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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 06/13/2023, 11/06/2024, 12/03/2025, 03/16/2026, and 04/10/2026 have been considered and the references therein are of record.
Claim Objections
Claim 8 is objected to because of the following informalities: contains a typographical error, reciting that "claim 1" has been added to the amended claim 8, yet "1" has also been struck-through. Appropriate correction is required. For purposes of compact prosecution, claim 8 will be interpreted to depend on claim 1.
Claim Rejections - 35 USC § 112(b)
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 54, 56, 62, 66-67, 71, and 94 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.
The term “at least about” in claims 54, 56, 62, 66, 71, and 94 is a relative term which renders the claims indefinite. The term “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification defines the relative term “about” (para [0088]), the phrase “at least about” is not defined and renders the claims as indefinite.
Claim 67 is rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claim recites the functional language of an albumin binding domain without specifying any specific structures required to perform the function of binding albumin. The requisite structure is merely implied by the functional language and thus the scope of the claim is undefined. Absent additional structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 1-2, 7-8, 47-48, 53-56, 58-60, 62, 64, 66-67, 69, 71, 73-74, and 94 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 claims contain 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. This is a written description rejection.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claims 1, 8, 47-48, 54, 56, 59, 62, 66-67, 71, and 94 recite a fusion protein with immunomodulatory activity comprising a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family capable of binding collagen (claim 1), a human type I glycoprotein having an Ig-like domain capable of binding collagen (claim 1), a domain capable of binding albumin (claim 67), a linear polypeptide spacer (claims 1, 8, & 47-48), and at least about 80% identity to SEQ ID NOs: 1-2, 5-6, 11, 13-14, 16-18, and 19 (claims 54, 56, 59, 62, 66, 71, & 94), each of which encompasses a genus of agents. Dependent claims 2, 7, 53, 55, 58, 60, 64, 69, and 73-74 do not materially limit the genus of agents and are therefore included in the rejection. The claims do not require that the genera of the polypeptides possess any particular structure or other distinguishing feature that is characteristic of each genus as a whole. Therefore, the claims are drawn to genera of peptides for which there is inadequate written description.
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 MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), 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 MPEP 2163(II)(3)(a)(i)(C).
Regarding the genera of the claims, it is clear the Applicant is in possession of the species illustrated in Figure 1 with 100% sequence identity to the sequences contained within the instant Sequence Listing. The claims are not limited to the disclosed species, however, but rather include an immense number of species encompassed by the genera of a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family capable of binding collagen (claim 1), a human type I glycoprotein having an Ig-like domain capable of binding collagen (claim 1), a domain capable of binding albumin (claim 67), a linear polypeptide spacer (claims 1, 8, & 47-48), and at least about 80% identity to SEQ ID NOs: 1-2, 5-6, 11, 13-14, 16-18, and 19 (claims 54, 56, 59, 62, 66, 71, & 94). The specification fails to provide a representative number of species within the recited genera and/or identification of particular portions of structure that must be conserved within each genus to preserve and confer the immunomodulatory activity of the composition. The claims recite functional domains and derivates of the domains that are fused together to form an immunomodulatory protein without providing the specific sequences and structures that are representative of each of the claimed genera, including those structures that can be mutated and still retain their claimed immunomodulatory function.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genera as a whole, or representative number of species within each of the genera, the specification does not provide adequate written description of the claimed genera.
With the exception of the species illustrated in Figure 1 with 100% sequence identity to the sequences contained within the instant Sequence Listing, the skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, 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 compound 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. The specification provided only the bovine sequence. Therefore, only isolated polypeptides illustrated in Figure 1 with 100% sequence identity to the sequences contained within the instant Sequence Listing, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. 112, first paragraph.
Scope of Enablement
Claims 1-2, 7-8, 47-48, 53-56, 58-59, 60, 62, 64, 66-67, 69, 71, 73-74, and 94 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the species of the immunomodulatory fusion protein illustrated in Figure 1 with 100% sequence identity to the sequences contained within the instant Sequence Listing, does not reasonably provide enablement for the vast genera of an immunomodulatory fusion protein comprising a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family capable of binding collagen (claim 1), a human type I glycoprotein having an Ig-like domain capable of binding collagen (claim 1), a domain capable of binding albumin (claim 67), a linear polypeptide spacer (claims 1, 8, & 47-48), and at least about 80% identity to SEQ ID NOs: 1-2, 5-6, 11, 13-14, 16-18, and 19 (claims 54, 56, 59, 62, 66, 71, & 94). Dependent claims 2, 7, 53, 55, 58, 60, 64, 69, and 73-74 do not materially limit the genera and are therefore included in the rejection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims:
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the claimed composition is that it covers a vast array of fusion proteins with immunomodulatory activity that have any variant of a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family capable of binding collagen (claim 1), a human type I glycoprotein having an Ig-like domain capable of binding collagen (claim 1), a domain capable of binding albumin (claim 67), a linear polypeptide spacer (claims 1, 8, & 47-48), and at least about 80% identity to SEQ ID NOs: 1-2, 5-6, 11, 13-14, 16-18, and 19 (claims 54, 56, 59, 62, 66, 71, & 94). As the breath of the claims encompass a wide scope of compositions, a skilled artisan would not know how to make the vast array of compositions with a reasonable expectation of success based solely on what is disclosed in the specification.
