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 .
Status of Claims
Receipt of Arguments/Remarks filed on 12/08/2025 is acknowledged. Claims 1-20 are pending. Claim 1 was amended. Claims 8-19 are withdrawn from consideration. Claims 1-7 and 20 are under examination herein.
Modified rejections necessitated by amendment
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 1-4, 6-7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yusoff et al., WO 2014/209101, in view of Lueyot et al., Phillips et al., Current Protocols in Protein Science; 38(1):4- (cited in IDS 10/19/2022); Khong et al., Food chemistry; 196:953-60 (cited in IDS 10/19/2022); and Sow et al., Food Hydrocolloids; 45:72-82.
Regarding claim 1, Yusoff teaches a simple, time and cost-effective process of extracting gelatin from aquatic animals (Yusoff pg. 2 lines 6-7). Yusoff teaches that the solids from the marine derived collagen source, i.e. aquatic animal tissue, are alkali treated, then soaked in aqueous acid for up to 4 h, which includes any amount of time below 4 h (Yusoff pg. 2 lines 17-27). When claimed ranges "overlap or lie inside the ranges disclosed by the prior art" (up to 4 h in citric acid), a prima facie case of obviousness exists. See MPEP 2144.05(I). The aqueous acid includes citric acid (Yusoff pg. 3 lines 26-27). The limitation “to open intact collagen molecules” is an intended result of the claimed method of soaking solids in citric acid. As Yusoff teaches this method, it is expected that this would result in opening of intact collagen molecules.
In a specific example of gelatin extraction from an edible jellyfish, Yusoff teaches that the tissue is treated with acetic acid for 3 h (pg. 5 lines 31-32), then the gelatin is extracted from blended tissue with acidified distilled water with stirring at 50 ± 5°C for 6 h (Yusoff pg. 6 lines 1-3). Homogenizing the marine collagen source, as recited in claim 1, would include blending the tissue as taught by Yusoff. The process of hydrolyzing in a water bath of the instant invention involves incubating the liquid product at 60°C for 4.5 h in a water bath (see instant Specification pg. 10 para. 55). Yusoff further teaches that the extraction with water can be performed at a range of 45-65°C for 6-8 h (Yusoff pg. 2 lines 30-31). When claimed ranges "overlap or lie inside the ranges disclosed by the prior art" and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See MPEP 2144.05(I). It is noted that "where 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". See MPEP 2144.05(II). The water treatment of the aquatic tissue taught by Yusoff would be expected to result in hydrolysis of the collagen molecules, i.e. extraction of gelatin. Gelatin is derived from the partial hydrolysis of collagen, as set forth in the instant specification pg. 8 para. 44.
Yusoff teaches dialyzing the liquid (supernatant) gelatin product against deionized distilled water, with exchange of distilled water every 6 h (Yusoff pg. 6 lines 6-7). Yusoff teaches that the dialysis step is performed at room temperature (Yusoff pg. 3 lines 4-5).
Regarding claim 2, Yusoff teaches lyophilizing the dialyzed collagen product (Yusoff pg. 6 lines 8-9).
Regarding claim 3, Yusoff teaches pulverizing the dialyzed and lyophilized marine collagen product (i.e. homogenizing in a blender) which would result in a gelatin powder (Yusoff pg. 6 line 10).
Regarding claim 4, Yusoff teaches that the marine collagen source is an edible jellyfish, Acromitus hardenbergi (Yusoff pg. 5 line 14).
Regarding claim 20, Yusoff teaches that the acid solution, which can be citric acid, is used in a concentration within the range of 0.05-3% wt./vol. (Yusoff pg. 3 lines 20-21). Yusoff teaches that collagen source is soaked in acid for up to 4 h, which includes any amount of time below 4 h, i.e. 10 minutes (Yusoff pg. 2 lines 26-27). When claimed ranges "overlap or lie inside the ranges disclosed by the prior art" (0.05-3% wt/vol, up to 4 h in citric acid), a prima facie case of obviousness exists. See MPEP 2144.05(I).
Yusoff does not teach that the collagen source is a salted, dried marine-derived collagen source as recited in claim 1.
