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 .
Status of Claims / Response to Amendments
The Amendments and Remarks filed 05/19/2028 in response to the Office Action of 02/20/202 are acknowledged and have been entered.
Claims 1, 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 are currently pending.
Claims 1, 4, 25, 32, 42, 48 and 65 have been amended by Applicant.
Claims 58 and 77 have been cancelled by Applicant.
Claims 1, 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 are currently under examination in the instant Office Action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
This Office Action contains New Rejections Necessitated by Amendments.
Objections - Withdrawn
The drawings objections are withdrawn.
The specification objections are withdrawn.
The nucleotide and/or amino acid sequence disclosures objections are withdrawn.
Claim Objections - Withdrawn
The objection of claims 25, 43, 42 and 48 has been withdrawn because Applicants have made amendments to the typographical errors in these claims.
Claim Rejections Withdrawn
The rejection of claims 4, 25 and 59 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph has been withdrawn.
The written description rejection of claim 65 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn.
The enablement rejection of claims 59 and 65 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn.
The natural phenomenon 101 rejection of claim 77 under 35 U.S.C. 101 has been withdrawn.
The rejections of claims 1, 11, 13, 14, 22, 24, 25, 31, 32, 38, 42, 43, 77 and 80 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hou et al. (US20200289567A1 Date Published 2020-09-17) and as evidenced by Shaw et al. (Molecular Therapy Volume 10, Issue 6, 2004, Pages 1032-1042), He et al. (Proc. Natl. Acad. Sci. USA Vol. 95, pp. 2509–2514, March 1998), Purbhoo et al. (J Immunol. 2006 Jun 15;176(12):7308-16) and Siegfried (Cancer Res (1987) 47 (11): 2903–2910) has been withdrawn.
The rejection of claim 77 under AIA 35 U.S.C. 102(a)(1) as being anticipated by Stevanovic and Hinrichs (WO2017189254A1 Date Published 2017-11-02) has been withdrawn.
The rejection of claim 77 under AIA 35 U.S.C. 102(a)(1) as being anticipated by Takahashi et al. (J Clin Invest. 2008;118(3):1099-1109) has been withdrawn.
The rejection of claims 1, 4, 23, 30 and 48 under 35 U.S.C. 103 as being unpatentable over Hou et al. (US20200289567A1 Date Published 2020-09-17) has been withdrawn.
The rejection of claims 1, 59, 65 and 80 under 35 U.S.C. 103 as being unpatentable over Hou et al. (US20200289567A1 Date Published 2020-09-17) as applied to claim 1 and further in view Stevanovic and Hinrichs (WO2017189254A1 Date Published 2017-11-02), Childs et al. (WO2018006054A1 Date Published 2018-01-04) and Li and Zhou (WO2019096127 Date Published 2019-05-23).has been withdrawn.
The rejection of claims 1 and 65 under 35 U.S.C. 103 as being unpatentable over Hou et al. (US20200289567A1 Date Published 2020-09-17) as applied to claim 1 above and further in view Robbins et al. (US20100034834A1 Date Published 2010-02-11) has been withdrawn.
The rejection of claims 1 and 80 under 35 U.S.C. 103 as being unpatentable over Hou et al. (US20200289567A1 Date Published 2020-09-17) as applied to claim 1 above and further in view Takahashi et al. (J Clin Invest. 2008;118(3):1099-1109) has been withdrawn.
Claim Objections
Claims 14 and 38 are objected to because of the following informalities:
Claim 14 appears to contain a typographical error. It is suggested that the word “the” be inserted into the phrase “wherein nucleic acid or vector” such that the phrase recites “wherein the nucleic acid or vector”.
Claim 38 appears to contain a typographical error. A space should be inserted before the term “LAGE-1” and after the term “HERV-K,“ in line 5.
Appropriate correction is required.
Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112(b)
Claims 1, 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 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 “….wherein the TCR-T comprises…..” It is unclear whether the “TCR-T” recited in the wherein clause refers to the TCR-T therapy in (i) and (iii) or the TCR-T in (ii) to which upregulated antigen presentation increases sensitivity. Dependent claims 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 are also rejected here.
Claim Rejections 35 U.S.C.112(a) - Necessitated by Amendments (First)
Claim 1, 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 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.
