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 .
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 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 128 and 130-133 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (USPGPub 2014/0079755).
Regarding claims 128 and 130, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. It is not stated that in order to use the implant of Eaton that a patient must exhibit any of the two symptoms claimed. However, the examiner is taking Official Notice that all of the symptoms listed are readily associated with the occurrence of nasal polyps. Therefore performing the implantation of Eaton in view of Ow would reasonably become more logical with the more symptoms associated with nasal polyps that a patient exhibited. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the implantation of Eaton on a patient experiencing a plurality of symptoms in order to treat said symptoms. Further it is noted that the drug of Eaton is intended to reduce polyp size.
Regarding claims 131-133, the teachings of Eaton are as shown above. Eaton fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in order to control the release rate, dose and treatment timeframe of the invention of Eaton.
Regarding claims 74-76 the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Ow in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Ow.
Claims 71-82, 87-100, 105-112, 129 and 134 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (USPGPub 2014/0079755) in view of Ow et al. (“Steroid-eluting sinus implant for in-office treatment of polyposis: a pharmacokinetic study” International Forum of Allergy and Rhinology, Vol. 4, 10/2014, pp. 816-822).
Regarding claims 71-73 and 77-78, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. Eaton fails to state that the condition being treated by his invention is polypsis caused by the presence of polys. However, Ow teaches that it is known to implant steroid eluting sinus implants which release mometasone furoate (see Results and Table 2) bilaterally, wherein the bilateral treatment is shown to provide successful treatment for sinus obstruction caused by polyposis. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the implants of Eaton unilaterally if polyps were present on one side or bilaterally as shown by Ow because Ow shows that placement of those types of devices is shown to effectively treat conditions such a polyposis.
Regarding claims 74-76 the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Ow in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Ow.
Regarding claim 79, Eaton teaches wherein the device may have uncompressed diameters in the range claimed [0064]
Regarding claims 80-82, the self-expanding devices of Eaton would be considered scaffolds (title).
Regarding claims 87-89 and 93-94, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. Eaton fails to state that the condition being treated by his invention is polypsis caused by the presence of polys. However, Ow teaches that it is known to implant steroid eluting sinus implants which release mometasone furoate (see Results and Table 2) bilaterally, wherein the bilateral treatment is shown to provide successful treatment for sinus obstruction caused by polyposis. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the implants of Eaton unilaterally if polyps were present on one side or bilaterally as shown by Ow because Ow shows that placement of those types of devices is shown to effectively treat conditions such a polyposis. Further it is noted that the drug of Eaton is intended to reduce polyp size.
Regarding claims 90-92, the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Ow in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Ow.
Regarding claims 95-96, Eaton teaches wherein the device may have uncompressed diameters in the range claimed [0064].
Regarding claims 97-99, the self-expanding devices of Eaton would be considered scaffolds (title).
Regarding claim 100, because Eaton teaches that the implants may be placed before or after surgery, it is reasonably implied that when the implant is placed after surgery, the space would be considered a surgically modified space.
Regarding claims 105-107 and 111-112, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. Eaton fails to state that the condition being treated by his invention is polypsis caused by the presence of polys. However, Ow teaches that it is known to implant steroid eluting sinus implants which release mometasone furoate (see Results and Table 2) bilaterally, wherein the bilateral treatment is shown to provide successful treatment for sinus obstruction caused by polyposis. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the implants of Eaton unilaterally if polyps were present on one side or bilaterally as shown by Ow because Ow shows that placement of those types of devices is shown to effectively treat conditions such a polyposis. It is not stated that in order to use the implant of Eaton in view of Ow that a patient must exhibit any of the two symptoms claimed. However, the examiner is taking Official Notice that all of the symptoms listed are readily associated with the occurrence of nasal polyps. Therefore performing the implantation of Eaton in view of Ow would reasonably become more logical with the more symptoms associated with nasal polyps that a patient exhibited. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the implantation of Eaton in view of Ow on a patient experiencing a plurality of symptoms in order to treat said symptoms. Further it is noted that the drug of Eaton is intended to reduce polyp size.
Regarding claims 108-110, the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Ow in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Ow.
