*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 .
Applicant’s response dated February 18, 2026 is acknowledged.
Priority
This application is a divisional of 14/745,091 filed on 06/19/2015, which is a CIP of
14/629,320 filed on 02/23/2015, which claims benefit in provisional applications 62/082,019
filed on 11/19/2014 and 61/943,287 filed on 02/21/2014.
Claim Status
Claims 1-5, 7, 9-11, 13, 14, 18, 22, and 28 are pending and examined. Claims 6, 8, 12, 15-17, 19-21, 23-27, and 29-31 were cancelled. Claim 1 was amended.
Withdrawn Claim Rejections -35 USC § 112
Rejections of claims 1-5, 7, 9-14, 18, 22, and 28 are withdrawn because claim 1 was amended to require water in the list of components that the aqueous compositions consist of, and claim 12 was canceled. The remaining dependent claims no longer depend from an indefinite base claim.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459
(1966), that are applied for establishing a background for determining obviousness under 35
U.S.C. 103(a) 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 at the time any inventions covered therein were effectively filed absent any evidence to
the contrary. Applicant is advised of the obligation under 37 CPR 1.56 to point out the inventor
and effective filing dates of each claim that was not commonly owned at the time a later
invention was effectively filed 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.
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.
Claims 1, 2, 4, 7, 9-11, 13, 14, 18, 22, and 28 are rejected under 35 U.S.C. 103 as being
unpatentable over HAROD (US 6,358,516; Issued Mar. 19, 2002 - of record in PTO-892 dated
02/08/2022) in view of GASQUE (US 9,717,757; Priority to Dec. 28, 2011 - of record in
PTO892 dated 02/08/2022), and OLIVEIRA (Int. J. Pharm., January 2014, 464, 145-151 - of
record in PTO-892 dated 05/02/2024); and any or all of LEECE (US 2006/0074029; Pub. Apr. 6,
2006 - of record in PTO-892 dated 02/08/2022), ROSZELL (US 2007/0160559; Pub. Jul. 12
2007 - of record in PTO-892 dated 02/08/2022), and SCHLESSINGER (US 2012/0100183; Pub.
Apr. 26, 2012 - of record in PTO892 dated 02/08/2022).
2. Harod discloses a skin care system that cleanses, therapeutically conditions, and
provides additional beneficial treatment to the skin in a simple, one-step application that air dries
quickly without rinsing (title; abstract). The composition is in the form of pre- moistened soft
cloths (abstract; col. 5, lines 52-62; Examples). Harod teaches the pH of the composition is
preferably close to that of human skin, that is, approximately 4.5-6.7, and that the composition
maintains this pH of the skin (col. 11, lines 4-5; Table II). Harod teaches application to intact
epidermis results in deep absorption into skin, which results in, inter alia, destruction of
pathogens throughout the layers of the skin, thus reducing infections due to bacteria, viruses, etc.
(i.e., the antimicrobial barrier properties are improved), and promotes increased blood circulation
in treated areas (col. 9, lines 13-16; col. 11, lines 1-3; col. 13, lines 5-9). Harod teaches use of the
composition for bed baths (which one of skill in the art would understand includes full body
cleansing including arms, legs, back, genital areas, etc.), and illustrates application to the chest or
back (Fig. 3). These areas are considered to be associated with muscle tissue subject to cramping
and/or soreness. Harod teaches the preferred usage includes re-wiping the skin (i.e., repeating
application of the composition) (col. 12, lines 50-57). In light of Harod's teachings and the fact
that the instant application states that Theraworx® (from the Harod Patent) is useful in the
invention, including lowering pH over the entire thickness of the outer layer of tissue (instant
pars. [0016], [0020]-[0021]), the instantly claimed properties (e.g., acidifying both the innermost
and outermost surface of the stratum corneum to a pH of about 4.5-6.0, as well as the outcomes
recited in claim 22) are considered to be met by applying the composition disclosed by Harod.
