DETAILED ACTION
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 .
Priority
The instant application is a national stage entry of PCT/KR2022/008257, filed June 10, 2022.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) by application nos. KR10-2021-0075738 and KR10-2022-0053009, filed in the Republic of Korea on June 10, 2021 and April 28, 2022, respectively, which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 8, 2023; January 14, 2025; July 9, 2025; October 29, 2025 in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS document was considered. A signed copy of form 1449 is enclosed herewith.
Election/Restrictions
5. Applicant’s election without traverse of Group I in the reply filed on March 30, 2026 is acknowledged.
6. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
7. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species
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makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. If art is found on a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. Since art was found on a non-elected species, subject matter not embraced by the elected species is therefore withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
8. Claims 1-18 are pending in the instant application. Claims 4 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-3 and 5-16 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Objections
9. Claim 5 is objected to for depending on a rejected base claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
10. Claims 6-12 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 the treatment of respiratory diseases, does not reasonably provide enablement for prevention of respiratory diseases. 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.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
A) Breadth of claims. The breadth of the claims is drawn to methods for treatment and prevention of respiratory diseases.
The prophylaxis or prevention means to anticipate or counter in advance, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds and compositions can be administered in order to have the "preventive" effect. How would one show a correlation that the diseases of the instant claims are prevented by the compounds of the invention, or that the subject would not have contracted the disease without administration of the instantly claimed compounds? How is the initial onset of the aforementioned diseases prevented?
B) The nature of the invention and predictability in the art. The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic or preventative regimen on its face.
C) Direction or Guidance and Working Examples. The direction provided is very limited.
The applicants have not provided any chemical or biological data and/or testing results of fibroblasts to prevent any of the aforementioned diseases, as encompassed by this language. In addition, no definition within the specification to any extent as to what is encompassed by the claim language in the current application. An applicant must clearly identify these things.
The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable and preventable by the claimed compounds.
There are absolutely no working examples present for the prevention of any disease or condition as claimed.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the broad list of disorders, as claimed herein, in order to prevent the initial onset of either disease. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for preventing the diseases by administering the instantly claimed fibroblasts.
See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed … Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”). The specification merely sets forth assay data which are not “reasonably correlated” to the prevention of the claimed diseases and the entirety of claimed compounds. See MPEP 2164.02 (“The issue of “correlation” is related to the issue of the presence or absence of working examples. “Correlation” as used herein refers to the relationship between in vitro … assays and a disclosed or a claimed method of use. An in vitro … example, in the specification, in effect, constitutes a “working example” if that example “correlates with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” … For a claimed genus [e.g., metabolic disorders], representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art … would expect the claimed genus could be used in the manner without undue experimentation”). While Applicants do indeed make various statements in the specification that their claimed compounds will effectively treat the genus of diseases associated encompassed by the claims, such is not supported by examples. That is, the limited testing set forth in the specification does not constitute a “working example” within the meaning of MPEP 2164.02 let alone a “representative” set of examples that would be required the describe this enormous genus.
D) State of the Prior Art. Fibroblasts have not been successfully used as an agent for the prevention of the full scope of claimed diseases.
E) Skill of those in the art.
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which fibroblasys exhibit the desired pharmacological activities (i.e. what compounds can prevent which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any preventative regimen on its face.
While a full discussion of each disease which is encompasses by Applicant’s claim language will not be given, the following examples teach that the state of the prior art with respect to the claimed diseases has not advanced to the point of being predictive of the treatment, and prevention of the breadth of diseases instantly claimed.
According to the Centers for Disease Control and Prevention, 2011, www.cdc.gov/copd,
“Approximately 75% of COPD cases are attributed to cigarette smoking (5). Occupation-related exposures may account for another 15% of COPD cases (6) and genetic factors, asthma, respiratory infections, and indoor and outdoor exposures to air pollutants also play a role (6,7). Thus, COPD largely can be prevented. Prevention of COPD begins with reducing and/ or eliminating smoking initiation among teenagers and young adults and encouraging tobacco cessation among current smokers. More than 20 million workers in the United States have been exposed to gases, vapors, fumes, and dusts that may cause COPD (6). Public health programs and policies that focus on tobacco-use prevention and cessation, reducing occupational exposure to dusts and chemicals, and reducing other indoor and outdoor air pollutants are critically important. Early treatment and control of asthma may also prevent the development of COPD.”
The prevention of COPD and asthma begins with reducing and/or eliminating smoking initiation among teenagers and young adults and encouraging tobacco cessation among current smokers, but the prevention of the initial onset of COPD and asthma has not yet advanced to the point of being preventable by the administration of medication.
