DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA
The Office Action is in response to the application filed December 18, 2023.
Response to Preliminary Claim Amendment filed 12/18/2023
Claims 1 and 4-10 were amended and supported in the claims as originally filed.
Claim 9 was amended and supported in [¶ 0010] of the Specification as originally filed.
New Claim 11 was added and supported in [¶ 0007] of the Specification as originally filed.
New Claim 12 was added and supported in [¶ 0008, 0018] of the Specification as originally filed.
New Claims 13-14 were added and supported in [¶ 0024] of the Specification as originally filed.
New Claim 15 was added and supported in [¶ 0039] of the Specification as originally filed.
Thus, no new matter is present.
Claim Analysis
Summary of Claim 1:
A medical treatment material that forms a hydrogel upon contact with water comprising:
a polymer (A) comprising a structural unit derived from an ethylenic unsaturated monomer (ma) which has a carboxyl group and a molecular weight of 115 or less, and
a polymer (B) comprising a structural unit derived from an ethylenic unsaturated monomer (mb) which has a functional group E that is capable of forming a hydrogen bond with a hydroxyl group, the polymer (B) not being the polymer (A),
wherein at least one of polymer (A) and the polymer (B) further comprises a structural unit derived from and ethylenic unsaturated monomer (mc) differing from the ethylenic unsaturated monomers (ma) and (mb), and the monomer (mc) is not an ethylenic unsaturated monomer having a cross-linkable functional group.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “wherein at least one of polymer (A) and the polymer (B) further comprises a structural unit derived from and ethylenic unsaturated monomer (mc) … and the monomer (mc) is not an ethylenic unsaturated monomer having a cross-linkable functional group.” The claim language could be grammatically interpreted as monomer (mc) is neither an ethylenic unsaturated monomer nor does it have a cross-linkable functional group which is inconsistent with the language of the instant Specification [¶ 0007].
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 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.
Claims 1 and 10 recite “an ethylenic unsaturated monomer (mc)… and the monomer (mc) is not an ethylenic unsaturated monomer having a cross-linkable functional group”. However, monomer (mc) is defined as having species such as methacrylates which contain crosslinkable groups. The monomer examples provided in the instant Specification [¶ 0018-0019] are known to be cross-linkable (e.g., maleic acid, fumaric acid, etc.). Thus, Claim 1 stating monomer (mc) is not having crosslinkable functional groups is indefinite. For purposes of examination, the claim language monomer (mc) “not having crosslinkable functional groups” will not be considered because monomer (mc) is defined as a species that has crosslinkable groups and be interpreted to include the monomer examples listed in the instant Specification.
Claim 14 recites monomer (mc2) is an alkyl (meth)acrylate ester, which has a carboxyl group. However, Claim 4, which Claim 14 depends upon, recites monomer (mc2) has no carboxyl group, which directly contradicts Claim 14 rendering Claim 14 indefinite. For the purposes of examination, Claim 14 will be interpreted to require an alkyl (meth)acrylate ester group.
Claims 1-2, 11 and 15 recite molecular weights. However, there are no units to establish the basis for the molecular weight (i.e., g/mol, amu, Da, etc.) in the claim language or the present Specification. For the purposes of examination, the recited molecular weights will be interpreted to have units of g/mol.
Claims 3-9 and 12-13 are rejected for being dependent on a rejected base claim.
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.
Claims 1-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Woller et al. (US 2005/0003012 A1; cited in the IDS submitted on 12/18/2023; hereafter as “Woller”).
