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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/03/2026 has been entered.
Applicants’ arguments, filed 08/03/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
(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.
1) Claims 1, 9, 25, 26, 28-34 and 39-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanazawa et al. (Chemical and Pharmaceutical Bulletin, 1997, vol. 45, no. 6, pages 1046-1051), as evidenced by Wagner (EPA Office of Prevention, Pesticides and Toxic Substances, 2006).
Kanazawa relates to the extraction of gamma-pyrone compounds from Gonystylus [title]. In the extraction process, Kanazawa discloses the solution comprising 15mL of methanol and about 1.3 mg of “compound 2” [p. 1049, left col., para. 3]. Compound 2 is defined in line 2 of Figure 1 on page 1046 (see below) and is the elected species.
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308
374
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Greyscale
1.3 mg (0.0013 gram) of “compound 2” in 15 mL can be expressed in a volume per weight percent as (0.0013 g / 15 mL)*100% = 0.0087% w/v.
Additionally, methanol is a known solvent and cosolvent in pesticides (i.e., agronomically-acceptable carrier or diluent) as evidenced by Wagner at page 3, Section II A.
The prior art anticipates claims 1, 9, 25, 26, 28-33 because it discloses a composition comprising an agronomically acceptable carrier (methanol) and the elected compound in an amount between 0.001-0.25% w/v (0.0087% w/v), wherein the compound is an extract of Gonystylus and the composition is a solvent based solution. Additionally, the composition would inherently possess the properties recited by claim 34 because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II]. The prior art anticipates instant claims 39-41 because the prior art compositions comprises 0.0087% w/v which falls entirely inside the ranges recited in instant claims 39-41 (0.001-0.1% w/v, 0.00625-0.25% w/v, and 0.00625-0.1% w/v, respectively).
Claim Rejections - 35 USC § 102 / 35 USC § 103
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.
(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.
35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 9, 25, 26, 28, 30, 31, 33, 34 and 39-41 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Muller-Kuhrt et al. (US 5646179, publication date 07/08/1997).
Muller-Kuhrt discloses the elected compound at “compound 4” in column 2:
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431
667
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Greyscale
Muller-Kuhrt discloses the substances of Table 1, which includes “compound 4”, were tested for their antiviral activity [col. 6, lines 1-20] and that “[s]ubsequent to preparation of a 10 mM solution, the substance to be tested is adjusted by serial 1:10 dilutions in the culture medium” (i.e., at least a solution of 1mM compound 4) [col. 6, lines 25-27]. Additionally, “[t]he y-pyrones of table 1 were recovered from Australian Podolepis heracioides by extraction” (i.e., instant claims 30 and 31) [col. 5, lines 65-67].
The 10mM solution of compound 4 may be represented as a weight per volume percent according to the following:
10
m
M
(
C
4
)
X
1
m
m
o
l
C
4
1
L
s
o
l
v
e
n
t
X
0.001
m
o
l
C
4
1
m
m
o
l
C
4
X
336.5
g
C
4
1
m
o
l
C
4
X
1
L
s
o
l
v
e
n
t
1000
m
L
s
o
l
v
e
n
t
=
3.365
g
C
4
1000
m
L
s
o
l
v
e
n
t
=
>
3.365
g
1000
m
L
*
100
%
=
0.3365
%
w
v
c
o
m
p
o
u
n
d
4
Thus, the serial 1:10 dilutions include, at least, a solution comprising 0.03365% w/v “compound 4” (i.e., the elected species).
The prior art anticipates claims 1, 9, 25, 26, 30, 31, and 33 because upon reading the disclosure a skilled artisan would have immediately envisaged a solution comprising and the elected compound in an amount between 0.001-0.25% w/v (0.03365% w/v), wherein the compound is an extract of Podolepis. Additionally, the composition would inherently possess the properties recited by claim 34 because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II]. The prior art anticipates instant claims 39-41 because the prior art compositions comprises 0.03365% w/v which falls entirely inside the ranges recited in instant claims 39-41 (0.001-0.1% w/v, 0.00625-0.25% w/v, and 0.00625-0.1% w/v, respectively).
In the alternative, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated solutions comprising 0.3365% w/v and 0.03365% w/v “compound 4”. One would have been motivated to, and had an expectation of success in doing so because Muller-Kuhrt discloses serial 1:10 dilutions of a 10mM solution of “compound 4”.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for the elected compound (i.e., “compound 4”) of 0.001-0.25% w/v, 0.001-0.1% w/v, 0.00625-0.25% w/v, and 0.00625-0.1% w/v (claims 1 and 39-41, respectively) overlap with the 0.03365% w/v taught by the prior art, and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a solution comprising the instantly elected species within the amounts recited by instant claims 1 and 39-41. Additionally, the composition would inherently possess the properties recited by claim 34 because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II].
