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
Summary
This is the Final Office Action based on application 16/489960 RCE response filed 10/06/2025.
Claims 1, 6-10, 16, 18-20, 71-72, 78-79 & 84-86 have been examined and fully considered.
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.
The claimed invention of claims 1, 6-10, 16, 18-20, 71-72, & 78-79 & 84-86 are directed to a natural correlation without significantly more.
Step 1, Are the claims directed to a statutory category of invention?
Yes, Claim 1 and those that depend therefrom are directed to a method.
Step 2A, Prong One: Identify the judicial exception.
Claim 1 recites the relationship/natural correlation of the claimed biomarkers (one or more of the glycosaminoglycans (GAGs), 6s chondroitin sulfate (6s CS), with the presence of prostate cancer, colon cancer, rectum cancer, lung cancer, uterine cancer, breast cancer, bladder cancer, brain cancer, blood cancer, ovarian cancer. This is a natural correlation which a law of nature judicial exception.
Step 2A Prong Two: Has the judicial exception been integrated into a particular practical application?
No.
After the determination of the concentration of the 6s Cs is found, nothing more is done. No particular treatment is performed.
In addition to the claimed judicial exception, the claims require that chondroitinase is used for fragmentation into disaccharide unit, and also that “electrophoresis, HPLC, and/or mass spectrometry,” and that a “detection reagent” is used. This does not add enough specificity as far as detection/measurement to overcome the instant 101 rejection.
These steps as recited in Claim 1 are recited at such a high level of generality such that it amounts to insignificant pre-solution activity, e.g., a mere data gathering step necessary to use the correlation. Detecting whether 6s Cs is present in the sample merely instructs a scientist to use any detection technique with any generic, “detection reagent,” which as shown in the instant specification can be a generic antibody. Further- the use of chondroitinase as claimed seems to be extra-solution activity as it is merely breaking the compounds down to smaller natural components, again so the judicial exception can be used, and the chondroitinase is not measured.
Further- no particular or machine or a transformation of a particular article, or particular processing steps are used.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
In addition to the claimed judicial exception, the claims require that chondroitinase is used for fragmentation into disaccharide unit, and also that “electrophoresis, HPLC, and/or mass spectrometry,” and that a “detection reagent” is used. This does not add enough specificity as far as detection/measurement to overcome the instant 101 rejection.
Processing a sample in order to perform tests is well-understood, routine and conventional (WURC) activity for those in the field of diagnostics, including the processing of GAG using chondroitinase, and using a generic, “Detection reagent,” as claimed which can be a generic antibody (See prior art, Page 764, column 1, last paragraph),
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from WURC data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed.
Further—the use of the chondroitinase as claimed does not change the structure of the naturally occurring disaccharide, it merely brings them out/breaks the sample down to show them, and chondroitinase is not measured itself. Further as shown by the prior art below is WURC, specifically for breakdown of GAG as instantly claimed. Therefore—the use of chondroitinase does not move the claims past the claiming of natural correlation of levels of GAGs disaccharides and cancers.
The claiming of “mass spectrometry” and/or HPLC for measuring detection, or electrophoresis is also WURC especially at the level of generality claimed, as applicant can choose any way to use either of these techniques that are also routine and conventional in the art.
See USPTO Subject Matter Eligibility Example 29, Claim 2, which the instant claims most closely map to from the USPTO examples. Though yes, the instant claims require the use of chondroitinase, which is from bacteria, and the examiner agrees is not found naturally in the human body, in looking at Example 29, Claims 2 & 3--- the examiner notes that the chondroitinase is not actually the compound or part of the compound that is detected in the instant claims. Further—the claimed “detection reagent,” and therefore the “detection entity,” can through a reading of the instant specification contain no more than a generic antibody or fluorophore. Therefore- these claims are most similar to Example 29, Claim 2 which was found not eligible.
See from MPEP 2106.05 (d) II, for examples of laboratory techniques which have been found to be well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
The dependent claims undergo the same analysis.
With respect to Claims 6, 9-10, & 16 they specify further compounds that are measured. This is part of the natural correlation itself. It also specifies that the compounds are measured in a ratio to each other. Ratios are math/mathematical process which are abstract ideas, another judicial exception. Therefore, there is nothing is this claim which makes it amount to a practical application or significantly more than the judicial exception/s above.