3. Regarding the composition itself, the composition disclosed by Harod is identical to that instantly claimed. For instance, Harod teaches that the composition is aqueous (col. 5, lines 36-38; col. 10, lines 53-55) and comprises (note-the elements below refer to those recited in instant claims 1 and 28):
an amphoteric surfactant in an amount of 1-7 wt. % (claims 1 and 5)
aloe vera (an anti-inflammatory, cell growth-promoting agent, immune system enhancing agent,
absorption facilitation agent, humectant and emollient, and healing promoting agent) in an
amount of 1-7 wt. %
allantoin (an anti-inflammatory, cell growth-promoting agent, immune system enhancing agent,
absorption facilitation agent, humectant and emollient, and free radical-scavenging agent) in an
amount of 0.2-1 wt. %
cocamidopropyl betain (an amphoteric surfactant and anti-inflammatory) in an amount of 0.2-2
wt.%
lauryl glucoside (a surfactant) in an amount of 0.1-2 wt. %
dimethicone copolyol (a silicone-based anti-foaming agent) in an amount of 0.1-2 wt. %
Citricidal® (which contains grapefruit extract, quaternary compounds derived from grapefruit
and glycerin according to col. 8, lines 3-7 of Harod and instant par. [0075]; Citricidal® is a fast acting antimicrobial, immune system enhancing agent, and cell growth promoting agent) in an
amount of 0.4-2 wt.%
colloidal silver (a fast-acting antimicrobial and absorption facilitation agent) in an amount of 0.2-
4 wt.%
beta glucan (an anti-inflammatory, cell growth-promoting agent, immune system enhancing
agent, free radical-scavenging agent, and absorption facilitation agent) in an amount of 0.1-6 wt.
%
vitamin E (a humectant and emollient and free radical-scavenging agent) in an amount of 0.01-2
wt.%.
See Table 1 and claims 1, 5, 8, 17, 18, 23, 25, and 30 of Harod. Note that for the sake of
clarity and simplicity the amounts listed here generally correspond to those in Table 1 of Harod,
but due to the multiple and overlapping roles of many of the components, Harod actually teaches
somewhat wider ranges for many of these components (see claims 1, 5, 8, 17, 18, 23, 25, and 30
of Harod).
The claimed composition contains the same elements as Harod' s aqueous composition
containing components (a)-(j).
The claimed method is described as consisting of steps (a)-(d). The combination of cited references teaches a method that contains steps a-d. It would have been obvious to have practiced the method of the prior art by only performing steps a-d because the prior art method
does not require steps in addition to steps a-d. Therefore, it would have been obvious to have
practiced a method consisting of steps a-d, which meets the claimed method. Prior art is not
required to recite "consisting of' language to render the claimed "consisting of' language
obvious. The lack of a requirement of steps besides a-din the prior art method implies that the
prior art method can be practiced by only performing steps a-d.
4. Regarding the specific use of treating muscle cramps or tightness, Gasque discloses a
method to treat and prevent muscle cramping, soreness, and/or swelling using a topical
composition comprising the same components as Harod (title; abstract; col. 2, lines 8-32). In
fact, Gasque specifically refers to the (Theraworx®) composition of Harod (US 6,358,516) as
suitable for use in the methods of the invention (col. 1, lines 33- 36; col. 5, lines 16-23; claims 1-
15). Gasque teaches application of the composition to the skin in and around the muscle tissue
sought to be treated before (1.e., prior to), during, or after athletic exercise to treat or prevent
muscle cramps (col. 9, lines 26-60).
5. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to use the topical
compositions of Harod to treat or prevent muscle cramping or soreness. One would have been
motivated to do so with a high expectation of success since Gasque directly teaches the
suitability of Harod's compositions for this use. Specifically, it would have been prima facie
obvious to one of ordinary skill in the art to apply a known composition for muscle soreness
prior to, during, and after exercising (i.e., strenuous physical activity, or exertion), since Gasque
suggests application at all of these times (col. 9, lines 26-60). Further, Gasque teaches use of the
composition to treat and prevent muscle cramps (col. 9, lines 26-29), which suggests application
both before and after cramp-causing exertion.
6. Harod teaches the preferred usage includes re-wiping the skin (i.e., repeating application of the composition) (col. 12, lines 50-57), but does not expressly teach re-applying
the composition in the instantly claimed timeframe. Nonetheless, it would have been prima facie
obvious to one of ordinary skill in the art at the time of the invention to apply the composition to
treat or prevent muscle cramping or soreness in the instantly recited timeframe. At the outset, it
is within the skill of the artisan to determine the frequency of applying a composition to treat or
prevent muscle cramping and/or soreness. One would repeatedly apply the composition for as
long as necessary to achieve the desired relief from muscle cramping or soreness. Further, it was
known in the art to apply similar topical compositions within the claimed timeframe.