Regarding claim 1, Lueyot teaches a method of producing collagen from salted, dried jellyfish (Lueyot Abstract). Lueyot teaches that during the processing for export, the by-product of salted jellyfish derived from cleaning, trimming, sorting, and sizing can be used to produce gelatin (Lueyot p. 3 first partial para.). Lueyot teaches that for gelatin production, factors such as different marine sources, chemical used for pretreatment, pH, and extraction condition directly affects gel strength and yield, and that jellyfish gelatin has been shown to have a gel strength from 47-118 g which is lower than other gelatin produced from marine sources (Lueyot p. 3 para. 1). The process taught by Leuyot involves an alkaline treatment, soaking the dried, salted jellyfish in acid solutions, then soaking in water (hydrolyzing in water bath) before further analysis (Lueyot pp. 3-4 “Preparation and optimization of type A jellyfish gelatin”). Lueyot teaches products having a variety of gel strengths with the lowest being 8.79 g and the highest 323.74 g (Lueyot p. 7 “Gel Strength”).
It would have been obvious to a skilled artisan, before the effective filing date, to utilize a dried, salted jellyfish as taught by Lueyot in place of the fresh jellyfish in the method of Yusoff. Jellyfish are known to be a good source of marine collagen and gelatin can be extracted from both fresh and dried, salted jellyfish. It would have been obvious to substitute dried, salted jellyfish, which are readily available due to commercial processing, in the method of Yusoff.
A person of ordinary skill in the art would have been motivated to make this substitution because salted, dried jellyfish are commonly available as a byproduct from processing jellyfish for export, and it would be beneficial to use such a byproduct for production of gelatin, which is widely used in food, pharmaceutical, and cosmetic products (Lueyot “Introduction”).
A skilled artisan would have had a reasonable expectation of success in making this substitution because Lueyot teaches that gelatin can be extracted from dried, salted jellyfish using acid extraction and water hydrolysis techniques, similar to the method of Yusoff. Lueyot additionally teaches that jellyfish gelatin is known to have a gel strength in the range of 47-118 g, which is lower than other marine gelatin sources, and that gelatin produced from salted, dried jellyfish can have lower gel strength depending on extraction conditions. Based on these teachings, a skilled artisan could reasonably expect success in substituting a salted, dried jellyfish in the method of Yusoff to produce marine-derived gelatin powders having a low Bloom strength of about 20 g to 75 g.
Yusoff does not teach draining excess liquid before homogenizing, or that the dialysis is under agitation in a sealed dialysis membrane having a molecular weight cutoff of 6-8 kD, as set forth in claim 1. Yusoff does not teach that the dialyzing removes mineral content as recited in claims 1, 6 and 7.
Regarding claim 1, Phillips teaches dialysis as a technique for removing excess salts (minerals) from a protein solution (Phillips pg. 4.4.1 para. 1; pg. 4.4.12, “Background Information” para. 1). Phillips teaches that dialysis membranes are characterized by their molecular weight cutoff value (MWCO), which filters out molecules with molecular weights below the MWCO and retains higher molecular weight molecules of interest, such as proteins (Phillips 4.4.12 “Background Information” para. 2-3). Phillips teaches that different MWCOs are used in different circumstances, for example using MWCO of 12,000 Da for general proteins and MWCO of 3500 Da for retention of small proteins (Phillips pg. 4.4.2 “Materials”). Phillips further teaches that dialysis membranes come in a range from 100-300,000 Da (Phillips pg. 4.4.3 step 4). For removing salts, Phillips teaches using a sealed dialysis membrane (pg. 4.4.3 “Dialyze the sample” step 5, 8) and then placing the membrane in dialysis buffer and stirring continuously, i.e. under agitation (Phillips pg. 4.4.3 “Dialyze the sample” step 9). Phillips teaches replacing the buffer with equal volume of fresh buffer as necessary (pg. 4.4.4 step 10).
Regarding claims 1 and 6, Khong teaches the nutritional composition of various edible jellyfish. The contents of the jellyfish include Na, K, Cl, Ca, P, Mg, S, Fe, Cu, Zn, Mn, Se, Mo, Ni, Si, Al, and As (Khong pg. 959 Fig. 4). Khong teaches that hazardous elements including Pb, Cd, Hg, and Sn were below the limit of detection (Khong pg. 959 first partial para.). Khong teaches that Na comprises ~10-30 weight % of the elemental content of jellyfish bell and oral arms (Khong Fig. 4). Khong teaches that elements in the jellyfish, particularly trace elements, are highly impacted by the habitats of the population and factors such as water pollution (Khong pg. 959 first partial para.).
