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 .
Detailed Action
Restriction/Election
Applicant’s election without traverse of group I, claims 1, 4-5, 7, 9, 12, 17, 22, 34-35, 42-43 and 82-84 in the reply filed on 07/13/26 is acknowledged. Applicant’s election without traverse of Species 1): poly(lactic acid-caprolactone) copolymers (PLCL) Species 2): Lipiodol (iodized poppyseed oil) Species 3): Rods and Species 4): Metal oxide is also acknowledged.
Claims 73-75 and 78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/13/26.
Claim Rejections - 35 USC § 112, indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims1, 4-5, 7, 9, 12, 17, 22, 34-35, 42-43 and 82-84 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 pre-AIA the applicant regards as the invention. Claims 1 and 82-83 recite the limitation in terms of the mechanical and/or physical property of the polymer whose meets and bounds are not defined thereby making the claim indefinite. Claims 1 and 83 recite the limitation “configured” without providing any specific structural limitations as to how it is configured, therefore, the claim is indefinite.
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, 4-5, 7, 12, 22, 35, 42 and 82-84 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruellan et al.( "Industrial vegetable oil by-products increase the ductility of polylactide", EXPRESS POLYMER LETTERS, vol. 9, no. 12, 1 January 2015 (2015-01-01), pages 1087-1103, presented in IDS).
Ruellan et al. discloses blends of polylactide (a polymer) with a series of vegetable oils. The blends are fabricated into films by melt blending of the polylactide with the oils at a temperature of 180°C under conditions of shear in a two-screw extruder (see Section 2.2). The "additives" (i.e. the oils) are described as being "solid" at room temperature on page 1089 of Ruellan et al.. The products in Ruellan et al. are therefore considered to constitute "a homogeneous solid blend" in the terms of present claim 1 (see also Figure 4 in Ruellan et al.). Further, the first entry in Table 6 of Ruellan et al. discloses a blend of polylactide (PLA) with 10 wt % of palmitic acid (C16) which has a "a mechanical property" in the terms of present claim 1 (i.e. Young's Modulus) which is 98% the same as that of the PLA itself i.e. "substantially identical" in the terms of present claim 1 ( see also page 6 paragraph 3 of the present description). Further disclosures in Table 6 are of PLA with 10 wt% of hydrogenated palm oil (HPO) with glass transition point which is 97 wt% of the PLA itself. The PLA used in Ruellan et al. has a number average molecular weight (Mn) of 103,700 gmol⁻¹ which corresponds to ca 1151 monomer units. Since the art teaches the claimed solid blend, it would be capable of being used in manufacturing biodegradable products. Since the art teaches the solid blend comprising a polymer and an oil as claimed, it would be used as an implantable fiducial marker.
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 9, 17, 34 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Ruellan et al.( "Industrial vegetable oil by-products increase the ductility of polylactide", EXPRESS POLYMER LETTERS, vol. 9, no. 12, 1 January 2015 (2015-01-01), pages 1087-1103, presented in IDS) in view of Allen et al. (US PG Pub. 2013/0004691A1) and further in view of SENTHAMARAIKANNAN C ET AL: "Overview of Polylactic acid and its derivatives in medicinal applications", IOP CONFERENCE SERIES: MATERIALS SCIENCE AND ENGINEERING, vol. 988, no. 1, 1 December 2020 (2020-12-01), page 012003, presented in IDS).
Ruellan et al. discloses blends of polylactide (a polymer) with a series of vegetable oils. The blends are fabricated into films by melt blending of the polylactide with the oils at a temperature of 180°C under conditions of shear in a two-screw extruder (see Section 2.2). The "additives" (i.e. the oils) are described as being "solid" at room temperature on page 1089 of Ruellan et al.. The products in Ruellan et al. are therefore considered to constitute "a homogeneous solid blend" in the terms of present claim 1 (see also Figure 4 in Ruellan et al.). Further, the first entry in Table 6 of Ruellan et al. discloses a blend of polylactide (PLA) with 10 wt % of palmitic acid (C16) which has a "a mechanical property" in the terms of present claim 1 (i.e. Young's Modulus) which is 98% the same as that of the PLA itself i.e. "substantially identical" in the terms of present claim 1 ( see also page 6 paragraph 3 of the present description). Further disclosures in Table 6 are of PLA with 10 wt% of hydrogenated palm oil (HPO) with glass transition point which is 97 wt% of the PLA itself. The PLA used in Ruellan et al. has a number average molecular weight (Mn) of 103,700 gmol⁻¹ which corresponds to ca 1151 monomer units.
The reference does not teach use of particles or drugs, encapsulated or non-encapsulated.
Allen et al. teaches molded article by using polylactic acid polymer among other polymers mixed with oil and in nanometer size wherein additives can be added, see claims 1-30.
Senthamaraikanan teaches lactic acid polymer being bio-compatible and biodegradable, see first paragraph. The reference shows the increase in the usage and application of PLA. The significant advantages of PLA are they do not damage bones when placed in the body; they reduce the medical cost because the second stage of surgery is not required for removing the implant. Bioabsorbable polymer makes cells to regenerate tissue and release drugs like antibiotics, painkillers, and anti-inflammatories, see second paragraph. The use of polylactide compositions in medical applications is well-known in principle as taught by Allen et al. and Senthamaraikannan et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized nanoparticulate form of mixture of a polymer and oil along with additives and drugs (encapsulated or unencapsulated) as taught by Allen et al. and Senthamaraikannan et al. into the solid homogeneous mixture of polylactic acid and oil of Ruellan et al. One of ordinary skill would have been motivated to do so because Allen teaches use of mixture of polymer and oil in particulate form which can be molded and Senthamaraikannan et al. teaches sue of PLA polymer with oil used in medicinal applications.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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