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 filed on 03/30/2026 in response to the Office Action of 01/28/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1, 3-4, 6, 9, 12, 15, 17 and 29, drawn to a polypeptide comprising:
(i) a first domain which is capable of downregulating cell surface expression of an MHC
class I molecule; and
(ii) a second domain which is capable of binding a component of T-cell receptor
(TCR)/CD3 complex or a MHC class II molecule.
Additionally, Applicant has elected HCMV US11 as species of the first domain.
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
3. Claims 1, 3-4, 6, 9, 12, 15, 17-19, 21-22, 27, 29-30, 35, 39-40 and 44-45 are pending in the application. Claims 18-19, 21-22, 27, 30, 35, 39-40 and 44-45 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 03/30/2026.
Claims 1, 3-4, 6, 9, 12, 15, 17 and 29 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of applications, is acknowledged.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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 1, 3-4, 6, 9, 12, 15, 17 and 29 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 1, 3-4, 6, 9, 12, 15, 17 and 29 are drawn to a polypeptide comprising: (i) a first domain which is capable of downregulating cell surface expression of an MHC class I molecule; and (ii) a second domain which is capable of binding a component of T-cell receptor (TCR)/CD3 complex or a MHC class II molecule.
Claim 6 is drawn to a sequence having at least 80% identical to SEQ ID NO: 19, 21, 23, or 42.
Claim 15 is drawn to a sequence having at least 80% identical to SEQ ID NO: 1,3,5,7,9,11,13,15,17 or 43.
Specification teaches anti-CD3 scFv-US11 fusion protein, anti-CD19 CAR-US11 fusion protein, anti-CD3 scFv-E19 fusion protein and anti-CD3 VHH-US11 fusion protein; see Examples 1-4. Specification teaches SEQ ID NOs: 1,3,5,7,9,11,13,15,17, 19, 21,23 and 42-43; see pages 6-11 and 14-16.
Thus, the claims are drawn to a genus of polypeptides comprising: (i) a first domain which is capable of downregulating cell surface expression of an MHC class I molecule, and (ii) a second domain which is capable of binding a component of T-cell receptor (TCR)/CD3 complex or a MHC class II molecule; and a genus of sequences having at least 80% identical to SEQ ID NO: 1,3,5,7,9,11,13,15,17 or 43.
Although the specification teaches anti-CD3 scFv-US11 fusion protein, anti-CD19 CAR-US11 fusion protein, anti-CD3 scFv-E19 fusion protein and anti-CD3 VHH-US11 fusion protein, and SEQ ID NOs: 1,3,5,7,9,11,13,15,17, 19, 21,23 and 43. However, the specification does not teach a genus of polypeptides comprise a first domain and a second domain, and a genus of sequences having at least 80% identical to SEQ ID NO: 1,3,5,7,9,11,13,15,17 or 43.
Given the fact that the claims are drawn to a genus of polypeptides, and a genus of sequences having at least 80% identical to SEQ ID NO: 1,3,5,7,9,11,13,15,17 or 43, which have no particular function or activity, there is no correlation between any one particularly identifying structural feature and any one particularly identifying functional feature. Consequently, it is submitted that the skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of polypeptide and sequence to which the claims are directed.
Although the specification teaches the fusion proteins and the SEQ ID NOs, the fusion proteins and the SEQ ID NOs are not reasonably representative of the plurality of polypeptides comprise a first domain and a second domain, and the plurality of sequences having at least 80% identical to the SEQ ID NOs. This is largely because each polypeptide or sequence has substantially varied structure and need not have any particular function or activity.
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 polypeptides comprise a first domain and a second domain, and a genus of sequences having at least 80% identical to SEQ ID NO: 1,3,5,7,9,11,13,15,17 or 43, which vary both structurally and 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.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
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, 3-4, 17 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Protzer et al. (WO 2015036606, published on 03/19/2015).
Claims 1, 3-4, 17 and 29 are herein drawn to a polypeptide comprising:
(i) a first domain which is capable of downregulating cell surface expression of an MHC
class I molecule; and
(ii) a second domain which is capable of binding a component of T-cell receptor
(TCR)/CD3 complex or a MHC class II molecule.
Protzer et al. teach a polypeptide comprising a first set of 6CDRs binds to a first antigen and a second set of 6CDRs binds to a second antigen, wherein the first antigen is HBV antigen, the second antigen is CD3 antigen; see entire document, e.g., claims 1-4, abstract, page 13-lines 16-30.
For claims 3-4, Protzer et al. teach the second set of 6CDRs comprises scFv fragment; see claim 2.
For claim 17, Protzer et al. teach the first set of 6CDRs is connected to the second set of 6CDRs by a covalent linkage; see claim 10.
For claim 29, Protzer et al. teach a pharmaceutical composition comprising the polypeptide; see claim 13.
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, 9, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Protzer et al. (WO 2015036606, published on 03/19/2015) in view of Jennifer et al. (WO 2020102709, published on 05/22/2020).
Claim 9 is herein drawn to the polypeptide of claim 1, wherein the first domain is a viral protein which is capable of downregulating cell surface expression of an MHC class I molecule or a functional fragment thereof.
