Annex J - Examples of Objections under PCT Articles 5 and 6

Example 1 (objections under Articles 5 & 6)

Claims

1.  A method of identifying a compound that inhibits a nematode secretion pathway comprising steps of:

providing a nematode, wherein the nematode produces a secretion product;

contacting the nematode with a test product; and,

detecting a decrease in the activity or amount of the secretion product when the test compound is present versus when the test compound is absent.

2.  A compound identifiable according to the method of claim 1.

3.  A pharmaceutical composition comprising:

a compound identifiable according to the method of claim 1; and,

a pharmaceutically acceptable carrier.

4.  An anti-nematode agent for use in preventing or reducing nematode infestation of a plant comprising:

a compound identifiable according to the method of claim 1; and

an agriculturally acceptable carrier.

Background

The only compound disclosed in the specification as inhibiting a nematode secretion pathway is 4,7-phenanthroline.

Objection under Article 5.

Present claims 2 to 4 relate to a compound defined by reference to a desirable characteristic or property, namely that it inhibits a nematode secretion pathway. The claims cover all compounds having this characteristic or property whereas the description only discloses one compound with this property, 4,7-phenanthroline (example 10, figure 8).

PCT Article 5 requires that the description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. The PCT Guidelines state that the disclosure of the claimed invention is considered sufficiently clear and complete if it provides information which is sufficient to allow the invention to be carried out by a person skilled in the art as of the international filing date, without undue experimentation.

Although a reasonable amount of trial and error is permissible, a person skilled in the art must, on the basis of the disclosure of the claimed invention and the general knowledge, be able to carry out the invention across the entire scope of the claim without undue experimentation.

While it may be possible to predict that particular compounds are likely to inhibit a nematode secretion pathway, there will still remain a large number of compounds where it cannot be predicted if they will or will not inhibit the secretory pathway. These may be screened to test for this ability, however the extremely large number of compounds to be screened means that not all possible compounds with the desired characteristic or property could be identified without undue experimentation. Therefore, based on the unpredictable nature of the invention and the extreme breadth of the claims, one skilled in the art could not carry out the invention across the entire scope of the claims without undue experimentation

Therefore the description does not meet the requirements of Article 5 of the PCT with regards to it being sufficiently clear and complete for the invention to be carried out by a person skilled in the art.

Objection under Article 6

Present claims 2 to 4 relate to a compound defined by reference to a desirable characteristic or property, namely that it inhibits a nematode secretion pathway. The claims cover all compounds having this characteristic or property whereas the description only provides support within the meaning of Article 6 of the PCT for one compound, 4,7-phenanthroline (example 10, figure 8).

The claims are considered to go beyond the scope of the disclosure of the specification as it is not reasonable to predict all possible compounds that are covered by the claims, nor could all possible compounds falling within the scope of the claims be identified through routine experimentation or analysis alone. As the claims are considered to lack enablement for all compounds thereby embraced, they are not fully supported across their entire scope as required by Article 6 of the PCT.

Restriction of search.

This lack of disclosure/support means that a meaningful search over the entire scope of claims 2 to 4 cannot be conducted. Consequently the search has been carried out for those parts of the claims which appear to be supported/disclosed, namely those parts relating to 4,7-phenanthroline.

Note - unity:

In situations such as this with “reach through” claims the examiner should also consider if unity of invention is lacking and object where appropriate.

Claiming by result.​​​​​​​

Note: claims should also be objected to as lacking clarity (see PCT/GL/ISPE/12 paragraph 5.35).

US objection under the PCT (for contrast).

Present claims 2 to 4 relate to a compound defined by reference to a desirable characteristic or property, namely that it inhibits a nematode secretion pathway.

The claims cover all compounds having this characteristic or property, whereas the application provides support within the meaning of Article 6 PCT and disclosure within the meaning of Article 5 PCT for only one compound. In the present case, the claims so lack support, and the application so lacks disclosure, that a meaningful search over the whole of the claimed scope is impossible. Independent of the above reasoning, the claims also lack clarity (Article 6 PCT). An attempt is made to define the compound by reference to a result to be achieved. Again, this lack of clarity in the present case is such as to render a meaningful search over the whole of the claimed scope impossible. Consequently, the search has been carried out for those parts of the claims which appear to be clear, supported and disclosed, namely those parts relating to the compound 4,7-phenanthroline (example 12, figure 8).

Example 2 (objection under Article 5)

Claims

1. A solid detergent composition comprising from 8 to 60 wt % of a surfactant system and having a Grand Compatibility Index of at least 0.5.

Background

The Grand Compatibility Index parameter is unknown in the prior art.  It turns out to be a function of a large number of other parameters, many of which are not quoted in the prior art.  Several pages of the application are taken up with an explanation of an elaborate testing procedure, using highly specialised laboratory equipment, which will, when followed, compute the grand compatibility Index of a given detergent.  There are five worked examples of detergent compositions satisfying the parameter in the description.

Objection under Article 5

Article 5 of the PCT requires that the description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. The PCT Guidelines state that the disclosure of the claimed invention is considered sufficiently clear and complete if it provides information which is sufficient to allow the invention to be carried out by a person skilled in the art as of the international filing date, without undue experimentation.

Although a reasonable amount of trial and error is permissible, a person skilled in the art must, on the basis of the disclosure of the claimed invention and the general knowledge, be able to carry out the invention across the entire scope of the claim without undue experimentation.

