Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendments and arguments of April 20, 2026, are entered.
Claims 1, 11, 17, 20, and 23 are amended.
No new claims have been added.
Status of Claims
Claims 1-23 are pending.
Priority
Claims 1-23 have priority to PRO 63/166,005 filed on March 25, 2021, and PRO 63/166,064 filed on March 25, 2021.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Applicant is advised that should claim 1 be found allowable, claim 10 would be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 10 is directed to a composition comprising a second predetermined size with a minimum and maximum. However, since the composition of claim 1 inherently includes a distribution of particle sizes that may be described by Gaussian or similar statistical distributions, the composition of claim 1 necessarily contains the subpopulations of particles that are characterized by narrower or secondary minimum and maximum sizes.
Applicant is advised that should claim 1 be found allowable, claim 8 objection is being maintained under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 8 recites that the predetermined size threshold pertains to length and/or width but not thickness. Claim 1 recites that “…particles of the decellularized fish skin…within a predetermined size threshold maximum and a minimum size…”. An Artisan, having read Claim 1, would have interpreted the “predetermined size threshold” because observation orientation would be determinative of what is length/width/thickness. Despite the difference in wording, the claims have substantially the same scope.
As stated in above, the language of claim 1 does not limit which particle dimensions are being measured, i.e. length, width, or thickness. Because of this, a person of ordinary skill in the art would understand that when describing a particle size, the specific orientation of measurement determines whether one is referring to length, width, or thickness, and that all three parameters are inherent descriptors of particle dimensions. Therefore, the limitations in claim 8 do not render the claim language patentably distinct. Claim 8 is merely clarifying a dimension that is already encompassed by the broader terminology of claim 1.
Claim Rejections - 35 USC § 112
Based on Applicant’s amendments, the rejections for Claims 3 and 21 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 is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments, the rejection to Claims 11-16, 18-19, and 22 under 35 U.S.C. §103 as being unpatentable over Han [CN 110732042 A, 2020], in view of Dorweiler et al. [The marine omega 3 wound matrix for treatment of complicated wounds, Gefasschirurgie, 2018], in view of Wound Care Advisor [https://woundcareadvisor.com/what-you-need-to-know-about-collagen-wound-dressings/, 2015], in view of Central Infusion Alliance [https://www.ciamedical.com/insights/wound-dressings-101/, Wound Dressings 101, 2019], in view of Otto [https://pharmamanufacturing.com/production/packaging, vials vs. dual chamber systems, 2014] is withdrawn.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 1-23 are newly rejected under 35 U.S.C. §103 as being unpatentable over Sigurjonsson et al. [US 2011 0244054 A1], in view of Hu et al. [CN 108187140 A, 2018], in view of Han [CN 110732042 A, 2020], in view of Dorweiler et al [The marine omega 3 wound matrix for treatment of complicated wounds, Gefasschirurgie, 2018], in view of Wound Care Advisor [https://woundcareadvisor.com/what-you-need-to-know-about-collagen-wound-dressings/, 2015], in view of Central Infusion Alliance [https://www.ciamedical.com/insights/wound-dressings-101/, Wound Dressings 101, 2019], in view of Otto [https://pharmamanufacturing.com/production/packaging, vials vs. dual chamber systems, 2014].
Regarding claim 1, Sigurjonsson et al. discloses a decellularized extracellular matrix derived from fish skin [Abstract]. Applicant’s claim further states that “the decellularized fish skin is obtained from mature and/or filletable sized fish”. Here, Sigurjonsson et al. teaches that the fish skin was removed from a fish fillet which also would imply a certain size and maturity [¶ 0044, 0066, 0088]. However, Sigurjonsson et al. does not disclose a predetermined percentage having a maximum and minimum size threshold. However, Hu et al. discloses a wound treatment comprising particles of decellularized fish skin with predetermined percentage of at least a first portion of the particles of decellularized fish skin have a greatest dimension within a predetermined size threshold and a minimum size threshold that is effective to preserve a matrix structure of the decellularized fish skin [Para starting with “Preferably, in the step (8), obtained by freeze”]. Lastly, Sigurjonsson et al. discloses that the scaffold material can be mixed with one or more active agents to form a composition or compound and that it also can be freeze dried [¶ 0034, 0062]. Additionally, Dorweiler et al., a study focused on the effectiveness of Kerecis® Omega3 Wound matrix and its effect on complicated type wounds, teaches that a decellularized fish skin is an effective treatment option for wound care [Abstract, Conclusion].
