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 05/01/2026 in response to the Office Action of 02/04/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125 and 152, drawn to a fusion protein comprising a first nanocage monomer or a subunit thereof linked to an Fc monomer, wherein the fusion proteins are capable of self-assembling to form a nanocage comprising one or more Fc dimers.
Additionally, Applicant has elected an infectious agent as species of antigen, apoferritin as species of nanocage monomer.
Upon review and reconsideration ferritin will be rejoined with apoferritin for examination.
3. Claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125, 152 and 156-159 are pending in the application. Claims 156-159 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 05/01/2026.
Claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125 and 152 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) and 365(c) for benefit of the earlier filing date of applications, is acknowledged.
Claim Objections
6. Claim 18 is objected to because of the following informalities:
A duplicate recitation “HIV-1 specific antigen-binding moiety” in claim 18.
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claims 5-7, 9 and 19-20 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.
The claims 5-7, 9 and 19-20 are herein drawn to a fusion protein comprising bioactive moiety for therapeutic or prophylactic use.
In this instance, the claims are directed to a genus of bioactive moieties for therapeutic or prophylactic use.
A genus of bioactive moieties may include, for example, a polypeptide, an antibody, a nucleic acid, or small molecule.
Although the specification teaches anti-HIV antibody (see Example 1), it is not representative of the claimed a genus of bioactive moieties; this is because the claimed bioactive moiety, for example, a polypeptide, an antibody, a nucleic acid, or small molecule have markedly different structures. The artisan would not expect that any given bioactive moiety would have therapeutic or prophylactic activity.
There is no correlation between any one particularly identifying structural feature that is shared by at least a substantial number of the members of the claimed a genus of bioactive moieties; because each bioactive moiety is structurally and functionally different. Although the artisan could potentially screen bioactive moieties, it cannot be predicted whether or not one will be successful. The written description provision set forth under 35 USC 112(a) is severable from its enablement provision, so that written description requirement cannot be met by describing how one might make the invention – rather the invention must be described in such clear and particular terms so as to reasonably convey to the skilled artisan that applicant had possession of the claimed invention as of the filing date of the application (i.e., the earlier effective US filing date sought).
The skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of the members of the claimed genus of bioactive moieties.
The specification therefore would not reasonably convey to the skilled artisan Applicant's possession of the claimed invention as of the filing date of the application.
Notably, the Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Furthermore, Applicant is reminded that “generalized language may not suffice if it does not convey the detailed identity of an invention.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1892 (CAFC 2004).
In this instance, there is no language that adequately describes with any of the requisite clarity or particularity the claimed a genus of bioactive moieties would have therapeutic or prophylactic activity. A description of what a material does, rather than of what it is, does not suffice to describe the claimed invention.
While the written description requirement can by satisfied without an actual reduction to practice, the disclosure of a catalog of potentially effective substances that might be found to be useful in practicing the claimed invention does not fulfill the written description requirement.
Recognizing that the claims are drawn to a genus of bioactive moieties would have therapeutic or prophylactic activity, it is aptly noted that the Federal Circuit has decided that a generic statement that defines a genus of substances by only their functional activity, does not provide an adequate written description of the genus. See The Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure, formula, chemical name, or physical properties of those members, rather than by merely reciting a wish for, or even a plan for obtaining a genus of molecules having a particular functional property. The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members.
Finally, Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of bioactive moieties would have therapeutic or prophylactic activity, but which otherwise vary materially, structurally and/or functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
10. 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
11. 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.
12. Claims 1-7, 9-10, 14-16, 19-20, 35, 50, 77, 110, 125 and 152 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Julin et al. (WO 2019023811, published on 07 February 2019, IDS).
Claims 1-7, 9-10, 14-16, 19-20, 35, 50, 77, 110, 125 and 152 are herein drawn to a fusion protein comprising a first nanocage monomer or a subunit thereof linked to an Fc monomer, wherein the fusion proteins are capable of self-assembling to form a nanocage comprising one or more Fc dimers.
Julin et al. teach a fusion protein comprising: a nanocage monomer; and
an antibody or fragment thereof linked to the nanocage monomer, the antibody or fragment thereof comprising a first member of a binding pair; wherein a plurality of the fusion proteins self-assembles to form a nanocage in which a plurality of the antibodies or fragments thereof decorate the exterior surface of the nanocage, whereby the first member of the binding pair is exposed for interacting with a second member of the binding pair, wherein the first member of the binding pair is a Fc portion of an antibody or fragment thereof and the second member of the binding pair is a Fc receptor; see entire document, e.g., abstract, pages 2-3, claims 1-4.
For claims 9-10 and 15-16, Julin et al. teach the antibody binds to HIV antigen; see page 29-lines 24-29, bridging paragraph of pages 35-36.
For claims 35 and 110, Julin et al. teach wherein the nanocage monomer is ferritin; see claim 5.
For claim 77, Julin et al. teach that the nanocage monomer is linked to an scFc; see Fig. 1
For claim 152, Julin et al. teach that the fusion protein can be used in therapeutic or prophylactic; see last paragraph on page 16, second paragraph on page 37.
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 1 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Julin et al. (WO 2019023811, published on 07 February 2019, IDS) in view of Sok et al. (Nat Immunol. 2018 November; 19(11): 1179–1188, pages 1-21, IDS).
