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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 01/11/2026, wherein the Amendment amended claims 1-6, 8-9, 12-17, 20-24, and 26.
Claims 1-26 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/885,163, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, ‘163 does not teach amino acids or preservatives. As such, the instant claims are afforded the effective filing date of the instant application, 12/23/2022.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Abstract Objections
Applicant’s amendment to the abstract are sufficient to overcome this objection.
Claim Objections
Applicant’s amendments to the claims are sufficient to overcome these objections.
35 U.S.C. § 112(b)
Applicant’s amendments to the claim have overcome the majority of the rejections. See below for the rejections that are maintained/modified.
35 U.S.C. § 112(d)
Applicant’s amendments to claims 6 and 20 are sufficient to overcome these rejections.
35 U.S.C. § 103
Applicant’s amendment to the independent claims that require the composition to be configured for topical formulation are sufficient to overcome the rejection over independent claims 1-4, and the claims that depend from these independent claims. Since Seidensticker and Richardson are directed toward oral compositions, the rejections of the claims over Seidensticker in view of Richardson, Sayers, and APG, are withdrawn.
REJECTIONS-MAINTAINED, NEW, & MODIFIED
Applicant’s amendments to the claims have resulted in the below new rejections.
35 U.S.C. 112(f)--Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
(New) The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) are: “configure for” and “configured to” in claims 1-3, 7-11, and 18.
In the instant case, the recitations “topical application” and “adhesive bandage pod,” imply sufficient structure for performing the claimed function. As discussed on pgs. 2 and 8 of the Specification, topical application is a composition form that is applied directly to a skin of the body. As discussed on pg. 3 of the Specification, an adhesive bandage pod is an adhesive bandage that holds a liquid or semiliquid that can be applied to the skin without soiling clothes or the skin of the user.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
(New) Claims 1-7 are objected to because of the following informalities:
-In claims 2-4, in the phrase “at least one active ingredient. . .(i) a nonsteroidal anti-inflammatory drug selected from diclofenac, ibuprofen, piroxicam, ketorolac;” the term - -and- - should be inserted prior to “ketorolac.” For guidelines on proper Markush language, see MPEP 2173.05(h).
-In claims 2 and 4, in the phrase, “at least amino acid or dipeptide selected from leucine, isoleucine, valine, glutamine, creatine, carnitine, betaine, beta-alanine and taurine and combinations thereof,” the term - -one- - -should be added following “at least,” and commas should be inserted following “beta-alanine” and following “taurine.”
-In claim 5, line 3, the comma following “nanosized” should be deleted and replaced with the term - -or- -, since both nanosized and micronized are referencing the suspension.
-In claim 7, line 4, the term “the” prior to “soiling” should be deleted.
-Claims 1 and 6, recite “airless container” and claims 3 and 4 recite “airless bottle.” For consistency, all claims should recite “airless container” or “airless bottle.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
(New) Claims 1-2 and 4-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
-In claims 1 and 2, the phrase “present in a topically effective amount” in reference to “pain reliever, in lines 3 of the claims, is new matter. While the instant specification provides percent weights of the pain reliever (pg. 3), it does not provide support for the pain reliever “present in a topically effective amount.”
-In claim 2, last 3 lines, the phrase “is dispensed from an airless container configured to limit exposure to air and assist in providing controlled topical delivery of the composition,” is new matter. The instant specification does not provide support for an airless container configured to limit exposure to air, or provide support for an airless container configured to assist in providing controlled topical delivery.” While the instant specification provides support for an airless container (pgs. 4, 6, 24, and 25), it does not provide support for the airless container configured to limit exposure to air. While the instant specification provides support for the composition being applied using a THADS (topical hands free applicator drug delivery system) applicator (pg. 6), it does not provide support for the airless container configured to assist in providing controlled topical delivery of the composition.