The amount of direction provided by the inventor and the level of predictability in the art:
The specification does not provide direction to how all species contained within the genera encompassed by the claims can maintain the required binding and immunomodulatory activities, nor how the claimed sequences can be mutated while maintaining the requisite functions. The number of mutations generally possible in any given protein that can be made with a reasonable expectation of success are limited. Certain positions in the sequence are critical to the protein's structure/function relationship, e.g., such as various sites or regions directly involved in binding, activity and in providing the correct three-dimensional spatial orientation of binding and active sites. The art provides evidence that mutations can be destabilizing and their effects unpredictable. Bhattacharya et al. (PLoS ONE 12(3): e0171355. 2017; 22 pages total) teach even single nucleotide variations have a "range of effects at the protein level that are significantly greater than assumed by existing software prediction methods, and that correct prediction of consequences remains a significant challenge" (p. 18, 1st and 2ⁿᵈ paragraphs). In addition, Fenton et al. (Medicinal Chemistry Research (2020) 29:1133-1146) review the unpredictability of making substitutions at non-conserved positions in a protein, which can have significant effects on protein function that computational algorithms cannot predict very well (p. 1134, right column, middle paragraph). Therefore, the art at the time of filing does not provide enabling guidance and the specification as filed does not provide guidance that overcomes this unpredictability within the art.
The existence of working examples:
What is enabled by the working examples is narrow in comparison to the breadth of the claims: the specification discloses Examples 1-13 (pg. 72-78), various constructs of the immunomodulatory fusion protein in Figure 1, and embodiments within the Sequence Listing, but does not provide working examples for the genera recited above. The examples disclose that the applicant made and used immunomodulatory fusion proteins with the constructs of IL12-LAIR-MSA-IL2, IL12-Lumican-MSA-IL2, and IL12-LAIR-ABD-IL2 (MSA: murine serum albumin; ABD: albumin binding domain) to treat mouse solid tumor models of melanoma (b16F10 cells), colorectal carcinoma (CT26 cells), and colon adenocarcinoma (MC38 cells). Figure 1 shows drawings of the IFPs that are constructed with various arrangements of the domains.
The quantity of experimentation needed to make or use the invention:
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed invention without first making a substantial inventive contribution.
Given that the nature of the invention is immunomodulatory fusion proteins, a person having ordinary skill in the art would have to make a vast array of polypeptides and perform multiple further experiments, in human clinical trials, or in animal models that are predictive of treatment, in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to make every embodiment of the claimed fusion protein capable of immunomodulation and the requisite binding ability and to use the method with a reasonable expectation of success.
Therefore, claims 1, 8, 47-48, 54, 56, 59, 62, 66-67, 71, and 94 lack enablement.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries 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.
Claims 1-2, 7-8, 53, 67, and 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Momin et al., 2019 (see instant PTO-892).
The instant claims are drawn to different embodiments of an immunomodulatory fusion protein that comprise an IL-2, an IL-12, a linear polypeptide spacer, and either a human type I glycoprotein having an Ig-like domain or a collagen binding domain, where the collagen binding domain comprises a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family. The instant claims are drawn to the linear polypeptide spacers being albumin. The instant claims are drawn to the leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family being lumican. The instant claims are drawn to the immunomodulatory fusion protein having a molecular weight of about 100 to about 1000 kDa. The instant claims are drawn to a pharmaceutical composition comprising the immunomodulatory fusion protein and a pharmaceutically acceptable carrier. The instant claims are drawn to the IL-2 is at the N-terminus and the IL-12 is at the C-terminus of the fusion protein. The instant claims are drawn to the linear polypeptide spacer in between the IL-2 and the collagen-binding domain and/or the collagen-binding domain in between the IL-12 and the linear polypeptide spacer.