7. For example, Leece discloses aqueous topical antimicrobial skin moisturizing
compositions particularly useful for healthcare workers (title; abstract; [0046]). Leece teaches
reapplying the compositions to skin on an hourly basis, and that such application resulted in an
additive moisturization effect over time ([0040], [0043]).
8. Similarly, Roszell discloses topical aqueous skin disinfectant compositions (title;
abstract). The compositions comprise many of the same ingredients as those of Harod, including
surfactants, anti-inflammatory agents, antioxidants, antimicrobial agents, emollients,
moisturizing agents, pH adjusting agents, etc. (e.g., aloe vera, vitamin E, EDTA, etc.) (abstract;
[0056], [0061], [0065], [0070], [0072]). Roszell teaches the compositions can exhibit disinfectant
properties at least two hours after application ((0009]; claim 17). To anyone of skill in the art,
this suggests reapplication at about 2 hours. One would be motivated to reapply the composition
in this timeframe if one wanted to be certain that the activity of the composition was maintained
for an extended period of time.
9. Similarly, Schlessinger discloses topical anti-inflammatory compositions and skin care
compositions (title; abstract). The compositions can be applied with a mat or cloth ([(0208]) and
comprise many of the same ingredients as those of Harod, including anti- inflammatory agents,
antioxidants, antimicrobial agents, skin healing agents, moisturizing agents, and combinations
thereof (e.g., aloe vera, vitamin E, etc.) (abstract; [0167], [0576]). Schlessinger teaches the
greater the number of applications to the skin within a given period of time, the greater an
improvement will be observed in the skin, and the less time will be required for achieving such
results. Schlessinger teaches that there generally is no upper limit to the number of applications
of the composition, and teaches up to about 48 applications to the skin within a one-day (24
hour) period ([0608]), or about every 30 mins.
10. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to have repeatedly applied
the Theraworx® compositions of Harod with a frequency of about every 30 minutes to about
every two hours, and repeating such application as necessary. The artisan recognizes that such
administration application is routine in the art, at least since such compositions may only exert
their effects for a few hours or less (per Roszell). One would have been motivated to do so since
the recited frequency is known in the art as preferred for topical skin protecting compositions
(per all of Leece, Roszell, and Schlessinger). One would have been motivated to do so with the
expectation of improving the cleaning, softening, moisturizing, and antimicrobial effects of the
composition in less time with increased application frequency (per Leece and Schlessinger), and
for achieving the desired improvement in muscle cramps, soreness, and pain as needed (Gasque).
Furthermore, it is well within the purview of the skilled artisan to determine the frequency and
duration of administration based on the particular area(s) and severity of muscle soreness
intended to be treated, and the situation(s) in which the composition is applied.
11. Regarding step (d), Oliveira reports on the effects of heat on skin barrier function and
dermal absorption (title; abstract). Oliveira teaches that enhanced delivery of ingredients across
the stratum corneum (SC) is of great interest for improving the efficacy of topically applied
formulations. Oliveira investigates the influence of topically applied heat in vivo on the dermal
uptake and penetration of a model active, allantoin from gel and lotion formulations (abstract).
Oliveira teaches that heat has long been known to enhance uptake of active agents into the skin,
and that topically applied heat at 42°C ( ~ 107.6°F) caused significantly more penetration of
allantoin without compromising the integrity of the skin (abstract; Introduction; Figs. 4-8;
Conclusions). Allantoin was selected for this proof-of-concept study since it is used in a wide
range of personal care products for application to the skin, but it does not possess ideal properties
for dermal delivery (Introduction). Note that allantoin is one of the components of Harod's
formulation (e.g., see Table 1). Further, 42°C was well tolerated by volunteers (Introduction).
It would have been obvious to have warmed the composition prior to applying the composition
in each of the steps a, b, and c, with a reasonable expectation of success because Oliveira teaches
benefits of warming a composition comprising allantoin prior to application to skin, as described
above.
12. Regarding claims 2 and 4, Harod teaches sterilization by exposure to electron beam or
gamma radiation (col. 5, lines 8-13; col. 10, lines 57-64; Example 3). Note that a sterility
assurance level (SAL) of 107 is generally considered "sterile" in this art. Thus, Harod's teaching
of "sterilization" directly suggests this SAL to any skilled artisan in this field.