In the instant case, the claim is inclusive of a genus of tumor haplotype different from the tumor haplotype endogenous to a population of tumor cells wherein the population of tumor cells have been genetically modified to express the “different tumor haplotype” to have increased sensitivity to a TCR-engineered T cell (TCR-T) therapy comprising a TCR comprising amino acid sequences of SEQ ID NOs: 5, 10, 16, 21, 27, 32, 38 and/or 43. The number of possible tumor haplotypes that are “different” can be enormous. In addition, as recited, the TCR comprising the amino acid sequences of SEQ ID NOs: 5, 10, 16, 21, 27, 32, 38 and/or 43 could potentially bind to any of the enormous number of “different tumor haplotypes” in a population of tumor cells.
However, the written description in this case only sets forth four species of T-cell receptor α-chains encompassed by the claim, namely SEQ ID NOs: 5, 16, 27 and 38, corresponding to the nucleic acid sequence of SEQ ID NOs: 6, 17, 28 and 39, respectively; and four species of T cell receptor β-chains encompassed by the claim, namely SEQ ID NOs: 10, 21, 32 and 43, corresponding to the nucleic acid sequence of SEQ ID NOs: 1, 12, 23, and 34, respectively. Further, Examples 1-3, Figures 10 to 12 and Sequence Listings of the instant specification also discloses three species of TCR for TCR-T therapy such that sensitivity for TCR was increased by modifying tumor cells to express a distinct haplotype, namely:
KKLC-1-TCR that is effective at recognizing the HLA-A*01 peptide of SEQ ID NO: 11 expressed in tumor cells modified to express HLA-A*01 peptide (Example 2 and Figures 10A and 10B):
alpha-chain: SEQ ID NO: 10 (amino acid) and SEQ ID NO: 6 (nucleic acid)
beta-chain: SEQ ID NO: 5 (amino acid) and SEQ ID NO: 1 (nucleic acid)
HERVE-TCR that is effective at recognizing the HLA-A*11 peptide of SEQ ID NO: 22 expressed in tumor cells modified to express HLA-A*11 peptide (Example 1 and Figures 11A and 11B):
alpha-chain: SEQ ID NO: 21 (amino acid) and SEQ ID NO: 17 (nucleic acid)
beta-chain: SEQ ID NO: 16 (amino acid) and SEQ ID NO: 12 (nucleic acid)
and
NY-ESO-1-TCR that is effective at recognizing the HLA-A*02 peptide of SEQ ID NO: 33 expressed in tumor cells modified to express HLA-A*02 peptide (Example 3 and Figures 12A and 12B):
alpha-chain: SEQ ID NO: 32 (amino acid) and SEQ ID NO: 28 (nucleic acid)
beta-chain: SEQ ID NO: 27 (amino acid) and SEQ ID NO: 23 (nucleic acid).
Therefore, the specification does not disclose, and the art does not teach, the genus of tumor haplotype different from the tumor haplotype endogenous to a population of tumor cells wherein the population of tumor cells have been genetically modified to express the “different tumor haplotype” to have increased sensitivity to a TCR-engineered T cell (TCR-T) therapy comprising a TCR comprising amino acid sequences of SEQ ID NOs: 5, 10, 16, 21, 27, 32, 38 and/or 43as broadly encompassed in the claim.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of tumor haplotype different from the tumor haplotype endogenous to a population of tumor cells wherein the population of tumor cells have been genetically modified to express the “different tumor haplotype” to have increased sensitivity to a TCR-engineered T cell (TCR-T) therapy comprising a TCR comprising amino acid sequences of SEQ ID NOs: 5, 10, 16, 21, 27, 32, 38 and/or 43, nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of three “different tumor haplotype” species disclosed in the instant specification is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections 35 U.S.C.112(a) - Necessitated by Amendments (Second)
Claims 1, 4, 11, 13, 14, 22-25, 30-32, 38, 42, 48, 65 and 80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for a method of increasing the sensitivity of a population of tumor cells to a TCR-T therapy comprising genetically modifying the population of tumor cells to express a particular tumor haplotype different from the tumor haplotype endogenous to the population of tumor cells that is: (a) a HLA-A*01 peptide and the peptide as set forth in SEQ ID NO:11, wherein the TCR-T comprises a TCR that comprises the α-chain and β-chain comprising the amino acid of SEQ ID NOs: 10 and 5, respectively as encoded by the nucleic acids of SEQ ID NOs: 6 and 1, respectively and as described in Example 2 and Figures 10A and 10B in the specification;
(b) a HLA-A*11 peptide and the peptide as set forth in SEQ ID NO:22, wherein the TCR-T comprises a TCR that comprises the α-chain and β-chain of SEQ ID NO:21 and 16, respectively as encoded by the nucleic acids of SEQ ID NOs: 17 and 12 and as described in Example 1 and Figures 11A & 11B in the specification; or
(c) a HLA-A*02 peptide and the peptide as set forth in SEQ ID NO: 33, wherein the TCR-T comprises a TCR that comprises the α-chain and β-chain of SEQ ID NOs: 32 and 27, respectively as encoded by the nucleic acids of SEQ ID NOs: 28 and 23 and as described in Example 3 and Figures 12A and 12B in the specification.
