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 .
Response to Amendment
Applicant’s amendment filed on January 21, 2026 has been entered. Claims 19, 22, 23, 29, 30, and 35 have been amended. Claims 20, 21, and 24-27 have been cancelled. New Claims 38 and 39 have been added. As such, Claims 19, 22, 23, and 28-39 are currently pending in the application, with Claims 34-37 withdrawn from consideration.
Priority
The Office has adopted the opinion expressed in the international preliminary report on patentability for corresponding International Application Serial No. PCT/JP2022/036701 that foreign priority application JP 2021-164555 does not disclose or suggest that the biodegradable polyester recited in Claim 19 is amorphous in its nature. As such, the international filing date of International Application Serial No. PCT/JP2022/036701, which is September 30, 2022, is considered the effective filing date for the present U.S. patent application. In order to establish an effective filing date back to JP 2021-164555, Applicant must submit a translation of the certified copy of said foreign application, and the translation must establish that each of the claim limitations is disclosed or suggested by that initial filing. Applicant cannot solely rely upon the certified copy of the foreign priority application to establish the effective filing date of October 6, 2021 because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See M.P.E.P. §§ 215 and 216.
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.
Claim 39 is 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 39 recites the biodegradation degree of the amorphous biodegradable polyester is 60% or more. However, Claim 39 does not set forth how the biodegradation degree is determined. What amount of degradation over what period of time is necessary for a material to be considered biodegraded? The scope of the limitation is unclear.
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 19, 22, 23, 31-33, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0070987 to Taylor et al. (“Taylor”) in view of U.S. Patent Application Publication No. 2023/0294355 to Tobin et al. (“Tobin”).
With regard to Claims 19 and 23, Taylor discloses a resin composition suitable for additive manufacturing, such as for 3D printing filament. See, e.g., Abstract, paragraph [0014], entire document. Taylor discloses that the filament comprises a water soluble polymer having a melting point in the range of 30 to 220 degrees C., such as polyethylene glycol, and a biodegradable polyester, such as polydioxanone. Paragraph [0268]. Taylor discloses that the water soluble polymer is present in an amount of 40%, by weight. Table 1. However, Taylor does not disclose the degree of crystallinity of the polydioxanone. Tobin is also related to polymer resin formulations for use in additive manufacturing, such as 3D printing. See, e.g., Abstract, entire document. Tobin teaches that amorphous thermoplastics are well known for use in 3D printing and are often selected for their wide processing windows. Paragraph [0007]. Tobin also notes that semicrystalline thermoplastic materials provide alternative benefits to amorphous thermoplastic materials, such as increased stiffness and chemical resistance. Id. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide an amorphous nature to the polydioxanone polymer disclosed by Taylor in order to provide a 3D printing filament with a wide processing window, as shown to be known in the art by Tobin. With regard to Claim 22, Taylor discloses that the polyethylene glycol has an average molecular weight of 20 kDa. Paragraph [0268]. With regard to Claims 31 and 32, although Taylor combined with Tobin does not disclose the property features of elastic modulus of 2.0 to 100.0 MPa and a recovery rate of 50%, it is reasonable to presume that these properties are inherent to the material disclosed by the combination of references. Support for the presumption is found because Taylor combined with Tobin provides similar materials, i.e., an amorphous biodegradable polyester, such as polydioxanone, combined with a water-soluble polymer different from the biodegradable polyester, such as polyethylene glycol, wherein the amount of water-soluble polymer is similar, and wherein the materials are used in combination to make a similar end-use product, i.e., 3D printer filament. The burden is upon the Applicant to show otherwise. The Patent and Trademark Office can require applicants to prove that prior art products do not necessarily or inherently possess characteristics of claimed products where claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes; burden of proof is on applicants where rejection based on inherency under 35 U.S.C. § 102 or on prima facie obviousness under 35 U.S.C. § 103, jointly or alternatively, and Patent and Trademark Office’s inability to manufacture products or to obtain and compare prior art products evidences fairness of this rejection. In re Best, Bolton, and Shaw, 195 USPQ 431 (CCPA 1977). “[I]nherency may supply a missing claim limitation in an obviousness analysis where the limitation at issue is the natural result of the combination of prior art elements.” Persion Pharmaceuticals. V. Alvogen Malta Oper., 945 F.3d 1184, 1191 (Fed. Cir. 2019). With regard to Claim 33, Taylor discloses that the filament has a diameter in the range of 1.5 to 3 mm with a fiber diameter variation of no more than ±0.01 mm. Paragraph [0137]. With regard to Claim 39, Taylor discloses that the polymer phase in the composition can be entirely biodegradable. Paragraph [0090]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide a biodegradation degree of an amorphous biodegradable polyester of 60% or more in the 3D printing filament taught by the combination of Taylor with Tobin to ensure that the material is fully biodegradable, as established to be desired by Taylor.
