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 August 20, 2025, are entered.
Claims 1-11, 20, and 23 have been amended.
Claim Objections
In light of Applicant’s argument, the objections to claims 1, 10-12, 22, and 23 are withdrawn.
Double Patenting
The double patent objection to claim 7 is withdrawn.
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 is newly 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. Therefore the double patenting objection is maintained.
Response to Argument
Applicant’s argument of August 20, 2025, has been considered but is not found persuasive.
In short, Applicant’s argument is that for the claim 8 limitation the predetermined size threshold maximum pertains only to length and/or width of the decellularized fish skin. Clam 8’s limitation excludes thickness.
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. Therefore the double patenting objection is maintained.
Claim Rejections - 35 USC § 112
In light of the amendments, the rejections to claims 20 and 21 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 are withdrawn.
Claim Rejections - 35 USC § 112
In light of the amendments, the rejections to claims 2-7 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 are withdrawn.
Claim Rejections - 35 USC § 103
The rejections to Claims 1-10 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] are being maintained.
Han 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]
Han does not teach that the animal skin particles used is from fish skin.
However, 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].
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 Han when animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds. There is a reasonable expectation of success that combining the teachings of Han with the teachings of Dorweiler et al. would lead an Artisan to grind fish skin and then separate the fish skin particles using a sieve for purposes of separating the particle size. There is also a reasonable expectation that an Artisan would also recognize using the ground animal skin particles, i.e. fish skin particles, on a wound in a manner that would further facilitate healing.
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 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 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. that decellularized fish skin particles could consist of particles greater than 2mm.
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.].
It would have been prima facie obvious to a person of ordinary skill in the art before the filing of the claimed invention to modify the systems and methods of Han et al. where animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds where Han et al. also taught the use of sieves for purposes of separating the animal skin particles based on size and then packaging the animal skin particles according to size. With this method, it would also allow a person of ordinary skill to separate the particles based on upper and lower limits of the predetermined dimensions of the animal skin particles. Given this, there is a reasonable expectation of success that combining the teachings of Han et al. with the teachings of Dorweiller et al. would allow an Artisan to mechanically cut the decellularized fish skin and then separate the fish skin particles by size through multiple sieves with varying filter size allow. By sieving the fish skin and/or animal skin, an Artisan would further be able to separate the animal skin particles 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 a second predetermined size threshold based on the method used for grinding or cutting the fish skin allowing an Artisan to mix and match the sizes according to use.
Response to Argument
Applicant’s argument of August 20, 2025, has been considered but is not found persuasive.
Applicant’s argument contends: Han is particularly focused on the tissue material being obtained from mammalian sources, including bovine and porcine origin, or sheep, horses, camels, donkeys, rabbits, cat, or dog “that are just born” or that are newly weaned. (Han, p. 12 of English translation, paragraphs 4-7).
Han makes no mention of other possible sources of the tissue material than mammalian sources. And this is purposeful by Han, in that the animals from which the tissue material was recently or just born. Indeed, the is the stated grounds for success for the skin repair biomaterial. But the fish skin material of Dorweiler would clearly fall outside the tissue material of Han, in that the fish clearly cannot be recently born or weaned. So considering the teachings of Han as a whole, Applicant respectfully submits 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—of an entirely different animal class than Han’s mammals.
Moreover, as described by Dorweiler, there are significant differences in the structure of the fish skin of Dorweiler and that of tissue of piglets or weaned calves of Han. For example, Dorweiler describes that the fish skin have “microscopically larger pores” with the matrix compared with porcine or bovine matrices. Due to these differences, and due to fish skin being of a different class of animals different both from Han and different from the subject to be treated, Applicant respectfully submits that it remains to be shown that there would be a reasonable expectation of success to combine the teachings of Han and Dorweiler. (See Dorweiler, p. 546, right-hand column).
Because Han is particularly directed to just born or freshly weaned tissue material of mammalian origin, and because, as described by Dorweiler, there are significant structural differences between the tissue of bovine and porcine origin, Applicant respectfully submits that one of ordinary skill in the art would not be motivated to modify the teachings of Han in view of Dorweiler to arrive at the features of claim 1 as a whole. For at least these reason, an obviousness-based rejection of amended claim 1 remains to be established.
Here, as Applicant points out, Han et al. is directed towards neonatal or freshly weaned mammalian sources. However, Han more broadly describes preparation of decellularized animal skin tissue for wound repair. Han et al. further teaches generally the decellularizing, fragmenting the material into particle size, applying those particles to a wound bed, that includes packing the material into the wound cavity allowing the decellularized tissue particles to conform to the shape and depth of the wound. Based on this general concept, Han et al. discloses the general concept of using decellularized animal tissue matrices for wound healing applications. Similarly, Han et al. teaches that the dermis of young animals, in general, and human skin have a high degree of genetic homology and homologous transformability [Para starting with “First: According to the same or similar structure”].
