DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/26 has been entered.
Claims 1-16, 18-22 have been cancelled. Claims 17, 23-25 are pending. Claim 17 has been amended. Claims 17, 23-25 are examined herein.
The claim amendments have rendered the 102 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below as a result of the new claim amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 17, 23-25 are rejected under 35 U.S.C. 103(a) as being obvious over Fan et al. (US Patent 7,514,453, of record).
The instant claims are directed to a method of treating Pompe disease by administering the compound of formula I.
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Fan et al. teach a method of treating a lysosomal storage disease by administering to an individual in need of treatment an effective amount of a competitive inhibitor of an α-glucosidase (claim 12), wherein the lysosomal storage disease is Pompe disease (Table 1 and claim 17). A preferred inhibitor of an α-glucosidase is compound 28 (below) in Figure 1B.
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Humans are taught (col. 3, lines 49-57). An effective amount is taught to be from 1-50 mg/kg (col. 6, lines 55-65). Fan et al. also teach a method of enhancing the in vivo cell activity of α-glucosidase in a mammal by administering a competitive inhibitor of the α-glucosidase in an amount effective to enhance α-glucosidase activity (claim 1), for example 1-deoxynojirimycin, α-homonojirimycin, or castanospermine (claims 18-22).
However, Fan et al. fail to specifically disclose a compound of formula I.
It would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have substituted the compound of formula I for compound 28 in the method of treating Pompe disease as taught by Fan et al.
A person of ordinary skill in the art would have been motivated to substitute the compound of formula I for compound 28 because both compounds are stereoisomers of one another, therefore expected to have similar properties, absent a showing of unexpected results. Accordingly, one of ordinary skill in the art would have had a similar reasonable expectation of success in treating Pompe disease with compound 21.
A novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Response to Arguments
Applicant argues that Fan’s teaching is non-enabled because it only discloses a laundry list of enzymes that may be substrate of another laundry list of compounds without providing any guidance on specific examples of treating Pompe disease with a particular compound. The genus to be considered is large, specifically 25 diseases or disorders while the compound genus contains 37 compounds. Applicant also argue that Fan did make a speculation that iminosugars are potent inhibitors and powerful enhancers for treatment of Pompe disease, however, compound 28 is not an iminosugar.
This is not persuasive because Fan teaches in claim 12 a method of treating a lysosomal storage disease by administering to an individual in need of treatment an effective amount of a competitive inhibitor of an α-glucosidase, wherein Pompe disease is a specifically claimed lysosomal storage disease (claim 17). Fan also teaches that compound 28 in Figure 1B is an inhibitor of an α-glucosidase. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating Pompe disease by administering compound 28.
Furthermore, Fan clearly teaches that the compounds disclosed herein and other competitive inhibitors of enzymes associated with lysosomal storage diseases which will be known to those of skill in the art will be useful according to the invention in methods of enhancing the intracellular activity of normal and mutant enzymes associated with such disorders and treating the disorders (col. 7, lines 19-24). While the compounds in the figures may not specifically be labeled as an inhibitor of α-glucosidase, they are labeled as inhibitors used in this study. Fan does teach that one of the several enzymes that are to be inhibited is α-glucosidase.
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. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that the technology is unpredictable. Specifically, the predictability of one compound useful for treating one disease (Gaucher disease) also be useful for treating another disease (Pompe disease) is low, thus this technology is unpredictable.
This is not persuasive because Applicant has not provided any supporting evidence to support that this technology is unpredictable. The state of the art cannot be determined as unpredictable just because Applicant makes a general statement without any corroborating evidence from the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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