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 .
Response to Amendment
Applicant’s response of 03/02/2026 has been received and entered into the application file. Claims 1-20 are pending in this application.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeginsu et al. (Bioglass as a pleurodesing agent as effective as talc in rabbits, Turkish Journal of Thoracic and Cardiovascular Surgery, 2005).
Yeginsu discloses that bioglass is a silica-based biomaterial and has a crystalline structure as talc. Because of the structural similarity of these materials, authors hypothesized that bioglass may have pleural inflammatory effects and cause pleurodesis when administered intrapleurally (pg 387, left col). The rabbit model of pleurodesis showed that bioglass provided an effective pleurodesis which was very similar to that of talc. Similar doses of bioglass and talc produced nearly an equivalent degree of pleurodesis in rabbits. Silicon dioxide, the major content of bioglass, is a crystalline type of silica (pg 388). Bioglass is biocompatible, nontoxic, and non-inflammatory bioactive material (pg 389, right col, 1st paragraph). In conclusion, bioglass is an effective pleurodesing agent and its effectiveness is comparable to that of talc (pg 390, left col, last paragraph). Bioglass forms gel-hydroxycarbonate apatite-bone when bonded with living bone and soft tissues (pg 389, left col, 2nd paragraph).
Yeginsu teaches a method of generating pleurodesis with a crystalline material (carbonate apatite). Therefore, claims 1 is anticipated.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yeginsu et al. (Bioglass as a pleurodesing agent as effective as talc in rabbits, Turkish Journal of Thoracic and Cardiovascular Surgery, 2005), Guo et al. (CN 101756908), and Tomoda (Hydroxyapatite particles as drug carriers for proteins, Colloids and Surfaces Biointerfaces, 2010).
Yeginsu discloses that bioglass is a silica-based biomaterial and has a crystalline structure as talc. Because of the structural similarity of these materials, authors hypothesized that bioglass may have pleural inflammatory effects and cause pleurodesis when administered intrapleurally (pg 387, left col). The rabbit model of pleurodesis showed that bioglass provided an effective pleurodesis which was very similar to that of talc. Similar doses of bioglass and talc produced nearly an equivalent degree of pleurodesis in rabbits. Silicon dioxide, the major content of bioglass, is a crystalline type of silica (pg 388). Bioglass is biocompatible, nontoxic, and non-inflammatory bioactive material (pg 389, right col, 1st paragraph). In conclusion, bioglass is an effective pleurodesing agent and its effectiveness is comparable to that of talc (pg 390, left col, last paragraph). Bioglass forms gel-hydroxycarbonate apatite-bone when bonded with living bone and soft tissues (pg 389, left col, 2nd paragraph).
Yeginsu teaches carbonate apatite, but does not explicitly mention hydroxyapatite.
Guo discloses hydroxyapatite microspheres used for encapsulating small molecule drugs with sustained release of the drug (pg 1). The biodegradable and absorbable hydroxyapatite microspheres are used as a carrier material for adsorbing drugs. The hydroxyapatite microspheres can be prepared from nano-hydroxyapatite particles by a spray drying method. Hydroxyapatite microspheres are loaded with suitable small-molecule drugs on the surface or inside, and then used as a medicinal product that is biodegradable and absorbable and is allowed to be implanted under the endothelium, intramuscular, or bone parts of the body (pg 2, Summary of the Invention). The surface of hydroxyapatite has a large number of adsorption sites. Usually, the drugs are adsorbed on the surface of hydroxyapatite. Hydroxyapatite microspheres can encapsulate many drugs such as doxycycline, bleomycin (pg 3, 4th paragraph).
Guo does not explicitly mention the crystalline material being spherical, amorphous or sintered.
