Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-23 and species: 100 mg to about 2000 mg of antibody, once every four weeks (Q4W), subcutaneous administration, formulation of claim 22, and the single pharmaceutical dosage unit of about 100 mg to about 2000 mg in the reply filed 10/21/2025 is acknowledged.
Claims 23-24, 26-28, 31 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 10/21/2025.
Claims 3, 5-6, 8-9, 11-13, 15, 17, 19-22 are now under consideration in the instant Office Action.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The Examiner notes an embedded hyperlink on page 24, though Applicant is encouraged to conduct a more thorough search for any additional links.
Drawings
The drawings are objected to because some of captions for the figures are upside down and out of alignment with the figure legends. 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. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 15 is objected to because of the following informalities: the “a” in “lipoprotein a level” should be capitalized as it is in apolipoprotein B level (see claim 13). 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 3 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.
Regarding claims 3 and 9, the phrase "such as" and “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 3, 5-6, 8-9, 11-13, 15, 17, and 19-22 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 a method of treating a cholesterol-related disease using the claimed antibody, does not reasonably provide enablement for a method for preventing a cholesterol-related disease using the claimed antibody. 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.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are 1) the amount of direction provided by the inventor and 2) the existence of working examples. In the instant case, the amount of direction provided by the inventor and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
(1) The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in preventing cholesterol-related diseases, the skilled artisan would need significant guidance in preparing the invention as a preventative measure. The skilled artisan recognizes that preventing the onset of cholesterol-related diseases is an intractable proposition, if not now wholly impossible, given, for example, that there are many known and unknown causes of the cholesterol-related diseases claimed. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause.
(2) The existence of working examples - As stated above the specification reasonably provides enablement for an antibody that may be used to treat cholesterol-related diseases; however, there is no showing in the specification of any means by which one skilled in the art could prepare a treatment to prevent all cholesterol-related diseases. Additionally, the state of the art does not clearly outline metrics or guidelines to predict an individual’s propensity to develop a cholesterol-related disease and prevent its onset, thus making the target of the treatment unclear as it is impossible to know if a person in the general public will develop one of the diseases listed with certainty and also qualify as a candidate for treatment using the instant invention. Therefore, one skilled in the art would be subject to undue experimentation to practice the instant invention as it is currently claimed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Applicant is informed that the instant rejection under 35 U.S.C. 112 (a) may be overcome by amending the claims to remove the recitation of “preventing.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tsun et al. (US 2020087416 A1, in IDS filed 05/18/2022).
Tsun et al. teaches “an antibody that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), an antigen-binding fragment of the antibody, and a composition comprising the antibody”, see Abstract, wherein the “antibodies or antibody fragments against PCSK9 of the invention may be administered prophylactically to prevent or alleviate the onset of hypercholesterolemia, hyperlipidemia, cardiovascular diseases, and/or the onset of any of the cholesterol-related diseases”, see paragraph 0167. Tsun et al. specifies that the methods are used for “lowering the level of cholesterol in a subject, the method comprises administering an effective amount of any of the anti-PCSK9 antibodies or fragments thereof described herein to the subject. In one embodiment, the cholesterol is LDL-cholesterol, preferably serum cholesterol”, see paragraph 0074. Tsun et al. also teaches that anti-PSCK9 monoclonal antibodies that shown remarkable efficacy in various types of primary hypercholesterolemia and in familial hypercholesterolemia (including heterozygous and homozygous familial hypercholesteremia, see paragraph 0014.
Tsun et al. discloses the structure for an antibody referred to as “ADI-10087” which shares 100% sequence identity to the instantly claimed antibody also referred to as “ADI-10087”. The sequence matches from Table B of the reference are as follows:
Instant SEQ ID NO: 4 is a 100% match for the reference’s SEQ ID NO: 10
Instant SEQ ID NO: 5 is a 100% match for the reference’s SEQ ID NO: 17
Instant SEQ ID NO: 6 is a 100% match for the reference’s SEQ ID NO: 19
Instant SEQ ID NO: 1 is a 100% match for the reference’s SEQ ID NO: 4
Instant SEQ ID NO: 2 is a 100% match for the reference’s SEQ ID NO: 5
Instant SEQ ID NO: 3 is a 100% match for the reference’s SEQ ID NO: 6
Instant SEQ ID NO: 8 is a 100% match for the reference’s SEQ ID NO: 30
Instant SEQ ID NO: 7 is a 100% match for the reference’s SEQ ID NO: 24
Instant SEQ ID NO: 10 is a 100% match for the reference’s SEQ ID NO: 41
Instant SEQ ID NO: 9 is a 100% match for the reference’s SEQ ID NO: 35.
