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.
Status of the Claims
The response filed 02/24/2026 is acknowledged.
Claims 14-17 and 19-24 are pending.
Applicant’s election of Group 2, claims 14-17 in the reply filed on 09/05/2025 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 14-17 and 19-24 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 Rejections not reiterated herein have been withdrawn.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive.
Applicant has argued Provonchee teaches unique methods to make specific agaroid structures allowing them to have particular properties compared to conventional agaroid structures for embolization methods (see Paragraph [003]). Applicant has argued Provonchee does not relate to just any agaroid structures but to very specific ones. Applicant has argued Provonchee explains that agarose is one of the two principal components of agar and is purified from agar by removing agar's other component, which is agaropectin (Paragraph [0002]). Applicant argues that is why such agarose (or agaroid) can be obtained from agar-agar. Applicant has argued there is no doubt that a person skilled in the art reading Provonchee will interpret the expression "agaroid structure" as a structure made of agarose (optionally as a mixture with water and glycol), and not a structure made of agar-agar, i.e. comprising a mixture of agarose and agaropectin. Applicant has argued the lack of agaropectin in the disclosed agaroid structure of Provonchee is a fundamental difference with the claimed method which comprises the use of compositions made of at least 95% of agar-agar, i.e., necessarily comprising both components of agar-agar, namely agarose and agaropectin, as disclosed in the present application on page 2, lines 15-25, and page 3, lines 7-10.
These arguments are unpersuasive. Applicant’s arguments acknowledge that Provonchee teaches agar. Applicant’s arguments acknowledge that Provonchee teaches agarose is a component of agar. Applicant’s arguments acknowledge that Provonchee teaches agar is agarose and agaropectin, i.e., agar agar. Applicant’s arguments acknowledge that Provonchee makes a distinction between agar, i.e., agar agar, and agarose.
The teachings of Provonchee are not limited to agarose. As pointed out in the previous office action, Provonchee teaches the agaroid may be agar, i.e., agar agar, or agarose (Provonchee, e.g., 0015). Thus, the skilled artisan would understand the term “agaroid” as used in Provonchee refers to a genus of specific agar compounds including agar agar. That is, the skilled artisan understood “agaroid” as used in Provonchee is not limited to the exemplified agarose. Rather, the skilled artisan understood Provonchee teaches the agaroid may be agar, i.e., agar agar, or agarose. Alternative embodiments taught by Provonchee, i.e., wherein the agaroid is agar agar or agarose constitutes a prior art teaching of agar agar as claimed. See MPEP 2123, II.
If Provonchee intended agaroid to refer only to agarose, Provonchee would have used the term agarose rather than agaroid. Since Provonchee acknowledges that agar is a mixture of agaropectin and agarose, and since Provonchee teaches the agaroid may be agar or agarose, it is clear that the skilled artisan understood that any embodiment exemplified with agarose may be equivalently embodied with agar agar. Therefore, the skilled artisan would have clearly understood that Provonchee’s method of embolization – hemostatic occlusion of a vessel – using an agaroid matrix found in ¶s 0066-0069 was a teaching that the method may be practiced with agar agar or agarose as the agaroid matrix material (Provonchee, e.g., 0066-0069).
Since Provonchee teaches the agaroid matrix as pure agarose (Provonchee, e.g., 0040-0044), the skilled artisan understood the agaroid matrix may alternatively be made similarly using pure agar, i.e., pure agar agar.
Since Provonchee teaches the agaroid material swells to occlude the site in which it is placed, and since Provonchee teaches the agaroid material is hemostatic (Provonchee, e.g., 0066-0069), it appears Applicant’s observed embolization properties are expected results. Further, Provonchee teaches the agaroid materials enjoy a high degree of biocompatibility, low cost, and ease of processing (Provonchee, e.g., 0071). Thus, Applicant’s observation of safety and absence of toxicity for patients is an expected result.
Since Provonchee teaches practicing the method with agar – which contains both agaropectin and agarose as acknowledged by Applicant – Provonchee teaches practicing the method with a dry foam made of pure agar agar containing both agarose and agaropectin.
Since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having an elasticity modulus in the claimed range, e.g., 0.02 MPa to 0.6 MPa (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has the claimed elasticity modulus.
