sDETAILED 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
The amendment filed 01/14/25 is acknowledged and has been entered. Claims 2, 4-6, 8, 10, 13-16 and 19 have been amended. Claims 1, 17-18 and 20-25 have been canceled. Claims 3, 7, 11-12 and 26-27 were previously canceled. New claims 28-35 have been added. Accordingly, claims 2, 4-6, 8-10 and 13-16, 19 and 28-35 are pending and under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites a broad limitation together with a narrow limitation in the same claims in reciting “comprising or consisting of the steps”. The comprising step is open language and allows for other steps or components whereas the more narrow consisting of steps would be closes language prohibiting any other steps. This could cause ambiguity to what the claims are actually intending. It is recommended but not required to delete the recitation “or consisting of” from the claims. 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 2, 4-6, 8-10, 13-15 and 28-33 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
Claim 2 describes an abstract idea, law of nature, or natural phenomenon in the claim by requiring obtaining a biological sample from a subject suspected of having early stage pancreatic ductal adenocarcinoma or pancreatitis and comparing the levels of the biomarkers to a control that is a healthy control subject or a subject with diabetes mellitus and without pancreatic cancer. Although the claims does not literally recite the relationship between adiponectin and IL-1Ra and pancreatic disease, it does describe that relationship and thus the claims are directed to an abstract idea, law of nature, or natural phenomenon.
Step 2A, Prong 2
The additional elements of obtaining a biological sample from a subject and contacting the sample with antibodies for adiponectin and IL-1Ra to form complexes; detecting the complexes and comparing to a control do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
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 art below it is well known routine and conventional in the art to obtain a sample from a subject and contacting the sample with antibodies for adiponectin and IL-1Ra to form complexes; detecting the complexes and comparing to a control.
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).
NOTE: It is noted that claim amended claim 16 imposes a meaningful limit on the judicial exception and therefore claim 16 and depending claims 19 and 34-35 have not been rejected under 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The currently recited claim does not refer to a preceding claim (claim 5 currently depends from claim 28) (see MPEP 608.01(n)) and therefore fail to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2, 4-6, 10, 13 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., (Pancreas, Vol 35, Number 1, July 2007, pages 16-21) in view of Goodson (US 2016/0231334) and further in view of Borrebaeck et al (US 9,863,960).
Chang et al discloses a method of the detection and differentiation of pancreatic ductal cancer and pancreatitis (e.g. abstract). Chang et al discloses that the method is for the early diagnosis of the pancreatic cancer (e.g. page 16). Chang et al discloses the method comprises obtaining a serum sample from a subject and detecting the level of adiponectin in the sample by enzyme-linked immunoassay (e.g. pg 17). Chang et al discloses comparing the level in the subject to that of a control (relevant matched control). Chang et al discloses that the levels in a pancreatic cancer subject is elevated compared to that of a pancreatitis subject and a control and that a pancreatitis subject to elevated compared to a control (e.g. pages 17-18 & Table 1). Chang et al shows that the adiponectin level in pancreatic cancer is 2-fold higher than that of a normal control (e.g. Table 1). Chang et al discloses that the control subjects showed no abnormality in routine blood tests, urine and stool occult blood test, chest radiograph examination and abdominal ultrasonography and were considered to be free of malignancy and CP (thus teaching healthy subject) (e.g. page 17). Chang et al also teaches the detection of CA19-9. Chang et al discloses that the CA19-9 is detected by immunoassay. Chang et al discloses the pancreatic carcinoma is ductal adenocarcinoma (e.g page 16). Chang et al discloses the method is for the early diagnosis of the ductal adenocarcinoma (e.g. page 16).
Chang et al differs from the instant invention in failing to explicitly teach the antibody that binds to adiponectin.
Goodson teaches that it is known and conventional in immunoassay to use an antibody that specifically binds to adiponectin to provide for the detection of the complex (e.g para 0071).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate an antibody such as taught by Goodson into the method of Chang for the detection of adiponectin because Goodson teaches that it is well known, routine and conventional. Further, as is known in the art immunoassays implies an assay with the use of an antibody. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating an antibody such as taught by Goodson into the method of Chang for the detection of adiponectin.
Chang et al and Goodson differ from the instant invention in failing to teach detecting IL-1Ra.
