DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election of Group I (claims 1-21) with species, (antigen components): all components identified as (a)-(e), SEQ ID NO: 40 in the reply filed on March 9, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Examiner misnamed the antigen components as macromolecule components, see Election/Restriction Requirement mailed January 9, 2026, page 5, lines 1 and 2.
3. Claims 1-23 are pending.
Claims 22 and 23, drawn to non-elected claims are not examined.
Claims 1-21 are examined on the merits with elected species (antigen components): all the components identified as (a)-(e), SEQ ID NO: 40. This species reads on a. in claim 1.
Specification
4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see page 22, line 16. 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 Interpretation
5. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
6. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
7. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "configured to” in claim 1
(lines 2 and 4).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them
being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-21 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 claims read on a macromolecule that depletes phospholipase A2 receptor (PLA2R)-specific antibodies from an individual’s serum, said macromolecule comprises a targeting component that is configured to bind to an internalizing cell surface receptor or other internalized cell surface molecule, and an antigen component that is configured to bind to a PLA2R-specific antibody, wherein the antigen component comprises a. at least part of each of the cysteine rich (CysR), fibronectin (FN), C-type lectin domain 1 (CTLD1), C-type lectin domain 7 (CTLD7) and C-type lectin domain 8 (CTLD8) domains of PLA2R, as well as mutations within the Fc fragment. The macromolecule also has reduced sequence homology to the elected species, SEQ ID NO: 40, see page 70 of the Specification. This species is not in the independent claim.
The written description in this instant case does not set forth a plethora of macromolecules comprising undefined and uncharacterized targeting components that bind internalizing cell surface receptor(s)/molecule(s), as well as an antigen component that too is undefined and uncharacterized. This plethora of macromolecules have not been fully defined and characterized. While the claims cite the antigen component has five components and at least part of each of the five domains there is no evidence or showing of any of the macromolecules that comprise a targeting component and an antigen component or parts of the said components.
The written description is not commensurate in scope with the plethora of macromolecules comprising a targeting component and an antigen component configured to bind to a PLA2R-specific antibody. The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of the targeting component and antigen component comprised within the macromolecule. The macromolecules of record seem to be solely characterized by art known structures. There are no be no identifying sequences in the independent claim that would evidence Applicant’s written descriptive support for the genus of macromolecules encompassed by the claims. The ability to make the macromolecules essential to the claimed products does not place the skilled artisan in possession of the relevant identifying characteristics of a genus of molecules commensurate in scope with the claimed invention.
The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of the macromolecules that places the skilled artisan in possession of the genera of macromolecules in scope with the claimed invention.
In Abbvie v. Centocor (Fed. Cir. 2014), the Court held that a disclosure of many different antibodies (in that case neutralizing antibodies to IL-12 with a particular binding affinity) was not enough to support the genus of all IL-12 neutralizing antibodies because the disclosed antibodies were very closely related to each other in structure and were not representative of the full diversity of the genus. The Court further noted that functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support especially in technology fields that are highly unpredictable where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
“A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
Vas-Cath Inc. V Mahurkar, 19 U5PQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of the broad class of macromolecules that are remiss of sequences, therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The polypeptide itself is required. See Fiers v. Revel, 25 U5PQ 2d 1601 at 1606 (CAFC1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts. 18 U5PQ2d 1016.
Furthermore, In The Reagents of the University of California v. Eli Lilly (43 U5PQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(l), the court states that "An adequate written description of a DNA...'requires a precise definition, such as by structure, formula, chemical name, or physical properties', not a mere wish or plan for obtaining the claimed chemical invention".
At the time the application was filed Applicants do not seem to be in possession of all the members of the genus of macromolecules. Applicants did not have possession of the breadth of these molecules.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of macromolecule essential to the claimed invention to demonstrate possession that fulfill the requirements of a structure-function relationships of written description. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genera and/or structural common to the members of the genera so the one of skill in the art can visualize or recognize the members of the genus of macromolecules.
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property, i.e., bind different entities.
The specification does not evidence the possession of all the macromolecules that are undefined and uncharacterized falling within the potentially large genus to establish possession. Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 U5PQ2d 1398.
The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
10. 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.