Tsun et al. also teaches that the “administration of an anti-PCSK9 antibody of the invention may occur prior to, simultaneously as and/or after the administration of the additional therapeutic agents/adjuvant”, see paragraph 0169. Tsun et al. teaches “an antibody of the invention (and any additional therapeutic agent) can be administered by any suitable means, including parenteral, intrapulmonary, and intranasal, and, if desired for local treatment, intralesional administration. Parenteral infusions include intramuscular, intravenous, intraarterial, intraperitoneal, or subcutaneous administration”, see paragraph 0170, and that the “pharmaceutical compositions or formulations of the present invention may also contain more than one active ingredient which is required for a particular indication to be treated, preferably those active ingredients which do not adversely affect each other's complementary activities”, see paragraph 0163.
In regards to the dosage, Tsun et al. recommends that “effective amount” refers to an amount or dose of an antibody or fragment of the invention that produces the desired effect in a patient to be treated, when administered to the patient in single or multiple doses. An effective amount can be readily determined by the attending physician as a person skilled in the art by considering various factors such as the species of the mammal; its size, age and general health; the particular disease involved; the extent or severity of the disease; the response of an individual patient; the specific antibody to be administered; mode of administration; bioavailability characteristics of the formulation to be administered; selected dosing regimen; and use of any concomitant therapy, see paragraph 0107.
Tsun et al. explicitly recites “for the prevention or treatment of diseases, the appropriate dosage of an antibody of the invention (when used alone or in combination with one or more other additional therapeutic agents) will depend on the type of disease to be treated, the type of antibody, the severity and course of the disease, whether the antibody is administered for preventive or therapeutic purposes, previous therapy, the patient's clinical history and response to the antibody, and the discretion of the attending physician. The antibody is suitably administered to the patient at one time or over a series of treatments. Exemplary dosage range for the antibody includes 3-30 mg/kg”, see paragraph 0171, with dosages being administered once a week with a total of four administrations, see paragraph 0266. Tsun et al. also recommends that the treatment with ADI-10087 at 3-30 mg/kg dosing be carried out until there is a significant decrease in the levels of serum LDL-C and HDL-C for 3-28 days after administration, see paragraph 0268.
While Tsun et al. does not explicitly teach that the dosage of antibody administered results in a certain percentage reduction of LDL-cholesterol levels, certain serum free PCSK-9 levels, certain reductions in cholesterol levels such as apolipoprotein B or non-high-density-lipoprotein, it is clear that the taught dosages using the same antibody as claimed would have the same characteristics and would respond to the same treatment as the instantly claimed methods since there is no evidence to the contrary. The antibodies when administered will produce the same results as the instantly claimed method since one is practicing the active steps, administering the same antibody to the same patient population. Note that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP §2112(III).
MPEP § 2112 (II), states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V). Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
See also MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
Therefore, claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-21 are rejected as anticipated by Tsun et al.
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 3, 5-6, 8-9, 11-13, 15, 17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tsun et al., in view of Sitlani et al. 2009 (in instant PTO-892).
The relevance of Tsun et al. is discussed above.
However, Tsun et al. does not teach a stable formulation for the antibody. Sitlani et al. remedies this deficiency.
