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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
Status of the Claims
The amendment filed on 02/03/2026 has been entered. Claims 1-5, 7, 9-10, 14 and 19-20 have been canceled and claim 14 has been amended. Claims 14 and 17-18 are currently pending and under examination.
Withdrawn Rejection
The definition of formulas (20a) and (20a-A) in claim 14 has been amended to now require at least one of R22 to R27 to be RA and by limiting RA to formula (f1), (a1), (b1) or (e1). 1-Octanocol of the prior art of record, Ryan (Ryan, H. et al. “Montanic Acid and its Derivatives” Proc. Roy. Irish Acad. 1913, 30, 97-105), fails to anticipate amended claim 14 and thus the 102(a)(1) rejection has been withdrawn.
Claim Rejections - 35 USC § 112 – Written Description
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 14 and 17-18 are newly 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.
Instant claims recite the generic “substituent” when defining the claimed R groups. This generic term encompasses a large amount of species and there is no disclosure of this term that would permit the determination of which species are within the scope of this generic term. The disclosure contains insufficient written description to demonstrate applicant was in possession of the generic term. Furthermore, the description does not place the public in possession of any of these generic groups of compounds.
The MPEP states that the purpose of the written description requirement is to
ensure that the inventor had possession, as of the filing date of the application, of the
specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe
an invention and do so in sufficient detail that one skilled in the art can clearly
conclude that "the inventor invented the claimed invention." Lockwood v.
American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.
1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir.
1989) ("[T]he description must clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed."). Thus, an applicant
complies with the written description requirement "by describing the invention,
with all its claimed limitations, not that which makes it obvious," and by using
"such descriptive means as words, structures, figures, diagrams, formulas, etc.,
that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at
1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate
written description to identify the genus of the claim. In Regents of the University of
California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a
description of a chemical species, 'requires a precise definition, such as by
structure, formula, [or] chemical name,' of the claimed subject matter sufficient to
distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In
re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In
other cases, particularly but not necessarily, chemical cases, where there is
unpredictability in performance of certain species or subcombinations other than
those specifically enumerated, one skilled in the art may be found not to have
been placed in possession of a genus ... ") Regents of the University of California
v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional
characteristic, without any disclosed correlation between function and structure of the
sequence, it is "not sufficient characteristic for written description purposes, even when
accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The
MPEP does state that for a generic claim the genus can be adequately described if the
disclosure presents a sufficient number of representative species that encompass the
genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must
describe a sufficient variety of species to reflect the variation within that genus. See
MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number
of representative species, the courts have indicated what do not constitute a
representative number of species to adequately describe a broad generic. In Gostelli,
the courts determined that the disclosure of two chemical compounds within a subgenus
did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The MPEP lists factors that can be used to determine if sufficient evidence of
possession has been furnished in the disclosure of the Application. These include "level
of skill and knowledge in the art, partial structure, physical and/or chemical properties,
functional characteristics alone or coupled with a known or disclosed correlation
between structure and function, and the method of making the claimed invention.
Disclosure of any combination of such identifying characteristics that distinguish the
claimed invention from other materials and would lead one of skill in the art to the
conclusion that the applicant was in possession of the claimed species is sufficient."
MPEP § 2163. While all of the factors have been considered, a sufficient amount for a
prima facie case are discussed below.
(1) Level of skill and knowledge in the art:
The relative level of skill possessed by one of ordinary skill in the art of chemical research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess an Ph.D. in a
scientific discipline such as organic synthetic chemistry, polymer chemistry, medicinal
chemistry, biochemistry, pharmacology, biology or the like. However, the skilled artisan would not know what species are encompassed by the term “substituent”
(2) Partial structure:
The specification describes the term “substituent” as not particularly limited and further sets forth some examples ([299], [305] and [314] of PGPub US2022/0112233A1), however, it is not understood what is encompassed by the term substituent beyond the exemplified ones.
(3) Physical and/or chemical properties:
The disclosure fails to provide the chemical and/or physical properties of the term “substituent” and thus a skilled artisan understands the metes and bounds of the term.
(4) Functional characteristics
No disclosure of functional characteristics of the generic “substituent” are present in the specification.
(5) Method of making the claimed invention:
The specification does not set forth method of making extensive representative compounds that encompass the generic term “substituent”.
As stated supra, the MPEP states that written description for a genus can be
achieved by a representative number of species within a broad generic. It is
unquestionable that instant claims are broad and generic, with respect to all possible
species encompassed by the claims. The possible structural variations are limitless
to any “substituent”. Although the claims may recite some functional characteristics, the
claims lack written description because there is no disclosure of a correlation between
function and structure of the compounds beyond those compounds specifically
disclosed in the examples in the specification. Moreover, the specification lacks
sufficient variety of species to reflect this variance in the genus. While having written
description of the elected species and compounds identified in the specification tables
and/or examples, the specification does not provide sufficient descriptive support for the
myriad of compounds embraced by the claims.