Borrebaeck et al teaches measuring the expression levels of biomarkers such as IL-1Ra in subjects with pancreatic cancer and comparing to a control to determine a difference (e.g. abstract, col’s 2-3, 31). Borrebaeck et al discloses that the IL-1Ra can be detected by use of immunoassay and antibodies (e.g col 15). Borrebaeck et al discloses that the expression level of IL-1Ra is up regulated (increased) in pancreatic cancer subjects compared to a normal control (e.g. col 9, lines 1-10). Borrebaeck et al discloses that the pancreatic cancer to be detected can be pancreatic ductal adenocarcinoma (e.g. col 10, lines 47-56).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the detection of IL-1Ra such as taught by Borrebaeck et al in the modified method of Chang et al because Borrebaeck et al teaches that IL-1Ra is up regulated in subjects with pancreatic ductal adenocarcinoma. Further, one of ordinary skill in the art would understand that additional tests and assessments known to be correlated with pancreatic cancer would provide a more confident assessment of pancreatic cancer. 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 incorporating the measurement of IL-1Ra such as taught by Borrebaeck et al in the modified method of Chang et al for the determination of pancreatic cancer.
With respect to the recitation “early stage pancreatic ductal adenocarcinoma or pancreatitis” as currently recited. Chang et al teaches that the method is for the early diagnosis (e.g. page 17) and although Chang et al is silent with respect to the stage as being early the combination of Chang et al., Goodson and Borrebaeck et al teach the detection of the same biomarkers in the same sample and the same steps as currently recited and therefore absent evidence to the contrary it is deemed that the modified method of Chang et al is detecting early stage pancreatic ductal adenocarcinoma or pancratitis.
Claims 8-9 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 2, 4-6, 10, 13 and 28-29 above, and further in view of Illes et al (Pancreatology, 16, 2016, pages 266-271).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing to teach testing for diabetes mellitus and also fails to teach the control is from a positive diabetes negative pancreatic cancer control.
Illes et al teaches that it is known and conventional in the art that type-2 diabetes mellitus is widely considered to be associated with pancreatic cancer (e.g. abstract). Illes et al teaches that the prevalence of pancreatic cancer in patients with new-onset type-2 diabetes is significantly higher than that in the general population and that screening of these patients is beneficial for detecting pancreatic cancer in asymptomatic T2DM.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the testing of new onset type-2 diabetes mellitus in the subjects in the modified method of Chang et al because Illes etal shows that patients with new-onset type-2 diabetes is significantly higher than that in the general population and that screening of these patients is beneficial for detecting pancreatic cancer in asymptomatic T2DM. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the testing of new onset type-2 diabetes mellitus in the subjects in the modified method of Chang et al.
It would have also been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a positive diabetes mellitus with negative pancreatic caner as a control because one of ordinary skill in the art would understand that this provides for a diagnosis of pancreatic cancer with reaffirmed assurance because one or ordinary skill in the art would recognize that both being increased in the sample indicates the subject as pancreatic cancer associated with diabetes.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 2, 4-6, 10, 13 and 28-29 above, and further in view of Hess et al (US 2013/0122530) and Drum et al (US 2014/0011728).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing to teach the use of monoclonal antibodies for the detection of adiponectin and IL-1Ra.
Hess et al teaches that it is known and conventional in the art to use monoclonal antibodies specific for adiponectin for the detection of adiponectin (e.g. para 0248).
Drum et al teaches that it is known and conventional in the art to use monoclonal antibodies specific for IL-1Ra for the detection of IL-1Ra (e.g. para 0124).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate antibodies such as taught by Hess et al and Drum et al into the modified method of Chang et al for the detection of adiponectin and IL-1Ra because Hess et al and Drum et al show that it is known and conventional. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating antibodies such as taught by Hess et al and Drum et al into the modified method of Chang et al for the detection of adiponectin and IL-1Ra.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 2, 4-6, 10, 13 and 28-29 above, and further in view of Tummala et al (Journal of Gastrointestinal Oncoloy, Vol. 2, No. 3, September 2011, pages 168-174).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing to teach the subject is imaged.
