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                          COMMISSIONER'S DECISION

 

ADEQUACY OF DISCLOSURE: SECTION 36 - Diaza-Cycloalkanes

 

The applicant claimed several methods to make new chemical compounds

useful medicinally. The examiner wished to restrict the applicant

to one method, holding that the others were not disclosed adequately.

It was decided that in the particular circumstances arising here

there was sufficient support.

 

Rejection: Reversed.

 

The final rejection of patent application 090755, class 260-263, filed

August 14, 1970, by Farbwerke Hoechst Aktiengesellschaft as assignee of

Robert Rippel et al, has been referred to the Patent Appeal board to

recommend what disposition should be made of the application. The title

of the invention is "2-(Thienyl-3'-amino)-1,3-Diaza-Cycloaklenes and

Process for Preparing Them." At the request of the applicant a Hearing

was held at which Miss M. Morency and Mr. David M. Rogers Q. C. represent-

ed the applicant.

 

In his final rejection, the examiner refused claim 1 under Section 36 of

the Patent Act on the grounds that the disclosure failed to provide adequate

support for all the subject matter covered by the claim. Section 41(1) was

also applied for the reason that some of the processes claimed mere not

"particularly described" in the application. The processes objected to

are those covered by parts c, d and e of claim 1, which reads as follows:

 

A process for preparing 2-(thienyl-3'-amino)-1,3-diazacycloalkenes

of the general formula

 

                       (See formula 1)

 

wherein R1, R2 and R3 represents hydrogen, low molecular weight, alkyl,

halogen, cyano or phenyl, or R2 and R3 may represent together a tri-

methylene or tetramethylene chain, and

Z represents a straight or branched alkylene radical having 2 - 4 C -atoms

of which 2 - 3 C-atoms are members of a ring,

in which

(a) a thienyl-3-isothiuronium salt, -thio-urea, -guanidine,

-nitroguanidine, or -cyanamide of the formula II

 

                        (See formula I)

 

wherein R1, R2 and R3 have the meanings given above, and

R represents the group

 

                            (See formula II)

 

 or            -CN                            (e) ,

 

wherein R5 represents low molecular weight alkyl and X rep-

resents an acid anion, is reacted with an alkylene-diamine of

the formula III

 

                  H2N-Z-NH2                  III

 

wherein Z has the meaning given above, or a mono salt thereof,

 

(b) an N-(3'-thienyl)-N' -aminoalkyl-thio urea of the formula IV

 

                        (See formula IV)

wherein R1, R2, R3 and Z have the meanings given above, and A

represents oxygen or sulfur, is cyclicized,

(c) an aminothiophen of the formula V

 

                          (See formula V)

 

wherein R1, R2 and R3 have the meanings given above, is reacted

with a 2-alkylmercapto-1, 3-diazacycloalkene of the formula VI

 

                          (See formula VI)

 

wherein R5 and Z have the meanings given above, or a salt thereof.

 

(d) an aminothiophen of the formula V is reacted with a bis-(2-oxo-1,

3-diaza-cycloalkyl)-phosphrine chloride of the formula VII

 

                              (See formula VII)

 

wherein Z has the meaning given above, or

 

(e) a thiophen-3-isocyanide-dihalide of the formula VIII

 

                       (See formula VIII)

 

wherein R1. R2 and R3 have the meanings given above, and Hal

stands for chlorine or bromine, is reacted with an alkylene-

diamine of the formula III.

 

Although the preamble to the claim implies one process is claimed, in fact

there are many different processes to make certain diazacycloalkenes.

These alkenes possess hypotensive properties which are useful medicinally, so

that Section 41 is applicable to them. In the disclosure some examples are

provided of processes (a) and (b), but not for processes (c), (d) and (e).

