DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the claims
Currently claims 1-20 are pending and under examination.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The present invention generally relates to”. This language should be avoided.
Specification
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 Objections
Claim 18 is objected to because of the following informalities: Claim 18, line 4 the recitation “malaise,sweats,” should be --malaise, sweats--. Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the levels of the recited biomarkers in a subject with e-cigarette or vaping, product use associated lung injury (EVALI).
Step 2A, Prong 2
The additional elements of obtaining a biological sample from a subject and measuring the level of the recited biomarker and making a comparison to a comparator does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “identifying said subject as having EVALI when the level of the one or more…”. The “identifying” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited biomarker(s) being correlated with EVALI. No active method steps are invoked or clearly required; the “identifying” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art to obtain a sample from a subject and measure one or more of the recited biomarkers.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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.
Written Description
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method of identifying e-cigarette, or vaping, product use associated lung injury (EVALI) by obtaining any and all biological samples from any and all subjects and measuring the level of any an all EVALI-associated biomarkers and comparing the level to that of a comparator and determining any substantial increase or decrease of the biomarker.
The limitation 'subject’ represents a genus and encompasses human and non-human including mouse, monkey, dog, rat, pig, insects, kangaroo, horse, canine and snake to name a few. The limitation ‘biological sample’ represents a genus and encompasses tears, semen, liver, urine, kidney, brain, peritoneal fluid, sputum, synovial fluid, lung tissues or vomit. Also, the current claim broadly allows for the determination of any and all substantial increases and decreases of the biomarkers in any biological sample. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘subject’, ‘ biological sample’, and the comparison amount of the biomarker such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on page 34, lines 13-14 discloses EVALI subjects and human 27- plex assay. The specification on page 46, lines 16-20 discloses hospitalized EVALI subjects (appear to be human) and that PE levels was determined in the subjects and that PEs are a class of phospholipids found in all human cells. All examples in the specification appear to be directed to human subjects. The specification on page 37 discloses the mean values of specific biomarkers in plasma or urine from EVLAI and healthy subjects. The specification on page 36 discloses lipid mediators measured in plasma samples. The specification on page 38 discloses that plasma and urine samples were used in EVALI subjects and non-users. The specification on page 43 discloses phosphatidylethanolamines as plasma biomarkers for diagnosing EVALI. Page 46 discloses PEs in plasma. The specification on page 38 discloses urine metalbolites associated with EVALI. The examples in the specification appear to be limited to urine and plasma samples from human subjects and very specific biomarkers which are unique to the urine or plasma sample for the correlation with EVALI. The specification does not provide data, testing or examples with a showing that any all and all biological samples from any and all subjects provide the recited biomarker at levels which can be specifically correlated with EVALI. The specification does not even provide evidence that the biomarkers which are present in the plasma samples are also present at values in urine which provide for the specific identification of EVALI. As shown by Singh et al (ERJ Open Res 2019, 5, pages 1-12) MMP-9 is significantly increased in plasma (e.g page 4) but not in urine (e.g. page 6). Singh et al actually shows that the MMP-9 is decreased in urine. Thus, teaching that different samples have different markers and at different levels in EVALI. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract). Also, Middlekauff et al (Journal of Translational Medicine, 2020, 18, pages 1-10) teaches that there is no major changes between electronic cigarette or non-smokers.
The only examples utilized in the specification appears to be limited to urine and plasma samples from human subjects and very specific biomarkers which are unique to the urine or plasma sample for the correlation with EVALI. The specification does not provide data, testing or examples with a showing that any all and all biological samples from any and all subjects provide the recited biomarker at levels which can be specifically correlated with EVALI. The specification does not disclose that the recited biomarkers which appear in serum or plasma also appear in samples such as stool, tears lung, brain, sputum, plural fluid etc. or that such proteins would be expected to be shed, excreted into or found in these samples and correlated with risk mortality.
The specification also fails to provide for a correlation of the recited biomarkers in all subjects such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) The specification also fails to provide that the recited biomarkers exist in samples such as lung tissue, kidney tissue, stool, saliva, tears, sputum, CSF or liver tissue or that a correlation of these biomarkers exist in such patients with suspected sepsis. Further, it is not well known in the art that these samples provide for the recited biomarkers and that a correlation exists between such biomarkers in the samples to mortality risk in a patient suffering from cardiogenic shock, or who has suffered from cardiogenic shock.
The examples in the specification appear to be limited to urine and plasma samples from human subjects and very specific biomarkers which are unique to the urine or plasma sample for the correlation with EVALI. The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or 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' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification fails to disclose the detection of the recited biomarkers in any and all biological samples from any and all subjects wherein any substantial difference of and increase or decrease of the biomarkers is expected to be in any all samples at levels which is directed correlated with EVALI. The specification also fails to teach markers that which are correlated with EVALI in plasma (e.g. PEs) are also present in urine and at levels which are specifically correlated with EVALI.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-4 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDonough et al (Am J Physiol Lung Cell Mol Physiol 320, January 27, 2021, pages L661-L679).
McDonough et al discloses a method of identifying e-cigarette use in a subject comprising obtaining a sample such as plasma or urine from the subject (e.g. pgs L661, L671) and measuring the level of a biomarker in the subject and comparing the level to that of nonsmokers (comparator). McDonought et al discloses that the biomarker can be 8-OHdG (8-hydroxy-2’-deoxyguanosine) (same biomarker in claim 4) (e.g. Table 2, page L671) and that the biomarker is significantly higher in the e-cig users than in nonsmokers (Thus, since McDonough et al is teaching the measurement of the same biomarker as currently recited and the same steps as currently recited then McDonough et al is identifying EVALI in the subject. McDonough et al discloses that the measuring comprises use of and ELISA (e.g. Table 2, page L671).
