Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Final Rejection
The Status of Claims:
Claims 1-18 are pending.
Claims 1-18 are rejected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The rejection of Claims 1-15 under 35 U.S.C. 101 is withdrawn due to the modification of the claims.
Claim Rejections - 35 USC § 112
Applicants’ argument filed 11/29/2025 have been fully considered, and some of them
are persuasive, while others are not persuasive.
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.
Regarding the hydrid claims, the rejection of Claims 1-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn due to the modification of the claims, while regarding the reach-through claims, the rejection of Claims 1-9, 13-16, and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is still maintained due to the incomplete modification of the claims.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding the term “preventing”, the rejection of Claims 1-15 under 35 U.S.C. 112, first paragraph, is withdrawn due to applicant’s convincing arguments.
However, in view of the revised claims, there are some issues to be resolved in the followings:
Claims 1, 9-12, 16-17 are rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the incorporation of essential material in the specification by reference to a foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference which have to be non-essentials to the claimed invention. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973).
The attempt to incorporate subject matter into this application by a reference to WO 2006/002421, lines 24-27 on page 12 and WO 2016/086136, lines 15-19 on page 14, EP 2404919, lines 28-31 on page 14, EP 2365972 A1, lines 11-14 on page 15, WO 2012/158885 A1, lines 4-10 on page 19 are improper because the specification mentions the following statements:
“WO 2006/002421 Al discloses CFTR potentiators according to Formula I such as Ivacaftor (Vertex Pharmaceuticals) and derivatives thereof. The content of WO 2006/002421 Al is incorporated herein by reference as regards any embodiment of a chemical compound disclosed therein with a structure according to Formula I or a derivative thereof”,
“CFTR correctors are disclosed in WO 2016/086136. The content of WO 2016/086136 is incorporated herein by reference as regards any embodiment of a chemical compound disclosed therein with a structural formula”.
“EP 2404919 Al discloses CFTR correctors according to formula IV such as Lumacaftor and derivatives thereof. The content of EP 2404919 Al is incorporated herein by reference as regards any embodiment of a chemical compound disclosed therein with a structure according to Formula IV”
“EP 2365972 Al discloses CFTR correctors according to formula V such as Tezacaftor and derivatives thereof”; “the content of EP 2365972 Al is incorporated herein by reference as regards any embodiment of a chemical compound disclosed therein with a structure according to Formula V ”
“ the content of WO 2012/158885 A1 discloses deuterated derivatives of Ivacaftor having the structural Formula XII”,” any embodiment of a chemical; compound disclosed therein with a structure acccroding to Formula XII or derivative thereof ”
Each of which is incorporated into the specification. It is a foreign patent; it does specify essential materials which are reflected in the instant claims. Applicant is required to amend the disclosure to include the material incorporated by references and to accompany the amendment by an affidavit or declaration by the applicant or the examiner recommends to delete the foreign patents , WO 2006/002421, lines 24-27 on page 12 and WO 2016/086136, lines 15-19 on page 14, EP 2404919, lines 28-31 on page 14, EP 2365972 A1, lines 11-14 on page 15, WO 2012/158885 A1, lines 4-10 on page 19.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 13-16 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for
a CFTR potentiator being a compound selected from Ivacaftor, GLPG2451 and GLPG1837, QBW251, PTI-808, FDL176 or a deuterated or pharmaceutically acceptable salt thereof; a CFTR corrector being a compound selected from Lumacaftor, Tezacaftor, Elexacaftor, Bamocaftor, Bamocaftor potassium, Posenacaftor, Cavosonstat, GLPG2222, GLPG2737, or a deuterated or pharmaceutically acceptable salt thereof; and a CFTR amplifier being a compound selected from Nesolicaftor and PTI- CH, or a deuterated or pharmaceutically acceptable salt thereof as a CFTR modulator.
for the method of treating a diseases involving endothelial and/or epithelial barrier dysfunctions such as acute respiratory distress syndrome (ARDS), ventilator induced lung injury (VILI), systemic inflammatory response syndrome (SIRS), transfusion- associated acute lung injury (TRALI), sepsis or pneumonia., does not reasonably provide enablement for any other CFTR modulator.
