DETAILED ACTION
This action is in response to the Applicant Remarks and Response to Election/Restriction received on December 18, 2025. Claims 1-16, 18, 20-31 are pending with claims 17 and 19 canceled, claims 1, 4, 11, 15, 16, 18, and 20-22 currently amended, claims 28-31 newly presented, and claims 16, 18, and 20-27 withdrawn from consideration.
In response to the restriction requirement, the Applicant has elected Group I, drawn to the three-dimensional anatomical model of claims 1-15.
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 .
Election/Restrictions
Applicant's election with traverse of a three-dimensional anatomical model in the reply filed on December 18, 2025 is acknowledged. The traversal is on the grounds that, “it would not be an undue burden for the Examiner to search and consider the invention of Groups II and III along with the elected invention of Group I” (Remarks, page 13, para 3). This is not found persuasive because, as recited within MPEP 808.02, serious search burden may be shown via a demonstration that separate classifications exist within the identified groups. As recited in the Requirement for Restriction/Election, the identified groups are as follows:
Claims 1-15, drawn to a three-dimensional anatomical model (i.e., Product), classified in G09B 23/00.
Claims 16-22, drawn to a method of making an anatomical model (i.e., Process of making a Product), classified in B29C 33/00 or B33Y 10/00.
Claims 23-27, drawn to a method of simulating a surgical treatment plan (i.e., Process of using a Product), classified in A61B 34/10.
This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 28 is objected to because of the following informality: the claim places the percentage symbol (%) as preceding the number in reciting, “the carbonyl containing compound is present at a concentration 1% to %25 by weight”. The following recitation, alongside typical formatting conventions, presents percentage symbols after the number: “the amine containing compound is present at a concentration 1% to 25% by weight”; therefore, for the purposes of examination, the Examiner assumes the Applicant intended the prior recitation to include the percentage symbol after the number.
Appropriate correction is required.
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 1-15 and 28-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites (emphasis added), “dry heat hydrogel composition having a cooling element optionally injected, embedded, or adjacent to said composition, wherein said hydrogel composition…”. The claim limitation is rendered indefinite as it is unclear to the extent at which the claim limitations are intended by the Applicant to be optional. Specifically, the term “wherein” functionally links the clause that follows the term (e.g., “…said hydrogel composition …” ) to the preceding structure (e.g., “…optionally injected, embedded, or adjacent to said composition…”), which is indefinite as it creates an ambiguity whether the subsequent “wherein” clause sets forth a required, structural limitation, or is merely an optional, descriptive phrase.
For the purposes of examination, the Examiner interprets the limitation, “wherein said hydrogel composition” and the remaining limitations that follow within claim 1 as optional.
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 6 recites the broad recitation, “wherein the mean degree of polymerization of the base polymer is 500 to 3000”, and the claim also recites, “more preferably 1000 to 2000”, and, “more preferably 1500 to 2000”, which are the narrower statements of the range/limitation. The claim is 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.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 28, the claim is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for ambiguous language that causes question or doubt as to whether the specific features introduced are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The subject claim recites a list of alternatives for a carbonyl-containing compound, including amine and non-amine members. Subsequently, the claim imposes limitations requiring an amine; therefore, it is unclear whether these limitations apply unconditionally or solely in the presence of the amine alternatives.
For the purposes of examination, the Examiner interprets the limitations that follow the optional list as only being required in the presence of an amine.
Regarding dependent claims 2-5, 8-15, and 29-31, the claims are rejected by virtue of their dependencies on prior claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-7, 10-15, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohta [US20200354557A1].
