Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the request for continued examination and amendment filed 1/12/26. As directed by the amendment, claim 41 has been added and no claims have been amended nor cancelled. As such, claims 21-41 are pending in the instant application.
Claim Objections
Claim 21 is objected to because of the following informalities: the language “a volume of pulse of the gas” (line 5-6) is objected to for a typographical/grammatical error; Examiner suggests amending to read –a volume of the pulse of the gas--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 41 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 41, the newly added claim sets forth that the nasal cannula has a lumen for delivery of nitric oxide and does not include a second/additional lumen for delivery of gas including oxygen appears to introduce new matter not found in the disclosure as originally filed. The embodiments of the original disclosure does not appear to support a single lumen which delivers gas including nitric oxide and excludes any other lumens, such as one for delivery of gas including oxygen.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9,795,756.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claim 15 includes each method step as claimed and includes additional features (such as the first through third lumens) such that it is a more narrow version of the instant claims. As such, any infringement of the patent claims would result in infringement on the instant claims.
Instant claims 21-23, 25, 28-30, 32, 35-37, and 39 correspond to patent claim 15.
Regarding instant claims 24, 31, and 38, the patent claim 15 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 15 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 15 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 15 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9,795,756 in view of Smith (3,513,844).
Regarding instant claim 41, the patent claim 15 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 15 and 13), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 15 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 15 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of U.S. Patent No. 9,032,959.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claim 30 includes each method step as claimed and includes additional features (such as the first through third lumens) such that it is a more narrow version of the instant claims. As such, any infringement of the patent claims would result in infringement on the instant claims.
Instant claims 21-23, 25, 28-30, 32, 35-37, and 39 correspond to patent claim 30.
Regarding instant claims 24, 31, and 38, the patent claim 30 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 30 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 30 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 30 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of U.S. Patent No. 9,032,959 in view of Smith.
Regarding instant claim 41, the patent claim 30 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 30 and 27), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 30 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 30 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26 of U.S. Patent No. 8,770,199.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claim 26 includes each method step as claimed and includes additional features (such as the first through third lumens) such that it is a more narrow version of the instant claims. As such, any infringement of the patent claims would result in infringement on the instant claims.
Instant claims 21-23, 25, 28-30, 32, 35-37, and 39 correspond to patent claim 26.
Regarding instant claims 24, 31, and 38, the patent claim 26 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 26 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 26 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 26 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26 of U.S. Patent No. 8,770,199 in view of Smith.
Regarding instant claim 41, the patent claim 26 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 26 and 23), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 26 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 26 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 10,556,082 in view of Figley et al. (6,668,828).
Regarding instant claims 21, 28, and 35, although the claims at issue are not identical, they are not patentably distinct from each other because the ordinary use of the nasal cannula includes each step and structural and functional limitation as claimed (see patent claims 7 and 1, specifically claim 7 regarding pulse delivery of nitric oxide). Patent claim 7 is silent as to the use of the nasal cannula for delivery of pulses of nitric oxide to explicitly be used to treat a patient suffering from pulmonary hypertension; however, pulsed delivery of nitric oxide to a user is known to treat pulmonary hypertension as taught by Figley (see Figley col. 1 ln. 26-32, col. 15 ln. 63 through col. 16 ln. 2, col. 16 ln. 65 through col. 17 ln. 10). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 7 device’s use method to be used to treat a patient suffering from pulmonary hypertension, as taught by Figley, as this is a well-known treatment method for pulmonary hypertension (see Figley col. 1 ln. 26-32).
Instant claims 22-23, 25, 29-30, 32, 36-37, and 39 correspond to patent claim 7.
Regarding instant claims 24, 31, and 38, the patent claim 7 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 7 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 7 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 7 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 10,556,082 in view of Figley and Smith.
Regarding instant claim 41, the patent claim 7 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 7 and 1), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 7 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 7 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4-5, 7, 8-9, 11-12, 14, 15-16, 18-19 of U.S. Patent No. 10,918,819.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims includes each method step as claimed and includes additional features (such as the volume being less than 20% of the pulse volume) such that it is a more narrow version of the instant claims. As such, any infringement of the patent claims would result in infringement on the instant claims.
Instant claims 21 and 25 correspond to patent claim 1.
Instant claims 28 and 32 correspond to patent claim 8.
