DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 11/3/2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 3, 5, 7, 9, 19, 21, 26, 28 and 39-41 have been amended. Claims 2 and 38 have been cancelled. No claims are newly added. Accordingly, claims 1, 3-37 and 39-63 remain pending in the application. Claims 10-18 and 42-62 stand withdrawn from further consideration, without traverse. Claims 1, 3-9, 19-37, 39-41 and 63 are currently under examination.
Applicant is kindly reminded to utilize underlining of any text that that is added to a claim (37 C.F.R. 1.121). For example, claim 5 appears to have text that has been added without the proper markings.
Applicant is also kindly reminded that the status of every claim must be indicated after its claim number (e.g., Original, Currently amended, Withdrawn, Canceled) (37 C.F.R. 1.121). For example, claims 42-62 do not have the correct status identifiers, i.e., Withdrawn.
Withdrawn Objections/Rejections
Applicant’s amendment renders the objection to the specification regarding the limitations of claim 41 moot. Specifically, the specification has been amended such that there is proper antecedent basis to the specification for the subject matter of claim 41. Thus, said objection has been withdrawn.
Applicant’s amendment renders the objection to the specification regarding the description of Figures 28 and 29. Specifically, the specification has been amended to include a brief description of said Figures at [0119] and [0120]. Thus, said objection has been withdrawn.
Applicant’s amendment renders the duplicate claim warning of claim 2 moot. Specifically, claim 2 has been cancelled. Thus, said warning has been withdrawn.
Applicant’s amendment renders the rejections of claims 5, 7, 9, 19, 21, 26-31, 33, 35- 39 and 41 under 35 USC 112(b) moot. Specifically, the claims have been amended to remedy the indefinite issues. Thus, said rejections have been withdrawn.
Applicant’s amendment renders the rejections of claims 2 and 38 under 35 USC 112(d) moot. Specifically, the claims have been cancelled. Thus, said rejections have been withdrawn.
Maintained Objections/Rejections
Specification
The disclosure stands objected to because of the following informalities: [0189] of the instant specification recites, “When used herein, “low viscosity” means 200 cps to 1,000,000 cps at 25°”. The temperature units are not recited. However, it appears to be an obvious error. It is suggested that the units (°C) are added.
Appropriate correction is requested.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the objection to the specification have been fully considered but they are not persuasive.
Applicant asserts that the specification has been amended to include the symbol for centigrade. Remarks, page 2.
In response, it is respectfully submitted that after a thorough review of the amended specification, the symbol for centigrade still appears to be missing at [0189].
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said objection is maintained.
Duplicate Claims
Applicant is advised that should claim 8 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 25 be found allowable, claim 32 will 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).
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the duplicate claim warnings of claims 20 and 32 have been fully considered but they are not persuasive.
Applicant asserts that claims 20 and 32 have been cancelled. Remarks, page 2.
In response, it is respectfully submitted that said claims are still pending.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said duplicate claim warnings are 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, 40 and 63 stand 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.
Claim 3 also recites, “long fibers” in line 5 of the claim. The term “long” is a relative term which renders the claim indefinite. The term “long” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 40 recites, “water-free” as well as “is hydrated with water” which are contradictory phrases. The claim is indefinite because it is unclear whether water is or is not permitted.
Regarding claim 63, the phrase "a preferred degree of hydrolysis" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejections of claims 3, 40 and 63 under 35 USC 112(b) have been fully considered but they are not persuasive.
Applicant asserts that the term “long fibers” in claim 3 is a term of art and is known by those skilled in the art. Remarks, page 2.
In response, it is respectfully submitted that there is no evidence to support applicant’s assertion that the term “long fibers” is understood by those skilled in the art. A search by the examiner has also not yielded documentation that would yield an understood or established definition of “long fibers”. Applicant’s argument is unpersuasive.
Applicant asserts that “’physically crosslinked polyvinyl alcohol water-free solid’ is the name of the material and that it is subjected to hydration ‘after manufacture’”. Remarks, page 3.
