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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 29, 2026 has been entered.
Applicants' arguments, filed July 29, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 21, 25-27, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Seo (KR 100877696; all citations from the machine translation) in view of Pawlik et al. (Materials Research Express, 2019; cited on PTO-892).
Regarding claim 21, Seo discloses nanoparticles comprising a Lipiodol® core and a biocompatible polymer film surrounding the core (Page 3, Lines 14-15; claim 1). Seo discloses that the Lipiodol®, an oil-based radiographic contrast medium made from poppy seed oil, is a drug widely known in clinical practice as an embolizing agent (Page 5, Lines 19-20), reads on an oil-based contrast agent. Seo discloses that the weight ratio of the biocompatible polymer and Lipiodol® can be 1:1 (Page 13, Lines 3-7; claim 4). Seo discloses that the content of Lipiodol® can be appropriately adjusted to a range that exhibits X-ray absorbency suitable for X-ray computed tomography contrast imaging (Page 6, Lines 1-3). Seo discloses that the biocompatible polymers can be polylactic acid (PLA) and poly(lactic-co-glycolic acid) (PLGA) (Page 6, Lines 11-15; claim 2). Seo discloses that the biocompatible polymers can be a PEGylated PLA (Page 6, Lines 11-15; claim 2) which is a biodegradable diblock copolymer comprising a hydrophilic biodegradable polyethylene glycol (PEG) block and a hydrophobic biodegradable PLA block.
Seo does not disclose that the biodegradable polymer is a mixture of a hydrophobic biodegradable polymer such as polycaprolactone (PCL) and a hydrophilic biodegradable polymer such as PLGA, wherein the weight mixing ratio of the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
Pawlik discloses the blending of biodegradable polymers PCL and PLGA (abstract). Pawlik discloses that the blending of two polymers can provide a good alternative to the relatively long and expensive route of synthesizing brand new polymers displaying desired properties (page 1, ¶ 1). Pawlik discloses that PCL and PLGA show good biocompatibility and distinct degradation rates, and that blending two well-known biomedical polymers by a simple, cost-effective, and reproducible method can be useful when designing materials for biomedical application with tailored properties and increased functionality (page 2, ¶ 2; page 12, ¶ 2). Pawlik discloses that the PCL/PLGA blending can provide controllable physicochemical properties depending on PCL/PLGA ratio (abstract). Pawlik discloses that the PCL/PLGA blend can be prepared at a volume ratio of PCL to PLGA (85 lactic acid:15 glycolic acid) at 50/50 (1:1) (page 2, ¶¶ 3-4). Because the densities of PCL and PLGA are similar (1.145 and 1.27 g/cm3), the weight ratio can be about 1:1 (1.0), which reads on the claimed range where the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to use a PCL/PLGA blend at a weight mixing ratio of 1:1 as the biocompatible polymer of Seo in order to easily tailor the degradation rate, mechanical strength, and release profile of the embolic material. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Pawlik teaches that a PCL/PLGA blend can be used for biomedical applications, and that the weight mixing ratio can be 1:1 to achieve desired characteristics. Further, a person of ordinary skill in the art would have been motivated to utilize a hydrophobic and hydrophilic polymer blend (mixture) in order to easily adjust the physical and chemical characteristics of the polymer according to the specific requirements of the target applications. Additionally blending existing biocompatible polymers provides a predictable, cost-effective alternative to synthesizing new block copolymers without undue experimentation. Further, a person of ordinary skill in the art would have been motivated to optimize the weight ratio of hydrophobic and hydrophilic polymers in the blend in order to adjust the degradation and release characteristics of the polymer according to the specific requirements of the target applications. The weight ratio of the hydrophobic biodegradable polymer is a clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of the polymer contents in order to best achieve the desired embolic material characteristics and performance as taught by Seo and Pawlik. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05. Accordingly, applying the teachings of Pawlik to the embolic material of Seo constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 21 obvious.
Regarding claim 25, as discussed above, Seo teaches that the weight volume ratio of the polymer to the contrast agent can be 1:1, and Pawlik teaches that a PCL/PLGA blend can be prepared at a 1:1 weight ratio to achieve desired properties. Thus, the weight ratio of PCL:PLGA:contrast agent would render a combined formulation of approximately 25%:25%:50% by weight. Therefore, the embolic material of Seo in view of Pawlik reads on the claimed range of the hydrophobic biodegradable polymer where the content of the hydrophobic biodegradable polymer is 20 to 40% by mass based on a total embolic material weight of 100%. Further, a person of ordinary skill in the art would have been motivated to optimize the weight ratio of hydrophobic and hydrophilic polymers in the blend in order to adjust physical and chemical characteristics of the polymer according to the specific requirements of the intended applications. The weight ratio of the hydrophobic biodegradable polymer is a clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of the polymer in order to best achieve the desired embolic material characteristics as taught by Seo and Pawlik. Modifying variable ranges within a known prior art combination falls squarely within ordinary skill. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05.
