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/Restriction
Claims 1, 4, 6-10, 12, 23, 26, 34-36, 48, and 61-62 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), Claims 37, 46-47, and 49-53, directed to a process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 54-56 are not directed to the allowable product of Claim 1 and have NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement among groups I-VII and species A-J as set forth in the Office action mailed on 01/10/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Note, MPEP § 706.07(a) states that if rejoinder occurs after a first Office action on the merits and if any of the rejoined claims are unpatentable, the next Office action may be made final if the rejection of the rejoined claims was necessitated by applicant’s amendment. Because Applicant’s amendment caused Claim 1 to be directed to an allowable product and the subsequent rejoinder, the rejection of rejoined claims is made final.
Claim Status
Claim listing filed on August 18, 2025 is pending. Claims 2-3, 5, 11, 13-22, 24-25, 27-33, 38-45, and 57-60 are canceled. Claims 1, 4, 6, 23, 26, and 61-62 are amended. Claims 54-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Claims 1, 4, 6-10, 12, 23, 26, 34-37, 46-53, and 61-62 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 15-22, 25, and 57-60 have rendered all previous rejections directed to these claims moot.
Applicant’s amendments to the specification and the claims have overcome the specification objections and claim objections of record; therefore, the specification objections and claim objections are withdrawn.
The rejection of claims 1, 4, 7-10, 12, 23, 26, 34-36, 48, and 61-62 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of applicant’s amendments. Because amended Claim 1 provides structure for the polypeptide (amino acid sequences), the claims are no longer directed to indefinite functional language.
The rejection of Claims 1, 4, 6-10, 12, 23, 26, 34-36, 48, and 61-62 under 35 U.S.C. 112(a) as failing to comply with the written description and enablement requirements is withdrawn in view of applicant’s amendments. Amended Claim 1 is no longer directed to a genus of polypeptides and recites 17 specific species that are taught in specification Tables 4-7 and Figure 1. Note, the specification defines that “LGC01” as recited in Figure 1 is used interchangeably with “FcRn” (paragraph [237]).
The rejection of Claims 61-62 under 35 U.S.C. 101 as being directed to nonstatutory subject matter is withdrawn in view of applicant’s amendments. Amended Claims 61-62 are no longer directed to a use and are now directed to a method.
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claim 6 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 regards as the invention is maintained.
Claim 6 is indefinite because nucleic acid hybridization is equivalent to annealing wherein a complimentary strand of DNA or RNA binds to the recited sequences. However, Tables 2-3 of the specification teach that nucleic acid SEQ ID NOs: 899, 902, 903, 905, 922, 925, 935, 975, 996, 1007, 1009, 1012, 1013, 1029, 1045, 1053, and 1063 of Claim 6 encode amino acid SEQ ID NOs: 605, 608, 609, 611, 628, 631, 641, 681, 702, 713, 715, 718, 719, 735, 751, 759, and 769 of Claim 1, respectively. What is currently claimed is that the nucleic acid sequences listed in Claim 6 are the complimentary strands that hybridize to the nucleic acid sequences that encode the polypeptides. What is claimed and what is defined in the specification differ, making Claim 6 indefinite. A possible correction could recite “… an amino acid sequence that can be encoded by a nucleic acid having a sequence selected from SEQ ID NOs:…”
Applicant's arguments filed August 18, 2025 have been fully considered but they are not persuasive. Applicant argues that the amendments overcome the indefinite functional language in Claim 6 because a structure is provided. Examiner agrees that the amendments overcome the indefinite functional language in Claim 6, but neither the amendments nor Applicant remarks address the indefiniteness directed to “coding sequence that hybridizes” and how what is claimed differs from what is defined in the specification. The rejection is maintained.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 50-52 and 62 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 regards as the invention is maintained.