Regarding claims 129 and 134, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. Eaton fails to state that the condition being treated by his invention is polypsis caused by the presence of polys. However, Ow teaches that it is known to implant steroid eluting sinus implants which release mometasone furoate (see Results and Table 2) bilaterally, wherein the bilateral treatment is shown to provide successful treatment for sinus obstruction caused by polyposis. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the implants of Eaton unilaterally if polyps were present on one side or bilaterally as shown by Ow because Ow shows that placement of those types of devices is shown to effectively treat conditions such a polyposis. It is not stated that in order to use the implant of Eaton in view of Ow that a patient must exhibit any of the two symptoms claimed. However, the examiner is taking Official Notice that all of the symptoms listed are readily associated with the occurrence of nasal polyps. Therefore performing the implantation of Eaton in view of Ow would reasonably become more logical with the more symptoms associated with nasal polyps that a patient exhibited. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the implantation of Eaton in view of Ow on a patient experiencing a plurality of symptoms in order to treat said symptoms. Further it is noted that the drug of Eaton is intended to reduce polyp size. Further, because Eaton teaches that the implants may be placed before or after surgery, it is reasonably implied that the area in which the implant is placed would be considered a surgically modified space.
Claims 83-86 and 101-104 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (USPGPub 2014/0079755) in view of Ow et al. (“Steroid-eluting sinus implant for in-office treatment of polyposis: a pharmacokinetic study” International Forum of Allergy and Rhinology, Vol. 4, 10/2014, pp. 816-822) as applied to claims 71-82, 87-100, 105-112, 129 and 134 above and further in view of Metson et al. (“Clinical Outcome of Endoscopic Surgery for Frontal Sinusitis” JAMA Otolaryngology-Head & Neck Surgery, Vol. 124, No 10, 1998 pp. 1-14).
Regarding claims 83-86, the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach performing CT scans before or after sinusitis surgery in order to measure opacification. However, Metson shows that CT scans are commonly performed prior art and after sinusitis surgery to measure opacification prior art and after treatment (see Results section). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to as a use of a known scanning methodology using to improve a sinusitis surgery outcome in the same way.
Regarding claims 101-104, the teachings of Eaton in view of Ow are as shown above. Eaton in view of Ow fails to teach performing CT scans before or after sinusitis surgery in order to measure opacification. However, Metson shows that CT scans are commonly performed prior art and after sinusitis surgery to measure opacification prior art and after treatment (see Results section). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to as a use of a known scanning methodology using to improve a sinusitis surgery outcome in the same way.
Claims 113, 115-121 and 123-127 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (USPGPub 2014/0079755) as applied to claims 128 and 130-133 above and further in view of Rudmik (“Using Preoperative SNOT-22 Score to Inform Patient Decision for Endoscopic Sinus Surgery” Laryngoscope, 07/2015, Vol. 7, pp 1517-1522).
Regarding claims 113, 115 and 119-120, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. It is not stated that in order to use the implant of Eaton that a patient must exhibit any of the two symptoms claimed. However, the examiner is taking Official Notice that all of the symptoms listed are readily associated with the occurrence of nasal polyps. Therefore performing the implantation of Eaton in view of Ow would reasonably become more logical with the more symptoms associated with nasal polyps that a patient exhibited. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the implantation of Eaton on a patient experiencing a plurality of symptoms in order to treat said symptoms. Further it is noted that the drug of Eaton is intended to reduce polyp size. . Eaton fails to teach wherein a SNOT test is performed before the implantation of the medical devices so as to determine if the patient is a candidate for a surgery wherein the implantation method using the sinus stents is used as an alternative and wherein the patient is found to be improved to a point such that at the end of a 12 week period following the implantation procedure the patient is no longer qualified for the surgical procedure that they would have been qualified for based on the SNOT test. However, Rudmik teaches that it is known to use pre-operative SNOT scores to determine if a patient is a good candidate for endoscopic sinus surgery (see Conclusions) wherein the SNOT score is used as part of the analysis of a doctor wherein they commonly weigh factors including risk versus benefit, known alternatives and respective costs (see Introduction) for the treatment of chronic sinusitis wherein ESS is one possible technique for treatment (see Objective) wherein it is noted that the purpose of the SNOT score to help achieve at least an MCID corresponding to a reduced SNOT score (see Results), wherein a low obtained SNOT score would disqualify a patient for surgery as described above. Based on the collective teachings of Rudmik and Eaton, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to obtain a SNOT score for a patient with sinusitis in order to determine if ESS was warranted as described by Eaton and thereafter to choose an alternative treatment technique based on factors such as risk versus reward, known alternatives and respective costs such as the technique provided by Eaton for treating sinusitis by implanting drug coated stents in the sinus cavities, wherein if the treatment were successful based on a post-treatment SNOT score as also provided by Rudmik a doctor could determine that a patient was no longer eligible for ESS considering the improvement provided to the patients quality of life as described by Rudmik and would be the presumed purpose of the invention of Eaton as an overview. It is further noted that SNOT scoring reads upon a measuring a reduction of symptoms.
