DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Status of Application
The response filed 11/18/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 32, 67, 69-70, 72 have been amended.
Claim 24, 59 has been cancelled.
Claims 1-4, 15-16, 22-23, 30-32, 34, 39, 50-51, 57-58, 67-72 are pending in the case.
Claims 1-4, 15-16, 22-23, 30-32, 34, 39, 50-51, 57-58, 67-72 are present for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
Information Disclosure Statement
The information disclosure statement filed 11/18/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed 11/18/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no English translation for the publication listed. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 recites the limitation “wherein the multikinase inhibitor is a pharmaceutically acceptable salt” in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites that “the multikinase inhibitor is selected from the group consisting of axitinib, nintedanib, regorafenib, and pazopanib, and a combination thereof” which are all free bases and does not recite or allow for a pharmaceutically acceptable salt; wherein it is unclear how it can be a pharmaceutically acceptable salt as the independent claim does not recite for the one and lacks antecedent basis. It does not allow one to ascertain the metes and bounds of the claim as written. For purposes of examination, it is treated to include a pharmaceutically acceptable salt of these recited claimed multikinase inhibitors.
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 30 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 claim recites “wherein the multikinase inhibitor is a free base” and depends from claim 1 which recites that “the multikinase inhibitor is selected from the group consisting of axitinib, nintedanib, regorafenib, and pazopanib, and a combination thereof” which are all free bases; wherein claim 30 does not further limit the claim from which it depends from.
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 31 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 claim recites “wherein the multikinase inhibitor is a pharmaceutically acceptable salt” and depends from claim 1 which recites that “the multikinase inhibitor is selected from the group consisting of axitinib, nintedanib, regorafenib, and pazopanib, and a combination thereof” which are all free bases and does not recite or allow for a pharmaceutically acceptable salt; wherein claim 31 is broader than the claim from which it depends – therein it does not further limit the claim from which it depends from.
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
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.
Claims 1, 30-32, 34, 39, 67-72 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (U.S. Pat. Pub. 2017/0172915).
Rejection:
Ni teaches treating pterygium and inducing pterygium regression including the hyperemia and symptoms in pterygium patients with the administration of a multikinase inhibitor in a patient in need thereof (identifying the subject, Abstract, claims 36-41, 56-58, 61). Symptoms of pterygium include hyperemia (red eye from blood vessels), ocular discomfort, and risk of visual impairment [27]. The multikinase inhibitors include nintedanib, which can be in free base or pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, claims 36 and 41 [8, 14-16]). The multikinase inhibitor can be given topically or in a sustained release formulation or implant ([10], claims 43-45, 63-65). It can be used to treat pinguecula and pseudopterygium of a patient in need of such treatment, with administering to an affected eye of the subject a therapeutically effective amount of a multikinase inhibitor [12]. Example 2 teaches treating pterygium in a mouse patient (a patient in need thereof) with 0.2% nintedanib which lead to a reduction in the pterygium a reduced neovascularization score [91, 99]. Example 3 teaches a nintedanib ophthalmic solution [100], suspension [101, emulation [102], semisolid [103], sustained release implant [104]. It is noted that any pterygium being treated must intrinsically be either the first appearance/presentation (primary) or a repeat/recurring appearance/presentation of pterygium.
While Ni does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit - if not prima facie obvious - that the patient is worried/anxious about the condition/appearance of the affected eye and reports their concern/worry/anxiety and symptoms when seeking treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium like red eye (hyperemia), if not concerned/worried/anxious about it and the doctor has determined the patient’s reported concern/worry/anxiety/symptoms before treating it). Wherein it is also implicit -if not prima facie obvious - that as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are centered on the assertion that Ni does not suggest identifying a subject with worry/anxiety about the appearance of the affected (claim 1) eye or the patient population that had previously been determined to have worry/anxiety about the appearance of the eye (claim 32) wherein the limitations of the claim are not suggested by Ni, and the assertion of surprising results in Example 1 and that the claims are commensurate in scope with the claims as multikinase inhibitors claimed (axitinib, nintedanib, regorafenib, pazopanib) have similar pharmacological potencies to VEGF receptors citing Table 1 of the prior art of Ni.
This is fully considered but not persuasive.
Applicant’s assertion that Ni does not suggest identifying a subject that is worried/anxious/concerned about the appearance of the pterygium that is seeking treatment is not persuasive as addressed above, it is implicit that the person that is seeking and having treatment for pterygium which is an abnormal growth extending from the nasal or temporal conjunctiva across the limbus onto the cornea and hyperemia which makes the eye red, is worried/anxious/concerned about the pterygium/appearance/symptoms which is why they are seeking/having treatment with the multikinase inhibitor as one does not seek treatment for the affected eye if you are not concerned/worried/anxious about its presentation. The concern/worry/anxiety about the pterygium/appearance/symptoms/hyperemia (red eye) would have been determined prior to delivering treatment where it is implicit if not prima facie obvious that as the condition like pterygium/hyperemia improves with treatment, that the concern/worry/anxiety about the pterygium/hyperemia improves (reduces); wherein there is a reasonable expectation of success.
