DETAILED ACTION
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 .
Election/Restrictions
Restriction:
Applicant’s election of Group I (claims 25-42) drawn to a polypeptide comprising a pLxIS motif and methods of using the polypeptide, in the reply filed on Aug 12th 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Claims 43-44 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Aug 12th 2026.
B. Species Selection:
Applicant’s election of MyD88 with STING in the same reply is also acknowledged.
Due to the close structural similarity between species, the species election is withdrawn.
Status of Claims
Claims 25-42 are under consideration.
Priority
This application is a CON of abandoned application 16/612713 which claims priority to PCT/US2018/032479 which claims priority to provisional application 62/505,819 filed 05/12/2017.
Specification
The title, abstract, and contents of the disclosure are objected to because:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The abstract is less than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The disclosure is objected to for referring to color (blue) in either the figures themselves or the figure legends within the Specification. Note: references to black, white, and/or grey/gray are acceptable.
Pg. 57, example 6 states, “novel component of my myddosome”. This does not make sense.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 Feb 2024 has been considered by the examiner.
A large number of references have been identified in the specification. Applicant is reminded of the MPEP requirements for incorporation by reference statements:
37 C.F.R. 1.57 Incorporation by reference.
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.
Drawings
The Drawings are objected to for:
Fig. 4A and 4B are identical to Fig. 10A and 10B.
The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Claim Objections
Claim 25 is objected to because of the following informalities: the claim recites a polypeptide comprising a pLxIS motif. Then it defines the abbreviation as:
wherein: p is a hydrophilic residue;
L is leucine;
x is any residue;
I is isoleucine; and
L is leucine.
It should define the abbreviation as:
wherein: p is a hydrophilic residue;
L is leucine;
x is any residue;
I is isoleucine; and
S is serine.
Claims 29, 32, 35, and 37 are objected to because they have a 5 amino acid sequence (the parenthetical) without a SEQ ID NO.
Applicants may consider the following options to overcome the objection:
Because the SEQ ID NO. with those 5-mers are not in the sequence listing, Applicants may delete the sequence in parentheses.
If Applicants wish to keep the parenthetical, Applicants must include the 5-mer in the sequence listing and recite the SEQ ID NO. of the 5-mer in the claim.
Appropriate correction is required.
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.
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 36-37 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.
Regarding claim 36, the phrase “an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 1, or fragment thereof” renders the claim indefinite because the specification does not provide a limiting definition for the term fragment. The description in the specification makes clear that Inventors have discovered a hitherto unknown function for a pLxIS motif, i.e., interferon activation. However, the specification does not provide any definition for what would be considered a fragment with respect to the functions described, and further how to assess these functions so as to aid in the creation of fusion proteins comprising the motif. This is further confusing with the recitation: having at least 95% identity to recited sequence; i.e., to what degree must the function of the fragment be maintained if identity is as low as 95% to recited sequence. An artisan would not be able to determine the metes and bounds of the term.
Claim 37 recites The synthetic gene of claim 25, wherein the polypeptide comprising the pLxIS motif comprises amino acids 13-17 of SEQ ID NO: 1 (RLLIS).
However, SEQ ID NO: 1 is listed in the sequence listing as:
1 VTMNAPMTSVAPPPSVLSQEPRLLISGMDQPLPLRTD 37
Amino acids 13-17 of this sequence are not RLLIS. Thus, the claim is indefinite.
Further, as discussed in the claim objection section, RLLIS must be identified by a SEQ ID NO since it is at least 4 amino acids in length, and if identified by a SEQ ID NO, must be part of the sequence listing. In addition to the options discussed in the claim objection section, Applicants may consider the following option:
Delete the parenthetical RLLIS and only claim the motif as a position of SEQ ID NO 1.