 

In the final rejection, the examiner stated his objections in the following

terms:

 

The rejection of variations c, d and e in claim 1 is maintained

and the reason for such rejection is lack of adequate support

from the disclosure; the disclosure fails to meet the require-

ments of Section 36(1) regarding variations c, d and e and is

inadequate to support claims, particularly under Section 41(1)

which is designed to limit the monopoly on drugs to their

relationship to processes "particularly described".

 

The disclosure does not contain the description of any particular

compound by any of the methods under rejection.

 

Referring to a paragraph of the last Office Action which was

apparently misunderstood: "Contrary to applicant's opinion, the

disclosure does not provide "the description necessary to enable one

skilled in the art to carry out said variations." The processes

are not properly speaking described."

 

The disclosure fails to indicate the particular way in which the re-

jected variations must be adapted to produce the desired result and

hence does not show their utility in the preparation of the claimed

compounds nor even their practicability in such preparation. The wide

temperature ranges mentioned as well as the broad list of solvents

do not constitute information but rather an absence of definite

information, and consequently the public is not put in possession

of anything which is not already in public possession.

 

A patent is not an invitation to experiment, and the disclosure, with

respect to the variations under rejection, is insufficient to exempt

the interested person from experimenting for the purpose of determining

the actual means of adapting the methods, and this without definite

guarantee of success.

 

The concept that a process derives patentability from the patent-

ability of its product is not an exemption from Section 36(1) and the

practice of allowing any suggested processes, if adopted, could render

Section 41(1) completely inoperative, through the simple expedient

of adjoining an exhaustive list of known methods as alternates to the

method employed in the original synthesis: Section 41(1) becomes dead

letter if a compound claim covers all methods,

 

In his response of November 28, 1974, one argument made by the applicant was

that:

 

All of the processes are conventional chemical reactions and derive

their patentability from the new and unobvious utility of the

products of the formula given above. This is in accordance with

the decision of the Supreme Court of Canada in Ciba v. The Commissioner

of Patents (1959) SCR 378.

 

As stated above, these reactions were considered to be conventional

chemical reactions prior to filing of the subject application.

Obviously, the same reactants had never previously been reacted with

one another since this would deny the novelty of the processes but

similar reactants had been so reacted.

 

Variation c is concerned with the reaction of a compound of the

formula V with a compound of the formula VI. This reaction is discussed

in the disclosure on page 6, second line from the bottom to page 7,

line 15. In this portion of the disclosure, instructions are given

concerning the various parameters of the process. In addition, the

preparation of the starting material of the formula VI is also

described on page 7.

 

He then referred to several publications which showed that reactions

analogous to processes c and d had been used earlier to make different com-

pounds than those claimed here. In discussing Section 36(1) he stated:

 

Applicant respectfully submits that the requirements of

Section 36(1) have been met in the subject application. The

invention resides in the novel compounds and their unexpected

utility in pharmaceutical preparations. This invention and

its use as contemplated by the inventors is correctly and fully

described in the application. According to Section 36, when

a process is involved, it is necessary to set forth clearly the

various steps in the process and this has been done for each

variation which may be used in the preparation of the novel

compounds of the invention. This has been done in such full,

clear, concise and exact terms as to enable any person skilled

in the art or science to which the invention appertains to use

the invention. In support of this statement, an affidavit of

Dr. Leopold Horner, a Professor of Chemistry at the University

of Mainz in Germany, is included.

 

From this affidavit you will note that Dr. Horner read the

disclosure of this application and, using process variations c,

d and e, prepared the compound of Example Ib, namely 2-

(4'-methylthienyl-3'-amino)-1,3-diazacyclopentene-(2). Dr. Horner's

note book records form part of his affidavit. You will also note

that it is Dr. Horner's belief that the disclosure is sufficient to

enable a skilled chemist to use variations c, d and a to produce

the novel compounds.