Claims 26 and 27 are product-by-process claims. The determination of patentability is based on the product itself and does not depend on its method of production. As discussed above, the embolic material of Seo and Pawlik renders the embolic material of claims 26 and 27 obvious. The embolic material of Seo and Pawlik possesses identical structural features and functional properties as the embolic material of claims 26 and 27. The embolic material of Seo and Pawlik is the same product as would be produced by the process of claims 26 and 27. Therefore, instant claims 26 and 27 are not patentably distinguishable over Seo in view of Pawlik.“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113.
Claim 40 is an intended use claim. The recitation of an intended use for a composition does not limit the scope of a product claim to that specific use unless the intended use results in a distinct structural difference between the claimed invention and the prior art. The intended use of the polymeric embolic material to allow for recanalization after one or two weeks imparts no structural limitation and is of no patentable significance with respect to the structure of the composition. Patentability is determined by the composition’s structure, not its intended use or functional use. As discussed above, the embolic materials of Seo in view of Pawlik are structurally the same as the claimed embolic materials, and the embolic materials of Seo in view of Pawlik are inherently capable of achieving the use recited in claim 40. Inherency applies because the identical physical composition will naturally exhibit identical functional behavior under similar conditions. Because the intended use does not distinguish the claimed composition from the prior art and the prior art composition is structurally identical to the claimed composition, the recitation of the intended use in claim 40 carries no patentable weight. Accordingly, claim 40 is obvious.
Applicant argues that amended claim 21 requires that the biodegradable polymer be a mixture of two distinct biodegradable polymers rather than a single block copolymer. Applicant argues that Seo discloses only block copolymers and that the “mixture” of the claim does not reasonably encompass block copolymers.
This argument is unpersuasive. As discussed above, Pawlik teaches a physical blend (mixture) of two distinct biodegradable polymers and provides a clear motivation to utilize such a blend over synthesizing complex block copolymers. A POSITA seeking to achieve tailored degradation rates and optimized physical and chemical properties would have been motivated to use the polymer blend of Pawlik as the polymer matrix for the embolic material of Seo. Although Seo alone may focus on block copolymers, block copolymers comprising hydrophobic and hydrophilic polymer blocks and blends (mixture) of hydrophobic and hydrophilic polymers function as technical equivalents because they perform substantially the same function, in substantially the same way, to achieve the same result. The resulting final product would have the same core-shell morphology, contrast retention capability, and controlled degradation characteristics as the claimed formulation. A POSITA would select the blend of polymers because of the benefits taught by Pawlik, namely achieving tailored degradation rates and physical stability while bypassing the complex, expensive synthesis required for block copolymers. A POSITA would reasonably expect that physical blending allows for straightforward tuning of the ratio of hydrophobic to hydrophilic components without requiring new chemical synthesis or altering the underlying chemical backbone of the individual polymers. The substitution of a recognized technical equivalent, a physical polymer mixture, for the block copolymer of Seo yields entirely predictable results. Because using a known polymer blend to perform the exact same physical and functional role as a block copolymer falls well within the ordinary skill in the art, the combination remains obvious.
Applicant argues that the relative amount of two independently synthesized hydrophobic and hydrophilic biodegradable polymers is critical for spherical formability, X-ray visibility, and in vivo degradation time. Applicant argues that Seo does not teach or suggest adjusting the weight-mixing ratio between two distinct biodegradable polymers to address the simultaneous constraints of spherical formability, X-ray visibility, and targeted biodegradation in the presence of an oil-based contrast agent. Applicant argues that claims are also characterized by a specific weight ratio of the oil-based contrast agent to the biodegradable polymer, and that none of the cited references discloses or suggests selecting the combination of hydrophobic:hydrophilic biodegradable polymer mixing ratio together with the contrast agent:polymer ratio in order to obtain embolic materials that are spherical, radiopaque, and biodegradable over about one to two weeks. Applicant argues that the claimed mixture and weight mixing ratio are not a matter of routine optimization but represent a non-obvious selection that yields a distinct and advantageous technical effect.
This argument is unpersuasive. As discussed above, Seo teaches that the contrast agent:polymer ratio can be adjusted in order to achieve suitable X-ray absorbency, and demonstrated a working ratio that falls directly within the claimed range. As discussed above, Pawlik teaches that the ratio of two distinct biodegradable polymers can be adjusted in order to tailor physicochemical properties, and shows efficiency at a ratio of 1:1 which is within the claimed range. Adjusting variable parameters within overlapping prior art ranges to achieve target performance features does not impart patentability. It is inherently within the skill of a POSITA to adjust such ratios in order to produce embolic materials that are spherical, radiopaque, and biodegradable over a target duration. Where the prior art recognizes the result-effective nature of these parameters, the simultaneous optimization of multiple variables falls within the routine experimentation of a POSITA. When prior art references individually teach optimizing different variables of a formulation to achieve known desirable characteristics, combining these teachings to optimize both variables simultaneously yields predictable results. It would be obvious to use the polymer blend at Pawlik’s ratio and contrast agent at Seo’s ratio. Further, it would have been obvious to adjust these ratios through routine optimization in order to improve the embolic material characteristics such as spherical formability, x-ray visibility, and degradation stability. Controlling such ratios to achieve targeted physical and chemical properties such as degradation rate, radiopacity, and particle morphology is a well-established design principle in the field of polymeric embolic agents as taught by Seo and Pawlik. Because adjusting these known parameters to achieve expected material properties represents routine optimization rather than an inventive step, the claims remain obvious.