Regarding claim 1 (Currently Amended), Ohta discloses:
A three-dimensional anatomical model configured to represent a biological tissue, organ or anatomical region (Ohta, Abstract, “…tissue model…”),
said model comprised of a temperature-sensitive, tissue-mimicking, dry heat hydrogel composition having a cooling element (Ohta, [0013], “FIG. 1 is a chemical formula representing a structure of polyvinyl alcohol constituting a hydrogel composition of the present invention.”)
optionally injected, embedded, or adjacent to said composition (Ohta, [0105], Preparation of Sample of Hydrogel Composition, “the polyvinyl alcohol solution was injected into a mold, and the mold into which the polyvinyl alcohol solution was injected…”), wherein said hydrogel composition:
(a) is subjected to one or more curing methods so as to induce a physical, chemical, or mechanical change selected from the group consisting of:
crosslinking (Ohta, [0036], “FIG. 3 is a schematic view illustrating a part of the crosslink region 14 by a hydrogen bond of the hydrogel composition 10 of the present invention.”), water content (Ohta, [0027], “The gel composition refers to a composition in which, in specific atoms or atom groups contained in chain-like polymer compounds, the polymer compounds are partially bonded to form a three-dimensional network structure and which contains a low-molecular-weight solvent, which is confined to lose fluidity, inside the three-dimensional network structure.”), phase separation (Ohta, [0045], “As the content of increase, the polyvinyl alcohol 1 is easily crystallized.”), porosity modification (Ohta, [0073], “it is possible to reduce air bubbles generated in the solution of the polyvinyl alcohol 1 discharged into the mold of the tissue model.”), incorporation of precursors for browning reaction (Ohta, [0061], “The amount of the colorant added to the hydrogel composition 10 is not limited, but for example, can be set to 1 wt % or less. The colorant is not limited, but for example, a dye such as a black dye, a magenta dye, a cyan dye, and a yellow dye, a pigment such as a red or magenta pigment, a blue or cyan pigment, a green pigment, a yellow pigment, and a black pigment, or the like is used.”), and structural stabilization (Ohta, [0060], “Also, to the hydrogel composition 10 of the present invention, as necessary, a small amount of an antiseptic for providing storage stability can be added.”), and
(b) undergoes a life-like transition upon exposure to thermal or non-thermal treatment, from a native first state into a visibly distinguishable second state that is analogous to a transition that arises in response to said same thermal or non-thermal treatment in the biological tissue organ, or anatomical region being represented further wherein said transition is selected from the group consisting of:
Discoloration (Ohta, [0061], “Further, to the hydrogel composition 10 of the present invention, as necessary, a small amount of a colorant can be added in order to replicate color of an actual soft tissue.”), denaturation, coagulation, carbonization, vaporization, cavitation, char formation, liquefactionliquefication, softening, melting full or partial structural collapse, and vessel sealing.
Regarding claim 2 (Original), Ohta discloses:
The anatomical model of claim 1, wherein said model includes additional structural elements designed to replicate, represent, or simulate the geometry, form, mechanical properties, or functional characteristics of said biological tissue, organ or anatomical region (Ohta, [0079], “Further, in the model of bone, by adding polyvinyl alcohol, a close contact state between the bone and the body soft tissue inside the living body can be replicated.”).
Regarding claim 3 (Original), Ohta discloses:
The anatomical model of claim 2, wherein said additional structural elements are selected from the group consisting of:
hooks, bases, guides, spacers, substrates, heat sinks, wires, cooling elements, tubes, markers, meshes, frames, rods, cages, and implants (Ohta, [0079], “For example, a model of bone can be manufactured by adding sawdust and polyvinyl alcohol to an acrylic resin. In the model of bone, the hardness of bone can be replicated according to an amount of the acrylic resin used, and the tactile sensation of bone can be replicated according to a particle size of the sawdust. Further, in the model of bone, by adding polyvinyl alcohol, a close contact state between the bone and the body soft tissue inside the living body can be replicated.”).