Instant claims 35 and 39 correspond to patent claim 15.
Instant claims 22, 29, and 36 correspond to patent claims 2, 9, and 16, respectively.
Instant claims 23, 30, and 37 correspond to patent claims 4, 11, and 18, respectively.
Instant claims 24, 31, and 38 correspond to patent claims 5, 12, 19, respectively.
Instant claims 26 and 33 correspond to patent claims 7 and 14, respectively.
Regarding instant claims 27, 34, and 40, the patent claims 1, 8, and 15, respectively, are silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claims 1, 8, and 15 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,918,819 in view of Smith.
Regarding instant claim 41, the patent claim 1 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 1), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 1 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this is a well-known nasal cannula configuration which would have been obvious to try one would expect the modified patent claim 1 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 9,550,039 in view of Figley.
Regarding instant claims 21, 28, and 35, the ordinary use of the nasal cannula of patent claim 7 includes each step and structural and functional limitation as claimed (see patent claims 7 and 1, patent claim 7 in particular regarding pulsed delivery of nitric oxide). Patent claim 7 is silent as to the use of the nasal cannula for delivery of pulses of nitric oxide to explicitly be used to treat a patient suffering from pulmonary hypertension; however, pulsed delivery of nitric oxide to a user is known to treat pulmonary hypertension as taught by Figley (see Figley col. 1 ln. 26-32, col. 15 ln. 63 through col. 16 ln. 2, col. 16 ln. 65 through col. 17 ln. 10). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 7 device’s use method to be used to treat a patient suffering from pulmonary hypertension, as taught by Figley, as this is a well-known treatment method for pulmonary hypertension (see Figley col. 1 ln. 26-32).
Instant claims 22-23, 25, 29-30, 32, 36-37, and 39 correspond to patent claim 7.
Regarding instant claims 24, 31, and 38, the patent claim 7 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 7 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 7 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 7 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 9,550,039 in view of Figley and Smith.
Regarding instant claim 41, the patent claim 7 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 7 and 1), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 7 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 7 to perform equally as well.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,786,687 in view of Figley.
Regarding instant claims 21, 28, and 35, the ordinary use of the nasal cannula of patent claim 15 includes each step and structural and functional limitation as claimed (see patent claims 15 and 11, patent claim 15 in particular regarding pulsed delivery of nitric oxide). Patent claim 15 is silent as to the use of the nasal cannula for delivery of pulses of nitric oxide to explicitly be used to treat a patient suffering from pulmonary hypertension; however, pulsed delivery of nitric oxide to a user is known to treat pulmonary hypertension as taught by Figley (see Figley col. 1 ln. 26-32, col. 15 ln. 63 through col. 16 ln. 2, col. 16 ln. 65 through col. 17 ln. 10). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 15 device’s use method to be used to treat a patient suffering from pulmonary hypertension, as taught by Figley, as this is a well-known treatment method for pulmonary hypertension (see Figley col. 1 ln. 26-32).
Instant claims 22-23, 25, 29-30, 32, 36-37, and 39 correspond to patent claim 15.
Regarding instant claims 24, 31, and 38, the patent claim 15 is silent as to the pulse of nitric oxide having a volume less than 1 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired amount of nitric oxide to a user to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 26 and 33, the patent claim 15 is silent as to the nitric oxide flow path having a volume less than or equal to 0.035 mL; however, this amount would have been an obvious mater of design choice and would have been obvious to choose in order to provide a desired flow path size to allow for a desired amount of nitric oxide delivery to the patient to achieve a therapeutic effect of the nitric oxide.
Regarding instant claims 27, 34, and 40, the patent claim 15 is silent as to explicitly stating that the cannula at least one of inhibits mixing of nitric oxide and oxygen or reducing delivery of nitrogen dioxide to the patient; however, the patent claim 19 includes each structural and functional limitation as claimed such that it would also inherently perform these functions.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,786,687 in view of Figley and Smith.
Regarding instant claim 41, the patent claim 15 includes a nasal cannula including a lumen for delivery of gas including nitric oxide (see patent claim 15 and 11), but is silent as to excluding a second lumen for delivery of gas including oxygen; however, Smith discloses a similar nasal cannula whose use includes method of delivery of gas through the cannula having a single lumen (see Fig. 1, 3, nasal prongs 14 are single lumen structures). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patent claim 15 nasal cannula to be a singular lumen nasal cannula, as taught by Smith, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 15 to perform equally as well.