As for the assertion of surprising results in Example 1 to the significant reduction in the worry/anxiety of the treated (drug) group verses the untreated (vehicle) group, and that the claims are commensurate in scope with the example, this is not persuasive. The arguments are not commensurate in scope with the example which is 0.2% nintedanib TID (3x/day) for 28 days for treating pterygium which is not the breath claimed (dosing and conditions are broadly claimed). The assertion for surprising/unexpected results is not persuasive especially as the prior art of Ni establishes that the 0.2% nintedanib is better than saline/vehicle in treating the pterygium and its symptoms/appearance, and is taught that it can be given at different doses including 3x/day [63] for an number of days [65, i.e.1-365 days] which can be determined by the physician; wherein improvement in worry/anxiety/concern is not unexpected as the pterygium condition has been treated with the 0.2% nintedanib TID for 28 days (treatment for 28 days TID) and as the pterygium condition improves, the concern/worry/anxiety about the pterygium and its appearance and symptoms will improve/reduce as demonstrated in the example. Applicant has not demonstrated evidence of criticality for the regimen as Ni teaches treating the pterygium with 0.2% nintedanib at doses including 3x/day [63] for an number of days [65, i.e.1-365 days] which can be determined by the physician; wherein as the condition improves – the worry/anxiety/concern improves/reduces. As for the assertion that axitinib, nintedanib, regorafenib, pazopanib have similar pharmacological potencies to VEGF receptors citing Table 1 of the prior art of Ni wherein it would be commensurate in scope with Example 1 of the specification, this goes to the prima facie case of obviousness presented by the Examiner as Applicant is pointing to the prior art of Ni that the multikinase inhibitors would be expected to perform similar functions wherein it multikinase inhibitors would be expected to treat the pterygium and the concern/worry about it for one to seek treatment for it, which goes against a showing of an unexpected result as it demonstrates the teaching of the prior art of Ni.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (U.S. Pat. Pub. 2017/0172915) as applied to claims 1, 30-32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
Rejection:
The teachings of Ni are addressed above.
Ni does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and inducing pterygium regression with the administration of a multikinase inhibitor in a patient in need thereof where is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it when seeking treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those presented in Ni and are addressed above. Applicant’s remaining argument that one would have been motivated to modify the questionnaire in www.rand.org to related to worry or anxiety about the appearance of the eye, and that the Office has not clearly articulated reasoning to do so.
This is fully considered but not persuasive. As addressed above, www.rand.org is presented merely to show that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life); wherein it is prima facie obvious to assess the level of concern/worry and impact the eye condition has on the quality of life of the patient seeking treatment with regards to their concern/grade/score the various feelings including worry and impact the eye condition they are seeking treatment for and how long they have been struggling to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time which has not been presented.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 67-72 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (U.S. Pat. Pub. 2017/0172915) in view of BoxerWachler (What are Pterygium?).
Alternatively, in so far that Ni does not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the condition (i.e. pterygium), the following rejection is presented.
Rejection:
Ni teaches treating pterygium and inducing pterygium regression including the hyperemia and symptoms in pterygium patients with the administration of a multikinase inhibitor in a patient in need thereof (identifying the subject, Abstract, claims 36-41, 56-58, 61). Symptoms of pterygium include hyperemia, ocular discomfort, and risk of visual impairment [27]. The multikinase inhibitors include nintedanib, which can be in free base or pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, claims 36 and 41 [8, 14-16]). The multikinase inhibitor can be given topically or in a sustained release formulation or implant ([10], claims 43-45, 63-65). It can be used to treat pinguecula and pseudopterygium of a patient in need of such treatment, with administering to an affected eye of the subject a therapeutically effective amount of a multikinase inhibitor [12]. Example 2 teaches treating pterygium in a mouse patient (a patient in need thereof) with 0.2% nintedanib which lead to a reduction in the pterygium a reduced neovascularization score [91, 99]. Example 3 teaches a nintedanib ophthalmic solution [100], suspension [101, emulation [102], semisolid [103], sustained release implant [104]. It is noted that any pterygium being treated must intrinsically be either the first appearance/presentation (primary) or a repeat/recurring appearance/presentation of pterygium.
While Ni does not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; Ni teaches treating pterygium (reduction, stabilization, preventing recurrence after surgery) with the administration of multitkinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; and for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a patient presenting with pterygium in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor -to treat the pterygium with the nintedanib as suggested by BoxerWachler, and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the appearance of the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety)). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are centered on the assertion that Ni does not suggest identifying a subject with worry/anxiety about the appearance of the affected (claim 1) eye or the patient population that had previously been determined to have worry/anxiety about the appearance of the eye (claim 32) wherein the limitations of the claim are not suggested by Ni, the assertion of surprising results in Example 1 and that the claims are commensurate in scope with the claims as multikinase inhibitors claimed (axitinib, nintedanib, regorafenib, pazopanib) have similar pharmacological potencies to VEGF receptors citing Table 1 of the prior art of Ni, and that BoxerWachler is directed to conjunctivoplasty to remove the growths wherein one would not have combined the reverences to arrive at the claimed invention.