Given this, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Sigurjonsson et la. where decellularized fish skin for treating wounds is combined with the additional teachings of Dorweiler et al. that also discloses the use of decellularized fish skin matrix is effective in treating complicated wounds further combined with the teachings of Hu et al. where they disclose a method for decellularizing fish skin for the purpose of treating wounds which discloses predetermined minimum and maximum sizes. Given this, there is a reasonable expectation of success that an artisan combining the teachings of Sigurjonsson et al. with the further teachings of both Dorweiler et al. and Hu et al. to develop decellularized fish skin with predetermined maximum and minimum sizes for treating complex wounds. Additionally, Sigurjonsson et al. further teaches that decellularized fish skin can be combined with “base materials” that include antibiotics, antiparasitics, anti-inflammatory agents, etc.
For Claim 2 where the predetermined size threshold size is greater than 1mm, Han teaches the animal skin can be mechanically cut or crushed into different sizes ranging from 0.3mm up to 2mm in size [Example five: preparing the product of different types, ¶ 1]
For Claim 3 where the predetermined size threshold of the fish skin particles is between 1mm to 1.39mm and 1.4mm to 2mm, Han teaches the animal skin can be mechanically cut or crushed into different sizes ranging from
0.3mm to 2mm in size [Id.]
For Claims 5 and 6 where the predetermined size threshold for fish skin particles is less than 1mm and between 1mm to 2mm respectively, Han teaches that animal skin be mechanically cut or crushed to produce sizes ranging from 0.3mm to 2mm [Id.]
Here, it would have been prima facie obvious to person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods taught by Sigurjonsson and Dorweiler et al. where researchers studied the effects of decellularized fish skin on complex wounds with the teachings of Han et al. where Han et al. provided an embodiment of their decellularized animal skin had been mechanically cut or crushed to produce sizes ranging from 0.3mm to 2mm. There is a reasonable expectation of success that combining the teachings of Dorweiler et al. with the teachings of Han et al., an Artisan would be able to mechanically cut or grind decellularized fish skin resulting in decellularized fish skin particles ranging from less than 1mm in size to 2mm in size as taught by Han et al. Further, MPEP 2144.05 citing In re Wetheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by prior art’ a prima facie case of obviousness exists”.
For claims 4 and 7 where the predetermined size threshold for the decellularized fish skin particles are between 2mm and 2.8mm and greater than 2mm, it would have prima facie obvious to a person skilled in the art before the filing of the claimed invention to modify the systems and methods of Sigurjonsson et al. and Dorweiler et al. where researchers studied the effects of decellularized fish skin on complex wounds with the teachings of Han et al. where Han et al. provided an embodiment of their decellularized animal skin had been mechanically cut or crushed to produce sizes ranging from 0.3mm to 2mm given the sizes are in close approximation as taught by Han et al. MPEP 2144.05 further states “… a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close [Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)]. Given this, there is a reasonable expectation of success that an Artisan would recognize the teachings of Han et al. combined with the teachings of Dorweiler et al. and Sigurjonsson et al. that decellularized fish skin particles could consist of particles greater than 2mm. This is especially true given that Hu et al. also discloses predetermined sizes that were cut forming both square and rectangular shapes.
For Claim 8 where the predetermined size threshold pertains to length or width, but not thickness, Han et al. teaches that the skin repairing material can be made into different specifications including preset size and thickness [Invention Theory 6)].
For Claim 9 where the predetermined size threshold of decellularized fish skin particles having the greatest dimension and minimum dimension within the predetermined size threshold, Han et al. teaches that sieves can be used in separating animal skin particles after whatever method of mechanical cutting or grounding and can then be sub-packaged depending on particle size [Example five: preparing the product of different types, ¶ 1].