With respect to Claims 7-8 they specify that the sample is a bodily fluid sample which is urine. That the sample is a natural sample from the human body, is part of the judicial exception itself, and if not is at least WURC to use to then detect a natural correlation. Therefore, there is nothing is this claim which makes it amount to a practical application or significantly more than the judicial exception/s above.
With respect to Claims 18-20, & 79 they specify further compounds that are measured. This is part of the natural correlation itself. It also specifies that the compounds are measured in relative levels compared to each other or to a control. Comparison to controls is WURC. Therefore, there is nothing is this claim which makes it amount to a practical application or significantly more than the judicial exception/s above.
With respect to Claims 71-72, they state that the subject is diagnosed with one or more cancers, or that the method is used for prognosis or monitoring occurrence of severity of disease. With respect to this, diagnosing (and prognosing, and monitoring of occurrence of) based on the claimed judicial exception is the natural correlation itself. Therefore, there is nothing is this claim which makes it amount to a practical application or significantly more than the judicial exception/s above.
With respect to Claim 78, it specifies that 6s Cs is measured by ESI- MS. ESI-MS is WURC in the art and therefore does not add significantly more to the judicial exception, and also is used to do a data pull for the natural correlation so also does not practically apply the judicial exception.
With respect to Claim 84, it specifies that the detection reagent is a fluorophore. Fluorophores are WURC in the art, especially at the level of generality claimed, and therefore do not make the claims significantly more.
With respect to Claim 85, it claims that the level of 6s Cs is determined to be increased on decreased in comparison to a control and an increase means cancer. This is part of the natural correlation itself. Therefore, it does not practically apply or make the claims significantly more.
With respect to Claim 86, specifies that HPLC and/or MS is used. These are both WURC, especially at the level of generality claimed, and the general measurement is used as a data pull to perform the natural correlation. Therefore, it does not practically apply or make the claims significantly more.
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.
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 non-obviousness.
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 1, 6-7, 9-10, 16, 18-20, 71-72, & 79 & 84-86 are rejected under 35 U.S.C. 103 as being obvious over IIDA in Analysis of glycosaminoglycans in human prostate by high-performance liquid chromatography (as cited on IDS dated 08/29/2019) in view of VALLEN in Highly sulfated chondroitin sulfates, a novel class of prognostic biomarkers in ovarian cancer tissue.
With respect to Claim 1 & 71, IIDA et al. teach of taking 17 samples and analyzing them for the presence of cancer. IIDA et al. specifically teach of determining whether the patient has prostate cancer (which is claimed in claim 1).
IIDA et al. further teach of processing the sample. Specifically, IIDA et al. teach of processing a glycosaminoglycan (GAG) sample (chondroitin sulfate, CS, is a GAG), by using chondroitinase in addition to other compounds to digest the CS into unsaturated disaccharides (since the same enzyme is used in IIDA, and the same starting compound- GAG/CS- the sample would break down and produce the same units as instantly claimed) (Page 764, column 1, last paragraph, page 763, column 2, paragraph 1 & materials and methods in paper body).
IIDA et al. further teach of measuring the total GAG using modified dimethybmethylene blue (DMB) (DMB is a fluorophore dye (detection reagent) that binds to the GAG digest to form a detection entity that would have the 6s compound in it since IIDA teaches that 6s compound is detected as shown below) method(abstract).
IIDA et al. further teach that six types of GAGs including chondroitin 4-sulphate
(Ch-48), chondroitin 6-sulphate (Ch-6s), dermatan sulphate (DS), chondroitin, heparan sulphate and hyaluronic acid, were analyzed qualitatively and quantitatively(abstract).
In applicants instant PGPub specification- they say that 6s CS (as instantly claimed) is also referred to as chondroitin-6-sulfate (which is taught by IIDA, but uses a different abbreviation) (see applicant’s PGPub, paragraph 0059- for note of this).
Therefore- IIDA teach of fragmentation/digestion chondroitin-6- sulphate (6s CS, as instantly claimed)—and the disaccharide units claimed by applicant.
IIDA et al. also teach of using high- performance liquid chromatography (HPLC) was used to quantify the extracted GAGs subunits (disaccharide units). IIDA et al. further teach that predominant GAGs that were found to be increased in hyperplastic and cancerous prostates are CH-6S (so chondroitin 6-sulphate, or 6s CS as claimed by applicant instantly) and DS (abstract).
