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 .
Claims 1-20 are pending and under examination.
Priority
Acknowledge is made that this application is continuation of US patent application 18368097, filed on 09/14/2023; which is continuation of US patent application 17399320, filed on 08/11/2021; which is continuation of US patent application 16483830, filed on 08/06/2019; which is national stage of international patent application PCT/KR2018/001617, filed on 02/06/2018; which claims priority from US provisional application 62/455148, filed on 02/06/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2025, 06/02/2025 and 10/29/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Won (WO2016013751, English translation relying on US equivalent US20170172923).
The limitation of claims 1-6 and 12-16 is met by Won disclosing A composition for delivering a bioactive material include a porous silica nanoparticle containing pores with an average pore diameter ranging from 1 nm to 100 nm, at least one of (i) a functional group which binds to the pore surface of the porous silica nanoparticle and gives the pore surface a negative charge or a positive charge, (ii) a ligand which binds to the pore surface of the porous silica nanoparticle and specifically binds to the bioactive material, and (iii) a combination of the functional group and the ligand, and a bioactive material having a size to be accommodated within the pores of the porous silica nanoparticle, the bioactive material bound to said at least one of the functional group and the ligand bound to the pore surface of the mesoporous silica nanoparticle and accommodated within the pores of the porous silica nanoparticle while the bioactive agent is cell-permeable peptide A (abstract; page 12-13, example 1, [0146-0152]; Fig. 11; claims 1-3 and 12-13, 17-18). In the above 102 rejections, Won is silent about all the properties including absorbance in claims 1-6, however, Won discloses a porous silica in example 1 obtained from a substantially same process and same starting materials as the applicant’s example 1(1) of specification. The inventive porous silica particle in applicant’s working example is expected to have all the properties in the claims 1-6 in the absence of evidence to the contrary. Therefore, the porous silica in Won is expected to be the same or substantially same as the inventive porous silica in working example, which reads on and discloses porous silica in claims 1 and 3-6. The principle of law states from MPEP 2112: II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the same or substantially same purpose silica is expected to have all the same properties. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claims 7-10, the limitation is met by Won disclosing porous silica particle with pore size of 28±2nm, BET surface area 388m2/g, pore volume 1.47 mL/g (page 13, [0151]) and particle size of 267±46nm (page 15, [0175]).
Regarding claim 11, the limitation is met by Won disclosing the ratio of active agent and porous silica particle 1:10 (page 13, [0155]).
Regarding claims 17-18, the limitation is met by Won disclosing growth hormone which is peptide hormone ([0054]).
Regarding claim 19-20, the limitation is met by Won disclosing subcutaneous administration (page 19, [0204]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 Won (WO2016013751, English translation relying on US equivalent US20170172923).
In arguendo that applicant’s claimed invention is not anticipated by Won, it is still obvious in the following analysis.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Won teaching in the above 102 rejection are incorporated herein by reference. The procedure to make the porous silica particle is also included herein.
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Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Won is that Won is not specific enough for anticipated.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
The limitation of claims 1-6 and 12-16 is met by Won teaching A composition for delivering a bioactive material include a porous silica nanoparticle containing pores with an average pore diameter ranging from 1 nm to 100 nm, at least one of (i) a functional group which binds to the pore surface of the porous silica nanoparticle and gives the pore surface a negative charge or a positive charge, (ii) a ligand which binds to the pore surface of the porous silica nanoparticle and specifically binds to the bioactive material, and (iii) a combination of the functional group and the ligand, and a bioactive material having a size to be accommodated within the pores of the porous silica nanoparticle, the bioactive material bound to said at least one of the functional group and the ligand bound to the pore surface of the mesoporous silica nanoparticle and accommodated within the pores of the porous silica nanoparticle while the bioactive agent is miRNA (abstract; page 12-13, example 1, [0146-0152]; Fig. 11; claims 1-3 and 12-13, 17-18). In the above 102 rejections, Won is silent about all the properties including absorbance in claims 1-6, however, Won discloses a porous silica in example 1 obtained from a substantially same process and same starting materials as the applicant’s example 1(1) of specification. The inventive porous silica particle in applicant’s working example is expected to have all the properties in the claims 1-6 in the absence of evidence to the contrary. Therefore, the porous silica in Won is expected to be the same or substantially same as the inventive porous silica in working example, which reads on and discloses porous silica in claims 1 and 3-6. The principle of law states from MPEP 2112: II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the same or substantially same purpose silica is expected to have all the same properties. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claims 7-10, the limitation is met by Won teaching porous silica particle with pore size of 28±2nm, BET surface area 388m2/g, pore volume 1.47 mL/g (page 13, [0151]) and particle size of 267±46nm (page 15, [0175]).
Regarding claim 11, the limitation is met by Won teaching the ratio of active agent and porous silica particle 1:10 (page 13, [0155]).
Regarding claims 17-18, the limitation is met by Won teaches growth hormone which is peptide hormone
Regarding claim 19-20, the limitation is met by Won teaching subcutaneous administration (page 19, [0204]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11786469. Both reference application and applicant’s claimed invention direct towards a composition comprising a porous silica and bioactive agent peptide (claim 4), it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11530132 in view of Won (WO2016013751, English translation relying on US equivalent US20170172923). Both reference application and applicant’s claimed invention direct towards a composition comprising a porous silica and bioactive agent, in view of Won teaching the same porous silica and peptide as bioactive agent, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11129796 in view of Won (WO2016013751, English translation relying on US equivalent US20170172923). Both reference application and applicant’s claimed invention direct towards a composition comprising a porous silica and bioactive agent, in view of Won teaching peptide as bioactive agent, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11793757 in view of Won (WO2016013751, English translation relying on US equivalent US20170172923). Both reference application and applicant’s claimed invention direct towards a composition comprising a porous silica, in view of Won teaching peptide as bioactive agent, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12138346 in view of Won (WO2016013751, English translation relying on US equivalent US20170172923). Both reference application and applicant’s claimed invention direct towards a composition comprising a porous silica, in view of Won teaching peptide as bioactive agent, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG, Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached on M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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