F) The quantity of experimentation needed. The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases, disorders, or conditions out of all diseases, disorders, or conditions would be benefited and would furthermore then have to determine which of the claimed compounds in the instant invention would provide prevention of the diseases claimed.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the fibroblasts for the full scope of the claimed intended uses.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The specification fails to provide sufficient support of the broad use of the methods of administering compounds of the formula (I) in the prevention of the claimed diseases as a result necessitating one of skill to perform an exhaustive search for which diseases can be treated or prevented by what compounds of the invention in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent 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 which diseases can be treated by the compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 102
11. 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.
12. 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.
13. Claim(s) 1-3 and 6-16 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 900128-67-8, Entered STN: 10 Aug 2006].
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RN 900128-67-8 anticipate the instant claims wherein V1 is
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, n is 1, R1 is H, A is piperazine, V2 is
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. Wherein in formula 1a of claim 4, R3 is Cl, R4 is COOR2, R2 is H, R1 is H, n is 1, R5 is H, R6 is OR2, R2 is methyl.
Registry number RN 900128-67-8 is available as prior art as of 10 Aug 2006, the date it was indexed into the CAplus database.
Regarding the compositions of claim 11, comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 900128-67-8 discloses a mass solubility of 0.0 g/L, in unbuffered water at pH 4.109. This teaching anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the limitations of composition claims 6-10 and 12-16 the limitations as follows: “for preventing or treating respiratory diseases (claim 6)…wherein the respiratory diseases are inflammatory airway diseases (claim 7)…. “wherein the inflammatory airway diseases is…(claim 8)….wherein the active ingredient acts as a pendrin inhibitor (claim 9)….wherein the active ingredient preserves or increases the volume of airway surface liquid (claim 10)…a health functional food for preventing or ameliorating respiratory diseases (claim 12)…a diuretic pharmaceutical composition (claim 13)…which is co-administered with other diuretics (claim 14, a composition claim, not a method claim)…the other diuretic is furosemide (claim 15, a composition claim, not a method claim)…a diuretic health functional food compositions (claim 16)” – it is noted that these claims merely recite properties of the anticipated compositions. “Products of an identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, and the application discloses that all of the claimed compositions have the claimed properties, these limitations are also anticipated. Since the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, comprising compounds of formula 1, and the application discloses that all of the claimed compositions have the claimed properties and no additional components are claimed (such as an excipient, adjuvant, carrier, etc.), these limitations are also anticipated. The claimed compositions teach a compound of formula 1 and no additional components. Therefore, the claims are anticipated by the aforementioned compounds of formula 1, capable of being used with the claimed intended uses, as quoted herein.
MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Since the compositions taught by the prior art do not have any structural difference from the claimed compositions and the prior art compositions are capable of the intended uses, those limitations are also anticipated, as discussed herein.
14. Claim(s) 1 and 6-16 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2012/058134.
WO 2012/058134 teaches anticipatory compounds and compositions, such as for example on page 162, Table 1:
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Wherein V1 is pyridine substituted with heteroaryl, n is 1, R1 is H,A is piperazine, V2 is C2 alkyl substituted with heteroaryl and pharmaceutical compositions comprising the same and comprising additional diuretics (see page 13, last paragraph).
Regarding the limitations of composition claims 6-10 and 12-16 the limitations as follows: “for preventing or treating respiratory diseases (claim 6)…wherein the respiratory diseases are inflammatory airway diseases (claim 7)…. “wherein the inflammatory airway diseases is…(claim 8)….wherein the active ingredient acts as a pendrin inhibitor (claim 9)….wherein the active ingredient preserves or increases the volume of airway surface liquid (claim 10)…a health functional food for preventing or ameliorating respiratory diseases (claim 12)…a diuretic pharmaceutical composition (claim 13)…which is co-administered with other diuretics (claim 14, a composition claim, not a method claim)…the other diuretic is furosemide (claim 15, a composition claim, not a method claim)…a diuretic health functional food compositions (claim 16)” – it is noted that these claims merely recite properties of the anticipated compositions. “Products of an identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, and the application discloses that all of the claimed compositions have the claimed properties, these limitations are also anticipated. Since the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, comprising compounds of formula 1, and the application discloses that all of the claimed compositions have the claimed properties and no additional components are claimed (such as an excipient, adjuvant, carrier, etc.), these limitations are also anticipated. The claimed compositions teach a compound of formula 1 and no additional components. Therefore, the claims are anticipated by the aforementioned compounds of formula 1, capable of being used with the claimed intended uses, as quoted herein.
MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Since the compositions taught by the prior art do not have any structural difference from the claimed compositions and the prior art compositions are capable of the intended uses, those limitations are also anticipated, as discussed herein.
Conclusion
15. No claims allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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