Regarding claim 4 (Currently Amended), Ohta discloses:
The anatomical model of claim 1, wherein said hydrogel composition is fabricated from a polymeric matrix comprised of a base polymer, a binder polymer (Ohta, [0009], “A hydrogel composition according to the present invention is used for a tissue model and comprises a polyvinyl alcohol and a pseudoplastic compound.” and Ohta, [0046], “a pseudoplastic compound, that is, a compound having pseudoplasticity is used as a thickener that improves the solubility of the polyvinyl alcohol 1 by reducing the content of the polyvinyl alcohol 1 and maintains the viscosity of the hydrogel composition 10.”), and a carbonyl-containing compound (Ohta, [0021], “The functional group 3 has m hydrophobic acetate groups 4 (—COOCH3), one of which is linked to one first hydrocarbon skeleton part 2a, and n hydrophilic hydroxyl groups 5 (—OH), one of which is linked to one second hydrocarbon skeleton part 2b.”),
wherein said polymeric matrix is cross-linked and cured to solid form (Ohta, [0075], “By the freezing treatment, the solution of the polyvinyl alcohol 1 in the mold of the tissue model is gelled into polyvinyl alcohol hydrogel including a polyvinyl alcohol resin of a three-dimensional network structure having a plurality of polymer chains and cross-linked regions connecting the plurality of polymer chains to each other”).
Regarding claim 5 (Original), Ohta discloses:
The anatomical model of claim 4, wherein said base polymer is selected from the group consisting of:
optionally modified polyvinyl alcohols (PVA), polyethylene glycols, polyacrylamides, chitosan, cellulose, starch, alginate, agar, collagen, polyaniline (See citations of claim 4.).
Regarding claim 6 (Original), Ohta discloses:
The anatomical model of claim 5, wherein the mean degree of polymerization of the base polymer is 500 to 3000, more preferably 1000 to 2000, more preferably 1500 to 2000 (Ohta, [0050], “In the case of manufacturing a soft tissue model, polyvinyl alcohol 1 having a degree of polymerization of 1000 to 2000 is used.”).
Regarding claim 7 (Previously Presented), Ohta discloses:
The anatomical model of claim 4, wherein said binder polymer is capable of forming with said base polymer a network in a gel matrix,
further wherein said binder polymer is selected from the group consisting of:
natural polysaccharides including carboxymethyl cellulose (CMC), sodium alginate, xanthan gum, guar gum, dextran, starch derivatives, chitosan, and hyaluronic acid; protein source like egg white or protein derivatives including gelatin, gelatin methacryloyl (GelMA); synthetic water-soluble polymers including PVA, polyacrylic acid (PAA), polyacrylamide, PEG, poly(ethylene oxide) (PEO), polyvinylpyrrolidone (PVP), polyethyleneimine (PEI), and poly(N-isopropylacrylamide) (PNIPA); hybrid binders combining polymers and crosslinkers such as tannic acid, citric acid-glycerol; and polymer blends including PAA-PVA and alginate-polyacrylamide (Ohta, [0046], “The pseudoplasticity refers to the property that the viscosity of a fluid decreases when pressure or the like is applied to the fluid. The pseudoplastic compounds is selected, for example, from the group consisting of xanthan gum, ultraxanthan gum, guar gum, welan gum, diutan gum, tamarind seed gum, locust bean gum, rhamzan gum, carrageenan, pullulan, curdlan, hydroxyethylcellulose, hydroxypropylethylcellulose, methylcellulose, acrylics, and salts and derivatives thereof, and combinations thereof.”).
Regarding claim 10 (Original), Ohta discloses:
The anatomical model of claim 4, wherein said hydrogel composition further includes one or more solid fillers or fibers selected from the group consisting of:
natural fibers including cotton, linen, wool, silk, hemp, jute, ramie, and kapok; regenerated fibers including rayon and viscose; animal-derived fibers including keratin and fibroin; plant-based nanofibers including cellulose nanofibers, nanocellulose, chitin nanofibers, and bamboo fibers; synthetic fibers including nylon, polyester, polypropylene, polyethylene, aramid fiber, acrylic fiber, glass fiber, carbon fiber, ceramic fiber, and basalt fiber; and particulate fillers including cellulose powder, microcrystalline cellulose, starch granules, silica, talc, titanium dioxide, calcium carbonate, kaolin, bentonite, montmorillonite, sepiolite, mica, alumina, hydroxyapatite, graphene, and carbon nanotubes (Ohta, [0062], “As the water-swellable layered clay mineral, although not limited, for example, water swellable smectite such as water swellable Hectorite, water swellable montmorillonite, and water swellable saponite, and water swellable mica such as water swellable synthetic mica can be used.”).
