DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 are pending.
Election/Restrictions
Applicant’s election of Group I in the reply filed on May 14, 2026 is acknowledged. Applicant’s election of the species, polyglycolide in the reply filed on May 14, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15 and 19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 12 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species.
Claims 1-11, 14 and 16-18 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-11, 14 and 16-18 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.
Claim 1 recites that the Fc receptor has a similar genetic origin as the delivered antibody. The specification does not disclose the definition of similar genetic origin. It’s not clear if this is referring to a specific species or similar allotype.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 4 recites the term “the delivered antibody”. Claims 16-18 depend from claim 8, which depends from claim 1 and recite the term an antibody to be delivered. However, claims 1 nor claim specifically require that an antibody is included as part of the fusion protein. Claim 1 only recites that the fusion protein can be used to deliver an antibody. Thus, claim 1 recites an intended use for the fusion protein.
Claim 5 recites the term “above-mentioned protein. It is not clear if this is referring to the fusion protein or the protein receptor.
Claims 8 and 9 have the limitation “its derivative through hydrophobic interaction”. The specification does not disclose what structures would be encompassed by derivative through hydrophobic. The term “derivative” is not one, which has a universally accepted meaning in the art nor is it one which has been adequately defined in the specification. The primary deficiency in the use of this phrase is the absence of an ascertainable meaning for said phrase. Since it is unclear how the a hydrophobic degradable polyester is to be derivatized, there is no way for a person of skill in the art to ascribe a discrete and identifiable class of compounds to said phrase.
In addition, claim 9 recites the limitation “wherein the hydrophobic degradable polyester or its derivative is a polyester, preferably an aliphatic polyester or its derivative, or a polyethylene glycol modified aliphatic polyester or its derivative. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation polyester, and the claim also recites aliphatic polyester or its derivative, or a polyethylene glycol modified aliphatic polyester or its derivative which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(a2) as being anticipated by Hogarth et al (WO 2008/070927, published June 19, 2008).
The claims are drawn to a fusion protein for delivering at least one antibody, including serum albumin and a protein receptor, wherein the serum albumin is connected to the protein receptor directly or through a peptide connector; the protein receptor is an Fc receptor.
Hogarth discloses an rsFcyR monomer fusion to HSA (page 9, lines 1-14; Figure 17). Hogarth disclose that The Fc binding regions may be linked through a peptide bond or via a short linker sequence (e.g. a single amino acid or a short peptide of, for example, 2 to 20 amino acids in length (page 4, lines 3-5). Hogarth discloses the linker sequence GGGGSGGGGS (page 15, lines 11-22). Hogarth discloses that that the fusion protein may be administered through a sustained release implant compositions depot-forming compositions (page 21, lines 5-12). Hogarth disclose the Fc binding region may comprise FcyRI (page 11, lines 8-19).
With regards to the limitations “for delivering at least one antibody and “Fc receptor is a receptor that specifically binds to the Fc segment of the delivered antibody”, it is noted that claim 1 does not specifically require the presence of an antibody and the claim only recites the intended use for the fusion protein.
Hogarth discloses rsFcyRIIa monomer fusion to HSA. Therefore, the fusion protein of Hogarth would inherently have the same activity and functionality as the claimed fusion protein. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” In regards to claim 7 and dependent claims 8-9, 12 and 14-16, instant claim 7 recites an “intended use”. The active compound in claim 7 is the polypeptide comprising SEQ ID NO: 1. Castillo et al teach a peptide comprising instant SEQ ID NO: 1. Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. Since the reference teaches a an rsFcyR monomer fusion to HSA, the reference anticipates instant claims 1 and 3-6.
Claim(s) 1 and 3-6 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(a2) as being anticipated by Andersen et al (WO 2015/063611, published May 7, 2015).
Andersen discloses FcRn binding to HAS and HAS mutants (page 1, 17-19; page 47, lines 16-20). Andersen discloses that FcRn is a bifunctional molecule that contributes to the maintaining high level of lgG and albumin in serum of humans (page 1, lines 17-22). Andersen discloses that IgG and albumin bind noncooperatively to distinct sites on FcRn (page 1, lines 23-25). Andersen disclose that the composition may be delivered through by a controlled-release mechanism, a liposome or applied on
a polymer (page 23, lines 11-18).
Claim(s) 1 and 3-6 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(a2) as being anticipated by Suppremol GMBH (CN 101611052, published December 23, 2009, IDS).