In response, it is respectfully submitted that the claim is drawn to a physically crosslinked polyvinyl alcohol water-free solid. Adding water to the water-free solid after manufacture no longer constitutes a water-free solid. The contradiction has not been remedied and, as such, Applicant’s argument is unpersuasive.
No amendment or argument is provided for claim 63. The indefinite issue remains.
Thus, for these reasons, said rejections are maintained.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-9, 20, 21, 26-28, 33-37, 39, 40 and 63 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”).
Claim 1 is drawn to a physically crosslinked polyvinyl alcohol hydrogel prepared using mixed solvents, containing continuous, uninterrupted immobilized water, said hydrogels having at least 88% by weight water content or higher and a syndiotacticity of fifty percent or greater.
Regarding instant claim 1, Tanihara teaches a polyvinyl alcohol containing structural units of the following formula (I) at a molar fraction of 0.05-0.50 and the structural units of the following formula (II) at a molar fraction of 0.0001 to 0.50;
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123
140
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(I)
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82
124
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(II)
wherein R1 is a hydrogen atom or a monovalent hydrocarbon group; R2 and R3 are, independently, a monovalent hydrocarbon group or R2 and R3 together form a ring along with the carbon atom to which R2 and R3 are bonded; or R1, R2 and R3 together form a ring along with the carbon atom to which R1, R2 and R3 are bonded (referred to as “structural unit (I)” hereinafter) and X is a group represented by the formula –CO–Y, –Y or –COCOOH, wherein Y represents a hydrocarbon group modified with at least one polar group selected from the group consisting of carboxyl, sulfo, amino and phosphonooxy; or Y represents a hydrocarbon group modified with a group having at least one polar group selected from the group consisting of carboxyl, sulfo, amino and phosphonooxy; or X forms phosphonooxy group together with the oxygen atom to which X is bonded (referred to as “structural unit (II)” hereinbelow), and its use in preparation of gels, particularly hydrogels, effective for use in wound dressing materials (abstract; col. 4, lines 25-58). Tanihara exemplifies polyvinyl alcohol hydrogels having at least 88% by weight water content and a syndiotacticity of 55% or greater (see Examples 1 and 2 in Table 1 at col. 28). Tanihara teaches that the polyvinyl alcohol hydrogel is physically crosslinked as evidenced by the method of making (Example 1 at cols 21-22).
It is noted that claims 1, 3-9, 19-25 and 32 are deemed product-by-process claims due to the limitation, “prepared using mixed solvents, containing continuous, uninterrupted immobilized water” (see independent claim 1) and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 4, Tanihara teaches the elements discussed above. While Tanihara does not explicitly teach that the hydrogel contains less than 1% acetate groups, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
The claimed and prior art products appear to be identical or substantially identical in structure or composition. Thus, a prima facie case of anticipation has been established absent evidence to the contrary.
Regarding instant claim 5, Tanihara teaches the elements discussed above. Tanihara further teaches that a temperature of 20°C is utilized in the making of the polyvinyl alcohol hydrogel (Example 1 at col. 22). It is noted that “low temperature” is defined in the instant specification as -25°C to 60°C ([0067]).
Regarding instant claims 6 and 7, Tanihara teaches the elements discussed above. It is noted the instant claims are deemed product-by-process claims due to the limitations, “prepared using a low viscosity” (claim 6) and “wherein the viscosity is in the range of 0.2 Pas or higher at 25°C” (claim 7) and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claims 8 and 20, Tanihara teaches the elements discussed above. It is noted that the instant claims are additionally deemed product-by-process claims due to the limitation, “is formed using 3-D printing” and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 9, Tanihara teaches the elements discussed above. The limitations of claim 9 further limit the product-by-process of claim 1. Determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113). It is further noted that Tanihara teaches the use of mixed solvents in the method of making the polyvinyl alcohol hydrogels (col. 18, line 60 – col. 19, line 23).
Regarding instant claim 21, Tanihara teaches the elements discussed above. The instant claim recites, “wherein said hydrogel is useable directly in a blood vessel”. Said limitation is being interpreted as an intended use recitation and, as such, does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding instant claim 26, Tanihara teaches the elements discussed above. Tanihara further teaches “thoroughly” removing the water contained in the hydrogel (col. 24, lines 8-10 and 19-20). Tanihara teaches that said hydrogels are biocompatible (wound dressing) (col. 1, lines 5-9 and 18-26).
