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 April 22, 2026 is acknowledged. Group (I), drawn to purines of formulas (Ia) and (Ib) and compositions thereof, embraced by claims 25-43 was elected by Applicant.
The traversal is on the ground(s) that “The required election between Groups I and II is improper because "[a]lthough lack of unity should be considered on its merits, the benefit of any doubt being given to the applicant." MPEP § 1850 (II) (emphasis added). The claims of the instant application do not qualify as a "clear case" of lacking unity of invention. According to the MPEP, the benefit of any doubt with respect to unity of invention must be given to the applicant. Here, a search of Groups I and II would not impose a serious burden upon the Examiner because a search concerning the patentability of Group I would likely uncover art of interest in the method of treatment in Group II.”
This is not persuasive. The search burden traversal does not apply to 35 USC 371 cases. Moreover, lack of unity is present because the present invention does not constitute a contribution over the prior art as evidenced by the 102 rejection herein.
Applicant has not pointed to any other errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species:
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144
328
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233
305
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322
415
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,
and indicated claims 25, 26, 28-30, 35, 41, and 43 read on said species.
The elected species was not found during the initial search; and thus, the search was expanded. Compounds of formula (Ia), wherein A1 and A2 = oxygen, X= sulfur, and R5 is NHC(A3)NHR6 and NHS(O)2R8 are free of the art.
Claims 25-44 are pending and claims 25, 26, 28-30, 35, 41, and 43 are under examination. Claims 27, 31-34, 36-40 and 42 are withdrawn based on the species election and claim 44 is withdrawn based on the lack of unity.
Specification
Drawings
The drawings are objected to because some of the figures are blurry, see figures 2A, 3B, 6C, 10B, 11A, 11B, etc. Please review the drawings and submit clear images. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 25, 26, 28-30, 35 and 43 is 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.
With regards to claim 25, the variable R7’ is defined but not found in the definitions of the variables for compound (Ia). Thus, claims 25, 26, 28-30, 35 and 43 are indefinite.
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 25, 26, 28-30, 35, 41 and 43 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 formulas (Ia) and (Ib), which demonstrates possession of antiviral properties, and more specifically, treating a coronavirus infection by inhibiting PARGi. The mere fact that Applicant may have discovered several specific compounds of formulas (Ia) and (Ib), 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]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
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.
Claims 25, 26, 28-30, 35 and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipatory by Uno et al. (Chemical & Pharmaceutical Bulletin, 1972, 20(12), 2603-2606) and as evidenced by Ochiai et al. (Chem. Ber., 1936, 69, 1650-1655).
The reference teaches the following species:
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302
790
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, see page 2606, Table II, compound V. The compound is synthesized and crystallized from ethanol as evidenced by Ochiai et al., see page 1654 for the experimental of synthesis as referenced by Uno et al.
Thus, said claims are anticipated by Uno et al.
Double Patenting
No obviousness-type double patenting rejections over U.S. 12491188, 11400096 and 10214529 are being made based on the elected species. However, upon broadening the search, the NSDP rejections will be reconsidered.
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
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