Claims 28-30 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Tobin as set forth above, and further in view of International Application Publication No. WO 2020/241624 to Harimoto et al. (the English equivalent U.S. Patent Application Publication No. 2022/0251372 is referred to herein) (“Harimoto”).
With regard to Claims 28 to 30, Taylor does not disclose the biodegradable polyester comprises a polyhydroxycarboxylic acid with two kinds of hydroxycarboxylic acid monomers meeting Equation 1. Nonetheless, such a feature is well known in the field of biodegradable polymers for use in medical devices. Harimoto to biodegradable polyesters useful in medical devices. Harimoto teaches that a polyhydroxycarboxylic acid with two kinds of hydroxycarboxylic acid monomers meeting Equation 1, paragraphs [0011] to [0017], provides improved flexibility and strength to the resulting product manufactured from the polymer. Paragraph [0098]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to utilize the polymer disclosed by Harimoto as the biodegradable polyester in Taylor in order to provide improved flexibility and strength to the end use product, as shown be known by Harimoto. With regard to Claim 39, Harimoto discloses that the degree of crystallization of monomer residue can be provided at 14% or less to provide softness. Paragraph [0049]. It would have been obvious to a person having ordinary skill in the art at the time of filing the invention to provide the polyester with an ester-bonding monomer residue composition of 20% or less in the filament taught by Taylor in view of Tobin and Harimoto in order to improve softness, as shown to be known by Harimoto.
Response to Arguments
Applicant's arguments filed January 21, 2026 have been fully considered but they are not persuasive.
Applicant argues that the present claims aim to reduce the stickiness of the amorphous biodegradable polyester and improve printability by blending an amorphous biodegradable polyester with a water-soluble polymer. Applicant asserts that this objective is different from those of Taylor and Tobin. However, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Taylor discloses to the skilled artisan that 3D printer filament comprises a water soluble polymer having a melting point in the range of 30 to 220 degrees C. in combination with a biodegradable polyester. Moreover, Tobin renders obvious the use of amorphous thermoplastic polymer for 3D printing, and teaches that such material is selected for providing wide processing windows.
Applicant argues that if the polydioxanone disclosed by Taylor is made amorphous, it would cause it to soften and be more susceptible to chain scission due to hydrolysis, and prone to swelling and degradation from solvent exposure. The Examiner disagrees. First, nothing in Taylor suggests that the filament need be exposed to a solvent prior to using it to print. Second, Tobin already teaches the person having ordinary skill in the art that amorphous polymers lack stiffness and are more prone to chemical reaction, paragraph [0007], but are still usable when used in combination with a semi-crystalline polymer. Paragraph [0010]. The person having ordinary skill in the art is presumed to have the capability to weigh pros and cons of different methods or technologies within their field, as part of their ability to solve problems using conventional wisdom and ordinary creativity. Tobin teaches that amorphous polymers are suitable for use in 3D printer filaments, and the person having ordinary skill in the art can use amorphous polymers in such filaments to increase processing windows, even if such a modification comes at the expense of another property, such as maximum stability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Patent Application Publication No. 2022/0282084 to Shaked et al., U.S. Patent Application Publication No. 2023/0023495 to Sakai, and U.S. Patent Application Publication No. 2022/0041816 to Wang.
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See M.P.E.P. § 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY R PIERCE whose telephone number is (571)270-1787. The examiner can normally be reached Monday - Friday, 9 am to 5 pm.
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JEREMY R. PIERCE
Primary Examiner
Art Unit 1789
/JEREMY R PIERCE/Primary Examiner, Art Unit 1789