This is fully considered but not persuasive.
Applicant’s assertion that Ni does not suggest identifying a subject that is worried/anxious/concerned about the appearance of the pterygium that is seeking treatment is not persuasive as addressed above, it is implicit that the person that is seeking and having treatment for pterygium which is an abnormal growth extending from the nasal or temporal conjunctiva across the limbus onto the cornea and hyperemia which makes the eye red, is worried/anxious/concerned about the pterygium/appearance/symptoms which is why they are seeking/having treatment with the multikinase inhibitor as one does not seek treatment for the affected eye if you are not concerned/worried/anxious about its presentation. The concern/worry/anxiety about the pterygium/appearance/symptoms/hyperemia (red eye) would have been determined prior to delivering treatment where it is implicit if not prima facie obvious that as the condition like pterygium/hyperemia improves with treatment, that the concern/worry/anxiety about the pterygium/hyperemia improves (reduces); wherein there is a reasonable expectation of success.
As for the assertion of surprising results in Example 1 to the significant reduction in the worry/anxiety of the treated (drug) group verses the untreated (vehicle) group, and that the claims are commensurate in scope with the example, this is not persuasive. The arguments are not commensurate in scope with the example which is 0.2% nintedanib TID (3x/day) for 28 days for treating pterygium which is not the breath claimed (dosing and conditions are broadly claimed). The assertion for surprising/unexpected results is not persuasive especially as the prior art of Ni establishes that the 0.2% nintedanib is better than saline/vehicle in treating the pterygium and its symptoms/appearance, and is taught that it can be given at different doses including 3x/day [63] for an number of days [65, i.e.1-365 days] which can be determined by the physician; wherein improvement in worry/anxiety/concern is not unexpected as the pterygium condition has been treated with the 0.2% nintedanib TID for 28 days (treatment for 28 days TID) and as the pterygium condition improves, the concern/worry/anxiety about the pterygium and its appearance and symptoms will improve/reduce as demonstrated in the example. Applicant has not demonstrated evidence of criticality for the regimen as Ni teaches treating the pterygium with 0.2% nintedanib at doses including 3x/day [63] for an number of days [65, i.e.1-365 days] which can be determined by the physician; wherein as the condition improves – the worry/anxiety/concern improves/reduces. As for the assertion that axitinib, nintedanib, regorafenib, pazopanib have similar pharmacological potencies to VEGF receptors citing Table 1 of the prior art of Ni wherein it would be commensurate in scope with Example 1 of the specification, this goes to the prima facie case of obviousness presented by the Examiner as Applicant is pointing to the prior art of Ni that the multikinase inhibitors would be expected to perform similar functions wherein it multikinase inhibitors would be expected to treat the pterygium and the concern/worry about it for one to seek treatment for it, which goes against a showing of an unexpected result as it demonstrates the teaching of the prior art of Ni.
BoxerWachler is presented merely to show that it is known that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor for a patient when present in the doctor’s office, wherein it is prima facie obvious when treating the condition as taught by Ni, it resolves the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the appearance of the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety)).
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (U.S. Pat. Pub. 2017/0172915) in view of BoxerWachler (What are Pterygium?).as applied to claims 1, 30-32, 34, 39, 67-72 above, further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
Rejection:
The teachings of Ni in view of BoxerWachler are addressed above.
Ni in view of BoxerWachler does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and inducing pterygium regression with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it when seeking treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with as it is a significant factor for the patient, it is prima facie obvious to apply that questionnaire process to the eye condition that a patient is concerned about and assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those presented with Ni and BoxerWachler which are addressed above.
Accordingly, the rejection stands.
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 1, 30, 32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5, 7 of U.S. Patent No. 12156873.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating ocular hyperemia in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims are not explicit about reciting that the patient is worried/anxious about the condition/appearance of the eye, it is implicit if not prima facie obvious - that the patient is worried/anxious about the condition/appearance of a red eye due to the excess blood vessels in the eye (hyperemia) to report it to the doctor and seek treatment for the condition/appearance of a red eye from the excess blood vessels in the eye which is not a normal presentation of the eye (one does not seek treatment for the hyperemia/appearance of the red eye due to excess blood vessels in the eye, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the red eye with excess blood vessels before treatment); wherein it is implicit if not prima facie obvious that as the hyperemia improves with treatment, that the patient would be relieved there is less redness/excess blood vessels (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same hyperemia (excess blood vessels in the eye), the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of a red eye due to the excess blood vessels in the eye (hyperemia) to report it to the doctor and seek treatment for the condition/appearance of a red eye from the excess blood vessels in the eye which is not a normal presentation of the eye (one does not seek treatment for the hyperemia/appearance of the red eye due to excess blood vessels in the eye, if not concerned/worried/anxious about its presentation as the eye is red which is not normal for the eye), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the red eye) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5, 7 of U.S. Patent No. 12156873 as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims do not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating ocular conditions like hyperemia, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2, 12, 15, 27, 32, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating hyperemia as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating hyperemia with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2,5, 7 of U.S. Patent No. 12156873 as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6 of U.S. Patent No. 12156873 in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims are directed to the method of treating ocular hyperemia in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims are not explicit about reciting that the patient is worried/anxious about the condition/appearance of the eye, it is implicit if not prima facie obvious - that the patient is worried/anxious about the condition/appearance of a red eye due to the excess blood vessels in the eye (hyperemia) to report it to the doctor and seek treatment for the condition/appearance of a red eye from the excess blood vessels in the eye which is not a normal presentation of the eye (one does not seek treatment for the hyperemia/appearance of the red eye due to excess blood vessels in the eye, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the red eye with excess blood vessels before treatment); wherein it is implicit if not prima facie obvious that as the hyperemia improves with treatment, that the patient would be relieved there is less redness/excess blood vessels (have less worry/anxiety).
