DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Any new grounds of rejection set forth below are necessitated by Applicant’s amendment.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claims 1-9 are pending.
Double Patenting
Claims 1, 3, 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8-9 of copending Application No. 18/552,349 in view of Buchholz et al. (US 2007/0014848).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1: An amendment to incorporate claims 2 and 5 into claim 1 of copending 18/552,349 arrives at claim 1 of the present invention. While copending 18/552,349 claims 1, 2, and 5 disclose a molded body including additional components, e.g. a plasticizer, claims 1, 2, and 5 of copending 18/552,349 arrives at claim 1 of the present invention in an obviouness type manner. While the molecular weight of chain B is not claimed, Buchholz et al. (US 2007/0014848) discloses the chain B include PEG having a weight average molecular weight of 1500 or greater and 25000 or less in the working examples. One skilled in the art would have been motivated to have selected the chain B of Buchholz for improved properties and can be produced simply on an industrial scale ([0011] Buchholz).
Regarding claims 3, 9: The reaction of the polyester and glycol produces an ester bond in 18/552,349. A molded article is claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Buchholz et al. (US 2007/0014848) in view of Masaki et al. (US 2015/0051119).
Regarding claim 1: Buchholz is directed to a glycolic acid copolymer composition comprising a glycolic acid copolymer. Specifically, the copolymer includes an absorbable polymer including polyglycolide ([0007]-[0008]) as a straight macromolecular chains A containing a repeating unit derived from glycolic acid. The polyglycolic acid is chemically bonded to a macromolecular chain B different than the macromolecular chains A.
The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 1500 or greater and 250000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples, which is substantially identical to PEG 7500 utilized in the present invention having a Tg of -67 ˚C, and therefore one skilled in the art would conclude PEG 6000 has a Tg of lower than 45 ˚C.
A carboxylic acid anhydride is not mentioned.
Masaki is directed to a biodegradable polymer comprising a glycolic acid copolymer composition comprising a glycolic acid and a carboxylic acid anhydride. The carboxylic acid anhydride is added as a degradation accelerator. One skilled in the art would have been motivated to have included a carboxylic acid anhydride degradation accelerator since it results in a polyester resin composition with excellent degradability and excellent storing properties ([0056] Masaki). This is relevant since Buchholz is directed to degradable materials ([0010] Buchholz). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have included a carboxylic acid degradation accelerator.
The weight average molecular weight of the glycolic acid copolymer is not mentioned.
Masaki teaches the molecular weight of the glycolic acid copolymer is preferably 20,000 to 600,000.
Regarding claim 2: The copolymer includes an ABA type block copolymer ([0011] Buchholz).
Regarding claim 3: The macromolecular chains A and B are bonded by an ester bond since the ABA block copolymer is a polyetherester.
Regarding claim 4: The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 2500 or greater and 50000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples.
The amount of macromolecular block B is 0.01-20 wt% in the copolymer ([0051] Buchholz) (equivalent to 0.5 or greater and 20 or less with respect to 100 total of the macromolecular chain A in mass ratio.
Regarding claim 5: The macromolecular chain B is derived from a macromolecular compound having a weight average molecular weight of 2500 or greater and 50000 or less in the working examples. Specific macromolecular chains B include PEG 6000 utilized in the working examples.
Regarding claims 6-8: The hydrophilic polyhydric alcohol based polymer having a terminal hydroxy group is polyethylene glycol having a weight average molecular weight of 500-10,000 daltons on average ([0048] Buchholz). A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding claim 9: A solidification and extrusion molded article comprising the glycolic acid copolymer composition is disclosed.
Response to Arguments
Applicant's arguments filed 6/23/2026 (herein “Remarks”) have been fully considered but they are not persuasive.
Applicant argues (p. 5-8 Remarks) the primary reference of Buchholz discloses an injection molded article of an ABA type polymer whose block A is L-lactide-co-glycolide and block B is PEG 2000. A POSA would understand the control of absorption kinetics is positioned as being achieved by blocks A and B. The aim of the polymer is to provide materials with a degree of purity which allows them to be used in the human or animal body. [0014]. They preferably contain no additives besides impurities [0079]. This clearly indicates removing low molecular remains as much as possible to provide materials with a high degree of purity is an important design of Buchholz. Therefore, POSA would understand a technical concept of controlling absorption kinetic properties by the copolymer to minimize the amount of external low molecular weight components introduced.
The secondary reference of Masaki discloses a composition containing PGA with excellent degradability and a carboxylic acid anhydride. The control of degradation is achieved by a degradation accelerator which is an additive. Therefore, the combination of Buchholz and Masaki is improper since adding an addition of a degradation accelerator to the invention of Buchholz would be contrary to the teachings therein,
This argument is not found persuasive since [0079] mentions no additives besides impurities from the polymerization process. However, [0079] also recites blends with other absorbable polyesters, which is advantageous in terms of achieving good mechanical properties. Hence, it is the Examiners position that an acceleration additive that also produces a molded article with sufficient strength and melt viscosity, as taught in [0025] Masaki, would be obvious, and not contrary, to a POSA.
Regarding the double patent rejection response set forth on page 8 of the Remarks, Applicant's request for abeyance is acknowledged to the extent that Applicant's lack of response to the cited rejection will not be treated as non-responsive under 37 CFR 1.111(b). However, since the rejection is considered proper it will be maintained until such time as a complete response is filed, or conditions appropriate for removal of the rejection are presented.
Conclusion
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT T BUTCHER whose telephone number is (571)270-3514. The examiner can normally be reached Telework M-F 9-5 Pacific Time Zone.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lanee Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT T BUTCHER/Primary Examiner, Art Unit 1764
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