Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE DANIEL BARTFELD, SHMARYAHU BLUMBERG, MARIAN GORECKI, DAN HADARY
AND MENACHEM ZEEVI
Appeal No. 89-1272
March 30, 1990
Application for Patent filed May 15, 1985, Serial No. 06/734,450, which is a continuation of Serial No. 06/644,435 filed August 27, 1984. Method For Recovering Purified Growth Hormones From Genetically Engineered Microorganisms.
John P. White et al., for appellants
Patent Examiner -- Howard E. Schain
Before Serota, Chairman, Calvert, Vice Chairman, Steiner, W. Smith and Martin
This is an appeal from the final rejection of claims 1 through 45. Subsequent to the final rejection, claim 13 was cancelled in an amendment filed under 37 CFR 1.116. Therefore, claims 1 through 12 and 14 through 45 remain for our consideration.
Claim 1 is illustrative of the subject matter on appeal and reads as follows:
1. A method for recovering a purified eucaryotic growth hormone or analog thereof from a bacterial cell in which the eucaryotic growth hormone or analog has been produced by means of expression of a DNA sequence encoding the hormone or analog which comprises the following steps:
a. suspending the bacterial cell or fragments thereof in a fermentation mash or in a buffered solution at a neutral pH;
b. disrupting the cell wall of the bacterial cell or fragments thereof to produce a lysate;
c. separating a precipitate containing particulate and insoluble material from the lysate;
d. preparing a suspension of the separated precipitate in an appropriate neutral pH buffer solution;
e. treating the suspension to effect contact between liquid and solids;
f. separating partially or completely precipitated material from the liquid-solids contacted suspension;
g. solubilizing the separated precipitated material containing the hormone or analog in a sufficient amount of water and adjusting the pH to an alkaline pH so as to form a solution;
h. separating the solubilized hormone or analog from other cellular components by ultrafiltration under conditions so as to produce an ultrafiltrate containing the hormone or analog and a retentate; and
i. treating the solubilized hormone or analog so as to further purify and concentrate the hormone or analog and thereby recover purified hormone or analog.
This application is assigned to Bio-Technology General Corp. and is apparently one of several patent applications filed as a result of a research project undertaken by the assignee with regard to growth hormones. As apparent from claim 1 reproduced above, the invention claimed in this application is directed to a method for recovering a purified eucaryotic growth hormone or analog thereof from a bacterial cell in which the eucaryotic growth hormone or analog has been produced by means of expression of a DNA sequence encoding the hormone or analog. This application has an effective filing date under 35 USC § 120 of August 27, 1984 via parent application Serial No. 06/644,435.
*2 During prosecution of this application the examiner determined that copending, commonly assigned Serial No. 06/514,188, filed July 14, 1983, contained disclosure relevant to the invention claimed in this application. Specifically, the examiner determined that Serial No. 06/514,188 is commonly assigned with this application, has a different inventive entity than this application and discloses a method of recovering a purified eucaryotic growth hormone which parallels that set forth in the claims on appeal with the sole exception of not disclosing the ultrafiltration separation step set forth in step h of claim 1 on appeal. Based upon these findings, which have not been disputed by appellants, the examiner instituted a provisional rejection under 35 USC § 103 using Serial No. 06/514,188 as a prospective prior art reference against the subject matter claimed under 35 USC § 102(e) in view of an issued U.S. patent 4,560,649 to Saxena et al. (Saxena). The institution of this provisional rejection was in accordance with a memorandum issued to the examining corps of the Patent and Trademark Office (PTO) by the Assistant Commissioner for Patents on December 11, 1984 entitled "Implementation of Public Law 98-622 (Patent Law Amendments Act of 1984)". A copy of this memorandum is attached to appellants' Appeal Brief as Exhibit C. [FN1]
Subsequent to the Examiner's Answer, Serial No. 06/514,188 became abandoned. In his Supplemental Examiner's Answer mailed August 1, 1988, the examiner took note of this fact and indicated that the relevant disclosure of this application is contained in other copending applications which are commonly owned and have different inventive entities than that of this application, i.e., Serial Nos. 06/691,230 and 07/159,526. Serial No. 06/691,230 is stated to be a continuation-in-part of Serial No. 06/514,188 while Serial No. 07/159,526 is stated to be a continuation of 06/514,188. The examiner restated the rejection in his Supplemental Examiner's Answer as a provisional rejection claims 1 through 12 and 14 through 45 under 35 USC § 103 as unpatentable over Serial No. 06/691,230 or 07/159,526 in view of Saxena.