-In claim 4, last two lines, the phrase “configured to assist in maintaining formulation stability and dispensing a consistent amount of the topical composition,” is new matter. While the instant specification provides support for an airless container (pgs. 4, 6, 24, and 25), it does not provide support for the airless container configured to assist in maintaining formulation stability and dispensing a consistent amount of the topical application.
-In claim 16, lines 2-3, the phrase “in an amount from about 0.1% to about 200% of daily applied volume of the composition administered to a user” is new matter. While the instant specification provides support for “In some embodiments, said inorganic salt is present in an amount from about 0.1% to about 200% of daily volume,” (pg. 7, Specification), it does not provide support for the % of daily applied volume of the composition administered to a user.
-In claim 22, last two lines, the phrase “such that the composition is positioned adjacent to a user’s skin when the adhesive bandage is applied,” is new matter. While the instant specification provides support for the adhesive bandage configured to be applied to the skin (pg. 6), it does not provide support for “such that the composition is positioned adjacent to a user’s skin when the adhesive bandage is applied.”
-In claim 20, lines 2-3, the phrase “dipeptide is present in an amount of about 0.1-18 weight percent” is new matter. While the instant specification provides support for 01.-0.18 weight percent of “amino acid” (pg. 7), it does not provide support for this percent weight in reference to dipeptide.
It is further noted that Applicant has not pointed to support for these new limitations in the Remarks filed 01/11/2026.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(New and Modified) Claims 1 and 5-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-In claim 1, last 3 lines, it is not clear if the phrase “configured to dispense the composition to the skin in a hands free manner,” is referencing just “an adhesive bandage pod” or if it is referencing both “an airless container” and “an adhesive bandage pod.”
In view of compact prosecution, for the purpose of applying prior art, this phrase is interpreted as referencing both.
-In claim 5, the phrase “wherein the composition is in a completely dissolved stated as a solution, nanosized or micronized suspension, gel, or an emulsion” renders the claim indefinite. Since suspensions, gels, and emulsions are not compositions that are “in a completely dissolved state,” it is not clear how the suspension, gel, and emulsion are “in a completely dissolved state.”
Note: This rejection is modified from the rejection over this claim in the previous Office Action in view of the amendments to this claim.
-Claim 6, lines 4-5, recites the limitation "the topical hands free applicator drug delivery system (THADS) compatible with the airless container or adhesive bandage pod." There is insufficient antecedent basis for this limitation in the claim.
-In claim 16 the phrase “about 0.1% to about 200% of daily applied volume of the composition administered to a user” renders the claim indefinite because it is not clear how the inorganic salt is administered in an amount based on a daily applied volume of the composition administered to a user. It is not clear how “of daily applied volume of the composition administered to a user” is applied as a baseline measure from which the amount of inorganic salt is administered, since this amount is not defined by the instant specification.
Note: This rejection is slightly modified from the rejection of claim 16 in the previous Office Action.
-In claim 20, the phrase “the amino acid or dipeptide is selected from glutamine, creatine, leucine, isoleucine, and valine,” renders the claim indefinite because glutamine, creatine, leucine, isoleucine, and valine are all amino acids. It is not clear how a dipeptide can be selected from amino acids.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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 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.
(New) Claims 1-4 and 6-26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/11535 to Martinez (published 06/02/2022, IDS of 07/14/2025) in view of Sayers (Treatment of delayed-onset muscle soreness: Is prevention the answer? GSSI, published 2007, PTO-892 of 07/11/2025), APG (How do airless pump bottles work? Apackinggroup.com, published 05/17/2022, PTO-892 of 07/11/2025), as evidenced by Drugs.com (Diclofenac, PTO-892 of 07/11/2025) and as evidenced by Pereira (Current Status of Amino Acid-Based Permeation Enhancers in Transdermal Drug Delivery, Membranes, published 2021, PTO-892).
Martinez teaches a method of reducing exercise induced injury and/or enhancing muscle recovery after exercise by administering compositions comprising 2’fucosyllactose (pg. 33, claim 1).