Momin teaches a linear immunomodulatory fusion protein (IFP) comprising murine lumican (Supp. Materials and Methods) linked to a linear polypeptide spacer (such as GGGS fused to murine serum albumin (MSA) [Table S1]), which is linked to either murine IL2 or IL12 (Results; Supp. Materials and Methods). Momin teaches the IL-12 at both the N-terminus and at the C-terminus (Table S1). Momin teaches the IL-2 at both the N-terminus and at the C-terminus (Table S1). Momin teaches the lumican domain of the IFP “binds collagen and demonstrates prolonged retention and systemic isolation after intratumoral injection” (see p. 2, Fig. 1). Momin teaches anchoring the IL-12 to collagen within the tumor using the collagen binding domain results in higher localized concentration of cytokine activity and reduces systemic toxicity (see p. 5, Fig. 3). Momin teaches that monotherapy with either IL-12-MSA-Lumican or Lumican-MSA-IL-2 treats cancer (see p. 4, Fig. 2 & p. 5, Fig. 3) and that coadministration of “IL12-MSA-Lumican plus Lumican-MSA-IL2 cures B16F10 tumors without systemic toxicity” (see p. 6, paragraph bridging left and right columns; p. 7, Fig. 4; & p. 9, Fig. 5). Momin teaches that “lumican is amenable to fusion to other immunomodulatory payloads and translation to several solid tumors” (see p. 9, right column, 2nd paragraph). Momin teaches the fusion protein in a pharmaceutically acceptable carrier (see p. 11, left column, last paragraph). Momin teaches that Lumican-MSA has a molecular weight (MW) of 104 kDA and that IL-2 has an MW of 16 kDa and IL-12 has an MW of 57 kDA (see p. 2, right column; p. 8, right column, 2nd paragraph), therefore all of the components of the fusion protein fall within the range of claim 73. Thus, Momin teaches limitations present in claims 1-2, 7-8, 53, 67, and 73-74.
The second factor to consider is to ascertain the differences between the prior art and the instant claims. Momin does not explicitly teach a IFP that comprises both IL2 and IL-12. It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Momin. One with ordinary skill in the art would be motivated to make and use the claimed invention because Momin teaches that combinational therapy of the two immunomodulatory fusion proteins, IL12-MSA-Lumican plus Lumican-MSA-IL2, act synergistically to treat cancer and that they are both useful and equivalents for the same purpose. Therefore, an ordinary artisan would have found it logical and obvious to make and use the claimed invention as Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalents for the same purpose. The court has held that it is obvious to combine two elements/compositions each of which is taught by the prior art to be useful for the same purpose. No specific teaching or suggestion is needed for combination – the idea of combining them flows logically from their having been individually taught in the prior art as useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Nevertheless, an ordinary artisan would have been motivated to fuse the two fusion proteins into one, creating a fusion protein that comprises IL12, MSA, Lumican, and IL2, since together they treat cancer better that either composition does alone. An ordinary artisan would be motivated to make various constructions of this fusion protein, with the constituents in various arrangements, to optimize the efficacy of the fusion protein. Furthermore, an ordinary artisan would have had a reasonable expectation of success because Momin has already demonstrated that using the two fusion proteins together is more effective than using either fusion protein alone. Thus, the claims do not contribute anything non-obvious over the prior art.
Claims 55 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Momin as applied to claims 1-2, 7-8, 53, 67, and 73-74 above, and further in view of Flies et al., 2018 (WO2018027039A1) (see instant PTO-892).
The instant claims are drawn to different embodiments of an immunomodulatory fusion protein that comprises an IL-2, an IL-12, a linear polypeptide spacer, and either a human type I glycoprotein having an Ig-like domain or a collagen binding domain, where the collagen binding domain comprises a leucine-rich repeat from a human proteoglycan Class II member of the small leucine-rich proteoglycan (SLRP) family. The instant claims are drawn to the human type I glycoprotein having an Ig-like domain being LAIR1 or LAIR2.
The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. The teachings of Momin and how they meet the limitations of claims 1-2, 7-8, 53, 67, and 73-74 are outlined above in the preceding rejection and are hereby incorporated. The second factor to consider is to ascertain the differences between the prior art and the instant claims. Momin does not explicitly teach a IFP that comprises IL2, IL-12, a linear polypeptide spacer comprising albumin, and either LAIR1 or LAIR2. As Momin teaches anchoring cytokines to tumor collagen using collagen-binding domains, an ordinary artisan would be motivated to look for alternative collagen-binding domain options in the pursuit of optimizing the composition.