Similarly, since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having a maximum compressive strength in the claimed range, e.g., from 0.008 to 0.11 MPa (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has the property of a maximum compressive strength recited in claim 19.
Similarly, since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having a density in the claimed range, e.g., from 0.01 to 0.042 g/cm3 (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has a density as recited in claim 20.
The claimed invention asserts that any dry foam comprising at least 95% agar agar has the claimed properties. The prior art teaches practicing the method with the same structure, i.e., dry foam comprising at least 95% agar agar. Further, the specification suggests the elasticity modulus, the maximum compressive strength and the density are all properties of a pure agar agar matrix formed by methods which comprise mixing agar agar in water at a concentration ranging from 1.5-7%. The prior art, e.g., Provonchee and Shin, teach practicing the embolization method using a pure agar agar matrix material prepared in substantially the same way. Since the prior art teaches the same structure, i.e., a dry foam comprising pure agar agar, made using a similar process, e.g., matrix obtained by drying an agar agar precipitate obtained from water at a concentration of about 1 to about 5% to optimize the swelling ratios around body temperature, the properties claimed are presumed to be inherent to the agar agar matrix material used in the prior art embolization method.
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 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 14-15, 19-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Provonchee, US 20200181293 A1 in view of Shin, KR 101875115 B1.
Provonchee teaches a method for embolization comprising placing a hemostatic sponge like agaroid matrix in a blood vessel (Provonchee, entire document, e.g., 0066-0069). Provonchee teaches wherein the agaroid matrix is agar corresponding to the claimed ‘agar agar’ (Provonchee, e.g., 0015). Provonchee teaches the agaroid matrix may be pure agar (Provonchee, e.g., 0040-0044) which is at least 95%. The agar sponge may be inserted dry (Provonchee, e.g., 0063 and 0068). Vessels in need of occlusion with a hemostatic agent are vessels with abnormal blood flow.
From Provonchee, it would have been obvious before the effective filing date of the presently claimed invention to practice a method comprising inserting a sponge like (foam) agar matrix in a blood vessel to achieve hemostasis (stop blood flow) with a reasonable expectation of success. The teachings of Provonchee provide express teachings which would have led the skilled artisan to practice a method having the recited steps for embolic effect in a blood vessel by occluding the vessel with an agar sponge material.
Provonchee does not expressly teach the elasticity modulus ranges from 0.02 to 0.6 MPa.
However, the properties of the foam are inherent to the composition of the foam.
The specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having an elasticity modulus in the claimed range.
Shin teaches agar materials processed for various fields including pharmaceutical products, cosmetics, wound dressings, medicine, or prosthetics (Shin, e.g., 0003, 0022). Shin teaches foams made from agar concentrations ranging from about 1 to about 5% exhibit the highest swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136). Thus, the concentration of agar used to prepare the foam was recognized in the art as a result effective parameter useful to achieve a desired degree of swelling at body temperature. The skilled artisan would have found this teaching in Shin useful to optimize the swelling degree of Provonchee’s agar sponge in the same way, thereby optimizing the body temperature swelling of the agar sponge used in the method to fill (occlude) an occlusion site (Provonchee, entire document, e.g., 0063 and 0067-0068). 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.
It would have been obvious before the effective filing date of the presently claimed invention to modify methods for embolizing vessels by optimizing the concentration of agar used to prepare hemostatic agar sponges in Provonchee’s methods of embolization as informed by the teachings of Shin to improve the swelling degree in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to prepare a foam using a concentration of agar ranging from about 1 to about 5 as suggested by Shin to optimize the degree of swelling at body temperature in the same way. The skilled artisan would have had a reasonable expectation of success since Provonchee suggests enhanced swelling will result in a desired degree of vessel occlusion and helps maintain the material in the desired position.
Applying the teachings of Shin to Provonchee, the skilled artisan would have practiced embolic methods using an agar sponge made from a concentration of agar for optimal swelling which is also the concentration of agar which results in an elasticity modulus in the claimed range. The skilled artisan would have practiced the method with an agar foam having an elastic modulus in the claimed range because the foams made using a concentration of agar for optimal swelling at body temperature from Shin also have an elasticity modulus in the claimed range as evidenced by the specification, e.g., table 1. Thus, the claimed properties appear to be inherent to the agar foams of the prior art.