Regarding claims 1, 6, and 7, Sow teaches that various salts including NaCl, MgCl-2, MgSO4, CaCl-2, and phosphate salt effect the physiochemical properties of marine derived gelatin (Sow pg. 72 para. 3). Sow teaches testing the effect of salt on texture, viscosity, and gelatin secondary structure (Sow pg. 73 para. 3). Sow teaches that addition of salt, specifically NaCl, to fish gelatin reduces gel strength and textural properties and causes changes to molecular structure and a disruption to the gel network (Sow pg. 81 “Conclusions”).
It would have been obvious to combine the teachings of Yusoff and Phillips, utilizing a sealed dialysis membrane under agitation. Yusoff teaches dialysis of the gelatin product. Phillips teaches common dialysis techniques for removing low molecular weight solutes such as salts from protein solutions. It would have been obvious that the specific dialysis steps taught by Phillips could be used in the process of Yusoff, incorporating a sealed dialysis membrane and agitation or stirring.
Regarding the limitation in claim 1 of a 6-8 kDa molecular weight cutoff, it would have been obvious to a skilled artisan that the MWCO is chosen depending on the size of the solutes to be retained or not retained. Phillips teaches dialysis membranes having a MWCO over a range of 100-300,000 Da (0.1-300 kDa), which includes 6-8 kDa. When claimed ranges "overlap or lie inside the ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05(I). It is noted that "where 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". See MPEP 2144.05(II). For removal of minerals and salts, which have low molecular weights, it would be obvious to a skilled artisan to choose a MWCO near the lower end of the range, i.e. 6-8 kDa, as this would filter out minerals and salts while retaining desired molecules.
Regarding the step in claim 1 of draining excess liquid, Yusoff does not explicitly teach this step. However, it would have been obvious to a person having ordinary skill in the art that after the solids are soaked in citric acid, excess liquid could be removed as necessary before moving on to subsequent steps.
A person of ordinary skill in the art would have been motivated to incorporate the specific teachings of Phillips regarding dialysis techniques in the method of Yusoff because the dialysis method taught by Phillips is commonly done to purify proteins and remove unwanted low molecular weight materials such as salts, which could pose an issue in future uses (Phillips pg. 4.4.1 para. 1). As Yusoff teaches dialysis of the gelatin product, a skilled artisan would have been motivated to additionally utilize the teachings of Phillips which provide more detailed steps and information such as the use of sealed dialysis membranes or agitation, which are not mentioned in the more general method taught by Yusoff. A skilled artisan would further be motivated to perform such a technique because marine animals such as jellyfish are known to contain many minerals and salts as taught by Khong, and as taught by Sow, salts negatively impact gelatin gel strength and textural properties, making it desirable to remove these minerals (Sow pg. 81 “Conclusions”).
A skilled artisan would have a reasonable expectation of success in utilizing the techniques taught by Phillips in the dialysis method of Yusoff because the method of Phillips is known in the art for protein purification and filtering out unwanted molecules, and as Yusoff already teaches dialysis of the gelatin product a skilled artisan could reasonably expect success in incorporating specific teachings of Phillips as part of the gelatin dialysis.
Regarding the limitation in claim 1 “for producing marine-derived gelatin powders having a low Bloom strength of about 20 g to 75 g”, this is an intended result of the claimed method. Any method comprising the same active method steps is expected to be capable of producing this result. As discussed above, Yusoff, Lueyot, and Phillips teach the steps of soaking a dried, salted marine-derived collagen product in citric acid, homogenizing, hydrolyzing, and dialyzing. Therefore, it is considered that the result of producing marine-derived gelatin powders having a low Bloom strength of about 20 g to 75 g would flow naturally from performance of the method steps.
Regarding the limitation in claim 1 “to at least partially demineralize the marine-derived collagen source to produce a dialyzed marine-derived collagen product with a reduced mineral content”, this recites an intended result of the claimed method. Phillips teaches that the dialysis technique, involving the steps taught by Yusoff of dialyzing against deionized water (dialysis buffer) for 24 h with exchange of the water every 6 h, in a sealed dialysis membrane under agitation, results in removal of salts and low molecular weight solutes (Phillips pg. 4.4.4 step 10; Yusoff pg. 6 lines 6-7). As taught by Khong, marine collagen sources such as jellyfish include many low molecular weight minerals and salts. Thus, it is expected that the method of dialysis as taught by Yusoff and Phillips, would result in the demineralization of the collagen source.