Applicant argues that the claimed weight mixing ratio of the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer in a mixture of 0.33 to 3.0 yields unexpected and critical results because compositions outside this effective mixing range either fail to form proper spheres or degrade too slowly or too quickly, and therefore do not provide the same combination of clinically desirable properties.
This argument is unpersuasive. Applicant’s assertions of unexpected results fail to satisfy the requisite legal criteria established under MPEP § 716.02. Objective evidence of unexpected results must be supported by an appropriate evidentiary showing, direct comparative data, and must be commensurate in scope with the claims. Applicant has failed to meet this burden based on the following criteria.
First, the alleged results are predictable, not truly unexpected. To establish unexpected results, the improvement or enhancement must significantly exceed what a person having ordinary skill in the art would have reasonably anticipated. The specific shape formation, size distribution, and biodegradability (stability) at the specific ratio of polymer mixture and agent shown in the specification represent predictable results rather than an entirely new mechanism that was unanticipated by the prior art. As discussed above, it is a well-established principle that the physical and chemical properties of the embolic material depend on the composition and ratio of polymer and agent. Adjusting the ratio of the composition is a standard, routine technique in preparing polymeric material such as embolic material, as taught by Seo and Pawlik. The results in the specification merely demonstrate that modifying variable parameters within known ranges to fine-tune physical performance produces predictable, incremental changes rather than unexpected differences in kind. Because adjusting result-effective parameters yields predictable functional shifts, this optimization does not impart patentability.
Second, Applicant fails to provide a direct comparison with the closest prior art (Seo and Pawlik individually or in a baseline combination). The evidence of unexpected results must involve a direct, side-by-side comparison between the claimed invention and the closest prior art. Without a direct comparison showing that the actual performance of the claimed composition is significantly better than what would be predicted from a simple additive effect of Seo and Pawlik, the showing is insufficient to rebut the prima facie case of obviousness. Applicant cannot establish unexpected results merely by comparing the claimed formulation against inferior or no-prior art control formulations.
Third, the results are not commensurate in scope of the claims. To effectively rebut a rejection of obviousness, the disclosure or evidence of unexpected results must be commensurate in scope with the claims to which the evidence is applied. Claim 21 encompasses several polymers and ratio ranges. However, Applicant’s arguments rely on narrow, specific examples such as PLA:PLGA:LPD 20:20:60 and 30:10:60. Applicant fails to provide examples of more combinations between claimed hydrophobic and hydrophilic polymers, and more combinations of ratios between the claimed ratio ranges of contrast agent:polymer and hydrophobic polymer:hydrophilic polymer. The limited experimental data does not establish that the entire claimed genus would exhibit the same allegedly unexpected properties.
Further, arguments or conclusory statements in the remarks section of a response do not take the place of evidence in the record. Allegations of unexpected results must be explicitly set forth in the originally filed specification or presented in a formal, signed declaration/affidavit accompanied by actual data. Absent the submission of such proper objective evidence, Applicant’s remarks remain mere unsubstantiated allegations that cannot overcome the rejection. Attorney arguments cannot serve as a substitute for comparative test data showing unexpected results.
Accordingly, because the combination of teachings would have been obvious to one of ordinary skill in the art, and because the Applicant has not provided sufficient objective evidence to demonstrate unexpected results, the rejection is maintained.
Claims 28 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Seo (KR 100877696; all citations from the machine translation) in view of Pawlik et al. (Materials Research Express, 2019; cited on PTO-892), Shea (US 2006 0002978), and Makadia et al. (Polymers 2011).
Regarding claims 28 and 32, as discussed above, Seo discloses nanoparticles comprising a Lipiodol® core and a biocompatible polymer film surrounding the core (Page 3, Lines 14-15; claim 1). Seo discloses that the Lipiodol®, an oil-based radiographic contrast medium made from poppy seed oil, is a drug widely known in clinical practice as an embolizing agent (Page 5, Lines 19-20), reads on an oil-based contrast agent. Seo discloses that the weight ratio of the biocompatible polymer and Lipiodol® can be 1:1 (Page 13, Lines 3-7; claim 4). Seo discloses that the content of Lipiodol® can be appropriately adjusted to a range that exhibits X-ray absorbency suitable for X-ray computed tomography contrast imaging (Page 6, Lines 1-3). Seo discloses that the biocompatible polymers can be PLA and PLGA (Page 6, Lines 11-15; claim 2). Seo discloses that the biocompatible polymers can be a PEGylated PLA (Page 6, Lines 11-15; claim 2) which is a biodegradable diblock copolymer comprising a hydrophilic biodegradable PEG block and a hydrophobic biodegradable PLA block.
