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 .
This is the first action on the merits.
Election/Restrictions
Applicant's election with traverse of Group (I) in the reply filed on July 24, 2026 is acknowledged. Group (I), drawn to compounds of formula (I) and compositions thereof, embraced by claims 1-9, 14 and 15 was elected by Applicant. The traversal is on the ground(s) that no search and examination burden is present. This is not found persuasive because search and examination burden only apply to U.S. filed applications, not 371 national phase applications. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species:
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137
223
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and indicated claims 1-9, 14 and 15 read on said species. The elected species was not found, and therefore, the search was expanded to the elected Markush group.
Claims 1-15 are pending and claims 1-9, 14 and 15 are under examination. Claims 10-13 are withdrawn based on the restriction requirement.
Claim Objections
Claim 1 is objected to because of the following informalities: the variables A, B and C should be renamed as ring A, ring B and ring C for consistency. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl” should be replaced with “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl in the definition of B”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl” should be replaced with “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl in the definition of substituents on B”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl” should be replaced with “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl in the definition of C”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl” should be replaced with “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl in the definition of substituents on C”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl” should be replaced with “wherein cycloalkyl, heterocycloalkyl, aryl and heteroaryl in the definition of X.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl” should be replaced with “wherein alkyl in the definition of R2”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein heterocycloalkyl” should be replaced with “wherein heterocycloalkyl as a substituent in the definition of R2.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl” should be replaced with “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl in the definition of substituents on R10”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl” should be replaced with “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl in the definition of substituents on R11, R12, R21, R22, R31, R32, R41 and R42. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase R11, R12, R21, R22, R31, R32, R41, R42” should be replaced with “R11, R12, R21, R22, R31, R32, R41 and R42.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “R13, R23, R33, R43” should be replaced with “R13, R23, R33 and R43.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl” should be replaced with “wherein alkyl, alkylene, 3- to 6-membered cycloalkyl and 3- to 6-membered heterocycloalkyl in the definition of substituents on R13”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the variables A, B and C should be renamed as ring A, ring B and ring C for consistency. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the term “or” should be inserted between the last two subformulas in the definition of Y. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “wherein alkyl, cyclopropyl or oxetan-3-yl” should be replaced with “wherein alkyl, cyclopropyl or oxetan-3-yl in the definition of substituents on R10”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “wherein alkyl” should be replaced with “wherein alkyl in the definition of R11”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “wherein alkyl” should be replaced with “wherein alkyl in the definition of R13”. Appropriate correction is required.
Claim Rejections
Claims 1-9, 14 and 15 are rejected as each directed to an improper Markush group. These Markush claims are rejected under the judicially approved ‘‘improper Markush grouping’’ doctrine when the claim contains an improper grouping of alternatively useable species. In re Harnisch, 206 USPQ 300 (CCPA 1980). A Markush claim contains an ‘‘improper Markush grouping’’ if: (1) the species of the Markush group do not share a ‘‘single structural similarity,’’ or (2) the species do not share a common use. The species of the present claims do not share a ‘‘single structural similarity. Therefore, a rejection on the basis that the claims contain an ‘‘improper Markush grouping’’ is appropriate. The rejection of the claims will be maintained on the basis that the claims contain an ‘‘improper Markush grouping’’ until the claims are amended to include only species that share a single structural similarity and a common use, or the applicant presents a sufficient showing that the species in fact share a single structural similarity and a common use.
Under principles of compact prosecution, the applicant elected a single disclosed species for search and examination (i.e., an election of species). The prior art search did not find the elected species in the prior art, and the search has been extended to those additional species that fall within the scope of a permissible Markush claim. In other words, the search has been extended to the species that share a single structural similarity and a common use. Proper Markush claims will be examined for patentability over the prior art with respect to the elected species or group of indistinct species, as well as the species that share a single structural similarity and a common use with the elected species or group of indistinct species (i.e., the species that would fall within the scope of a proper Markush claim). Federal Register, Vol. 76, No. 27, 02-09-2011, page 7166.
Claims 1-9, 14 and 15, directed to the nonelected species, are withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
To overcome the rejection, the claims may be limited to wherein ring A is a sulfur-containing five-membered heteroaryl ring.
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.
Claims 1 and 5 are 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 pre-AIA the applicant regards as the invention.
In claim 1, the phrase, “ring A having one or more hydrogen atoms in alkyl” is vague. Ring A does not have alkyl groups but may be substituted with an alkyl group.
In claim 1, the phrase “the aryl or heteroaryl moiety” lacks antecedent basis in the definition of B, page 5, line 5; and definition of C, page 6, line 1.
In claim 1, the phrase “wherein this additional cycle” lacks antecedent basis in the definition of B, page 5, line 8; the definition of C, page 6, line 4; and the definition of R11.
In claims 1 and 5, the phrase “the residue” lacks antecedent basis in the definition of B, page 5, line 11; and page 11, line 3.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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 4 is rejected under 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 phrase “wherein one or more hydrogen atom(s) in any substituent is replaced by deuterium” does not further limit claim 1. 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 8 is rejected under 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. There are species that do no fall within the definition of ring A on formula (I), e.g. on page 14, the first and third species in the second row and the first species in the third row; and the last species on page 15. There may be others. 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.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 14 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written basis for the scope of the compounds of formula (I), which demonstrates possession as a DHODH inhibitor. The mere fact that Applicant may have discovered several specific compounds of formula (I), is not sufficient to claim the entire genus, especially with regards to ring A, B and C.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
Double Patenting
No obviousness-type double patenting rejections over co-pending application 19429750 is being made because there is no overlap when Y is COOH. Thus, the obviousness-type double patenting was considered but not applied. The structural difference between the species of co-pending application 19429750 means that the two are patentably distinct.
Furthermore, application 18621364 is currently abandoned.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
