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
Status of Claims
The amendments and arguments filed on 11/03/2025 are acknowledged and have been fully considered. Claims 1, 3-4, and 11-30 are now pending. Claims 2 and 5-10 are canceled; claims 1 and 11 are amended; claims 18-30 are withdrawn.
Claims 1, 3-4, and 11-17 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
New rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-13 and 15-17 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.
Claims 12-13 recite the limitation "the disease or disorder" in line 2 of each claim. There is insufficient antecedent basis for this limitation in the claim. For purposes of search and consideration, the claims are understood as reading “onset of the muscle soreness” instead of “the disease or disorder.”
Claim 15 recites the limitation "the foot pain" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16-17 recite the limitation "the inflammation or inflammatory-related condition" in lines 1-2 of each claim. There is insufficient antecedent basis for this limitation in the claim.
As claim 1 has been amended to remove the diseases and disorders other than muscle soreness, one with ordinary skill in the art would not understand the metes and bounds of claims 15-17. For purposes of search and consideration, the claims are understood as being drawn to muscle soreness instead of foot pain and inflammation and inflammatory-related conditions.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In line with the interpretation of claims 15-17 above, the claims are not further limiting as claim 1 is drawn towards muscle soreness. As claims 15-17 are being interpretated as being drawn to muscle soreness as well, they are not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified rejection
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20160045634 (Williams, 2016) in view of US PGPUB 20120004390 (Zhao, 2012), US Patent 6579543 (McClung, 2003; as submitted on IDS of 10/24/2022), US PGPUB 20170056465 (Tobin, 2017; as submitted on IDS of 10/24/2022), and US Patent 6949582 (Wallace, 2005; as submitted on IDS of 10/24/2022).
Regarding claims 1 and 14-17, Williams discloses a medical dressing and analgesic formulation that is operable to provide pain relief to an injured area of the human body (see Williams, abstract). Williams discloses a formulation that is pine resin based and disclosed that the formulation includes about 5% wt to about 75% wt of Pine Resin (see Williams, paragraph 0019). Williams discloses a formulation with 10% by weight of pine resin (see Williams, table 1). Williams discloses that the formulation can be used to treat both chronic pain conditions as well as acute injuries such as but not limited to sprains and other muscle injuries (see Williams, paragraph 0026).
Regarding claims 3 and 4, any properties exhibited by or benefits provided by the composition are considered inherent, absent evidence to the contrary, and are not given patentable weight over the prior art. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not inherently possess the same properties as instantly claimed product.
Regarding claim 11, Williams discloses that the formulation can be a gel, lotion, spray or enhanced oil (see Williams, paragraph 0019).
Regarding claim 13, Williams discloses that the formulation is administered after the onset of the disease or disorder (see Williams, paragraph 0026).
Williams does not teach that the pine resin is from Pinus caribaea or Pinus elliottii, or the use of about 0.1 to about 10% by weight Arnica extract, at least one extract derived from the group consisting of Harpagopthum, Bryophyllus pinnatum, Calendula officinalis, Boswellia serrata, Cinnamomum camphora, Mentha piperita, Ruta graveolens, Symphytum officinale and combinations thereof, cannabidiol, or magnesium sulfate.
Zhao teaches preparing resin acid from pine oleoresin or rosin (see Zhao, paragraph 0001). Zhao teaches that the resin acids mainly include abietic acid (see Zhao, paragraph 0002). Zhao teaches pimaric type resin acids have biological activities against cancer, viruses, phlogosis, bacteria, and parasites, etc., and have potential therapeutic actions against diseases such as hypertension, tonic cystitis, allergic bronchitis, and chemical central nervous system disorders (see Zhao, paragraph 0004). Zhao teaches that the pine oleoresin can come from various pines, including Pinus elliottii pine oleoresin and Pinus Caribaea pine oleoresin (see Zhao, paragraph 0018), and specifically teaches an example utilizing Pinus elliottii pine oleoresin (see Zhao, Example 2).
McClung teaches a composition for topical application to an animal's skin for relief from a variety of symptoms caused by medical conditions or physical injuries (see abstract). McClung teaches that the composition for topical application to an animal's skin may be in the form of a lotion, a cream or a gel (see McClung, column 2, lines 22-24). McClung teaches that the composition is used to treat sore muscles, including muscle cramps and muscle spasms; auto accident injuries; knee, hip, shoulder and hand pain; sports injuries, strains and sprains; musculoskeletal injuries; post-surgery pain; insect stings and bites, burns, including sunburn; and nerve damage pain from diseases such as diabetes (see McClung, column 2, lines 25-38). McClung teaches arnica extract can be used to provide anti-inflammatory effects to provide relief from at least one of swelling, redness, fever and inflammation, and teaches 1-10% by weight arnica extract (see McClung, column 5, lines 33-35 and lines 43-45). McClung teaches that the composition also includes at least one compound having anti-inflammatory effects such as calendula (see McClung, column 2, lines 39-67).McClung also teaches that marigold (i.e., Calendula officinalis) is known for reducing pain (see McClung, paragraph bridging columns 8-9). McClung teaches that the composition may also include extracts such as those from pine, as well as pine oil, and pine tar oil (see McClung, column 17, lines 40-60).