Since the date of the Supplemental Examiner's Answer, Serial No. 06/691,230 has issued as U.S. Patent No. 4,871,835 to Aviv et al. (Aviv). Thus, the provisional nature of the examiner's rejection as based upon this patent application has been removed.
At this time, claims 1 through 12 and 14 through 45 stand rejected under 35 USC § 103 as unpatentable over Aviv in view of Saxena and are provisionally rejected under 35 USC § 103 as unpatentable over the disclosure of copending application Serial No. 07/159,526, also in view of Saxena.
Appellants have raised as a threshold issue in this appeal the propriety of the examiner instituting a provisional rejection under 35 USC § 103 based upon a patent application which would become actual prior art under 35 USC § 102(e) only if issued as a patent. Appellants argue that the language of 35 USC § 102(e) requires that the cited reference be an issued patent, not a patent application. Appellants also argue that the examiner's provisional reliance upon 35 USC § 102(e) is an attempt to circumvent the 1984 amendment to 35 USC § 103 which eliminated, under certain circumstances, the use of subject matter in a § 103 rejection which qualifies as prior art under 35 USC § 102(f) or (g).
*3 Appellants' observation that the statute requires a rejection under 35 USC § 103 based upon 35 USC § 102(e) to be based upon a patent is, of course, correct. However, this observation is not relevant to the issue at hand, i.e., the propriety of a provisional rejection under 35 USC § 102(e) and § 103.
A predecessor of our reviewing court expressed its approval of a similar provisional rejection in the context of an obviousness-type double patenting rejection. In re Wetterau, 53 CCPA 916, 356 F.2d 556, 148 USPQ 499 (1966). See also Ex parte Karol, 8 U.S.P.Q.2d 1771 (BPAI 1988). As explained in Wetterau, the provisional nature of this type of rejection means that if a patent did not issue on related application Serial No. 07/159,526, the provisional rejection would evaporate. The court noted in the obviousness-type double patenting context of that case that certain benefits inured to applicant and the PTO through use of such a provisional procedure, i.e., by making applicant aware at the earliest possible time of the existence of a double patenting issue, applicant has an opportunity to elect which application to let issue, while prosecution in the PTO is hastened.
We find similar benefits accrue from the practice of making provisional § 103/102(e) rejections as in the present application. First, applicant and/or the assignee is put on notice at the earliest possible time of the possible prior art relationship between copending applications. In this way, applicant and/or the assignee has the fullest opportunity to consider submitting appropriate amendments or evidence under 37 CFR 1.131 and/or 1.132 in either or both applications in response to the rejection. Since both applications are pending before the PTO, applicant has more options available to overcome such a provisional rejection as compared with a rejection based upon an issued patent. Prosecution in the PTO will be hastened since prior art issues under § 103/102(e) vis-a-vis two pending applications may be resolved during the initial ex parte examination of the applications along with other prior art and non-prior art issues. In effect, an application such as the present application need only be examined once, with all issues being resolved, instead of a first examination resolving issues of patentability apart from those raised by related applications which may become references under 35 USC § 102(e) followed by a second examination if and when such applications issue as patents and become statutory prior art.
In view of these benefits and keeping in mind the provisional nature of this procedure, we find no reason on this record to overturn the procedure set forth in MPEP 706.02.