Applicable to Claim 14: Since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having an elasticity modulus in the claimed range, e.g., 0.02 MPa to 0.6 MPa (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has the claimed elasticity modulus.
Applicable to claim 15: Provonchee teaches inserting the spongy agaroid matrix for hemostatic effect which means the vessel has undesired blood flow.
Applicable to claim 19: Since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having a maximum compressive strength in the claimed range, e.g., from 0.008 to 0.11 MPa (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has the property of a maximum compressive strength recited in claim 19.
Applicable to claim 20: Since the combined teachings of Provonchee and Shin teach practicing the embolization method with pure a pure agar agar matrix which has been made from agar concentrations ranging from about 1 to about 5% to optimize the swelling ratios around body temperature, e.g., 30°C to 40°C (Shin, e.g., 0136); and since specification indicates foams prepared from agar concentrations ranging from 1.5% to 7% result in a foam having a density in the claimed range, e.g., from 0.01 to 0.042 g/cm3 (Specification, e.g., pg. 6:5-8), the combined teachings of Provonchee and Shin would have led the skilled artisan to practice Provonchee’s method of embolization using a pure agar agar matrix which naturally has a density as recited in claim 20.
The claimed invention asserts that any dry foam comprising at least 95% agar agar has the claimed properties. The prior art teaches practicing the method with the same structure, i.e., dry foam comprising pure agar agar. Further, the specification suggests the elasticity modulus, the maximum compressive strength and the density are all properties of a pure agar agar matrix formed by methods which comprise mixing agar agar in water at a concentration ranging from 1.5-7%. The prior art, e.g., Provonchee and Shin, teach practicing the embolization method using a pure agar agar matrix material prepared in substantially the same way. Since the prior art teaches the same structure, i.e., a dry foam comprising pure agar agar, made using a similar process, e.g., matrix obtained by drying an agar agar precipitate obtained from water at a concentration of about 1 to about 5% to optimize the swelling ratios around body temperature, the properties claimed are presumed to be inherent to the agar agar matrix material used in the prior art embolization method.
Applicable to claim 22: Provonchee teaches the foam has interconnected pores which means the dry foam has an open porosity.
Applicable to claim 23: Provonchee does not teach the foam has a uniform pore size or distribution. Therefore, Provonchee appears to teach wherein the foam is non-uniform.
Accordingly, the subject matter of claims 14-15, 19-20, and 22-23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 14-17, 19-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Provonchee, US 20200181293 A1 in view of Shin, KR 101875115 B1 as applied to claims 14-15, 19-20, and 22-23 above, and further in view of Kipshidze, US 20200268670 A1.
The combined teachings of Provonchee and Shin enumerated above apply here.
The combined teachings of Provonchee and Shin teach a method of vessel embolization according to claim 14.
The combined teachings of Provonchee and Shin do not expressly teach wherein the blood vessel supplies blood to a cancer. However, the teachings of Kipshidze cures this defect.
The limitation of “a cancer” is interpreted to read on a tumor.
Kipshidze teaches embolic methods for treating tumors wherein the embolic agent is placed in blood vessels that supply blood to tumors (Kipshidze, entire document, e.g., Abstract). The method is practiced to treat a tumor (Kipshidze, e.g., entire document, e.g., claim 1). The method may be practiced to improve delivery of anticancer therapeutic agents (Kipshidze, entire document, e.g., 0063). Kipshidze desires effective vessel occlusion to prevent complete systemic release of anticancer agents (Kipshidze, e.g., 0037 and 0062-0063) and to reduce interstitial fluid pressure at the location of the solid tumor thereby improving local delivery of anticancer agents (Kipshidze, e.g., 0029-0033). Kipshidze does not expressly teach the embolic agent is at least 95% agar agar having an elasticity modulus in the claimed range. However, this defect is cured by the teachings of Provonchee and Shin.
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Provonchee, Shin, and Kipshidze to arrive at a method as claimed with a reasonable expectation of success.
Starting from the combined teachings of Provonchee and Shin, the skilled artisan would have been motivated to practice embolic methods suggested by the combined teachings of Provonchee and Shin by inserting the agar sponge in a blood vessel which supplies blood to a tumor with a reasonable expectation of success. The skilled artisan would have been motivated to practice a method in this manner for improved tumor treatment, e.g., local delivery of anticancer agents, in the same way reported by Kipshidze. The skilled artisan would have had a reasonable expectation of success because the combined teachings of Provonchee and Shin teach methods for occluding naturally occurring vessels in body and Kipshidze identifies blood vessels which supply blood to tumors were known naturally occurring vessels which are in need of occlusion to improve treatment of cancer in subjects.