Tobin teaches a therapeutic topical composition useful for treatment of localized pain, inflammation, and/or swelling (see Tobin, abstract). Tobin teaches that the composition includes magnesium sulfate (see Tobin, abstract).
Wallace teaches a method of relieving analgesia and reducing inflammation using a cannabinoid delivery topical liniment composition (see Wallace, abstract). Wallace teaches that the liniment is applied topically and contains cannabidiol (see Wallace, abstract). Wallace teaches that the relief of pain and reduction in inflammation associated with such ailments as arthritis, bursitis, fibromyalgia, carpal tunnel syndrome, gout, and other muscular and joint aches and pains (see Wallace, column 1, lines 18-25).
Regarding claims 1, 3-4, and 11-17, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize Pinus elliottii or Pinus Caribaea as taught by Zhao in the method of Williams. One would be motivated to do so with a reasonable expectation of success as Zhao teaches that pimaric type resin acids have biological activities, and teaches that they can be isolated from various pines, including Pinus elliottii pine oleoresin and Pinus Caribaea pine oleoresin (see Zhao, paragraph 0018). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06(I)). In the instant case, it would be prima facie obvious to combine the teachings of Williams and Zhao as they both are known to be used to treat similar conditions (i.e. tonic cystitis and muscle injuries). Further, the MPEP states that the selection of known materials based on their suitability for their intended uses is prima facie obvious. See MPEP § 2144.07. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to add 1-10% by weight arnica extract as taught by McClung to the method of Williams. One would be motivated do so with a reasonable expectation of success as McClung teaches arnica extract provides relief from at least one of swelling, redness, fever and inflammation and specifically teaches it in a composition for the treatment of sore muscles, including muscle cramps and muscle spasms; auto accident injuries; knee, hip, shoulder and hand pain; sports injuries, strains and sprains; musculoskeletal injuries; post-surgery pain; insect stings and bites, burns, including sunburn; and nerve damage pain from diseases such as diabetes.
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to add at least one compound having anti-inflammatory effects such as calendula (see McClung, column 2, lines 39-67), to the method of Williams. One would be motivated to do so with a reasonable expectation of success as McClung teaches that marigold or calendula is known to reduce pain and specifically teaches it in a composition for the treatment of sore muscles, including muscle cramps and muscle spasms; auto accident injuries; knee, hip, shoulder and hand pain; sports injuries, strains and sprains; musculoskeletal injuries; post-surgery pain; insect stings and bites, burns, including sunburn; and nerve damage pain from diseases such as diabetes.
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to add magnesium sulfate as taught by Tobin to the method of Williams. One would be motivated do to so as Tobin teaches that magnesium sulfate is useful in the treatment of localized pain, inflammation, and/or swelling. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06(I)). In the instant case, it would be prima facie obvious to combine the teachings of Williams and Tobin as they both are known to be used to treat inflammatory conditions. It would be obvious to one with ordinary skill in the art to combine the teachings of Williams with the teachings of Tobin according to the known method of treating chronic and acute conditions (see Williams, paragraph 0026) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to add cannabidiol as taught by Wallace to the method of Williams. One would be motivated to do so with a reasonable expectation of success as Wallace teaches that cannabidiol can effectively be topically applied for the relief of pain and reduction in inflammation associated with such ailments as arthritis, bursitis, fibromyalgia, carpal tunnel syndrome, gout, and other muscular and joint aches and pains. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06(I)).
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s arguments that muscle soreness is not the same as muscle injuries, however it is pointed out that Williams teaches that the composition is drawn towards treating sprains (see Williams, paragraph 0026). Instant claim 14 recites that a sprain is a type of muscle soreness. As such, Williams reads on the muscle soreness of the instant claims. If applicant is arguing that sprains are not a type of muscle soreness then this is an issue with the scope of the claims. Further, the rejection is not made over just Williams, but over all of the other references together. Importantly, McClung teaches that the composition is used to treat sore muscles (see McClung, column 2, lines 25-38). The rationale and motivation for combining the references has been discussed in the above rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611