Regarding the limitation in claim 6, “wherein the mineral content comprises calcium, potassium, magnesium, phosphorus, sulfur, aluminum, boron, cadmium, chromium, copper, iron, manganese, molybdenum, sodium, nickel, lead, and zinc”, this limitation is directed to the composition of the marine collagen source used in the claimed method. The specific composition of minerals in the collagen source will vary depending on environmental factors as taught by Khong, but in general comprises the minerals recited in claim 6. However, the specific composition of minerals in the starting collagen source does not result in a manipulative difference in carrying out the claimed method of dialysis, which is taught by Yusoff and Phillips as set forth above.
Regarding limitations in claims 6 and 7, “wherein the dialyzing removes…”, these limitations recite intended results of the dialysis technique. As set forth above, Yusoff and Phillips teach the recited dialysis method step in claim 1. Thus, it is expected that the method taught by Yusoff and Phillips, which is the same as the instantly claimed method and is known based on the teachings of Phillips to result in reduction in mineral and small molecule content in protein samples, would result in removal of 75% or more of total mineral content and 90% of Na from the collagen source. Applicant is directed to MPEP 2111.04(II), which states, “a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”.
Additionally, Khong teaches that marine collagen sources include the minerals recited in claim 6, with main components being Na and Cl. Sow further teaches that the addition of salts such as NaCl to marine gelatin are detrimental to gelatin physiochemical properties, making it desirable to remove these minerals. Thus, a skilled artisan would have motivation to perform a dialysis method for the removal of a majority of the minerals and specifically Na, as this is known to negatively impact gelatin properties.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yusoff in view of Lueyot, Phillips, Khong, and Sow, as applied to claims 1-4, 6-7, and 20 above, and further in view of Hsieh et al., Hydrobiologia; 451(1):11-7 (cited in IDS 10/19/2022).
Yusoff, Lueyot, Phillips, Khong, and Sow teach the method of claim 1. Yusoff teaches that the collagen source is an edible jellyfish Acromitus hardenbergi (Yusoff pg. 5 line 14). Lueyot teaches a salted, dried jellyfish as a collagen source. The above references do not teach that the edible jellyfish is dried, salted Stomolophus meleagris as recited in claim 5.
Regarding claim 5, Hsieh teaches that a number of edible jellyfish are dried and salted for commercial use (Hsieh pg. 12 “Jellyfish processing”). Hsieh teaches that Stomolophus meleagris or cannonball jellyfish are of significant interest commercial interest for production of valuable products, specifically as a collagen source (Hsieh pg. 15 para. 1-2; pg. 16 para. 1, 4).
It would have been obvious to a skilled artisan, before the effective filing date, to combine the teachings of Yusoff, Lueyot, Phillips, Khong, Sow, and Hsieh and utilize Stomolophus meleagris as the marine collagen source in the method of obtaining gelatin. Lueyot teaches that salted, dried, edible jellyfish can be used in the method of extracting gelatin. Hsieh teaches multiple common edible jellyfish of commercial interest, including Stomolophus meleagris, which are typically salted and dried. It would have been obvious to substitute the jellyfish in the method of Yusoff and Leuyot with salted, dried, Stomolophus meleagris, given the teachings of Hsieh that Stomolophus meleagris is also a useful collagen source and is normally commercially available in a salted, dried form.
A person of ordinary skill in the art would have been motivated to substitute the jellyfish taught by Yusoff with Stomolophus meleagris because Stomolophus meleagris is of significant interest for commercial use and the development of valuable products including collagen products, and these jellyfish are abundant in the coastal waters of the US, making them easy to obtain (Hsieh pg. 15 para. 1-2; pg. 16 para. 1, 4).
A skilled artisan would have a reasonable expectation of success in making this substitution to achieve the predictable outcome of gelatin extraction from Stomolophus meleagris using the method of Yusoff, Lueyot, Phillips, Khong, and Sow, given the teachings of Hsieh that Stomolophus meleagris is a good source of collagen and the successful use of other edible jellyfish in the method as taught by Yusoff.