Seo does not disclose that the biodegradable polymer is a mixture of a hydrophobic biodegradable polymer such as PCL and a hydrophilic biodegradable polymer such as PLGA, wherein an amount of lactic acid in the hydrophobic PLGA is greater than an amount of glycolic acid, and an amount of glycolic acid in the hydrophilic PLGA is equal to or greater than an amount of lactic acid, wherein the weight mixing ratio of the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
As discussed above, Pawlik discloses the blending of biodegradable polymers PCL and PLGA (abstract). Pawlik discloses that the blending of two polymers can provide a good alternative to the relatively long and expensive route of synthesizing brand new polymers displaying desired properties (page 1, ¶ 1). Pawlik discloses that PCL and PLGA show good biocompatibility and distinct degradation rates, and that blending two well-known biomedical polymers by a simple, cost-effective, and reproducible method can be useful when designing materials for biomedical application with tailored properties and increased functionality (page 2, ¶ 2; page 12, ¶2). Pawlik discloses that the PCL/PLGA blending can provide controllable physicochemical properties depending on PCL/PLGA ratio (abstract). Pawlik discloses that the PCL/PLGA blend can be prepared at a volume ratio of PCL to PLGA (85 lactic acid:15 glycolic acid) at 50/50 (1:1) (page 2, ¶¶ 3-4). Because the densities of PCL and PLGA are similar (1.145 and 1.27 g/cm3), the weight ratio can be about 1:1 (1.0), which reads on the claimed range where the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
Shea discloses blends of differing PLGA polymers which have the same constituent units but have distinct properties can be used to take advantage of the properties of both (Page 12, ¶ 114).
Makadia discloses that the presence of methyl side groups in PLA makes it more hydrophobic than poly glycolic acid (PGA) and hence lactide rich PLGA copolymers are less hydrophilic compared to the PLGA copolymers having a lower amount of lactide (page 1379, Lines 6-7).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a blend of different PLGA polymers (hydrophilic PLGA and hydrophobic PLGA prepared by varying the ratio of lactic acid and glycolic acid) at a weight ratio of 1:1 as the biodegradable polymer of Seo. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pawlik teaches that a blend of hydrophobic and hydrophilic polymers can be used and that the weight ratio of hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer can be 1.0; Shea teaches that different PLGA polymers which have the same constituent units but have different properties can be blended; and Makadia teaches that PLGA polymers with different hydrophobicities can be obtained by varying the ratio of lactic acid and glycolic acid. Further, a person of ordinary skill in the art would have been motivated to prepare hydrophobic PLGA and hydrophilic PLGA by adjusting the amount of monomers (lactic acid and glycolic acid) in order to simply prepare hydrophilic and hydrophobic polymers. A person of ordinary skill in the art would have been motivated to utilize a blend of the polymers having the same monomer units rather than a blend of two different polymers having different monomer units in order to prevent chemical mismatch and phase separation, and to achieve better compatibility. Further, a person of ordinary skill in the art would have been motivated to optimize the weight ratio of contrast agent:polymer and hydrophobic polymer:hydrophilic polymer in the blend in order to adjust characteristics of the embolic material according to the specific requirements of the intended applications. Such ratios are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of the polymer in order to best achieve the desired embolic material characteristics as taught by Seo and Pawlik. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05.
Claims 33 and 34 are product-by-process claims. The determination of patentability is based on the product itself and does not depend on its method of production. As discussed above, the embolic material of Seo, Pawlik, Shea, and Makadia renders the embolic material of claims 33 and 34 obvious. The embolic material of Seo, Pawlik, Shea, and Makadia possesses identical structural features and functional properties as the embolic material of claims 33 and 34. The embolic material of Seo, Pawlik, Shea, and Makadia is the same product as would be produced by the process of claims 33 and 34. Therefore, instant claims 33 and 34 are not patentably distinguishable over Seo in view of Pawlik, Shea, and Makadia. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113.
Applicant argues that Shea does not disclose any embolic material produced by the O/W emulsion method using a PLA/PCL or PLGA/PCGA mixture at the claimed ratio. Applicant argues that Makadia does not teach blending two separate biodegradable polymers in a defined mixing ratio of 0.33-3.0 to form embolic beads containing an oil-based contrast agent. Applicant argues that none of the secondary references, alone or in combination, remedies the absence in Seo and Nakanishi of a mixture of two distinct biodegradable polymers with the claimed 0.33-3.0 mixing ratio for embolic materials.
This argument is unpersuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As discussed above, the embolic material with specific polymers at a specific weight ratio is obvious over Seo in view of Pawlik. Shea is relied upon to demonstrate that different PLGA polymers which have the same constituent units but have different properties can be blended, and Makadia is relied upon to demonstrate that PLGA polymers with different hydrophobicities can be obtained by varying the ratio of lactic acid and glycolic acid. As discussed above, production methods do not impart patentable weight to an otherwise identical or obvious product. Because the embolic material itself is obvious over the combined teachings of Seo, Pawlik, Shea, and Makadia, the specific method used to produce it such as O/W emulsification cannot render the product patentable. Because the combined teachings of Seo, Pawlik, Shea, and Makadia render the embolic material of claim 28 obvious, Applicant’s attempt to critique individual references in isolation fails to overcome the rejection.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Seo and Pawlik as applied to claims 21, 25-27, and 40 above, further in view of Duran et al. (Theranostics, 2016; cited on IDS filed Aug 22, 2023).
