DETAILED ACTION
This action is in reply to papers filed 8/6/2025. Claims 10-23 and 35-30 are pending and examined herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20250345393A1, Published 11/13/2025.
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 10-23 and 35-30 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 claimed invention is a composition comprising an isolated polypeptide comprising a neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide, and wherein the polypeptide has at least 80% homology to a naturally occurring Nell-1 polypeptide or a fragment thereof.
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 should "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).
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a 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. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (See In re Shokal 113USPQ283 (CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
However, the specification does not teach what is the complete structure of any species of the genus of polypeptides that have at least 80% homology to a naturally occurring Nell-1
polypeptide or a fragments of Nell-1 polypeptides. This is problematic.
The specification at para. 35 teaches Nell-1 peptide to be at 810 amino acids in length. The claim also requires the polypeptide to lack the TSP1 domain. The specification teaches a Nell-1 peptide lacking a TSP1 (SNell-1) is 570 amino acids in length. As such, “the genus of polypeptides that have at least 80% homology” embraces polypeptides that must match at least 408 amino acids of Snell-1 in the exact order~ subsequence. Fragments of SNell-1, as claimed, include a subsequence of 10 to 20 amino acids in length. Note no functionality is attached to the fragments of Snell-1 or polypeptides that have at least 80% homology to Snell-1. However, methods claims 27 and 28 do require the administered composition comprising the isolated polypeptide to increase bone formation or regeneration in a subject and treat osteoporosis.
Nevertheless, it is then determined whether a representative number of polypeptides that have at least 80% homology to Snell-1 or fragments of Snell-1 have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide or amino acid sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, no polypeptides that have at least 80% homology to Snell-1 or Snell-1 peptide fragments are disclosed that could perform any particular functional property.
Indeed, the specification does not disclose any identifying characteristic as to how an artisan would have differentiated polypeptides that have at least 80% homology to Snell-1 or peptide fragments of Snell-1 that might perform a first function from any other polypeptide sequence or fragment that might perform a second function. It is noted that all these fragments vary greatly in structure and function per their different amino acid sequences, and therefore each represents a subgenus. Again, the members of any of the subgenera themselves would have very different structure and the specification does not provide any description of any identifying characteristics of the species of the subgenera.
"The claimed invention as a whole may not be adequately described if the claims require an essential or critical element which is not adequately described in the specification and which is not conventional in the art", "when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus", "in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus". MPEP §2163
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
Possession may also be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 1 19 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998), Regents of the University of California v. Eli Lilly , 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997)*, Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. See Fiers v. Revel, 25 USPQ2d 1602 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, 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 ("definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is").
The applicant has not provided any description or reduction to practice of the genus of polypeptides that have at least 80% homology to Snell-1 or Snell-1 peptide fragments. Based on the applicant's specification, the skilled artisan cannot envision the detailed chemical structure of the amino acid sequence(s) of the genus of polypeptides that have at least 80% homology to Snell-1 or Snell-1 peptide fragments reasonably encompassed by the claims. Accordingly, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that the applicant is in possession of the broad genus of polypeptides that have at least 80% homology to Snell-1 or Snell-1 peptide fragments.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph. 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).
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 10-23 and 35-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 9974828. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons:
Instant claim 1 is drawn to a composition comprising an isolated polypeptide comprising
a neural epidermal growth factor-like (EGFL)-like-1 (Nell-I) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSPl) domain of a naturally occurring Nell-I polypeptide, and wherein the polypeptide has at least 80% homology to a naturally occurring Nell-I polypeptide or a fragment thereof.
Instant claim 27 is drawn to a method of increasing bone formation or regeneration in a
subject in need thereof comprising administering the composition of claim 10 to the
subject.
Instant claim 28 is drawn a method of treating osteoporosis in a subject in need thereof comprising administering the composition of claim 10 to the subject.
Claim 1 of U.S. Patent ‘828 is drawn to a method of increasing bone formation or regeneration in a subject in need thereof comprising administering to the subject a composition comprising an isolated polypeptide comprising a naturally occurring human, rat, or mouse neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide.
