-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 January 5, 2026, is acknowledged.
Priority
This application is a CON 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 1-4 and 10-49 are pending. Claims 5-9 were cancelled. Claim 16 was
amended. Claims 1-4, 10-15, and 27-46 remain withdrawn. Claims 16-26 and 47-49 are
examined.
Maintained Claim Rejections - 35 USC§ 103
Modified as Necessitated by Amendment
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 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.
Claims 16-26 and 47-49 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 02/27/2018) in
view of STOESZ (US 2010/0096287; Pub. Apr. 22, 2010 - of record in PTO-892 dated
02/27/2018).
1. Harod discloses a skin care system (composition) 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 an aqueous
solution that contains 70-90 wt. % water and at least four additional ingredients (column 5 lines
34-51). 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 IL). The composition may be impregnated into cloths and packaged in a resealable
container ( col. 6, lines 37-40). Harod teaches application of the composition 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 increased blood circulation in treated areas
(col. 9, lines 13-16; col. 11, lines 1-3; col. 13, lines 5-9). Harod suggests application of the
composition to burns or wounds ( col. 1, lines 34-46; Table I). 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
([0016], [0020]), the instantly claimed composition (and any properties thereof) are considered to
be met by Harod, absent objective evidence to the contrary.
2. 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:
an amphoteric surfactant in an amount of 1-7 wt.%;
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, zwitterionic 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 (an 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 a 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, and absorption facilitation agent) in an amount of 0.1-6 wt. %;
methylparaben, propylparaben, EDTA (preservatives) in an amount of 0.1-2%; and
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, 7, 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 (reads on "a
plurality of ingredients configured to perform a plurality of functions, at least one of the plurality
of ingredients configured to perform multiple functions of the plurality of functions"), Harod
actually teaches somewhat wider ranges for many of these components (see claims 1, 5, 7, 8, 17,
18, 23, 25, and 30 of Harod). Further, applicant admits that the formulation (product) is the same
as that taught in Harod (see the top par. on p. 22 of the 12/27 /19 response).
3. While Harod teaches sterilization by electron beam or gamma 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 the resulting sterility assurance level (SAL). However, anyone of ordinary skill in the art
would find the instantly claimed amounts of gamma radiation and SAL to be obvious at least
because they are routine in the art.
4. 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 dose of radiation at least 10 kGy or at least 25 kGy, to achieve a SAL of at least
10-6 ([0017], [0019], [0070)).
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 gamma radiation at
the claimed levels to provide a SAL of 10-6 or less (SAL values smaller than 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.
6. The "wherein" clause at end of claim 16 is simply a statement of the intended outcome
of the method steps positively recited. The MPEP states that a "'whereby clause in a method
claim is not given weight when it simply expresses the intended result of a process step
positively recited." /d. (quoting Minton v. Nat'l Ass'n of Securities Dealers, Inc., 336 F.3d 1373,
1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP § 2111.04. Further, in the absence of
objective evidence to the contrary, performing the recited method steps (which the prior art
renders obvious) is considered to read on these limitations.
Claim 16 was amended to require the method to consist of steps a-c. Harod modified with
Stoesz meets this requirement because Harod teaches sterilizing the formulation and Stoesz
teaches suitable sterilization techniques. It would have been obvious to have practiced Harod's
method of sterilizing the formulation consisting of steps of treating the formulation and exposing
the formulation to sterilization techniques of Stoesz. The step ( c ), preserving the efficacy of the
formulation as a result of the exposure of the formulation in step (b ), would have occurred in the
prior art method because the prior art method performs step (b) and preserving the efficacy is the
effect of performing step (b ).