Response to Arguments
Applicant's arguments filed 1/12/26 have been fully considered but they are not persuasive.
Applicant argues that claim 7 of U.S. Patent No. 10,556,082; claim 7 of U.S. Patent No. 9,550,039; and claim 15 of U.S. Patent No. 11,786,687 are directed to nasal cannulas per se and not necessarily used for delivery of a pulse of a gas including nitric oxide for the treatment of pulmonary hypertension as currently claimed (see pg. 7 of the response). This is not well-taken as each of the claims of the above noted U.S. Patents disclose pulsed delivery of nitric oxide, but are silent as to this being done explicitly to treat pulmonary hypertension. The patent claims all disclose that the nasal cannula is used for therapeutic gas delivery “to a patient in need thereof” (see the independent claims the above noted claims depend on), and Figley teaches that pulsed delivery of nitric oxide can be used to treat various diseases/conditions such as pulmonary hypertension (see Figley col. 1 ln. 26-32, col. 15 ln. 63 through col. 16 ln. 2, col. 16 ln. 65 through col. 17 ln. 10) and thus it would have been obvious to one of ordinary skill in the art to modify the above noted patent claims to be explicitly targeted for a patient with pulmonary hypertension as the ‘patient in need thereof’ of the claims as it is well-known that pulsed nitric oxide delivery is capable to treating such a patient/condition.
Applicant argues that Figley describes disadvantages to using dual lumen nasal cannula for pulsed delivery of nitric oxide and therefore Figley teaches away from one of ordinary skill in the art from combining Figley with the patent claims (see pg. 7-8 of the response). This is not well-taken as the Figley reference was relied upon for the well-known teaching that nitric oxide delivery can treat pulmonary hypertension and was not relied upon for any teaching regarding the structure of the nasal cannula for pulsed delivery of nitric oxide. Therefore, even if Figley describes certain modes of pulsed delivery of nitric oxide as having disadvantages that does not negate the teaching of Figley that nitric oxide delivery treats pulmonary hypertension. One of ordinary skill in the art would not have been dissuaded from modifying the patent claims, which already teach pulsed delivery of nitric oxide, to explicitly deliver pulsed nitric oxide to a patient suffering from pulmonary hypertension as the patent claims already are for “a patient in need thereof” (in need of pulsed nitric oxide delivery) and Figley teaches that a patient with pulmonary hypertension is such a patient in need thereof.
Applicant’s argument that portions of Figley which allegedly teach nitric oxide delivery for treatment of pulmonary hypertension cannot be relied upon and disregard portions of Figley which teach away (see pg. 8-9 of the response) is not well-taken. The portion which Applicant cites (col. 3 ln. 8-18) describes a known method of pulse delivery of nitric oxide with supplemental oxygen delivery and Figley describes this method’s disadvantages in the context of the Figley invention; however, this would not dissuade one of ordinary skill in the art from recognizing that Figley teaches the well-known treatment of pulmonary hypertension with pulsed nitric oxide gas delivery. One of ordinary skill in the art would still recognize the above cited teachings of Figley (col. 1 ln. 26-32, col. 15 ln. 63 through col. 16 ln. 2, col. 16 ln. 65 through col. 17 ln. 10) would still apply to the reference patents above. For example, the reference patent 10,556,082 claims a nasal cannula for therapeutic gas delivery to a patient in need thereof (see preamble to patent claim 1) and pulsed delivery of a gas including nitric oxide (see patent claim 7) and one of ordinary skill in the art would be motivated by the teachings of Figley to choose, as the ‘patient in need thereof’ of patent claim 1, a patient suffering from pulmonary hypertension. One of ordinary skill in the art would not have been dissuaded from such a combination in view of Figley’s description of other known methods of pulsed nitric oxide delivery in col. 3 ln. 8-18. Figley’s description of other known methods of pulsed nitric oxide delivery does not negate Figley’s recognition that pulsed delivery of nitric oxide is beneficial to treat a patient with pulmonary hypertension.
Conclusion
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/COLIN W STUART/Primary Examiner, Art Unit 3785