The claims are directed to a detergent composition characterised by the Grand Compatibility Index (GCI) parameter, which is a parameter that is not standard in the art and is calculated from other non-standard parameters in the art which an require elaborate testing procedure, using highly specialised laboratory equipment. Accordingly it is considered that the GCI parameter does not form part of the common general knowledge of the person skilled in the art, and that it would not be possible for the addressee to predict which detergent compositions possess the specified parameter at the specified level.  Given the use of parameters which are unusual in the art, it is considered that the skilled addressee could not, on the basis of the disclosure, determine which compositions will have a GCI of at least 0.5 without undue experimentation.  Hence it is considered that the specification does not disclose the invention of claim 1 in a manner sufficiently clear and complete for the invention to be carried out by the skilled addressee and that the description therefore does not meet the requirements of Article 5 of the PCT.

Example 3 (objection under Article 6)

Claims

1. A cloned non-human mammal.
2. A method of cloning a non-human mammal comprising:

i. fusing a non-human mammalian differentiated cell with an unactivated, enucleated metaphase II arrested oocyte to reconstruct an embryo;

ii. maintaining the reconstructed embryo without activation for sufficient time to reprogram the nucleus;

iii. activating the reconstructed embryo;

iv. transferring said reconstructed embryo to a non-human host mammal such that the reconstructed embryo develops to term.

Objection under Article 6

Claim 1 does not meet the requirements of Article 6 of the PCT because it is not fully supported by the specification.  Claim 1 is considered to be broader than is justified by the disclosure of the specification and lacks enablement across its entire scope.

Claim 1 is directed to a cloned non-human mammal and encompasses cloned mammals produced by any possible means. This is a problem which others have attempted to solve and is a desired result in the art, as evidenced by:

D1; WO 1996/007732 (ROSLIN INSTITUTE);

D2; Liu L et al, “Nuclear remodelling and early development in cryopreserved, porcine primordial germ cells following nuclear transfer into in vitro-matured oocytes” The International Journal of Developmental Biology, 1995, 39(4):639-644.

Accordingly, it is considered that more than routine experimentation would be required to determine each and every possible method of producing a cloned non-human mammal, and that methods beyond those disclosed in the description would be required to achieve the desired result. Therefore claim 1 is considered not to meet the requirements of Article 6 of the PCT, as it extends beyond the disclosure of the specification.

[Documents cited to be included in the ISR.]

Example 4 (objection under Article 6)

Claims

1. A compound of general formula R’—O—Sn(R)2—O—R’ wherein each R’ individually represents hydrocarbyl, alkyl, cycloalkyl, aryl or aralkyl; and each R individually represents a hydrocarbyl group, e.g., alkyl, cycloalkyl, aryl or aralkyl.
2. The novel di-sucrose mono-tin intermediates,
3. (sucrose-6-ester) – O – Sn(R)2-O- (sucrose-6-ester).
4. A process of production of a compound of claim 1 when the compound is of general formula (sucrose-6-ester)-O-Sn(R)2-O-(sucrose-6-ester), comprising, sequentially:
   1. Dissolving sucrose and a di(hydrocarbyl)tin catalyst, preferably dibutyltin oxide in appropriate molar proportions, preferably around 1:0.5 with respect to moles of sucrose taken, in a solvent, preferably N,N-dimethylformamide (DMF),
   2. Allowing reaction to occur for a period of time ranging from 6 to 18 hours, preferably for about 10-13 hours under conditions facilitating continuous removal of water, preferably involving continuous heating of the reaction mixture at elevated temperature preferably at around 80-85 degrees Celsius.

Background:  

A regioselective method of producing a sucrose ester via a particular mono-tin intermediate, wherein two sucrose molecules are attached to a tin core, is disclosed.  

Citation:  

D1 discloses a process for producing a di-tin adduct from sucrose and a tin catalyst using methanol as solvent.

Objection under Article 6

Claim 1 is not fully supported.  The claim defines a compound of general formula R’—O—Sn(R)2—O—R’ wherein R’ individually represents hydrocarbyl, alkyl, cycloalkyl, aryl or aralkyl, thus encompassing non-sucrose based stannylene adducts.   However, the invention relates to a process for the regioselective synthesis of a sucrose-6-ester via a sucrose based stannylene adduct, which is the product of the organo-tin catalyst and sucrose (see paragraph 1 page 5).  All the examples are directed to processes involving sucrose, and there is no indication that the reaction mechanism will be identical for non-sucrose adducts. In the absence of any information regarding the use of non-sucrose adducts in the specification as filed, the person skilled in the art would be unable to extend the teaching of the description to the whole of the field claimed by using routine methods of experimentation or analysis.  Therefore, insofar as it defines a non-sucrose based stannylene adduct, the subject matter of claim 1 is not fully supported by the specification as required by Article 6 of the PCT.

Claim 4 is not fully supported for the purposes of Article 6 of the PCT. This claim recites a process of producing a specified sucrose mono-tin adduct involving the use of “a solvent”. D1 teaches that if methanol is used as the solvent, a different di-tin adduct results, thus establishing that it is not reasonable to expect that any solvent will produce the specified sucrose mono-tin adduct. Therefore, insofar as claim 4 does not identify the solvent, or class of solvents, necessary to produce the sucrose mono-tin adduct specified in the claim, this claim lacks full support.