Regarding claim 11 (Currently Amended), Ohta discloses:
The anatomical model of claim 4, wherein polymeric matrix includes a carbonyl-containing compound selected from the group consisting of
monosaccharides including glucose, fructose, galactose, mannose, ribose, xylose, arabinose, erythrose, sedoheptulose, ribulose, and tagatose; disaccharides including lactose, maltose, sucrose, and cellobiose; oligosaccharides including raffinose and trehalose; sugar alcohols including mannitol and sorbitol; deoxy sugars including fucose and rhamnose; amino sugars including glucosamine, galactosamine, and N-acetylglucosamine; sugar acids including gluconic acid, glucuronic acid, galacturonic acid, and iduronic acid; and sugar derivatives modified by phosphorylation, sulfation, acetylation, methylation, or other chemical modifications (See citations of claim 7.).
Regarding claim 12 (Original), Ohta discloses:
The anatomical model of claim 4, wherein said polymeric matrix is ionically or covalently cross-linked by means of a physical or chemical process (Ohta, [0059], “Incidentally, to the hydrogel composition 10 of the present invention, as necessary, a small amount of a gelling agent can be added as an adjuvant for physical crosslinking by a hydrogen bond. The gelling agent is not limited, but for example, borates such as sodium tetraborate are used” and Ohta, [0036], “Further, as illustrated in FIG. 3, in the present invention, the crosslink region 14 of the hydrogel composition 10 is physically crosslinked by a hydrogen bond of the hydroxyl group 5 that is the functional group 3 of the polyvinyl alcohol 1.”).
Regarding claim 13 (Original), Ohta discloses:
The anatomical model of claim 12, wherein said chemical curing process encompasses the use of ionic curing agents, natural curing agents, covalent curing agents, photo-initiated curing agents, and enzymatic curing agents (See the citations of claim 12.).
Regarding claim 14 (Original), Ohta discloses:
The anatomical model of claim 13, wherein said physical curing process includes
UV, heat, freeze-thaw cycling, ionic gelation agents, and hydrogen bonding enhancers (Ohta, [0075], “Further, the number of times of the freezing treatment of the mold of the tissue model can be plural times, also taking physical properties of the hydrogel composition 10 into consideration.” Also, see the citations of claims 4 and 12.).
Regarding claim 15 (Currently Amended), Ohta discloses:
The anatomical model of claim 1, wherein said biological tissue, organ or anatomical region is selected from the group consisting of:
healthy or unhealthy skin, muscle, vasculature, urethra, bladder, prostate, bone, cartilage, fat, nerve, tumor, cyst, polyp, ribs, stomach, abdominal wall, diaphragm, gallbladder, intestines, bone marrow, liver, eye, vascular bed, aorta, inferior vena cava, superior vena cava, pulmonary arteries, pulmonary veins, portal vein, hepatic veins, hepatic artery, renal arteries, renal veins, femoral arteries, femoral veins, iliac arteries, iliac veins, mesenteric arteries, mesenteric veins, splenic artery, splenic vein, carotid arteries, vertebral arteries, jugular veins, subclavian arteries, subclavian veins, brachiocephalic artery, brachiocephalic vein, coronary arteries, coronary sinus, left atrium, right atrium, left ventricle, right ventricle, mitral isthmus, atrial appendages, papillary muscles, pulmonary trunk, bronchial arteries, segmental and lobar pulmonary vessels, trachea, mainstem bronchi, cerebrospinal fluid spaces, intervertebral disc, nucleus pulposus, annulus fibrosis, lateral ventricles, third ventricle, fourth ventricle, cerebral aqueduct, central canal of the spinal cord, basilar artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, internal carotid arteries, arteries and veins of the Circle of Willis, spinal venous plexus, vertebral venous plexus, cancellous bone, liver parenchyma, kidney cortex, kidney medulla, adrenal glands, pancreas, spleen, uterus, vagina, ureter, seminal vesicles, ovaries, testicles, pelvic venous plexuses, and rectum (Ohta, [0049], “Incidentally, in the following description, “the soft tissue” means a tissue excluding a hard tissue such as bone, tooth, or cartilage unless specified otherwise. The soft tissue is not limited, but for example, includes a vascularized tissue, an oral soft tissue such as oral mucosa, a nasal soft tissue such as nasal mucosa, an aural soft tissue such as aural mucosa, a visceral tissue of brain, heart, liver, pancreas, spleen, kidney, bladder, lung, stomach, small intestine, large intestine, uterus, esophagus, or the like, a dermal tissue, a muscle tissue, an eyeball tissue, and the like. In addition, “the body hard tissue” means a hard tissue such as bone, tooth, or cartilage.”).