Regarding Claims 1, 6, and 8-10, Woller teaches a medical treatment material and a method for preparing the same, wherein the medical treatment material comprises a gel matrix and water [Claims 34, 52], corresponding to the medical treatment material that forms a hydrogel upon contact with water of Claim 1; and to the method for producing a medical treatment material of Claim 10. Woller teaches the medical treatment material further comprises:
polyacrylic acid-based gel matrix that comprises a copolymer of vinyl pyrrolidone as a crosslinker [Claim 20], wherein:
the polyacrylic acid corresponds to polymer (A) comprising a structural unit derived from an ethylenic unsaturated monomer (ma) of Claims 1 and 10; wherein an acrylic acid monomer has a carboxyl group and a molecular weight of 72 g/mol, which corresponds with the carboxyl group and a molecular weight of 115 or less of Claims 1 and 10; and corresponding to wherein the polymer (A) is a cross-linked polymer of Claim 6;
the copolymer of vinyl pyrrolidone corresponds to polymer (B) comprising an ethylenic unsaturated monomer (mb), the polymer (B) not being the polymer (A) of Claims 1 and 10; wherein the vinyl pyrrolidone has a carbonyl group, which corresponds with the functional group E that is capable of forming a hydrogen bond with a carboxyl group of Claims 1 and 10; and thereby reading on the polyvinylpyrrolidone of Claim 8.
Woller further teaches:
the gel matrix is pressed or rolled into a layer [¶ 0025-0026, 0038], corresponding to the film-shape solid comprising polymer (A) and polymer (B) of Claims 9 and 10;
the gel matrix does not require water [Claim 34; ¶ 0014], which will be interpreted to read on the product is dried of Claims 9 and 10;
water may be separately added to the gel matrix [Claim 34; ¶ 0014], which will be interpreted for the purposes of examination to read on which forms a hydrogel upon absorption of water of Claim 9; and
wherein the gel matrix may be attached to an adhesive matrix for use in medical bandages [Claims 49-52; ¶ 0030], corresponding to an adhesion property to biotissue of Claim 9.
Regarding Claims 1 and 10, however, Woller does not explicitly mention the claimed polymer (A) further comprising the particular ethylenic unsaturated monomer (mc) with sufficient specificity to constitute anticipation within the meaning of 35 U.S.C. 102.
Nevertheless, Woller teaches the polyacrylic acid may be a copolymer comprising alkyl acrylic acids and specific examples of alkyl acrylic acids such as a methacrylic acid dimer [¶ 0020], which corresponds to the claimed polymer (A) further comprising a structural unit derived from an ethylenic unsaturated monomer (mc) of Claims 1 and 10. According to Woller, the addition of alkyl acrylic acid monomers, such as the claimed methacrylic acid dimer, to the polyacrylic acid could be used to control the crosslinking properties, and thus the final viscosity of the resulting polyacrylic acid-based gel matrix [¶ 0013-0015]. Moreover, although Woller exemplifies multiple alkyl acrylic acids other than the claimed methacrylic acid dimer, this teaching indicates that the other alkyl acrylic acids listed are equally suitable for the purposes of forming a polyacrylic acid-based gel matrix for producing a medical treatment material, see MPEP §2123 [R-5].
Given the above teachings, it would have been obvious to one of ordinary skill in the art to select the claimed polymer (A) further comprising the particular ethylenic unsaturated monomer (mc) from the those listed in Woller, with a reasonable expectation of successfully using the same for producing medical treatment material and obtaining desired viscosity properties of the resulting polyacrylic acid-based gel matrix. See MPEP § 2141 [R-6], III (“obviousness can be established when there exists a finite number of predictable solutions with a reasonable expectation of success.”).
Additionally, as explained above, Woller teaches the same steps of preparing a film, bringing polymer (A) in contact with polymer (B), and drying for making the same medical treatment material as claimed. Furthermore, Woller teaches the same purpose for each step: the polyacrylic acid and vinyl pyrrolidone are mixed to produce the same hydrogel, the film is pressed or rolled to produce the same adhesive product as applicants. Thus, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. It follows that it would have been obvious to one of ordinary skill to employ the particular steps in any order, including those claimed, for the purposes of preparing the medical treatment material as suggested by Woller. See MPEP section 2144.04.IV.C.