Flies teaches an immunomodulatory fusion protein comprising a LAIR1 or LAIR2 collagen-binding domain (abstract; claims) which can be co-administered with cytokines to enhance the function of the fusion protein (V. Combination Therapies). It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Momin and Flies. One with ordinary skill in the art would be motivated to make and use the claimed invention because Flies teaches that LAIR1 and LAIR2 are useful for the same purpose as lumican in an IFP, which is the purpose of binding collagen to anchor a fusion protein to a specific tissue. An ordinary artisan would find it obvious to try using an alternative collagen binding domains in the composition in the pursuit of optimizing the composition’s anti-tumor function. Furthermore, the person of ordinary skill in the art could have reasonably expected success because an ordinary artisan would readily recognize from the teachings of Momin and Flies that LAIR1, LAIR2, and Lumican are functional equivalents for the same purpose of binding collagen and are therefore interchangeable within the fusion protein. Thus, the claims do not contribute anything non-obvious over the prior art.
Claims 47-48, 54, 56, 59-60, 62, 64, 66, 69, 71, and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Momin and Flies as applied to claims 1-2, 7-8, 53, 55, 58, 67, and 73-74 above, and further in view of Mumper et al., 2002 (US20020058795A1), Mingala et al., 2006, Rosen et al., 2003 (US20020044941A1), St. Croix et al., 2003 (US20030017157A1), Xie et al., 2003 (US20030166512A1) and Wittrup et al., 2017 (US20170216402A1) (see instant PTO-892).
The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. The teachings of Momin and Flies and how they meet the limitations of claims 1-2, 7-8, 53, 55, 58, 67, and 73-74 are outlined above in the preceding rejection and are hereby incorporated. The second factor to consider is to ascertain the differences between the prior art and the instant claims. Neither Momin or Flies teaches SEQ ID NOs: 1-2, 5-6, or 11-19. Mumper, Mingala, Rosen, St. Croix, Xie, and Wittrup remedy this deficiency by teaching sequences that an ordinary artisan would understand to be useful to make the claimed composition.
Mumper teaches a human IL-2 in Mumper SEQ ID NO: 3 (Db) that has 100% sequence identity to instant SEQ ID NO: 1 (Qy), as shown below.
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343
648
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Mingala teaches an IL-12 subunit p40 (Db) that has 100% sequence identity to instant SEQ ID NO: 5 (Qy), as shown below.
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584
639
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St. Croix teaches a human lumican in St. Croix SEQ ID NO: 259 (Db) that has 100% sequence identity to instant SEQ ID NO: 11 (Qy), as shown below.
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591
669
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Rosen teaches a human LAIR1 in Rosen SEQ ID NO: 791(Db) that has 100% sequence identity to instant SEQ ID NO: 13 (Qy), as shown below.
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493
659
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Greyscale
Xie teaches a human albumin binding domain in Xie SEQ ID NO: 23(Db) that has 100% sequence identity to instant SEQ ID NO: 16 (Qy), as shown below.
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1017
645
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Wittrup teaches a human albumin binding domain in Wittrup SEQ ID NO: 36 (Db) that has 97.9% sequence identity to instant SEQ ID NO: 17 (Qy), as shown below.
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1197
723
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Wittrup teaches a human albumin binding domain in Wittrup SEQ ID NO: 36 (Db) that has 100% sequence identity to instant SEQ ID NO: 18 (Qy), as shown below.
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1186
647
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It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Momin, Flies, Mumper, Mingala, Rosen, St. Croix, Xie, and Wittrup. One with ordinary skill in the art would be motivated to make and use the claimed invention because, in the pursuit of making the immunomodulatory fusion protein that could be used to treat a human patient, an ordinary artisan would look to the prior art for known human sequences, or sequences that could be useful in a composition meant for humans, and would find sequences for each of the domains of the fusion protein in the disclosures of Mumper, Mingala, Rosen, St. Croix, Xie, and Wittrup. An ordinary artisan would find it obvious that there are many known sequence variations of each domain from which that they could pick and choose as they attempted to make the most effective version of the immunomodulatory fusion protein, and as such would have a reasonably expected success in this pursuit. In regards to the human albumin binding domain taught by Wittrup, although it does not have 100% sequence identity to SEQ ID NO: 17, there is no evidence that the claimed sequence differs substantially enough to alter the structure in a way that alters its function. Therefore, an ordinary artisan would be motivated to combine the sequences taught by the prior art references to obtain the claimed IFP that is obvious in view of Momin and Flies. Thus, the claims do not contribute anything non-obvious over the prior art.
Conclusion
No claims are allowed.
Advisory Information
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/JOSEPH D. CESARE/Examiner, Art Unit 1675
/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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