Seo and Pawlik are discussed above.
Neither Seo nor Pawlik discloses that the embolic material has an average particle size of 100 to 500 µm.
Duran discloses a radiopaque bead for transarterial embolization (title). Duran discloses that the average size of the bead can vary with different physical properties, providing specific examples such as a 164 µm bead, (page 34, Tables 1 and 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic materials of Seo and Pawlik to have a particle size of 164 µm. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Duran teaches that the microspheres for embolization can have a 164 µm diameter. Further, a person of ordinary skill in the art would have been motivated to adjust the particle size according to specific clinical application requirements. Particle size of the embolic material is a clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal size of the embolic material in order to best achieve the desired embolic material characteristics. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05. Accordingly, applying the teachings of Duran to the embolic materials of Seo and Pawlik constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 38 obvious.
Applicant argues that Duran does not address the composition or hydrophobic/hydrophilic polymer mixture at all. Applicant argues that none of the secondary references, alone or in combination, remedies the absence in Seo and Nakanishi of a mixture of two distinct biodegradable polymers with the claimed 0.33-3.0 mixing ratio for embolic materials.
This argument is unpersuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As discussed above, the embolic material of claim 21 with specific polymers at a specific weight ratio is obvious over Seo in view of Pawlik. Duran is relied upon to demonstrate that the microspheres for embolization can have a 164 µm diameter. Because the combined teachings of Seo, Pawlik, and Duran render the embolic material of claim 38 obvious, Applicant’s attempt to critique individual references in isolation fails to overcome the rejection.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Seo and Pawlik as applied to claims 21, 25-27, and 40 above, further in view of Kim et al. (Chemical Communications, 2010; cited on IDS filed Aug 22, 2023).
Seo and Pawlik are discussed above.
Neither Seo nor Pawlik discloses that the embolic material has depressions on its surface.
Kim discloses PLGA microparticles with a golf ball-like dimpled surface (abstract; Fig. 1) which reads on depressions on the surface of instant claim 39. Kim discloses that the dimpled surface can have advantages of reducing the drag force exerted on the microparticles when they are necessary to move in the fluid, similar to a golf ball with dimple structures (page 7433, col. 1, ¶ 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic materials of Seo and Pawlik by fabricating dimples on the surface. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Kim teaches that the particles can have a dimpled surface. Further, a person of ordinary skill in the art would have been motivated to utilize a dimpled surface in order to improve the delivery of embolic materials comprising a contrast agent. Accordingly, applying the teachings of Kim to the embolic materials of Seo and Pawlik constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 39 obvious.
Applicant argues that Kim does not address the composition or hydrophobic/hydrophilic polymer mixture at all. Applicant argues that none of the secondary references, alone or in combination, remedies the absence in Seo and Nakanishi of a mixture of two distinct biodegradable polymers with the claimed 0.33-3.0 mixing ratio for embolic materials.
This argument is unpersuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As discussed above, the embolic material of claim 21 with specific polymers at a specific weight ratio is obvious over Seo in view of Pawlik. Kim is relied upon to demonstrate that Kim teaches that the particles can have a dimpled surface. Because the combined teachings of Seo, Pawlik, and Kim renders the embolic material of claim 39 obvious, Applicant’s attempt to critique individual references in isolation fails to overcome the rejection.
Claims 21, 25-27, 35, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi et al. (JP 2007 325910 A; cited on IDS filed Aug 22, 2023; all citations from the machine translation accompanying the office action mailed December 5, 2025) in view of Seo (KR 100877696 B1; all citations from the machine translation) and Pawlik et al. (Materials Research Express, 2019; cited on PTO-892).
Nakanishi discloses a spherical particle produced by dispersing a solution of block copolymer and a contrast agent such as Lipiodol® (Abstract; Page 4, ¶ 12). The block polymer is obtained by copolymerizing a hydrophilic polymer segment such as PEG and a hydrophobic polymer segment such as PLGA (Page 4, ¶ 3). Regarding claims 35 and 37, Nakanishi discloses a method for producing spherical particles by adding a block copolymer solution dropwise to an aqueous solution while maintaining specific stirring and flow rates (Page 2, ¶ 10; Page 5 ¶ 5).
Nakanishi does not disclose a weight mixing ratio of the oil-based contrast agent to the biodegradable polymer of 1.0 to 2.0. Nakanishi does not disclose that the biodegradable polymer is a mixture of a hydrophobic biodegradable polymer such as polycaprolactone (PCL) and a hydrophilic biodegradable polymer such as PLGA, wherein the weight mixing ratio of the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0. Nakanishi does not disclose a content of the hydrophobic biodegradable polymer of 20 to 40% by mass when a content of the embolic material is 100% by mass.