 

Applicant is unaware of any statutory requirement that examples

be included in support of a process claim. In Gilbert v. Sandoz 64

CPR 14, The Exchequer Court found a claim invalid since there was

no particular example in the disclosure directed to the particular

process claimed. However, the Supreme Court in reversing this stated

that:

 

"In my view, this cannot be of very great consequence seeing

that the "condensation" process is not claimed as new and it

is not denied that a competent chemist, using only general

knowledge available, could have successfully carried it out

without more information than is supplied in the general

description." (Sandoz v. Gilcross 8 CPR (2d) 216).

 

It should be noted that Mr. Justice Pigeon, who delivered the judgement

of the Supreme Court, considered the process to be "described" even

though it was not "exemplified".

 

This latter point is of considerable importance since the Examiner

has stated that the disclosure in this application is inadequate to

support the claims, particularly under Section 41(1) which is designed

to limit the monopoly on drugs to their relationship to processes

"particularly described". Applicant respectfully submits that

each of process variations c, d and e has been particularly des-

cribed and considers that the Supreme Court decision in Sandoz v.

Gilcross supports the submission.

 

In rebutting other objections of the examiner the applicant states:

 

It is applicant's contention that the disclosure does indicate tile

particular way in which variations c, d and e must be adapted to

produce the desired result. This position is substantiated by the

affidavit of Dr.Horner, the "person skilled in the art" to whom

a patent specification is addressed. It is submitted that an

example is unnecessary to show the utility of these processes or

their practicability and that there is no statutory requirement or

judicial decision which make exemplification necessary.

 

The Examiner has also stated that the wide temperature ranges mentioned

as well as the broad list of solvents do not constitute information

but rather an absence of definite information, and consequently the

public is not put in possession of anything which is not already in

public possession. Applicant has not at any time alleged that the

processes of variations c, d and e were new chemical processes but

merely processes which were conventional at the time of filing of the

subject application. These processes, however, had never before been

used to react the various reactants to produce the novel compounds of

the invention which have unexpected utility as pharmaceuticals. With

reference to the disclosure taken as a whole, the public is put in

possession of something which was not in public possession, namely the

knowledge of these compounds and their use.

 

and

 

The Examiner has stated that a patent is not an invitation to experiment

and the disclosure with respect to the variations under rejection is

insufficient to exempt the interested person from experimenting for

the purpose of determining the actual means of adopting the method and

this without the definite guaranty of success. Applicant submits that

the disclosure is sufficient to allow a person skilled in the art

to practise the invention and this is all that is required.

 

Mr. Justice Maclean in the BVD v. Canadian Celanese decision 1936 Ex CR 140

held that:

"Where a specification described an invention sufficiently

clearly to enable a reasonably skilled workman to make use of

it, even though some experiments are necessary, the patent will

be good so long as those experiments do not require any

exercise of the inventive faculty".

and

 

The Examiner has stated that the practice of allowing any

suggested processes, if adopted, could render Section 41(1)

completely inoperative through the simple expedient of joining

an exhaustive list of known methods as alternates to the

method employed in the original synthesis. Applicant has not

merely suggested processes but has, in fact, described

processes. The claims of the subject application do not,

in fact, describe all methods but five methods which have

been described in the disclosure in such a manner to enable

a person skilled in the art to practice the invention.

 

It is evident that a principal issue is whether the disclosure is

adequate to permit certain of the processes to be claimed. In this case

the core of the invention is the product, and it is from it that the

process claims must acquire their necessary element of inventive ingenuity.

As the applicant has put it: "All of the processes are conventional

chemical reactions and derive their patentability from the new and

unobvious utility of the products....He relies upon Ciba v.

Commissioner of Patents (1959) S.C.R. 378 for that proposition. While

he has implied that there are other methods for making the products

(response of November 28, 1974, p.7), claim 1 covers the practical

methods which would normally be employed to make them, and it is in effect a

claim for all known ways to produce them. It comes close to being a

claim for a process for making the new compounds by all known methods

by which they might be prepared. It would not block others from

making the products if they were to develop inventively new methods to

prepare them, but barring that contingency would control all useful routes

to the compounds. Whether Section 41 permits applicant to claim so broadly

is another issue which must be considered.

