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 sequence election in the reply filed on 2/9/2026 is acknowledged.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: in the preamble of the claim there is a limitation “optionally an engineered polypeptide;” since all of the claimed sequences are engineered, this phrase is redundant and does not improve the language in any manner. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-13, 16-18 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The primary independent claim is drawn to an engineered polypeptide with SEQ ID 1, 2, or at least 50% homology to one of the sequences, wherein the polypeptide immunoglobulin protease activity. The sequences defined as SEQ ID 1, 2, and 3 all appear to provide for the claimed immunoglobulin protease activity. However, it does not appear as though the Applicant was in possession of a reasonable number of embodiments that are consistent with the claimed homology and possess immunoglobulin activity. When looking at the instant specification, it appears as though the only embodiments that are clearly shown to have immunoglobulin protease activity are the explicitly claimed sequences; however, there is no evidence to suggest that the Applicant was in possession of embodiments with the claimed activity, and possessed as little as 50% homology to the claimed sequences.
The Applicant is directed to the USPTO website, which provides for 35 USC 112(a) Written Description examples for the chemical and biological arts. In the examples, it is noted that if there is a functional limitation provided in a claim drawn to a sequence with less than 100% homology, the Applicant must show a reasonable cross-section of embodiments in order to show possession of the entire species. This is further underscored by the fact that SEQ ID No 1 has 557 residues and SEQ ID No 2 has 312, wherein homology of at least 50% represents more possible embodiments than there are atoms in the universe. Since the Applicant has only provided three embodiments, it does not appear as though the Applicant was in possession of the claimed range of embodiments, wherein all of them provide for immunoglobulin protease activity.
Claims 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of a narrow range of diseases, like certain autoimmune diseases, does not reasonably provide enablement for the treatment and prevention of all diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims. The claims are drawn to a method of administering the peptide claimed in claim 1, wherein the step of administration provides for the treatment and/or prevention of any disease.
When looking at the instant specification, there are no applied examples of providing the claimed composition, wherein the step of administration either treats or prevents a disease. However, the specification does provide a general theoretical underpinning as to why the composition might be useful for the treatment of certain autoimmune diseases. See page 24 and 25 of the instant specification. As such, even though there are no applied examples, it would not be unreasonable to suspect that the claimed method might work in methods of treating or mitigating certain autoimmune diseases. With that being said, there is absolutely no evidence to suggest that the claimed composition would be useful in any other method that involves treating or preventing a disease. For example, there is no evidence to suggest that the composition can treat heart disease, viral or bacterial infections, or neurological conditions. Since there is no reasonable evidence to suggest that the claimed method could be used to treat or prevent any disease the claimed method is not enabled; nevertheless, since the Applicant has provided a reasonable theoretical underpinning for the claimed composition to treat certain autoimmune diseases, this embodiment could be considered enabled.
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.
Claims 1-13, 16-18 and 23 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 provides for all three transitional phrases (comprises, consists essentially of, and consists of). See MPEP 2111.03. Since all three directly define how to interpret the scope of the invention, it is unclear what the scope of the invention should be.
Claim 3 provides for two transitional phrases, it is unclear what the intended claim scope should be.
Regarding claims 7 and 9, the term "preferably/ most preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 23, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The claims that were no explicitly described above are rejected under 35 USC 112(b), insofar as they all claim dependence on claim 1 and do not remedy the above-described indefiniteness.
Allowable Subject Matter
Although no specific claims are currently considered allowable, SEQ ID NO 1-3 are free of the prior art, and would likely be allowable if provided in a claim-set that is compliant under 35 USC 112(a) and 112(b). Furthermore, since the claimed polypeptides are free of the prior art, methods drawn to using the polypeptides would also be considered free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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