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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-7, in the reply filed on 04/20/2026 is acknowledged.
Claim Status
The response of 04/20/2026 has been entered. Claims 1-18 are pending in this US patent application. Claims 8-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
Claims 1-7 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 03/26/2024 has been received and considered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Songulashvili et al., Fungal Biology 120(4): 481-488 (2016; cited on the IDS filed 03/26/2024), in view of US patent 6294365 granted to De Rosier et al., issued 09/25/2001.
Songulashvili teaches the production of a laccase enzyme from Coriolopsis gallica strain 1184 (see entire document, including pages 481-483). The enzyme of Songulashvili is the same enzyme isolated from the same strain in the instant application following culture of the strain in the same culture medium and isolation of the enzyme following a highly similar process of separation from solids, microfiltration, cross flow-ultrafiltration, and dialysis (see pages 19-20 of the instant specification as filed; cf. claims 1-7).
However, Songulashvili does not teach the lyophilization of the laccase enzyme or the properties recited in claims 1-7.
De Rosier teaches that lyophilization is a step used to store enzymes under stable conditions (see entire document, including claim 1).
While Songulashvili does not teach the lyophilization of the laccase enzyme, it would have been obvious to one of ordinary skill in the art to do so because De Rosier teaches that lyophilization is used to store enzymes while maintaining their stability. One of ordinary skill in the art would have a reasonable expectation that lyophilizing the laccase enzyme of Songulashvili in the manner taught by De Rosier would successfully result in the improved storage stability of the enzyme of Songulashvili.
Songulashvili does not specifically teach the particular levels of thermostability after storage recited in instant claims 1-5 or the particular N-glycosylation sites and levels recited in instant claims 6-7. However, Songulashvili isolates the same enzyme from the same fungal strain using the same culture medium and highly similar isolation processes as recited in the instant application, as discussed above. As such, it is highly likely that the enzyme of Songulashvili exhibits the same properties in terms of thermostability and N-glycosylation as the enzyme recited in the instant claims. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ composition differs and, if so, to what extent, from that of discussed references. Therefore, with the showing of the references, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants. Even if, arguendo, the properties of the prior art enzyme differ from those of the instantly recited enzyme, the differences appear to be so small as to not amount to patentable levels of difference.
Therefore, claims 1-7 are rendered obvious by Songulashvili in view of De Rosier and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 05/01/2026
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