 

In discussing Section 36 (then Section 35) in RCA v Raytheon (1956-1960)

Ex. C.R. 98 at 109 the Exchequer Court indicates that the onus of disclosure

that the section places on an inventor is a heavy and exacting one.

 

It stated at p. 108:

 

It is a cardinal principal of patent law that an inventor may

not validly claim what he has not described. In the patent

law jargon it is said that the disclosure of the specification

must support the claims. If they do not, the claims are

invalid. Moreover, there is a statutory duty of disclosure

and description that must be complied with if a claim for an

invention is to stand....

 

It further indicated that:

 

The purpose underlying this requirement is that when the period

of monopoly has expired the public will be able, having only

the specification, to make the same successful use of the

invention as the inventor could at the time of his application

(p. 109).

 

It is a principle reiterated in Noranda Mines v Minerals Separation (1947)

Ex. C.R. 306 at 316; in French's Complex Ore v Electrolytic Zinc 1930

S.C.R. 462 at 470; in B.V.D. v Canadian Celanese 1936 Ex. C.R. 139 and

1937 S.C.R. 22; in Smith Incubator v Sealing 1937 S.C.R. 251; in Gilbert v

Sandoz (1971) 64 C.P.R. 7 at 42-45; and in Rh“ne-Poulenc & CIBA v Gilbert

1966 Ex. C.R. 59 & 1967 S.C.R. 45.

 

On an earlier occasion we considered the question of sufficiency of disclosure

when application 028123 came before the Board. Our findings there were pub-

lished in the Patent Office Record for November 11, 1975, beginning at

page X1. We think it would be useful here to reexamine one of the cases

referred to at that time.

 

In the Gilbert v Sandoz decision supra , at p. 52, the Exchequer Court found

a process claim invalid because:

 

... the requirement of S. 36(1) is that the applicant describe

his invention and its operation or use as contemplated by him.

The public and the reader are entitled to a description of the

invention which the inventor has made and to say that a group of

substituted phenothiazines may be made by a known type of

chemical reaction is, as I see it, to assert merely what is

already known as a general proposition rather than to say that he

has carried it out in a particular way using particular materials

and found that such is a practical method of producing an

unexpectedly useful new substance known as thioridazine.

 

The Supreme Court of Canada, however, (1974 S.C.R. 1336 at 1344) reversed

the lower court on this point, saying:

...In my view this cannot be of very great consequence

 seeing that the "condensation" process is not claimed

 as new and it is not denied that a competent chemist,

 using only general knowledge available could have success-

 fully carried it out without more information than is

 supplied in the general description. Furthermore it is

 not denied that the bromo-ethane process can be successfully

 carried out using the procedures and reagents that are

 described in Example I which illustrates the carrying out

 of the process as applied to the chloro-ethane compound.

 Thus, the only objection to the sufficiency of the

 description of the means of carrying out the invention by the

 bromo-ethane process is that the inventor did not say that one

 could proceed as in Example 1 for the chloro-ethane process,

 although any skilled chemist would know that this must be

 expected in the absence of any mention of some anomaly in

 the behaviour of the bromo-ethane compound in the reaction.

 

 We also refer to the following passage in our earlier decision:

 

 As was held in Riddel v. Patrick Harrison (1956-1960) Ex. C.R. 213

 at 253, an inventor need not restrict his claims to what has

 been "specifically described in the specification and illustrated

 in the accompanying drawings," but within the breadth of his

 invention, may claim it as broadly as it would normally be

 construed by persons skilled in the art. For such reasons, we

 do not consider that Section 36 prohibits the grant of claims

 20-30.

