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.
DETAILED ACTION
This action is in response to claim amendments filed 10/20/25. Claims 1-20 are pending and under examination.
Specification
The disclosure is objected to because of the following informalities: Figure 2 does not contain a legend. The brief description of figure 2 identifies the black squares, but not the grey circles. While the description of the figure should be brief, it should also be sufficient to describe the details in the figure, e.g., what one of the two lines represents.
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 1-20 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 peptide consisting of SEQ ID NO:4 in the treatment of subjects with anti-Ro antibodies, does not reasonably provide enablement for prevention, treatment of subjects without Ro antibodies, peptides comprising SEQ ID NO: 4, or administration of the other claimed peptides. 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.
There are many factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: 1) nature of the invention, 2) breadth of claims, 3) amount of direction or guidance by the inventor, 4) relative skill of those in the art, 5) level of predictability in the art, 6) state of the prior art, 7) existence of working examples, and 8) quantity of the experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The nature of the invention is administration of peptides that act as “decoys”, i.e., bind pathogenic antibodies and, in doing so, prevent those antibodies from eliciting their pathogenic effects.
The breadth of the claim is that the peptide need only comprise one of eight different “core” sequences (instant SEQ ID NOs: 1-8) but may contain any additional amino acids. These subjects may or may not have the pathogenic antibodies which are the therapeutic mechanism by which the decoys function. These peptides are claimed as fully preventing the claimed diseases and symptoms. See paragraph 34 defining “prevent” as “preventing in whole”. While this sentence also includes “partial” prevention and amelioration, these terms are included in the definition of “treating” (paragraph 31). Thus, the use of both “prevent” and “treat” in the claim overlap but it is the “preventing in whole” aspect that this rejection will address with respect to the term “prevent” in the claims.
The guidance in the specification is such that instant SEQ ID NO: 4 (also referred to as peptide-4) treats/ameliorates prolonged QTc. Figure 2 demonstrates that administration is therapeutic but that QTc returns to untreated control levels after a few days. Figure 5 corroborates this trend, demonstrating that multiple administrations are required to reduce levels to normal. Notably, these experimental subjects were administered an Ro52 antigen to elicit the pathogenic antibodies intended to be inhibited by peptide-4.
While skill in the art is generally high, predictability in the art is generally low. Complex biological systems—including therapeutic treatment of disease—is rarely a straightforward, predictable endeavor.
None of the examples demonstrate the full prevention of any disease or symptom. Moreover, the examples in the specification ensure that the subject has the pathogenic RO autoimmune antibodies which serve as the target for the claimed decoy peptides. There are no examples of administration of these peptides to subjects without those autoantibodies. In contrast, administration of a peptide may instead elicit those same antibodies. Fabis (IDS 1/5/24 NPL citation B) administers a peptide comprising each of the instantly claimed SEQ ID NOs: 1-8 but, rather than being therapeutic, causes QTc prolongation (p. 6183 C2; abstract) because the peptide elicited high titers of anti-E-pore antibodies (p.6183 C1; abstract). Thus, Fabis demonstrates that administering a peptide meeting the limitations of instant claim 1 causes rather than treats QTc prolongation in a subject whereas the instant specification provides no evidence that these same peptides could somehow be used to prevent such prolongation. The quantity of experimentation is such that others would need to make and test an essentially infinite number of peptides which include both native and non-native flanking residues around the claimed sequences when the art recognizes that such a peptide may cause rather than prevent/treat the disease. This amounts to undue experimentation. Further, the instant specification notes that the decoy peptides function by mimicking the 3D structure of the autoantibody epitopes (paragraph 106). Fabis also suggests using fragments as decoys, but states that “it is not clear what specific sequence on the Ro52 antigen is responsible for immunogenicity and describes conflicting reports regarding which sequences are responsible, including an indication that other sequences also generate high antibody titers in patients with certain diseases (p.6184 C1). Fabis notes the need to develop non-pathological peptides, but neither Fabis nor the instant specification provides adequate guidance on which peptides those might be other than the peptide consisting of SEQ ID NO: 4. While Applicant claims other peptides, these a) comprise the sequence, thus encompass the peptide of Fabis which does not accomplish the goal and b) provides no examples to provide a reasonable expectation of success when using the other peptides. While Applicant has demonstrated a peptide consisting of SEQ ID NO: 4 treats prolonged QTc, Fabis demonstrates a peptide meeting the instant claims which does the opposite. Those peptides which are claimed but untested may treat, may cause, or may not affect the disease or symptoms with no predictability as to which outcome will be achieved.
Therefore, claims 1-20 are not enabled for their full scope.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11787840. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference patent claims peptides consisting of the same sequences as instantly claimed and, as such, the reference claim anticipates the claimed peptides themselves. The reference claims also claim the modifications such as those in instant claim 4. The difference between the documents is that the reference patent is limited to a composition while the instant claims are a method of treating.
However, where a reference patent claims a composition of matter, the specification may be inspected to determine the disclosed utilities of that composition. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims.
In this case, every limitation of the instant method is a disclosed utility of the reference peptide. As such, the instant claims represent an obvious variation/patentably indistinct invention from the reference claims.
Allowable Subject Matter
No prior art rejections have been made. As noted above, Fabis is the closest prior art. However, while Fabis suggests decoy peptides would be therapeutic, Fabis does not provide the sequence of any specific peptide which would accomplish this goal. Rather, as discussed in the scope of enablement rejection, the Fabis disclosure supports the unpredictability of this venture, demonstrating certain peptides will cause rather than treat the disease. This unpredictability is sufficient to render the instant claims non-obvious.
Conclusion
US Patent 11306122 is noted. While this patent also claims peptide decoys to treat disease, the claimed peptides do not contain the instantly claimed sequences and are from a wholly different protein (5-HT2A). As such, the reference patent is patentably distinct.
Qu (form 892) was published 2 May 2019, prior to the effective filing date of the instant application. Qu discusses the role of anti-Ro antibodies in autoimmune disease and qtc prolongation. While Qu suggests the benefits of decoy peptides, Qu does not disclose any specific sequence for such peptides, noting that the therapeutic path “awaits further development” and highlights the need for non-pathogenic peptides. The disclosure of Qu adds further background to the enablement rejection above as well as adds to the unpredictability leading to the conclusion of non-obviousness.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675