The formulation in claim 16 was amended to require the composition to consist of a plurality of ingredient followed by a list of generic ingredients. Harod’s composition meets this requirement because Harod’s composition contains:
an amphoteric surfactant in an amount of 1-7 wt.%;
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, zwitterionic 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 (an 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 a 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, and absorption facilitation agent) in an amount of 0.1-6 wt. %;
methylparaben, propylparaben, EDTA (preservatives) in an amount of 0.1-2%; and
vitamin E (a humectant and emollient and free radical-scavenging agent) in an amount of 0.01-2 wt.%.
Each of the instantly claimed generic components is accounted for in Harod’s composition, and Harod’s composition does not contain components that are outside the scope of instantly claimed generic components.
Regarding claim 17, Harod teaches cloth impregnated with the composition and packaged
in a tray or a bag. Hard does not limit the number of impregnated cloths per container and it
would have been obvious to have packaged from 1 cloth or greater per package, which meets the
limitation that requires a formulation packaged individually or in bulk.
Regarding claim 18, Harod' s composition is the same as the instantly claimed
composition, and any properties thereof are considered to be met by Harod including properties
required by claim 18.
Regarding claim 19, Harod's composition contains grapefruit derived quaternary
compounds.
Regarding claim 20, Harod' s composition comprises a mixture of the claimed
preservatives.
Claims 21 and 24, Harod's composition is tissue-compatible, non-antibiotic, and has a pH
of 4.5-6.7. The composition comprises an anti-inflammatory agent, antifoaming agent, a cell
growth promoting agent, an immune system enhancing agent, an absorptive agent, a healing
promoting agent, a free radical scavenging agent, and a humectant and emollient agent, as
described in section 2 above.
Regarding claims 22 and 4 7, all limitations of the claim are met as described in section 2
above.
Regarding claims 23 and 26, all limitations of the claim are met as described in section 2
above, and the claimed concentration ranges are obvious because they overlap with
concentration ranges disclosed by Harod.
Regarding claim 25, all limitations of the claim are met as described in section 2 above.
7. Regarding claims 48 and 49, Stoesz teaches sterilization by gamma radiation using a
dose of radiation as low as 10 kGy to achieve a desired SAL (pars. [0011], [0017], [0070)). The
MPEP states that a prima facie case of obviousness exists where the claimed ranges or amounts
do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v.
Banner, 778 F.2d 775,783,227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a
rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1 %
iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25%
molybdenum, balance titanium and 0.94% nickel, 0.31 % molybdenum, balance titanium. "The
proportions are so close that prima facie one skilled in the art would have expected them to have
the same properties."). In this case, applicants disclose that the full range of "about 4 to less than
about 35 kGy" is useful in the invention (see claim 6). Thus, the narrower range would be
expected to have the same properties as the wider range.
Claims 16-26 and 47-49 are rejected under 35 U.S.C. 103(a) as being unpatentable over
HAROD (US 6,358,516; Issued Mar. 19, 2002) in view of DANILOFF (US 2011/0033540; Pub.
Feb. 10, 2011), and ZHANG (US 2011/0283662; Pub. Nov. 24, 2011).
11. The teachings of Harod are presented supra, and are incorporated herein. As
discussed in the rejection above, claims 48 and 49 are properly rejected over Stoesz. However,
Daniloff and Zhang are cited to further show the obviousness of using low amounts of radiation
to sterilize various topical pharmaceutical compositions.
12. For instance, Daniloff discloses formulations for the delivery of bioactive agents
(title; abstract). The formulations may be ointments or lotions for topical delivery to the skin
([0096], [0190], [0203]). Like Harod (and Stoesz) Daniloff teaches sterilization by either
electron beam or gamma radiation, and the dose may be as low as 5 kGy ([0181]- [0182]) to
achieve a SAL of 10-6 ([0018]). Daniloff also teaches that the dose of radiation is determined as
needed based on the bioburden level (initial contamination) and packaging of the composition
((0182]).