As discussed above, Seo discloses nanoparticles comprising a Lipiodol® core and a biocompatible polymer film surrounding the core (Page 3, Lines 14-15; claim 1). Seo discloses that the Lipiodol®, an oil-based radiographic contrast medium made from poppy seed oil, is a drug widely known in clinical practice as an embolizing agent (Page 5, Lines 19-20), reads on an oil-based contrast agent. Seo discloses that the weight ratio of the biocompatible polymer and Lipiodol® can be 1:1 (Page 13, Lines 3-7; claim 4). Seo discloses that the content of Lipiodol® can be appropriately adjusted to a range that exhibits X-ray absorbency suitable for X-ray computed tomography contrast imaging (Page 6, Lines 1-3). Seo discloses that the biocompatible polymers can be PLA and PLGA (Page 6, Lines 11-15; claim 2). Seo discloses that the biocompatible polymers can be a PEGylated PLA (Page 6, Lines 11-15; claim 2) which is a biodegradable diblock copolymer comprising a hydrophilic biodegradable PEG block and a hydrophobic biodegradable PLA block.
As discussed above, Pawlik discloses the blending of biodegradable polymers PCL and PLGA (abstract). Pawlik discloses that the blending of two polymers can provide a good alternative to the relatively long and expensive route of synthesizing brand new polymers displaying desired properties (page 1, ¶ 1). Pawlik discloses that PCL and PLGA show good biocompatibility and distinct degradation rates, and that blending two well-known biomedical polymers by a simple, cost-effective, and reproducible method can be useful when designing materials for biomedical application with tailored properties and increased functionality (page 2, ¶ 2; page 12, ¶2). Pawlik discloses that the PCL/PLGA blending can provide controllable physicochemical properties depending on PCL/PLGA ratio (abstract). Pawlik discloses that the PCL/PLGA blend can be prepared at a volume ratio of PCL to PLGA (85 lactic acid:15 glycolic acid) at 50/50 (1:1) (page 2, ¶¶ 3-4). Because the densities of PCL and PLGA are similar (1.145 and 1.27 g/cm3), the weight ratio can be about 1:1 (1.0), which reads on the claimed range where the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic material of Nakanishi by making a weight mixing ratio of the oil-based contrast agent to the biodegradable polymer be 1.0, using a PCL/PLGA blend at a weigh mixing ratio of 1.0, and making the hydrophobic polymer constitutes about 25% of the total weight of the embolic material in order to tailor the degradation rate, mechanical strength, and release profile of the embolic material. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Seo teaches that the weight ratio of the polymer and Lipiodol® can be 1.0, and Pawlik teaches that a PCL/PLGA blend can be used for biomedical applications, and that the weight mixing ratio can be 1:1 to achieve desired characteristics. The combination of Seo and Pawlik teaches that the weight ratio of PCL:PCGA: Lipiodol® can be 25%:25%:50%. Further, a person of ordinary skill in the art would have been motivated to utilize a hydrophobic and hydrophilic polymer blend (mixture) in order to easily adjust the physical and chemical characteristics of the polymer according to the specific requirements of the target applications. Additionally, blending existing biocompatible polymers provides a predictable, cost-effective alternative to synthesizing new block copolymers without undue experimentation. Further, a person of ordinary skill in the art would have been motivated to optimize the weight ratios of contrast agent and polymer, and hydrophobic and hydrophilic polymers in the blend in order to adjust the degradation and release characteristics of the polymer according to the specific requirements of the target applications. The weight ratios are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of contrast agent and polymer, and the polymer contents in order to best achieve the desired embolic material characteristics and performance as taught by Seo and Pawlik. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05.
Claims 26 and 27 are product-by-process claims. The determination of patentability is based on the product itself and does not depend on its method of production. As discussed above, the embolic material of Nakanishi, Seo, and Pawlik renders the embolic material of claims 26 and 27 obvious. The embolic material of Nakanishi, Seo, and Pawlik possesses identical structural features and functional properties to the embolic material of claims 26 and 27. The embolic material of S Nakanishi, Seo, and Pawlik is the same product as would be produced by the process of claims 26 and 27. Therefore, instant claims 26 and 27 are not patentably distinguishable over Nakanishi in view of Seo and Pawlik.“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113.
Claim 40 is an intended use claim. The recitation of an intended use for a composition does not limit the scope of a product claim to that specific use unless the intended use results in a distinct structural difference between the claimed invention and the prior art. The intended use of polymeric embolic material to allow for recanalization after one or two weeks imparts no structural limitation and is of no patentable significance with respect to the structure of the composition. Patentability is determined by the composition’s structure, not its intended use or functional use. As discussed above, the embolic materials of Nakanishi in view of Seo and Pawlik are structurally the same as the claimed embolic materials, and the embolic materials of Nakanishi in view of Seo and Pawlik are inherently capable of achieving the use recited in claim 40. Inherency applies because the identical physical composition will naturally exhibit identical functional behavior under similar conditions. Because the intended use does not distinguish the claimed composition from the prior art and the prior art composition is structurally identical to the claimed composition, the recitation of the intended use in claim 40 carries no patentable weight. Accordingly, claim 40 is obvious
Applicant argues that the rejection is improper because Nakanishi discloses particles based on block copolymers and does not disclose a numerical weight mixing ratio between a hydrophobic biodegradable polymer and a hydrophilic biodegradable polymer in a mixture.