Claims 12 and 15 are herein drawn to the polypeptide of claim 1, wherein the first domain comprises human cytomegalovirus (HCMV) unique short 11 (US11) as set forth in SEQ ID NO: 1, or at least 80% identity to SEQ ID NO: 1.
The teachings of Protzer et al. have been set forth in the above rejection of claims 1, 3-4, 17 and 29 under 35 U.S.C. 102(a)(1).
Protzer et al. do not teach the first domain is a viral protein which is capable of downregulating cell surface expression of an MHC class I, and the first domain comprises HCMV US11 having the sequence SEQ ID NO: 1.
However, these deficiencies are remedied by Jennifer et al.
Jennifer et al. teach MHC class I antigen presentation pathway inhibitor polypeptides include HCMV US11, HCMV US2, HCMV US3, E19, Nef, KSHV K3, KSHV K5, and HBV; see entire document, e.g., pages 35-40, 48-50.
Jennifer et al. teach US 11 polypeptide comprising the amino acid sequence SEQ ID NO: 962; see page 37. SEQ ID NO: 962 of Jennifer et al. is 99.6% identical to instant claimed SEQ ID NO: 1; see below sequence alignment.
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 have a polypeptide comprises a first domain comprising US11 and a second domain binds to CD3. One would have been motivated to do so because Protzer et al. teach a polypeptide comprising a first set of 6CDRs binds to HBV and a second set of 6CDRs binds to CD3; Jennifer et al. teach MHC class I antigen presentation pathway inhibitor polypeptides include HCMV US11, HCMV US2, HCMV US3, E19, Nef, KSHV K3, KSHV K5, and HBV. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute HBV of Protzer et al. for another virus e.g., HCMV US11 of Jennifer et al. to arrive the instant claimed invention, because simple substitution of the HBV virus of Protzer et al. for another virus e.g., HCMV US11 of Jennifer 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 HBV virus of Protzer et al. for another virus e.g., HCMV US11 of Jennifer 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.
Conclusion
16. No claim is allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment
BHU77556
ID BHU77556 standard; protein; 215 AA.
XX
AC BHU77556;
XX
DT 09-JUL-2020 (first entry)
XX
DE Therapeutic polypeptide delivering US11 polypeptide, SEQ ID 962.
XX
KW CRISPR-Cas system; US11 protein; genome editing; virus-like particle.
XX
OS Unidentified.
XX
CC PN WO2020102709-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061778.
XX
PR 16-NOV-2018; 2018US-0768508P.
PR 03-MAY-2019; 2019US-0843139P.
PR 21-AUG-2019; 2019US-0889867P.
XX
CC PA (REGC ) UNIV CALIFORNIA.
XX
CC PI Doudna JA, Hamilton JR;
XX
DR WPI; 2020-439275/046.
DR GENBANK; APG57339.
XX
CC PT New nucleic acid comprising nucleotide sequence encoding virus-like
CC PT particle comprising fusion polypeptide, therapeutic polypeptide, and
CC PT heterologous protease cleavage sites, used to make virus-like particle.
XX
CC PS Disclosure; SEQ ID NO 962; 323pp; English.
XX
CC The present invention relates to a method for making a virus-like
CC particle (VLP). The VLP comprising a therapeutic polypeptide. The
CC invention further relates to: a nucleic acid comprising a nucleotide
CC sequence encoding a VLP comprising a fusion polypeptide; a system; a
CC eukaryotic cell; and a method for delivering a therapeutic polypeptide to
CC a target cell. The fusion polypeptide comprises a retroviral GAG
CC polyprotein, a therapeutic polypeptide and heterologous protease cleavage
CC sites corresponds to SEQ ID NOs: 854, 883-890 (see BHU77448, BHU77477-
CC BHU77484). The invention also relate to compositions and methods for
CC delivering CRISPR/Cas effector polypeptides and CRISPR/Cas system useful
CC for genome editing.
XX
SQ Sequence 215 AA;
Query Match 99.6%; Score 1163; Length 215;
Best Local Similarity 99.5%;
Matches 214; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MNLVMLILALWAPVAGSMPELSLTLFDEPPPLVETEPLPPLSDVSEYRVEYSEARCVLRS 60
||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||
Db 1 MNLVMLILALWAPVAGSMPELSLTLFDEPPPLVETEPLPPLPDVSEYRVEYSEARCVLRS 60
Qy 61 GGRLEALWTLRGNLSVPTPTPRVYYQTLEGYADRVPTPVEDVSESLVAKRYWLRDYRVPQ 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GGRLEALWTLRGNLSVPTPTPRVYYQTLEGYADRVPTPVEDVSESLVAKRYWLRDYRVPQ 120
Qy 121 RTKLVLFYFSPCHQCQTYYVECEPRCLVPWVPLWSSLEDIERLLFEDRRLMAYYALTIKS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 RTKLVLFYFSPCHQCQTYYVECEPRCLVPWVPLWSSLEDIERLLFEDRRLMAYYALTIKS 180
Qy 181 AQYTLMMVAVIQVFWGLYVKGWLHRHFPWMFSDQW 215
|||||||||||||||||||||||||||||||||||
Db 181 AQYTLMMVAVIQVFWGLYVKGWLHRHFPWMFSDQW 215
Prosecution Insights