However, the claims are not enabled for a method of increasing the sensitivity of a population of tumor cells to a TCR-T therapy comprising genetically modifying the population of tumor cells to express just any tumor haplotype different from the tumor haplotype endogenous to the population of tumor cells and wherein the TCR-T comprises a TCR that comprises the amino acid sequence of SEQ ID NOs: 5, 10, 16, 21, 27, 32, 38 and/or 43. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The nature of the invention is a method for increasing sensitivity of a population of tumor cells to a TCR-T therapy by modifying tumor cells to express a particular haplotype wherein the TCR-T comprises TCRs of amino acid sequences encompassed in the claims.
The breadth the claims is a method of increasing the sensitivity of a population of tumor cells to a TCR-T therapy, wherein the tumor cells of the claims are genetically modified to express just any tumor haplotype different from the tumor haplotype endogenous to the population of tumor cells, wherein the TCR-T comprises a TCR that comprises the amino acid sequences of SEQ ID NOs: 5, 10, 16, 21,27, 32, 38, and/or 43, which includes TCRs that comprise only a single recited SEQ ID NO or combinations of recited SEQ ID NOs which can be a combination of two, three, four or up to eight (all) of the recited SEQ ID NOs in the claims; and where the combinations of two SEQ ID NOs can be performed randomly, for example, SEQ ID NOs: 5 and 21 or SEQ ID NOs: 27 and 43.
The level of skill of one skilled in this art is high.
The amount of direction and working examples provided in the instant specification is such that there are four species of T-cell receptor α-chains, namely nucleic acid sequence of SEQ ID NOs: 6, 17, 28 and 39 that correspond to amino acid sequence of SEQ ID NOs: 5, 16, 27 and 38 respectively, and four species of T cell receptor β-chains, namely nucleic acid sequence of SEQ ID NOs: 1, 12, 23, and 34 that correspond to amino acid sequence of SEQ ID NOs: 10, 21, 32 and 43 respectively. Further, the Examples 1-3, Figures 10 to 12 and Sequence Listings also discloses three species of TCR for TCR-T therapy such that sensitivity for TCR of each therapy was increased by modifying tumor cells to express a distinct haplotype, namely:
KKLC-1-TCR that is effective at recognizing the HLA-A*01 peptide of SEQ ID NO: 11 expressed in tumor cells modified to express HLA-A*01 peptide (Example 2 and Figures 10A and 10B):
alpha-chain: SEQ ID NO: 10 (amino acid) and SEQ ID NO: 6 (nucleic acid);
beta-chain: SEQ ID NO: 5 (amino acid) and SEQ ID NO: 1 (nucleic acid);
HERVE-TCR that is effective at recognizing the HLA-A*11 peptide of SEQ ID NO: 22 expressed in tumor cells modified to express HLA-A*11 peptide (Example 1 and Figures 11A and 11B):
alpha-chain: SEQ ID NO: 21 (amino acid) and SEQ ID NO: 17 (nucleic acid);
beta-chain: SEQ ID NO: 16 (amino acid) and SEQ ID NO: 12 (nucleic acid);
and
NY-ESO-1-TCR that is effective at recognizing the HLA-A*02 peptide of SEQ ID NO: 33 expressed in tumor cells modified to express HLA-A*02 peptide (Example 3 and Figures 12A and 12B):
alpha-chain: SEQ ID NO: 32 (amino acid) and SEQ ID NO: 28 (nucleic acid);
beta-chain: SEQ ID NO: 27 (amino acid) and SEQ ID NO: 23 (nucleic acid).
