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
2. The election without traverse filed on 01/27/2026 in response to the Office Action of 12/03/2025 is acknowledged and has been entered.
Applicant has elected Group III, claims 17, 22-25, 28-30, 32, 34, and 37, drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500.
Additionally, Applicant has elected wherein: each X1 has an amino acid sequence comprising SEQ ID NO:91; each X2 has an amino acid sequence comprising SEQ ID NO:21; Y is an organic linker shown in claim 25; Z is a biocompatible polymer that is a hyaluronic acid having a molecular weight of about 0.8 MDa; and subscript n is 101.
3. Claims 1, 11, 14-18, 22-25, 28-30, 32, 34-38 and 43 are pending in the application. Claims 1, 11, 14-16, 18, 35-36, 38 and 43 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/27/2026.
Claims 17, 22-25, 28-30, 32, 34 and 37 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) for benefit of the earlier filing date of application, is acknowledged.
Claim Rejections - 35 USC § 112
6. The following is a quotation 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.
7. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
8. Claims 17, 22-25, 28-30, 32, 34, and 37 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise 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 lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
In this instance, claims 17, 22-25, 28-30, 32, 34, and 37 are drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer.
Specification teaches conjugates #1-38 (see Table 15-18). Thus, the claims are drawn to a genus of conjugates comprising a genus of peptide of claim 1, a genus of peptide linker, a genus of organic linker and a genus of biocompatible polymers.
The specification does not provide adequate written description of the claimed a genus of conjugates for treating a disease. The specification only teaches conjugates #1-38. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention the genus of conjugates for treating a disease.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, a genus of conjugates for treating a disease. The specification only teaches conjugates #1-38. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
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”).
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
Thus, the instant specification may provide an adequate written description of the genus of conjugates for treating a disease, per Lilly by describing structural features common to the members of the genus, which features constitute a substantial portion of the genus.
The following quotation from section 2163 of the MPEP is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through
sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately
described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
It is noted that AbbVie v. Janssen Biotech and Centocor Biologics (Fed. Cir. 2014) confirms a strong Post-Ariad Written Description requirement - especially with regard to genus-species claim situations. In the decision, Judge Lourie focuses particularly on the alleged infringing antibodies and notes that: [While] AbbVie patents need not describe the allegedly infringing [compound] in exact terms . . . [t]he patents must at least describe some species representative of antibodies that are structurally similar to [the accused compound]. Because the patent document lacked any such structural description, the court confirmed that the corresponding claims were invalid under 112(a). In discussing the case, Judge Lourie was clear that one problem here is that the invention was described in terms of its function rather than its structure. Lourie writes:
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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed or through disclosure of a functional characteristic of the claimed genus coupled with a known or disclosed non-functional characteristic (structure) that correlates to the function.
Alternatively, per Enzo, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In this case, the specification does not describe the genus of conjugates for treating a disease that satisfies either the Lilly or Enzo standards. The specification does not disclose a sufficient number of the genus of conjugates for treating a disease. There are insufficient structural features common to all members of the genus of conjugates for treating a disease. However, the Specification only discloses conjugates #1-38. One of ordinary skill in the art would not be able to identify the broad claimed genus of conjugates for treating a disease. Thus, the Specification does not provide an adequate written description of the genus of conjugates for treating a disease that is required to practice the claimed invention.
The instant disclosure does not adequately describe the scope of the claimed genus, which encompasses a substantial variety of subgenera. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
9. 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 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.
Claim Rejections - 35 USC § 102
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
11. Claims 17, 28-30 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Healy et al. (US 20180318431, published on 11/08/2018, IDS).
Claims 17, 28-30 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500.
Healy et al. teach a conjugate of formula: X-(Y)n-Z, wherein X is a biologically active polypeptide, Y is a linker, n is 1-10, Z is a biocompatible polymer comprising from about 50 subunits to 100,000 subunits, and/or having a molecular weight of from 10 kDa to 500 kDa; see entire document, e.g., [0060-0063], claim 1.
Healy et al. teach the linkers (Y)n include peptide linker and non-peptide linker; see [0098-0099].
Healy et al. teach the biologically active polypeptide is the amino acid sequence (SEQ ID NO: 6) of a VHH anti-VEGF antibody; see [0023]. SEQ ID NO: 6 of Healy et al. is 100% identical with the Applicant elected species of X1 (SEQ ID NO: 91); see below sequence alignment 1.
