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 .
Response to Amendment
Applicant's amendment and argument filed 05/26/2025 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claim 2 was deleted and claims 1 and 4 were amended.
Claims 1 and 3-5 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Amany Zain Alaabedien Mahmoud Alshahidy (SA113340923B1), hereinafter Alshahidy, Aline Fleck et. al. (Punica granatum L. Hydrogel for Wound Care Treatment: From Case Study to Phytomedicine Standardization, Molecules, 22-Aug-2016, 21(8), 1059) and Zengsong (CN107669594A).
Alshahidy’s general disclosure is to suppository for hemorrhoids (see abstract).
Alshahidy teaches “A pharmaceutical formulation for the treatment of hemorrhoids, suitable for rectal administration, containing a triple mixture of dried aqueous extract of pomegranate peel (Punica Granatum); Dried ethanolic extract Commiphora Myrrh jell and Alum (potassium and aluminum sulfite)” (see claim 1) and teaches each amount to be at 10% w/w (see abstract). Alshahidy teaches the three components in a mixture with an emulsion base (see abstract) and it is known to those skilled in the art that emulsions act as carriers.
Alshahidy does not specifically teach that the pomegranate peel extract is an ethanolic extract.
Fleck’s general disclosure is a report on the wound healing effects of pomegranate hydrogels (see abstract).
Fleck teaches that “the pharmacological activities of many Punica granatum L. components suggest a wide range of clinical applications for the prevention and treatment of diseases where chronic inflammation is believed to play an essential etiologic role” and “formulations containing extracts with not less than 0.49% (w/w) total punicalagin might find good use in wound healing therapy.” (see abstract)
Crude aqueous or ethanolic herbal extracts have been used to treat various skin ailments such as wounds, psoriasis and inflammatory conditions [ 3]. They are also important sources of biologically active natural products and have been extensively used in pharmaceutical industry research and development studies that have resulted in the identification of compounds with therapeutic potential [ 4]. Punica granatum L. (Punicaceae), commonly known as pomegranate, is a shrub or a small tree native to the Mediterranean region. The different parts of pomegranate ( L.) have been known as a reservoir of bioactive compounds with potential biological Punica granatum activities [ 5]. This species is rich in phenolic compounds and is an important source of hydrolysable tannins, ellagitannins and ellagic acid [ 6]. In addition to the tannins, pomegranates also contain flavonoids, including flavones, flavonols and anthocyanidins. Epicatechin, epigallocatechin and their derivatives are also present in pomegranates. The brilliant red colour is attributed to anthocyanins, which are the major constituents of arils [ 7]. Pomegranate fruit juice, fruit and peel (See Introduction page 4).
Punica granatum shown that the extract-treated animals were found to epithelialize faster when compared to respective controls and exhibited a 95% reduction in the wound area. These extracts were also investigated for healing effects on deep second-degree burns in rats [ 10]. Histological results indicated that inflammatory cells substantially disappeared and were replaced by new granulation tissue in extract treatment, while that of the control rats still showed severe inflammatory cell infiltration. In vivo potential of P. granatum described for a 5% ( / ) methanolic extract based-ointment formulated and evaluated for its wound healing in guinea pigs. The ointment peels was also ww significantly enhanced wound contraction, period of epithelialization and also the biochemical and histopathological characteristics [ 11]. In a previous work, the ellagitannins punicalin and punicalagin (Figure 1a,b) were isolated from the hydroalcoholic extracts of P. granatum peels and punicalagin was found to be responsible for the antimicrobial activity of the extract against sensitive and multi-drug resistant bacteria, especially species of staphylococci, such as [ 12]. Punicalagin has also been reported to have a wide Staphylococcus aureus range of biological effects, including antioxidant, hepatoprotective, antimicrobial, antiproliferative, apoptotic, chemopreventive and immunesuppressive activities [ 13]. Polyphenols are known for their ability to precipitate proteins, which is one of the supportive clues for their wound healing properties [ 14]. Due to the high rates of recurrence of chronic wounds, new effective therapeutic strategies need to be developed. Plants represent important sources of alternative formulations that will complement the skin therapy arsenal in either prevention or treatment. Despite the promise of extracts as a therapeutically active ingredient for many applications, there is little data available concerning the P. granatum standardization and stability of extracts that would potentially be suitable for the development of an appropriate topical preparation for use in clinical trials. In order to find a suitable biomarker to establish quality control parameters of P. granatum consideration of its physiochemical properties and stability, a hydrogel-based formulation was developed and evaluated. (see page 2).