Martinez teaches the composition as further comprising amino acids, such as leucine, valine, and others (pg. 34, claim 14).
Martinez teaches the composition as further comprising vitamin B6 and/or Vitamin C (pg. 34, claim 16).
Martinez teaches the composition as further comprising electrolytes, wherein the electrolytes are sodium, magnesium, potassium, and other salts (pg. 34, claim 17; pg. 15, lines 9-18).
Martinez teaches the composition as topical and as prepared according to conventional methods and techniques known to those skilled in the art (pg. 22, lines 10-21; pg. 28, lines 3-20), wherein emulsions, solutions, suspensions, cream, gels, bandages, and other dosage forms are taught, wherein carriers and excipients include aqueous vehicles, water-miscible vehicles, and others (pg. 28, lines 14-20).
Martinez teaches preservatives as excipients that inhibit the growth of microorganisms in the composition (pg. 28, lines 14-20).
Regarding claims 1-4, while Martinez teaches topical compositions comprising water, electrolyte inorganic salts, amino acids, and natural supplements, such as vitamin B6 and C, in the form of liquids, creams, and gels, it differs from that of instant claims 1-4, in that it does not teach a pain reliver, such as an NSAID.
Martinez teaches that its compositions can be used in combination with NSAIDs (pg. 14, lines 1-5).
Sayers teaches that the recreational or trained athlete would benefit from a reliable treatment strategy for delayed onset muscle soreness (DOMS), which is the perception of pain and discomfort in muscles appearing in the days following strenuous, unaccustomed physical activity (pg. 1, “Introduction”). Sayers teaches that diclofenac has demonstrated efficacy in reducing the symptoms of DOMS during both short term as well as long term administration following exercise (pg. 1, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add diclofenac to the composition of Martinez to arrive at a topical liquid to semisolid composition comprising water, electrolyte inorganic salts, amino acids, natural supplements such as vitamins B6 and C, preservative, and NSAID/pain reliever. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
-both Martinez and Sayers are directed toward post-exercise treatments,
-Martinez teaches that NSAIDs can be added to its compositions,
-Sayers teaches that the recreational or trained athlete would benefit from a reliable treatment strategy for delayed onset muscle soreness (DOMS), and
-Sayers teaches administering diclofenac post-exercise as reducing the symptoms of DOMS.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a composition that further reduces enhances muscle recovery after exercise (title, abstract of Martinez) by reducing the symptoms of DOMS.
As evidenced by Drugs.com, diclofenac treats mild to moderate pain. As such, the teaching of diclofenac in the combined composition of Martinez and Sayers meets the limitations of both the instantly claimed pain reliever and the NSAID.
Further regarding claims 1-4, while the combination of Martinez and Sayer teaches topical compositions comprising water, electrolyte inorganic salts, amino acids, natural supplements, such as vitamin B6 and C, and diclofenac, in the form of liquids, creams, and gels, it differs from that of instant claims 1-4, in that it does not teach an airless bottle.
APG teaches that airless bottles are designed to isolate sensitive formulations and restrict exposure to air to prevent oxidation and deterioration, as well as avoid introduction of bacteria (pg. 1). When using airless bottles, the product is drawn from the top of the bottle, and is continually pushed closer towards the dispensing nozzle, minimizing waste and administering exact product doses (pg. 2). APG teaches these bottles as especially helpful for products containing compounds that are oxygen sensitive such as vitamins.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select an airless bottle to contain and dispense the composition of the combination of Martinez and Sayers, to arrive at instant claims 1-4. One of ordinary skill in the art would have been motivated to make such a selection with a reasonable expectation of success, because:
-APG teaches airless bottles as preventing oxidation and deterioration, and as avoiding introduction of bacteria, and
-APG teaches airless bottles as minimizing waste and administering exact doses.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a product that a) prevents oxidation, deterioration, and introduction of bacteria, b) minimizes waste, and c) administers exact dosages.