For Claim 10 where a second predetermined percentage containing a different predetermined size of fish skin particles are used and are different from the first predetermined size of fish skin particles, Han et al. teaches that multiple particle sizes can by generated based on method of cutting and/or grinding allowing the particles sizes to be separated and packaged based on size [Id.].
Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Sigurjonsson et al. and Dorweiler et al. with the additional teachings of both Han and Hu et al. where Hu et al. disclosed predetermined sizes of a minimum and maximum nature with the additional teachings of with Han that further discloses mechanically cut pieces of decellularized animal tissue allowing an Artisan to separate the fish skin particles by size through multiple sieves with varying filter size. This would further allow an Artisan to separate based on size where the different sizes would comprise at least 75% of the specified size based on the size of the sieve filter. And given that Han et al. teaches multiple sizes, and depending on the method chosen for cutting the decellularized fish skin, an Artisan would further be able to choose secondary predetermined size thresholds based on the method used for grinding or cutting decellularized fish skin allowing a person of ordinary skill to mix and match the sizes according to need.
Regarding claim 11, Sigurjonsson et al. discloses a decellularized extracellular matrix derived from fish skin [Abstract] for purposes of treating wounds. Applicant’s claim further states that “the decellularized fish skin is obtained from mature and/or filletable sized fish”. Here, Sigurjonsson et al. teaches that the fish skin was removed from a fish fillet which also would imply a certain size and maturity [¶ 0044, 0066, 0088]. However, Sigurjonsson et al. does not disclose a predetermined percentage having a maximum and minimum size threshold. However, Hu et al. discloses a wound treatment comprising particles of decellularized fish skin with predetermined percentage of at least a first portion of the particles of decellularized fish skin have a greatest dimension within a predetermined size threshold and a minimum size threshold that is effective to preserve a matrix structure of the decellularized fish skin [Para starting with “Preferably, in the step (8), obtained by freeze”]. Lastly, Sigurjonsson et al. discloses that the scaffold material can be mixed with one or more active agents to form a composition or compound and that it also can be freeze dried [¶ 0034, 0062]. Additionally, Dorweiler et al., a study focused on the effectiveness of Kerecis® Omega3 Wound matrix and its effect on complicated type wounds, teaches that a decellularized fish skin is an effective treatment option for wound care [Abstract, Conclusion]. Han further teaches a wound treatment comprising particles of decellularized animal skin wherein a predetermined percentage of at least a first portion of the particles of decellularized animal skin have a greatest dimension within a predetermined size threshold maximum and a minimum size threshold that is effective to preserve a matrix structure of the decellularized animal skin and to promote cellular regenerative ingrowth into a wound [Example five: Preparing the product of different types ¶ 1, Invention content ¶ 1]
Lastly, Wound Care 101 teaches that collagen paste can be applied to a wound and that, depending on application, may require a secondary cover dressing [Formulations, How to Apply].
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the methods and systems of both Sigurjonsson et al. and Dorweiler et al. with the additional teachings of Hu et al. that discussed decellularized fish skin being mechanically cut into predetermined sizes and used for wound healing with the additional teachings of Han teaching the use of a decellularized animal skin, including ground decellularized animal skin particles and Wound Care 101 teaching collagen paste could be applied directly to the wound and that it would likely require a secondary dressing for covering but would depend on manufacture recommendations. Given this, there is a reasonable expectation of success that a person skilled in the art would combine the teachings of Sigurjonsson et al. with the additional teachings of Dorweiler et al. and Hu et al. given all three are directed at decellularized fish skin being used for treating various types of wounds with the further teachings of Han that discloses that decellularized animal tissue can be mechanically cut into predetermined maximum and minimum sizes with the routine teachings of Wound Care 101 where the wound is treated by spreading a composition directly onto the wound itself is then covered by an additional dressing.
For Claim 12 where the wound site is prepared for treatment and secured with a dressing, Central Infusion Alliance teaches that the wound should be assessed for type of wound, then cleaned, i.e. preparing wound bed for treatment, applying the necessary type of treatment based on wound type, including medications to the affected site, determining the type of dressing required, and finally, applying the requisite wound dressing.