The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that nintedanib is known to be useful in treating ocular conditions like hyperemia, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2, 12, 15, 27, 32, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating hyperemia as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating hyperemia with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same hyperemia (excess blood vessels in the eye), the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6 of U.S. Patent No. 12156873 in view of Ni (U.S. Pat. Pub. 2017/0172915) as applied to claims 1, 30-32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni are addressed above.
The patented claims in view of Ni does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10, 12-13 of U.S. Patent No. 12491183.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating ocular conditions like pinguecula in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like axitinib or nintedanib (a free base) or their pharmaceutical salts; while the patented claims are not explicit about reciting that the patient is worried/anxious about the condition/appearance of the eye, it is implicit if not prima facie obvious - that the patient is worried/anxious about the condition/appearance of a red eye due to the excess blood vessels in the eye (hyperemia) to report it to the doctor and seek treatment for the condition/appearance of a red eye from the excess blood vessels in the eye which is not a normal presentation of the eye (one does not seek treatment for the hyperemia/appearance of the red eye due to excess blood vessels in the eye, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the red eye with excess blood vessels before treatment); wherein it is implicit if not prima facie obvious that as the hyperemia improves with treatment, that the patient would be relieved there is less redness/excess blood vessels (have less worry/anxiety). As the same actives are being administered for the same condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of these actives for the same recited condition.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable claims 9-10, 12-13 of U.S. Patent No. 12491183 as applied to claims 1, 30-32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Claims 1, 30-32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 11 of U.S. Patent No. 12491183 in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims are directed to the method of treating abnormal neovascularization in the front part of an eye like pinguecula in a subject (identifying the subject), with the topical administration to the eye of certain inhibitors including VEGFR 1-3 inhibitors. While the patented claims are not explicit about reciting that the patient is worried/anxious about the condition/appearance of the eye, it is implicit if not prima facie obvious - that the patient is worried/anxious about the condition/appearance of the eye like pinguecula to report it to the doctor and seek treatment for the condition/appearance of the eye (one does not seek treatment for the abnormal neovascularization like pinguecula, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the eye before treatment); wherein it is implicit if not prima facie obvious that as the pinguecula improves with treatment, that the patient would be relieved (have less worry/anxiety).
The patented claims are silent on the specific VEGFR 1-3 inhibitor.
Ni teaches that nintedanib is a multikinase inhibitor that is an inhibitor of VEGFR1-3 and known to be useful in treating ocular conditions like pinguecula, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, Table 1, [2, 12, 15, 27, 32, 40-43, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pinguecula as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful kinase inhibitors that are inhibitors of VEGFR1-3 and their known salt forms for treating pinguecula with a reasonable expectation of success. As the same inhibitors are being administered for the same pinguecula, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of inhibitors for the same recited condition.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 11 of U.S. Patent No. 12491183 in view of Ni (U.S. Pat. Pub. 2017/0172915) as applied to claims 1, 30-32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni are addressed above.
The patented claims in view of Ni does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 9, 14 of U.S. Patent No. 9980901 or alternatively over claims 3, 9, 14 of U.S. Patent No. 9980901 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating pterygium in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims do not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 3, 9, 14 of U.S. Patent No. 9980901 in view of BoxerWachler (What are Pterygium?).
The teachings of the patented claims are addressed above, and while the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient with pterygium in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 9, 14 of U.S. Patent No. 9980901 or alternatively over claims 3, 9, 14 of U.S. Patent No. 9980901 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims (or alternatively the patented claims in view of BoxerWachler) do not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating pterygium as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating pterygium with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 9, 14 of U.S. Patent No. 9980901 or alternatively over claims 3, 9, 14 of U.S. Patent No. 9980901 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims (or alternatively the patented claims in view of BoxerWachler) are addressed above.
