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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 11-15, in the reply filed on September 8, 2025 is acknowledged. Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-9 and 11-15 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.
Regarding claim 1, the claim recites “mixing polyhydroxyalkanoate raw materials”. The limiting effect of the recitation is unclear. It is not clear whether “materials” refers to multiple different compositions of polyhydroxyalkanoate materials (e.g. more than one type of polyhydroxyalkanoate resin) or whether other materials besides polyhydroxyalkanoate are in view (e.g. a polyhydroxyalkanoate resin and additives/fillers) or whether something else is intended. Appropriate correction and correction are required.
Additionally, claim 1 recites “higher than a melting point of polyhydroxyalkanoate resin”. The limiting effect of the recitation is unclear. It is not clear whether “polyhydroxyalkanoate resin” is referring back to the “polyhydroxyalkanoate materials” previously recited. It is not clear why different terminology is being used. Further, it is not clear whether the melting point being recited is the melting point of the polyhydroxyalkanoate materials/resin actually being utilized in the process or whether some generic reference to the melting point of some other polyhydroxyalkanoate resin is intended. Appropriate correction and clarification are required.
As to claims 3, 4, 9, 14 and 15, the claims recite “during the preparation process”. The recitation lacks antecedent basis in the claims. It is not clear whether the recitation is referring back to the “preparation method” or whether something else is intended. Appropriate correction and clarification are required.
The other claims are rejected as dependent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Lamee et al. (US 2015/0230946).
Regarding claim 1, Al-Lamee et al. teach a preparation method for a polyhydroxyalkanoate molded body, wherein, the preparation method comprises steps of: mixing polyhydroxyalkanoate raw materials (paragraphs [0052], [0091], [0160], [0161] – materials; paragraphs [0122] – a screw extruder mixers the materials), processing at a first temperature (paragraphs [0087], [0182], [0241], [0244]), and stretching at a second temperature (paragraphs [0081], [0113], [0116]-[0121] [0124]-[0126], [0131], [0132], [0206]-[0213], [0227]); wherein, the first temperature higher than the melting point of the polyhydroxyalkanoate resin (paragraphs [0087], [0182] and [0241], [0244]; Tm = 188°C; Processing temp = 220 °C; wherein the general teaching of processing the polymeric materials in a molten state, taken with an exemplified processing step of PLLA at a temperature of 32 °C above the melting temperature renders the claimed range of 10 °C to 60 °C above the melting temperature of the polyhydroxyalkanoate prima facie obvious); and the second temperature is a temperature above the a glass transition temperature of the polyhydroxyalkanoate resin and below the melting point of the polyhydroxyalkanoate resin; and stretching under the conditions of at the second temperature must meet the following requirements: a draw ratio of 1.0 times or more, and a heating time under at the second temperature condition of 30 seconds or more; or, a draw ratio of 3.0 times or more, and a heating time under at the second temperature condition of 10 seconds or more (paragraphs [0081], [0113], [0116]-[0121] [0124]-[0126], [0131], [0132], [0206]-[0213], [0227]).
As to claim 2, Al-Lamee et al. teach temperatures within or which overlap the claimed range (paragraphs [0081], [0113], [0116]-[0121] [0124]-[0126], [0131], [0132], [0206]-[0213], [0227])
As to claims 3 and 4, Al-Lamee et al. teach draw ratios and heating times with or which overlap the claimed range (paragraphs [0081], [0113], [0116]-[0121] [0124]-[0126], [0131], [0132], [0206]-[0213], [0227]).
As to claim 5, Al-Lamee et al. explicitly teach a 4-hydroxyalkanoate structural unit (paragraphs [0052], [0091], [0160] and [0161]; P4HB).
Claims 6-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Lamee et al. (US 2015/0230946), as applied to claims 1-5 above, and further in view of either one of Ganatra et al. (US 2016/0166727) or Williams et al. (US 2002/0156150).
As to claims 6-8 and 11-13, Al-Lamee et al. teach the polyhydroxyalkanoate structural unit can be polyhydroxybutyrate and separately disclose, in a narrower sense, 4-polyhydroxybutyrate (paragraphs [0052], [0091], [0160] and [0161]). Al-Lamee et al. do not explicitly recite a “3-hydroxybutyrate” structural unit.
However each of Ganatra et al. (paragraph [0083]) and Williams et al. (paragraphs [0003], [0004], claims 4 and 5) disclose analogous methods and materials wherein it is taught and suggested that 3-hydroxybutyrate is in view (e.g. “polyhydroxybutyrate” without further specificity is referring to 3-hydroxybutyrate, which is also further supported by the specific disclosure of P4HB and the separate disclosure of polyhydroxybutyrate in A-Lamee et al.) or that the material may be effectively utilized in tube/stent/medical applications.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of A-Lamee et al. and either one of the secondary references and to have utilized poly(3-hydroxybutryate) as the polyhydroxyalkanoate/polyhydroxybutyrate in the method of Al-Lamee et al., as suggested by either one of the secondary references, for the purpose, as suggested by the references of utilizing the material already suggested/implied by Al-Lamee et al. (as evidenced by Ganatra et al.) or for the purpose, as suggested by Williams et al., of utilizing a specific form of polyhydroxybutyrate known in the art to be effective at forming a polyhydroxyalkanoate/polyhydroxybutyrate tube/stent/medical device having desired properties (e.g. degradability).
Claims 9, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Lamee et al. (US 2015/0230946) and further in view of either one of Ganatra et al. (US 2016/0166727) or Williams et al. (US 2002/0156150), as applied to claims 6-8 and 11-13 above, and further in view of Uradnisheck (US 2009/0099313).
