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
Applicant’s election with the species of virus like particle made by human papilloma virus antigen in the reply filed on 12/22/2025 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)).
Status of claims
New claims 23-31 are added.
Claims 1-31 are pending.
Claims 1-2, 5-20 and 22-31 with the elected species of human papilloma virus antigen are considered.
Clams 3-4 and 21 that does not read on the elected species are withdrawn from consideration.
Claim Objections
Claims 1 and 5 are objected. Please spell the full names of all short abbreviations upon they are first cited in the claims, These short names are Al, Algel, and IMDG. 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 1 and 5-7, 12-22, 24, 28-29 are rejected for citing the claimed subject matters as a trade name(s) and/or trademarks, these are Al, IMDG, Algel, Algel-IMDG. Appropriate corrections are required.
Applicants’ attention is directed to MPEP 2173.05(u) Trademarks or Trade Names in a Claim [R-07.2022], which cites:” The presence of a trademark or trade name in a claim is not, per se, improper under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, but the claim should be carefully analyzed to determine how the mark or name is used in the claim. It is important to recognize that a trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. Thus a trademark or trade name does not define or describe the goods associated with the trademark or trade name. See definitions of trademark and trade name in MPEP § 608.01(v). If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020) ("Following Patent Office procedure, the Examiner in this case rejected the claims of the '821 application as indefinite because they improperly used the trade name 'ALIMTA.' In response to the rejection, Lilly canceled its claims reciting the trade name and pursued claims using the generic name for the same substance, which mooted the rejection. Additionally, as the district court observed, the Examiner 'explicitly noted that pemetrexed disodium was 'also known by the trade name ALIMTA' ' in the contemporaneous obviousness rejection."). The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. If the applicant responds to such a rejection by replacing the trademark or trade name with a generic term, the examiner should determine whether there is sufficient support in the application for use of a generic term. See MPEP § 2163, subsection II.A.3(b).
Moreover, the structure of the claimed subject matter of Algel-IMDG cited in the claims are undefined in claims 1-2, 5-7, 11-22 needs to be defined for two reasons:
(1) . It is well known in the art three are two kinds of adsorption can be formed between two compounds, i.e. chemisorption or physical sorption. It is well known that Chemisorption is known as chemical adsorption that can take place in adsorbed substance by chemical bonds highly specifically, non-naturally and also irreversible. However, a physisorption on the other hand I due to a formation of van der Wasasl forces, which is reversible in nature.
(2). Claims 11-and 30-31 are drafted as a product by process for the subject matter of Algel-IMDG, the claimed product cited in the claims 23-24 comprising the meta-amine gallamide N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-trihydroxybenzamide in isopropanol, but the method cited in claims 11 and claims 30-31 comprises N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-tri-hydroxybenzamide and meta-amine gallamide N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-trihydroxybenzamide in isopropanol. .
Claim 2 is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter as a such as a human papilloma virus antigen. Regarding this rejection, Applicants ‘ attention is directed to MPEP 2173.5, which cites: “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C 112 (b) or pre-AIA U.S.C. 112, second paragraph should be made. The examiner should analyze whether the metes and bounds of the claim are clearly set forth. Note that the mere use of the phrase “ such as “ or "for example" in a claim does not by itself render the claim indefinite.
In the instant case, it is not sure what is the metes and bounds of virus like particles cited in the claim are. It is well known in the art that human Papilloma virus (HPV) capsid protein L1 and/or L2 can be expressed or made as a virus like particle (VLP) to carry /present a heterologous antigen epitope on its surface. Moreover, the L1 and/L2 of the HPV are antigenic proteins too. Therefore, it is unclear for citing said vaccine antigen is VLP such as human papilloma virus antigen.
Hence, it is worth be noted herein, based on the compact prosecution practice of BRI , the broad scope of the claim is reasonable interpretation as both situations describe supra.
Claim Rejections - 35 USC § 112
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.
Claims 11 and 30-31 are 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. In the instant case, the limitations cited in depended claims 30-31 beyond the limitation of claims 5 and 23-24. In particular, the claimed product cited in the claims 23-24 comprising the meta-amine gallamide N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-trihydroxybenzamide in isopropanol, however, the claims 11 and 30-31 cite that the methods all comprise N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-tri-hydroxybenzamide and meta-amine gallamide N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-trihydroxybenzamide in isopropanol.
Applicant need to explain what is the final product INDG is or cancel or amend the claim(s) in order to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form, or present a sufficient explanation to show that the dependent claim(s) complies with the statutory requirements.