13. Regarding claim 7 step (d), the "wherein" clause is met because it describes an effect
of a method step positively recited. The combination of prior art references teaches every
limitation of method step (d), therefore the effects of method step (d) are necessarily present in
the prior art, including to increase absorption of the composition into the integumentary
associated tissues.
14. Further, regarding claim 22, a whereby clause in a method claim is not given weight
when it simply expresses the intended result of a process step positively recited. See MPEP §
2111(04). Claim 22 merely recites the intended result(s) of the positive steps recited in claim 1.
Claims 1-5, 7, 9-11, 13, 14, 18, 22, and 28 are rejected under 35 U.S.C. 103 as being
unpatentable over HAROD (US 6,358,516; Issued Mar. 19, 2002) in view of GASQUE (US
9717,757; Priority to Dec. 28, 2011), STOESZ (US 2010/0096287; Pub. Apr. 22, 2010 - of
record in PTO-892 dated 02/08/2022), and OLIVEIRA (Int. J. Pharm., January 2014, 464, 145-
151); and any or all of LEECE (US 2006/0074029; Pub. Apr. 6, 2006), ROSZELL (US
2007/0160559; Pub. Jul. 12 2007), SCHLESSINGER (US 2012/0100183; Pub. Apr. 26, 2012).
16. The teachings of Harod, Gasque, Oliveira, Leece, Roszell, and Schlessinger are
presented supra, and are incorporated herein.
17. Regarding claims 3-5, while Harod teaches sterilization by gamma (or electron beam)
radiation (col. 5, lines 8-13; col. 10, lines 57-64; Example 3), Harod is silent as to the amount of
gamma radiation applied and to the resulting sterility assurance level (SAL). However, anyone of
ordinary skill in the art would understand the instantly claimed amounts of gamma radiation and
SAL are routine in the art.
18. For example, Stoesz discloses topical pharmaceutical formulations that have been
packaged and sterilized (title; abstract). Stoesz teaches sterilization by electron beam or gamma
radiation, using a sterilizing dose of at least 10 kGy or at least 25 kGy, to achieve a SAL of at
least 10-3, preferably 10-6 ([00ll], [0017], [0070)).
19. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to use gamma radiation at
the claimed levels to provide a SAL of at least 10-3, preferably 10-6. One would have been
motivated to do so to provide a sterilized topical formulation and would have had a high
expectation of success since these values are known in the art for similar topical formulations.
Using such known, standard sterilization parameters amounts to no more than combining prior
art elements according to known methods to yield predictable results or the use of a known
technique (known sterilization parameters) to improve similar devices (methods, or products) in
the same way.
Claims 1, 2, 4, 7, 9-1, 13, 14, 18, 22, and 28 are rejected under 35 U.S.C. 103 as being
unpatentable over HAROD (US 6,358,516; Issued Mar. 19, 2002) in view of GASQUE (US
9,717,757; Priority to Dec. 28, 20ll), SHUDO (US 2007/0093555; Pub. Apr. 26, 2007 - of
record in PTO-892 dated 12/08/2022), and OLIVEIRA (Int. J. Pharm., January 2014, 464, 145-
151).
24. The teachings of Harod are presented supra, and are incorporated herein.
25. Regarding the specific use of treating muscle cramps or tightness, Gasque discloses a
method to treat and prevent muscle cramping, soreness, and/or swelling (e.g., in the legs) using a
topical composition comprising the same components as Harod (title; abstract; col. 2, lines 8-32;
col. 9, lines 66-67). In fact, Gasque specifically refers to the (Theraworx®) composition of
Harod (US 6,358,516) as suitable for use in the methods of the invention (col. 1, lines 33-36; col.
5, lines 16-23; claims 1-15). Gasque teaches application of the composition to the skin in and
around the muscle tissue sought to be treated before (i.e., prior to), during, or after athletic
exercise to treat or prevent muscle cramps (col. 9, lines 26-60).
26. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to use the topical
compositions of Harod to treat or prevent muscle cramping or soreness. One would have been
motivated to do so with a high expectation of success since Gasque directly teaches the
suitability of Harod's compositions for this use. Specifically, it would have been prima facie
obvious to one of ordinary skill in the art to apply a known composition for muscle soreness
prior to, during, and after exercising (i.e., strenuous physical activity, or exertion), since Gasque
suggests application at all of these times (col. 9, lines 26-60). Further, Gasque teaches use of the
composition to treat and prevent muscle cramps (col. 9, lines 26-29), which suggests application
both before and after cramp-causing exertion.