Fleck also teaches that a higher concentration of phenolics from the ethanolic peels of P. granatum peels led to different mechanisms of physiochemical interactions with the hydrogel formulation (see page 7, Discussion 1st para.).
Zengsong teaches an aloe extract for wound healing properties (see abstract).
Zengsong teaches an aloe which is oil-soluble (aloe oil) effective for treating wounds and can be in a weight range of 1% to 30% (see claim 1 and abstract).
Zengsong teaches “It was found that aloe frost being capable of significantly accelerated contraction of wounds and wound healing. Some growth factors in aloe can neutralize wound Mouth healing mortifier, steroid substance has preferable anti-inflammatory activity, so as to promote the healing of wound. Phosphoric acid in aloe gel Mannose has anti-inflammatory activity and can promote wound healing. In vitro and in vivo experiment shows: Aloe can suppress leucocyte and stick together and promote Enter revascularization, so as to promote the healing of wound. The polysaccharide component of aloe, as mannosan glycosides has antibacterial, antivirus action, Can increase the content of collagen and hydroformylation thing in granulation tissue, reduce aldehyde solubility, to the glutinous polysaccharide of wound healing matrix into Point have an impact, can also increase the crosslinking of newborn collagen by accelerating the biosynthesis and degraded of collagen and accelerate The agglutination of wound. Aloe can shorten the anti-inflammatory of wound healing time and aloe, hemostasis, promote re-epithelilization and promote It is relevant to enter the effect such as wound healing. Modern pharmacology experimental study shows that aloe induced by endotoxin is inhibited and with concentration Increase and raise. In addition, aloe also has certain anti-oxidant and moistening wound effect.” (see bottom of page 8 and top of page 9).
Zengsong teaches that aloe is known to reduce wound tissue edema, have analgesic activity, and can suppress the formations of scars.
Therefore it would have been obvious to persons having skill in the art to select ethanol for the pomegranate peel solvent for extraction because Fleck teaches that the alcoholic pomegranate peel extractions, specifically ethanolic ones have a higher concentration of phenolic content and are known for their wound healing properties. It would have also been obvious to combine aloe vera oil as taught by Zengsong in the anal fissure wound healing composition taught by Alshahidy because this oil can speed up recovery, have analgesic activity, reduce wound edema and shorten the anti-inflammatory period of the wound healing time of the fissure. Optimizing the aloe vera oil to be at 5% or less would have been obvious given that its effectiveness is reported at 1% by Zengsong.
Response to Arguments
Applicant's arguments filed 05/26/2025 have been fully considered but they are not persuasive. The applicant argues that ethanolic vs aqueous extracts of pomegranate peels would contain different components and thus would make up different wound healing compositions. The Office relies on new art that teaches wherein ethanolic extracts of the pomegranate peels also have wound healing properties.
The applicant argues that aloe vera cream is not the same as aloe vera oil. The Office relies on new art to show that the aloe vera oil also has wound healing properties as claimed.
The applicant argues that there is synergy with the combined ingredients however does not elaborate on why they believe there is synergy. Figure 2B shows each individual ingredient tested and indeed the combined ingredients effects are greater than each individual components activities however this appears to be additive and would have been expected given the prior art.
Conclusion
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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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655