The patented claims (or alternatively the patented claims in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and other ocular conditions with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
.www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to the eye condition that a patient is concerned about and assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 10-13, 15-20 of U.S. Patent No. 9980901 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1-2, 4-8, 10-13, 15-20 of U.S. Patent No. 9980901 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The patented claims are directed to the method of treating pterygium in a patient (identifying the subject), comprising administration to the eye a multikinase inhibitor and an antimetabolite; while the patented claims do not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like pterygium, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating pterygium with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same pterygium, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 1-2, 4-8, 10-13, 15-20 of U.S. Patent No. 9980901 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The teachings of the patented claims in view of Ni are addressed above, and while the patented claims in view of Ni do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims in view of Ni teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient with pterygium in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 10-13, 15-20 of U.S. Patent No. 9980901 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1-2, 4-8, 10-13, 15-20 of U.S. Patent No. 9980901 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?) as applied to claims 1, 30-32, 34, 39, 67-72 above, further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) are addressed above.
The patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular pterygium with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 or alternatively over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating/regressing/reducing/stabilizing pterygium in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the pterygium (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 in view of BoxerWachler (What are Pterygium?).
The teachings of the patented claims are addressed above, and while the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor and to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 or alternatively over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims (or alternatively the patented claims in view of BoxerWachler) do not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating pterygium as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating pterygium with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above. Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 or alternatively over claims 3, 7, 11, 19, 23 of U.S. Patent No. 9987223 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims (or alternatively the patented claims in view of BoxerWachler) are addressed above.
The patented claims (or alternatively the patented claims in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and other ocular conditions with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8-10, 12-18, 20-22, 24 of U.S. Patent No. 9987223 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1-2, 4-6, 8-10, 12-18, 20-22, 24 of U.S. Patent No. 9987223 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The patented claims are directed to the method of treating pterygium in a patient (identifying the subject), comprising administration to the eye a multikinase inhibitor and an antimetabolite; while the patented claims do not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like pterygium, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating pterygium with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same pterygium, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 1-2, 4-6, 8-10, 12-18, 20-22, 24 of U.S. Patent No. 9987223 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The teachings of the patented claims in view of Ni are addressed above, and while the patented claims in view of Ni do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims in view of Ni teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient with pterygium in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable claims 1-2, 4-6, 8-10, 12-18, 20-22, 24 of U.S. Patent No. 9987223 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1-2, 4-6, 8-10, 12-18, 20-22, 24 of U.S. Patent No. 9987223 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?) as applied to claims 1, 30-32, 34, 39, 67-72 above, further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) are addressed above.
The patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular pterygium with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-5 of U.S. Patent No. 10149820 or alternatively over claims 2, 4-5 of U.S. Patent No. 10149820 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating symptoms of pterygium like ocular hyperemia in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium and its symptoms improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 2, 4-5 of U.S. Patent No. 10149820 in view of BoxerWachler (What are Pterygium?).
The teachings of the patented claims are addressed above, and while the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office where the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-5 of U.S. Patent No. 10149820 or alternatively over claims 2, 4-5 of U.S. Patent No. 10149820 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims (or alternatively the patented claims in view of BoxerWachler) do not recite the multikinase inhibitor (i.e. nintedanib) to be a pharmaceutical salt.
Ni teaches that multikinase inhibitor like nintedanib is known to be useful in treating ocular conditions like hyperemia and pterygium, are useful as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2, 12, 15, 27, 32, 47], claims 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known forms of multikinase inhibitors for treating hyperemia and pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of multikinase inhibitors like nintedanib for treating hyperemia or pterygium with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-5 of U.S. Patent No. 10149820 or alternatively over claims 2, 4-5 of U.S. Patent No. 10149820 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims (or alternatively the patented claims in view of BoxerWachler)are addressed above.
The patented claims (or alternatively the patented claims in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular hyperemia or pterygium with the administration of a multikinase inhibitor like nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-11 of U.S. Patent No. 10149820 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1, 3, 6-11 of U.S. Patent No. 10149820 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The patented claims are directed to the method of treating the hyperemia or symptoms in pterygium in a patient (identifying the subject), comprising administration to the eye a multikinase inhibitor; while the patented claims do not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance from the pterygium, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like pterygium and its hyperemia, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating pterygium with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same pterygium, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 1, 3, 6-11 of U.S. Patent No. 10149820 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The teachings of the patented claims in view of Ni are addressed above, and while the patented claims in view of Ni do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims in view of Ni teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient with pterygium in the doctor’s office, that the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor to treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium as the condition improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable claims 1, 3, 6-11 of U.S. Patent No. 10149820 in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claims 1, 3, 6-11 of U.S. Patent No. 10149820 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?) as applied to claims 1, 30-32, 34, 39, 67-72 above, further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) are addressed above.