It is noted that claims 26-31, 33-37 and 39-41 are deemed product-by-process claims due to the limitation, “prepared using mixed solvents” and “treated to induce biocompatibility, said treatment selected from …” (see independent claim 26) and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 27, Tanihara teaches the elements discussed above. It is noted that the instant claim is additionally deemed a product-by-process claim due to the limitation, “is formed using 3-D printing” and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 28, Tanihara teaches the elements discussed above. The instant claim recites, “wherein said hydrogel is useable directly in a blood vessel”. Said limitation is being interpreted as an intended use recitation and, as such, does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding instant claim 33, Tanihara teaches the elements discussed above. While Tanihara does not explicitly teach that the hydrogel contains less than 1% acetate groups, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
The claimed and prior art products appear to be identical or substantially identical in structure or composition. Thus, a prima facie case of anticipation has been established absent evidence to the contrary.
Regarding instant claim 34, Tanihara teaches the elements discussed above including “thoroughly” removing the water contained in the hydrogel (col. 24, lines 8-10 and 19-20). While Tanihara does not explicitly teach that the hydrogel contains 1% or less of water, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
The claimed and prior art products appear to be identical or substantially identical in structure or composition. Thus, a prima facie case of anticipation has been established absent evidence to the contrary.
Regarding instant claims 35 and 36, Tanihara teaches the elements discussed above. Tanihara further teaches that a temperature of 20°C is utilized in the making of the polyvinyl alcohol hydrogel (Example 1 at col. 22).
Regarding instant claim 37, Tanihara teaches the elements discussed above. It is noted that the instant claims are additionally deemed product-by-process claims due to the limitations, “prepared using a low viscosity” and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 39, Tanihara teaches the elements discussed above. The limitations of claim 39 further limit the product-by-process of claim 26. Determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113). It is further noted that Tanihara teaches the use of mixed solvents in the method of making the polyvinyl alcohol hydrogels (col. 18, line 60 – col. 19, line 23).
Regarding instant claim 40, Tanihara teaches the elements discussed above including the hydrogel is a hydrated and dehydrated state. The limitation, “is hydrated with water after manufacture” is considered a product-by-process limitation. Determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 63, Tanihara teaches the elements discussed above including
physically crosslinked polyvinyl alcohol hydrogels having about 89% by weight water content and a syndiotacticity of 61% (see Examples 1 and 2 in Table 1 at col. 28; Example 1 at cols 21-22).
It is noted that claim 63 is deemed a product-by-process claim due to the limitation, “prepared using mixed solvents, containing continuous, uninterrupted immobilized water” and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
While Tanihara does not explicitly teach all of the recited characteristics, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
The claimed and prior art products appear to be identical or substantially identical in structure or composition. Thus, a prima facie case of anticipation has been established absent evidence to the contrary.
Thus, the teachings of Tanihara render the instant claims anticipated.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 102 over Tanihara have been fully considered but they are not persuasive.
Applicant asserts that Tanihara’s disclosure does not have anything to do with the instant invention. Applicant asserts that Tanihara is not using polyvinyl alcohol homopolymers as set forth in the instant invention. Remarks, pages 3-4.
In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., polyvinyl alcohol homopolymer) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s argument is unpersuasive.
Applicant asserts that the specific molecular parameters set forth in the claims with regard to which PVA polymers are useful have been ignored. Remarks, page 4.
In response, it is respectfully submitted that the instant claims are drawn to a product and not the method of using said product. As explained in the rejection, any intended use recitation does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim. Tanihara teaches a variety of end uses, such as wound dressing materials, the base material for patches, gels for immobilizing enzymes or bacteria, contact lenses, artificial muscles, artificial cartilage, artificial joints, artificial organs, sensors, functional separation membranes, release control membranes, switches, actuators, and micro-machines (col. 3, lines 49-60). While Applicant has asserted that the instant invention is structurally different than the prior art, the claims do not reflect a structural difference as they are currently written. Applicant’s argument is unpersuasive.