Regarding claims 116-118, the teachings of Eaton in view of Rudmik are as shown above. Eaton in view of Rudmik fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Rudmik in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Rudmik.
Regarding claims 121, 123 and 127, Eaton teaches providing a self-expanding (abstract) implant wherein the implant, based on the zero order release of Eaton [0115], drug amounts that can be released per day [0114] and the number of days over which the drug may be released [0091], may contain more than 5000 micrograms of mometasone furoate [0114] wherein the implant is described as being implanted near a paranasal sinus [0003] or within one or more sinus cavities or sinus regions including the nasal passage [0006] wherein this teaching is reasonably implicit of the middle meatus and have a zero order release for 120 days or longer [0005]. Further, Eaton teaches that his implants may be used “before or after surgery” [0203], reasonably implying use on a patient that has not yet had a surgery. It is not stated that in order to use the implant of Eaton that a patient must exhibit any of the two symptoms claimed. However, the examiner is taking Official Notice that all of the symptoms listed are readily associated with the occurrence of nasal polyps. Therefore performing the implantation of Eaton in view of Ow would reasonably become more logical with the more symptoms associated with nasal polyps that a patient exhibited. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform the implantation of Eaton on a patient experiencing a plurality of symptoms in order to treat said symptoms. Further it is noted that the drug of Eaton is intended to reduce polyp size. . Eaton fails to teach wherein a SNOT test is performed before the implantation of the medical devices so as to determine if the patient is a candidate for a surgery wherein the implantation method using the sinus stents is used as an alternative and wherein the patient is found to be improved to a point such that at the end of a 12 week period following the implantation procedure the patient is no longer qualified for the surgical procedure that they would have been qualified for based on the SNOT test. However, Rudmik teaches that it is known to use pre-operative SNOT scores to determine if a patient is a good candidate for endoscopic sinus surgery (see Conclusions) wherein the SNOT score is used as part of the analysis of a doctor wherein they commonly weigh factors including risk versus benefit, known alternatives and respective costs (see Introduction) for the treatment of chronic sinusitis wherein ESS is one possible technique for treatment (see Objective) wherein it is noted that the purpose of the SNOT score to help achieve at least an MCID corresponding to a reduced SNOT score (see Results), wherein a low obtained SNOT score would disqualify a patient for surgery as described above. Based on the collective teachings of Rudmik and Eaton, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to obtain a SNOT score for a patient with sinusitis in order to determine if ESS was warranted as described by Eaton and thereafter to choose an alternative treatment technique based on factors such as risk versus reward, known alternatives and respective costs such as the technique provided by Eaton for treating sinusitis by implanting drug coated stents in the sinus cavities, wherein if the treatment were successful based on a post-treatment SNOT score as also provided by Rudmik a doctor could determine that a patient was no longer eligible for ESS considering the improvement provided to the patients quality of life as described by Rudmik and would be the presumed purpose of the invention of Eaton as an overview. It is further noted that SNOT scoring reads upon a measuring a reduction of symptoms. Further because Eaton teaches that the implants may be placed before or after surgery, it is reasonably implied that the area in which the implant is placed would be considered a surgically modified space.
Regarding claims 124-126, the teachings of Eaton in view of Rudmik are as shown above. Eaton in view of Rudmik fails to teach drug release for periods longer than 120 days in detail although he explicitly teaches periods longer than 120 days. However, those of ordinary skill in the art would readily recognize that period over which the drug releases would directly affect the amount of drug released, the dosage over a given period of time and the total treatment period. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the release timeframe of the invention of Eaton in view of Rudmik in order to control the release rate, dose and treatment timeframe of the invention of Eaton in view of Rudmik.
Claims 114 and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (USPGPub 2014/0079755) in view of Rudmik (“Using Preoperative SNOT-22 Score to Inform Patient Decision for Endoscopic Sinus Surgery” Laryngoscope, 07/2015, Vol. 7, pp 1517-1522) as applied to claims 113, 115-121 and 123-127 above and further in view of Ow et al. (“Steroid-eluting sinus implant for in-office treatment of polyposis: a pharmacokinetic study” International Forum of Allergy and Rhinology, Vol. 4, 10/2014, pp. 816-822).
Regarding claim 114 the teachings of Ow are reasonably applicable to the teachings of Eaton in view of Rudmik in the same way that they were applicable to the teachings of Eaton alone as in the rejection of claim 128 above.
Regarding claim 122 the teachings of Ow are reasonably applicable to the teachings of Eaton in view of Rudmik in the same way that they were applicable to the teachings of Eaton alone as in the rejection of claim 128 above.
Conclusion
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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