27. Harod teaches the preferred usage includes re-wiping the skin (i.e., repeating
application of the composition) (col. 12, lines 50-57), but does not expressly teach re-applying
the composition in the instantly claimed timeframe. Nonetheless, it would have been prima facie
obvious to one of ordinary skill in the art at the time of the invention to apply the composition
treat or prevent muscle cramping or soreness in the instantly recited timeframe. At the outset, it
is within the skill of the artisan to determine the frequency of applying a composition to treat or
prevent muscle cramping and/or soreness. One would repeatedly apply the composition for as
long as necessary to achieve the desired relief from muscle cramping or soreness. Further, it was
known in the art to apply similar topical compositions within the claimed timeframe.
28. For example, Shudo discloses topical pain relief compositions particularly useful for
muscle pain and fatigue (title; abstract; [0042], [0045]-[0046]; claim 18). Shudo teaches the pain
relief compositions are generally applied to the skin site for a period of time sufficient for the
desired amount of pain relief to be achieved, where in representative embodiments, the topical
composition is applied to the target skin site for a period of time ranging from 0.25 to 24 hours,
such as from about 0.5 to 10 hours, including from about 1 to about 8 hours, during which time
the subject experiences relief from pain ([0035]). Shudo teaches reapplying the compositions as
necessary if the pain recurs, and teaches the patient will typically experience some pain relief for
about 0.25 to 30 min following topical application ((0036]).
29. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to have repeatedly applied
the Theraworx® compositions of Harod with a frequency of about one to two hours, and
repeating such application as necessary to achieve the desired relief of muscle soreness. The
artisan recognizes that administration in this timeframe routine in the art, at least since such
compositions may only exert their effects for minutes to hours (per Shudo). One would have had
a high expectation of success since the recited frequency is known in the art for topical pain
relief compositions for muscle pain. The artisan also recognizes that such compositions are
applied as-needed to achieve the desired amount of relief from muscle pain and soreness, and for
achieving the desired improvement in muscle cramps, soreness, and pain as needed (per both
Gasque and Shudo). Furthermore, it is well within the purview of the skilled artisan to determine
the frequency and duration of administration based on the particular area(s) and severity of
muscle soreness intended to be treated, and the situation(s) in which the composition is applied.
Regarding step (d), Oliveira reports on the effects of heat on skin barrier function and dermal
absorption (title; abstract). Oliveira teaches that enhanced delivery of ingredients across the
stratum corneum (SC) is of great interest for improving the efficacy of topically applied
formulations. Oliveira investigates the influence of topically applied heat in vivo on the dermal
uptake and penetration of a model active, allantoin from gel and lotion formulations (abstract).
Oliveira teaches that heat has long been known to enhance uptake of active agents into the skin,
and that topically applied heat at 42°C ( ~ 107.6°F) caused significantly more penetration of
allantoin without compromising the integrity of the skin (abstract; Introduction; Figs. 4-8;
Conclusions). Allantoin was selected for this proof-of-concept study since it is used in a wide
range of personal care products for application to the skin, but it does not possess ideal properties
for dermal delivery (Introduction). Note that allantoin is one of the components of Harod's
formulation (e.g., see Table 1). Further, 42°C was well tolerated by volunteers (Introduction).
It would have been obvious to have warmed Harod' s composition prior to applying the
composition in each of the steps a, b, and c, with a reasonable expectation of success because
Oliveira teaches benefits of warming a composition comprising allantoin prior to application to
skin, as described above.
30. Regarding claims 2, and 4, Harod teaches sterilization by exposure to electron beam
or gamma radiation (col. 5, lines 8-13; col. 10, lines 57-64; Example 3).
31. Regarding claim 7, the "wherein" clause describes an intended result of a method step
positively recited. The prior art teaches the same steps as claimed and it would have increased
absorption of the composition into the integumentary associated tissues, absent evidence to the
contrary.
