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
Claims 3-4, 6-8, and 11-13 are cancelled. Claims 1, 5, and 9 are amended in the claim set filed on 06/11/2025. Claims 1, 2, 5 and 9 are pending and currently under examination.
Summary of this Final Office
Previous rejection of claims 1-5 and 9-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (preAIA ), first paragraph, because the specification, while being enabling for measuring expression levels of the six elected genes in a biological sample from a subject and calculating a decision index for breast cancer, it does not reasonably provide enablement to determine cancer prognosis as recited in claims 4 and 12, is withdrawn because claims 4 and 12 are cancelled and claims 1, 5, and 9 are amended in the claim set filed on 06/11/2025.
Previous rejection of claims 1-5 and 9-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (preAIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn because claim 1 is amended to recite “ER+/HER2- breast cancer” in the claim set filed on 06/11/2025.
Previous rejection of claims 1-5 and 9-13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (preAIA ), 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn because claims 1 and 9 are amended in the claim set filed on 06/11/2025.
Previous rejection of claim(s) 1, 3-5, 9, and 11-13 under 35 U.S.C. 103 as being unpatentable over Han et al. (KR20180052985A) in view of Gamboa et al. (PLoS One, 16;8(9): e74250, eCollection 2013), is withdrawn because claims 1, 5, and 9 are amended in the claim set filed on 06/11/2025.
Previous rejection of claims 2 and 10 under 35 U.S.C. 103 as being unpatentable over Han in view of Gamboa as applied to claims 1, 3-5, 9, and 11-13 above, and further in view of Saini et al. (Biomed Res Int, 2014:459203, Epub 2014), is withdrawn because claim 1 is amended in the claim set filed on 06/11/2025.
Previous rejection of claims 1, 4-5, 9, and 12-13 under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 2011 /0123990 Al) in view of Paik et al. (J Clin Oncol;24(23):3726-34, 2006) is withdrawn because claims 1, 5, and 9 are amended in the claim set filed on 06/11/2025.
Previous rejection of claims 2-3 and 10-11 under 35 U.S.C. 103 as being unpatentable over Baker in view of Paik as applied to claims 1, 4-5, 9 and 12-13 above, and further in view of Saini et al. (Biomed Res Int, 2014:459203, Epub 2014), is withdrawn because claims 1, 5, and 9 are amended in the claim set filed on 06/11/2025.
Previous rejection of claim 9 is under 35 U.S.C. 103 as being unpatentable over Baker in view of Paik and Saini as applied to claims 1-5, and 9 -13 above, and further in view of Steelman (US 2020/0181710 Al) is withdrawn because claims 1 and 9 are amended in the claim set filed on 06/11/2025.
Claims 1, 2, 5, and 9 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, a law of nature and a natural phenomenon without significantly more. The rejection has been revised/updated in response to Applicant’s arguments and amendments of claims 1, 5, and 9 in the claim set filed on 06/11/2025.
Claims 1, 2, 5 and 9 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. This rejection is necessitated by claims amendments filed on 06/11/2025.
Claims 1, 2, 5 and 9 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. This rejection is necessitated by claims amendments filed on 06/11/2025.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This rejection is necessitated by claims amendments filed on 06/11/2025.
Claim Rejections - 35 USC§ 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 5 and 9 remain/are rejected under 35 U.S.C. 101 because the claimed
invention is directed to an abstract idea, a law of nature and a natural phenomenon
without significantly more.
Step 1: The claims are directed to the statutory judicial category of a process
Step 2A, prong one: The claims recite judicial exceptions.
The claims recite measuring gene expression levels and calculating a decision
index based on the gene expression levels to predict (i.e. a correlation, a judicial exceptions) ER+/HER2- breast cancer in a female subject. Claim 1 further define the equation used to calculate the decision index (DI), which is a mathematical calculation and thus is an abstract idea. Calculating a decision index is a mathematical calculation and thus is an abstract idea.
Decision Index (DI) = 0.62 x KIF23 + 0.60 x SLC7A5 + 0.59 x KPNA2 + 0.53 x AURKA+ 0.34 x E2F8 + 0.34 x MMP11 + 0.24 x SHCBP1 + 0.20 x CTSL2 + 0.16 x CENPE + 0.16 x TFRC + 0.15 x KIF18A + 0.14 x CCNE2 + 0.04 x KIF14 + 0.04 x RRM2 + (-0.04) x CX3CR1 +(-0.05) x JMJD5 + (-0.33) x CACNA1D + (-0.36) x ESR1 + (-0.48) x GSTM1 + (-1.45) x PGR +(-2.04) x SCUBE2 + 41.16.
