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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on June 30, 2026.
Restrictions/Elections.
Applicant election of the following species: rhinovirus (HRV) is acknowledged.
Status of Claims
Claims 1-30 are currently pending and are the subject of this office action.
Claims 1-30 are presently under examination.
Priority
PNG
media_image1.png
74
300
media_image1.png
Greyscale
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-3, 6, and 11-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lambert et. al. (US 2011/0257192).
For claims 1 and 3, Lambert teaches a method of treating rhinovirus (HRV, an enterovirus) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir (3-ethoxy-6-{2-[1-(6-methyl-pyridazin-3-yl)-piperidin-4-yl]-ethoxy}-benzo-[d]-isoxazole, also known as BTA 798) (See [0016], [0026], [0047] and claims 7-9).
For claim 2, Lambert teaches the administration of 800 mg per day (400 mg b.i.d (twice a day) of Vapendavir (see [0067]) which anticipates the instantly claimed range (between about 250 mg and about 2,000 mg per day).
Lambert is silent regarding the statement in instant claim 6: “wherein the therapeutically effective amount of Vapendavir is an amount that achieves a Cmax of about 2,000 ng/mL to about 12,000 ng/ml”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the therapeutically effective amount of Vapendavir is an amount that achieves a Cmax of about 2,000 ng/mL to about 12,000 ng/ml” appears to be the result of the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Further, even though Lambert does not teach the required Cmax, Cmax is defined by the experimental limitations of the treatment like patient population, drug administered, mode of administration, etc., all of which are anticipated by the prior art (Lambert). The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method disclosed by Lambert does not possess the same material, structural and functional characteristics of the method claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the method is different from the one taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 11, Lambert teaches the administration of stable maintenance therapy for COPD (see [0061]).
Lambert is silent regarding the statement in claim 12:
“wherein treating the respiratory enterovirus infection in the subject comprises decreasing a viral load in the sputum, nasal passages, or a combination thereof in the subject compared with a viral load in the sputum, nasal passages, or a combination thereof of the subject prior to treatment”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “decreasing a viral load in the sputum, nasal passages, or a combination thereof in the subject compared with a viral load in the sputum, nasal passages, or a combination thereof of the subject prior to treatment” appears to be the result of the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Similar rejections are being made for the “wherein clauses” in claims 13-26 and 28-29.
Lambert is silent regarding the statement in instant claim 27: “wherein treating the respiratory enterovirus infection (i.e. HRV) in the subject comprises reducing of viral shedding”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “reducing of viral shedding” appears to be the result of the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Lambert is silent regarding the statement in instant claim 30: “wherein treating the respiratory enterovirus infection (i.e. HRV) in the subject comprises reducing the days wherein the subject is positive for bacteria in the sputum”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “reducing the days wherein the subject is positive for bacteria in the sputum” appears to be the result of the process anticipated by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 4-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambert et. al. (US 2011/0257192).
Lambert teaches all the limitations of claims 4-5 (see above 102(a)(1) above), except for the exact dose regimen claimed. However, Lambert teaches unit doses of up to 1,000 mg of Vapendavir (see [0054]) and 400 mg twice a day (see [0067]) which overlap or are very close to the amounts claimed (1,000 mg single dose and 500 mg twice a day)
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also
In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
Finally, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claims 4 and 5 with a reasonable expectation of success.
Lambert teaches all the limitations of claims 7 and 8 (see above 102(a)(1) above), except for the patient being in a fed state or consuming solid food. Dose regimens that require patients to be in a fed state (or consuming solid food) are routine practice in the pharmaceutical art. As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claims 7-8 with a reasonable expectation of success.
Claim 9 recites the same structural limitations as claim 8, wherein the method “results in a higher plasma concentration of Vapendavir or a pharmaceutically acceptable salt thereof than administering the single loading dose and maintenance dose to a subject in a fasted state”.
Lambert is silent regarding wherein the method “results in a higher plasma concentration of Vapendavir or a pharmaceutically acceptable salt thereof than administering the single loading dose and maintenance dose to a subject in a fasted state”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir, wherein the single dose and the maintenance dose are administered within about 30 minutes of the subject consuming a meal with solid food.”
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “higher plasma concentration of Vapendavir or a pharmaceutically acceptable salt thereof than administering the single loading dose and maintenance dose to a subject in a fasted state” appears to be the result of the process made obvious by the prior art: “a method of treating rhinovirus (HRV) infection in a subject with COPD, comprising orally administering to the subject a therapeutically effective amount of Vapendavir, wherein the single dose and the maintenance dose are administered within about 30 minutes of the subject consuming a meal with solid food", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 9 with a reasonable expectation of success.
2) Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambert et. al. (US 2011/0257192) as applied to claims 1-3, 6, and 11-30 above, further in view of Thibaut et. al. (Rev. Med. Virol. (2016) 26:21-33).
Lambert teaches all the limitations of claim 10 (see above 102(a)(1) rejection), except for the different COPD stages. However, Thibaut teaches that there are four COPD stages: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (very severe) (see Table 2 on page 22).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat any patient suffering from HRV and any COPD grade, thus resulting in the practice of claim 10 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 17, 2026.
.
Prosecution Insights