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 . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/29/2024 and 05/08/2024 have been considered by the examiner.
Status of the Claims
The response filed 04/27/2026 is acknowledged.
Claims 1-9 are pending.
Claims 1, 4, and 7 are independent.
Applicant’s election of Group I, claims 1-3, in the reply filed on 04/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/27/2026.
Claims 1-3 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Nazzal, WO 2019152695 A1 (cited on Applicant’s IDS dated 05/08/2024).
Nazzal teaches films comprising a biodegradable polymer composition, i.e., PCL-PVAc-PEG (Nazzal, entire document, e.g., Abstract, 0004, 0033, examples, and claims). Nazzal teaches polymer compositions having a storage modulus between 1 and 10 MPa, a loss modulus between 1 and 10 MPa, a viscosity of 1000 Pa·s, and a ratio of loss modulus over storage modulus of at least 1 and within the claimed range. See Figs. 5-7, e.g., compositions having 15-25% polymer. As seen in Fig. 6A and 6B at least the 15% polymer composition has a G’ of about 2.5 and a G” of about 5.5 which is a tan δ of 2.2. Nazzal teaches the composition comprising an active agent (Nazzal, e.g., claim 11). PCL is polycaprolactone as recited in claim 2.
Nazzal anticipates the subject matter of instant claims 1-3.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abe, Dental Materials, 2020.
Abe teaches a dental membrane comprising a biodegradable polymer, wherein the biodegrdable polymer comprises a poly(lactide – caprolactone polymer). See Abe, entire document, e.g., Abstract). Applicable to claim 2: the polymer comprises polycaprolactone.
Abe does not characterize the viscosity, storage modulus and ratio of loss modulus over storage modulus (tan δ).
However, since Abe teaches the identical structure (biodegradable polymer, including polycaprolactone as recited in claim 2), this suggests the prior art composition will have a viscosity, storage modulus and ratio of loss modulus over storage modulus (tan δ) between 1 and 30 as claimed absent evidence to the contrary. See MPEP 2112, e.g., 2112 V and 2112.01 I-II.
Abe anticipates the subject matter of instant claims 1-3.
Claim Rejections - 35 USC § 102/35 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 of this title, 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 1-3 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Markland, US 20110129422.
Markland teaches a composition comprising a biodegradable polymer (Markland, entire document, e.g., Example 9 and table 4) with an active additive (Markland, e.g., Table 7). The polymer may be in the form of shaped articles, e.g., a film (Markland, e.g., 0161). The claimed dental membrane reads on a film. Markland does not characterize all of the properties of the composition. However, the composition has a biodegradable polymer structure as required the common subject matter, and the properties which are characterized by Markland appear to be the same as those required by the claims, e.g., the composition appears to have properties within the claimed ranges, e.g., example 9: viscosity 20540 Poise (Table 4) is 2054.0 Pa.s; storage modulus (G’) ranges from 1 – 100,000 Pa depending on the angular frequency (Markland, e.g., Fig. 6). Markland teaches the loss modulus (G”) ranges from about 1 to about 100000 Pa depending on the angular frequency (Markland, e.g., fig. 6). The claimed range is silent to the angular frequency. At each frequency in Fig. 6, the loss modulus is higher than the storage modulus, i.e., the ratio of the loss modulus over the storage modulus is greater than 1. Markland teaches desired polymers have a loss modulus (G”) which is greater than the storage modulus (G’) (Markland, e.g., 0209). This means Markland teaches polymer compositions where the ratio of loss modulus over storage modulus is at least 1. Applicable to claim 2: Markland teaches a copolymer comprising polycaprolactone (Markland, e.g., examples 1-14 including example 9, 0191). The limitations of claim 2 are interpreted to read on any copolymer, terpolymer, or mixture comprising at least one of the recited polymers. Applicable to claim 3: Markland teaches the composition further comprising bioactive agents (Markland, e.g., 0107-0134 and Table 7). Markland teaches the combination of properties is desirable so that the composition may be formed as desired without the need for organic solvents (Markland, e.g., 0008), and useful as a drug delivery platform for controlled drug delivery (Markland, e.g., 0085), e.g., tissue regeneration (Markland, e.g., 0110). Markland teaches the properties of the polymer, e.g., viscosity, may be predictably modified by selection of molecular weight, initiator and monomer composition of the polymer (Markland, e.g., 0084).
Markland does not expressly characterize the ratio of loss modulus over storage modulus (tan δ) between 1 and 30. However, e.g., examples 9 and 10, and Fig. 6, show polymer compositions having a loss modulus close to, and higher than, the storage modulus, when measured at room temperature which is in the claimed temperature range, particularly at higher angular frequency, e.g., 100. Example 10, Fig. 3 shows a viscosity in the claimed range, e.g., about 10,000 poise is about 1000 Pa·s. Example 9 polymer composition has a viscosity in the claimed range, e.g., 20540 poise is 2054.0 Pa·s (Markland, e.g., Table 4). Further, the identical structure (biodegradable polymer, including polycaprolactone as recited in claim 2) and similar viscosity and storage modulus to the claimed invention suggests the prior art composition will have a ratio of loss modulus over storage modulus (tan δ) between 1 and 30 as claimed absent evidence to the contrary. See MPEP 2112, e.g., 2112 V and 2112.01 I-II.
In the event it can be shown that Markland does not teach a singular polymer composition having the claimed properties: It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to optimize the viscosity, storage modulus and loss modulus of a polymer film composition within the ranges suggested by Markland with a reasonable expectation of success. Since the claimed ranges overlap with the ranges suggested by Markland the skilled artisan would have found it obvious to optimize within the recited ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. The skilled artisan would have been motivated to optimize the viscosity, e.g., as set forth in table 4, storage modulus, as seen in Fig. 6, and ratio of loss modulus over storage modulus (tan δ) greater than 1 as reported in Markland, e.g., 0209 so that the composition is formable without the need for organic solvents as a controlled release drug delivery system. The skilled artisan would have had a reasonable expectation of success since Markland teaches the properties of the polymer, e.g., viscosity, may be predictably modified by selection of molecular weight, initiator and monomer composition of the polymer.
Accordingly, the subject matter of claims 1-3 was anticipated, or would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
Prosecution Insights