Claim Interpretation
“Motif” is broadly defined (top of pg. 25). Therefore, it is being given this broad interpretation. The commonly accepted meaning in the art is also broad; i.e., Motifs are “minimal peptide units that exert biological functions” (1st line of summary, Shiba K., Chem. Soc. Rev. (2010) 39 (1): 117–126.). Further, the word as defined in the disclosure and its accepted meaning in the art do not require a particular orientation in reading the motif because in the same para as where the above definition is taken from, Shiba state: The manifestation of associated functions is influenced substantially by the motif’s context. MPEP 2144.09 provides a discussion on close structural similarity. In instant application, the 3D folding of the fusion protein will dictate the function of the motif. However, for claim 25, no function is recited.
Regarding claim 25, the polypeptide comprising the pLxIS motif is being broadly interpreted as amino acid residues pLxIS in N-terminal to C-terminal orientation or SIxLp in C-terminal to N-terminal orientation.
Claim Rejections - 35 USC § 112(a)
Written Description
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.
Claims 25-42 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 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.
The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997).
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). 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, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163.
Scope of the Invention
In the instant case, the genera are
a polypeptide comprising a pLxIS motif, wherein: p is a hydrophilic residue; L is leucine; x is any residue; I is isoleucine; and S is serine (recited in claim 25);
fragments of pLxIS containing sequences (recited in claims 27, 30, 33, and 36).
The broadest reasonable interpretation of the scope of the genera listed above is a min seq of 5 amino acid residues, pLxIS, that is engineered into a hybrid/fusion protein with MyD88, and induces cytokines and interferons. Thus, such a hybrid protein is suitable for MyD88 oligomerization/myddosome formation, which in turn is required for IFN responses [Example 2: MyD88-pLxIS studies].
Disclosure of a Complete or Partial Structure
Regarding 1) a polypeptide comprising a pLxIS motif, Applicant describes engineering the MyD88 allele containing the pLxIS motif. The same is depicted in Fig. 4A-B. Detailed description of Generation of synthetic MyD88 molecules on pg. 65 states: To generate MyD88-NpLxIS and MyD88-CpLxIS alleles, the cDNA sequence encoding the STING pLxIS motif (340-378 a.a.) was fused in tandem then attached to the cDNA sequence encoding the MyD88 protein either at the 5-prime end (for MyD88-NpLxIS) or at the 3-prime end (for MyD88-CpLxIS). The Figures show that the pLxIS motif is within a sequence of the CTD of STING. This sequence is 100% identical to SEQ ID NO: 1. Thus, the cDNA sequence encoding the STING pLxIS motif (340-378 a.a.) is SEQ ID NO: 1. The pLxIS motif is RLLIS. No other pLxIS motif containing MyD88 fusion protein is described.
Functionally, MyD88-pLxIS studies are described in Example 2. Example 4 is a summary. the enhancer and variants must have liver-selective enhancer activity [pg. 3, first para]. Further
description is not relevant to MyD88-pLxIS.
However, it is not clear how the remaining recited SEQ IDs, other than SEQ ID NO: 1, and pLxIS motifs in the claims correspond to these superiorly working pLxIS motif within STING CTD.
Regarding 2) it is not clear how fragments may be obtained from the recited sequences yet retain the function that defines it; i.e., interferon activation, as described by the rest of the disclosure. In this regard it is not clear how SEQ ID NO: 1 may be varied so that they retain 95% identity to the original sequence yet retain the function that defines it; i.e., interferon activation, as described by the rest of the disclosure.
Applicant describes one sequence, SEQ ID NO: 1 from one protein, STING, as the hybrid partner of MyD88. The inventive concept requires the pLxIS motif, when juxtaposed at any end of MyD88 to retain the fusion’s ability to activate interferon.
Species Not Described
The pLxIS motif itself. pLxIS motif allows for variability: “p” could be any 11 amino acids and “x” could be any 20 amino acids.
The fragments could be any size as long as they contain the pLxIS motif. No fragment is described.
SEQ ID NO: 1 is 39 amino acids in length. A sequence having at least 95 % identity to SEQ ID NO: 1 includes a large genus of sequences comprising nucleotide sequences that may be ≤5% different from SEQ ID NO: 1; i.e., 2 amino acids could be different. Furthermore, a protein sequence could be or have:
up to 5% of the nucleotides removed from SEQ ID NO: 1;
a single chunk comprising ≤5% of the nucleotides different from SEQ ID NO: 1;
every 19th nucleotide (starting at any position) different from SEQ ID NO: 1;
every 19th nucleotide (starting at any position) removed from SEQ ID NO: 1;
any other combination of nucleotides mutated or removed as long as the total adds up to ≤5% of total nucleotides.