Sitlani et al. teaches antagonistic antibodies for human proprotein convertase subtilisin-kexin type 9 or “PCSK9”, see Abstract. Sitlani et al. also teaches compositions for the administration of the PCSK-9 specific antagonistic antibody comprising the following, see claims 9 and 10:
about 50 mg/mL to about 200 mg/mL of a PCSK9-specific antagonist;
a polyhydroxy hydrocarbon (including but not limited to sorbitol, mannitol, glycerol and dulcitol) and/or a disaccharide (including but not limited to sucrose, lactose, maltose and trehalose); the total of said polyhydroxy hydrocarbon and/or disaccharide being about 1% to about 6% w/v of the formulation;
about 5 mM to about 200 mM of histidine, imidazole, phosphate or 35 acetic acid;
about 5 mM to about 200 mM of arginine, proline, phenylalanine, alanine, glycine, lysine, glutamic acid, aspartic acid or methionine;
about 0.01 M to about 0.1 M of hydrochloric acid ("HCl") in an amount sufficient to achieve a pH in the range of about 5.5 to about 7.5;
a liquid carrier including but not limited to sterile water, petroleum, animal oil, vegetable oil, mineral oil, synthetic oil, physiological saline solution, dextrose or other saccharide solution or glycols, such as ethylene glycol, propylene glycol or polyethylene glycol; wherein said pharmaceutical composition has a pH in the range of about 5.5 to 10 about 7.5;
about 0.01% to about 1% w/v of the formulation of a non-ionic surfactant (including but not limited to Polysorbate-80 (Tween 80™), Polysorbate-60 (Tween 60™), Polysorbate-40 (Tween 40™), and Polysorbate-20 (Tween 20™), polyoxyethylene alkyl ethers, including but not limited to Brij 58™, Brij35™, as well as others such as Triton X-100™, Triton X-1 14™, NP40™ Span 15 85 and the Pluronic series of non-ionic surfactants (e.g., Pluronic 121)).
It would be obvious at the time of the instant invention to use the antibody and dosage regimen taught by Tsun et al., which is an effective treatment that results in the reduction of serum cholesterol levels as a result of hypercholesterolemia, with the formulation taught by Sitlani et al. which keeps the proteins of the antibody stable and able to retain its physical or chemical stability, conformational integrity, its ability to exhibit less denaturation, protein clipping, aggregation, fragmentation, acidic variant formation or loss of biological activity compared with a control sample at a temperature in the range of 4-37 degrees Celsius for at least about 30 days until 12 months. One would be motivated to combine the antibody and the dosage regimen with the composition for the same genus of antibody with the expectation of maintaining a stable antibody formula safe for effective administration whilst treating cholesterol-related diseases.
Therefore, claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-22 are rejected as obvious over Tsun et al. and Sitlani et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 5-6, 8-9, 11-13, 15, 17, 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 11, 14, 16-17, 24-26, 28, 32-34, 36, and 38-39 of copending Application No. 17/050,179, in view of Sitlani et al. (see reference in the rejection above). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the same antibody, methods of use, and composition.
‘179’s claims are drawn to a method of lowering the cholesterol level in a subject and a method for treating a cholesterol-related disease in a subject comprising administering a composition. The composition of ‘179 comprises the same concentration for a histidine buffer, the same weight by volume concentration for a viscosity inhibitor such as sorbitol or arginine, the same antibody as the instantly claimed sequences and antibody concentration of 50 mg/ml to about 200 mg/mL, the same concentration of surfactants such as polysorbate 20 and polysorbate 80, the same pH range, and the same route of administration of the composition (subcutaneous) as recited by the instant claims and taught in view of Sitlani et al. The sequence identity matches to the instantly recited sequences are as follows:
Instant SEQ ID NO: 4 is a 100% match for the reference’s SEQ ID NO: 10
Instant SEQ ID NO: 5 is a 100% match for the reference’s SEQ ID NO: 17
Instant SEQ ID NO: 6 is a 100% match for the reference’s SEQ ID NO: 19
Instant SEQ ID NO: 1 is a 100% match for the reference’s SEQ ID NO: 4
Instant SEQ ID NO: 2 is a 100% match for the reference’s SEQ ID NO: 5
Instant SEQ ID NO: 3 is a 100% match for the reference’s SEQ ID NO: 6
Instant SEQ ID NO: 8 is a 100% match for the reference’s SEQ ID NO: 30
Instant SEQ ID NO: 7 is a 100% match for the reference’s SEQ ID NO: 24
Instant SEQ ID NO: 10 is a 100% match for the reference’s SEQ ID NO: 41
Instant SEQ ID NO: 9 is a 100% match for the reference’s SEQ ID NO: 35.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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