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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicants elected group I (polypeptides) and a formulation of SEQ ID 1 in an aqueous buffer without traverse in the reply filed on 2 Sept, 2025. SEQ ID 1 was determined to be both novel and unobvious, but other rejections applied.
Claims Status
Claims 1, 4, 5, 7, 8, 21, 29, 30, 33, 34, 40, 54, 56, 58, 60, 81, 82, 97, and 98 are pending.
Claims 1, 4, 5, 7, 8, 30, 33, 40, 54, and 81 have been amended.
Claims 97 and 98 are new.
Claims 33, 34, 40, 54, 56, 58, 60, 81, 82, and 97 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 4, 5, 7, 8, 21, 29, and 30 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to uncertainty as to how the compound can be truncated or mutated is hereby withdrawn due to amendment.
The rejection of claims 1, 4, 5, 7, 8, 21, 29, and 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph due to uncertainty caused by integral percent identities with a prime number of amino acids is hereby withdrawn due to amendment.
The rejection of claim(s) 1, 4, 5, 7, 8, 21, 29, and 30 under 35 U.S.C. 102(a) as being anticipated by Altermann et al (US 20140220636) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, 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.
Claims 1, 4, 5, 7, 8, 21, 29, 30, and 98 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a 3 part test for eligibility under this statute:
Is the claim drawn to a process, machine, manufacture, or composition of matter?
2a) If test 1 is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there something beyond the judicial exception?
Applying the test:
The claims are drawn to polypeptides, and compositions comprising polypeptides, a composition of matter.
2a) The polypeptide was isolated from a thermophilic fungus, TM-417 (p4, 1st paragraph, p21, 3d paragraph of applicant’s disclosure, for example). It is thus naturally occurring, and the judicial exception of a natural phenomenon applies. A limitation on the amount of the peptide does not change that. Claims 4, 5, 7, 8, 21, and 29 just specify properties of the polypeptide, which are inherent to the sequence. Claim 30 just specifies a pharmaceutical composition, which reads on the pure peptide, or the peptide dissolved in a naturally occurring solvent, such as carbonate buffered water.
2b) All the rejected claims read on a purified polypeptide in a naturally occurring buffer. There is no evidence that buffering a solution of the polypeptide does anything beyond the functionality of the polypeptide itself. Thus, the claims are not patent eligible under this statute.
response to applicant’s arguments
Applicants argue that the claims do not monopolize the natural phenomenon, and that the natural phenomenon is incorporated into a practical use.
Applicant’s arguments filed 5 March, 2026 have been fully considered but they are not persuasive.
Applicants argue that the claims do not monopolize the natural phenomenon. The claims are drawn to the polypeptide in a formulation with a buffer. Water itself is a buffer at very high and very low pH, as small amounts of acids or bases will not meaningfully change the pH in those pH regimes. In essence, anything with any sort of acid/base activity (including the polypeptide itself) will act as a buffer. Compare this to the examples in the MPEP, of a cell phone with gold electrical contacts (gold as a natural product) or a plastic chair with wood trim that discuss not monopolizing the natural phenomenon (MPEP 2106.06(a)), it is clear that applicant’s claims are much more closely tied to the natural phenomenon than contemplated by streamlined analysis. Note that this is used when eligibility is self evident, which is not the case with the examined claims.
Applicants further argue that limitations on activity on biofilms integrate the claims into a practical application. The claims can be met by a formulation of the polypeptide in carbonate buffer, such as tap or river water. There is no requirement that the polypeptide be used in any method. Note that a requirement to do so would convert the claims to a method of use.
Claim Rejections – 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 requires that the enzyme activity be thermally stable. However, the test used is poorly defined. A test run for 20 milliseconds with a sterile solution is very different than for 3 weeks with a non-sterilized solution.
response to applicant’s arguments
Applicants argue that they have amended around this rejection.
Applicant’s arguments filed 5 March, 2026 have been fully considered but they are not persuasive.
Applicants have specified a temperature minimum, but not a time; a requirement that will change the result. In addition, the temperature range allowed is very wide – it reads on the peptide being stable if thrown into the sun. So, while applicants have placed some additional limitations on the test used, it is still not defined to the point where the allowed test parameters will yield consistent results.
New Rejections
Claim Rejections – 35 USC § 112(b)
The legal basis for rejections under this statute was given above, and will not be repeated here.
second rejection
Claims 1, 4, 5, 7, 8, 21, 29, 30, and 98 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, and claims dependent on it, require an amount of the polypeptide to reduce an amount of biofilm by a certain amount. However, the patient population is not specified. A patient with infected burns over large portions of their body with a resistant biofilm over much of them will require more material than a mouse with a very small burn infected with a sensitive bacterium producing a biofilm.
It is also not clear if this limitation is a concentration, a total amount of polypeptide in the composition, or some amalgam of the two. Nor is it clear if “biofilm associated with an area” includes biofilm in such areas as bandages (which will be removed when the bandage is changed) or not.
third rejection
Claim 98 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 98 lists multiple amounts the biofilm must be reduced by. This makes it unclear what the cutoff allowed by the claim is. If it is only the lowest value, the additional, higher values are confusing and redundant. If it is a higher value, than the lower values do not make sense in the claim. Note that the lowest value is the same as for claim 1; if this is interpreted as the cutoff, there is a rejection under 35 USC 112(d) on the claim, for failure to further limit.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658