Each of those categories I-III, comprises a subgenus with diverse members and different structures that affect their functions. Some of those structures may have altered regulatory activity or other altered function(s).
Structure/Function Correlation
Regarding the genera, as discussed above, Applicant’s claims encompasses particular sequences comprising pLxIS motif within them with the proviso that they allow for the sequences, working in combination with MyD88, to induce interferon so as to function in immunotherapy of cancer [claim 41], while only specific sequences are described in the instant specification without any correlation to what core sequence is encompassed by the recited sequences. The breadth of the claimed genera is enormously broad with an unfathomable number of structurally divergent and diverse pLxIS motif containing sequences.
Regarding all the sequences claimed, Applicant has not demonstrated possession of any sequence that could be called a pLxIS motif containing sequence that will still work with the MyD88 to induce Ifn, other than the full-length sequence identified as SEQ ID NO: 1. The examples do not provide support for the entire genus/subgenera of pLxIS motif containing sequences claimed because the examples show an individual species. The Specification does not provide sufficient evidence that each member of the entire genus of pLxIS motif containing sequences (MAVS / TRIF) claimed would produce the intended outcome. The Specification does not provide specific guidance for determining what the structure of species of sequences should be; the functional characteristic is not coupled with a known structure.
Altogether, the number of species disclosed by complete structure is not sufficient to provide the written description support for the huge genus of pLxIS motif containing sequences.
These are broad genera with diverse members and different structures that underly their functions. Although the claims recite compounds that inherently possess a pLxIS motif, the intended functional characteristic is not coupled with a known structure.
Knowledge from the State of the Art
Patel (US 10,176,292 B2, IDS), teaches various STING proteins. Fig. 19 aligns human and mouse STING. It is evident from this alignment that there are species differences between STING proteins. hSTING consists of ELLIS as the pLxIS motif, while murine STING consists of RLLIS. While the consensus sites (pLxIS motif) are deemed important, nothing in the art teaches one of skill how to vary the regions in between such sites, and whether interchanging a stretch of 39 amino acids containing the pLxIS motif from the murine for the human will achieve the same function.
In fact, the art teaches that validation of STING sequences from mouse does not provide a framework to advance to studies in humans. BenchChem (retrieved from the BenchChem webpage on the internet < Species-Specific Activity of STING Agonists: A Human vs. Mouse Comparison) teaches species differences in STING activity> 8 pages [retrieved on 24th Sept 2026]). BenchChem teaches the extreme differences in mouse vs. human STING activity; e.g., mouse cells expressing STING show a 15 fold induction of IFN when stimulated with DMXAA, human cells shown none (Table on pg. 2).
Dependent Claims
Claims 26-42 do not further limit the genus of nucleic acid molecules so as to resolve the issues above, and are therefore, not sufficiently described for at least the reasons above.
Conclusion of Written Description
While none of these elements is specifically required to demonstrate possession, in combination their lack means that one skilled in the art at the time of filing would conclude that the inventors lacked possession of an invention of any pLxIS motif containing sequence (claims 25-42), or fragments thereof having 95% identity to the SEQ ID NO: 1 (claim 36 again).
Only SEQ ID NO: 1 as the pLxIS motif containing sequence but not the full breadth of the claims is supported by Applicant’s disclosure.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 25 and 39-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (WO 2014/039961, IDS 2/5/2024).
Regarding claim 25, 41, and 42, Stone teaches a nucleic acid encoding a fusion protein, wherein the fusion protein comprises a domain of LMP1, and at least one signaling domain from an adaptor protein. The nucleic acid can be combined with a pharmaceutically acceptable excipient and used in the treatment of, e.g., cancer. The nucleic acid can also be used to transduce an immune cell, which can be used to treat cancer. Cancers to be treated include melanoma, prostate cancer, and breast cancer, See, e.g., paragraphs [0005], [00027], [00050], [00063], [00074], [00083], [00090], and [000100]; and claims 1, 6, 17, 18, 21, 23, 24-26, and 28.