The scope of the compounds in the claims is too broad including the undiscovered compounds in the future since the specification describes only the limited number of compounds of formulas I-XIII (see pages 12-19).
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention is as shown below:
A method of preventinq and/or treatinq of diseases involving endothelial and/or epithelial barrier dysfunctions, the method comprisinq administerinq a CFTR modulator, wherein the disease does not comprise cystic fibrosis.
9. (Currently Amended) the method according to claim 1 wherein the CFTR modulator is a CFTR potentiator, a CFTR corrector or a CTFR amplifier,
14. A method of preventinq and/or treating of a disease involving endothelial and/or epithelial barrier dysfunctions, the method comprisinq administerinq a pharmaceutical composition comprisinq a CFTR modulator as an active ingredient, wherein the disease does not comprise cystic fibrosis.
15. (Currently Amended) A method of preventinq and/or t treatinqof a disease involving endothelial and/or epithelial barrier dysfunctions, the method comprising administering the components of a kit of parts comprisinq i) a CFTR modulator and ii) a further CFTR modulator wherein the disease does not comprise cystic fibrosis.
The recited limitations of “a CFTR modulator “, “ a CFTR potentiator”, “a CFTR corrector”, “a CTFR amplifier “ encompass many numerous possible species having a plethora of chemically diverse substituents. As non-limiting examples of the broad scope and diverse nature of the claimed genera, various hypothetical species are all encompassed by the claimed genera. Accordingly, the claims are extremely and unduly broad, especially in view of the limited guidance and direction provided by applicants’ disclosure as discussed below.
The State of the Prior Art and the Predictability or Lack of thereof in the Art
Morgan (US 2014/0073667 A1) discloses a method of treating COPD or Parkinson's disease or a bile duct disorder or a kidney ion cham1el disorder in a subject comprising administering to the subject the pharmaceutical composition comprising
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Strohmeier et al (WO 2016/057730 a1) teaches a method of treating or lessening the severity of a disease in a patient, wherein said disease is selected from hereditary emphysema, COPD, or dry-eye disease, the method comprising the step of administering to the patient a therapeutic effective amount of the co-crystal of
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and with its kit.
Strohbach et al ( US 2018/0170938 Al) discloses the mothed of treating asthma, bronchiectasis, chronic obstructive pulmonary disease (COPD), constipation, Diabetes mellitus, dry eye disease, pancreatitis, rhinosinusitis, Sjgren's Syndrome, and other CFTR associated disorders by using 1,3-disubstituted-1H-pyrazolo[3,4-d]pyrimidin-4-amine, 5, 7-disubstituted-pyrrolo[2,l-f] [l ,2,4]triazin-4-amine or 5,7-disubstituted-derivatives.
Since the current claims do not reveal the exact chemical structures of “a CFTR modulator “, “ a CFTR potentiator”, “a CFTR corrector”, and “a CTFR amplifier “
as for the treatment of a disease involving endothelial and/or epithelial barrier dysfunctions such as acute respiratory distress syndrome (ARDS), ventilator induced lung injury (VILI), systemic inflammatory response syndrome (SIRS), transfusion- associated acute lung injury (TRALI), sepsis or pneumonia, there is an uncertainty or unpredictability that any kinds of a CFTR modulators would provide an equivalent functionality among various kinds of CFTR modulators as for the treatment of diseases involving endothelial and/or epithelial barrier dysfunctions in a subject in need because
some prior art do show that some CFTR modulators can be used in the treatment of chronic pancreatitis and non-CF bronchiectasis which are slightly different from treating diseases involving endothelial and/or epithelial barrier dysfunctions. Thus, there is an unpredictability of all the known in the present or unknown CFTR modulators in the future can be used for treating diseases involving endothelial and/or epithelial barrier dysfunctions in a subject successfully.
The amount of direction or guidance provided and the presence or absence of working examples
The specification does not provide any guidance for making the claimed “ CFTR modulator “, “ CFTR potentiator”, “ CFTR corrector”, and “ CTFR amplifier “. The specification only shows the ready-made compounds (see pages 45- 66) and furthermore, there are no guidance whatsoever regarding the preparation of those compounds of formulas I-XIII (see pages 12-19). It is entirely unclear how the skilled artisan would prepare all those claimed compounds in the absence of synthetic strategic plans which would need to make such compounds.
