DETAILED ACTION
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 the Claims
Claims 45-64 are pending. Claims 1-44 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/IL2021/051537, filed on December 27, 2021. This application also claims the benefits of U.S. Provisional Application No. 63/131,075, filed on December 28, 2020.
Specification - Abstract
The abstract of the disclosure is objected to because it is not in compliance with 37 C.F.R. 1.72 (b). Specifically, the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an Abstract of the Disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary. Complete revision of the content of the abstract is required on a separate sheet.
The abstract of the disclosure is objected to as it can be more descriptive. An example of an amended abstract is provided below:
The present invention provides a pharmaceutical composition comprising one or more cannabinoids wherein one of the cannabinoids must be a compound having a structure represented by Formula II:
PNG
media_image1.png
205
452
media_image1.png
Greyscale
. The present invention also provides a method for treating a subject afflicted with an estrogen receptor (ER)-related disease comprising administering to the subject the pharmaceutical composition comprising the compound of Formula II. The present invention further provides a combination therapy comprising one or more cannabinoids, wherein one of the cannabinoids is the compound of Formula II, and an ER activation inhibitor and use thereof in sensitizing subjects that are resistance to treatment with the ER activation inhibitor alone.
Appropriate correction is required.
Specification - Disclosure
The disclosure is objected to because of the following informalities:
Each page of the specification includes a header displaying the application number of the corresponding international (PCT) application. However, on a majority of the specification pages, the header overlaps with the specification text as exemplified below (top of pg. 40 of instant specification):
PNG
media_image2.png
70
700
media_image2.png
Greyscale
.
On pg. 38, line 22, “semi-perp HPLC” should read “semi-prep HPLC.”
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 45-64 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As stated in the MPEP 2164.01(a), “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.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a pharmaceutical composition comprising one or more cannabinoids wherein one of the cannabinoids must be a compound having a structure represented by Formula II:
PNG
media_image1.png
205
452
media_image1.png
Greyscale
. The present invention also provides a method for treating a subject afflicted with an estrogen receptor (ER)-related disease comprising administering to the subject the pharmaceutical composition comprising the compound of Formula II. The present invention further provides a combination therapy comprising one or more cannabinoids, wherein one of the cannabinoids is the compound of Formula II, and an ER activation inhibitor and use thereof in sensitizing subjects that are resistance to treatment with the ER activation inhibitor alone.
State of the prior art
According to STN, there is no prior art that discloses the compound of Formula II as described in instant claim 1 (see above and instant claim 1 for structure).
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in oncology, medicinal chemistry, and/or organic chemistry and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The amount of direction or guidance present and quantity of experimentation necessary
Since the prior art does not disclose the compound of Formula II (herein, referred to as CF2), it is crucial for Applicant to provide the method used to isolate the newly discovered compound of Formula II from Cannabis extract, CANN14. However, the instant specification does not provide the conditions/parameters necessary to isolate the compound of Formula II and merely states “To reveal the specific substances responsible for the synergetic effect of tamoxifen and CANN14, CANN 14 extract was fractionized using a semi-[prep] HPLC according to a hydrophobic gradient and four fractions (F1-F4) were obtained” (pg. 38, lines 21-23). In the absence of information disclosing the chromatographic system, column (i.e., stationary phase) identity and dimensions, mobile phase composition, flow rate, column temperature, injection loading amount, detection parameters, and fraction-collection criteria, a POSITA would require undue experimentation to isolate CF2 from CANN14 extract. Additionally, the instant specification neither states the method of extracting CANN14 from a Cannabis plant nor discloses the Cannabis plant used to extract CANN14. See pg. 828, right col., section 2.2, para. 2 of the following reference for an example of the set of conditions/parameters that should be disclosed in a semi-prep HPLC isolation method:
Peng, Y. et al. HPLC analysis, semi-preparative HPLC preparation and identification of three impurities in salidroside bulk drug. J. Pharm. Biomed. Anal. 2009, 49, 828-832.
The instant specification also states “CF2 was then synthesized and characterized by 1H NMR” (pg. 39, line 21), yet no synthetic steps were provided. In the absence of synthetic steps, a POSTIA would require undue experimentation to synthesize CF2.
Therefore, instant claims 45-64 fail to comply with the enablement requirement.