Claim 1 further define the DI score greater than 20 for prognosis of ER+/HER2- breast cancer being poor, which remains as a correlation derived from a process of data collection as a consequence of natural processes.
Step 2A, prong two: The judicial exceptions are not integrated into a practical
application.
The correlation between the genes occurring in a sample and the gene expression levels of those 21 genes divided in six groups and recited in the calculation of decision index (DI) of claim 1 could be a correlation derived from a process of data collection as a consequence of natural processes. These judicial exceptions are not integrated into a practical application because the steps in addition to the judicial exception are mere data gathering steps recited at a high level of generality and do not apply or use the judicial exception in any practical application. The step of administering chemotherapy to the female subject determined to have a poor prognosis, is at a high level of generality, and well-understood, routine, conventional treatment for various cancers, including ER+/HER2- breast cancer, and does not add significant more to the judicial exceptions, which is further elaborated in Step 2B analysis documented below.
Step 2B: The claims do not provide an inventive concept.
MPEP 2106.05(d)):
The courts have recognized the following laboratory techniques as well-understood,
routine, conventional activity in the life science arts when they are claimed in a merely generic
manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101
USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859
F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir.2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v.
Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed.
Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at
1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir.
2017);
Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC,
659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic
Techs. Ltd., 818 F.3d at 1377, 118 USPQ2d at 1546;
Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
Amplifying and sequencing nucleic acid sequences, University of Utah Research
Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir.
2014); and
Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
In addition to the judicial exceptions, claim 1 recites a single step of measuring gene expression levels of gene groups. Obtaining data such as generating a gene expression profile is routine in the art and is recited at a high level of generality such that it amounts to insignificant data gathering needed to use the correlation or apply the judicial exceptions. For example, the disclosure of the instant invention recites that "Analysis methods for measuring the expression levels include, but are not limited to, RT-PCR, competitive RT-PCR, real-time RT-PCR, RNase protection assay (RPA), northern blotting, and DNA microarray chip assay, and measurement of the expression levels may be performed by any appropriate method that is commonly used in the art" (specification para. 39). The step of administering chemotherapy to the female subject determined to have a poor prognosis, is at a high level of generality, and well-understood, routine, conventional treatment for various cancers. In this regard, for instance, at the time of effective filing date of instance application, Yang et al. (2019) discloses that “chemotherapy remains the standard treatment for first- and second-line management of small cell lung cancer (SCLC)”. (See Abstract, Yang et al., Emerging therapies for small cell lung cancer, J Hematol Oncol., 2019 May 2;12(1):47. doi: 10.1186/s13045-019-0736-3). As additional example, in the context of a specific compound for cancer chemotherapy, Makevec (2019) discloses that “Platinum-based anticancer drugs are widely used in the chemotherapy of human neoplasms” (See Abstract, Makevec, Cisplatin and beyond: molecular mechanisms of action and drug resistance development in cancer chemotherapy, Radiol Oncol. 2019 Mar 28;53(2):148-158. doi: 10.2478/raon-2019-0018).
Claim 2 is intended further define the calculation of the decision index, by additionally adding a correction coefficient to the value obtained by multiplying the expression level of each gene of interest, which is a mathematical calculation and thus is an abstract idea. However, it is noted that claim 2 fails to further limits claim 1 as documented below in the rejection of claim 2 under 112(d) in this office action because “a correction coefficient to the value obtained by multiplying the expression level of each gene of interest” is incorporated in the mathematical calculation of Decision Index (DI) recited in amended claim 1 filed on 06/11/2025.
Decision Index (DI) = 0.62 x KIF23 + 0.60 x SLC7A5 + 0.59 x KPNA2 + 0.53 x AURKA+ 0.34 x E2F8 + 0.34 x MMP11 + 0.24 x SHCBP1 + 0.20 x CTSL2 + 0.16 x CENPE + 0.16 x TFRC + 0.15 x KIF18A + 0.14 x CCNE2 + 0.04 x KIF14 + 0.04 x RRM2 + (-0.04) x CX3CR1 +(-0.05) x JMJD5 + (-0.33) x CACNA1D + (-0.36) x ESR1 + (-0.48) x GSTM1 + (-1.45) x PGR +(-2.04) x SCUBE2 + 41.16.