For claim 28, Healy et al. teach the polymer is hyaluronic acid; see [0004], claims 3 and 5.
For claims 29-30, Healy et al. teach the biocompatible polymers having a molecular weight from 1 MDa to 1.5 MDa, from 1.5 MDa to 2 MDa; see [0076].
For claim 37, Healy et al. teach a composition comprises the conjugate and a pharmaceutically acceptable excipient; see [0118].
12. Claims 17, 24, 28-30, 32 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (US 20210046181, published on 02/18/2021, IDS).
Claims 17, 24, 28-30, 32 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500.
Jackson et al. teach a conjugate of formula: (X—Y)n—Z, wherein X is a plurality of peptides, Z is the biocompatible polymer, Y is an optional linker, and n is from 5 to 500; see entire document, e.g., [0077], claim 32.
For claim 24, Jackson et al. teach a linker
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See [0081].
For claim 28, Jackson et al. teach wherein the biocompatible polymer is hyaluronic acid; see claim 36.
For claims 29-30, Jackson et al. teach wherein the biocompatible polymer has a molecular weight of from about 0.2 MDa to about 1.5 MDa, from about 0.8 MDa to about 3 MDa; see claims 37 and 39.
For claim 32, Jackson et al. teach subscript n is from 5 to 500; see [0077].
For claim 37, Jackson et al. teach a pharmaceutical composition comprising the conjugate and a pharmaceutically acceptable carrier; see claim 57.
Claim Rejections - 35 USC § 103
13. 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 of this title, 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.
14. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
15. Claims 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Healy et al. (US 20180318431, published on 11/08/2018, IDS) in view of Edelman et al. (WO 2017196986, published on 16 November 2017).
Claim 25 is herein drawn to the conjugate of claim 17, wherein the organic linker has the structure:
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The teachings of Healy et al. have been set forth in the above rejection of claims17, 28-30 and 37 under 35 U.S.C. 102(a)(1).
Healy et al. do not teach the linker of the instant claim 25.
However, this deficiency is remedied by Edelman et al.
Edelman et al. teach a conjugate comprising the linker
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See entire document, e.g., pages 6-8.
It would have been prima facie 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 so as to substitute the non-peptide linker of Healy et al. for another non-peptide linker of Edelman et al. to arrive the instant claimed invention, because simple substitution of the non-peptide linker of Healy et al. for another non-peptide linker of Edelman et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the non-peptide linker of Healy et al. for another non-peptide linker of Edelman et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Double Patenting
16. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
17. Claims 17, 28-30 and 37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,723,982. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 17, 28-30 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500.
Claims 1-16 of U.S. Patent No. 11,723,982 are drawn to a method of treating an ocular disease or disorder in an individual, the method comprising administering to the individual an effective amount of a conjugate comprising: a) a biologically active polypeptide having a molecular weight of from about 5 kDa to about 2000 kDa, wherein the biologically active polypeptide comprises an antibody specific to vascular endothelial growth factor (VEGF); and b) a biocompatible polymer having a molecular weight of from about 500 kDa to about 1 MDa, wherein the polypeptide is covalently linked to the polymer directly or via a linker, and wherein the molar ratio of the biologically active polypeptide to the polymer is at least 25:1, wherein said administering is by intravitreal administration.
In Pfizer, Inc., v. Teva Pharamaceutical USA, inc. (Fed. Cir, 2008), the Court concluded that the safe harbor of section 121 is limited to divisional applications only. The instant application is not filed as a result of a restriction requirement of U.S. Patent No. 11,723,982. The conjugates claimed in the claims of the patent are the same as the instantly claimed conjugates.
18. Claims 17, 28-30 and 37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,765,759. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 17, 28-30 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500.
Claims 1-12 of U.S. Patent No. 10,765,759 are drawn to a method of treating an ocular disease or disorder in an individual, the method comprising administering to the individual an effective amount of a conjugate comprising: a) a biologically active polypeptide having a molecular weight of from about 5 kDa to about 250 kDa, wherein the biologically active polypeptide is a single-chain Fv (scFv) anti-vascular endothelial growth factor (VEGF) antibody or a single-domain camelid (VHH) anti-VEGF antibody; and b) a biocompatible polymer comprising hyaluronic acid having a molecular weight of from about 500 kDa to about 1 MDa, wherein the polypeptide is covalently linked to the polymer directly or via a linker, and wherein the molar ratio of the biologically active polypeptide to the polymer is at least 25:1, wherein said administering is by intravitreal administration.