13. Similarly, Zhang discloses low dose gamma sterilization of packaged topical adhesive
compositions for use in the medical and/or veterinary fields (title; abstract; [0002]). The package
and its contents should be sterile, having a (SAL) of preferably at least 10-6 ((0056]). Zhang
teaches that although gamma sterilization is thorough and requires no post-processing cooling, a
downside to the use of gamma radiation is that it can adversely affect the package and
composition contained therein, which is well known in the art for high gamma doses (e.g., 25
kKGy) commonly used in the art ([0008]). Zhang teaches that the use of lower doses is also
known, and teaches the preferred use of lower doses (5-20 kGy) specifically to avoid these
unwanted adverse effects of gamma radiation ([0009]-[0015], [0018], [0053]; Table l;
Examples; Claims 1-18).
14. 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 desired reduction in microbial contamination and achieve a SAL
of 10-6 or lower (i.e., a SAL of 10-6 or less, such as 10-7 or 10-8). One would have been motivated to use low levels of gamma radiation to avoid the known adverse effects of higher doses on the packaging and composition as taught by Zhang. In doing so, one would have expected to provide a suitably sterilized topical composition for medical use and would have had a high expectation of success since these values are known in the art for other topical formulations (e.g., per Daniloff).
Claim 16 was amended to require the method to consist of steps a-c. Harod modified with
Daniloff and Zhang meets this requirement because Harod teaches sterilizing the formulation and
Daniloff and Zhang teach suitable sterilization techniques. It would have been obvious to have
practiced Harod' s method of sterilizing the formulation consisting of steps of treating the
formulation and exposing the formulation to sterilization techniques of Daniloff and Zhang. The
step ( c ), preserving the efficacy of the formulation as a result of the exposure of the formulation
in step (b ), would have occurred in the prior art method because the prior art method performs
step (b) and preserving the efficacy is the effect of performing step (b ).
The formulation in claim 16 was amended to consist of a plurality of ingredient followed by a list of generic ingredients. Harod’s composition meets this requirement because Harod’s composition contains:
an amphoteric surfactant in an amount of 1-7 wt.%;
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, zwitterionic 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 (an 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 a 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, and absorption facilitation agent) in an amount of 0.1-6 wt. %;
methylparaben, propylparaben, EDTA (preservatives) in an amount of 0.1-2%; and
vitamin E (a humectant and emollient and free radical-scavenging agent) in an amount of 0.01-2 wt.%.
Each of the instantly claimed generic components is present in Harod’s composition, and Harod’s composition does not contain components that are outside the scope of instantly claimed generic components.
Response to Arguments
Applicant’s arguments submitted in the remarks dated January 5, 2026, were fully considered however the arguments are not persuasive for the following reasons.
Harod teaches sterilizing the formulation and the secondary references were relied upon for specific sterilization techniques. Thus, Harod' s method of sterilizing the formulation, as modified by secondary references, consists of the instantly claimed steps a-c.
The claimed formulation was amended to require the composition to consist of the recited elements. Harod’s composition contains elements where every element is accounted for in the instantly claimed list of elements. Harod is not required to recite “consisting of” in the list of components to render the claimed composition obvious because Harod’s composition is defined by a list of components and therefore consists of said components.
Maintained 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.
US Patent No. 6,358,516
Claims 16-26 and 47-49 are non-provisionally rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over claims 10-17 of US
Patent No. 6,358,516, in view of Stoesz, Daniloff and/or Zhang. 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 treating the composition with gamma
radiation or the recited amounts thereof to achieve a specific SAL or warming the composition to
the recited temperature. However, Harod suggests the sterilization feature (e.g., col. 5, lines 8-12;
col. 10, 57-64 ). Further, Stoesz, Daniloff, and Zhang render obvious the use of radiation in the
claimed amounts to achieve a desired SAL (e.g., of 10-6) based the bioburden level (initial
contamination) and packaging of the composition. 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(1).
Double patenting rejections are maintained because applicant requested that the rejections
be held in abeyance until the claims are otherwise in condition for allowance.
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