*4 Appellants' argument that this procedure is an unwarranted attempt to subvert the amendments to 35 USC § 103 is without basis. As set forth in 130 CONG.REC. H10925 (Daily ed. October 1, 1984); PATENT LAW AMENDMENTS ACT of 1984, Pub.L. No. 98-622, § 104, 98 Stat. 3385, reprinted in 1984 U.S.Code Cong. & Ad. News 5833:
The subject matter which is disqualified as prior art under section 103 is strictly limited to subject matter which qualifies as prior art only under sections 102(f) or (g). If the subject matter qualifies as prior art under any other subsection--e.g., subsection 102(a), (b) or (e)--it would not be disqualified as prior art under the amendment to section 103. (emphasis added)
It is readily apparent from the above-quoted legislative history that Public Law 98-622 is not relevant to the issue at hand.
Apart from the propriety of the provisional rejection made by the examiner, appellants also argue that they should be able to overcome the rejection made by the examiner by filing a terminal disclaimer as obviousness-type double patenting rejections. Specifically, appellants argue at page 10 of the Appeal Brief:
[t]he C.A.F.C. [Court of Appeals for the Federal Circuit] more recently, in In re Longi, 759 F.2d 889 [225 USPQ 645] (CAFC 1985), specifically addressed factual circumstances almost identical to those present in the subject application and held that in such circumstances, the applicant was entitled to overcome the rejection by a terminal disclaimer. In doing so, the Court implicitly recognized the right of the patent applicant to overcome a § 103/§ 102(e) reference, which comprised an earlier filed, commonly owned application, with a terminal disclaimer. [emphasis added]
However, a reading of the reported decision in Longi makes it clear that the only rejection before the court was one of obviousness-type double patenting, not one under 35 USC § 103/102(e). Unlike appellants, we do not find that the court "implicitly" ruled that a terminal disclaimer will overcome a prior art rejection since a rejection under 35 USC § 103 was not before the court in Longi. To "imply" what the court might have decided if such a rejection had been before it for review would be speculative. We decline to engage in such speculation.
Further, appellants' arguments concerning the "implicit" nature of the court's decision in Longi overlook the long standing distinction between prior art rejections and obviousness-type double patenting rejections. This distinction is outlined in In re Bowers, 53 CCPA 1590, 359 F.2d 886, 149 USPQ 570 (1966) where the court stated in footnote 7:
Appellant apparently tried to avoid the section 103 obviousness rejection by calling it "double patenting" so as to argue that a terminal disclaimer obviated the rejection. The solicitor apparently wished to characterize the issues in In re Robeson [51 CCPA 1271, 331 F.2d 610, 141 USPQ 485 (1964) ] and in In re Kaye, [51 CCPA 1465, 332 F.2d 817, 141 USPQ 829 (1964) ] as involving section 103, which they did not.
*5 While in those cases we held that an "obvious" type double patenting rejection could be overcome by filing a terminal disclaimer, that does not mean that a section 103 rejection for obviousness may be similarly overcome. Under section 103, a reference patent is available for all it fairly discloses to one of ordinary skill in the art. There is no inquiry as to what is claimed therein. In the "obviousness" type double patenting rejections, the test is not what would be obvious to one of ordinary skill in the art from reading the specification or the claims. In re Sarett, 51 CCPA 1180, 327 F.2d 1005, 140 USPQ 474. Rather, the inquiry is much more limited in nature and the patent is considered only to compare the invention defined in the patent claims with the invention defined in the application claims. (emphasis in original)
Further, the court stated in Bowers that it agreed with the decision in Hayes v. Reynolds, 242 F.Supp 206, 145 USPQ 665 (D.D.C.1965), aff'd sub nom Hayes v. Brenner, 357 F.2d 287, 148 USPQ 365 (D.C.Cir.1966), that a terminal disclaimer will not obviate a rejection for obviousness in view of prior art under 35 USC § 103.
Appellants argue on pages 16-17 of the Appeal Brief that under the present circumstances rejections under 35 USC § 103/102(e) and double patenting are not distinct. This is incorrect. As set forth by the court in In re Ornitz, 54 CCPA 1304, 376 F.2d 330, 153 USPQ 453 (1967):
Where the terms of section 102(e) are satisfied, as here, we think the Patent Office should apply the statutes as the basis for refusing a patent. Where it is possible to conduct the broader inquiry permitted by sections 102(e) and 103 because the references are "prior art," it does not make sense to resort to the narrower inquiry which underlies a "double patenting" rejection.