 

 In the case which is now before us the applicant has submitted an affidavit

 of one Dr. Leopold Homer affirming that the disclosure is sufficient to

 enable a skilled chemist to carry out variations (c), (d), & (e), and

 copies of articles predating the filing of this application illustrating,

 that the methods had been used to make other compounds. The issue has

 certain similarities to that decided in Gilbert v Sandoz. We are consequently

 persuaded that there is adequate disclosure of methods (c), (d) & (e),

 and that the rejection based on Section 36 should not be maintained. We

 are satisfied that those skilled in the art would be able to make the desired

 compounds using any of the three methods without difficulty.

 

 Turning to the second main branch of the examiner s objection, we must look

 at subsection (1) of Section 41 of the Patent Act, It provides that:

 

 In the case of inventions relating to substances prepared

 or produced by chemical processes and intended for food or

 medicine, the specification shall not include claims for

 the substance itself, except when prepared or produced by the

 methods or processes of manufacture particularly described

 and claimed or by their obvious chemical equivalents.

 (underlining added)

 

It is the examiners view that this provision would be rendered "completely in

operative, through the simple expedient of adjoining an exhaustive list of

known methods as alternatives to the method employed in the original synthesis."

He considers the provision would become a dead letter if a compound claim

could cover all methods of making the compound.

 

We have already discussed the Gilbert v Sandoz case, in which, the invention,

it may be noted, has also governed by Section 41. In finding the process for

making the bromine derivatives valid, the Supreme Court implicitly determined

that the claim to it satisfied Section 41.

 

In Hoechst Pharmaceuticals v Gilbert (1965) 1. Ex. C.R. 710 and 1966 S.C.R. 189

both the Exchequer Court and the Supreme Court considered claims for several

processes to make new pharmaceuticals. The lower court made the following

observations:

 

(at p. 720)... There follow several pages of general description

of the methods - all of which were already well known to chemists

and of various starting materials of which it is stated that many

of them "suitable for use in the present process have been described in

the literature." Up to the end of this portion of the disclosure

there is accordingly nothing whatever to indicate a patentable

invention for there is nothing inventive in applying known methods to

known materials or kinds of materials even if no one has previously

applied the methods to the particular materials and even if the result

is a new product. To have a patentable invention the products in such

a case besides being new must be useful in the patent sense and only

if they are both new and useful can they and the process for producing

them be the subject of a patent. Vide Jenkins, J. in Re May & Baker

et al (65 RPC 255 at 281).

 

and at p. 726

 

....In the case of each patent the method of preparing the ureas re-

ferred to in claim 1 was not new and it is stated in the patent that

many of the starting materials were already known. It was moreover

admitted in the course of the trial that for the purposes of this

case it could be taken that all of them were known. In this situation

the principles stated by Jenkins, J. in Re May & Baker (supra) and

applied by the Supreme Court of Canada in Commissioner of Patents v. Ciba Ltd.

(1959 S.C.R. 378) appear to me to apply.

 

The court subsequently held the claims invalid for "preposterous" overclaiming

because it could not be said that "... all, or substantially all, members of

the class of sulphonyl areas defined in them possess some previously unknown

usefulness." (p. 731) But implicit in its findings is the proposition that

absent broad overclaiming,and if it would be a sound prediction that sub-

stantially all the members of the class possessed the required utility, then

the process claims would be valid. The Supreme Court put it this way (p.191):

 

It is conceded that tolbutamide, standing by itself, could

have been the subject matter of a valid patent if claimed as

such when prepared or produced by the methods or processes of

manufacture particularly described and claimed in the patent

or by their obvious chemical equivalent. (underlining added).

 

In the application we are considering, no objection has been made that the

breadth of the class of products produced by the processes is too great,

and that consideration does not arise.

 

   It will also be useful to consider what was said in Boehringer Sohn v Bell

    Craig 1962 Ex. C.R. 201, where the effect of the phrase "particularly

described and claimed" in Section 41, subsection (1) was weighed. At p. 235

we find:

 

When s. 41(1) applies... it requires that the claim to such substance

be limited to that substance when prepared or produced by the methods

or processes which have been (a) particularly described, and (b) claimed,

or (c) by the obvious chemical equivalents of the methods or processes

which have been particularly described and claimed.