Claim 4 of U.S. Patent ‘828 is drawn to a method of treating, preventing or ameliorating osteoporosis in a subject in need thereof comprising administering to the subject a composition comprising an isolated polypeptide comprising a naturally occurring human, rat, or mouse Nell-1 polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide..
Claim 35 of U.S. Patent ‘828 is drawn to a method of increasing bone formation or regeneration in a subject in need thereof comprising administering to the subject a composition comprising an isolated polypeptide having an amino acid sequence with at least 93% sequence homology to a carboxy-terminal domain of a neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide having the amino acid sequence of SEQ ID NO:3, wherein the carboxy-terminal domain extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, and wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of the naturally occurring Nell-1 polypeptide.
Instant claims and patented claims are not patentably distinct as both sets of claims ultimately administer a Nell-1 polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain and lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide in vivo and for the purposes of increasing bone formation or regeneration.
Claims 10-23 and 35-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No 12186367. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons:
Instant claim 1 is drawn to a composition comprising an isolated polypeptide comprising
a neural epidermal growth factor-like (EGFL)-like-1 (Nell-I) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSPl) domain of a naturally occurring Nell-I polypeptide, and wherein the polypeptide has at least 80% homology to a naturally occurring Nell-I polypeptide or a fragment thereof.
Instant claim 27 is drawn to a method of increasing bone formation or regeneration in a
subject in need thereof comprising administering the composition of claim 10 to the
subject.
Instant claim 28 is drawn a method of treating osteoporosis in a subject in need thereof comprising administering the composition of claim 10 to the subject.
Claim 1 of U.S. Patent ‘367 is drawn to a method of increasing bone formation or regeneration at a bone fracture site in a subject in need thereof, the method comprising increasing the concentration of a polypeptide at the bone fracture site by administering a nucleic acid encoding the polypeptide, wherein the polypeptide comprises a naturally occurring human, rat, or mouse neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide.
Claim 4 of U.S. Patent ‘367 is drawn to a method of treating or ameliorating osteoporosis by administering to a bone tissue at a pre-selected site an effective amount of a polypeptide by administering a nucleic acid encoding the polypeptide, wherein the polypeptide comprises a naturally occurring human, rat, or mouse neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide.
Claim 14 of U.S. Patent ‘367 is drawn to a method of administration of a nucleic acid encoding a polypeptide for treatment of osteoporosis to a patient in need thereof, wherein the polypeptide comprises a naturally occurring human, rat, or mouse neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide, comprising the steps of: diagnosing a patient with osteoporosis;
pre-selecting a tissue site in need of osteoporosis amelioration; making in incision proximate to the tissue in need of osteoporosis amelioration; and delivering, via the incision, a therapeutically effective amount of the nucleic acid.
Instant claims and patented claims are not patentably distinct as both sets of claims ultimately administer a Nell-1 polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain and lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide in vivo and for the purposes of increasing bone formation or regeneration.
Claims 10 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11000570. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons:
Instant claim 1 is drawn to a composition comprising an isolated polypeptide comprising
a neural epidermal growth factor-like (EGFL)-like-1 (Nell-I) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSPl) domain of a naturally occurring Nell-I polypeptide, and wherein the polypeptide has at least 80% homology to a naturally occurring Nell-I polypeptide or a fragment thereof.
Instant claim 13 is drawn to wherein the composition further comprises a synthetic bone graft material, a biocompatible matrix, a polymer, a bone morphogenic protein (BMP), collagen, or demineralized or mineralized bone powder or granules, or is combined with a prosthetic device.
Claim 1 of the ‘570 Patent is drawn to a synthetic bone graft material comprising an isolated polypeptide comprising a naturally occurring human, rat, or mouse neural epidermal growth factor-like (EGFL)-like-1 (Nell-1) polypeptide that extends from the beginning of the first chordin-like cysteine-rich domain to the end of the fifth chordin-like cysteine-rich domain, wherein the isolated polypeptide lacks the N-terminal thrombospondin-1 (TSP1) domain of a naturally occurring Nell-1 polypeptide.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. For example, patent claims teach the isolated polypeptide comprising a naturally occurring human, rat, or mouse. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claim s]. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