Stone does not explicitly teach: 1) LMP1 comprises the pLxIS motif or 2) a nucleic acid encoding a fusion protein comprising LMP1 and MyD88.
However, 1) Stone disclose the sequence of LMP1. As seen from scanning the sequence, the pLxIS motif is seen in the cytoplasmic domain of LMP1. See bolded below and claim interpretation above.
> SEQ 2_LMP1:
MEHDLERGPPGPRRPPRGPPLSSSLGLALLLLLLALLFWLYIVMSDWTGGALLVLYSFALMLIIIILIIFIFRRDLLCPLGALCILLLMITLLLIALWNLHGQALFLGIVLFIFGCLLVLGIWIYLLEMLWRLGATIWQLLAFFLAFFLDLILLIIALYLQQNWWTLLVDLLWLLLFLAILIWMYYHGQRTTSHLFFWDMWYIYYFWKAKIKGYQHLQSMESCYDAFIVYDTKNSAVTEWVLQELVAKLEDPREKHFNLCLEERDWLPGQPVLENLSQSIQLSKKTVFVMTQKYAKTESFKMAFYLSHQRLLDEKVDVIILIFLEKPLQKSKFLQLRKRLCRSSVLEWPANPQAHPYFWQCLKNALTTDNHVAYSQMFKETV (SEQ ID NO: 2).
Stone teach a protein, SEQ ID N0:19 comprising Epstein Barr Virus latent membrane protein 1 (without the cytoplasmic domain) fused to the human IPS-1 fused to the cytoplasmic domain of human TLR7 fused to the cytoplasmic domain of Epstein Barr Virus latent membrane protein 1. Thus, such a fusion protein contains the recited motif.
And 2) Stone teaches that its fusion proteins comprising LMP1 can comprise more than one signaling domain, and that the signaling domains can be selected from adapter proteins including MyD88. See, e.g., paragraph [00047], [00049], and [00050] and recitation from [00060]: In methods of inducing an immune response against cancer and methods of inducing an immune response against an HIV infection, the at least first fusion protein may include a transmembrane domain of LMP1 and a signaling domain from IPS-1 or a signaling domain from MyD88. In such a method, the nucleic acid encoding the at least first fusion protein may also encode a full-length LMP1 protein.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form a nucleic acid encoding a fusion protein comprising LMP1 and MyD88, because Stone teaches forming a fusion protein comprising LMP1 and multiple signaling domains; because Stone exemplifies MyD88 as useful signaling domains and adapter proteins which can be used in the fusion proteins; and because forming a nucleic acid encoding a fusion protein comprising LMP1 and MyD88 would have the expected benefit that the LMP1 would anchor the fusion proteins in membranes and aggregate the fused signaling domains into clusters, leading to altered gene expression (see especially page 10, last 5 lines).
Regarding claims 39-40, Stone teaches fusion proteins with MyD88 comprising fusions on either side of MyD88. See for e.g., Fig. 6 pNP-LMP1-MyD88dTIR-CD40 (MyD88dTIR-CD40
refers to an LMP1 fusion protein containing the LMP1 intracellular domain, MyD88 with a
deletion of the TIR domain, and the CD40 intracellular domain as stated in [00083]).
Thus, Stone make obvious instant claims 25 and 39-42.
Allowable Subject Matter
The entire sequences of SEQ ID NO: 1, 2, 6, and 8 in a hybrid protein with MyD88 are not known in the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHABANA MEYERING, Ph.D. whose telephone number is (703)756-4603. The examiner can normally be reached M - F: 9am to 5pm EST.
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SHABANA S. MEYERING, Ph.D.
Examiner
Art Unit 1635
/SHABANA S MEYERING/ Examiner, Art Unit 1635
/CATHERINE KONOPKA/ Primary Examiner, Art Unit 1635
Prosecution Insights