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, 5-20 and 22-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making an immunogenic composition and a method for using to produce an enhanced immune response, wherein the composition comprising an inactive SARS-Cov-2 inactivated virus or its antigen thereof with the Toll-like agonist T7/T8 meta-amine gallamid N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl) methyl) benzyl)-3,4,5-tri-hydroxybenzamide (IMDG), does not reasonably provide enablement for a vaccine composition for any or all antigen to prevent any or all viral infections. 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 use the invention commensurate in scope with these claims.
The test of an enablement or scope of enablement is whether one skilled in the art could make and use the claimed invention from the disclosure in the application coupled with information known in the art would render undue experimentation (See United States v. Theketronic Inc., 8USPQ2d 1217 (fed Cir. 1988). Whether undue experimentation is required is not based upon a single factor but rather a conclusion reached by weighting many factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in re Wands, 8USPQ2d 1400 (Fed. Cir. 1988), which are set forth below: 1). Nature of invention; 2). Scope of claims; 3). State of art; 4). Unpredictability; 5). Level of skill; 6). Number of working examples and 7). Amount of guidance presented in the specification.
The nature of invention as it is described supra in paragraph 13, that is directed to a method for making an immunogenic composition and a method for using the same, wherein the immunogenic composition comprising (a) either inactivated SARS virus or an immunogenic protein of a SARS virus , (b) Algel-IMDG, wherein the IMDG is coated onto the surface of Alum. Hydroxide gel (c) preservative; and (d) a physiologically acceptable buffer, wherein the effectiveness of the SARS immunogenic composition is increases (See 0089).
However, the scope of the claims read on a method for making a vaccine composition for any virus with said Algel-IMDG as an adjuvant;
It is well known in the art that not every virus neutralizing antigen is identified to be able to induce an neutralizing antibody, hereby producing a protective immunity. For example, HIV and HCV or SARS have not identified to possess a neutralizing antigen capable of producing a protective immune response to HIV, HCV and even SARS. It is very unpredictable that using T7/&8 agonist as an adjuvant is able to overcome such problems for such viruses, hereby to produce a viral vaccine. The specification does not provide adequate guidance to teach how to select any neutralizing antigen among so many viruses in the field except the SARS-Cov-2 and its variant. Moreover, the specification does not provide a sufficient evidence to support the broadly claimed scope of invention that is read on the claimed composition as a vaccine for any or all viruses.
Therefore, given the above analysis of the factors which the courts have determined are critical in asserting whether a claimed invention is enabled, it must be considered that the skilled artisan would have to conduct undue and excessive experimentation in order to practice the claimed invention.
Claims 1, 5-20 and 22-31 are rejected under 35 U.S.C. 112 (a) , the 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(s), at the time the application was filed, had possession of the claimed invention. In the instant case, the claimed are directed to any or all vaccine composition and a method for making an using the same, wherein the composition comprises(a) an immunogenic spike protein of a SARS-CoV-2 virus , (b) Algel-IMDG as an adjuvant; (c) preservative; and (d) a physiologically acceptable buffer. However, the applicants do not have the possession for the claimed method since the method is not described in the current application either.
The first paragraph of 35 U.S.C. requires that the specification shall contain a written description of the invention. This requirement has several objectives: 1). To clearly convey the information that an applicant has invented the subject matter which is claimed; 2). To put the public in possession of what the applicant claims as the invention; and 3). To promoter the progress of the useful arts by ensuring that patentee adequately describe their inventions in their patent specification in exchange for the right to exclude others from participating the invention for the duration of the patent term.
In order to satisfy a written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably concluded that the inventor had possession of the claimed invention. The possession of claimed invention can be shown by describing the claimed invention with all limitation in the specification including drawing or description of an actual reduction to practice. The written description may arise in the following situations: a). The claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention; b). The claimed invention as a whole may not 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; and c). The 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 etc.
The specification does not provide adequate guidance to teach how to select any neutralizing antigen among so many viruses in the field except the SARS-Cov-2 and its variant. Moreover, the specification does not provide a sufficient evidence to support the broadly claimed scope of invention that is read on the claimed composition as a vaccine for any or all viruses. In particular, no any essential or critical structural feature of an antigen or immunogenic polypeptide or epitope capable of inducing a protective immune response is described.
Therefore, the claimed invention in the current application is a new matter and applicants do not have the possession of claimed invention.
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.