All the three TCRs above comprise BOTH the TCR alpha chain and the TCR beta chain, meaning a set of three alpha-chain CDRs are combined with a set of three beta-chain CDRs. In addition, the SEQ ID NOs have specific pairings that enable binding to specific antigens as described above. However, these teachings do not enable the full breadth of the claims because a TCR lacking a full set of six CDRs would not predictably bind an antigen.
The state of the prior art is such that it is well established in the art that the formation of an intact antigen-binding site of TCRs generally requires the association of the complete α-chain and β-chain of a given TCR, each of which consists of three CDRs or hypervariable regions, which provide the majority of the contact residues for the binding of the TCR to its target HLA peptide (Sharma and Kranz Journal of Biological Chemistry, Volume 293, Issue 5, 2018, Pages 1820-1834; see in particular Pg. 1820 paragraph spanning columns left and right). Thus, the HLA peptide that genetically modifies the population of tumor cells to express a tumor haplotype different from the tumor haplotype endogenous to the population of tumor cells have to be expressed by the tumor cells that can be specifically recognized by the TCRs that are taught in the specification as described above.
Therefore, one cannot extrapolate the teachings of the specification to the scope of the claim because the claim is broadly drawn to methods of increasing sensitivity of a population of tumor cells to a TCR-T therapy, wherein the tumor cells of the claim are genetically modified to express just any haplotype and where the TCR-T therapy comprise just any of TCR amino acid sequences of SEQ ID NOs: 5, 10, 16, 21,27, 32, 38, and/or 43, either singly or in combinations, and Applicant has not demonstrate that sensitivity of the population of tumor cells to the TCR-T therapy wherein the TCR-T therapy comprises just any of TCR amino acid sequences of SEQ ID NOs: 5, 10, 16, 21,27, 32, 38, and/or 43, either singly or in combinations encompassed by the claims predictably increases sensitivity of the population of tumor cells to the TCR-T therapy. Rather, the specification clearly discloses that sensitivity of a population of tumor cells to a TCR-T therapy is specifically increased by genetically modifying tumor cells to express a particular haplotype in a TCR-specific manner. Further, undue experimentation would be required to determine which genetic modifications to tumor cells to express a tumor haplotype different from the tumor haplotype endogenous to the tumor cells would increase sensitivity of the tumor cells for every pairings of TCR alpha-chain and TCR beta-chain encompassed by claim 65 in order to perform the method as claimed.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Examiner confirms that Applicant is enabled for TCRs comprising the following paired SEQ ID NOs wherein the population of tumor cells that express the specific corresponding “tumor haplotype different from the tumor haplotype endogenous to the population of tumor cells” have been genetically modified to have increased sensitivity to the TCR-T that comprises the paired TCR:
alpha-chain: SEQ ID NO: 10 (amino acid) paired with beta-chain: SEQ ID NO: 5 (amino acid) wherein HLA-A*01 peptide (SEQ ID NO:11) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells;
alpha chain: SEQ ID NO: 6 (nucleic acid) paired with beta-chain: SEQ ID NO: 1 (nucleic acid) wherein HLA-A*01 peptide (SEQ ID NO:11) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells;
alpha-chain: SEQ ID NO: 21 (amino acid) paired with beta-chain: SEQ ID NO: 16 (amino acid) wherein HLA-A*11 peptide (SEQ ID NO:22) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells;
alpha chain: SEQ ID NO: 17 (nucleic acid) paired with beta-chain: SEQ ID NO: 12 (nucleic acid) wherein HLA-A*11 peptide (SEQ ID NO:22) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells;
alpha-chain: SEQ ID NO: 32 (amino acid) paired with beta-chain: SEQ ID NO: 27 (amino acid) wherein HLA-A*02 peptide (SEQ ID NO:33) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells; and
alpha chain: SEQ ID NO: 28 (nucleic acid) paired with beta-chain: SEQ ID NO: 23 (nucleic acid) wherein HLA-A*02 peptide (SEQ ID NO:33) is the corresponding tumor haplotype different from that endogenous to the population of tumor cells.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yie-Chia (Tonya) Lee (Tonya) whose telephone number is (571)272-0123. The examiner can normally be reached Monday - Friday 8.30a - 5.30p Eastern Time Zone.
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.
/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642
Prosecution Insights