For Claim 13 where the dressing is a non-adherent dressing comprising a synthetic non-woven or cotton woven dressing, Central Infusion Alliance teaches that, depending on wound type, dry bandages can be chosen that include gauze pads and rolled gauze [Wound Dressings].
For Claim 14 where the decellularized fish skin particles are applied in a manner that the particles conform to the shape of the wound, Dorweiler et al. teaches that the fish skin can be cut in a manner to mimic the shape of the wound bed [Fig. 4, Part E].
For Claim 15 where the decellularized fish skin particles are moistened prior to application, Central Infusion Alliance teaches that wet to dry types of dressings can be utilized where the gauze or cotton is soaked in saline before being placed on the wound [Wound Dressings, Wet-to-dry].
For Claim 16 where the wound bed is checked for up to two weeks after application of the decellularized fish skin particles, Central Infusion Alliance further teaches that it is important to monitor the dressing and change when necessary. Dorweiler et al. also teaches that dressings were changed at intervals of 2-3 days while leaving the decellularized fish skin in place [Methods ¶ 1].
Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the methods and systems of Sigurjonsson et al. and Dorweiler et al. discussing the use of decellularized fish skin with the additional teachings of Central Infusion Alliance and Han et al. where it is disclosed that decellularized animal skin, including ground decellularized animal skin particles, were applied to wounds to facilitate better healing where gauze and/or cotton dressings can be pre-soaked prior to being placed on the wound site. Additionally, Dorweiler et al. teaches that decellularized fish skin can be shaped to mimic the shape of the wound. Therefore, there is a reasonable expectation of success that a person of ordinary skill would recognize the teachings of Han et al. discussing mechanically cutting and/or crushing the decellularized animal tissue could be applied to decellularized fish skin as well in order to apply the decellularized fish skin particles in a way as to mimic the shape of the wound where the wound is essentially “packed” with the decellularized fish skin prior to covering with a gauze type dressing since. Additionally, there is a reasonable expectation that an Artisan would recognize the need to monitor the wound and dressing based on the teachings of both Dorweiler et al. and Central Infusion Alliance in order to avoid the possibility of infection setting in.
For claim 17 where the analysis is similar to the analysis for claims 11, 14, and 15 with the additional limitation where the decellularized fish skin define a substantially rectangular configuration, Hu et al. discloses both square and rectangular shapes [Para starting with “Preferably, in the step (8), obtained by freeze-drying”].
For claim 18 where the decellularized fish skin particles are provided in a package capable of receiving liquid, Otto teaches the use of a dual chamber system that allow mixing or reconstitution where the dry substance is in one chamber and the diluent or saline solution is in another chamber allowing for the drug or wound application to be mixed just prior to application [Packaging for the competitive market ¶ 1].
Claim 19 where the moistened particles form into a paste, Otto teaches that a diluent could be placed in one chamber with a dry substance placed in the other chamber. Once combined, it would allow the reconstituted substance, i.e. paste, to be directly inside ready for whatever application [Id.]. Furthermore, Wound Care Advisor also teaches that collagen powder can be reconstituted into a paste [Formulations].
Regarding claim 20 where the analysis is similar to claims 1, 14, 15, 17-19, with the addition that the method further comprises providing and applying a sheet-based decellularized fish skin scaffold to or over the wound bed, Doreweiler et al. discloses introducing as a roll into the wound channel and then covering the wound channel and matrix roll with an additional matrix [Fig. 7]. Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Dorweiler et al. where instead of “packing” the wound with a decellularized fish skin roll, an artisan would pack the wound with decellularized fish skin particles and/or paste and then cover the decellularized fish skin particles with an additional decellularized fish skin matrix providing an additional barrier prior to being covered with a gauze type dressing. Based on this, there is a reasonable expectation of success that a person of ordinary skill could combine the teachings of Sigurjonsson et al. and Dorweiler et al. with the additional teachings of Han where Han is being relied on for teaching that decellularized animal skin can be mechanically cut or crushed forming particles of a predetermined size and shape and can be used individually or be made into a paste with a base substance could reasonably be applied to decellularized fish skin for the same purpose for treating various wound types.