In Pfizer, Inc., v. Teva Pharamaceutical USA, inc. (Fed. Cir, 2008), the Court concluded that the safe harbor of section 121 is limited to divisional applications only. The instant application is not filed as a result of a restriction requirement of U.S. Patent No. 10,765,759. The conjugates claimed in the claims of the patent are the same as the instantly claimed conjugates.
19. Claims 17, 22-25, 28-30, 32, 34 and 37 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-29 of copending Application No. 18/856982. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 17, 22-25, 28-30, 32, 34 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500, wherein the peptide linker has the amino acid sequence comprising AEAAAKEAAAKEAAAKAGC (SEQ ID NO: 21).
Claims 1-29 of copending Application No. 18/856982 are drawn to a method for treating uveitis in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a conjugate of Formula V: (X—Y)n—Z, wherein each X is independently an anti-inflammatory peptide having a molecular weight of from about 5 kDa to about 200 kDa; each Y is an organic linker; Z is a hyaluronic acid polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1000, wherein the linker having the amino acid sequence comprising SEQ ID NO: 21, wherein X is a peptide having the amino acid sequence comprising SEQ ID NO: 91.
SEQ ID NOs: 21 and 91 of copending Application No. 18/856982 are 100% identical with the instant claimed SEQ ID NO: 21 and the Applicant elected species of X1 (SEQ ID NO: 91); see below sequence alignment 2.
In Pfizer, Inc., v. Teva Pharamaceutical USA, inc. (Fed. Cir, 2008), the Court concluded that the safe harbor of section 121 is limited to divisional applications only. The instant application is not filed as a result of a restriction requirement of copending Application No. 18/856982. The conjugates claimed in the claims of the copending Application are the same as the instantly claimed conjugates.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
20. Claims 17, 22-25, 28-30, 32, 34 and 37 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of copending Application No. 18/848753. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 17, 22-25, 28-30, 32, 34 and 37 are herein drawn to a conjugate of Formula Ila: (X1-X2-Y)n-Z (Ila), wherein each X1 is independently a peptide of claim 1; each X2 is independently a peptide linker of from 3 to 100 amino acids in length; each Y is independently an organic linker; Z is a biocompatible polymer having a molecular weight of from about 0.1 MDa to about 3 MDa; and subscript n is an integer of from 1 to 1500, wherein the peptide linker has the amino acid sequence comprising AEAAAKEAAAKEAAAKAGC (SEQ ID NO: 21).
Claims 1-25 of copending Application No. 18/848753 are drawn to a conjugate of Formula (I): (X—Y)n—Z, wherein each X is a peptide having a molecular weight of from about 5 kDa to about 150 kDa; each Y is an organic linker having a molecular weight of from about 100 Da to about 500 Da; Z is a biocompatible cellulose polymer having a molecular weight of from about 0.01 MDa to about 3 MDa; and subscript n is an integer of from about 5 to about 500.
Copending Application No. 18/848753 teaches peptide linker has the amino acid sequence comprising AEAAAKEAAAKEAAAKAGC (SEQ ID NO: 21); see [0124].
SEQ ID NO: 21 of copending Application No. 18/848753 are 100% identical with the instant claimed SEQ ID NO: 21; see below sequence alignment 3.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
21. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment 1
US-15-781-395-6
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 6, US/15781395
Publication No. US20180318431A1
GENERAL INFORMATION
APPLICANT: Healy, Kevin E.
APPLICANT: Altiok, Eda I.
APPLICANT: Schaffer, David V.
APPLICANT: Jackson, Wesley A.