IIDA et al. teach of using prostate gland samples, and do not call out that a body fluid sample is used. IIDA et al. also do not call out detection of breast cancer—though many other possibilities are claimed for cancer detection- and the instant method at least as claimed is not limited to breast cancer, applicant did elect breast cancer, so for compact prosecution, VALLEN is used to remedy this.
VALLEN et al. teach of detecting chondroitin sulfates in ovarian and other cancers, and that chondroitin sulfates have been known to be related to a number of cancers including breast cancer (abstract, Page 208, column 2, 2nd paragraph). VALLEN et al. also teach of detecting chondroitin sulfate in serum samples (Page 203, column 2, paragraph 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect breast cancer/cancer variants and in serum and one would have reasonable expectation of success, in the method of detecting chondroitin sulfate of IIDA due to the fact that tumor cells themselves and what is on the cell surface are usually investigated for cancer and that the surroundings(extracellular matrix) and fluids surrounding the cells have been neglected for detection, and since GAG are prevalent in the surroundings, that this hold great promise in many kinds cancer diagnostics (VALLEN, Page 202, column 2, last paragraph and Page 203, column 2, first paragraph).
With respect to Claims 6 & 9-10, 16, 18-20, IIDA et al. teach of measuring both total chondroitin 4-sulphate (they abbreviate as Ch-48, but is the same as applicant’s 4s CS) and total 6s CS as shown in the rejection for Claim 1. Measuring both of the compounds reads on measuring a “ratio” (abstract).
With respect to Claim 7, VALLEN et al. teach of CS being increased in serum/blood samples (Page 203, column 2, paragraph 1).
With respect to Claim 72, IIDA et al. teach of using the instant method of prognosis or monitoring of cancer and further of differentiating between normal, hyperplastic, and cancerous patients(abstract).
With respect to Claim 79, IIDA et al. call out detection of heparin sulfate (sulfated or un-sulfated) (abstract).
With respect to Claim 84, IIDA teach of measuring GAG digest with dimethylene blue (DMB) (DMB is a fluorophore dye that binds to the GAG digest (First page and abstract).
With respect to Claim 85, IIDA teaches “total amount of GAG,” “with the predominant components being DS and Ch-6s”, which reads on applicants 6s CS, were “increased in hyperplastic and cancerous prostates,” (abstract and results).
With respect to Claim 86, IIDA et al. teaches of using high- performance liquid chromatography (HPLC) was used to quantify the extracted GAGs subunits (disaccharide units) (which include 6s Cs).
Claims 8 & 78 are rejected under 35 U.S.C. 103 as being obvious over IIDA in Analysis of glycosaminoglycans in human prostate by high-performance liquid chromatography (as cited on IDS dated 08/29/2019) in view of VALLEN in Highly sulfated chondroitin sulfates, a novel class of prognostic biomarkers in ovarian cancer tissue and further in view of CRAWFORD in US 20120009616.
With respect to Claims 8 & 78, IIDA and VALLEN et al. teach of the claimed invention as shown in the above rejection. IIDA and VALLEN et al. do not teach of the use of a urine sample or of electrospray ionization mass spectrometry. CRAWFORD et al. is used to remedy this.
CRAWFORD et al. teach of a method of detection of oligosaccharides(abstract), including ones with 6S (abstract, paragraph 0040, 0048, 0135, 0140, among others) and of detection in urine (paragraph 0102). CRAWFORD et al. also teach of detecting GAG degradation and that this can show presence of cancer (paragraph 0115). CRAWFORD et al. further teach of detecting urine, and of using atmospheric pressure electrospray (which is a type of ESI) (0311) and HPLC and mass spectrometry and that these methods are non-limiting (paragraph 0233, 0088, 0102). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to use a urine sample and use electrospray with the mass spectrometry for detection as is done in CRAWFORD in the method of IIDA and VALLEN due to the advantage this offers for sensitive detection (CRAWFORD, paragraph 0311).
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive.
With respect to the 101 rejection, it was added back to the record in the last office action which was a Non-Final action after RCE and dated 05/07/2025, after consultation with the examiner’s SPE.
Applicant argues with respect to the 101 rejection that the claims are instead eligible. The examiner disagrees and the rejection is maintained.
Specifically, applicant argues that Claim 1 in particular recites the steps of "fragmenting the GAG using a chondroitinase to obtain the disaccharide units and derivatizing the disaccharide units with a detection reagent to provide a detection entity,” and that this is significantly more than the claimed judicial exception. Applicant further emphasizes that, “It is well understood that derivatization of a target (e.g., a disaccharide) induces a change in the state of said target by the attachment of the derivatizing agent to form a new entity (e.g., a detection entity).”