In claims 1-24, the following are intended use recitations:
-“topical workout muscle recovery composition” (claims 1-24);
-“for localized topical application to muscle tissue at an application site” (claim 1, line 2);
-“to provide localized muscle recovery at the application site” (claim 1, last two lines);
-“for localized topical application” (claim 2, lines 1-2);
-“for topical application to the skin” (claim 3, second to last line);
-“is applied using the topical hands free applicator drug delivery system (THADS) (claim 6, lines 4-5);
-“applied to the skin of human or animals. . .to prevent soiling of cloths and provide hands-free application” (claim 7);
-“to be applied to the skin” (claim 8);
-“prevent any reduction or loss from any external contact of a treatment via rubbing of a hand or absorption of clothing” (claim 9);
-“such that the composition is positioned adjacent to a user’s skin when the adhesive bandage is applied” (claim 22);
-“to the skin of a user” (claim 26).
Since the product of the combination of Martinez, Sayer, and APG is capable of performing these intended uses, it meets the intended use limitations recited in the instant claims; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim.
It is further noted that the term “topical workout muscle recovery” occurs in the preamble of the claims. As discussed in MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
See MPEP 2111.02 and 2112.01.
Regarding claim 6, as evidenced by Pereira, leucine is a skin permeation enhancer (abstract; pgs. 11, Table 2; pg. 12, last paragraph; pg. 16, last paragraph).
Further regarding claim 6, while the combination of Martinez, Sayer, and APG teaches topical compositions comprising water, electrolyte inorganic salts, amino acids, such as leucine which is a skin permeation enhancer, natural supplements, such as vitamin B6 and C, and diclofenac, in the form of liquids, creams, and gels, contained in an airless bottle, it differs from that of instant claim 6 in that it does not teach the % weight of the combination of water and skin permeation enhancer.
Martinez further teaches that ingredients can be added in any suitable amount (pg. 15, lines 18-29).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to modify the amount of water and leucine in the combined composition of Martinez, Sayer, and APG, to arrive at a composition comprising 1-90% weight leucine and water. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because:
-Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21), and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification to predictably arrive at a composition that optimized for topical absorption to enhance muscle recovery.
Regarding claims 7-13, 18-19, 21-26, these claims depend from claim 6 and ultimately claim 1, and further limit “an adhesive bandage pod.” Claim 1 recites “is contained within an airless container or an adhesive bandage pod.” Claim 6 recites “the airless container or adhesive bandage pod.” Neither claims 1 nor 6 limit the composition as contained in “an adhesive bandage pod.” As such, claims 7-13, 18-19, and 21-26 are interpreted as if the composition is contained within an adhesive bandage pod, then the limitations of claims 7-13, 18-19, and 21-26 apply. Since the combined composition of Martinez, Sayers, and APG teach an airless bottle, the limitations of claims 7-13, 18-19, and 21-26 are met.
Regarding claim 14, Martinez teaches L-glutamine as an exemplary nutritional supplement (pg. 14, lines 10-17). However, Martinez does not teach glutamine in an amount of about 0.01% to about 20% weight.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to add about 0.01% to about 20% weight glutamine to the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 14. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
- Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21),
-Martinez teaches amino acids in its compositions, and teaches glutamine as an additional agent that can be added to its composition, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such an addition to predictably arrive at a composition that optimizes the amount of glutamine and amino acid effect, to enhance muscle recovery.
Regarding claim 15, Martinez teaches methyl and propyl paraben, and sorbic acid as preservatives (pg. 25). However, Martinez does not teach an amount of water corresponding to about 0.05 mL-5mL per pound of treated muscle tissue or the preservative in an amount of about 0.015% to about 2% weight.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to modify the amount of water and add about 0.015% to about 2% weight methylparaben, propylparaben, or sorbic acid, in the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 15. One of ordinary skill in the art would have been motivated to make such a modification and addition, with a reasonable expectation of success because:
- Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21),
-Martinez teaches preservatives in its composition to limit the growth of bacteria, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification and addition to predictably arrive at a composition that is optimized to enhance muscle recovery and minimize the growth of microorganisms.
