this box blank.

210-56a Field will be populated by USPTO.

210-56b Field will be populated by USPTO.

210-56c Field will be populated by USPTO.

210-57 Field will be populated by USPTO.

210-58a,b,c Use these spaces as a continuation for reference citations in items 210-51a, 210-

51b and 210-51c.

210-59 Use this box for overflow from item 210-36