Regarding claim 29 (New), Ohta discloses:
The anatomical model of claim 1, wherein said thermal or non-thermal treatment generates a plurality of temperature-sensitive layers in said model,
further wherein a series of treatment activations allows for gradual or incremental formation of a treatment field profile analogous to that arising in said represented biological tissue, organ or anatomical region in response to said same series of activations (Ohta, [0063], “When the water-swellable layered clay mineral is added to the hydrogel composition 10, physical properties such as elasticity of the model of the organ, that is, mechanical strength can be made similar to mechanical strength of an actual organ.”).
Regarding claim 30 (New), Ohta discloses:
The anatomical model of claim 1, wherein said hydrogel composition undergoes said life-like transition upon exposure to a thermal treatment involving working temperatures of between 40 and 150°C while maintaining structural integrity (Ohta, [0105], “The polyvinyl alcohol solution produced by the method shown in Example 1 was cooled to 40 degrees C under a thermoneutral environment.”).
Regarding claim 31 (New), Ohta discloses:
The anatomical model of claim 1, wherein said model includes a cooling element capable of dissipating heat and modulating the response of said hydrogel composition to said thermal treatment exposure,
further wherein said cooling element is in the form of a solid structure or a liquid or gaseous injectate and is selected from the group consisting of:
a static layer of inert gas or liquid; a spray or stream of gas, liquid, gel, or aerosol particles; an ice layer; a phase change liquid which turns into a gas upon exposure to said thermal treatment, a thermally conductive material; a circulating cooling fluid; an inflatable element; a thermally insulating yet poorly conductive material; and combinations thereof (Ohta, [0074], “A material for the mold of the tissue model is not particularly limited as long as it is a material with which the hydrogel composition 10 can be produced into a shape of a tissue, but for example, a material such as a silicone resin, quartz glass, a metal, gypsum, wax, or a synthetic resin can be used. For example, in the case of a metal such as brass, stainless steel, nickel titanium, or alumina as the material for the mold of the tissue, thermal conduction at the time of a freezing treatment can be improved and the freezing time can be decreased.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 8, 9, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ohta and Bender [US20150045507A1].
Regarding claim 8 (Original), Ohta discloses:
The anatomical model of claim 7, wherein hydrogel composition comprises a viscoelastic polymeric matrix of PVA (Ohta, [0117], “Further, in the dynamic viscoelasticity G′ of the hydrogel composition, errors of at least ±10% are considered to occur from errors among products such as the content of salts in the xanthan gum and measurement errors such as a measurement apparatus.”).
Ohta does not disclose a peptide polymer.
Bender, however, discloses:
A peptide polymer (Bender, [0064], “In a preferred embodiment the backbone of the electrophilically activated cross-linking agent is selected from the group of polymers consisting of polyesters, polyolefins, polystyrenes, polycarbonates, polyamides, polyacetates, poly(alkylene oxalates), polyanhydrides, poly iminocarbonates, polyoxaesters, polyorthoesters, polyphosphazenes, polyphosphoesters, polyethers, polyetheresters, polyacrylamides, polyimides, polyphenylenes, polysilanes, polysiloxanes, polybenzimidazoles, polybenzothiazoles, polysulfides, polyesteramides, polyetheramides, polyamines, polyetheramines, polyarylene vinylenes, polyether ketones, polyurethanes, polysulfones, polyacrylates, polymethacrylates, polysaccharides, glycosaminoglycans, polypeptides, and combinations thereof.”).