NOTE: It is noted that the McDonough et al publication and the current application have inventors in common (Irfan Rahman). However, there is no evidence explaining the involvement of Samantha R. McDonough and Isaac Kirubakaran Sundar therefore the 102(a)(1) rejection has been made.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blount et al (The New England Journal of Medicine, Feb. 30, 2020, Vol 382, No. 8, pages 697-705).
Blount et al discloses a method of identifying subjects with EVALI comprising obtaining a sample such as bronchoalveolar-lavage (BAL) (biological sample) from the subject (e.g. abstract, pgs 698-701). Blount et al discloses measuring the level of vitamin E acetate in the subject and comparing the level to that of a healthy comparator (e.g. abstract, page 701). Blount et al discloses that the level were determined by limit of detection and that the results higher than the limit of detection are reported as positive and the results lower are reported as negative (e.g. p. 699 & 701). Blount et al teaches that 48/51 cases were positive and 0 of the nonusers were positive (thus showing a substantial difference between the EVALI subject levels and that of the comparators.
Claims 1-7 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al., (ERJ Open Res 2019, 5, pages 1-12).
Singh et al discloses the identified biomarkers that are used for determining e-cig vaping associated lung injury (e.g. pgs 1 and 9). Singh et al discloses a method comprising obtaining a biological sample such as plasma or urine (e.g. abstract, pgs 3, 6, 8-9). Singh et al discloses measuring the levels of biomarkers such as resolvin D1, TnFa, and 8-oxo-dg (8-OHdG) (8-hydroxy-2’-deoxyguanosine) (e.g. pages 4-6). Singh et al discloses that levels are measured in the subject and compared to that of a control (comparator) (e.g. pgs 4-6) and that the measurement can be done by ELISA (e.g. page 4). Singh et al discloses that the levels of resolvin D1 (lipid) were significantly decreased in e-cig users compared with subjects (e.g. pg 6). Singh et al discloses that the 8-oxo-dg is significantly increased in urine sample of e-cig users compared with normal subjects (e.g. page 6). Singh et al discloses that markers such as the resolving D1 and 8-oxo-dg (8-OHdG) (8-hydroxy-2’-deoxyguanosine) had statistically significant levels (Figs 1-4 and p values).
Claim Rejections - 35 USC § 103
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.
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al in view of Middlekauff et al (Journal of Translational Medicine, 2020, 18, pages 1-10).
See above for the teachings of Singh et al.
Singh et al differs from the instant invention in failing to teach the biomarker if a phosphatidylethanolamine (PE).
MiddleKauff et al teaches an association of phosphatidylethanolamine (PE) such as PE (P-16:0/18:2) in female electronic cigarette (e.g. page 3). Middlekauff et al teaches that PE (P-16:0/18:2) is significantly lower in female electronic cigarette users compared to a control (e.g. page 3).
It would have been obvious before the effective filing date of the claimed inventio to a person having ordinary skill in the art to incorporate the detection of PE (P-16:0/18:2) such as taught by MiddleKauff et al into the method of Singh et al because MiddleKauff et al shows a distinct correlation of PE (P-16:0/18:2) in female electronic cigarette uses and one would recognize that this marker would provide for further confirmation in female subjects. Further, It has long been held that it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, one of ordinary skill in the art would have a reasonable expectation of success to incorporate the detection of PE (P-16:0/18:2) such as taught by MiddleKauff et al into the method of Singh et al.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Blount et al or Singh et al in view of Blagev et al (Lancet 2019, Vol 394, pages 2073-2083).
See above for the teachings of Blount et al or Singh et al.
Blount et al and Singh et al differ from the instant invention in failing to teach confirming the presence or amount of cough or fever. Blount et al and Singh et al also fail to teach treating the subject.
Blagev et al teaches that it is known and conventional in the art that subject having EVALI shows symptoms such a coughing, chest pain and signs such as fever. (e.g. page 2078). Blagev et al also teaches that subjects having EVALI can be treated by giving antibiotics or steroids for the EVALI (e.g. page 2078).
It would have been obvious before the effective filing date of the claimed inventio to a person having ordinary skill in the art to incorporate the detection or confirmation of a cough and/or fever in the subject in the method of Blount et al or Singh et al because Blagev et al shows that it is known and conventional in the art that these subjects can have cough and fever. Further, one of ordinary skill in the art would understand that the confirmation of more signs and symptoms of EVALI would provide for more confidence in the assessment of EVALI. Further, It has long been held that it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, one of ordinary skill in the art would have a reasonable expectation of success to incorporate the confirmation of cough or fever in the subject of Blount et al or Singh et al for the assessment of EVALI.
It would have been obvious before the effective filing date of the claimed inventio to a person having ordinary skill in the art to incorporate a treatment such as taught by Blagev et al for the EVALI subjects of Blount et al or Singh et al because Blagev et al shows that it is known and conventional to treat EVALI subjects and one would understand that a subject that has been identified as having EVALI would need treatment. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a treatment such as taught by Blagev et al for the EVALI subjects of Blount et al or Singh et al.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Madison et al (The Journal of Clinical Investigation, Vol 129, No. 10, October 2019, pages 4290-4304). Madison et al teaches altered PE levels in e-cigarette smokers (e.g. abstract,t page 4296).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678