Starting from Kipshidze, the skilled artisan would have been motivated to practice Kipshidze’s embolic methods using an agar foam embolizing agent for the hemostatic, swelling, and effective vessel occlusion properties combined with reduced tissue trauma, improved location retention, and ease of application as reported in the combined teachings of Provonchee and Shin. The skilled artisan would have had a reasonable expectation of success because the agar foam is reported to swell upon delivery at the occlusion site thereby essentially filling the occlusion site with a hemostatic material which would have reasonably been expected to prevent complete systemic release of anticancer agents, and improve local delivery of therapeutic substances to the tumor desired by Kipshidze.
Applicable to claim 17: Provonchee teaches the agar foam further comprising therapeutic agents (Provonchee, e.g., 0011) which may be selected based on the intended use of the agaroid (Provonchee, e.g., 0004). Provonchee teaches a number of agents (Provonchee, e.g., 0064) but does not expressly teach wherein the agent is an anticancer drug. Kipshidze teaches the method as effective for improving delivery of anticancer drugs to the tumor (Kipshidze, e.g., 0063). It would have been obvious before the effective filing date of the presently claimed invention to practice the method with an agar foam further comprising an anticancer agent since Kipshidze suggests the anticancer agent may be delivered in the method by agarose and since Provonchee teaches the agar foam may contain therapeutic agents for delivery selected according to the intended use.
Accordingly, the subject matter of claims 14-17, 19-20, and 22-23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Provonchee, US 20200181293 A1 in view of Shin, KR 101875115 B1 as applied to claims 14-15, 19-20, and 22-23 above, and further in view of Molaei, US 20130253572.
The combined teachings of Provonchee and Shin enumerated above apply here.
The combined teachings of Provonchee and Shin teach a method of vessel embolization according to claim 14.
Provonchee teaches the porosity and pore size may be optimized using known techniques (Provonchee, e.g., 0033, 0071-0074).
The combined teachings of Provonchee and Shin teach wherein the agaroid matrix a dried foam, i.e., sponge which is dried (Provonchee, e.g., 0036, 0050, 0066-0068) and is porous, e.g., comprising interconnected pores (Provonchee, e.g., 0070-0075 and claims 1-2 and 17).
The combined teachings of Provonchee and Shin do not expressly teach the dried sponge agar matrix having a porosity in the range of 75% to 95% or in the range of 80% to 85%.
The combined teachings of Provonchee and Shin do not expressly teach the dried sponge agar matrix having an average pore size in the range of 250-700 microns or 400-600 microns, and a median pore size in the range of 200-400 microns or 200-300 microns.
However, Molaei teaches occlusive devices (Molaei, e.g., title, abstract, claims) comprising a device having embolic properties so as to interfere with blood flow in the body space, in which the occlusive device is employed (Molaei, e.g., 0064). Molaei teaches the porosity and average pore size are optimizable variables effective to optimize the occlusive properties of the device (Molaei, e.g., 0065-0066). For example, Molaei teaches configuring the device with an average pore size that is less than or equal to 500 microns, e.g., less than about 320 microns, e.g., from about 50 microns to 320 microns, and wherein the pore size is generally constant, i.e., the median pore size is within the claimed range (Molaei, e.g., 0065 and 0066).
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.
It would have been obvious before the effective filing date of the presently claimed invention to modify a method for embolization and vessel occlusion suggested by the combined teachings of Provonchee and Shin by optimizing the pore size and porosity of the dry agar sponge as taught by Molaei to improve the occlusion of blood flow in the same way with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar occlusive devices in the same way. The skilled artisan would have been motivated to optimize the pore size and porosity of the agar sponge within the ranges suggested by Molaei for increased blood flow interference and sufficient thrombosis formation to result in improved occlusion of the vessel in the same way. The skilled artisan would have had a reasonable expectation of success since Provonchee teaches the pore size and porosity of the porous agar sponge may be varied using known techniques.
Accordingly, the subject matter of claims 21 and 24 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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.
Correspondence
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615