Response to Arguments
In light of amendments to the claims, the previous rejections of claims 1-7 and 20 under 35 U.S.C. § 103 have been withdrawn. However, upon further consideration, new grounds of rejection of claims 1-7 and 20 are made under 35 U.S.C. § 103 as set forth above.
Responses to pertinent arguments are set forth below.
Applicant argues that the products derived from the instant claims have low Bloom strength and soft properties, and that amended claim 1 recites methods tailored to producing this collagen product that cannot be obtained by the prior art methods. Specifically, applicant argues that Yusoff teaches fresh jellyfish, which have higher moisture content and collagen integrity compared to salted, dried jellyfish; and that Yusoff also teaches an alkaline treatment which alters the hydrolysis product and results in higher Bloom strength gels. Applicant argues that this alkaline treatment is not part of the claimed method, which is directed to a citric acid-only soak on salted, dried jellyfish, and omitting the alkaline pretreatment in Yusoff would not predictably produce a low-Bloom gelatin because salting and drying and acid-only processing alter structural integrity.
In response to the argument that Yusoff teaches fresh jellyfish, which have a different moisture content and collagen integrity, Lueyot is now relied upon to teach methods of obtaining collagen from salted, dried jellyfish, as discussed above.
In response to the argument that Yusoff teaches an alkaline treatment that is not part of the instant method, it is noted that claim 1 uses the transitional phrase “comprising”, which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP § 2111.03(I)). The instant method as claimed does not recite a citric-acid only soak or recite that there is no alkaline treatment step. Therefore, although Yusoff does teach an alkaline pretreatment, given the transitional phrase “comprising”, such an additional step is not excluded from the method as instantly claimed. As the combined teachings of the prior art references include all of the active method steps recited in claim 1, as set forth above, it is expected that the method of the prior art is capable of producing the claimed results.
Applicant argues that the results of the process which omits alkali treatment and uses salted, dried, jellyfish are unexpected, yielding gels with lower melting points, faster dissolution, and low Bloom strength. Applicant argues that substituting Yusoff’s alkaline, unsalted jellyfish would retain high Bloom strength gels. Applicant argues that Yusoff’s method produces a gel with 200-300 g Bloom, unlike the instant method which produces 3-65 g Bloom strength gels, indicating that the method of Yusoff produces a product with different properties.
In response to this argument, it is again noted that the instant claims do not exclude additional unrecited method steps such as an alkaline treatment. As discussed in the above rejection, a skilled artisan would have found it obvious to substitute the fresh jellyfish of Yusoff with the salted, dried jellyfish of Lueyot, thus providing a starting product as instantly claimed. The claimed active method steps are rendered obvious in view of the prior art references, and it is considered that these results would naturally flow from performance of the method steps.
Applicant argues that Phillips does not teach that dialysis would result in low Bloom from salted sources without alkali, and neither Yusoff or Phillips provide motivation to use dialysis for demineralization of marine collagen to obtain a low Bloom product. Applicant argues that dialysis of the products in the prior art does not mean that the product will have improved properties, as the claimed method uses more than routine optimization but is a combination of parameters developed for maximal results.
In response to this argument, it is noted that using dialysis for demineralization of marine collagen to obtain a low Bloom product is an intended result of the claimed method. It is expected that performing dialysis on a marine-derived collagen product as claimed would result in the demineralization of the marine collagen. Yusoff and Phillips teach dialysis as claimed. Further, as discussed above, the absence of an alkali step is not required in the method as claimed.
Applicant argues that Yusoff teaches fresh river jellyfish, and a skilled artisan would not have been motivated to substituted salted, dried Stomolophus meleagris for fresh Acromitus hardenbergi and reasonably expect success.
In response to this argument, it is the position of the examiner that a substitution of a salted, dried jellyfish in place of fresh jellyfish would be obvious in light of prior art teachings that salted, dried jellyfish are successfully used for production of gelatin and are a good source of collagen. An ordinary artisan would be motivated to use salted, dried jellyfish because they are readily available as commercial food products and byproducts of the food production process that provide a kosher, halal source of gelatin. As both fresh and dried, salted jellyfish are comprised of collagen, a skilled artisan would have found it obvious to use either of these as the source of marine-derived gelatin.
Conclusion
Claims 1-7 and 20 are rejected. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653