Applicant asserts that the instant PVA polymers are prepared in a mixed solvent and then cooled to low temperatures which provides non-immunogenic surfaces whereas the invention of Tanihara cannot achieve the same properties. Remarks, page 4.
In response, it is respectfully submitted that the instant claims are directed to products and not the method of making the product. If the method of making results in a different structural product or an unexpected property, it is Applicant’s burden to provide evidence that shows that the claimed product and the prior art product differ. Arguments presented by the applicant cannot take the place of evidence in the record. Furthermore, as discussed in the rejection above, Tanihara teaches using mixed solvents as well as a low temperature within the definition provided by the instant specification. For these reasons, Applicant’s argument is unpersuasive.
Applicant asserts with respect to claim 63, Tanihara discloses the use of physical crosslinking, but does not provide any evidence that such process yields any meaningful contribution to stability and strength of their hydrogels. Remarks, page 4.
In response, it is respectfully submitted that while the claim requires crosslinking, there is nothing setting out the extent of crosslinking or that the crosslinking itself yields a particular stability or strength value. Tanihara teaches crosslinking and as such meets the requirements of the crosslinking limitation. It is Applicant’s burden to provide evidence that shows that the claimed product and the prior art product differ. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s product differs and, if so, to what extent, from that of the discussed reference. Applicant’s argument in unpersuasive.
Applicant asserts that Tanihara teaches a copolymer composed of comonomer repeat units that have large side groups such that no measurable crystallization can take place in such polymer systems. Remarks, page 4.
In response, it is respectfully submitted that the claims do require crystallization. Applicant is arguing limitations that are not in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, Applicant’s argument is unpersuasive.
Applicant asserts that no observable physical crosslinking takes place. Applicant further asserts that Tanihara provides no evidence that such crosslinking is taking place. Applicant states that Tanihara’s hydrogels have very low strength and in order to improve handing deficiencies, Tanihara subjects their hydrogel to covalent crosslinking. Applicant further asserts that the instant invention has a tensile strength that is at least two orders higher than any covalently crosslinked hydrogel including Tanihara’s hydrogels Remarks, pages 4-5.
In response, it is respectfully submitted that Tanihara teaches that the polyvinyl alcohol hydrogel is physically crosslinked as evidenced by the method of making (Example 1 at cols 21-22). While the claims require crosslinking, there is nothing setting out the extent of crosslinking. The claims also do not set out any particular strength limitations nor do the claims exclude covalent crosslinking. Applicant is arguing limitations that are not in the claims. Tanihara teaches physical crosslinking and as such meets the requirements of the crosslinking limitation. It is Applicant’s burden to provide evidence that shows that the claimed product and the prior art product differ. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s product differs and, if so, to what extent, from that of the discussed reference. Applicant’s argument in unpersuasive.
For the above reasons, the rejection is maintained.
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.
Claim 3 stands rejected under 35 U.S.C. 103 as being unpatentable over Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”), as applied to claim 1 above, in view of Gvozdic (US 2009/0305024 A1, Dec. 10, 2009, hereafter as “Gvozdic”).
The instant claims are described above.
Tanihara teaches the elements discussed above.
Tanihara is silent to the hydrogel being reinforced with materials selected form long fibers, woven fibers, woven fabrics, non-woven fibers, non-woven fabrics and combinations thereof.
Gvozdic teaches a reinforced, laminated composite material comprising a cross-linked polyvinyl alcohol hydrogel and long continuous fibers in the form of strands, mats, woven, non-woven structures/textiles, various braided structures, etc. (abstract; [0031] and [0064]). Gvozdic teaches that the fibers provide improved and tailored strength to the hydrogel ([0062]). Gvozdic also teaches that said composites can be used in various biomedical applications including wound treatment ([0082]).
The references are both drawn to crosslinked polyvinyl alcohol hydrogels for biomedical applications, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include long fibers, woven or non-woven fibers, or woven or non-woven fabrics into the invention of Tanihara as suggested by Gvozdic with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Gvozdic teaches that the incorporation of fibers, woven or non-woven fibers, or woven or non-woven fabrics into a polyvinyl alcohol hydrogel provides improved strength that can be tailored to the desired specifications.