Claims 1-2, 5-10, 12-20 and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Rowling (Immuno Horizons, Volume 2, Issue 6, July 2018, Pages 185–197) for claims 1, 5-6, 9-10, 18-20, 22, 25, further in view of Jochmus et al. (Achieve of Medical Research, Volume 30, Issue 4, July–August 1999, Pages 269-274) for claim 2; Hung et al. (Clinical Infectious Diseases, Volume 59, Issue 9, 1 November 2014, Pages 1246–1255) for claims 7-8, 23-24, 26-29 and Heidary et al. (Dermatitis Vol. 16, Issue 3, published 1, September 2005, pages 115-120) for claim 12-17,
The claims 1, 5-6 and 9-10 are drawn to a composition against viral infections, comprising:(a) a vaccine antigen; (b) Algel-IMDG as an adjuvant; wherein the Algel is alum sale is a gel selected from hydroxide or phosphate and IMDG is an Imidazoquinoline class molecule (page , (c) preservative; and (d) a physiologically acceptable buffer, wherein Algel- IMDG is a small molecule of Toll-like receptor 7and 8 (TLC7/8), which comprises Alum hydroxides gel as delivery system.
Rowling teaches in Fig. 1 that small molecules , e.g. imidazoquilnolines is a TLR7 and TLR8 agonist that can bind and active the Immunological activation related Monocytes or Debritic cells and then induce the type I INF gene expression and pro inflammatory cytokine and chemokine gene expressions, hereby to produce an enhanced immune response. (Fig; 1). i.e. Immune responses induced by TLR TLR7/8 ligands in primary human DC subsets. The natural ligand of TLR7 and TLR8 is ssRNA. Small molecule IMQ compounds such as imiquimod and resiquimod (R848) also activate both receptors and are the subject of adjuvant research. TLR7 and TLR8 agonists differ in their DC subset selectivity and IFN/cytokine/chemokine induction profile. TLR7-specific agonists activate pDCs and induce mainly IRF7-driven signaling, IFN-α, and IFN-regulated cytokines. TLR8-specific agonists activate monocytes and myeloid DCs, leading primarily to the NF-κB activation and production of proinflammatory cytokines and chemokines, such as IL-12p70. The ability of TLR7/8 agonists to activate DCs and thus elicit Th1-like responses (IFN-γ–producing CD4 cells and IgG2-producing B cells) can be exploited to enhance the efficacy of vaccination. IRAK, IL-1R–associated kinase.
Furthermore, Rowling describe a method for making and using an immunogenic or vaccine composition to induced an enhanced immune response against a virus infection comprises adding the small molecule of TLR 7/8 agonist, i.e. imiquimod or IMQ analogue, i.e. IMQ 3M-052 as describe above, as an alum gel carried adjuvant , wherein the imiquimod as a small molecule of TLC7/TLC8 activation ligands or agonists first chemisorbed with alum hydroxide gel, and then added into the a virus composition, wherein the virus antigen used and tested include influenza, RSV, and HIV etc. in a pharmaceutical composition (Fig. 1-3 and Tables 11-3). Rowling concluded there are several synthetically defined TLR7/8 adjuvanted vaccine formulations at various stages of clinical development, which may well offer significant advantages compared with current alum-based subunit vaccines. The adaptive response induced in these TLR7/8-focused adjuvant studies can be summed up as producing Th1-like response (IFN-γ–producing CD4 cells and IgG2-producing B cells) with concomitant inhibition of Th2 immunity. Continued evaluation and optimization of these TLR7/8 adjuvant approaches, including potential dose-sparing effects, improved reactogenicity profiles, long-term safety, and efficacy outcomes, are clearly merited.
It is worth to note that specification of the current Application (page 6, lines 16-18) cites: “ In the said vaccine formulation, Algal-IMDG comprises meta-amine gallamide N-(3-((4-amino-2-butyl-1H-imidazo[4,5-c] quinolin-1-yl) methyl) benzyl)-3,4,5-trihydroxybenzamide (Imidazoquiinoline class molecule), chemisorbed with Aluminum hydroxide gel.
Because Rowing teaches to use imiquimod which is a structurally and functionally very closely related to the claimed imidazoquinolines (IMDG) and also using the same method for being chemisorbed with the Allum Hydroxyls gel or alum phosphate gel, to produce a complex same as the claimed Algel-IMDG, and the cited reference teaches the limitation of a viral antigen and Algel-IMDG cited in claims 1, 5-6, 9-10, 18, 12-20, 22 and 25 explitely and inherently based on that claims 19-20, 22 and 25 are considered as product with an intended use.
Regarding to this interpretation of the rejection, Applicants’ attention is directed to the case law of In re Sussman, 141 F. 2d 267, 60 U.S.P.Q. 538 (CCPA 1944), which cites "since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, Applicant(s) is (are) claiming an invention employing the same process steps but the product(s) is(are) alleged to be different. If the claimed products are structurally different, Applicant is required to recite the missing steps to form the alleged different product(s) in view of the above cited decision.