In the current case, applicant claims “a CFTR modulator “, “ a CFTR potentiator”, “a CFTR corrector”, and “a CTFR amplifier “, which encompass many numerous possible species having a plethora of chemically diverse substituents. Applicant discloses that those agonists without the concrete chemical structure of the compounds can be used as treating any disease involving endothelial and/or epithelial barrier dysfunctions such as acute respiratory distress syndrome (ARDS), ventilator induced lung injury (VILI), systemic inflammatory response syndrome (SIRS), transfusion- associated acute lung injury (TRALI), sepsis or pneumonia. However, the structural features actually required for biological activity cannot be predicted on the basis of the limited guidance and direction provided by applicant.
Also, those skilled in the art further cannot predict the reagents and reaction conditions required for making the immense scope of those compounds of formulas I-XIII (see pages 12-19) in view of the very limited guidance and direction provided by applicant.
Furthermore, there are 5 examples for testing the reductions of fibrosis only using Ivacafttor and/ or Lumacaftor for the effect in pneumolysin treated HPMECs on cell permeability, the effect on endothelial permeability, S. pneumoniae infection with lung edema the patient with severe COVID-19 However, these can not be the representative for all the CFTR modulators, CFTR potentiators, CFTR correctors and CTFR amplifiers,31 But there are no other actual working examples for the treatment for all the other heterogeneities of any diseases involving endothelial and/or epithelial barrier dysfunctions using the claimed CFTR modulators in the specification. Also, the specification does not contain any pharmacological data regarding the treatments for all the other heterogeneities of those diseases while using the claimed CFTR modulators. Thus, the specification fails to provide sufficient working examples as to how the treatment of all the other heterogeneities of those conditions diseases can be treated successfully by the claimed the CFTR modulators without any unexpected negative effects of using the claimed those the CFTR modulators. Furthermore, it is well-known in the art that the most common side effects using a the CFTR modulators gonists include headaches, upper respiratory infections, gastrointestinal issues, liver problems, mood changes.
The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that the instantly claimed genera of the CFTR modulators could be predictively made and used for treating any diseases involving endothelial and/or epithelial barrier dysfunctions f as inferred in the claims and contemplated by the specification .
.
Thus, the specification fails to provide sufficient support for the treatment of all the other heterogeneities of the claimed diseases involving endothelial and/or epithelial barrier dysfunctions. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed diseases involving endothelial and/or epithelial barrier dysfunctions suitable for the claimed CFTR modulators in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test whether or not all the claimed diseases involving endothelial and/or epithelial barrier dysfunctions can be treated by the claimed CFTR modulators, which is encompassed in the instant claims, with no assurance of success.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claim 5 sets forth the method according to claim 1 wherein the disease is an inflammatory disease.
However, the scope of treating an inflammatory disease generally is extraordinarily broad. Inflammation is a process which can take place in virtually any part of the body, not to mention about the inflammatory condition. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. It is one of the most pervasive of all body processes. Inflammation is a very general term which encompasses a huge variety of specific processes.
Inflammation is the reaction of vascularized tissue to local injury; it is the name given to the stereotyped ways tissues respond to noxious stimuli. These occur in two fundamentally different types. Acute inflammation is the response to recent or continuing injury. The principal features are dilatation and leaking of vessels, and recruitment of circulating neutrophils. Chronic inflammation or "late-phase inflammation" is a response to prolonged problems, orchestrated by T-helper lymphocytes. It may feature recruitment and activation of T- and B-lymphocytes, macrophages, eosinophils, and/or fibroblasts. The hallmark of chronic inflammation is infiltration of tissue with mononuclear inflammatory cells. Mechanistically, chronic inflammation encompasses a broad spectrum of immunologic processes, including antibody formation, antibody-dependent cell-mediated cytotoxicity, and cell-mediated immunity (delayed-type hypersensitivity). Granulomas are seen in certain chronic inflammation situations. They are clusters of macrophages which have stuck tightly together, typically to wall something off. Granulomas can form with foreign bodies such as aspirated food, toxocara, silicone injections, and splinters.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of Claim(s) 1-3, 7, 9-10,12, 14 under 35 U.S.C. 102(a)(1) as being anticipated clearly by Simmons et al (J Physiol 597.4 (2019) pp 997–1021) is withdrawn.