As to claims 9, 14 and 15, Al-Lamee et al. teach the method set forth above. Further, Al-Lamee et al. teach additives can be included (paragraph [0163]) but do not disclose a nucleating agent as claimed.
However, Uradnisheck ‘313 teaches an analogous material wherein a nucleating agent is added in amounts within or which overlap the claimed range (Abstract; paragraphs [0015], [0021], [0027], [0040] and [0046]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Al-Lamee et al. and Uradnisheck and to have included nucleating agents in amounts as claimed in the method of Al-Lamee et al., as suggested by Uradnisheck, for the purpose, as suggested by Uradnisheck, of forming a product having desired final product properties (e.g. crystallinity with the associated physical properties).
Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Uradnisheck et al. (US 2009/0131566).
Regarding claim 1, Uradnisheck et al. teach a preparation method for a polyhydroxyalkanoate molded body, wherein, the preparation method comprises steps of: mixing polyhydroxyalkanoate raw materials (Abstract; paragraphs [0019], [0043]), processing at a first temperature (paragraphs [0044]-[0049], and stretching at a second temperature (paragraphs [0016] and [0050]-[0053]); wherein, the first temperature is higher than a melting point of polyhydroxyalkanoate resin and overlaps the claimed range (paragraphs [0044]-[0049]; e.g. more than 20 °C above the melting point; overlapping ranges are prima facie obvious); and the second temperature is a temperature above the a glass transition temperature of the polyhydroxyalkanoate resin and below the melting point of the polyhydroxyalkanoate resin; and stretching under the conditions of at the second temperature must meet the following requirements: a draw ratio of 1.0 times or more, and a heating time under at the second temperature condition of 30 seconds or more; or, a draw ratio of 3.0 times or more, and a heating time under at the second temperature condition of 10 seconds or more (paragraphs [0050]-[0053]; draw ratios and times within or which overlap the claimed ranges).
As to claim 2, Uradnisheck et al. teach temperatures within or which overlap the claimed range (paragraphs [0016], [0050]-[0053]).
As to claims 3 and 4, Uradnisheck et al. teach draw ratios and times within or which overlap the claimed range (paragraphs [0050]-[0053]).
As to claims 5-8 and 11-13, Uradnisheck et al. teach materials as claimed (paragraph [0019]).
As to claims 9, 14 and 15, Uradnisheck et al. teach nucleating agents in amounts within or which overlap the claimed range (paragraph [0018]).
Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Iwata et al. (US 2008/0061467) in view of Uradnisheck (US 2009/0099313).
Regarding claim 1, Iwata et al. teach a preparation method for a polyhydroxyalkanoate molded body, wherein, the preparation method comprises steps of: providing polyhydroxyalkanoate raw materials (Abstract; paragraphs [0016], [0033]-[0035]), processing at a first temperature (paragraphs [0045], [0048]-[0050]), and stretching at a second temperature (paragraphs [0065]-[0067]); wherein, the first temperature is higher than the a melting point of polyhydroxyalkanoate resin at temperature within or which overlap the claimed range (paragraphs [0045], [0048]-[0050]); and the second temperature refers to is a temperature above the a glass transition temperature of the polyhydroxyalkanoate resin and below the melting point of the polyhydroxyalkanoate resin; and stretching under the conditions of at the second temperature must meet the following requirements: a draw ratio of 1.0 times or more, and a heating time under at the second temperature condition of 30 seconds or more; or, a draw ratio of 3.0 times or more, and a heating time under at the second temperature condition of 10 seconds or more (paragraphs [0065-[0067]; draw ratios and times at amounts within or which overlap the claimed range).
Iwata et al. teach the provided composition may be extruded and that the composition may include additional additives (paragraph [0072]). Iwata et al. do not explicitly teach mixing the polyhydroxyalkanoate raw materials. However, Uradnisheck ‘313 teaches an analogous material wherein the materials are mixed prior to further processing (paragraph [0040]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Iwata et al. and Uradnisheck ‘313 and to have mixed the materials as claimed in the method of Iwata et al., as suggested by Uradnisheck ‘313, for the purpose, as suggested by Uradnisheck ‘313, of forming a homogeneous composition of polymer and additives prior to further processing the materials into the final article/molded body.
As to claim 2, Iwata et al. teach temperatures within or which overlap the claimed range (paragraphs [0065]-[0067).
As to claims 3 and 4, Iwata et al. teach draw ratios and times within or which overlap the claimed range (paragraphs [0065]-[0067).
As to claims 5-8 and 11-13, Iwata et al. teach materials as claimed (paragraphs [0016], [0033]-[0035]).
As to claims 9, 14 and 15, Iwata et al. teach the provided composition may include additional additives, such as nucleating agents (paragraph [0072]). Iwata et al. do not explicitly teach the amount of nucleating agent to add. However, Uradnisheck ‘313 teaches an analogous material wherein the nucleating agent is added in amounts within or which overlap the claimed range (Abstract; paragraphs [0015], [0021], [0027], [0040] and [0046]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Iwata et al. and Uradnisheck ‘313 and to have included nucleating agents in amounts as claimed in the method of Iwata et al., as suggested by Uradnisheck ‘313, for the purpose, as suggested by Uradnisheck ‘313, of forming a product having desired final product properties (e.g. crystallinity, haze).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cite prior art references disclose analogous methods for preparing polyhydroxyalkanoate molded bodies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742