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 claims priority as follows:
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Receipt of claim amendments and arguments filed on 05/04/2026 is acknowledged. Claims 3-6 have been added, therefore, claims 1-6 are currently pending.
Rejections and objections not reiterated herein have been withdrawn in view of the amendments. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
Claims 1-6 are the subject of this Final Office action.
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.
Claims 1-6 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 amended claims are drawn to
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The genus of products is “an amide-containing, polymeric thiophene hueing agent”. The product made is thus, of any size, contains any groups with any number of atoms and bonded in any form, as long as the product contains anywhere an amide, a thiophene and a polymer group. The genus does not recite that the amide is directly bonded to the thiophene group or to a polymer. The genus does not recite if the “polymeric thiophene” is a polymer made of thiophene as monomer, or if the polymer is separate and bonded to the thiophene or some another group.
The genus of starting material is a nitrile (-CN), bonded to any groups of any sizes, with any number of atoms, which is converted to the amide via hydrolysis.
The claims recite “hueing agent”, however, the phrase “amide-containing, polymeric thiophene” appears to set forth all of the structural limitations of the product made.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
To satisfy the written description requirement, a specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed. Cir. 2003). Where, as here, the claims cover a broad genus, 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.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not 36 supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”).
“The examples and description should be of sufficient scope as to justify the scope of the claims”. See MPEP § 608.01(p). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1 (MPEP 2163).
In the instant case, the specification only discloses producing formula I
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, and exemplifies only one product with its synthesis at page 50 of the specification:
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.
This is not a representative sample of the claimed genus of “amide-containing, polymeric thiophene hueing agent” and “product of hydrolysis of a nitrile”. In addition, the formula I is not a representative sample of the claimed genus.
The species of product produced in this application supports only the structure of formula I, and the nitrile starting material of the specification has a particular structure in relation to formula I.
In conclusion: (i) substantial structural variation exists in the genus/subgenus embraced by the claims; (ii) disclosure of species supporting the genus is limited to only 1 product/reaction reduced to practice, which scope is not commensurate with the scope of genus/subgenus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification does not describe in sufficient detail the genus of compounds in the claims and how to use them and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Applicant’s arguments have been considered but were found unpersuasive.
Applicant argues that the specification describes the method in sufficient detail to convey possession of the claimed invention. The examiner disagrees for the reasons of record. The formula I
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and only species made in the specification of this application are not representative of the entire genus claimed which is:
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.
MPEP 2163 states that for each claim drawn to a genus, If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. 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 Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005).
Note that in this case there is substantial variation within the genus and there is only one embodiment of what is claimed.
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.
Claim(s) 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Back et al. (Chem. Eur. J. 2016, 22, 18335-18338).
The claims recite:
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In the second step represented by numeral i#, the prior art teaches making an amide containing polymeric thiophene directly via hydrolysis of a nitrile without isolation of an intermediate, under basic conditions as follows:
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Basic conditions are formed in NaOH, and the compounds has polymeric thiophene.
See Scheme 1.
Instant claims recite “hueing agent” in the preamble of the claims. The term “hueing agent” is considered an intended use of the amide-containing, polymeric thiophene defined in the claims. See MPEP 2111.02 (II) regarding preamble statements reciting purpose or intended use: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
In the instant case, the body of claim 1 intrinsically sets forth all of the
limitations of the compound of claim 1. Accordingly, any compound disclosed in the prior art having the elements recited in the body of the instant claim 1 is considered to be capable of the intended use as a “hueing agent”.
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.
Claims 1-6 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. The claim recites “without isolation of an intermediate functional group”. There is no “intermediate functional group” disclosed in the original specification or claims.
The original specification would not have reasonably lead those skilled in the art to the now claimed limitations. The new recitation would not have been obvious from the application description. See MPEP 2163 I. A and B.
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 1-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In the claims, it is unclear what is meant by the phrase “the amide is directly formed as an isolated reaction product”. This is ambiguous because there are reactants/reagents in the same reaction mixture and the amide reaction product cannot be formed isolated from them.
In the claims, it is unclear what is meant by “ without isolation of an intermediate functional group”. A functional group is a substituent or moiety in a molecule. A functional group is not a compound.
Conclusion
Claims 1-6 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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