The description requirement of the patent statue 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 fails to provide
adequate written description for the genus of the claims 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.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 14 and 17-18 are newly 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.
Regarding claims 14 and 17-18, the limitation “substituent” renders the claims vague and indefinite. Upon review of the specification, the Examiner cannot determine which substituents of claimed structures are embraced by the claims. It is unclear how many substituents are tolerated to fall within the metes and bounds of the aforementioned limitation.
Regarding claims 14 and 18, RA is selected from formulas (f1), (a1), (b1), (e1) and (f2), and requires that the number of carbon atoms in an aliphatic hydrocarbon group in at least on RA is 18 or more, however the R groups in formulas (f1), (a1), (b1), (e1) and (f2) do not encompass aliphatic hydrocarbon with carbon atoms of 18 or more, specifically:
(f1) R9 = a divalent hydrocarbon group, and R10 = a monovalent aliphatic hydrocarbon group having 5 or more carbon atoms;
(a1) R20 = a divalent aliphatic hydrocarbon group having 5 or more carbon atoms;
(b1) Rb3 represents an aliphatic hydrocarbon group having 5 or more carbon atoms;
(e1) Re2 = a methyl group or an organic hydrocarbon group having 5 or more carbon atoms;
(f2) R10 = a monovalent aliphatic hydrocarbon group having 5 or more carbon atoms.
As such, there is a lack of antecedent basis for the above R groups of formulas (f1), (a1), (b1), (e1) and (f2).
Claims 17-18 are also rendered indefinite for their dependency on claim 14.
Claim 17 recites the limitation "wherein RA in formula (10a)…are each independently a group represented by formula (f1) or formula (a1)" that renders the claim vague and indefinite because it is unclear what formula (f1) or formula (a1) encompasses. In view of claim 14, formula (f1) or formula (a1) are only recited to define RA of formula (20a) but not of formula (10a).
For purpose of applying art, formula (f1) or formula (a1) in claim 17 will be interpreted as only limiting RA in formula (20a).
Claims 18 is also rendered indefinite for its dependency on claim 17.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 14 and 17-18 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishigaki (Ishigaki, Y. et al. “Three-way output molecular response system based on tetrakis(3,4-dialkoxyphenyl)-3,4-dihydro[5]helicenes: Perturbation of properties by long alkyl chains” HETEROCYCLES, Vol. 90, No. 1, 2015).
Regarding claim 14, Ishagaki teaches compounds 7b and 7c that are species of formula (10a) (Scheme 4, pg. 128):
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168
155
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17
167
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In the above,
- YB = OH
- R100 = aryl group
- n10 = 1
- Rs = substituent or RA (when alkyl is C16H31 and has an organic group having an aliphatic hydrocarbon with 32 carbon atoms)
- R10 = RA an organic group having an aliphatic hydrocarbon with 62 carbon atoms (alkyl is C16H31) or 32 carbon atoms (alkyl is C8H15).
- R12 to R17 = hydrogen
Regarding claims 17-18, as set forth above, claim 17 is interpreted as formula (f1) or formula (a1) only limiting formula (20a) and not formula (10a). As such, the above compounds of Ishagaki still read on the instant claims 17-18.
Claims 14 and 17-18 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki (Suzuki, T. et al. “Multi-Input/Multi-Output Molecular Response System Based on the Dynamic Redox Behavior of 3,3,4,4-Tetraaryldihydro[5]helicene Derivatives: Reversible Formation/Destruction of Chiral Fluorophore and Modulation of Chiroptical Properties by Solvent Polarity” Chem. Eur. J. 2009, 15, 9434-9441).
Regarding claim 14, Suzuki teaches compounds 6b and 6c that are species of formula (10a) (Scheme 3, pg. 9436):
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84
136
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28
81
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In the above,
- YB = OH
- R100 = aryl group
- n10 = 1
- Rs = substituent or RA (when alkyl is C16H31 and has an organic group having an aliphatic hydrocarbon with 32 carbon atoms)
- R10 = RA an organic group having an aliphatic hydrocarbon with 62 carbon atoms (alkyl is C16H31) or 32 carbon atoms (alkyl is C8H15).
- R12 to R17 = hydrogen
Regarding claims 17-18, as set forth above, claim 17 is interpreted as formula (f1) or formula (a1) only limiting formula (20a) and not formula (10a). As such, the above compounds of Suzuki still read on the instant claims 17-18.
Conclusion
Claims 14 and 17-18 are rejected.
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/MEDHANIT W BAHTA/Primary Examiner, Art Unit 1692