Dorweiler et al. further discloses a marine omega-3 wound matrix for treatment of complicated wounds that is derived from Atlantic cod skin. Additionally, Dorweiler et al. also expressly acknowledges that the vast majority of commercially available dermal matrices are derived from bovine and porcine sources. Dorweiler et al. goes on to disclose decellularized fish skin matrix exhibits advantageous properties over traditional bovine and porcine tissue, including similarity to human skin and intact microstructure allowing dermal cell and capillary growth, as well as other properties such as inhibiting macrophage secretion of pro-inflammatory cytokines.
However, both references address a common problem, i.e. wound healing using decellularized animal tissue. Han et al. teaches the use of mammalian sources, while Dorweiler et al. identifies that mammalian sources dominate the art and introduce fish skin as a viable alternative with beneficial biological properties over and above the existing advantageous properties found in more traditional sources, e.g. bovine and porcine tissues. Furthermore, Dorweiler et al. provides clear reasoning for using decellularized fish skin in place of bovine/porcine tissue given the advantages that fish skin had over the existing decellularized animal tissue properties available for wound treatment. Therefore, a person of ordinary skill in the art would have been motivated to substitute Han et al.’s mammalian sources with Dorweiler et al.’s fish derived decellularized matrices with the expectation of achieving predictable wound healing results.
Additionally, both Han et al. and Dorweiler et al. teach the various preparation methods that include treating a wound site. Han et al. teaches fragmenting decellularized tissue into particles of defined dimensions and applying the composition to a wound, while Dorweiler et al. teaches that decellularized fish skin matrices can be applied while still being structurally intact.
Because of these reasons, it would have been prima facie obvious to a person of ordinary skill in the art at the time the claimed invention was filed given the teachings of both Han et al. and Dorweiler et al. would have been a predictable use of known elements to achieve the same purpose.
With respect to Applicant’s amendments to claims 1 wherein the decellularized fish skin is in a dry form, wet form, etc., Dorweiler et al. expressly teaches a decellularized fish skin that is hydrated and placed on the wound and covered [Fig. 4].
Because of the reasons stated above, the rejection to claims 1-10 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] are being maintained is maintained.
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 maintained.
Claims 11-16, 18-19, and 22 are rejected 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].
Han 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]
Han does not teach that the animal skin particles used is from fish skin.
However, 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 et al. does not teach applying the decellularized fish skin particles to a wound bed.
Han et al. does not teach covering the wound bed with a dressing.
Han does not teach that the animal skin particles used is from fish skin.
However, 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].
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 Han when animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds. There is a reasonable expectation of success that combining the teachings of Han with the teachings of Dorweiler et al. would lead an Artisan to grind fish skin and then separate the fish skin particles using a sieve for purposes of separating the particle size. There is also a reasonable expectation that an Artisan would also recognize using the ground animal skin particles, i.e. fish skin particles, on a wound in a manner that would further facilitate healing.
For Claim 11 where the decellularized fish skin particles are applied to the wound bed and then covered with a dressing, 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].
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 taught by Han et al. and Dorweiler et al. where Han et al. taught the use of a decellularized animal skin, including ground decellularized animal skin particles, to be applied various wounds to facilitate better healing with Dorweiler et al. that taught decellularized fish skin could be applied to complex wounds in order to promote healing with the teachings of Wound Care 101 that taught that 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 combining the teachings if Han et al. and Dorweiler et al. with the teachings of Wound Care 101 an Artisan would recognize the need for a secondary dressing for covering the decellularized fish skin particles after application to a wound site.
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].
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of claimed invention to modify the systems and methods of taught by Han et al. and Dorweiler et al. where Han et al. taught the use of a decellularized animal skin, including ground decellularized animal skin particles, to be applied various wounds to facilitate better healing with Dorweiler et al. that taught decellularized fish skin could be applied to complex wounds in order to promote healing with the teachings of Central Infusion Alliance that teaches the necessary steps in prepping an open wound with how to decide on proper dressing depending on wound type, including using dry gauze which can be non-adherent, and then securing the non-adherent gauze with medical tape [Wound Dressings]. There is a reasonable expectation of success that combining the teachings of Han et al. and Dorweiler et al. with the teachings of Central Infusion Alliance for the purposes of prepping the wound site, to include cleaning, and then applying a non-adherent gauze dressing.