Suppremol discloses a fusion protein comprising human serum albumin and rsFcyRIIa a carrier protein and two or more connected Fc binding regions and a
modified Fc domain to form a fusion. (page 7, paragraph 2; figure 17; Summary of Invention). Suppremol disclose that the Fc-binding regions may be linked by peptide bonds or by short linker sequences (Id). Suppremol disclose that the carrier protein is a human serum protein improve bioavailability (p. 13, paragraph 2). Suppremol discloses that the Fc binding region is derived from an FcyR-type receptor (claim 6). Supremol disclose that the leukocyte receptors FcγRI and FcγRIIa bind to an Fc region distinct from the Fc recognized by nascent FcR. (reference 32).
bind to an Fc region distinct from the Fc recognized by nascent FcR and protein A. Suppremol discloses subcutaneous administration can be achieved by sustained release implant compositions or injectable depot compositions (Detailed Description).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hogarth et al (WO 2008/070927, published June 19, 2008, cited previously) in view of Walter et al (US 2020/0148767, published May 14, 2020) and Yehuda et al (WO 2019/220441 published November 21, 2019).
Hogarth does not specifically disclose a nanoparticle comprising polylactide.
Walther disclose an antibody fused to serum albumin that binds to FcRn (paragraph 105). Walther further disclose that the composition can be formulated as a sustained-release system comprising polylactide (paragraph 197).
Yehuda disclose nanoparticles comprising polylactide having a diameter of 50-800nm (page 4, lines 9-11; page 26, lines 6-28; page 31, lines 18-19).
One of ordinary skill in the art would have been motivated to apply Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to Hogarth’s fusion protein comprising serum albumin and an Fc receptor because Hogarth disclose that the composition may be delivered through by a controlled-release mechanism, a liposome or applied on a polymer. It would have been prima facie obvious to combine Hogarth’s fusion protein comprising serum albumin and an Fc receptor with Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to have a polylactide nano-assembly comprising a fusion protein including serum albumin and an Fc receptor. One of ordinary skill in the art would have had a reasonable expectation of success because Li et al (Drug Delivery Trans Res 10:1267-1277, 2020) disclose the encapsulation of serum albumin by PLGA microspheres (Abstract; page 1268, 2nd column to page 1269, 2nd column).
Claims 1, 3-6, 8-11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen et al (WO 2015/063611, published May 7, 2015, cited previously) in view of Walter et al (US 2020/0148767, published May 14, 2020, cited previously) and Yehuda et al (WO 2019/220441 published November 21, 2019, cited previously).
Andersen does not specifically disclose a nanoparticle comprising polylactide.
Walther disclose an antibody fused to serum albumin that binds to FcRn (paragraph 105). Walther further disclose that the composition can be formulated as a sustained-release system comprising polylactide (paragraph 197).
Yehuda disclose nanoparticles comprising polylactide having a diameter of 50-800nm (page 4, lines 9-11; page 26, lines 6-28; page 31, lines 18-19).
One of ordinary skill in the art would have been motivated to apply Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to Andersen’s fusion protein comprising serum albumin and an Fc receptor because Andersen discloses that that the fusion protein may be administered through a sustained release implant compositions depot-forming compositions (page 21, lines 5-12). It would have been prima facie obvious to combine Andersen’s fusion protein comprising serum albumin and an Fc receptor with Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to have a polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor. One of ordinary skill in the art would have had a reasonable expectation of success because Li et al (Drug Delivery Trans Res 10:1267-1277, 2020, cited previously) disclose the encapsulation of serum albumin by PLGA microspheres (Abstract; page 1268, 2nd column to page 1269, 2nd column).
Claims 1-11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen et al (WO 2015/063611, published May 7, 2015, cited previously) in view of Walter et al (US 2020/0148767, published May 14, 2020, cited previously) and Yehuda et al (WO 2019/220441 published November 21, 2019, cited previously) in further view of Wang et (US 2019/0216898, published July 18, 2019) and Liu et al (Antibodies 9:1-34, 2020).
Neither Andersen, Walter nor Yehuda disclose that the Fc receptor is FcyRI or a linker comprising GlyGlyGlyGlySer.
Wang discloses a GGGGS linker that links serum albumin to various proteins (paragraph 27, paragraph 55 SEQ ID NOS:17-18).
One of ordinary skill in the art would have been motivated to apply Wang’s GGGGS linker to Andersen, Walter and Yehuda’s polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor because Andersen discloses that the fusion proteins may comprise linker sequences separating the various components of the fusion polypeptide page (lines 29-34). It would have been prima facie obvious to combine Andersen, Walter and Yehuda’s polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor with Wang’s GGGGS linker to have polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor linked with a GGGGS linker.