This argument is unpersuasive. As discussed above, Pawlik teaches a physical blend (mixture) of two distinct biodegradable polymers and a weight mixing ratio of the hydrophobic and hydrophilic polymers within the claimed range. Pawlik also provides a clear motivation to utilize such a blend over synthesizing complex block copolymers. A POSITA seeking to achieve tailored degradation rates and optimized physical and chemical properties would have been motivated to use the polymer blend of Pawlik as the polymer matrix for the embolic material of Nakanishi. Although Nakanishi alone may focus on block copolymers, block copolymers comprising hydrophobic and hydrophilic polymer blocks and blends (mixture) of hydrophobic and hydrophilic polymers function as technical equivalents because they perform substantially the same function, in substantially the same way, to achieve the same result. The resulting final product would have the same core-shell morphology, contrast retention capability, and controlled degradation characteristics as the claimed formulation. A POSITA would select the blend of polymers because of the benefits taught by Pawlik, namely achieving tailored degradation rates and physical stability while bypassing the complex, expensive synthesis required for block copolymers. A POSITA would reasonably expect that physical blending allows for straightforward tuning of the ratio of hydrophobic to hydrophilic components without requiring new chemical synthesis or altering the underlying chemical backbone of the individual polymers. The substitution of a recognized technical equivalent, a physical polymer mixture, for the block copolymer of Nakanishi yields entirely predictable results. Because using a known polymer blend to perform the exact same physical and functional role as a block copolymer falls well within the level of ordinary skill in the art, the combination remains obvious.
Claims 28 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi et al. (JP 2007 325910 A; cited on IDS filed Aug 22, 2023; all citations from the machine translation accompanying the office action mailed December 5, 2025) in view of Seo (KR 100877696 B1; all citations from the machine translation), Pawlik et al. (Materials Research Express, 2019; cited on PTO-892), Shea (US 2006 0002978), and Makadia et al. (Polymers 2011).
Regarding claims 28 and 32, as discussed above, Nakanishi discloses a spherical particle produced by dispersing a solution of block copolymer and a contrast agent such as Lipiodol® (Abstract; Page 4, ¶ 12). The block polymer is obtained by copolymerizing a hydrophilic polymer segment such as PEG and a hydrophobic polymer segment such as PLGA (Page 4, ¶ 3). Regarding claims 35 and 37, Nakanishi discloses a method for producing spherical particles by adding a block copolymer solution dropwise to an aqueous solution while maintaining specific stirring and flow rates (Page 2, ¶ 10; Page 5 ¶ 5).
Nakanishi does not disclose a weight mixing ratio of the oil-based contrast agent to the biodegradable polymer of 1.0 to 2.0. Nakanishi does not disclose that the biodegradable polymer is a mixture of a hydrophobic biodegradable polymer such as PLGA and a hydrophilic biodegradable polymer such as PLGA, wherein an amount of lactic acid in the hydrophobic PLGA is greater than an amount of glycolic acid, and an amount of glycolic acid in the hydrophilic PLGA is equal to or greater than an amount of lactic acid, wherein the weight mixing ratio of the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
As discussed above, Seo discloses nanoparticles comprising a Lipiodol® core and a biocompatible polymer film surrounding the core (Page 3, Lines 14-15; claim 1). Seo discloses that the Lipiodol®, an oil-based radiographic contrast medium made from poppy seed oil, is a drug widely known in clinical practice as an embolizing agent (Page 5, Lines 19-20), reads on an oil-based contrast agent. Seo discloses that the weight ratio of the biocompatible polymer and Lipiodol® can be 1:1 (Page 13, Lines 3-7; claim 4). Seo discloses that the content of Lipiodol® can be appropriately adjusted to a range that exhibits X-ray absorbency suitable for X-ray computed tomography contrast imaging (Page 6, Lines 1-3). Seo discloses that the biocompatible polymers can be PLA and PLGA (Page 6, Lines 11-15; claim 2). Seo discloses that the biocompatible polymers can be a PEGylated PLA (Page 6, Lines 11-15; claim 2) which is a biodegradable diblock copolymer comprising a hydrophilic biodegradable PEG block and a hydrophobic biodegradable PLA block.
As discussed above, Pawlik discloses the blending of biodegradable polymers PCL and PLGA (abstract). Pawlik discloses that the blending of two polymers can provide a good alternative to the relatively long and expensive route of synthesizing brand new polymers displaying desired properties (page 1, ¶ 1). Pawlik discloses that PCL and PLGA show good biocompatibility and distinct degradation rates, and that blending two well-known biomedical polymers by a simple, cost-effective, and reproducible method can be useful when designing materials for biomedical application with tailored properties and increased functionality (page 2, ¶ 2; page 12, ¶2). Pawlik discloses that the PCL/PLGA blending can provide controllable physicochemical properties depending on PCL/PLGA ratio (abstract). Pawlik discloses that the PCL/PLGA blend can be prepared at a volume ratio of PCL to PLGA (85 lactic acid:15 glycolic acid) at 50/50 (1:1) (page 2, ¶¶ 3-4). Because the densities of PCL and PLGA are similar (1.145 and 1.27 g/cm3), the weight ratio can be about 1:1 (1.0), which reads on the claimed range where the hydrophobic biodegradable polymer to the hydrophilic biodegradable polymer is 0.33 to 3.0.