 

Here, the only limitation expressed in claim 8 is contained in the

words "when produced by the process of claim 1, 2 or 3, or by an ob-

vious chemical equivalent". And when one turns to claim 1 to see what

process for preparing or producing 2-phenyl-3-methylmorpholine is

therein claimed, one finds that it is not a claim for a process for

the preparation of that substance but a claim for a process for the

preparation of an enormous class of substances of which this substance is

but one. In my view, claim 1 is not a claim for a process for the

production of 2-phenyl-3-methylmorpholine even though that substance is

one of the class, because it is clear that not all the members of the

class of starting materials can be used to make 2-phenyl-3-methylmorpholine and

claim 1 does not say that they can be used for that purpose, and at

the same time, claim 1 does not say what starting material or materials

may be used to make 2-phenyl-3-methylmorpholine. It thus does not

state distinctly or in explicit terms any process for the production

of that substance and we are back at the comment made earlier,

that claim 1 as expressed does not fit the invention of 2-phenyl-3-

methylmorpholine, but is a claim related solely to the alleged invention

of the process for production of the class of substances. In

Winthrop Chemical Co. Inc. v. Commissioner of Patents, the Supreme

Court held that "a claim cannot be entertained for a substance failing

within s-s. (1) of s. 41 unless a claim is also made in respect of

the process by which it is produced", vide Martland J. in Parke,

Davis & Co. v. Fine Chemicals of Canada, Ltd.; "A process implies

the application of a method to a

material or materials", per Martland J, in Commissioner of Patents

v. Ciba Ltd..

 

and at p. 237:

 

It was also urged in connection with the same submission that under

s. 41(1) the claim for 2-phenyl-3-methylmorpholine must be limited

not only to that substance when prepared by methods or processes which

have been particularly described, or their obvious chemical equivalents,

and that the claim to that substance in claim 8 is not limited to the

methods or processes which have been particularly described. This, in

my opinion, raises a second fatal objection to the validity of

claim 8. The only processes for the preparation of 2-phenyl-3-

methylmorpholine which, in my opinion, can be said to be particularly

described anywhere in the specification are those described in

examples 2 and 9. Example 2 describes a process for production of 2-

phenyl-3-methylmorpholine by dissolving B-phenyl-a-methyl-B,B1-

dihydroxydiethylamine-hydrochloride in concentrated sulphuric acid,

allowing it to stand overnight at room temperature, then making alkaline

and extracting. Example 9 describes a process by which the same diethanol-

amine hydrochloride is warmed with 10 per cent hydrochloric acid for

six hours in a water bath and the product then worked up "in the usual

manner".

 

The claim to 2-phenyl-3-methylmorpholine in claim 8 is not stated to

be limited to that substance when prepared or produced by these two

processes or by their obvious chemical equivalents. It is not even

stated to be limited to that substance when produced by the processes

which were described generally, earlier in the specification or their

obvious chemical equivalents, since the processes so described consist

only in (a)introducing a diethanolamine of the class without heating

into concentrated (96%) sulphuric acid; or (b) by treating it with

diluted acid at a moderate temperature. Thus, even if contrary to my

opinion, the general description of these processes could be regarded as

sufficiently particular to meet the requirements of the expression

"particularly described" in s.41(1), and, if also contrary to my opinion,

claim 1 does claim a process for the preparation or production of 2-phenyl-3-

methylmorpholine, claim 8 would still not comply with the subsection.

 

To limit the substance claim of claim 8 only by reference to the

substance when prepared by the process of claim 1, or an obvious chemical

equivalent, is to ignore the requirement of s. 41(1) that the claim be

limited as well to the substance "when prepared or produced by the

methods or processes of manufacture particularly described... or by their

obvious chemical equivalents". For, as previously pointed out, claim 1

is not limited as is the description to the use of concentrated sulphuric

acid at room temperature and to the use of dilute acid at moderate

temperatures, nor to the production of the morpholine ring closure by the

action of acid on the diethanolamine. Nor do I think that whatever is

embraced in claim 1 is necessarily embraced either within the processes

described in the specification, or their obvious chemical equivalents".