Appellants also argue at this portion of the Appeal Brief that use of a terminal disclaimer to overcome a prior art rejection such as the present would encourage corporate patent departments to file applications early and foster the public policy objectives of making inventions available to the public more promptly. However, the policy of making provisional prior art rejections under 35 USC § 103/102(e), as done here, already fosters this public policy objective by examining a patent application as to these issues at the earliest possible moment and apprising an applicant as to the impact these issues may have on a particular application. Again, confronting these issues when both applications are pending provides applicant/assignee a broader spectrum of possible responses than when confronted with a rejection over an issued patent.
*6 Appellants argue in the Supplemental Brief filed April 10, 1989, that they followed a "remedy" suggested by the examiner, i.e., refiled the disclosure of this application and Serial No. 06/514,188 as a combined application, only to be confronted with yet another provisional § 103/102(e) rejection. In essence, appellants are asking that prior art under 35 USC § 102(e), whether provisionally applied as a pending application or actually applied as an issued patent, be not applied under 35 USC § 103 to the claims of this application since all of the involved patents or applications are commonly assigned. Such action would be contrary to the statute and is beyond the authority of the PTO. The relief appellants are apparently seeking in making these arguments would be available only from Congress through a change in the statute, not from this agency.
Turning to the merits of the examiner's rejection, we note that appellants have chosen not to separately argue the limitations added by the dependent claims. Therefore, these claims shall stand or fall based upon the limitations found in independent claim 1. In re Burckel, 592 F.2d 1175, 1179, 201 USPQ 67, 70 (CCPA 1979).
The examiner has determined without contradiction by appellants that Aviv and Serial No. 07/159,526 each discloses the method set forth in claim 1 on appeal with the sole exception of the ultrafiltration step set forth in step h of claim 1. The examiner has determined that ultrafiltration is a common separation step used in purifying proteins. See column 5, lines 11-32 of Saxena.
From these disclosures, the examiner has concluded that one of ordinary skill in the art would have found it obvious to use such a conventional ultrafiltration step in the purification methods disclosed in Aviv or Serial No. 07/159,526. Inasmuch as Aviv and Serial No. 07/159,526 disclose a process for purifying growth hormone produced in a bacterial cell and Saxena does disclose ultrafiltration is a well known, conventional separation step used in purifying proteins, we agree with the examiner's conclusion. One of ordinary skill in this art would routinely develop purification procedures using known technology in this art which, as evidenced by Saxena, includes ultrafiltration.
The only arguments directed to the merits of the examiner's rejection are found on pages 6-8 of the Reply Brief filed April 15, 1988. Appellants argue that the present method is a method for purifying eucaryotic growth hormones from genetically engineered bacterial cells while Saxena is concerned with the purification of human luteinizing hormone or human chorionic gonadotropin receptors from natural bovine cells. Appellants observe that the present proteins are obtained from genetically engineered cells while those of Saxena are obtained from natural cells and that the involved proteins are different. However, appellants have not established on this record that these differences have any bearing on the separation steps one of ordinary skill in the art would have found useful in developing purification processes to obtain purified forms of these proteins. There is no evidence of record that a genetically engineered cell differs in a manner from a natural cell that would affect the manner in which proteins produced from such cells are purified or that there are differences in the respective proteins which would dissuade one of ordinary skill in the art from using a conventional ultrafiltration step in purifying growth hormone in Aviv or Serial No. 07/159,526.
*7 Appellants have not relied upon any objective evidence of nonobviousness in rebuttal of the examiner's prima facie case.
The decision of the examiner is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
Saul I. Serota,
Ian A. Calvert,
Arthur J. Steiner,
William F. Smith,
FN1. The procedure set forth in this Memorandum for making provisional rejections under the present circumstances has since been incorporated into the Manual of Patent Examining Procedure. See MPEP 706.02.
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