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
1. The Election filed 5/28/2026, in response to the Office Action of 3/31/2026, is acknowledged and has been entered. Applicants elected without traverse the species of a binding agent that binds to DPEP-1 comprising SEQ ID NOs:21, 22, and 23; further comprising SEQ ID NO:12 or SEQ ID NO:48. Claims 1-4, 8, 12-16, 19-20, 39-40, 42-43, 46, 48, and 50 are pending and currently under prosecution as drawn to the elected species.
Priority
2. Application claims the benefit and priority of PCT/CA2022/050546 filed on 4/8/2022 which claims the benefit of provisional application 63/172,530 filed on 4/8/2021. Application has been reviewed and the application is granted the priority of provisional application 63/172,530 and the effective filing date of 4/8/2021.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink on page 29 line 18 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
4. Claim 13 is objected to because of the following informalities: “among” should be amended to “amount”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claim 8 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 8 recites the limitation "the antibody" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends on claim 1 which does not recite an antibody.
To overcome this rejection, either amend claim 8 to depend from claim 4 or amend to recite “wherein the binding agent is an antibody or antigen-binding fragment.”
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.
6. Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to a binding agent wherein the binding agent is a monoclonal, polyclonal, chimeric or humanized antibody or antigen-binding fragment and further wherein the antibody or antigen-binding fragment is fully human, mouse, llama, rabbit, sheep, or goat antibody.
The specification discloses only VHH regions that function to bind DPEP-1, therefore the binding agents could not be polyclonal. The specification further discloses producing the claimed CDR regions in llamas, therefore the CDR sequences of claim 1 are camelid.
Given the claimed binding agents comprise a single defined binding domain sequence and are camelid, they are not enabled to be polyclonal or further human, mouse, rabbit, sheep, or goat.
Examiner suggestion: Amend claim 4 to remove, “polyclonal” from line 2 and “optionally the antibody or antigen binding fragment is
7. Claims 13-16, 19-20, 39-40, 42-43, 46, and 48 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 a method of treating or preventing conditions associated with DPEP-1 expression, does not reasonably provide enablement for a method of treating or preventing disorders not associated with DPEP-1 expression. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims as currently constituted encompass methods of treating or preventing acute kidney injury, sepsis-induced condition, tumor metastasis, inflammation, ischemia-reperfusion injury, and ischemia-reperfusion injury related disorders through administration of a DPEP-1 binding agent.
The instant specification discloses binding agents that are capable of binding DPEP-1 and examples of in vivo treatment and prevention of inflammation and tumor metastasis and growth following administration of the binding agent. (Examples). The instant specification does not demonstrate a binding agent that binds to any other target proteins or treats and prevents any disorders in the absence of DPEP-1 expression.
One cannot extrapolate the disclosure of the specification to the scope of the claims because the claimed invention functions to bind DPEP-1, the breadth of the claims allows for the binding agents to be able to treat or prevent disorders in the absence of DPEP-1 expression, the specification has provided very little guidance in how these binding agents can treat or prevent any disorders that are not associated with DPEP-1 expression, the specification only provides working examples of treatment of disorders associated with DPEP-1 expression.
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that the binding agent that binds to DPEP-1 will predictably function to treat or prevent disorders not associated with DPEP-1 expression as claimed.
Therefore, in view of the state of the art, the breadth of the claims, lack of guidance in the specification, and the absence of working examples, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
Examiner Suggestion: To overcome this rejection, examiner suggests amending claim 13 to recite “A method for treating or preventing a disorder associated with DPEP-1 expression in a human subject in need thereof,”.
Prior Art
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Robbins (US2022/0251140 A1, effectively filed 11/30/2018) discloses a method of treating or preventing acute kidney injury, sepsis, tumor metastasis, inflammation, and ischemia-reperfusion injury by administering a DPEP-1 binding peptide comprising one or more amino acids that are D-amino acids, modified amino acids, or amino acid analogs.
Robbins is not cited as prior art because it does not disclose the required amino acid sequences of SEQ ID NOs:21, 22, 23, 12, or 48.
Allowable Subject Matter
9. Claims 1-3, 12, and 50 are allowed.
Conclusion
10. Claims 4, 8, 13-16, 19-20, 39-40, 42-43, 46, and 48 are rejected. Claims 1-3, 12, and 50 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642
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