TITLE OF INVENTION: METHODS OF TREATING AN OCULAR DISEASE OR DISORDER
FILE REFERENCE: BERK-318WO
CURRENT APPLICATION NUMBER: US/15/781,395
CURRENT FILING DATE: 2018-06-04
PRIOR APPLICATION NUMBER: US 62/265,293
PRIOR FILING DATE: 2015-12-09
NUMBER OF SEQ ID NOS: 8
SEQ ID NO 6
LENGTH: 156
TYPE: PRT
ORGANISM: Artificial sequence
FEATURE:
OTHER INFORMATION: Synthetic polypeptide
Query Match 100.0%; Score 645; Length 156;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVQLVESGGGLVQPGGSLRLSCAASGRTFSSYSMGWFRQAPGKEREFVVAISKGGYKYDA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 4 DVQLVESGGGLVQPGGSLRLSCAASGRTFSSYSMGWFRQAPGKEREFVVAISKGGYKYDA 63
Qy 61 VSLEGRFTISRDNAKNTVYLQINSLRPEDTAVYYCASSRAYGSSRLRLADTYEYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 64 VSLEGRFTISRDNAKNTVYLQINSLRPEDTAVYYCASSRAYGSSRLRLADTYEYWGQGTL 123
Qy 121 VTVSS 125
|||||
Db 124 VTVSS 128
Sequence alignment 2
US-18-856-982-21
Filing date in PALM: 2024-10-15
Sequence 21, US/18856982
Publication No. US20250255972A1
GENERAL INFORMATION
APPLICANT: Valitor, Inc. (en)
TITLE OF INVENTION: METHOD OF TREATING UVEITIS WITH MULTIVALENT PROTEIN-HYALURONIC ACID POLYMER CONJUGATE (en)
FILE REFERENCE: 052566-508001WO
CURRENT APPLICATION NUMBER: US/18/856,982
CURRENT FILING DATE: 2024-10-15
NUMBER OF SEQ ID NOS: 154
SEQ ID NO 21
LENGTH: 19
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..19
QUALIFIERS: mol_type = protein
organism = synthetic construct
FEATURE:
NAME/KEY: REGION
LOCATION: 1..19
QUALIFIERS: note = aH linker
Query Match 100.0%; Score 89; Length 19;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AEAAAKEAAAKEAAAKAGC 19
|||||||||||||||||||
Db 1 AEAAAKEAAAKEAAAKAGC 19
US-18-856-982-91
Filing date in PALM: 2024-10-15
Sequence 91, US/18856982
Publication No. US20250255972A1
GENERAL INFORMATION
APPLICANT: Valitor, Inc. (en)
TITLE OF INVENTION: METHOD OF TREATING UVEITIS WITH MULTIVALENT PROTEIN-HYALURONIC ACID POLYMER CONJUGATE (en)
FILE REFERENCE: 052566-508001WO
CURRENT APPLICATION NUMBER: US/18/856,982
CURRENT FILING DATE: 2024-10-15
NUMBER OF SEQ ID NOS: 154
SEQ ID NO 91
LENGTH: 125
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..125
QUALIFIERS: mol_type = protein
organism = synthetic construct
FEATURE:
NAME/KEY: REGION
LOCATION: 1..125
QUALIFIERS: note = anti-VEGF VHH
Query Match 100.0%; Score 645; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVQLVESGGGLVQPGGSLRLSCAASGRTFSSYSMGWFRQAPGKEREFVVAISKGGYKYDA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQLVESGGGLVQPGGSLRLSCAASGRTFSSYSMGWFRQAPGKEREFVVAISKGGYKYDA 60
Qy 61 VSLEGRFTISRDNAKNTVYLQINSLRPEDTAVYYCASSRAYGSSRLRLADTYEYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VSLEGRFTISRDNAKNTVYLQINSLRPEDTAVYYCASSRAYGSSRLRLADTYEYWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Sequence alignment 3
US-18-848-753-21
Filing date in PALM: 2024-09-19
Sequence 21, US/18848753
Publication No. US20250213704A1
GENERAL INFORMATION
APPLICANT: Valitor, Inc. (en)
TITLE OF INVENTION: METHOD OF TREATING A CANCER WITH A MULTIVALENT PEPTIDE CONJUGATE (en)
FILE REFERENCE: 052566-509001WO
CURRENT APPLICATION NUMBER: US/18/848,753
CURRENT FILING DATE: 2024-09-19
NUMBER OF SEQ ID NOS: 27
SEQ ID NO 21
LENGTH: 19
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..19
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 89; Length 19;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AEAAAKEAAAKEAAAKAGC 19
|||||||||||||||||||
Db 1 AEAAAKEAAAKEAAAKAGC 19
Prosecution Insights