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 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
Applicant’s election of Group I (claims 1-43 and 87) in the reply, without traverse, filed on 04/01/2026, is acknowledged.
A prior art search for the elected species (compound 3 of claim 43) did not retrieve any applicable prior art reference. Extended Markush searches to the full scope of instant claim 1 but did not retrieve any prior art; in fact, only the instant application was retrieved (see Search 6 of the attached search notes).
The prior art searches of the elected species and extended Markush structures read on claims 1-43 and 87-96 after the amendment of the claims.
6. Claims 44-86 and 97-106 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions of Groups II and IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/01/2026.
Current Status of 18/494,601
7. This Office Action is responsive to the amended claims of 04/01/2026.
8. Claims 1-13, 15-30, 35-43, and 87-96 have been examined on the merits. Claims 1-9, 14-15, 19, 40-43, 88-89 and 92-96 are currently amended. Claims10-13, 16-18, 20-39, and 90-91 are original. Claims 14, 19, 31-34 and 94 have not been examined due to the indefiniteness.
Priority
9. The effective filing date is 10/26/2022.
Information Disclosure Statement
10. The information disclosure statement (IDS) submitted on 04/01/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
11. Claim 92 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. first paragraph, because the specification and/or prior art, while being enabling for treating immunoglobulin light chain misfolding and/or endoproteolysis with the compounds (p 65 of Specification), does not reasonably provide enablement for treating or preventing the scope of diseases of instant claim 1 and the dependent claims thereof, with any compounds of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Wands Factors used in an (scope of) enablement rejection include (per
MPEP 2164.01(a)):
1. The breadth of the claims:
The broadest reasonable interpretation (BRI) of instant claim 92 is drawn to a
method to treat or prevent immunoglobulin light chain misfolding and/or endoproteolysis with the compounds of claim 1.
2. The Nature of the Invention:
The invention belongs to medicinals, more specifically, the administration of the compounds of claim 1 to stabilize immunoglobulin light chain and thus minimize misfolding and/or endoproteolysis.
3. The state of the prior art:
A review of the prior art shows that small molecules have been used to stabilize immunoglobulin light chain:
Stabilization of amyloidogenic immunoglobulin light chains by small molecules | PNAS
Small Molecule Kinetic Stabilizers Reduce Amyloidogenicity of Free Light Chain Proteins of Diverse Sequences in λ Light Chain Amyloidosis | Blood | American Society of Hematology
However, nothing in the prior art supports prevent immunoglobulin light chain misfolding and/or endoproteolysis of the claim 92. Moreover, nothing in the prior art supports preventing or treating prevent immunoglobulin light chain misfolding and/or endoproteolysis with the compounds of claim1.
4. The Level of one of ordinary skill:
The level of one of ordinary skill includes the knowledge/skill to engage in a
reasonable amount of experimentation to make and use the compounds/compositions
underlying the instant method claims. The level of one of ordinary skill also includes knowledge in using treat immunoglobulin light chain misfolding (per prior art, above). However, no one has skill to engage in the undue burdensome level of experimentation required to provide guidance/enablement for treating or preventing immunoglobulin light chain misfolding of the instant method claim 92.
5. The level of predictability in the art:
The art is predictable to make the instantly claimed pharmaceutical compositions. However, the art does not provide predictability as to which diseases and disorders can be treated or prevented beyond those reported, above, as known in the prior art. To generate this level of guidance, one has to engage in undue burdensome experimentation (since no predictability in the art) to test the pharmaceutical composition against complexed immunoglobulin light chains to determine if the
pharmaceutical composition can treat and/or prevent said disease(s). This level of experimentation would be required to match the scope of instant claims 92 and many other claims.
6. The amount of direction provided by the inventor:
While the Specification provides stability data for some compounds (see Example on page 65-66 of Specification) and shows that Applicants formulated the tested compounds, the Specification does not provide direction for treating or preventing immunoglobulin light chain misfolding of instant claim 92.
7. The existence of working examples; and
While the Specification provides stability data for some compounds (see Example on page 65-66 of Specification) and shows that Applicants formulated the tested compounds the Specification does not provide direction for treating or preventing immunoglobulin light chain misfolding of instant claim 92.
8. The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Treating or preventing immunoglobulin light chain misfolding and/or endoproteolysis of instant claim 92 would require an undue amount of experimentation to use the invention as claimed to treat or prevent immunoglobulin light chain misfolding and/or endoproteolysis. Moreover, the amount of experimentation required to prevent any diseases would be undue as well, absent evidence in the Specification or prior art.
To render moot this scope of enablement rejection: Applicants should delete “prevent” and/or “prevention”/”preventing” from claim 92 and other places (if any).
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.
12. Claims 14, 19, 31-34 and 94 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 14 recites the limitations “R” and “Ar” groups attached to the pyrrolidine rings on the most left side of the two structures (shown by the red arrows):
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Both R and Ar are not defined in claim 14 and claim 1 is silent on R and Ar.
Similarly, claim 19 recites the limitations “Ar” attached to the structure, but, Ar is not defined in claim 19 and claim 1 is silent on Ar.
In addition, claims 31 and 33 recite the limitation "R is methyl” in claim 1, claims 32 and 34 recite the limitation "R is ethyl” in claim 1. There is insufficient antecedent basis for the limitations in the claims since claim 1 is silent on R.
These render the metes and bounds of claims 14, 19 and 31-34 undefined, hence rendering claims 14, 19 and 31-34 indefinite under 35 USC 112(b).
Regarding claim 94, the phrase "e.g." and a pair of parentheses recited in the claim render 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 recitation of “steroids (e.g., dexamethasone)” leaves it unclear if dexamethasone is a required limitation or merely an exemplary embodiment. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
In addition, claim 94 contains the trademark/trade name Thymoglobulin®, Atgam®). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an anti-amyloid antibody and, accordingly, the identification/description is indefinite.
To overcome: Applicant could amend the claim to delete the pairs of parentheses in the claim, including the trade marks.
Please do not use parentheses around any limitation other than acronyms
Conclusion
13. Claims 1-13, 15-30, 35-43, 87-91, 93, and 95-96 are free of the prior art.
14. Claims 14, 19, 31-34, 92 and 94 are rejected.
15. Note: Double patenting was briefly considered by the Examiner with a co-pending application of similar compounds and their compositions to treat light chain amyloidosis. The general Markush structures are similar, but there are no overlaps among all the illustrated compounds in the reference and those in the instant application.
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/B.T./Examiner, Art Unit 1625
Prosecution Insights