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 systems and methods of Han et al. and Dorweiler et al. where Han et al. taught the use of a decellularized animal skin, including ground decellularized animal skin particles, to be applied various wounds to facilitate better healing with Dorweiler et al. that taught decellularized fish skin could be applied to complex wounds in order to promote healing with the teachings of Central Infusion Alliance where gauze or cotton 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 would have been a reasonable expectation of success to combine the teachings of Han et al. and Dorweiler et al. with the teachings of Central Infusion Alliance in a manner to allow an Artisan to essentially “pack” the wound site with the moistened decellularized fish skin particles prior to covering with a gauze type dressing. 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.
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].
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 Han et al. and Dorweiler et al. where Han et al. taught the use of a decellularized animal skin, including ground decellularized animal skin particles, to be applied various wounds to facilitate better healing with Dorweiler et al. that taught decellularized fish skin could be applied to complex wounds in order to promote healing with the teachings of Otto and Wound Care Advisor where Otto discussed the use of a dual chamber vial allowing a dry substance and diluent to be placed in separate chambers that could then be reconstituted with the teachings of Wound Care Advisor that teaches the collagen that was derived from animal skin or organs exists in a powder and/or paste. There is a reasonable expectation of success to combine the teachings of Han et al. and Dorweiler et al. with the teachings of both Otto and Wound Care Advisor where it would be feasible to place the decellularized fish skin particles in a package capable of receiving a liquid in order to mix the dry fish skin particles with a diluent for reconstituting into a paste.
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].
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 Han when animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds given that Han et al. teaches that decellularized animal skin can be ground into multiple sized particles through mechanical means, separated by using sieves, and then packaged according to size. Given this, there is a reasonable expectation of success that an Artisan would be able to combine the teachings of Han et al. with the teachings of Dorweiler et al. where the decellularized fish skin particles would be separated through the use of sieves in a manner that an Artisan could further separate the fish skin particles based on predetermined threshold sized based on first and second portions.
Response to Argument
Applicant’s argument of August 20, 2025, has been considered but is not found persuasive.
Applicant’s argument contends: Han is again the primary reference relied on in the rejection of claim 11. (Office Action, pp. 16-17). Dorweiler, Wound Care Advisor, Central Infusion Alliance, and Otto are relied on in the rejection of claim 11. But for reasons similar to those provided above, Dorweiler, Wound Care Advisor, Central Infusion Alliance, and Otto each individually and collectively fail to remedy the deficiencies of Han.
As stated in the maintained rejection for claims 1-10, Han is particularly directed to “just born” or freshly weaned tissue material of mammalian origin, and because, as described by Dorweiler, there are significant structural differences between the tissue of bovine and porcine origin, Applicant respectfully submits that one of ordinary skill in the art would not be motivated to modify the teachings of Han in view of Dorweiler to arrive at the features of claim 11 as a whole. Wound Care Advisor, Central Infusion Alliance, and Otto are relied on in the rejection of claim 11. But Wound Care Advisor, Central Infusion Alliance, and Otto fail to remedy the deficiencies of Han and Dorweiler.
Here, as Applicant points out, Han et al. is directed towards neonatal or freshly weaned mammalian sources. However, Han more broadly describes preparation of decellularized animal skin tissue for wound repair. Han et al. further teaches generally the decellularizing, fragmenting the material into particle size, applying those particles to a wound bed, that includes packing the material into the wound cavity allowing the decellularized tissue particles to conform to the shape and depth of the wound. Based on this general concept, Han et al. discloses the general concept of using decellularized animal tissue matrices for wound healing applications. Similarly, Han et al. teaches that the dermis of young animals, in general, and human skin have a high degree of genetic homology and homologous transformability [Para starting with “First: According to the same or similar structure”].
Dorweiler et al. further discloses a marine omega-3 wound matrix for treatment of complicated wounds that is derived from Atlantic cod skin. Additionally, Dorweiler et al. also expressly acknowledges that the vast majority of commercially available dermal matrices are derived from bovine and porcine sources. Dorweiler et al. goes on to disclose decellularized fish skin matrix exhibits advantageous properties over traditional bovine and porcine tissue, including similarity to human skin and intact microstructure allowing dermal cell and capillary growth, as well as other properties such as inhibiting macrophage secretion of pro-inflammatory cytokines.
However, both references address a common problem, i.e. wound healing using decellularized animal tissue. Han et al. teaches the use of mammalian sources, while Dorweiler et al. identifies that mammalian sources dominate the art and introduce fish skin as a viable alternative with beneficial biological properties over and above the existing advantageous properties found in more traditional sources, e.g. bovine and porcine tissues. Furthermore, Dorweiler et al. provides clear reasoning for using decellularized fish skin in place of bovine/porcine tissue given the advantages that fish skin had over the existing decellularized animal tissue properties available for wound treatment. Therefore, a person of ordinary skill in the art would have been motivated to substitute Han et al.’s mammalian sources with Dorweiler et al.’s fish derived decellularized matrices with the expectation of achieving predictable wound healing results.