Regarding Claims 2-4, and 11-12, Woller further teaches:
one or more monomers of methacrylic acid [¶ 0020], such as a methacrylic acid dimer which has a molecular weight of 172 g/mol, which the instant Specification [¶ 0018] discloses as an example of the unsaturated monomer (mc1), which corresponds to an ethylenic unsaturated monomer (mc1) which has a carboxyl group and molecular weight of more than 115 of Claims 2 and 11; and the instant Specification also discloses the expression “(meth)acrylic” refers to “acrylic and/or methacrylic.” [¶ 0019], thereby reading on wherein the ethylenic unsaturated monomer (mc1) is an acrylic acid dimer of Claims 3 and 12; and
methacrylic esters [¶ 0020], which corresponds to an ethylenic unsaturated monomer (mc2) which has no carboxyl group and no functional group E of Claim 4.
Regarding Claim 7, Woller further teaches polyamides [¶ 0014], corresponding to wherein polymer (B) has an amide group of Claim 7.
Regarding Claim 5, however, Woller does not explicitly teach the ratio by mass ((ma)/(mc)) of the ethylenic unsaturated monomer (ma) to the ethylenic unsaturated monomer (mc) of 99.7/0.3 to 50/50 of Claim 5.
Nevertheless, Woller teaches the gel matrix properties are influenced by the degree of substitution and degree of crosslinking of the polyacrylic acid [¶ 0015]. Since the degree of substitution and degree of crosslinking are heavily influenced by the monomers present in the gel matrix, the amount of the of monomer (ma) with respect to monomer (mc) can be optimized to reach the desired gel matrix properties via a routine optimization. The case law has held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). See MPEP 2144.05. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to adjust the amount of monomer (ma) with respect to monomer (mc) for the intended application via a routine optimization, thereby obtaining the present invention.
Regarding Claims 15, Woller further teaches wherein the copolymer of vinyl pyrrolidone has an average molecular weight in a range from 2,500 to 700,000 g/mol [Claim 23], which overlaps with wherein the polymer (B) is a polymer having an average molecular weight of 10,000 or more of Claim 15.
However, Woller does not explicitly teach wherein the polymer (B) is a polymer having an average molecular weight of 10,000 or more of Claim 15.
Nevertheless, one of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the range taught by Woller for the polymer molecular weight (2,500 to 700,000 g/mol) overlaps the instantly claimed range (10,000 or more) and is therefore considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP 2144.05.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Woller et al. (US 2005/0003012 A1; cited in the IDS submitted on 12/18/2023; hereafter as “Woller”) as applied to Claims 1-12 and 15 above, and further in view of Kato et al. (US 2019/0313931 A1; hereafter as “Kato”).
Woller teaches the medical treatment material, polymer (A), polymer (B) and monomer (mc) of Claims 1 and 10 as set forth above and incorporated herein by reference.
However, Woller does not teach the methacrylate alkyl esters of Claims 13-14.
Nevertheless, Kato teaches methacrylate alkyl esters with the alkyl group containing 1 to 18 carbon atoms [¶ 0030], inclusive of the claimed alkyl (meth)acrylate ester in which an alkyl group of an alkyl ester moiety has 1 to 4 carbon atoms.
Kato offers the motivation that hydrophobic monomers such methacrylate esters can produce polymer products with high adhesion [¶ 0048-0049].
Woller and Kato are considered to be analogous art as the claimed invention, as all are in the same field of methods of preparing medical adhesive films comprising ethylenic unsaturated monomers such as polyacrylic acid, and polyvinyl alcohol [Abstract; ¶ 0014, 0047].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the methacrylate alkyl esters of Kato with the medical treatment material of Woller, with the motivation to improve adhesion, thereby arriving at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DORIS LING whose telephone number is (571)270-3961. The examiner can normally be reached Monday-Friday, 8:30am-5:00pm.
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/DORIS LING/Examiner, Art Unit 1764
/HANNAH J PAK/Primary Examiner, Art Unit 1764
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