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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/10/2026 has been entered.
Election/Restrictions
Claims 1, 5-7, 12-14, 17 are allowable. The restriction requirement between species, as set forth in the Office action mailed on 05/16/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 05/16/2025 is fully withdrawn. Claims 15-16, directed to protein conjugates, is no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is 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Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claim Status
Claims 1, 5-9, 12-17 are under consideration in the instant Office Action.
Withdrawn Rejections
Rejections of claims 1, 5-14, and 17-18 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims.
Rejections of claims 10-11 and 18 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of the cancellation of the rejected claims.
New Rejections
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.
Claims 8-9 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.
Instant claims 8-9 recite a “polypeptide” that includes the Fc variant of claim 1. The term “polypeptide” is incredibly broad and it is unclear what is encompassed by this terminology. Polypeptides range from short amino acid linkers, to antibodies, to larger structures such as hormones. As recited, the instant claims do not ascertain what type of peptide the term “polypeptide” encompasses.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “human growth hormones, growth hormone releasing hormones, growth hormone releasing peptides, interferons, colony-stimulating factors, interleukins, interleukin water-soluble receptors, TNF water-soluble receptors, glucocerebrosidase, macrophage activating factors, macrophage peptides, B-cell factors, T-cell factors, Protein A, allergy inhibitors, cell necrosis glycoproteins, immunotoxins, lymphotoxins, tumor necrosis factor, tumor suppressors, transforming growth factor, alpha-1 anti-trypsin, albumin, apolipoprotein-E, erythropoietin, highly glycosylated erythropoietin, blood factor VII, blood factor VIII, blood factor IX, plasminogen activators, urokinase, streptokinase, Protein C, C-reactive protein, renin inhibitor, collagenase inhibitor, superoxide dismutase, leptin, platelet- derived growth factor, epidermal growth factor, bone formation growth factor, bone formation stimulating protein, calcitonin, insulin, insulin derivative, glucagon, glucagon-like peptides-1 (GLP-1), atriopeptin, cartilage inducing factor, connective tissue activating factor, follicle stimulating hormone, luteinizing formation hormone, follicle stimulating hormone releasing hormone, nerve growth factors, parathyroid hormone, relaxin, secretin, somatomedin, insulin- like growth factor, adrenocortical hormone, cholecystokinin, pancreatic polypeptide, gastrin releasing peptide, corticotropin releasing factor, thyroid stimulating hormone, receptors, receptor antagonists, cell surface antigens, monoclonal antibodies, polyclonal antibodies, antibody fragments, and virus derived vaccine antigens” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: they contain various genera of protein structures only bound by their function of being peptides that are “physiologically active”. Amongst the genera, numerous species are named and claimed together as part of a larger group despite not sharing a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 15-16 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.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Instant claims 15-16 are drawn to groupings of “physiologically active polypeptides” that consist of a large group of peptides ranging from “human growth hormones, growth hormone releasing hormones, growth hormone releasing peptides, interferons, colony-stimulating factors, interleukins, interleukin water-soluble receptors, TNF water-soluble receptors, glucocerebrosidase, macrophage activating factors, macrophage peptides, B-cell factors, T-cell factors, Protein A, allergy inhibitors, cell necrosis glycoproteins, immunotoxins, lymphotoxins, tumor necrosis factor, tumor suppressors, transforming growth factor, alpha-1 anti-trypsin, albumin, apolipoprotein-E, erythropoietin, highly glycosylated erythropoietin, blood factor VII, blood factor VIII, blood factor IX, plasminogen activators, urokinase, streptokinase, Protein C, C-reactive protein, renin inhibitor, collagenase inhibitor, superoxide dismutase, leptin, platelet- derived growth factor, epidermal growth factor, bone formation growth factor, bone formation stimulating protein, calcitonin, insulin, insulin derivative, glucagon, glucagon-like peptides-1 (GLP-1), atriopeptin, cartilage inducing factor, connective tissue activating factor, follicle stimulating hormone, luteinizing formation hormone, follicle stimulating hormone releasing hormone, nerve growth factors, parathyroid hormone, relaxin, secretin, somatomedin, insulin- like growth factor, adrenocortical hormone, cholecystokinin, pancreatic polypeptide, gastrin releasing peptide, corticotropin releasing factor, thyroid stimulating hormone, receptors, receptor antagonists, cell surface antigens, monoclonal antibodies, polyclonal antibodies, antibody fragments, to virus derived vaccine antigens” defined only by a functional requirement of being physiologically active when conjugated to an Fc variant via a non-peptidyl polymer. There is no specific structural requirement for the physiologically active polypeptide beyond the required function. Further, instant claims 15-16 recite that the physiologically active polypeptide can be a monoclonal antibody, which the term reading on any generic antibody with no specificity to a particular antigen and the recited antibody lacks structural details such as sequences for the heavy and light chain CDR sequences or heavy and light chain variable region sequences. The required function of the antibody can be achieved in any form, no specific structure is required, as long as the function of being a physiologically active polypeptide. The scope of the claim is so broad and reads on so many possible genera of physiologically active polypeptides that it is clear that the specification fails to describe all of the possible means of achieving the response of an increased in vivo half-life when conjugated to an Fc variant protein. The claims do not require that the physiologically active polypeptide conjugated to the Fc variant possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There are a few specific examples of species of physiologically active polypeptides in the instant specification on page 18 describing potential species of each of the categories listed in the instant claims. However, there is no support provided that the Applicant has envisioned all of the possible variants encompassed by these functional requirements of the instant claims. Further, the instant claims do not require that the claimed antibody possess any particular conserved structure or other disclosed distinguishing feature. The scope of the term “physiologically active polypeptide” is so broad and reads on so many possible genera and the instant specification fails to describe any of the possible peptides that are encompassed by this term. The “physiologically active polypeptide” encompasses any peptide that has the required function but the instant specification fails to teach all the possible antibodies encompassed by the “physiologically active polypeptide” in the instant claims. The claims do not require that the “physiologically active polypeptide” possess any particular conserved structure or other disclosed distinguishing feature. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of antibodies that are encompassed by this claim.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. There is not even identification of any particular portion of the structure that must be conserved for said activity except its function. The specification does not provide a complete structure of all possible forms of the claimed peptides and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of antibodies with Fc variants.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 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 they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed agents, fragments and variants, and 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 reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. 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 1115).
Response to Arguments
Applicant’s arguments with respect to claims 1, 5-9, 12-14, and 17, see Remarks filed 01/29/2026, in response to the previous rejection(s) have been fully considered and are persuasive. Thus, the rejections of the prior Office Action have been withdrawn in view of the newly amended claims.
Conclusion
Claims 1, 5-7, 12-14, 17 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 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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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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