Claims 1-5, 7, 9-11, 13, 14, 18, 22, and 28 are rejected under 35 U.S.C. 103 as being
unpatentable over HAROD (US 6,358,516; Issued Mar. 19, 2002) in view of GASQUE (US
9717,757; Priority to Dec. 28, 2011), OLIVEIRA (Int. J. Pharm., January 2014, 464, 145-151),
STOESZ (US 2010/0096287; Pub. Apr. 22, 2010), and SHUDO (US 2007/0093555; Pub. Apr.
26, 2007).
33. The teachings of Harod, Gasque, Oliveira, and Shudo are presented supra, and are
incorporated herein.
34. Regarding claims 3-5, while Harod teaches sterilization by gamma (or electron beam)
radiation (col. 5, lines 8-13; col. 10, lines 57-64; Example 3), Harod is silent as to the amount of
gamma radiation applied and to the resulting sterility assurance level (SAL). However, anyone of
ordinary skill in the art would understand the instantly claimed amounts of gamma radiation and
SAL are routine in the art.
35. For example, Stoesz discloses topical pharmaceutical formulations that have been
packaged and sterilized (title; abstract). Stoesz teaches sterilization by electron beam or gamma
radiation, using a sterilizing dose of at least 10 kGy or at least 25 kGy, to achieve a SAL of at
least 10-3, preferably 10-6 (pars. [0011], [0017], [0070)).
36. In light of these teachings, it would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to use gamma radiation at
the claimed levels to provide a SAL of at least 10-3, preferably 10-6. One would have been
motivated to do so to provide a sterilized topical formulation and would have had a high
expectation of success since these values are known in the art for similar topical formulations.
Using such known, standard sterilization parameters amounts to no more than combining prior
art elements according to known methods to yield predictable results or the use of a known
technique (known sterilization parameters) to improve similar devices (methods, or products) in
the same way.
Response to Arguments
Applicant's arguments submitted in the remarks dated February 18, 2026, were fully considered but are not persuasive because amendment to claim 1 and cancellation of claim 12 are not sufficient to overcome obviousness rejections because Harod teaches a composition that consists of claimed components a-j and water.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Patent Application No. 15/187,484
Claims 1-5, 7, 9-11, 13, 14, 18, 22, and 28 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 16-26 and 47-49 of U.S. Patent Application No. 15/187,484, in view ofHarod, Gasque, Leece, Roszell,
Schlessinger and Stoesz or in view of Harod, Gasque, Shudo, and Stoesz, all optionally also in
view of Oliveira. Although the conflicting claims are not identical, they are not patentably
distinct from each other because the scope of the '484 claims renders obvious that of the instant
claims. The difference between the two claim sets is that the '484 claims recite a different
intended use in the preamble and do not recite a specific frequency of reapplication in claim 1.
The frequency of reapplication is taught by any or all of Leece, Roszell, Schlessinger, and/or
Shudo. Note that Harod teaches packaging cloths impregnated with the composition in a prepackaged kit and sterilization by gamma ore-beam radiation ( col. 6, lines 29-40; col. 10, lines
57-64). Thus, the instant claims are an obvious variation of the '484 claims.
U.S. Patent No. 6,358,516
Claims 1-5, 7, 9-11, 13, 14, 18, 22, and 28 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 10-17 of U.S. Patent No. 6,358,516, in view of Gasque, Leece, Roszell, Schlessinger, Stoesz, and Oliveira or in view of Harod, Gasque, Shudo, Stoesz, and Oliveira. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '516 claims anticipates or renders obvious that of the instant claims. The difference between the two claim sets is that the '516 claims do not expressly recite reapplying the composition with the claimed frequency. However, Harod suggests this feature (e.g., col. 12, lines 50-57), and all of Leece, Roszell, Schlessinger, and Shudo teach reapplication of similar topical (antimicrobial/acidifying or muscle treatment) formulations within the instantly claimed time frame as well. Moreover, the instant application (and Harod's teachings) makes it clear that the '516 Patent meets all the instant functional limitations. Thus, although the '516 claims do not
expressly recite the same effects as the instant claims, the effects are considered an inherent
result of topically (re)applying the composition, absent evidence to the contrary. Thus, the instant
claims are merely an obvious variation of the '516 claims.
Response to Arguments
In the remarks dated February 18, 2026, the applicant requested the double patenting rejections be held in abeyance until the claims are otherwise in conditions for allowance.
Double patenting rejections are maintained because applicant did not traverse the
rejections nor file a terminal disclaimer.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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