Claims 17-18 are herein drawn to the fusion protein of claim 16, wherein the HIV-1-specific antigen-binding moiety binds to an MPER peptide, wherein the HIV-1 specific antigen-binding moiety comprises 10E8v4.
The teachings Julin et al. have been set forth in the above rejection of claims 1-7, 9-10, 14-16, 19-20, 35, 50, 77, 110, 125 and 152 under 35 U.S.C. 102(a)(1).
Julin et al. do not teach the HIV-1 specific antigen-binding moiety 10E8v4 binds to an MPER peptide.
However, these deficiencies are remedied by Sok et al.
Sok et al. teach anti-HIV antibody 10E8v4 binds to MPER; see entire document, e.g., second paragraph on page 6, third paragraph on page 7, Table 1 on page 21.
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 anti-HIV antibody of Julin et al. for another anti-HIV antibody 10E8v4 of Sok et al., because simple substitution of the anti-HIV antibody of Julin et al. for another anti-HIV antibody 10E8v4 of Sok 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 anti-HIV antibody of Julin et al. for another anti-HIV antibody 10E8v4 of Sok 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.
16. Claims 1, 77, 36-39 and 111-112 are rejected under 35 U.S.C. 103 as being unpatentable over Julin et al. (WO 2019023811, published on 07 February 2019, IDS) in view of Douglas et al. (US 20070258889, published on 11/08/2007).
Claims 36-39 and 111-112 are herein drawn to the fusion protein of claim 1 or 77, wherein the first nanocage monomer or subunit thereof is an apoferritin.
The teachings Julin et al. have been set forth in the above rejection of claims 1-7, 9-10, 14-16, 19-20, 35, 50, 77, 110, 125 and 152 under 35 U.S.C. 102(a)(1).
Julin et al. do not teach the nanocage monomer is an apoferritin.
However, this deficiency is remedied by Douglas et al.
Douglas et al. teach a self-assembling protein cage comprising a) a plurality of subunits, wherein at least one of said subunits is a modified subunit; b) a first agent; and c) a targeting moiety; see entire document, e.g., abstract, [0012-0016], claim 1. Douglas et al. teach wherein the protein cage includes ferritin and apoferritin, the apoferritin is an analog of ferritin; see [0005], [0078]. Douglas et al. teach that the targeting moiety is an antibody targeting HIV-1; see [0349], [0355].
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 ferritin of Julin et al. for the analog of ferritin (e.g., apoferritin) of Douglas et al., because simple substitution of the ferritin of Julin et al. for the analog of ferritin (e.g., apoferritin) of Douglas 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 ferritin of Julin et al. for the analog of ferritin (e.g., apoferritin) of Douglas 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
17. 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.
18. Claims 1-7, 9-10, 19-20, 35, 50, 77, 110 and 125 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 12,214,052. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-7, 9-10, 19-20, 35, 50, 77, 110 and 125 are herein drawn to a fusion protein comprising a first nanocage monomer or a subunit thereof linked to an Fc monomer, wherein the fusion proteins are capable of self-assembling to form a nanocage comprising one or more Fc dimers.
Claims 1-7 of U.S. Patent No. US 12,214,052 are drawn to a fusion protein comprising an antibody fragment consisting of a single-chain Fc (scFc), wherein the antibody fragment is fused to a nanocage monomer via a linker, wherein the nanocage monomer comprises a ferritin chain.
19. Claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125 and 152 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 6-7, 35-36, 47, 61, 97-98 and 115 of copending Application No. 17/631588. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125 and 152 are herein drawn to a fusion protein comprising a first nanocage monomer or a subunit thereof linked to an Fc monomer, wherein the fusion proteins are capable of self-assembling to form a nanocage comprising one or more Fc dimers, wherein the first nanocage monomer or subunit thereof is apoferritin.
Claims 1, 4, 6-7, 35-36, 47, 61, 97-98 and 115 of copending Application No. 17/631588 are drawn to a fusion protein comprising: a first apoferritin monomer; and an antibody or fragment thereof inked to the first apoferritin monomer subunit wherein the first apoferritin monomer subunit:(a) is the "N" region of apoferritin and is capable of assembling with the "C" region of apoferritin to form an apoferritin monomer, or (b) is the "C" region of apoferritin and is capable of assembling with the "N" region of apoferritin to form an apoferritin monomer, wherein the "N" region of apoferritin consists of a sequence at least 70% identical to that of SEQ ID NO: 11 and the "C" region of apoferritin consists of a sequence at least 70% identical to that of SEQ ID NO: 12
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
20. Claims 1-7, 9-10, 19-20, 35, 50, 77, 110 and 125 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of copending Application No. 18/691267. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-7, 9-10, 19-20, 35, 50, 77, 110 and 125 are herein drawn to a fusion protein comprising a first nanocage monomer or a subunit thereof linked to an Fc monomer, wherein the fusion proteins are capable of self-assembling to form a nanocage comprising one or more Fc dimers.
Claims 1-10 of copending Application No. 18/691267 are drawn to a fusion polypeptide comprising: (1) an Fc polypeptide and (2) a nanocage monomer or subunit thereof, wherein the Fc polypeptide comprises an IgG1 Fc chain, wherein said IgG1 Fc chain comprises (1) an amino acid residue other than glycine at position 237 and (2) a proline residue at position 329, according to EU numbering.
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
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