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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election of group II, drawn to a method for treating heli. pylori in a patient via administering compounds of group I to a patient in need thereof and elected species:
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in the reply filed on 5/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 7-13 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover similar species and actual working examples in the specification that are clearly articulated in structure.
Priority
This application is the U.S. Continuing Application of International Application
No. PCT/CN2024/080223 filed on 6 March 2024 which designated the U.S. and claims priority to Chinese Application No. CN202410042684.5 filed on 10 January 2024. However, an original and certified English version of the foreign priority document was not received.
Failure to provide a certified translation may result in no benefit being accorded for the non-English application (i.e. the examiner respectfully requests submission of the appropriate English translated version and original copy of the foreign priority document if benefit is sought). See MPEP 213.04.
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 7-13 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.
Claim 7 recites “of claim 1” where there is no claim 1 currently pending. Thus the claim and claims dependent on it which do not rectify the issue are indefinite.
Claim 7 recites “wherein the anti-helicobacter pylori derivative comprises a compound”. The latter suggests that the claims are not limited to the formula seen in claim 7 and may embrace other components not defined within the claim itself or specification. Thus the language is indefinite.
The scope of “acyl” is indefinite. The reason is that there are multiple definitions, and there is no one, generally accepted, definition. The broadest notion sets no limitation at all on the nature of the acid used to form the acyl. Thus, the Wikipedia entry says “the term acyl or acyl group refers to a functional group obtained from an acid by removal of a hydroxyl group.” If you take OH from nitric acid, you have nitro group, so nitro is an acyl. If you take OH off of hypochlorous acid (Cl-OH), you get Cl as acyl. Hydrogen peroxide is a (very) weak acid, so take away OH, and you have OH left as an acyl. What does Applicant intend? For whichever choice is made, Applicants must show that one of ordinary skill in the art would have been able to determine that this choice, and not some other, was intended. Additionally the scope of R groups being selected from “aldehyde” is unclear as it is uncertain that Applicants are referring to a formyl group “-C(O)H” attached directly to the ring or any possible moiety containing a formyl group. Correction is required.
Claims 12-13 recite “under a reduced pressure until no alcohol smell exists” which is indefinite as there is no guidance in the claims or specification to ascertain the metes and bounds of this limitation. Additionally language such as “fractions Fr.1-1 to Fr.1-5”, etc. is indefinite as it is unclear what fractions are encompassed within this range (e.g. Fr.1-2, Fr.1-1a, Fr. 1-1-1, or something else). The examiner recommends that these fractions are explicitly recited individually in the claims.
Claim Rejections - 35 USC § 112
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 7, 8, 10, and 11 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.
The skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed genus shown in claim 7 based on the information provided in the specification. Note that embodiments of the structural formula in claim 7 may contain various functional groups which are not viewed as equivalents in the art. The only working examples described in the specification consists of 9 species possessing a scaffold containing specific moieties at designated positions on the molecule. No where does the specification allude to the identities of other species which may be embraced by the formula in claim 7. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if only one working embodiment was presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation.
The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples, nature of the described genus, and indefiniteness of the claims (see rejections herein), Applicants are not in possession of the claimed genus.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 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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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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