The patented claims in view of Ni (or alternatively the patented claims in view of Ni and BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular pterygium with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8, 10 of U.S. Patent No. 10149819.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating symptoms of pinguecula or pseudopterygium like hyperemia in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor like nintedanib (a free base); while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the eye, it is implicit that the patient is worried/anxious about the condition/appearance of the eye as pinguecula is a bump on the white part of the eye which is not a normal presentation and the hyperemia makes the eye red from all the blood vessels which is implicitly worrisome and one reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance of a bump on the eyeball and redness from the blood vessels, if not concerned/worried/anxious about it), if not prima facie obvious; wherein it is implicit if not prima facie obvious that as the condition improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persuasive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of pinguecula or pseudopterygium like a bump on the eyeball or hyperemia (a red eye) due to the excess blood vessels in the eye to report it to the doctor and seek treatment for the condition/appearance of a red eye from the excess blood vessels in the eye which is not a normal presentation of the eye (one does not seek treatment for the hyperemia/appearance of the red eye due to excess blood vessels in the eye or a bump on the eyeball, if not concerned/worried/anxious about its presentation as the eye which is not normal), and the doctor assesses the patient (determines the symptoms/concern/worry/anxiousness/appearance of the red eye) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10149819 as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims do not recite the multikinase inhibitor (i.e. nintedanib) to be a pharmaceutical salt.
Ni teaches that multikinase inhibitor like nintedanib is known to be useful in treating ocular conditions pinguecula and pseudopterygium and symptoms thereof including hyperemia, are useful as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2, 12, 15, 27, 32, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known forms of multikinase inhibitors for treating pinguecula and pseudopterygium and symptoms thereof including hyperemia as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of multikinase inhibitors like nintedanib for treating pinguecula and pseudopterygium and symptoms thereof including hyperemia with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10149819 as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pinguecula and pseudopterygium and symptoms thereof including hyperemia with the administration of a multikinase inhibitor like nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 11 of U.S. Patent No. 10149819 in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims are directed to the method of treating symptoms of pinguecula or pseudopterygium like hyperemia in a patient (identifying the subject), with the administration to the eye a multikinase inhibitor; while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the eye, it is implicit that the patient is worried/anxious about the condition/appearance of the eye as pinguecula is a bump on the white part of the eye which is not a normal presentation and the hyperemia makes the eye red from all the blood vessels which is implicitly worrisome and one reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance of a bump on the eyeball and redness from the blood vessels, if not concerned/worried/anxious about it), if not prima facie obvious; wherein it is implicit if not prima facie obvious that as the condition improves with treatment, that the patient would be relieved (have less worry/anxiety).
The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like symptoms of pinguecula and pseudopterygium and hyperemia, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pinguecula and pseudopterygium and hyperemia suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating these conditions with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same conditions, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable claims 1-6, 9, 11 of U.S. Patent No. 10149819 in view of Ni (U.S. Pat. Pub. 2017/0172915) as applied to claims 1, 30-32, 34, 39, 68, 71 above, further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims in view of Ni are addressed above.
The patented claims in view of Ni does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular conditions like pinguecula and pseudopterygium and hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10980741 or alternatively over claims 1-19 of U.S. Patent No. 10980741 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating pterygium in a patient (identifying the subject), with the administration to the eye the multikinase inhibitor nintedanib (a free base); while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the eye (one does not seek treatment for the condition/appearance of the pterygium, if not concerned/worried/anxious about it); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 1-19 of U.S. Patent No. 10980741 in view of BoxerWachler (What are Pterygium?).
The teachings of the patented claims are addressed above, and while the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office where the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor and treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10980741 or alternatively over claims 1-19 of U.S. Patent No. 10980741 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The patented claims (or alternatively the patented claims in view of BoxerWachler) do not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating pterygium as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating pterygium with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10980741 or alternatively over claims 1-19 of U.S. Patent No. 10980741 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims (or alternatively the patented claims in view of BoxerWachler) are addressed above.
The patented claims (or alternatively the patented claims in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12186424 or alternatively over claims 1-6 of U.S. Patent No. 12186424 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the method of treating/inhibiting/reducing/regressing pterygium in a patient (identifying the subject), with the administration to the eye nintedanib (a multikinase inhibitor, free base form) and 5-fluorouracil; while the patented claims does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance of the pterygium, if not concerned/worried/anxious about its appearance); wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitor is being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claims 1-6 of U.S. Patent No. 12186424 in view of BoxerWachler (What are Pterygium?).
The teachings of the patented claims are addressed above, and while the patented claims do not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the patented claims teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office where the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor and treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments center on the assertion that the patented claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12186424 or alternatively over claims 1-6 of U.S. Patent No. 12186424 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The teachings of the patented claims (or alternatively the patented clams in view of BoxerWachler) are addressed above.
The patented claims (or alternatively the patented clams in view of BoxerWachler) do not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating pterygium as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating pterygium with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12186424 or alternatively over claims 1-6 of U.S. Patent No. 12186424 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the patented claims (or alternatively the patented claims in view of BoxerWachler) are addressed above.