For, as previously pointed out, claim 1 is not limited as is the description

to the use of concentrated sulphuric acid at room temperature and to the use

of dilute acid at moderate temperatures, nor to the production of the mor-

pholine ring closure by the action of acid on the diethanolamine. Nor do

I think that whatever is embraced in claim 1 is necessarily embraced

either within the processes described in the specification, or their

obvious chemical equivalents. Claim 8 is thus broader than s.41(1)

permits and is accordingly invalid.

 

The Supreme Court affirmed (1963 S.C.R. 410) one of the reasons of the lower

court - without expressing an opinion on the others - by holding that the

process claim was too broad and therefore invalid, and that the product claim

dependent on it was invalid by virtue of that depending upon an invalid

process claim. From what it said in the Gilbert v Sandoz decision (supra),

however, we think it can be taken that every method claimed need not be illustrated

in full detail. However the "very process" by which a product is manufactured

must be claimed where Section 41 applies before the product may be claimed. As

the Supreme Court said in Boehringer (p.414):

 

... The subsection (41(1)) was intended to place strict limitations

upon claims for substances produced by chemical process intended for

food or medicine. Such a substance cannot be claimed by itself. It

can only be claimed when produced by a particular process of manufacture.

Not only that, the claimant must claim, not only the substance, but

that very process by which it is manufactured....(underlining added).

 

In our case each product claim is dependent on a process claim which produces

it. The issue of overclaiming has not been raised, and does not seem to be

present. And in any event, the claim which has been refused is a process

claim, not a product claim to which objections for failures in particularly

claiming would be more properly addressed.

 

In Soci‚t‚ Rh“ne-Poulenc v. Gilbert, 1967 S.C.R. 45, the Supreme Court did not

have any compunction about multiple methods being claimed where Section 41 is

involved, and the methods are all known. It said, at p. 48:

 

This s. 41(1) patent is for a substance produced by three methods

or processes. This is permitted by s. 41(1). Section 41(1) does

not make it necessary to have three separate applications for the

same substance, one by each process....

 

The patent was subsequently found invalid (1967, 35 F.P.C. 174 and 1968 S.C.R. 950)

for overclaiming, because the class of substances claimed was much too broad

for the invention made, and in the class of compounds claimed many were not

therapeutically useful. That, however, is not the objection made in the

rejection of this application. Thee Exchequer Court also found there was an

inadequate disclosure of the therapeutic use of the substances claimed, ar_

objection which conceivably might have been made, but the examiners implicit

acceptance of methods (a) & (b), and of product claims dependent thereon rules

out that consideration at this time,

 

In Boehringer Sohn v. Bell-Craig (1962) Ex. C.R. 201 and (1963) S,C.R. 410,

Martland J., in delivering the judgement of the Supreme Court, said of the

Section 41 at p. 414:

 

... The subsection was intended to place strict limitations upon

claims for substances produced by chemical process intended

for food or medicine. Such a substance cannot be claimed by

itself. It can only be claimed when produced by a particular

process of manufacture. Not only that, the claimant must claim,

not only the substance, but that very process by which it is

manufactured. To comply with the subsection he must, therefore,

make two claims. In my opinion this means that he must make

valid claim to both the process and the substance, if he is to be

entitled, successfully, to claim the latter. To interpret

the subsection as meaning that all that is necessary is to file a

claim for the process, valid or not, would be to defeat its purpose.

A person who claims a substance within the subsection, supported

only by a process claim which is invalid, is in no better position

than was the respondent in the Winthrop case (Commissioner of Patents

v. Winthrop Chemical 1948 S.C.R. 46). In the Winthrop case the

claimant had claimed too little. In the present case he has claimed

too much....