Tomoda discloses hydroxyapatite (HA) particles as drug carriers for proteins. Tomoda discloses that hydroxyapatite particles were prepared by three methods including solvent diffusion methods, the method using sintering porous HA microgranules. Complicated spiky crystals were prepared by solvent diffusion method, whereas spherical amorphous agglomerates were prepared by sintering of porous HA granules (Abstract). As an injectable drug carrier, HA with the spherical shape having the surfaces of high adsorption capacity for proteins is proper, since spherical shape can minimize the damage to patients and high adsorption capacity and slow release of proteins from HA can maintain therapeutic concentration of proteins for long time (pg 226, right col).
Yeginsu discloses that bioglass (carbonate apatite) can generate pleurodesis. Guo discloses that hydroxyapatite is used to encapsulate or adsorb various drugs. Tomoda discloses that hydroxyapatite can be prepared in various methods to yield spherical, amorphous shapes through sintering. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to generate pleurodesis by using hydroxyapatite encapsulating fusogenic substance. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 2-3, carbonate apatite is disclosed above. Furthermore, one of ordinary skill in the art would experiment with different forms of apatite (such as hydroxyapatite which is routinely used to encapsulate various drugs) to potentially generate pleurodesis in a subject.
Regarding claims 4-6, sintered, spherical, amorphous crystalline materials are disclosed by Tomoda. The methods are widely used by one of ordinary skill in the art.
Regarding claims 7-10, hydroxyapatite adsorbing fusogenic substance such as doxycycline is discussed above.
Regarding claim 11, Guo discloses that the carrier can be degraded or absorbed in the human body (pg 3, 1st paragraph).
Regarding claim 12, Yeginsu discloses that the rabbits were randomly divided into three groups – equal doses of bioglass or talc were given through the chest tube (pg 387, Surgical Procedure). Guo teaches adsorbing one or more drugs to biodegradable and absorbable hydroxyapatite microspheres as the carrier material as discussed above. One of ordinary skill in the art would be motivated to use other crystalline material that can encapsulate fusogenic substance for delivering drugs to the lungs of a mammalian subject.
Regarding claims 13-14, hydroxyapatite is discussed above.
Regarding claims 15-17, hydroxyapatite encapsulating fusogenic substance is discussed above.
Regarding claims 18-19, doxycycline and bleomycin are discussed above. Yeginsu discloses that many chemicals (tetracyclines, povidone-iodone) and biologic agents have been used for pleurodesis (pg 389, right col, last paragraph)
Regarding claim 20, one of ordinary skill in the art would certainly contemplate a mammalian subject to be human if the research is geared to create new drug delivery carriers for human conditions.
Response to Arguments
Applicant’s arguments filed 03/03/2026 have been fully considered but they are not persuasive.
On page 1 of remarks, applicant argues that Yeginsu does not disclose every element of Applicants’ claimed invention. Specifically, “administering a crystalline material that is cleared over time by biodegradation”. Yeginsu teaches using bioglass for pleurodesis and bioglass was found to be effective at pleurodesing similar to Talc (pg 387, Results section). One of ordinary skill in the art would immediately envisage that bioglass has pleurodesing properties. Further evidenced by MO SCI (Bioactive Glass, Aug 2018), bioactive glasses have the ability to bond to soft and/or hard tissues and are biodegradable in the body (page 1). Biodegradation is an inherent property of bioglass and thus the bioglass as a pleurodesing agent taught by Yeginsu would inherently biodegrade over time. Yeginsu teches that similar doses of bioglass and talc produced nearly an equivalent degree of pleurodesis in rabbits. The effect of bioglass may be attributable to its silicon dioxide content similar to talc’s. Silicon dioxide, the major content of bioglass, is a crystalline type of silica (pg 388). Claim 1 of instant application does not describe specific particles but rather any and all particles comprising a crystalline material. Therefore, anticipation of claim 1 is maintained. Yeginsu does mention that bioglass can bond the living bone and soft tissues, but the basis of this bonding depends on its chemical reactivity with body fluids.
On page 2 of remarks, applicant argues that there is nothing in the disclosure of Yeginsu that would lead one skilled in the art to believe that carbonate apatite, without the bioglass, would be useful for pleurodesis. However, claim 1 does not exclude bioglass. The argument is not commensurate in scope of claim 1.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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