The patented claims (or alternatively the patented claims in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 67-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18307449 (reference application) or alternatively over claim 42 of copending Application No. 18307449 in view of BoxerWachler (What are Pterygium?).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim is directed to the method of treating ocular conditions including pterygium and hyperemia and pinguecula in a patient (identifying the subject), with the administration to the eye an emulsion comprising about 0.01-about 1% nintedanib (a multikinase inhibitor, free base), about 0.3% to about 0.7% w/w of polyoxyl-35 castor oil, about 0.1% to about 0.5% w/w of castor oil, about 8% to about 12% w/w of 2-hydroxypropyl-beta-cyclodextrin, about 0.1% to about 1% w/w of polysorbate 80, and water; while the copending claim does not expressly recite that the patient is worried/anxious about the condition/appearance of the eye, it is implicit that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment for the condition/appearance of the eye (one does not seek treatment for the condition/appearance like hyperemia or ocular discomfort from the pterygium, if not concerned/worried/anxious about it), if not prima facie obvious; wherein it is implicit if not prima facie obvious that as the pterygium improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the copending claim does not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is presented to the instant claims above over claim 42 of copending Application No. 18307449 in view of BoxerWachler (What are Pterygium?).
The teachings of the copending claim is addressed above, and while the copending claim does not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the copending claim teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office where the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor and treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant's arguments center on the assertion that the copending claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18307449 (reference application) or alternatively over claim 42 of copending Application No.18307449 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The copending claim (or alternatively over the copending claim in view of BoxerWachler) does not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating pterygium as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating pterygium with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant's arguments are those to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18307449 (reference application) or alternatively over claim 42 of copending Application No. 18307449 in view of BoxerWachler (What are Pterygium?) as applied to claims 1, 30, 32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the copending claim (or alternatively over the copending claim in view of BoxerWachler) is addressed above.
The copending claim (or alternatively over the copending claim in view of BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and other ocular conditions with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant's arguments are those to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30-32, 34, 39, 67-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 17927796 (reference application) in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claim 17 of copending Application No. 17927796 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?).
The copending claim is directed to the method of treating ocular conditions including pterygium and pinguecula in a patient (identifying the subject), with the administration to the eye a composition comprising a multikinase inhibitor and perfluorohexyloctane liquid vehicle; while the copending claim does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance of the condition, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the pterygium or pinguecula improves with treatment, that the patient would be relieved (have less worry/anxiety). The patented claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like symptoms of pinguecula and pseudopterygium and hyperemia, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating pinguecula and pseudopterygium and hyperemia suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating these conditions with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same conditions, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Alternatively, in so far that the copending claim in view of Ni does not explicitly recite that the patient is worried/anxious about the appearance of the eye affected by the pterygium, the following rejection is provisionally presented to the instant claims above over claim 17 of copending Application No. 17927796 in view of Ni and BoxerWachler (What are Pterygium?).
The teachings of the copending claim in view of Ni are addressed above, and while the copending claim in view of Ni does not explicitly recite that the patient is worried/anxious about the appearance of the eye with pterygium; the copending claim teach treating the pterygium in the subject/patient with the multikinase inhibitors like nintedanib.
BoxerWachler teaches that pterygium are typically are associated with symptoms like dry eye, inflammation, irritation and foreign body sensation; for most people the appearance of the pterygium is the most significant factor for the patient even though the eye may feel completely normal (What are Pterygium?).
Wherein it would be obvious to one or ordinary skill in the art when having a subject/patient in the doctor’s office where the appearance of the pterygium is a significant factor for the patient (concern/worry/anxiety) if not the most significant factor and treat the pterygium with the nintedanib as suggested by BoxerWachler and produce the claimed invention; as it is prima facie obvious to treat the condition and resolve the concern/anxiety/worry about the pterygium improves with treatment with a reasonable expectation of success (as the pterygium regresses with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant's arguments center on the assertion that the copending claims do not identify a subject with worry/anxiety about the appearance of the affected eye. This is not persasuive.as addressed above, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the pterygium affected eye to report it to the doctor and seek treatment for the condition/appearance of the affected eye which is not a normal presentation of the eye (one does not seek treatment for the condition, if not concerned/worried/anxious about its presentation), and the doctor assesses the patient (determines the appearance/symptoms/worry/anxiety/concern) before treating it (previous to treatment).
Accordingly, the rejection stands.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 17927796 (reference application) in view of Ni (U.S. Pat. Pub. 2017/0172915) or alternatively over claim 17 of copending Application No. 17927796 in view of Ni (U.S. Pat. Pub. 2017/0172915) and BoxerWachler (What are Pterygium?) as applied to claims 1, 30-32, 34, 39, 67-72 above; further in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the copending claim in view of Ni (or alternatively the copending claim in view of Ni and BoxerWachler) are addressed above.
The copending claim in view of Ni (or alternatively the copending claim in view of Ni and BoxerWachler) does not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating ocular conditions like pinguecula and pseudopterygium and hyperemia with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment.