 

It is thus clear that there must be present a valid process claim. The

Court then proceeded in Boehringer to find the process claim invalid, not, it

should to noted, because the process was defined inadequately, but because it

was too broad, since it covered the production of a large number of compounds

which did not possess the utility ascribed to them. That particular objection

has not been made by the examiner in the present case, the scope of the

product claim is much more circumscribed, and, more important, the breadth

of what is claimed is supported by numerous examples of compounds within

the class possessing the desired utility, sufficient in number we believe,

to surmount the obstacle upon which Boehringer foundered. In this instance,

it is probable that "a substantial number of the conceivable substances

comprised within the class defined" (Boehringer, p. 413) have the utility

referred to in the specification.

 

If the applicant is not allowed to protect his invention by claiming such

obvious ways of making it as are disclosed "... some area is left open be-

tween what is the invention as disclosed and what is covered by the claims,

(and) the patent may be just as worthless as if it was invalid. Everybody

will be free to use the invention in the unfenced area." Burton Parsons

v Hewlett Packard, S.C.C., 17 C.P.R. (2d) 97 at 106) Later on the same page

the Court refused to approve an objection that the claims covered "every

practical embodiment," leaving it to the man skilled in the art to work out

the details.

 

In Boehringer Sohn v Bell Craig 1962 Ex. C.R. 201 at 235 (affd. 1963 S.C.R.410)

we also find that S. 41(1) requires that claims to "substances be limited to

that substance when prepared or produced by the methods or processes which

have been (a) particularly described, and (b) claimed, or (c) by the obvious

chemical equivalents of the methods or processes which have been particularly

described and claimed." (Emphasis added)

 

What we distil from these several cases relative to the matter now before

us is the following.

 

(1) A process claim is bad if it claims so broadly as to encompass

the production of inoperative species, or so broadly that it is

improbable that a substantial number of the substances made by it

do not possess the utility claimed for them. It cannot be speculative,

nor encompass large numbers of compounds which have never been prepared.

 

(2) Where Section 41 applies the applicant can only claim such methods

as are specifically described, or, provided they are specifically

referred to, one skilled in the art would readily appreciate how

to carry them out.

 

(3) A chemical compound governed by Section 41 can only be claimed

when made dependent upon a process claim which prepares it. If it

is dependent upon a broad process claim which is bad for over-claiming,

then it too is bad.

 

It is also important in our view, that it be clearly indicated in the

original disclosure that the process has been carried out and is operative.

A reference, to a "possible" process for preparing the products would

we think be speculation, and not meet that test. In this disclosure,

however, we find clear indications that the process has been tried and

operates. For example in describing process (e) on page 7 of the specification

the solvents used, the temperatures employed, and information about the

reaction are given in some detail.

 

Consequently we are satisfied that claim 1 should not be rejected on the

grounds applied against it, and recommend that the refusal be withdrawn.

This should not be taken as meaning, however, that broad process claims

are always allowable, nor that they are allotvable where the factual

situation is different, nor that there might not be other reasons for re-

fusing them. In many instances broad process claims which derive their

patentability from the new and unobvious utility of the products they

produce may be objectionable as speculative, forxxx encompassing the production

of groups of compounds so large that it is improbable that a substantial

number of the substances made by it possess the utility claimed for them,

when it is evident that many of the compounds have never been prepared,

or where there has been an inadequate disclosure of how the compounds have

been used. These, however, were not the objections made against claim 1.

G. Asher

Cfiair~nan

Patent Appeal Board

x concur tvith the findings of the Patent Appeal Board, and direct that

claim 1 sh_~ud not be refused for the reasons given in the final rejection.

fhe application is to be returned to the examiner to resume prosecution.

J.H.A. Gariepy

Commissioner of Patents

Dated at dull, Quebec

thlS 10th day of August, 1076

~cnt for Applicant

Rogers, Bereskin $ Parr

Rox. 100

401 I3ly St .

Toronto 1, Ontario

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