The presence or absence of working examples
In the instant specification, “the terms ‘treatment’ or ‘treating’ of a disease, disorder or condition encompasses alleviation of at least one symptom thereof, a reduction in the severity thereof, or inhibition of the progression thereof. Treatment does not necessarily mean that the disease, disorder, or condition is totally cured. To be an effective treatment, a useful composition herein needs only to reduce the severity of a disease, disorder, or condition, reduce the severity of symptoms associated therewith, or provide improvement to a patient or subject’s quality of life. In some embodiments, alleviated symptoms of the disease, disorder or condition include reduced cell viability, induced cell apoptosis, inhibited cell proliferation, or increased sensitivity to an ER activation inhibitor, e.g., tamoxifen” (pg. 32, lines 17-25). Based on this definition of “treatment” and “treating,” the instant specification does provide working examples of a pharmaceutical composition comprising CF2 that alleviates the symptoms of breast cancer and endometriosis (see Examples 1 through 4). There are, however, no working examples of a pharmaceutical composition comprising CF2 alleviating the symptoms of all ER-related diseases including those listed in instant claim 59.
Therefore, instant claims 58-64 further fail to comply with the enablement requirement.
The instant specification only provides working examples (see Examples 1 through 3) of a pharmaceutical combination comprising CF2 and one ER activation inhibitor wherein the ER activation inhibitor is specifically tamoxifen. There are no working examples of a pharmaceutical combination comprising CF2 and other ER activation inhibitors that are not tamoxifen.
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
In other words, the instant specification only disclosing the pharmaceutical combination comprising CF2 and tamoxifen does not provide adequate written description of a claimed genus that embraces a pharmaceutical combination comprising CF2 and at least one of any known ER activation inhibitors.
Therefore, instant claims 53-57 further fail to comply with the enablement requirement.
The breadth of the claims
The claims are broad insofar as the instant claims recite a pharmaceutical composition comprising CF2 and at least one additional cannabinoid of any kind, a pharmaceutical combination comprising CF2 and at least one ER activation inhibitor of any kind, and a method for treating any ER-related disease.
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 58 and 64 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 58 states the limitation “A method for treating a subject afflicted with an ER-related disease or increasing or enhancing the therapeutic efficacy of an ER activation inhibitor in a subject in need thereof” but never recites that an ER activation inhibitor is already present in a subject or that the ER activation inhibitor must be co-administered with the pharmaceutical composition comprising CF2. Hence, the scope of the invention cannot be ascertained.
Claim 64, which is dependent on claim 58, is also rejected for further requiring and/or reciting the indefinite limitation of claim 58.
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 45-48 and 63 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claims 45 and 46:
Claims 45 and 46 recite a pharmaceutical composition comprising CF2. Since no additional components are required, the claim also reads on a composition comprising solely CF2 (i.e., the CF2 compound itself). As noted above, there are no prior art disclosure of CF2; accordingly, Examiner relies on the instant specification which describes CF2 as a compound extracted from CANN14 that is obtained from a Cannabis plant (instant specification, pg. 14, lines 25-30; pg. 35, lines 13-15; pg. 38, lines 21-23; pg. 39, lines 5-7). In other words, CF2 is a product of nature and is, therefore, not patentable.
Regarding claims 47 and 48:
Claims 47 and 48 recite a pharmaceutical composition comprising CF2 and at least one additional cannabinoid wherein the latter is THC, CBN, or both. The instant specification describes the CANN14 extract, which is obtained from a Cannabis plant, to naturally comprise THC, CBN, and CF2 (instant specification, pg. 14, lines 25-30; pg. 35, lines 13-15; pg. 39, lines 11-12). Therefore, claims 47 and 48 encompass an extract of a Cannabis plant which is a product of nature and is, therefore, not patentable.
Regarding claim 63: Claim 63 requires a pre-treatment assessment to evaluate a subject’s suitability for treatment with a composition comprising CF2. If the subject is determined not to be suitable, the method, as claimed, results in no administration and no therapeutic use of the composition. In such circumstances, the invention lacks utility and the claim does not fall within at least one of the four categories of patent eligible subject matter.
Note on 35 USC § 102 and § 103 Rejections
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102/103
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 45-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Turner et al. (Turner) (Turner, C. E. Constituents of Cannabis Sativa L. XVII. A Review of the Natural Constituents. Journal of Natural Products 1980, 43, 169-234.) or, in the alternative,
Claims 45-48 are rejected under 35 U.S.C. 103 as being obvious over:
Turner et al. (Turner) (Turner, C. E. Constituents of Cannabis Sativa L. XVII. A Review of the Natural Constituents. Journal of Natural Products 1980, 43, 169-234.)