Additionally, both Han et al. and Dorweiler et al. teach the various preparation methods that include treating a wound site. Han et al. teaches fragmenting decellularized tissue into particles of defined dimensions and applying the composition to a wound, while Dorweiler et al. teaches that decellularized fish skin matrices can be applied while still being structurally intact.
Because of these reasons, it would have been prima facie obvious to a person of ordinary skill in the art at the time the claimed invention was filed given the teachings of both Han et al. and Dorweiler et al. would have been a predictable use of known elements to achieve the same purpose.
With respect to Applicant’s amendments to claims 11 wherein the decellularized fish skin is in a dry form, wet form, etc., Dorweiler et al. expressly teaches a decellularized fish skin that is hydrated and placed on the wound and covered [Fig. 4].
Because of the reasons stated above, 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] are being maintained is maintained.
Claim Rejections - 35 USC § 103
In light of the amendment, the rejection to claim 23 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] is being maintained.
Han et al. teaches the use of a decellularized animal skin that is shredded or ground from one or more sheets of decellularized animal skin into particles of predetermined size based on method chosen for mechanically cutting or grinding the animal skin which results in multiple sizes ranging from 0.3mm to 2mm.
Han does not teach that the animal skin particles used is from fish skin.
However, 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].
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 Han when animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds. There is a reasonable expectation of success that combining the teachings of Han with the teachings of Dorweiler et al. would lead an Artisan to grind fish skin and then separate the fish skin particles using a sieve for purposes of separating the particle size. There is also a reasonable expectation that an Artisan would also recognize using the ground animal skin particles, i.e. fish skin particles, on a wound in a manner that would further facilitate healing leading to cellular regenerative ingrowth into a wound.
Response to Argument
Applicant’s argument of August 20, 2025, has been considered but is not found persuasive.
Applicant’s argument contends for the same issues raised in the argument for Claim 1.
For similar reasons to the rejection under 35 U.S.C. 103 being maintained for claims 1-10 and claims 11-16, 18-19, and 22, the rejection to claim 23 is being maintained.
Additionally, With respect to Applicant’s amendments to claims 23 wherein the decellularized fish skin is in a dry form, wet form, etc., Dorweiler et al. expressly teaches a decellularized fish skin that is hydrated and placed on the wound and covered [Fig. 4].
Because of the reasons similarly stated in the response to argument for claims 1-10 and Claims 11-16, 18-19, and 22, the rejection to claim 23 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] is being maintained is maintained.
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 3 and 21 is newly 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “between 1mm…1.99 mm, and the claim also recites “…1.39 mm…1.4 mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 21 recites the limitation "the particles of decellularized fish skin" in Lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 23 is newly rejected 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].
Han does not teach that the animal skin particles used is from fish skin.
However, 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 et al. does not teach applying the decellularized fish skin particles to a wound bed.
Han et al. does not teach covering the wound bed with a dressing.
Han does not teach that the animal skin particles used is from fish skin.
However, 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].
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 Han when animal skin material is used in healing acute and chronic skin wounds with the teachings of Dorweiler et al. where researchers studied the effects of fish skin on complex wounds. There is a reasonable expectation of success that combining the teachings of Han with the teachings of Dorweiler et al. would lead an Artisan to grind fish skin and then separate the fish skin particles using a sieve for purposes of separating the particle size. There is also a reasonable expectation that an Artisan would also recognize using the ground animal skin particles, i.e. fish skin particles, on a wound in a manner that would further facilitate healing.
For Claim 11 where the decellularized fish skin particles are applied to the wound bed and then covered with a dressing, 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].
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 taught by Han et al. and Dorweiler et al. where Han et al. taught the use of a decellularized animal skin, including ground decellularized animal skin particles, to be applied various wounds to facilitate better healing with Dorweiler et al. that taught decellularized fish skin could be applied to complex wounds in order to promote healing with the teachings of Wound Care 101 that taught that 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 combining the teachings if Han et al. and Dorweiler et al. with the teachings of Wound Care 101 an Artisan would recognize the need for a secondary dressing for covering the decellularized fish skin particles after application to a wound site.
For claim 21 where the wound treatment of claim 11 comprises applying a sheet-based decellularized fish skin scaffold to or over the wound bed, Dorweiler et al. teaches applying sheet-based decellularized fish skin scaffold over difficult to treat open wounds [Fig. 4]. Therefore, it would have been prima facie obvious to a person of ordinary skill prior to the filing of the claimed invention to modify the systems and methods of Han et al. with the additional teachings of Dorweiler et al. to place a decellularized sheet of fish skin over an open wound in order to promote healing given the healing properties disclosed in Dorweiler et al.
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.
Conclusion
No Claims 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 an