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cally for 1 hour and then left to sediment overnight. The extract was separated and concentrated * *. The crude concentrate was then extracted into ether and transferred into phosphate buffer

Partition chromatography. In this work, we left out the counter-current distribution procedure for the preliminary purification of the crude extract. Instead, this extract was directly subjected to reversed-phase chromatography with 50% methanol/water as moving phase and 50% isooctanol/chloroform as stationary phase, supported on Hostalen (Hoechst). In most cases the extract from 12.5 kg of prostate glands weighed 5-7 g and this material was put on a column with 67 ml of stationary phase on 100 g of Hostalen. The result of such a chromatography is shown in Fig. 1. The peak of physiological activity appeared at about 1.5 1 effluent. * * * A 10 to 30-fold purification of the active material was obtained with the reversed phase chromatography.

The material obtained was found to lower rabbit blood pressure. This effect is not obtained with previously isolated PGF. It was found, however, that PGE, alt gh being eluted somewhat later than PGF, was not separated from this compound. Therefore, a second reversed-phase chromatography was run using 35% (v/v) methanol/water saturated with 1/10 of its volume of 40% (v/v) isoamyl acetate/chloroform as moving phase. The hydrophobic phase was used as stationary phase, 4 ml being supported on each 4.5 g of silane treated kieselguhr. With this system, PGF is eluted just after the front, separated from PGE which is eluted at about 50 ml effiuent from a 4.5 g column. *** an approximate 4-fold purification was obtained.

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Crystallization of prostaglandin E. The fractions from the second reversed phase chromatography, containing the last half of the active band, were combined as also were those containing the first half. After evaporation to dryness in vacuo, the residues were dissolved in a few ml of ethyl acetate and allowed to stand overnight at room temperature. Needle-shaped crystals were usually obtained from the material contained in the last half of the active band *

In Examples 4 and 5 of the present application, appellants describe a procedure for separate isolation of PGE, and PGE, in addition to PGE, which closely resembles the process described in their 1960 publication up to the point where the second reversed-phase chromatography run was begun. Thereupon, appellants changed their procedure and subjected the pooled effluent fractions from the first chromatography run to a different chromatographic process. They obtained three separate fractions having physiological activity from which pure PGE,, PGE2, and PGEwere individually isolated.

Faced with that set of facts, the examiner rejected claims 23 and 53 under $ 101. Inasmuch as the "claimed compounds are naturally occurring,” said the examiner, they therefore “are not 'new' within the connotation of the patent statute," citing Ex parte Snell, 86 USPQ 496 (1950). In support of her rejection, and in contrast to appellants' contention that both claims are directed not to naturally occurring materials but to pure compounds which do not exist in pure form in nature, the examiner noted that she could not "determine from the claims exactly what is included or excluded." She thought the language of both claims sufficiently broad to embrace and not distinguish from either (1) the mother liquors which apparently inherently contain PGE, and PGE, and from which PGE, is crystallized, as described in the 1960 Bergstrom et al. publication, or (2) those compounds as they inherently occur in previously known crude extracts or even in nature. In view of that, and because the smooth musclestimulating, blood pressure-depressing functions of somethingan unidentified active material—in the sheep prostate glands and crude extracts thereof (from which appellants isolated PGE and other active components) was known by von Euler and others in the art prior to appellants' isolation of them and discovery of precisely what they were, the examiner felt that “[m]erely determining the structure of the active components of Von Euler's ‘Prostaglandin' does not make the claimed products new.” [Emphasis supplied.]

The board approached the issue in quite a different manner. At the outset, we observe that it apparently disagreed with the examiner's interpretation of the claims and agreed with appellants that their claims are directed to pure chemical compounds, variously referring in its opinion to "the claimed pure materials,” “the claimed pure compounds,” and “the pure products claimed.” After summarizing : its understanding of the examiner's rejection, the board noted that appellants had not denied that PGE, and PGE, were in fact inherently present in the glandular material, extracts and liquors described in the Bergstrom publication. Indeed, when it compared the procedure described in Examples 4 and 5 of appellants' specification for obtaining a product from the first partition chromatography with that described in the Bergstrom reference, heretofore quoted under the heading “Partition chromatography," it found a striking similarity of procedure up to that point[emphasis supplied). “Accordingly," said the board, “if appellants’ material with a 'peak of physiological activity ... at about 1500 ml.' contains PGE, and PGE, , then the corresponding material of the reference with a 'peak of physiological activity ... at about 1.5 1.' must likewise contain PGE, and PGEZ."