Regarding claim 16, the combination of Martinez, Sayer, and APG does not teach the inorganic salt in an amount of about 0.1% to about 200% of daily applied volume of the composition administered to a user.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to modify the amount of inorganic salt in the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 16. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because:
- Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21), and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification to predictably arrive at a composition that is optimized for fluidity to enhance muscle recovery.
Regarding claim 17, Martinez teaches caffeine as an exemplary nutritional supplement that can be added to its compositions (pg. 14, lines 10-18). However, Martinez does not teach an the caffeine in an amount of about 0.01% to about 40% weight of the composition.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to add about 0.1% to about 40% weight caffeine to the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 17. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
- Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21),
-Martinez teaches that caffeine can be added to its compositions, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification to predictably arrive at a composition that is optimized to enhance muscle recovery and provides a caffeine benefit for muscle recovery.
Regarding claim 20, the combination of Martinez, Sayer, and APG does not teach about 0.1-18 weight T of glutamine, creatine, leucine, isoleucine, or valine.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claim invention to modify the amount of glutamine, leucine, or valine in the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 20. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because:
- Martinez teaches that ingredients can be added in any suitable amount, and that topical dosage forms can be prepared according to conventional methods and techniques known to those skilled in the art ( (pg. 22, lines 10-21), and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification to predictably arrive at a composition that is optimized in amino acid amount, to enhance muscle recovery.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Martinez (published 06/02/2022, IDS of 07/14/2025), Sayers (Treatment of delayed-onset muscle soreness: Is prevention the answer? GSSI, published 2007, PTO-892 of 07/11/2025), and APG (How do airless pump bottles work? Apackinggroup.com, published 05/17/2022, PTO-892 of 07/11/2025), as evidenced by Drugs.com (Diclofenac, PTO-892 of 07/11/2025) and as evidenced by Pereira (Current Status of Amino Acid-Based Permeation Enhancers in Transdermal Drug Delivery, Membranes, published 2021, PTO-892), as applied to claims 1-4 and 6-26 above, and further in view of Prowting (Effects of Collagen Peptides on Recovery Following Eccentric Exercise in Resistance-Trained Males-A Pilot Study, International Jn of Sport Nutrition and Exercise Metabolism, published 2020, PTO-892).
Martinez, Sayer, and APG are applied as discussed above, and incorporated herein.
While the combination of Martinez, Sayer, and APG teaches topical compositions comprising water, electrolyte inorganic salts, amino acids, such as leucine which is a skin permeation enhancer, natural supplements, such as vitamin B6 and C, and diclofenac, in the form of liquids, creams, and gels, contained in an airless bottle, it differs from that of instant claim 5 in that it does not teach collagen.
Prowting teaches that collagen supplementation attenuates performance decline 24 hours following muscle damage from exercise, and that collagen peptides provide a performance benefit the day following a bout of damaging exercise.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add collagen to the combined composition of Martinez, Sayer, and APG, to arrive at instant claim 5. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both the combination of Martinez, Sayer, and APG, and Prowting, are directed toward treating muscle recovery following exercise, and
-Prowting teaches collagen as attenuating muscle damage from exercise.
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a composition that further effectively attenuates muscle damage from exercise.
Response to Arguments
The above rejections are new. Martinez, the primary reference, was not relied upon in the previous Office Action. As such, only arguments directed toward the secondary references Sayers and APG, and the evidentiary reference, Drugs.com, are addressed below.
On pg. 15, Remarks, regarding arguments directed toward the Drugs.com reference, it is respectfully pointed out that this reference is relied upon as an evidentiary reference to evidence that diclofenac is a pain reliever.