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claims 29, 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Muller-Kuhrt et al. (US 5646179, publication date 07/08/1997) as applied to claims 1, 9, 25, 26, 28, 30, 31, 33, 34 and 39-41 above, and in further view of Price (In Vitro Cellular & Developmental Biology – Animal, 2017, vol. 53, p. 673-681).
Muller-Kuhrt does not anticipate claims 29, 32 and 35 because it does not disclose the specific diluent for the compounds in table 1 (e.g., compound 4, the elected species) and a group consisting of emulsifiers, wetting agents surfactant, stabilizers and spreaders.
However, Muller-Kuhrt does disclose the compounds are diluted with culture media [p. 12, para. 2].
Price, which relates to the best practices selecting culture mediums [title & abstract], discloses that water is a key component of culture medium [p. 674, left col., para. 3].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected a culture medium comprising water as the culture medium disclosed by Muller-Kuhrt. One would have been motivated to, and had an expectation of success in selected a culture medium comprising water because Price discloses water is a key component of culture medium. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising water (i.e., agronomically-acceptable diluent; instant claim 29) and the elected compound (i.e., a water-based composition; instant claim 32).
Regarding instant claim 35, Price discloses “zwitterion buffers (such as HEPES) are often included as buffers in a formulation” for pH balance [p. 674, col. 2, para. 3, lines 8-9].
Organic acids are stabilizing agents according to the instant specification at page 25, paragraph [0189].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) of Price with the composition taught by Muller-Kuhrt and Price. One would have been motivated to add the HEPES buffer to balance the pH of the formulation. One would have had an expectation of success because Price discloses HEPES is often included in culture medium formulations. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a composition comprising the elected compound, water and a stabilizer (i.e., organic acid; (HEPES).
2) Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller-Kuhrt et al. (US 5646179, publication date 07/08/1997) as applied to claims 1, 9, 25, 26, 28, 30, 31, 33, 34 and 39-41 above.
The prior art does not anticipate instant claim 42 because it does not disclose on example or embodiment comprising the instantly elected species at 0.00625% w/v.
Muller-Kuhrt discloses “FIG. 1 illustrates the dose/activity relationship for inhibition of protein 24, inhibition of HIV RNA, and viability for compound 4 of table 1” [col. 7, lines 1-3]. “Viability of the infected cells is determined by the trypan blue technique. […] The viability results from the difference of total cells and dead cells and is similarly given in percent” [col. 6, lines 60-61 and 66-67]. Figure 1 is reproduced below:
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761
1285
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The 20 microM solutions of “compound 4” comprises 0.00673 grams “compound 4” per 1000 mL:
20
m
i
c
r
o
M
(
C
4
)
X
1
m
i
c
r
o
m
o
l
C
4
1
L
s
o
l
v
e
n
t
X
0.000001
m
o
l
C
4
1
m
i
c
r
o
m
o
l
C
4
X
336.5
g
C
4
1
m
o
l
C
4
X
1
L
s
o
l
v
e
n
t
1000
m
L
s
o
l
v
e
n
t
=
0.00673
g
C
4
1000
m
L
s
o
l
v
e
n
t
The weight per volume percent is therefore
0.00673
g
C
4
1000
m
L
s
o
l
v
e
n
t
X
100
%
or 0.000673% w/v “compound 4” (i.e., the elected species).
Muller-Kuhrt also discloses 10mM solutions of the substances were prepared and the “the substance to be tested is adjusted by serial 1:10 dilutions” [col. 6, lines 25-26]. As discussed above, the serial 1:10 dilutions includes, at least, a solution comprising 0.03365% w/v “compound 4” (i.e., the elected species).
Given the disclosure of concentrations greater than and less than the instantly claimed 0.00625% w/v (i.e., 0.03365% w/v and 0.000673% w/v), and given the disclosure of 1:10 serial dilutions, the instantly claimed concentration 0.00625% w/v is within the scope of what the prior art would have used. Accordingly, a prima facie case of obviousness exists for instant claim 42. See MPEP 2144.05(I).
Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising the compound 4 of Muller-Kuhrt (i.e., elected compound) within the instantly claimed amounts through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to adjust the concentrations of “compound 4” to optimize the concomitant antiviral activity (e.g., the viability of infected cells). One would have had an expectation of success because Muller-Kuhrt teaches the concentration of “compound 4” affects the viability of infected cells.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising 0.00625% w/v of the elected compound.
Response to Arguments
1) On page 10 of their Remarks, Applicant argues that the prior art does not anticipate the instant claims because it does not disclose the instantly claimed concentrations.
This argument is moot in view of the new rejections set forth above. Furthermore, Kanazawa et al. discloses the elected species in an amount of 0.0087% w/v, not 0.87% w/v. See below:
1.3 mg (0.0013 gram) of “compound 2” in 15 mL can be expressed in a volume per weight percent as (0.0013 g / 15 mL)*100% = 0.0087% w/v.
2) On page 11 of their Remarks, Applicant argues that the obviousness rejections should be withdrawn because the prior art does not teach the instantly claimed ranges.
This argument is moot in view of the new rejections set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612