Thus, the combined teachings of Tanihara and Gvozdic render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 103 over Tanihara in view of Gvozdic have been fully considered but they are not persuasive.
Applicant asserts that Tanihara does not teaches the hydrogels of the instant invention. Remarks, page 6.
In response, it is respectfully submitted that for the same reasons as discussed above under the 102 rejection over Tanihara, Applicant’s arguments are not persuasive. As explained above, Tanihara teaches the invention as it is currently claimed.
Applicant asserts that the examiner cannot take the position that Gvozdic discloses the reinforcement of the instant hydrogels as it is not disclosed in Gvozdic nor is it suggested in Gvozdic. Applicant asserts that Gvozdic does not suggest how, or what specifically, can be used to reinforce the hydrogels of the instant invention.
In response, it is respectfully submitted that the rejection is based on the combined teachings of Tanihara and Gvozdic. It is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Further, under 103, a patent cannot be obtained 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. Tanihara does not teach reinforcing materials including those that are claimed in instant claim 3. However, Gvozdic teaches a reinforced, laminated composite material comprising a cross-linked polyvinyl alcohol hydrogel and long continuous fibers in the form of strands, mats, woven, non-woven structures/textiles, various braided structures, etc. (abstract; [0031] and [0064]). Gvozdic teaches that the fibers provide improved and tailored strength to the hydrogel ([0062]). Gvozdic also teaches that said composites can be used in various biomedical applications including wound treatment ([0082]). Both Tanihara and Gvozdic are drawn to crosslinked polyvinyl alcohol hydrogels for biomedical applications and Gvozdic teaches that the incorporation of fibers, woven or non-woven fibers, or woven or non-woven fabrics into a polyvinyl alcohol hydrogel provides improved strength that can be tailored to the desired specifications. Thus, Gvozdic provides the motivation to modify the hydrogel of Tanihara by incorporating reinforcing elements and reasonably expect improved strength of the hydrogel. For these reasons, applicant’s arguments are unpersuasive.
The rejection is maintained.
Claim 19 stands rejected under 35 U.S.C. 103 as being unpatentable over Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”), as applied to claim 1 above, in view of Kudva et al. (US 2020/0188558 A1, Jun. 18, 2020, hereafter as “Kudva”.
The instant claims are described above.
Tanihara teaches the elements discussed above. Tanihara teaches that the hydrogel may be prepared in any desired form with no specific limitation including the particular forms, powder (fine particle), film, sheet, fiber, woven knit, non-woven fabric, tube, in a mass, or thin slice (col. 20, lines 20-26 and 45-48).
Tanihara is silent to the hydrogel being formed into a pouch manufactured from a hydrogel selected from sheets, corrugated sheets, multiple hole punctured surfaces, ribbons, tapes, hollow fibers, hollow threads, hollow rods, and hollow tubes.
Kudva teaches encapsulation devices comprising hydrogels for biomedical purposes (abstract). Kudva teaches that one or more hydrogel precursor films can be shaped into a pouch shape defining a cavity ([0060]).
The references are both drawn to hydrogels for biomedical applications, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the hydrogel advanced by Tanihara into the shape of a pouch as suggested by Kudva with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Kudva teaches that a hydrogel is suitable to shape into the form of a pouch for biomedical purposes. Furthermore, it is noted that changes in shape are generally considered an obvious modification absent evidence that the particular configuration is significant (MPEP 2144.04(IV)(B)).
Thus, the combined teachings of Tanihara and Kudva render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 103 over Tanihara in view of Kudva have been fully considered but they are not persuasive.
Applicant asserts that Tanihara does not teaches the hydrogels of the instant invention. Remarks, page 6.
In response, it is respectfully submitted that for the same reasons as discussed above under the 102 rejection over Tanihara, Applicant’s arguments are not persuasive. As explained above, Tanihara teaches the invention as it is currently claimed.