On pg. 17, Remarks, Applicant argues that Sayers does not teach or suggest a topical composition configured for transdermal delivery using a defined applicator or container, nor does it provide any formulation guidance, and that it only provides background context regarding muscle soreness, which is insufficient to supply the missing claim elements.
This argument has been fully considered, but is not found persuasive. Sayers is not relied upon as an anticipatory reference to teach all the limitations of instant claims 1-4. Sayers is relied upon to teach the benefits of administering diclofenac, for muscle soreness, following exercise. For the reasons stated in the above rejection, it would have been obvious to add diclofenac to the composition of Martinez, wherein the combination of Martinez, Sayers, and APG, teach the limitations of instant claims 1-4.
On pg. 17, Remarks, Applicant argues that APG does not disclose any particular therapeutic composition, does not address muscle treatment, and does not teach or suggest combining an airless container with a topical composition formulated for transdermal delivery to muscle tissue.
This argument has been fully considered, but is not found persuasive. It is first pointed out that the instant claims do not recite transdermal delivery. Further, APG teaches the benefits of using airless bottles for storing and applying topical compositions, and APG is relied upon for such teachings in combination with Martinez and Sayers. It is the combination of Martinez, Sayers, and APG that is relied upon to teach the limitations of claims 1-4; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As such, Applicant’s arguments are not persuasive to overcome the prior art rejections.
Double Patenting
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.
(Slightly Modified) Claims 1-14 and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 19/224,255 (claim set dated 05/30/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘255 claims a topical formulation, in solution or liquid form with adhesive application pod, a pod based delivery system, for muscle recovery, comprising 5-95% water, 0.05-10% mineral salts, such as sodium, magnesium, potassium, and calcium (instant inorganic salt), 0.1-10% amino acids, topical pain relievers such as diclofenac (instant pain reliever and NSAID), collagen (instant claim 5), vitamins or other materials (natural supplement), penetration enhancers and more (claim 18).
‘255 claims the compositions as comprising preservatives (claim 1).
‘255 claims that the composition can have caffeine, melatonin, and other ingredients (claims 13, 19).
‘255 claims L-alanyl-L-glutamine as an amino acid (claim 25).
‘255 claims its formulations in airless containers (claims 4, 23).
Regarding the different amounts, the optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
On pg. 19, Remarks, Applicant argues that ‘255 is more broadly to topical formulations comprising water, mineral salts, amino acids, preservatives, and optional additional components, without requiring the particular combination of pain relievers, defined classes of active drug derivatives, naturally occurring plant derivatives, and the specific delivery configuration of recited in claims 1-4.
This argument has been fully considered, but is not found persuasive. As discussed in the above rejection, ‘255 teaches a topical composition comprising the same components recited in instant claims 1-4, i.e., water, diclofenac (pain reliever and NSAID), inorganic salt, amino acid, vitamin natural supplement, and preservative, and teaches these compositions in the same form (i.e., solution or liquid) contained in an adhesive application pod or airless container, and utilized for the same purpose, i.e., muscle recovery.
As such, it is not clear from this argument how the composition and form of the composition taught by ‘255 is distinct from the instantly claimed composition.
On pg. 19, Remarks, Applicant argues that the principle of optimization of known ranges is inapposite in the context of nonstatutory double patenting, where the inquiry is whether the claims are patentable distinct in scope, not whether certain parameters might be optimized.
This argument has been fully considered, but is not found persuasive. As discussed in MPEP 804, “Nonstatutory double patenting includes rejections based on anticipation, a one-way determination of ‘obviousness,’ or a two-way determination of “obviousness”. . .the factual inquires set forth in Graham v John Deere Co. . .that are applied for establishing a background for determining obviousness under 35 USC 103 should be considered when making a nonstatutory double patenting analysis based on ‘obviousness.’” As such, the above reliance upon optimization to arrive at the instantly claimed amounts, is proper.
For these reasons, Applicant’s arguments are not persuasive to overcome the Double Patenting Rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAUREN WELLS/Examiner, Art Unit 1622