11. Claims 1-21 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.
a. Claims 1, 6-8 and 18-20 recite the antigen component of the macromolecule comprises at least a part of each domain, CysR, FN, CTLD1, CTLD7 and CTLD8. However, it is not clear what segment, piece or fragment of each of the domain will function and able to bind a PLA2R-specific antibody. Accordingly, the metes and bounds cannot be determined.
b. Claim 21 recites “the antigen component of the macromolecule comprises substantially the entirety of said domains”. It is not clear what amount of the domains, how little, or how much of the domains are comprised within the macromolecule. Accordingly, the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 103
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claim(s) 1-11 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez et al., WO 2025/030003 A2 (effective filing date 01 August 2023/ Foreign Patent Documents, IDS reference #12 submitted August 15, 2025), and further in view of Payne et al., WO 2023/015239 A1 (published 09 February 2023/ U.S. Patent Application Publication, IDS reference #8 submitted August 15, 2025). Gutierrez teaches “…a molecule that selectively targets and neutralizes and/or depletes pathogenic autoantibodies in a subject. Molecules described herein comprise a first polypeptide and a second polypeptide, wherein the first polypeptide comprises an autoantibody-binding domain and a first Fc domain and the second polypeptide comprises a second Fc domain.”, see page 1, sections 0003 and 0004. “For example, a PLA2R autoantigen domain (or a fragment or variant thereof) may be used in a molecule in order to target anti-PLA2R, wherein the “…autoantigen domain includes a PLA2R, or a fragment or variant thereof. PLA2R protein includes a cysteine-rich (CysR) domain, a fibronectin type II (FnII) domain, 8 sequential C- type lectin domains (CTLDs), and an intracellular C-terminal tail.”
“Challenges exist in producing heterodimerized Fc domains of two different polypeptides from a single composition, particularly because the random pairing of different polypeptides can yield undesired species…One approach to solve the problem of mispaired byproducts is known as “knob-into-holes technology” (KIH), which aims to force the pairing of two different polypeptides containing Fc domains by ntroducing mutations into the CH3 regions of the Fc domains to modify the contact interface.”, see page 109, section 0282. “As described herein, a first and/or second Fc domain in a molecule described herein may comprise certain mutations that utilize KIH technology that include, but are not limited to, a CH3 modification. In some embodiments, a molecule comprises first and second Fc domains that form a heterodimer using knobs-in-holes (KIH) modifications… In some embodiments, a KIH mutation comprises T366W, S354C, T366S, L368A, Y407V, and Y349C, according to the EU numbering scheme. In some embodiments, the first Fc domain comprises the T366W and S354C mutations and the second Fc domain comprises the T366S, L368A, Y407V, and Y349C mutations. In some embodiments, the first Fc domain comprises the T366S, L368A, Y407V, and Y349C mutations and the second Fc domain comprises the T366W and S354C mutations.”, see page 110, section 0284.
“In some embodiments, the autoantibody-binding domain is covalently linked to the first Fc domain through a linker. In some embodiments, the linker comprises the amino acid sequence of SEQ ID NO: 150 (GGGGS),”, see page 8, section 0035.
Gutierrez does not the macromolecule has a targeting component and the PLA2R autoantigen has a fibronectin domain (FN) and a CTLD8 domain. Gutierrez does not teach the macromolecule, wherein at least part of the CysR, FN and CTLD1 domains are linked to at least part of the CTLD7 and CTLD8 by a Ser-Gly (SG) linker peptide.
However, Payne teaches a chimeric autoantibody receptor (CAAR) specific comprising PLA2R autoantigen comprising an extended cysteine rich (eCysR) domain further comprising a fibronectin type II (FNII) domain, a C-type lectin domain (CTLD1), a C-type lectin domain 7 (CTLD7) and a C-type lectin domain 8 (CTLD8) in a N-terminal to C-terminal orientation, see page 4. “In some embodiments, the extracellular domain of the CAAR further comprises a C-terminal glycine-serine (GS) linker.”, see paragraph (para.) bridging pages 27 and 28.
It would not be outside the scope of the skilled artisan to substitute the fibronectin type I with the fibronectin type II domain. It is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement CTLD8 domain and the GS linker in the antigen component.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in all the references and in particular, Payne.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references to effectively assemble the molecule in the manner set forth in the claims given they are easily manufactured, see all references in their entireties.
Double Patenting
14. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
15. Claims 1-21 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-21 of copending Application No. 19/237,700 (filed June 13, 2025). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
16. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however can normally be reached between 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-0859. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
Alana Harris Dent
18 March 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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