Turner teaches the natural constituents of the Cannabis Sativa L. plant which include THC, CBN, and other cannabinoids (pg. 172-173, “Chemical Constituents” section). In other words, the Cannabis Sativa L. plant naturally contains a composition of THC, CBN, and other cannabinoids. Although Turner does not explicitly disclose CF2 as one of the constituents of the Cannabis plant, the instant specification states that CF2 is isolated from CANN14 extract which is obtained from a Cannabis plant (instant specification, pg. 14, lines 25-30; pg. 35, lines 13-15; pg. 38, lines 21-23; pg. 39, lines 5-7), indicating that the CF2 compound inherently exists in the Cannabis plant that naturally contains a composition of other cannabinoids. The failure to recognize CF2 as a constituent in the Cannabis plant in 1980 does not mean that CF2 was not present in the plant and a later discovery of a pre-existing natural product does not create patentable subject matter. However, the instant specification does not disclose which Cannabis plant the CANN14 extract was obtained from. If CANN14 was extracted from the Cannabis Sativa L. plant, then Turner anticipates instant claims 45-48.
According to MPEP §2112:
“SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
In this case, the “unknown property” is the CF2 compound as a constituent of a natural composition comprising cannabinoids that is present in a Cannabis plant. This property is unknown because the prior art reference is silent on this property. However, as stated above, the specification also never discloses which Cannabis plant the CANN14 extract is obtained from and, therefore, Examiner cannot confirm that the CF2 compound is inherent in, specifically, the Cannabis Sativa L. plant discussed in Turner.
MPEP §2112 further states:
“A REJECTION UNDER 35 U.S.C. 102 AND 103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”
In this case, the “characteristic” which the prior art is silent on is the CF2 compound as a constituent of a natural composition comprising cannabinoids that is present in a Cannabis plant.
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 45-52 and 58-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37-40, 42, 44, 45, and 49-54 of U.S. Patent Application No. 18/879,213 (‘213).
Instant claims 45 and 46 disclose a pharmaceutical composition comprising the CF2 compound. As noted above in this office action, since no additional components are required in the pharmaceutical composition disclosed in instant claims 45 and 46, the claim also reads on a composition comprising solely CF2 (i.e., the CF2 compound itself).
Application ‘213 discloses CF2 in claims 37-40, 42, 44, 45, and 49 as CF2 is a compound of formula I and formula Ia of Application ‘213 wherein:
R1 = pentyl (i.e., a C5 alkyl)
R2 = CH3 (i.e., a C1 alkyl)
R3 = R5 = R6 = R7 = R8 = H
X = C (applies to formula I only)
R4 = C6 alkenyl
Application ‘213 also discloses deuterated analogs of the CF2 compound (see claim 49, compounds 9, 13, and 19.
Although the claims at issue are not identical, they are not patentably distinct from each other as there is overlap between the instant claim set and the co-pending claim set. Also, a POSITA would find it obvious to claim the non-deuterated form of the CF2 compound (i.e., a composition comprising only the CF2 compound as disclosed in instant claims 45 and 46).
Instant claims 45-52 disclose (i) a pharmaceutical composition comprising CF2 as the only cannabinoid, (ii) a composition comprising CF2 and at least one additional cannabinoid (including THC, CBN, or both), and (iii) a composition comprising at least CF2 and a pharmaceutically acceptable carrier.
Application ‘213, claims 50-52, disclose a pharmaceutical composition comprising at least one compound of claim 37 (which encompasses CF2) and a pharmaceutically acceptable carrier or excipient.
Although the claims at issue are not identical, they are not patentably distinct from each other as there is overlap between the instant claim set and the co-pending claim set. Both claim sets employ the open-ended transitional term, “comprising,” such that instant claims 45-52 read on compositions within the scope of ‘213 claims 50-52 and vice versa. See MPEP §2111.03 for information on the open-ended transitional term, “comprising.”
Instant claims 58-61 disclose a method for treating a subject afflicted with an ER-related disease, the method comprising administering to said subject a therapeutically effective amount of a pharmaceutical cannabinoid composition comprising CF2 or comprising CF2 and at least one additional cannabinoid wherein the latter is THC, CBN, or both.
Application ‘213, claims 53-54, disclose a method of treating an ER-related disease or disorder, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of at least one compound according to claim 37 (which encompasses CF2) and a pharmaceutically acceptable carrier or excipient.
Although the claims at issue are not identical, they are not patentably distinct from each other as there is overlap between the instant claim set and the co-pending claim set. Both claim sets employ the open-ended transitional term, “comprising,” such that composition disclosed in instant claims 58-61 read on the compositions within the scope of ‘213 claims 53-54 and vice versa.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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, JEFFREY H. MURRAY can be reached at (571) 272-9023. 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.
/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624