Though the examiner understands that yes, derivatization agents can induce a change in state of the target to form a new detection entity, claims are read in light of the broadest reasonable interpretation of the claim. As claimed, the “detection reagent,” and “detection entity,” could be almost anything. For example, though it is understood that applicant does not intend water to be something which the detection reagent could be, it can currently be interpreted that way and if the detection reagent is water, then the detection entity can be a diluted sample. Therefore, the examiner disagrees that as claimed the derivatization agent and detection agent necessarily induce a change in state in the measured compounds and therefore result in significantly more than the claimed judicial exception. The 101 rejection is maintained.
Further—with respect to determinations of what is significantly more--- the question asked, is not, “is there a change in state.” It is—does the claim when looking it as a whole include additional elements which make it result in something which is significantly more than the claimed judicial exception? The answer to that question for instant Claim 1 is no. With respect to the instantly claimed “detection reagent,” and “detection entity,” and also the generally claimed “Derivatizing,” laboratory techniques which have been found to be well-understood, routine, conventional (WURC) activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, and things that are shown to be WURC are not found to amount to significantly more than the judicial exception. See MPEP 2106.05 (d) II. This is especially the case at the level of generality the claimed detection reagent, derivatizing, and detection entity are claimed at.
Applicant further argues that the above in addition to the claimed use of chondroitinase, which is a non-naturally occurring enzyme make their case even more so, and references the CellzDirect case where a process reciting a combination of individually well-known freezing and thawing steps was “far from routine and conventional and thus eligible.” This examiner still disagrees with applicant for the reasons shown above and also emphasizes that the CellzDirect claims did not encompass a law of nature/natural correlation judicial exception, unlike the instant claims which do. Therefore, the facts of the instant application are different and diverge from those of the CellzDirect case.
Applicant further argues with respect to Pages 4-6 of Non-Final Office Action dated 05/07/2025 that chondroitinase treatment and derivatization with the detection reagent as claimed in Claim 1 is not standardly used in the art for GAG isolation and detection, and therefore is not routine and conventional. To emphasize this, applicant points to the prior art of Iida and argues that no derivatization step is performed. With respect to this--- the examiner notes that applicant is arguing about the prior art in response to the 101 rejection.
Though the 101 rejection was not made using the prior art, making applicant’s argument not commensurate with the rejection made--- the examiner will respond to this anyway.
IIDA does in fact teach of processing the sample, a glycosaminoglycan (GAG) sample (chondroitin sulfate, CS, is a GAG), by using chondroitinase (as claimed) in addition to other compounds to digest the CS into unsaturated disaccharides (Page 764, column 1, last paragraph, page 763, column 2, paragraph 1 & materials and methods in paper body). IIDA further teaches of measuring the total GAG using modified dimethybmethylene blue (DMB) (DMB is a fluorophore dye that can be interpreted as the instantly claimed detection reagent, which derivatizes the sample (abstract).
Applicant argues that the DMB is a labelling reagent and does not derivatize the sample. The examiner disagrees with this, particularly at the level of generality the claim terms “detection reagent,” “detection entity,” and “derivatizing,” using the detection reagent is claimed. If applicant means something more specific, then it is suggested that they claim it.
Applicant argues similarly with respect to prior art references they have submitted with their instant filing dated 10/06/2025 (Maszota-Zieleniak and Zhang and Anower-E-Khuda). The examiner has reviewed these references, but is not responded directly to applicant’s comments on these, since they were not part of the examiner’s rejection, and the rejection with respect to 101 was made with respect to the broadest reasonable interpretation of the claim terms. Again, if applicant means something more specific, then they should claim it.
Therefore, all claims remain rejected under 101, and all steps noted as so in the 101 rejected above as being considered WURC and still considered so.
With respect to the prior art, applicant argues again that the references dot not teach of derivatizing a disaccharide of a GAG using a detection agent as claimed. Applicant specifically argues, “IIDA teaches using DMMB as a labeling agent which does not derivatize to chondroitin.” The examiner assumes, this is a typo, but notes that this argument is not commensurate in scope with the instant claims--- as there is nothing claimed about derivatizing with chondroitin. Instead, what is claimed, is processing the GAG sample using chondroitinase to get disaccharide units, and then using a detection reagent to derivatize the disaccharides. The examiner maintains that IIDA does in fact teach of this as shown in the above 103 rejection, and that the instant invention remains obvious from the prior art. Again--- this is true especially at the level of generality claimed for the detection reagent, detection entity, and derivatization. If applicant means something more specific, then they should claim it.