The cited reference does not teaches using the antigen from a virus like particle (VLP) of human papilloma virus (HPV). However, prior to the current Application was filed, making Virus-like Particles of the Human Papillomavirus, such as Type 16 (HPV 16) and using the same as a Prophylactic and Therapeutic Vaccine is so well known in the field.
Jochmus et al. teach that in an attempt to develop a vaccine that combines prophylactic and therapeutic properties, we have generated chimeric virus-like particles (CVLP) consisting of a C-terminally truncated L1 protein fused to sequences of the HPV 16 E7 oncoprotein. We were able to demonstrate that CVLPs induce neutralizing antibodies and CTLs, and that they also confer protection against HPV 16 E7 positive tumors. Thus, we speculate that they are suitable not only to prevent infection by HPV 16 but also to cure infected diseased individuals. Hence , they found that on expression by recombinant baculovirus, a 34-amino acid carboxy-terminal truncated L1 protein of HPV 16 (designated HPV 16L1ΔC) was able to assemble into VLPs at an even higher efficiency than the wild type L1. Based on this observation, we fused several different sequences of HPV 16 of heterologous origin onto HPV 16L1ΔC and analyzed them after expression in insect cells. Insertion of a maximum of 60 amino acids was shown by electron microscopy to be compatible with the formation of virus capsids (albeit more heterogeneous in size than HPV 16L1ΔC VLPs). One of these chimeras containing the nucleotide coding for the first 60 amino acids of the HPV 16 E7 protein (see Figure 1) was characterized in more detail. After banding in CsCl gradients, the yield of HPV 16L1ΔCE7 CVLPs was estimated by electron microscopy and found to be about five-fold lower when compared to HPV 16L1ΔC VLPs. The presence of HPV 16 E7 sequences within the VLPs was proven by Western blot analysis of the CsCl purified material and also by immunofluorescence using E7-specific antibodies. Therefore, HPV 16L1ΔC VLPs containing the first 60 aa of the HPV 16 E7 protein were named HPV 16L1ΔCE71-60 chimeric virus-like particles (CVLPs). Base on their study, they had generated chimeric virus-like particles (CVLP). Immunization of mice with CVLPs induces neutralizing antibodies directed against L1 virus-like particles (devoid of the E7 portion) and E7-specific T cells as measured in vitro. Vaccinated animals are protected against tumor growth following inoculation of syngeneic HPV 16-transformed cells. In addition, we observed a therapeutic effect of vaccination on pre-existing tumors. This data allowed us to conclude that CVLPs are suitable for prevention and therapy of HPV infection. (See Method section of GENERATION OF CHIMERIC VIRUS LIKE PARTCILES AND Abstract, Figs. 1-23 and Table 1).
The cited reference does not teach using imidazoquinolone amine analogue. Hung et al. teach to apply a topical imiquimod, a low-weight synthetic imidazoquinolone amine analogue, which stimulates TLR7 by upregulation of HLA molecules, thereby activating the dendritic cell presentation of the 3 influenza vaccine antigens. Imiquimod also induces proinflammatory cytokine production and stimulation of T-helper cells. TLR7 plays an important part in the induction of adaptive immune response by enhancing antibody-producing B-cell differentiation, by facilitating antibody isotype class switching, and, more importantly, by increasing B-cell memory. They finally concluded that pretreatment with topical imiquimod significantly expedited, augmented, and prolonged the immunogenicity of influenza vaccination. This strategy for influenza immunization should be considered for the elderly population (Last paragraph of the conclusion of Abstract) .
The cited primary reference does not teach any concentration for each components used for preparation of the combination of adjuvants in the vaccine composition , i.e. Thimerosal or 2-phenoxy ethanol as well as aluminum.
Heidary et al. teach that the concentration for Thimerosal, is about 0.01% , 2-Phenoxyethanol is about 2.5 mg/ml and aluminum hydroxide is less than ½ mg/ml or 600µ/0.5 ml (Table 1).
Therefore, it would have been obvious for a person with an ordinarily skilled in the art to be motivated by combining the disclosures taught by the cited prior arts to arrive the claimed subject matter drawn subject matter drawn to vaccine formulation for prophylactic vaccine against viral infections, comprising: (a) a vaccine antigen; (b) Algel-IMDG as an adjuvant; (c) preservative; and (d) a physiologically acceptable buffer with a proper concentrations for an antigen, adjuvant of alum hydroxide and the IMDG with a reasonable expectation of success.
Hence, as there are no unexpected results have been provided, hence the claimed invention as a whole is prima facie obvious absence unexpected results.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
Dio/BAO Q LI/Primary Examiner, Art Unit 1671
Prosecution Insights