It would have been obvious to one of ordinary still in the art before the effective filing date of the claimed invention to include in the tissue model of Ohta the use of a peptide polymer as taught by Bender since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 9 (Original), Ohta/Bender discloses:
The anatomical model of claim 8, wherein said peptide polymer is collagen or albumin (Bender, [0065], “the backbone of the electrophilically activated cross-linking agent is selected from the group of polymers consisting of agar, starch, pullulan, inulin, levan, silk, fibronectin, pectin, cellulose (e.g. carboxymethyl cellulose, hydroxyethyl cellulose, oxidized cellulose or methyl cellulose), collagen, elastin, gelatin, albumin, fibrin, fibrinogen, dextran, methyl cellulose, hyaluronic acid, chondroitin sulfate, keratosulfate, heparan sulfate, dermatan sulfate, alginic acid, chitosan, chitin, heparin, polyvinyl alcohol, polyethylene glycol and combinations thereof.”).
Regarding claim 28 (New), Ohta discloses:
The anatomical model of claim 5, wherein:
said binder polymer (See the citations of claims 4 and 7.); and
said polymeric matrix includes a carbonyl-containing compound selected from among:
a monosaccharide selected from among glucose, fructose, galactose, mannose, ribose, xylose, arabinose, erythrose, sedoheptulose, ribulose, and tagatose; a disaccharide selected from among lactose, maltose, sucrose, and cellobiose; an oligosaccharide selected from among raffinose and trehalose; a sugar alcohol selected from among mannitol and sorbitol; a deoxy sugar selected from among fucose and rhamnose; an amino sugar selected from among glucosamine, galactosamine, and N-acetylglucosamine; a sugar acid selected from among gluconic acid, glucuronic acid, galacturonic acid, and iduronic acid; and a sugar derivative modified by phosphorylation, sulfation, acetylation, methylation, or other chemical modification (See citations in claims 7 and 8.);
further wherein:
the molar ratio of the carbonyl containing compound to the amine containing compound is selected within a range 0.3:1 to 5:1;
the carbonyl containing compound and the amine containing compound is dispersed within a hydrogel matrix comprising a polymer with particle size 3000 pm or less; and
the carbonyl containing compound is present at a concentration 1% to {{%}}25% by weight (Ohta, Table 1) and the amine containing compound is present at a concentration 1% to 25% by weight.
Ohta does not disclose one or more protein or protein derivatives from egg white, gelatin, or gelatin methacryloyl (GelMA).
Bender, however, discloses:
one or more protein or protein derivatives from egg white, gelatin, or gelatin methacryloyl (GelMA) (Bender, [0065], “the backbone of the electrophilically activated cross-linking agent is selected from the group of polymers consisting of agar, starch, pullulan, inulin, levan, silk, fibronectin, pectin, cellulose (e.g. carboxymethyl cellulose, hydroxyethyl cellulose, oxidized cellulose or methyl cellulose), collagen, elastin, gelatin, albumin, fibrin, fibrinogen, dextran, methyl cellulose, hyaluronic acid, chondroitin sulfate, keratosulfate, heparan sulfate, dermatan sulfate, alginic acid, chitosan, chitin, heparin, polyvinyl alcohol, polyethylene glycol and combinations thereof.”).
It would have been obvious to one of ordinary still in the art before the effective filing date of the claimed invention to include in the tissue model of Ohta the use of a peptide polymer as taught by Bender since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY JOSEPH POLLOCK whose telephone number is (703)756-5952. The examiner can normally be reached Monday-Friday 10:00am-8:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, XUAN THAI can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715