As discussed above, Shea discloses blends of differing PLGA polymers which have the same constituent units but have distinct properties that can be used to take advantage of the properties of both (Page 12, ¶ 114).
As discussed above, Makadia discloses that the presence of methyl side groups in PLA makes it more hydrophobic than PGA and hence lactide rich PLGA copolymers are less hydrophilic compared to the PLGA copolymers having a lower amount of lactide (page 1379, Lines 6-7).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a blend of different PLGA polymers (hydrophilic PLGA and hydrophobic PLGA at a weight mixing ratio of 1.0, prepared by varying the ratio of lactic acid and glycolic acid) instead of the block copolymer of the embolic material of Nakanishi, wherein a weight mixing ratio of the contrast agent to the polymer is 1.0. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Seo teaches that the weight ratio of the polymer and Lipiodol® can be 1.0; Pawlik teaches that the weight mixing ratio of hydrophobic and hydropilic polymers can be 1:1 to achieve desired characteristics; Shea teaches that different PLGA polymers which have the same constituent units but have different properties can be blended; and Makadia teaches that PLGA polymers with different hydrophobicities can be obtained by varying the ratio of lactic acid and glycolic acid. Further, a person of ordinary skill in the art would have been motivated to prepare hydrophobic PLGA and hydrophilic PLGA by adjusting the amount of monomers (lactic acid and glycolic acid) in order to simply prepare hydrophilic and hydrophobic polymers. A person of ordinary skill in the art would have been motivated to utilize a blend of the polymers having the same monomer units rather than a blend of two different polymers in order to prevent chemical mismatch and phase separation, and to achieve better compatibility. Further, a person of ordinary skill in the art would have been motivated to optimize the weight ratio of contrast agent:polymer and hydrophobic polymer:hydrophilic polymer in the blend in order to adjust characteristics of the embolic material according to the specific requirements of the intended application. Such ratios are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of the polymer in order to best achieve the desired embolic material characteristics as taught by Seo and Pawlik. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05.
Claims 33 and 34 are product-by-process claims. The determination of patentability is based on the product itself and does not depend on its method of production. As discussed above, the embolic material of Nakanishi, Seo, Pawlik, Shea, and Makadia renders the embolic material of 33 and 34. The embolic material of Nakanishi, Seo, Pawlik, Shea, and Makadia possesses identical structural features and functional properties to the embolic material of claims 33 and 34. The embolic material of Nakanishi, Seo, Pawlik, Shea, and Makadia is the same product as would be produced by the process of claims 33 and 34. Therefore, instant claims 33 and 34 are not patentably distinguishable over Nakanishi in view of Seo, Pawlik, Shea, and Makadia. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi, Seo, and Pawlik as applied to claims 21, 25-27, 35, 37, and 40 above, further in view of Duran et al. (Theranostics, 2016; cited on IDS filed Aug 22, 2023).
Nakanishi, Seo, and Pawlik are discussed above.
None of Nakanishi, Seo, and Pawlik discloses that the embolic material has an average particle size of 100 to 500 µm.
As discussed above, Duran discloses a radiopaque bead for transarterial embolization (title). Duran discloses that the average size of the bead can vary with different physical properties, providing specific examples such as a 164 µm bead, (page 34, Tables 1 and 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic material of Nakanishi, Seo, and Pawlik to have a particle size of 164 µm. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Duran teaches that the microspheres for embolization can have a 164 µm diameter. Further, a person of ordinary skill in the art would have been motivated to adjust the particle size according to specific clinical application requirements. Particle size of the embolic material is a clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal size of the embolic material in order to best achieve the desired embolic material characteristics. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05. Accordingly, applying the teachings of Duran to the embolic materials of Nakanishi, Seo, and Pawlik constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 38 obvious.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi, Seo, and Pawlik as applied to claims 21, 25-27, 35, 37, and 40 above, further in view of Kim et al. (Chemical Communications, 2010; cited on IDS filed Aug 22, 2023).
Nakanishi, Seo, and Pawlik are discussed above.
None of Nakanishi, Seo, and Pawlik discloses that the embolic material has depressions on its surface.
As discussed above, Kim discloses PLGA microparticles with s golf ball-like dimpled surface (abstract; Fig. 1) which reads on depressions on the surface of instant claim 39. Kim discloses that the dimpled surface can have advantages of reducing the drag force exerted on the microparticles when they are necessary to move in the fluid, similar to a golf ball with dimple structures (page 7433, col. 1, ¶ 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic materials of Nakanishi, Seo, and Pawlik by fabricating dimples on the surface. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Kim teaches that the particles can have a dimpled surface. Further, a person of ordinary skill in the art would have been motivated to utilize a dimpled surface in order to improve the delivery of embolic materials comprising a contrast agent. Accordingly, applying the teachings of Kim to the embolic materials of Nakanishi, Seo, and Pawlik constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 39 obvious.
Conclusion
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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