Tummala et al teaches that it is known and conventional in the art to image a subject (e.g. abstract, page 172). Tummala et al teaches that this imaging provides promise in differentiating pancreatic cancer from pancreatitis (e.g page 172).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate imaging such as taught by Tummala et al into the modified method of Chang et al because Tummala et al shows that it is known and conventional in the art and provides for differentiating pancreatic cancer from pancreatitis. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating imaging such as taught by Tummala et al into the modified method of Chang et al.
Claims 16, 19 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 2, 4-6, 10, 13 and 28-29 above, and further in view of Conroy et al (The Ne England Journal of Medicine, Vol. 379, NO.25, December 2018, pages 2395-2406).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing to teach treating the subject once identified with the pancreatic cancer.
Conroy et al teaches that it is known in the art that surgery such as resection is the only chance of cure in pancreatic adenocarcinoma (e.g. pag 2396). Conroy et al also teaches chemotherapy with FOLFIRINOX which leads to longer overall survival (e.g. abstract, page 2403).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate resection and/or FOLFIRINOX into the modified method of Chang et al for treatment to a subject identified with pancreatic adenocarcinoma because Conroy et al teaches that surgery such as resection is the only chance of a cure and also teaches that therapy with FOLFIRINOX leads to longer overall survival. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating resection surgery and/or FOLFIRINOX therapy such as taught by Conroy into the modified method of Chang et al.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 1-2, 4-6, 10 and 13 above, and further in view of Blankenberg et al (US 20060105419).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing to teach detection of the IL-1Ra at a 2-fold level.
However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease) the test is considered to be indicative of one state or condition (e.g., diseased) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate comparison to a control and to arrive at the claimed invention by optimizing cutoff levels (e.g. at a 2-fold) in order to achieve a desired sensitivity and specificity as claimed, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such levels of sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson and Borrebaeck et al as applied to claims 1-2, 4-6, 10 and 13 above, and further in view of Haab et al (US 2011/0257029).
See above for the teachings of Chang et al., Goodson and Borrebaeck et al.
Chang et al., Goodson and Borrebaeck et al differ from the instant invention in failing explicitly teach the use of a monoclonal antibody to bind the CA-19-9 for detecting the CA-19-9.
Haab et al teaches that it is known and conventional in immunoassay to use a monoclonal antibody that specifically binds to CA-19-9 to provide for the detection of the complex (e.g para 0071).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate an antibody such as taught by Haab et al into the method of Chang for the detection of Ca-19-9 because Chang et al specifically teaches that an immunoassay can be used for the detection and Haab et al teaches that it is well known, routine and conventional. Further, as is known in the art immunoassays implies an assay with the use of an antibody. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating an antibody such as taught by Haab et al into the modified method of Chang for the detection of Ca-19-9.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al., in view of Goodson., Borrebaeck et al and Conroy et al as applied to claims 2, 4-6, 10, 13 and 28-29 above, and further in view of Blankenberg et al (US 20060105419).
See above for the teachings of Chang et al., Goodson., Borrebaeck et al., and Conroy et al.
Chang et al., Goodson., Borrebaeck et al and Conroy et al differ from the instant invention in failing to teach detection of the IL-1Ra at a 2-fold level.
However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease) the test is considered to be indicative of one state or condition (e.g., diseased) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate comparison to a control and to arrive at the claimed invention by optimizing cutoff levels (e.g. at a 2-fold) in order to achieve a desired sensitivity and specificity as claimed, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such levels of sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al).
Response to Arguments
Applicant's arguments filed 01/14/26 have been fully considered but they are not persuasive.
103 Rejections:
Applicant argues that the references are silent with respect to the association of both adiponenction and IL-1Ra with early-stage pancreatic ductal adenocarcinoma or pancreatitis.
This argument is not found persuasive because as stated supra Chang et al teaches that the method is for the early diagnosis (e.g. page 17) and although Chang et al is silent with respect to the stage as being early the combination of Chang et al., Goodson and Borrebaeck et al teach the detection of the same biomarkers in the same sample and the same steps as currently recited and therefore absent evidence to the contrary it is deemed that the modified method of Chang et al is detecting early stage pancreatic ductal adenocarcinoma or pancreatitis.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
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, Gregory Emch can be reached at 571-272-8149. 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.
/GARY COUNTS/ Primary Examiner, Art Unit 1678