Liu discloses that IgG molecules bind to Fc gamma receptors (FcR). Humans possess 6 different FcR: hFcγRI, hFcγRIIA, hFcγRIIB, hFcγRIIC, hFcγRIIIA and hFcγRIIIB which bind IgG at the cell surface but with varying affinity (page 2, 4th paragraph). hFcγRI contains three extracellular immunoglobulin domains and is the
only high-affinity FcR, able to bind monomeric IgG, whilst the other FcR contain two extracellular immunoglobulin domains and are low to intermediate affinity, only binding IgG in immune complex or when bound to a pathogen or cell surface (Id).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. In Ball Aerosol v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art.
Exemplary rationales that may support a conclusion of obviousness include:
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Simple substitution of one known element for another to obtain predictable results;
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To reject a claim based on simple substitution one known element for another to obtain predictable results, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
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(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
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(2) a finding that the substituted components and their functions were known in the art;
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(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
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(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
Andersen discloses FcRn binding to serum albumin while Liu discloses that hFcγRI contains three extracellular immunoglobulin domains and is the only high-affinity FcR, able to bind monomeric IgG. It would have been obvious to substitute Liu’s hFcγRI for FcRn in the composition comprising an FcR and serum albumin because Liu discloses that hFcγRI is the only high-affinity FcR, able to bind monomeric IgG.
Claims 1-6, 8-11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Suppremol GMBH (CN 101611052, published December 23, 2009, IDS, cited previously) in view of Walter et al (US 2020/0148767, published May 14, 2020) and Yehuda et al (WO 2019/220441 published November 21, 2019).
Suppremol GMBH does not specifically disclose a nanoparticle comprising polylactide.
Walther disclose an antibody fused to serum albumin that binds to FcRn (paragraph 105). Walther further disclose that the composition can be formulated as a sustained-release system comprising polylactide (paragraph 197).
Yehuda disclose nanoparticles comprising polylactide having a diameter of 50-800nm (page 4, lines 9-11; page 26, lines 6-28; page 31, lines 18-19).
One of ordinary skill in the art would have been motivated to apply Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to Suppremol GMBH’s fusion protein comprising serum albumin and an Fc receptor because Suppremol GMBH discloses that that the fusion protein may be administered through a sustained release implant compositions depot-forming compositions (page 21, lines 5-12). It would have been prima facie obvious to combine Suppremol GMBH ’s fusion protein comprising serum albumin and an Fc receptor with Walther’s sustained-release system comprising polylactide and Yehuda’s nanoparticles comprising polylactide having a diameter of 50-800nm to have a polylactide nano-assembly comprising a fusion protein including serum albumin and a protein receptor and an Fc receptor. Furthermore, it would have been obvious to substitute FcγRI for FcγRIIa because Supremol disclose that the leukocyte receptors FcγRI and FcγRIIa bind to the same Fc region. One of ordinary skill in the art would have had a reasonable expectation of success because Li et al (Drug Delivery Trans Res 10:1267-1277, 2020, cited previously) disclose the encapsulation of serum albumin by PLGA microspheres (Abstract; page 1268, 2nd column to page 1269, 2nd column).
Claims 1-11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Suppremol GMBH (CN 101611052, published December 23, 2009, IDS, cited previously) in view of Walter et al (US 2020/0148767, published May 14, 2020, cited previously) and Yehuda et al (WO 2019/220441 published November 21, 2019, cited previously) in further view of Wang et (US 2019/0216898, published July 18, 2019, cited previously)
Neither Suppremol GMBH, Walter nor Yehuda disclose a linker comprising GlyGlyGlyGlySer.
Wang discloses a GGGGS linker that links serum albumin to various proteins (paragraph 27, paragraph 55 SEQ ID NOS:17-18.
One of ordinary skill in the art would have been motivated to apply Wang’s GGGGS linker to Suppremol GMBH, Walter and Yehuda’s polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor because Suppremol GMBH discloses that the fusion proteins may comprise linker sequences separating the various components of the fusion polypeptide page (lines 29-34). It would have been prima facie obvious to combine Suppremol GMBH, Walter and Yehuda’s polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor with Wang’s GGGGS linker to have polylactide nano-assembly comprising a fusion protein including serum albumin and a Fc receptor linked with a GGGGS linker.
Summary
No claims allowed.
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/MARK HALVORSON/ Primary Examiner, Art Unit 1646
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