Applicant also presents arguments regarding the Gvozdic reference (Remarks, pages 6-7), however the Gvozdic references is not unutilized in the rejection of claim 19. Applicant’s argument is not relevant to the merits of the instant rejection.
For these reasons, applicant’s arguments are unpersuasive. The rejection is maintained.
Claims 22-24 and 29-31 stand rejected under 35 U.S.C. 103 as being unpatentable over Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”), as applied to claims 1 and 26 above, in view of Malhi (US 2011/0034906 A1, Feb. 10, 2011, hereafter as “Malhi”).
The instant claims are described above.
Tanihara teaches the elements discussed above.
Tanihara is silent to the hydrogel being in the form of a string of catenated beads, micro beads or macro beads.
Malhi teaches a surgical wound dressing incorporating connected hydrogel beads (title; abstract; Fig. 1). Malhi teaches that said hydrogel can be poly(vinyl alcohol) ([0054]). Malhi teaches that the beads may have a length or diameter L1 and any desirable distance/length relationship may be established between bead length and the distance between adjacent beads ([0047]). Malhi teaches that L1 can vary, but they should be sized to achieve a proper pore size through a bead arrangement to facilitate cell proliferation and allow fluid and air to be evacuated from the wound ([0048]). Malhi teaches that porosity in the range of 10-1000 microns has been found beneficial in stimulating cell proliferation and in allowing fluid and air to be evacuated from the wound ([0048]). In one embodiment, Malhi teaches that the length or diameter, L1, of beads may be of any size (from a few mm to a few inches) ([0057]). Malhi also teaches that by having a plurality of hydrogel beads that are connected in a strand allows an end user (e.g., surgeon, nurse, etc.) to better pack a wound with a plurality of hydrogel beads and to also allow for the remnants of the plurality of hydrogel beads, following their useful life or some predetermined period of time, to be more easily removed from the wound since the plurality of hydrogel beads are connected in a strand ([0092]).
The references are both drawn to polyvinyl alcohol hydrogels for treating wounds, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hydrogel in the form of a string of catenated beads into the invention of Tanihara as suggested by Malhi with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Malhi teaches that having a plurality of hydrogel beads that are connected in a strand allows an end user (e.g., surgeon, nurse, etc.) to better pack a wound with a plurality of hydrogel beads and to also allow for the remnants of the plurality of hydrogel beads, following their useful life or some predetermined period of time, to be more easily removed from the wound since the plurality of hydrogel beads are connected in a strand. It would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the hydrogel beads as micro beads or macro beads into the invention of Tanihara as suggested by Malhi with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Malhi teaches that diameter/length of the beads can be optimized to achieve a proper pore size (ideally 10-1000 microns) through a bead arrangement to facilitate cell proliferation and allow fluid and air to be evacuated from the wound. MPEP 2144.05(II)(A) states, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Thus, it would have been obvious to optimize the bead size in the micro or macro size range by way of routine experimentation in order to achieve a proper pore size (space between the beads) of ideally 10-1000 microns.
Thus, the combined teachings of Tanihara and Malhi render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 103 over Tanihara in view of Malhi have been fully considered but they are not persuasive.
Applicant asserts that Tanihara does not teaches the hydrogels of the instant invention. Remarks, page 7.
In response, it is respectfully submitted that for the same reasons as discussed above under the 102 rejection over Tanihara, Applicant’s arguments are not persuasive. As explained above, Tanihara teaches the invention as it is currently claimed.
No further arguments are presented regarding the combined teachings of Tanihara and Malhi. Thus, applicant’s argument is unpersuasive.
The rejection is maintained.
Claims 25 and 32 stand rejected under 35 U.S.C. 103 as being unpatentable over Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”), as applied to claim 1 above, in view of Crawley et al. (US 2005/0165447 A1, Jul. 28, 2005, hereafter as “Crawley”).
The instant claims are described above.
Tanihara teaches the elements discussed above.
Tanihara is silent to the hydrogel being in the form of a corrugated sheet.