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
Response to Arguments:
Applicant's arguments are those to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 30, 32, 34, 39, 68, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 22-26 of copending Application No. 18931914 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim is directed to the method of treating hyperemia in a patient (identifying the subject), with the administration to the eye a composition comprising a multikinase inhibitor like nintedanib (free base) and brimonidine; while the copending claim does not expressly recite that the patient is worried/anxious about the condition/appearance of the eye, it is implicit that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment for the condition/appearance of the eye (one does not seek treatment for the condition/appearance like hyperemia (excessive blood vessels), if not concerned/worried/anxious about it), if not prima facie obvious; wherein it is implicit if not prima facie obvious that as the condition improves with treatment, that the patient would be relieved (have less worry/anxiety). As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 22-26 of copending Application No. 18931914 (reference application) as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of Ni (U.S. Pat. Pub. 2017/0172915).
The copending claims does not recite nintedanib to be a pharmaceutical salt.
Ni teaches that nintedanib is known to be useful in treating hyperemia as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [15], claim 36 and 41).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known salt form of nintedanib for treating the hyperemia as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful forms of nintedanib for treating the condition with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 22-26 of copending Application No. 18931914 (reference application) as applied to claims 1, 30, 32, 34, 39, 68, 71 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the copending claims are addressed above.
The copending claims do not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and other ocular conditions with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 30-32, 34, 39, 67-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 22-26 of copending Application No. 18931914 (reference application) in view of Ni (U.S. Pat. Pub. 2017/0172915).
The copending claim is directed to the method of treating an ocular condition associated with ocular hyperemia like pterygium in a patient (identifying the subject), with the administration to the eye a composition comprising a multikinase inhibitor; while the copending claim does not explicitly recite that the patient is worried/anxious about the condition/appearance of the affected eye, it is implicit if not prima facie obvious that the patient is worried/anxious about the condition/appearance of the affected eye and reports it in order to seek treatment for the condition/appearance of the affected eye (one does not seek treatment for the condition/appearance of the condition, if not concerned/worried/anxious about its presentation); wherein it is implicit if not prima facie obvious that as the hyperemia (i.e. from pterygium) improves with treatment, that the patient would be relieved (have less worry/anxiety). The copending claims are silent on the specific multikinase inhibitor.
Ni teaches that multikinase inhibitors like nintedanib is known to be useful in treating ocular conditions like symptoms of hyperemia and hyperemia from pterygium, as a free base and as a pharmaceutical salt (e.g. nintedanib esylate (ethanesulfonate salt, [2-3, 12, 15-16, 27, 31, 33-34, 42, 47]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize nintedanib and its known salt form for treating hyperemia such as from pterygium as suggested by Ni and produce the claimed invention; as it is prima facie obvious to utilize the known useful multikinase inhibitors and their known salt forms for treating these conditions with a reasonable expectation of success. As the same multikinase inhibitors are being administered for the same conditions, the amount of reduction of signs/symptoms by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-4, 15-16, 22-23, 50-51, 57-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 22-26 of copending Application No. 18931914 (reference application) in view of Ni (U.S. Pat. Pub. 2017/0172915) as applied to claims 1, 30-32, 34, 39, 67-72 above, in view of www.rand.org (National Eye Institute Visual Functioning Questionnaire).
The teachings of the copending claims in view of Ni are addressed above.
The copending claims in view of Ni do not expressly teach a questionnaire to assess the level of worry/anxiety about the disease/appearance of the eye by the patient, but does teach treating pterygium and other ocular conditions with the administration of a nintedanib in a patient where is implicit in not prima facie obvious that the patient is worried/anxious about the condition/appearance of the eye and reports it in order to seek treatment (or alternatively teaches treating pterygium with the administration of a multikinase inhibitor in a patient in need thereof where the appearance of the pterygium is a significant factor for the patient (the patient is concerned/worried/anxious about the condition/appearance of the affected eye) and reports it in order to seek treatment).
www.rand.org teaches that it is known in the ophthalmic art to assess the level of impact on daily life and feeling with regards to an eye condition a patient is having a problem with (i.e. vision) including worry (question 3, five point scale) and difficulty with activities (impact on quality of life).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the level of concern (i.e. worry, 5 point scale) and impact on the quality of life of the eye condition the patient is seeking treatment for by questionnaire as suggested by www.rand.org and produce the claimed invention; as www.rand.org establishes that it is known to assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with, it is prima facie obvious to apply that questionnaire process to any eye condition that a patient is concerned about assess and grade/score the various feelings including worry and impact on life the eye condition the patient is struggling with for a desired period of time (i.e. the past week, the past two weeks, the past month) to better assist in the treatment of the patient and to also assess the patient during and post treatment (standard of care to follow up) to ascertain that the treatment is resolving the issues with a reasonable expectation of success absent evidence of criticality for a specific period of time. As the same multikinase inhibitors are being administered for the same eye condition, the amount of reduction of signs/symptoms and rating by the patient would be expected to be the same as the instant claims as disclosed by the instant specification for the administration of multikinase inhibitors for the same recited condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4, 15-16, 22-23, 30-32, 34, 39, 50-51, 57-58, 67-72 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613