Claim 5 only further add a step of normalizing the measured gene expression levels using a reference gene. Normalizing gene expression data is routine diagnostic diagnostics in the field and does not add a meaningful limitation to the claim that distinguishes it from well-understood conventional techniques. For example, the disclosure of the instant invention recites that "the type of the reference gene in the present disclosure particularly limited" (para 48) and that "reference gene" refers to all transcripts that are maintained at approximately the same level regardless of the cell or tissue type, or the presence of a confounding agent" (para 47) and further that "the normalization process is not limited thereto as long as it corresponds to a normalization
method that is commonly used in the art" (para 46).
Claim 9 does not impose a meaningful limitation because claim 9 merely recites the method is performed using a generic device comprising a detection unit, an arithmetic unit and an output unit, to perform the method of claim 1. In this regard, claim 9 as written encompasses any device, including any computer used in microarray studies, which can perform the recited functions. This interpretation is consistent with the disclosure of the instant invention recites that "the diagnostic device may be, but is not limited to, any type of device that includes a detection unit, an arithmetic unit, and an output unit, and is capable of analyzing a gene from the above substances" (para. 29).
Collectively, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are mere data gathering steps of gene expression levels; and the amended limitation recite din step (d) of claim 1, “administering a chemotherapy drug”, is at a high level of generality which employ only conventional techniques common in the field prior to applicant's invention, at the time the application was filed.
Applicant’s Arguments: Claim 1 has been amended to add a step for administration of a chemotherapy drug to the female subject based upon determined prognosis. See, [0108], [0188], and [0189]. Claim 1 enables not only the prediction of prognosis of ER +/HER2- breast cancer, but also the classification of female subjects into subgroups with different risks of recurrence. See [0021]. The amendment of claim 1 provides meaningful additional elements of administration of chemotherapy to female subjects. This amendment captures that the value of the DI greater than 20 indicates poor prognosis, and said poor prognosis includes high risks of recurrence, and therefore the calculated DI values provide meaningful guidance as to whether chemotherapy should be administered. Thus, Applicant submits that the amendment to claim 1 adding the step of administering chemotherapy to the female subject determined to have a poor prognosis imposes a meaningful element that is sufficient to amount to more than just mere data gathering steps as asserted by the Office. See, e.g., Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018); Robert W. Bahr, "Memorandum - Subject: Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals," June 7, 2018, available at https://www.uspto.gov/sites/default/files/documents/memo-vanda-20180607.PDF
Response to Applicant’s arguments: Applicant’s arguments have been fully considered and found not persuasive. The amendments of claim 1 filed on 06/11/2025 is acknowledged. Claim 1 further define the equation used to calculate the decision index, which is a mathematical calculation and thus is an abstract idea, a judicial exception. Regarding the step of administering
chemotherapy to the female subject determined to have a poor prognosis, the added administering step is at a high level of generality, routine and conventional, and is in direct contrast to the example of administering a specific compound at a specific dosage as documented in Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals “if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
If the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day”
Claim Rejections - 35 USC§ 112
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 1, 2, 5 and 9 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.
This rejection is necessitated by claims amendments filed on 06/11/2025.
This is a new matter rejection regarding “decision index (DI) is greater than 20” in the context of determining ER+/HER2- breast cancer prognosis in a female subject.
Claim 1 is amended to recite “ER+/HER2-breast cancer in the female subject” at the end of step (b). However, the preamble of claim 1 recites “ER +/HER2- breast cancer prognosis” without specifies the subject being female. In this regard, the preamble is broader in scope than the recited active steps (a) to (d). Fox et al. (2022) discloses that “Male breast cancer (MBC) is rare, accounting for less than 1% of all breast cancer but the incidence has increased worldwide.
Risk factors include increased longevity, obesity, testicular diseases and tumors, and germline mutations of BRCA2. BRCA2 carriers have 80 times the risk of the general population. Men generally present with breast cancer at an older age compared with women. Histologically, MBC is often of grade 2, hormone receptor positive, HER2 negative, ---" (See Abstract, Fox et al., Male breast cancer: an update. Virchows Arch, 2022 Jan;480(1):85-93. doi: 10.1007/s00428-021-03190-7. Epub 2021 Aug 30).