Having firmly established inherency to its satisfaction—a "sound and unrefuted basis for holding that PGE, and PGE, are present in the material obtained from the first partition chromatography of the publication"—the board then said:

3

* the issue remaining to be decided is whether the claimed pure materials

8 The board stated :

Claims 23 and 53 have been rejected as lacking in novelty under 35 U.S.C. 101 by virtue of the presence of PEG, and PGE, in natural glandular material or in various fractions and liquors derived from the glandular material, The Examiner cites appellants' 1960 publication for materials which inherently contain PGE, and PGE3. * As we recently pointed out in In re Land, 54 CCPA 806, 368 F. 2d 866. 151 USPQ 621 (1969), quoting from In re Hilmer, 53 CCPA 1288, 359 F.2d 859, 149 USPQ 480 (1966) :

are novel as compared with less pure materials of the reference. Here we must
consider the various decisions cited by appellants and the Examiner, most of
which were reviewed by us in the case of Ex parte Reed et al., 135 USPQ 34 (on
reconsideration, 135 USPQ 105). The consistent principle, and the one which we
follow, is that a claim to a purified material cannot be allowed unless the purified
material exhibits properties and utilities not possessed by the unpurified ma-
terial. (Emphasis supplied.]
On review of that matter, the board found no new properties for the
pure materials claimed that the impure materials of the reference do
not also have--namely, both stimulate smooth muscle and lower blood
pressure—and affirmed the examiner's rejection.

Appellants petitioned the board for reconsideration, voicing objection to the manner in which the board had used their own specification to establish both inherency of the presence of PGE, and PGE, in the materials of the Bergstrom publication, and the subsequent asserted anticipatory effect of that reference. They argued :

But appellants again insist that there is no evidence whatever in the Bergstrom et al. article or elsewhere in the Patent Office record of this appealed application that the art knew or should have known that PGE, and PGE: could be isolated in pure form from the same animal tissues from which PGE, had been isolated. This is a point which has been presented again and again to the Patent Office in writing and orally. Nowhere in the record has the Patent Office discussed or even acknowledged this point. The board responded :

The issue involved in the Examiner's rejection under 35 U.S.C. 101 is the inherent presence of PGE, and PEG, in the material of the reference. Neither the Examiner nor we have held that the publication explicitly spells out the presence of these two substances. On the question of the inherent existence of PGE, and PGE;, any evidence may be used, pro or con, and appellants are free to prove the negative, just as we used circumstantial evidence to demonstrate the affirmative in * * * our decision. [Emphasis supplied.]

A preliminary question has arisen concerning the status of the 1960 Bergstrom et al., publication as “prior art” in the case. Both the examiner and board cited it as a "reference," presumably to serve as an evidentiary basis * for their rejection of the claimed subject matter as not “new” or as “lacking in novelty.” The only statutory basis stated by them for so employing it was not 35 USC 102 but 35 USC 101.5 The

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Much confused thinking could be avoided by realizing that rejections are based on statutory provisions, not on references, and that the references merely supply the evidence of lack of novelty, obviousness, loss of right or whatever may be the

ground of rejection. 5 Section 101 reads : $ 101. Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture,

situation thus presented to us is rather unique, the only comparable one in recent years that comes to mind being In re Seaborg, 51 CCPA 1109, 328 F. 2d 996, 140 USPQ 662 (1964), where a reference was used by the Patent Office to support a rejection under $ 101 on the basis that the subject matter claimed, though not described, nevertheless was inherently present in material produced by the reference process and therefore was not new. The solicitor seeks to explain the position taken below this way: With regard to the prior art, it should be noted that neither the examiner nor the Board relied upon the Bergstrom et al. article or any other reference under S102. In fact, appellants appear to have the benefit of the filing date of their 1958 application as to the subject matter of their 1960 publication which is also disclosed by the 1958 application. However, the examiner and Board did rely upon the 1960 publication as evidence of the prior art in accordance with the Court's holding in In re Wilson, 50 CCPA 773, [311 F.2d 266), 135 USPQ 442.