Claims 50-52 recite intended uses for the polypeptide of Claim 1 (for use in treating an autoimmune disease, cancer, or cardiovascular disease). Note, these claims are not directed to methods of treating but are instead directed to the polypeptide. Claims 50-52 do not provide a clear cut indication of scope because the intended use of the polypeptide imposes no structural limitations of the polypeptide. It is unclear how Claims 50-52 further limit the structure of the polypeptide itself, rendering the claims indefinite.
Claim 62 recites a method of extending the serum half-life of a therapeutic molecule comprising administering the polypeptide of Claim 1. “Administering the polypeptide of Claim 1” is the only methodological step, and it is unclear where the polypeptide is it to be administered (into a sample comprising the therapeutic molecule? Into a subject? In vitro?). Are the polypeptide and the therapeutic molecule administered in combination or separately? Claim 62 is vague and fails to particularly point out and distinctly claim the subject matter, specifically how the polypeptide can be used in a method of extending the serum half-life of a therapeutic molecule.
Claim 61 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.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is
“undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex. Claim 61 recites a method of treating a subject comprising administering the polypeptide of Claim 1 for targeting FcRn in the subject. The specification defines “treating” as alleviating at least one symptom associated with a disease (paragraph [134]). Therefore, the broadest reasonable interpretation of Claim 61 encompasses a method of treating a subject with any type of disease.
When evaluating enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. Pyzik et al. Nat Rev Immunol. 2023 teaches a continued lack of predictability in treating diseases by targeting FcRn, even after the effective filing date. Pyzik teaches that FcRn plays a role in protection from infectious diseases, and FcRn-deficient mice exhibited increased infections (pg. 422, col. 2). Pyzik teaches that the role of FcRn expression in cancer is still emerging, because some tumors have been shown to downregulate FcRn and other tumors have been shown to upregulate it (pg. 423, col. 1). In autoimmune diseases, the therapeutic approach is to block FcRn function (pg. 424 col. 1 and Table 1). Therefore, depending on the disease context, the therapeutic strategy is to promote FcRn expression, block FcRn activity, or the role of FcRn is unknown.
The state of the art shows a continued lack of predictability even after the effective filing date of the instant invention, and there is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in treating any type of disease by administering the polypeptide of Claim 1.
Level of skill in the art:
The level of skill would be high encompassing oncology, virology, immunology, in vivo treatment assays, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches that the polypeptides of Claim 1 bind to FcRn (Examples 6-7), and the polypeptides have a higher concentration of uptake and recycling as compared to human IgG1 (Figure 9) which indicates an increased half-life. There are no examples that define if the polypeptides bind FcRn with agonist or antagonist activity. There are no examples of treating any type of disease by administering the polypeptides. Further, the specification teaches that the advantageous effect of the invention is that the polypeptide binds to FcRn to extend the serum half-life of any other therapeutic molecules to which it is conjugated (paragraph [13]). Based on this teaching, it is understood that the polypeptide on its own (as described in Claim 1) does not have therapeutic activity but rather extends the half-life of a separate therapeutic molecule.
A person having ordinary skill in the art would have to make a substantial inventive contribution in order to use the polypeptide of Claim 1 to treat any type of disease.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Given that the nature of the claim is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of treatment in a representative number of disease types in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the treatment with a reasonable expectation of success.
The instant specification does not enable the invention to treat a subject by administering the polypeptide (Claim 61).
Allowable Subject Matter
Claims 1, 4, 7-10, 12, 23, 26, 34-37, 46-49, and 53 are allowed. Note, Claim 1 is interpreted wherein “optionally” only applies to the limitation “a Kd for binding human FcRn at pH 7.4 that is at least half a log greater than the Kd for binding at pH 6.0.” The limitation wherein the polypeptide comprises an amino acid sequence selected from SEQ ID NOs: 605, 608, 609, 611, 628, 631, 641, 681, 702, 713, 715, 718, 719, 735, 751, 759, or 769 is interpreted as a required claim limitation. Claims 7-10 and 12 are considered inherent properties of the polypeptides comprising the structures defined in Claim 1 (MPEP § 2112.01.I-II).
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH COOPER PATTERSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675