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(11) Patent Number: KE 23
(45) Date of grant: 25/03/1997
(51) Int.Cl.7: A 61K 47/36, C 12P 19/14
(73) Owner: ENZYME BIO SYSTEM LTD of , International Plaza, Englewood Cliffs, New Jersey 07632, U.S.A.
(22) Filing Date: 28/10/1993
(30) Priority data: 07/967,762 28/10/1992 US
(74) Agent/address for correspondence: Hamilton Harrison & Mathews, P.o.Box 30333 Nairobi ICEA Building, Kenyatta Avenue
(54) Title: A PROCESS FOR THE NON-RANDOM CLEAVAGE OF STARCH AND THE LOW D. E. STARCH CONVERSION PRODUCTS PRODUCED THEREFROM
(57) Abstract: Starch containing amylopectin is hydrilyzed with an alpha-amylase, preferably derived from Bacillus stearothermophilus, under conditions which cause a non-random cleavage of the starch molecules to yield fragments (molecules) having similar size and branching characteristics and molecular weight range from about 20,000 to about 50,000 daltons are made. The hydrolysate is treated to enrich the concentration of the desired fragments and the enriched portion can be processed further to make a maltodextrin having a D. E. of less than about 8.
Part III DETAILED ACTION
1. The preliminary amendment filed June 20, 1994, has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior office action.
2. Claims 2, 18 and 20-23 have been cancelled. Note also that claim 16 was cancelled on page 2 of the amendment filed March 8, 1994.
3. Claims 1, 5, 8, 9, 17 and 19 are currently pending and are examined on the merits.
Claim Rejections - 35 USC § 112
4. For the reasons of record set forth at page 3 of the office action dated November 10, 1993, claims 1, 5, 8, 9 and 17 are rejected under 35 U.S.C. S 112, first paragraph, as the disclosure is enabling only for claims limited to the a-amylase designated as G995. See M.P.E.P. SS 706.03(n) and 706.03(z).
Essentially, applicant's claims recite a method of hydrolyzing starch wherein a specific product is obtained by using a specific set of reaction parameters. However, it is not clear from the record that all B. stearothermophilus a-amylases will respond to applicant's process parameters by yielding the desired product. The optimum reaction parameters for an enzyme with a particular specificity can vary greatly, even between strains of the same bacterial species. Thus, the skilled artisan would not expect that all B. stearothermophilus a-amylases would work in the process as claimed. The skilled artisan would therefore have to experiment unduly to determine which B. stearothermophilus a-amylases will and will not work in the claimed process.
In sum, applicant discloses a specific process using a specific enzyme. Given the unpredictability inherent in enzymatic processes, applicant's claims to subject matter beyond the scope of the disclosure are properly rejected under 35 U.S.C. S 112, first paragraph.
5. Claims 1, 5, 8, 9, 17 and 19 are rejected under 35 U.S.C.112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The term "treating" in claim 1 is indefinite in that the term fails to set forth positive process steps such that one can determine with certainty the metes and bounds of the subject matter claimed.
The phrase "derived from is indefinite in that it is not clear what subject matter is encompassed by the phrase. For example, an enzyme derived from B. stearothermophilus could be an enzyme which is not naturally produced by this microorganism.
The phrase "is subject to" in claim 5 renders the claim indefinite because it is not clear whether or not the slurry is actually subjected to further treatment.
The phrase the alpha amylase" in claim 19 lacks antecedent basis in claim 1, thereby rendering claim 19 indefinite.
Claim Rejections - 35 USC S 103
Claims 1, 5, 8, 9, 17 and 19 are rejected under 35 U.S.C. § 103 as being unpatentable over Tamuri et al. in view of Armbruster for the reasons of record set forth at pages 6-8 of the office action dated June 2, 1993.
Applicant's argues that this rejection is based on impermissible hindsight. In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin 443 F.2d 1392; 170 USPQ 209 (CCPA 1971).
In the instant case all elements of the claimed process were disclosed in the prior art at the time of applicant's invention. The selection of a particular set of method parameters to yield a particular product would have been obvious in view of the art cited. Specifically, the artisan of ordinary skill at the time of applicant's invention would clearly have known that by varying parameters known to be variable, for example starting materials and recovery procedures, one could affect the properties of the product in a predictable fashion. Moreover, it appears that, while the references do not disclose the amylopectin content of the starting material or the molecular weight or D.E. of the enzymatic hydrolysate, the starting materials meet the claimed limitations. Also, as fractionation of starch hydrolysates is well known in the art, the recovery of any desired product must be deemed obvious, absent, for example, a showing of unexpected result. Lastly, the incorporation of the heat inactivation of the enzyme is clearly disclosed in Armbruster as advantageous. The combination of these references would therefore clearly have been desirable to the artisan of ordinary skill at the time of applicant's invention.
Claims 1, 5, 8, 9, 17 and 19 fail to be patentably distinguishable over the state of the art discussed above. Therefore, the claims are properly rejected under 35 U.S.C. 103.