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 June 18, 2026 is acknowledged. Group (I), drawn to the tricyclic compounds of formula (I) and compositions and kits thereof, embraced by claims 1-15 and 18-20 was elected by Applicant. The traversal is on the ground(s) that the Examiner did not meet the burden of proof to establish that unity of invention is lacking. This is not persuasive. The special technical feature can be found in, e.g. US 20140367657, see page 46, compound I-7 and I-8. Both species read upon at least the present claim 1. Therefore, Groups I-III lack a common technical feature that defines a contribution over the prior art. Note also the art rejection(s). Applicant has not pointed to any other issues 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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and indicated claims 1-10, 13,14 and 15-21 read on said species. However, only claims 1-10, 13-15 and 18-20 read on the elected group.
The elected species was not found during the search, and therefore, the search was expanded.
Claims 1-21 are pending and claims 1-10, 13-15 and 18-20 are under consideration. Claims 11, 12, 16, 17 and 21 are withdrawn based on the species election and lack of unity,
Claim Rejections
Claims 1-10, 15 and 18-20 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 1-10, 15 and 18-20, directed to the nonelected species, are withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Note also the 112(a) written description rejection below, which is incorporated herein.
To overcome the rejection the claims may be amended to wherein A and B are defined as found in claim 13, and R1 as a six-membered aromatic ring or (CH2)n-cycloalkyl.
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 1-10 and 13-14 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.
The phrase, “including mixtures thereof in all ratios” is vague. The claims are drawn to compounds and therefore are not mixtures. Thus, said claims are rejected as being vague.
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 1-10, 15 and 18-20 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 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 description for the full scope of the compounds in claim 1. The mere fact that Applicant may have discovered several tricyclic five-membered ring cores with R1 as a six-membered aromatic ring or (CH2)n-cycloalkyl, is not sufficient to claim the entire genus.
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]."
Thus, said claims are rejected under 35 USC 112(a) (Written Description).
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 § 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.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kim et al. (US 20140367657).
The reference teaches the following species:
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,
see page 46 and 48, respectfully. Thus, said claims are anticipated by Kim et al.
Claim(s) 1-3, 6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nenajdenko et al. (Russian Chemical Bulletin, International Edition, 2012, 61(7), 1463-1468).
The reference teaches the following species:
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, amongst others, see page 1465.
The present specification teaches aliphatic groups may be substituted, see page 93, last paragraph, and page 95, first paragraph. Therefore, the COOH and COOEt are a substituted methyl group.
Thus, said claims are anticipated by Nenajdenko et al.
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.
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, 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
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