For Claim 22 where the second portion of maximum and minimum predetermined size threshold particles are different from the first portion of maximum and minimum predetermined size threshold particles, Han et al. teaches that animal skin particle size can be separated by use of a sieve allowing the animal skin particles to be packaged based on size [Example five: preparing the product of different types, ¶ 1].
Regarding claim 23, the same analysis applied to claim 1 is applicable to claim 23.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Sigurjonsson et al. and Dorweiler et al. where both are directed to decellularized fish skin being used in the treatment of complicated wounds and that the fish skin is originally derived from filletable fish with the additional teachings of Han et al., although directed at the use of non-human mammal tissue, teaches that decellularized non-human animal skin can be mechanically cut or crushed forming particles of a predetermined maximum and minimum size and then separating the fish skin particles using a sieve. Here, there is a reasonable expectation of success that an Artisan could combine the above-mentioned prior art references so that a person of ordinary skill in the art could use decellularized fish skin that has been mechanically cut or crushed forming particles could be applied to a wound where the particles are combined with a base substance, e.g. antibiotic, in a manner that would facilitate healing leading to cellular regenerative ingrowth into a wound.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument
Applicant argues that a person of ordinary skill in the art would not look to the Han reference given that Han is directed towards newborn or freshly weaned mammal skin, e.g. bovine or porcine, where the mammal skin is then decellularized, mechanically cut and/or crushed to form particles, and used in the treatment of wounds in humans. Applicant points out that “one of ordinary skill in the art would not be motivated to replace the tissue material obtained from recently born or weaned mammalian tissue with skin of fish”. Applicant further argues that there are significant differences in the structure of fish skin and that of skin tissue of piglets or weaned calves as taught in the Han reference, and that due to these differences, plus that fish skin belongs in a different “class of animals” that there would not have been a reasonable expectation of success to combine the teachings of Han and Dorweiler.
The examiner does not find Applicant’s argument persuasive.
First, the new rejection does not rely on Han to teach or suggest the use of fish skin as a source material. Rather, Han is relied upon for its teaching of mechanical processing of decellularized tissue, including cutting and crushing tissue into particles to be combined into such things as paste suitable for application. Han is directed to the form and processing of decellularized tissue, not the biological source itself.
The additional references cited independently teach the use of decellularized fish skin for wound healing applications. This establishes fish skin as a known and suitable scaffold material in the art. The combination does not require modification of Han to include fish tissue. However, the rejection is using Han’s known processing techniques that could easily be applied to decellularized fish skin given that mechanical cutting and crushing are known methods in the art of tissue engineering (as seen in Hu et al. reference). Based on this, a person of ordinary skill and ordinary creativity working in the field of tissue engineering would have understood that decellularized tissue, whether it was derived from a mammalian source or fish source, could function as extracellular matrix-based scaffold. Therefore, it would have been prima facie obvious to a person of ordinary skill in the art to apply the mechanical processing, as well as the predetermined sizing, to other known decellularized tissue sources, e.g. fish skin as taught by Sigurjonsson et la., Hu et al., and Dorweiler et al., in order to obtain predictable material forms that include particles and/or paste suitable for wound treatment.
With respect to the mature and/or filletable fish skin, as mentioned above in the new §103 rejection, Sigurjonsson et al. teaches that the fish skin was derived from filletable fish. This reasonably suggest the use of both mature and filletable fish. Furthermore, the selection of fish size suitable for harvesting usable skin would have been a routine consideration for a person of ordinary skill in the art and does not represent a non-obvious distinction.
Lastly, Applicant’s argument regarding a lack of reasonable expectation of success is unpersuasive. The processing steps disclosed in Han, as well as the predetermined sizes, represent physical manipulations that are not dependent on specific biological origin or tissue. Given that decellularized fish skin was already known in the art as a suitable scaffold for wound healing, a person of ordinary skill in the art would have reasonable expectation that such mechanical processing techniques and predetermined sizes could be successfully applied to fish derived material.
Conclusion
No claims allowed.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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