The rejection of Claim(s) 1-10, 12-15 under 35 U.S.C. 102(a)(2) as being anticipated clearly by Luisi et al( US 2013/0281487) is withdrawn..
The rejection of Claim(s) 1-10, 12-14 under 35 U.S.C. 102(a)(2) as being anticipated clearly by Copeland et al (WO 2019/099946 A1) is withdrawn..
However, in view of the revised claims and finding a new prior art , another 102 rejection seems necessary in the followings:
Claim(s) 1, 5, 7, 9-14,16-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Morgan (US 2014/0073667 A1)
Morgan discloses the methods of treating diseases such as COPD or Parkinson's disease ,a bile duct disorder , a kidney ion channel disorder that are beneficially treated by administering a CFTR potentiator in the followings:
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12. The compound of claim 1, wherein the compound of Fomrnla I is any one of the compounds of the table below,
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15. A pharmaceutical composition comprising a compound of claim 1 or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier.
17. A method of treating COPD or Parkinson's disease in a subject comprising administering to the subject the pham1aceutical composition of claim 15.
18.A method of treating a bile duct disorder or a kidney ion channel disorder in a subject comprising administering to the subject the pharmaceutical composition of claim 15.
The choice of second therapeutic agent may be made from any second therapeutic agent known to be useful for co-administration with VX-770 (see page 13, a paragraph#0128); in particular, the combination therapies of thisinvention include co-administering a compound of Formula Ior a pharmaceutically acceptable salt thereof and a second therapeutic agent such as VX-809 (lumacaftor) or VX-661, to
a subject in need thereof for treatment (see page 13, a paragraph#0129).
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(see page 14, example 1, compound110) (see page 16, 125)
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(see page 20, compound123). These are identical with the claims.
Applicants argue the following issues:
he Office further asserts that the terms "a cystic fibrosis transmembrane conductance regulator (CFTR) modulator,""a CFTR modulator" and "a further CFTR modulator" can be vague and indefinite because the terms can be read on the reach- through claim.
In response, Applicant submits that the terms "CFTR modulator","CFTR potentiator,""CFTR correctors" and "CFTR amplifiers" are fixed designations of classes of substances that are summarized under the term "CFTR modulators" having a common mode of action. The present application provides detailed information as to the general classification of CFTR modulators and their mode of action particularly in the treatment of cystic fibrosis in the specification, and defines these terms. See page 11, lines 4-25; page 11, line 31-page 12, line 4; and page 13, lines 17-30 of the present specification. The claims are read in light of the specification.
Applicant is also submitting via IDS a copy of Ong, New Therapeutic Approaches to Modulate and Correct CFTR, Pediatr. Clin. North. Am. 2016 August ; 63(4): 751-764. doi:10.1016/j.pcl.2016.04.006. Applicant submits that Ong provides third-party evidence that these terms "CFTR modulator,""CFTR corrector" and "CFTR potentiator," (see page 2,2nd paragraph) would be understood by one of ordinary skill in the arts. These terms are fixed designations for classes of CFTR modulators, and do not define the compounds in terms of a desired technical effect to be achieved, as the Office asserts. Thus, Applicant submits these terms are definite. Applicant requests withdrawal of this basis for rejection.
Applicants’ arguments have been noted. However, each of the terms "CFTR modulator","CFTR potentiator,""CFTR correctors" and "CFTR amplifiers"are known in the specification, but the main issue is that the terms can be still read on the reach-through claims in the absence of any particular chemical formulars and the corresponding chemical strcutures for each of the terms. A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity or to test every known compound and every conceivable and undiscovered future compound for this activity to see if it falls within the scope of the claims. In effect, the applicant is attempting to patent what has not yet been invented. Therefore, they are still rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. The examiner recommends to replace them with their corresponding chemical names in the claims.
Conclusion
Claims 1-18 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 2/17/2026