[1] We note, however, that neither the examiner nor the board relied on the case cited by the solicitor in support of his hypothesis, or the exceptional circumstances illustrated therein, to explain or justify their use of the Bergstrom publication here. In any event, it should also be observed that the subject matter of the present claims is not "disclosed in the manner provided by the first paragraph of section 112” in appellants' 1958 parent application, 35 USC 120. Inasmuch as the Bergstrom article appears to have been published more than one year prior to the date of any application by appellants which does describe the subject matter of the present claims, it is eligible as a timewise statutory bar under 35 USC 102(b), if indeed the present invention was "described" in or rendered obvious by that publication. To that matter we now turn.

or composition of matter, or any new and useful improvement thereof, may obtain a

patent therefor, subject to the conditions and requirements of this title. Section 102 reads in pertinent part:

8 102. Conditions for patentability; novelty and 1088 of right to patent A person shall be entitled to a patent unless

(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

(b) the invention was patented, or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one

year prior to the date of the application for patent in the United States * * See, for example, In re Foster, 52 CCPA 1808, 343 F. 2d 980, 145 USPQ 166 (1965), cert. denied 383 U.S. 966; In re Hassler, 52 CCPA 1546, 347 F. 2d 911, 146 USPQ 167 (1965); In re Ruscetta, 45 CCPA 968, 255 F. 2d 687, 118 USPQ 101 (1958). As is evident from the decisions below, appellants and the solicitor are on sound ground in agreeing that:

* * . obviousness of the claimed pure compounds is not an issue here since there is no rejection under 35 U.S.C. 103.

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Appellants argue that the subject matter of the claims-pure PGE, and pure PGE;-is "new." - Tested by the conventional evidentiary criteria or "conditions for patentability” relevant to the present factual situation which Congress has expressed in the various provisions of 35 USC 102, appellants are undoubtedly correct, for the Patent Office has not been able to cite-or supply evidence under—any of those statutory provisions to establish that the claimed subject matter lacks "novelty." Indeed, the board concedes that "[n]either the Examiner nor we have held that the [Bergstrom] publication explicitly spells out the presence of these two substances,” making it apparent that the claimed pure compounds were not "described in a printed publication in *** a foreign country” more than one year prior to the filing date of appellants' present application. As far as the record shows, then, the claimed subject matter is described and made known to the public for the first time only in the present application.

The question remains whether there is some other, perhaps extrastatutory criteria standing apart from $ 102 for determining whether given subject matter is “new” in the sense Congress has utilized that term in $ 101 or, to put it another way, whether the Bergstrom publication can be used as evidence to support a rejection under $ 101 in a manner different and apart from what would have been its normal use to support a rejection under $ 102, had it in fact described the claimed subject matter. The board and solicitor seem to have taken an affirmative view on those matters, but for rather different reasons. The solicitor says:

The only reasonable conclusion from the evidence of record is that the compounds claimed by appellants are present in some form in the prior art extracts.

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7 Appellants also insist that the Patent Office has not established that those in the art were even in possession of impure PGE, and impure PGEs, and consequently that those substances too are new. To a certain extent, we suppose, their contention has some merit, but primarily for the reason that appellants were evidently the first to ascribe the names “PGE;" and "PGE3" (or the more standard systematic nomenclature reflected in the claims) to what they isolated in pure form either from sheep prostate gland or particularly from von Euler's "semi-purified” prostaglandin. Moreover, appellants say, the art knew nothing of the existence of PGE, and PGEs prior to their isolation of them, and the skilled worker would attribute all the activity of the known secretions and extracts, such as von Euler's prostaglandin, to the presence of PGE,

On the other hand, the examiner pointed out that the art knew full well that something in impure form existed in von Euler's prostaglandin which possessed smooth muscle-stimulating, blood pressure-lowering activity. She apparently thought that claiming that something in terms of a newly discovered formula or structure in a manner sufficiently broad to dominate it wherever and however found, including the impure form in the known semi-purified extracts of von Euler, would not make that claimed subject matter new because workers in the art in fact already had possession of it as claimed that broadly, albeit they did not know precisely what its structure was and had not given it the name appellants have given it. See In re King, 27 CCPA 754, 107 F. 2d 618, 43 USPQ 400 (1939). The examiner's position seems to have been, in other words, that "a rose by any other name would smell as sweet."

We need not further discuss the merits of appellants' argument, or the examiner's position as reiterated by the solicitor here, in light of appellants' agreement with the board's finding that the claims are directed to pure, rather than impure, PGE, and PGES.

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