Moreover, the amended limitation “ER+/HER2-breast cancer in the female subject” encompasses ER+/HER2-breast cancer in any female mammal. Instant specification does not provide any written description how the calculation of Decision Index (DI), regarding specific genes and their respective correction coefficients, could be applicable from a female human subject to any other species of mammalian female subject. Furthermore, the specification supports the limitation “wherein the output unit is configured to predict and output a poor prognosis when the value of the decision index (DI) is greater than 20” when the limitation is disclosed in the context of any cancer (a large genus of all cancers) in general (see [00119], page 22, instant application filed on 11/02/2021), not in the context of “ER+/HER2- breast cancer” (a species of breast cancer sub-genus). Additionally, relevant to various embodiments encompassed by the limitation “ER+/HER2- breast cancer” in human, instant specification discloses that “ER+/HER2- breast cancer in all age groups, particularly in an age group ranging from 20s to 80s in one embodiment, and in pre- and postmenopausal women in another embodiment” (See [00252], pages 41-42, instant application filed on 11/02/2021).
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 1, 2, 5 and 9 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.
This rejection is necessitated by claims amendments filed on 06/11/2025.
(i) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “determining ER+/HER2- breast cancer prognosis” in the preamble, and the claim also recites “predicting ER+/HER2- breast cancer prognosis in the female subject” in step (b), which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
(ii) Claim 1 is unclear regarding whether and how the calculation of Decision Index (DI) recited in claim 1 is affected by the limitation “normalizing the measured expression level” recited at the end of step (a) in the context of the limitation “normalizing the expression level of each gene group using any one or more reference genes selected from the group consisting of ---” recited in claim 5. In this regard, each gene used for normalization recited in claim 5 has its own expression level in its unique pattern in various tissues. For instance, an actin gene (ACTB) is a house-keeping gene whose gene expression is constitutively on, independent of cell cycle progression, whereas the expression of CDK1 (cyclin-dependent kinase 1) is regulated in a cell cycle dependent manner. Accordingly, as an example, does the 0.62 (correction coefficient of KIF23 gene) in the calculation Decision Index (DI), “0.62 x KIF23”, remain the same when the expression level is normalized to (i) ACTB gene only, (ii) CDK1 only, or (iii) combination of both ACTB and CDK1 genes? It is noted that there are 21 genes with 21 different correction coefficients recited in the equation of Decision Index (DI).
Decision Index (DI) = 0.62 x KIF23 + 0.60 x SLC7A5 + 0.59 x KPNA2 + 0.53 x AURKA+ 0.34 x E2F8 + 0.34 x MMP11 + 0.24 x SHCBP1 + 0.20 x CTSL2 + 0.16 x CENPE + 0.16 x TFRC + 0.15 x KIF18A + 0.14 x CCNE2 + 0.04 x KIF14 + 0.04 x RRM2 + (-0.04) x CX3CR1 +(-0.05) x JMJD5 + (-0.33) x CACNA1D + (-0.36) x ESR1 + (-0.48) x GSTM1 + (-1.45) x PGR +(-2.04) x SCUBE2 + 41.16.
Claims 2, 5 and 9 depend from claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “The method of claim 1, wherein the decision index (DI) is obtained by additionally adding a correction coefficient to the value obtained by multiplying the expression level of each of the first gene group, the second gene group, the third gene group, the fourth gene group, the fifth gene group and the sixth gene group by the regression coefficient (weight) value and summing the multiplied values.”
However, claim 1 as amended on 06/11/2025 has already recited the equation of Decision Index (DI) as follows:
Decision Index (DI) = 0.62 x KIF23 + 0.60 x SLC7A5 + 0.59 x KPNA2 + 0.53 x AURKA+ 0.34 x E2F8 + 0.34 x MMP11 + 0.24 x SHCBP1 + 0.20 x CTSL2 + 0.16 x CENPE + 0.16 x TFRC + 0.15 x KIF18A + 0.14 x CCNE2 + 0.04 x KIF14 + 0.04 x RRM2 + (-0.04) x CX3CR1 +(-0.05) x JMJD5 + (-0.33) x CACNA1D + (-0.36) x ESR1 + (-0.48) x GSTM1 + (-1.45) x PGR +(-2.04) x SCUBE2 + 41.16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 Wu-Cheng Winston Shen whose telephone number is (571)272-3157. The examiner can normally be reached Mon.-Fri. 8:00 AM-5:00 PM.
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/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682