Applicant further argues with respect IIDA reference, that they firmly submit the offices interpretation of IIDA is not accurate in that they think IIDA does not teach of any difference in the concentration of 6s CS when comparing cancer tissue to normal tissue. Applicant further argues that IIDA state that the total amount of GAG is increased in cancerous patient does not mean or suggest that CH-6s or DS being increased. Applicant further argues that IIDA does not demonstrate any significant difference in the concentration of 6s Cs when comparing to control or normal tissue. The examiner disagrees with this, however notes that results (an increased level) is not required by the claims. What is required is comparing the sample to a control sample. Whether there is an increase or not will be dependent on the sample used.
However, with respect to measuring an increased level, Specifically in the abstract- results section- IIDA teaches “total amount of GAG,” “with the predominant components being DS and Ch-6s”, which reads on applicants 6s CS, were “increased in hyperplastic and cancerous prostates.” This is because the total amount of GAGs includes 6s CS—which is also shown by IIDA.
In applicants instant PGPub specification- they say that 6s CS (as instantly claimed) is also referred to as chondroitin-6-sulfate (which is taught by IIDA, but uses a different abbreviation) (see applicant’s PGPub, paragraph 0059- for note of this).
IIDA teach of fragmentation/digestion to chondroitin-6 sulphate (6s CS, as instantly claimed)—and the disaccharide units claimed by applicant. IIDA et al. further teach that predominant GAGs that were found to be increased in hyperplastic and cancerous prostates are CH-6S (so chondroitin 6-sulphate, or 6s CS as claimed by applicant instantly) and DS (abstract), (Abstract- results section- “total amount of GAG,” “with the predominant components being DS and Ch-6s”, which reads on applicants 6s CS, were “increased in hyperplastic and cancerous prostates.”)
Applicant further argues that IIDA does not teach of using bodily fluid samples that specifically contain 6s Cs.
With respect to this, the examiner points out that a 103 rejection was made and that a single reference does not have to teach of all parts of a claim, but instead make it obvious. VALLEN was used in combination with IIDA to teach of this, and there is reasonable expectation of success.
Applicant argues that VALLEN, the secondary reference does not teach of detecting 6s CS in a body fluid sample or a detecting entity. The examiner notes that VALLEN was used to teach the obviousness of using a body fluid sample to detection chondroitin sulfate (which contains subtypes including 6s CS). IIDA already taught of detecting 6s CS and a detection entity and reagent as shown above.
Applicant also seemingly argues that VALLEN does not teach of body fluid samples at all. The examiner disagrees. VALLEN et al. also teach of detecting chondroitin sulfate in serum samples (Page 203, column 2, paragraph 1). No matter what other teachings are in VALLEN, the sentence, “An increase of chondroitin sulfate in serum has been noted in ovarian cancer patients,” in VALLEN does in fact direct one to look for chondroitin sulfate and its subtypes in body fluid (serum) samples.
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that is not reasonable expectation of success for the combination of IIDA and VALLEN and that one would not have combined them to arrive at the instant invention since they both focus on body tissue and not the claimed bodily fluid. The examiner disagrees and maintains the mention of chondroitin sulfate detection in serum and the reason for combination from VALLEN show reasonable expectation of success of the instant inventions detection of chondroitin sulfate in body fluids.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect breast cancer/cancer variants and in serum and one would have reasonable expectation of success, in the method of detecting chondroitin sulfate of IIDA due to the fact that tumor cells themselves and what is on the cell surface are usually investigated for cancer and that the surroundings (extracellular matrix) and fluids (body fluids) surrounding the cells have been neglected for detection, and since GAG are prevalent in the surroundings, that this hold great promise in many kinds cancer diagnostics (VALLEN, Page 202, column 2, last paragraph and Page 203, column 2, first paragraph). The examiner emphasizes the “extracellular matrix,” is tissues is composed of fluids (body fluids) and non-fluids, and in blood the extracellular matrix is completely fluid.
Applicant makes no substantive arguments about the CRAWFORD reference.
All claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758