Crawley teaches a corrugated sheet material that may be made from any desired bioabsorbable or non-bioabsorbable material and can be useful in planar form for the repair of various tissue defects where a somewhat flexible, but “reinforced” sheet is desired ([0043]; Fig. 2A and 2B). Crawley teaches that the corrugated sheet results in a plurality of hollow members 12 (Fig. 2A) which provides good axial stiffness, good radial compliance, and allow rapid access for body fluids and living cells ([0013]).
The references are both drawn to devices for wound/tissue repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the hydrogel of Tanihara into a corrugated form as suggested by Crawley with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Crawley teaches that a corrugated shape results in a plurality of hollow members which provides improved mechanical properties and allow rapid access for body fluids and living cells for the similar purpose of tissue repair.
Thus, the combined teachings of Tanihara and Crawley render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 103 over Tanihara in view of Crawley have been fully considered but they are not persuasive.
Applicant asserts that Tanihara does not teaches the hydrogels of the instant invention. Remarks, page 7.
In response, it is respectfully submitted that for the same reasons as discussed above under the 102 rejection over Tanihara, Applicant’s arguments are not persuasive. As explained above, Tanihara teaches the invention as it is currently claimed.
No further arguments are presented regarding the combined teachings of Tanihara and Crawley. Thus, applicant’s argument is unpersuasive.
The rejection is maintained.
Claim 41 stands rejected under 35 U.S.C. 103 as being unpatentable over Tanihara et al. (USPN 5,880,216, Mar. 9, 1999, hereafter as “Tanihara”), as applied to claim 26 above, in view of Han et al. (CN 103736140 A, Apr. 23, 2014, machine translation, hereafter as “Han”).
The instant claims are described above.
Tanihara teaches the elements discussed above.
Tanihara is silent to surface treatment with a dilute hydrosol solution.
Han teaches a medical dressing hydrogel composite fabric comprising a hydrosol solution on the surface layer for the purpose of acute and chronic wound hemostasis and tissue repair (abstract).
The references are both drawn to medical dressings comprising a hydrogel, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hydrosol solution on the surface of a medical dressing such as the one advanced by Tanihara as suggested by Han with a reasonably expectation of success. A skilled artisan would have been motivated to do so because Han teaches that a hydrosol solution on the surface of a medical dressing is suitable for the purpose of wound hemostasis and tissue repair.
Thus, the combined teachings of Tanihara and Han render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/3/2025, regarding the rejection under 35 USC 103 over Tanihara in view of Han have been fully considered but they are not persuasive.
Applicant asserts that Tanihara does not teaches the hydrogels of the instant invention. Remarks, page 7.
In response, it is respectfully submitted that for the same reasons as discussed above under the 102 rejection over Tanihara, Applicant’s arguments are not persuasive. As explained above, Tanihara teaches the invention as it is currently claimed.
No further arguments are presented regarding the combined teachings of Tanihara and Han. Thus, applicant’s argument is unpersuasive.
The rejection is maintained.
New Rejections
In light of Applicant’s amendments, the following rejections have been newly added:
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 34 and 39 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.
Claim 34 recites that the physically crosslinked polyvinyl alcohol water-free solid as claimed in claim 26 containing 1% or less of water. Claim 26 sets out that the solid is water free, however claim 34 attempts allow for up to 1% water. The claim is indefinite because it is unclear whether water is or is not permitted.
Claim 39 recites, “The physically crosslinked polyvinyl alcohol water-free solid as claimed in claim 26 wherein said mixed solvents are selected from the group consisting of: dimethylsulfoxide, glycerin, ethyl alcohol, propanol, butanediol, poly(ethylene glycol), propylene glycol, poly(propylene glycol), triethylene glycol, said mixed solvent being mixed with water in the range of 2 weight percent water to 98 percent water”. Claim 26 sets out that the solid is water free, however claim 39 attempts to add water. The claim is indefinite because it is unclear whether water is or is not permitted.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34 recites that the physically crosslinked polyvinyl alcohol water-free solid as claimed in claim 26 containing 1% or less of water. Claim 26 sets out that the solid is water free, however claim 34 attempts broaden the scope of the claim and allow for up to 1% water. Thus, the claim does not further limit the subject matter of claim 26. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
All claims have been rejected; no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617
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