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 .
Election/Restrictions
Applicant's election with traverse of claims 1-8 and 13-19 in the reply filed on June 16, 2026 is acknowledged.
Claims 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on June 16, 2026.
In the response, it was argued that that unity of invention does exist between Groups I-III (see Response pages 2-4). In the response, it was argued that there is a technical relationship that involves the same special technical feature. This argument is deemed unpersuasive. The lack of unity is made a posteriori, so the shared technical feature applicant argues is acknowledged but it does not make a contribution over the prior art.
In the response, it was argued that “a search of all the claims would not impose a serious burden on the Office” (see Response page 3). This argument is deemed unpersuasive. In the present application, each of the Groups have a serious search burden either due to their recognized divergent subject matter, their different classifications, their different search queries and/or different search strategies, and/or the use of different electronic resources to search for each separate Group. It is noted that Group I can be classified as B01J 20/3217, Group II can be classified as B01J 20/3092, and Group III can be classified as B01J 2220/52.
The requirement is still deemed proper and is therefore made final.
In the next reply to the Office, Applicant must provide the Office with an updated claim set with the correct status identifier for each claim (see MPEP 1893.01(a)(1)). A Notice of Non-Compliant will be issued if an updated claim set with the correct status identifiers are not provided.
Claim Objection
Claim 5 recites “method of claim 1, wherein…”. Claim 5 does not begin with “The”. It is respectfully requested that claim 5 be amended as follows “The method of claim 1…”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “a first sieve having a mesh opening of 10% or greater and smaller than 200%, with respect to a mean volume diameter of the solid phase support before sieve classification (2a-d) as 100%”. Claim 5 is deemed indefinite because the claimed mesh opening of 10% or greater and smaller than 200% limitation is based upon an unknown element, i.e. “a mean volume diameter of the solid phase support before sieve classification (2a-d) as 100%”. The claimed opening of the claimed second sieve having a mesh is deemed indefinite for similar reasonings.
Claim 5 is deemed indefinite because it is unclear what “sieve classification (2a-d)” means. The as-originally filed specification does not provide a definition for the term “sieve classification (2a-d)”. It is unclear the meaning of “(2a-d)”. Also, claim 5 recites “sieve classification” and “sieve classification (2a-2d)”. It is unclear if these are two separate and distinct limitations.
Claim 5 recites “a sieve classification with a first sieve” and “a sieve classification of the residue with a second sieve”. Claim 5 also recites “a residue over a sieve”. Claim 5 is deemed indefinite because it is unclear what “sieve” is in reference to, i.e. a first sieve, a second sieve or some other sieve element. For the sake of compact prosecution, “a residue over a sieve” is understood as being over the first sieve.
Claim 5 is deemed indefinite because it recites that step (2a) and step (2b) may be formed in either order but step (2b) requires the claimed residue that is formed in step (2a). It is unclear how step (2b) can be formed first, which is “performing a sieve classification of the residue with a second sieve”, when the claimed residue has not been recovered.
Claim 15 recites “the mesh opening is of 62% or greater and 90% or less of the particle size of the solid phase support before the sieve classification (2a-d)”. Claim 15 is deemed indefinite. It is unclear if the “mesh opening” is in relation to the first sieve or the second sieve. For the sake of compact prosecution, claim 15 is understood as the mesh opening of the first sieve or the second sieve.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5-8, 13 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2017037069 A (hereinafter JP 069 (Citations correspond to the accompanying machine generated translation).
Regarding claim 1, JP 069 discloses “a separation agent suitably used as a packing material for chromatography, and more particularly to a separation agent having high selectivity for biomacromolecules such as proteins, a method for producing the same, a separation method using the separation agent, and a chromatography column. a method for producing a chromatography carrier” (see JP 069 paragraph 0001) and a method of forming said separation agent (see JP 069 abstract, paragraphs 0008-0012, 0088), which is deemed a method for producing a chromatography carrier.
JP 069 discloses the porous particles are subjected to a sieve classification wherein the porous particles larger than 32 micrometers are collected using a sieve with a 32-micrometer opening and then passed through a sieve with a 53-micrometer mesh opening (see JP 069 paragraph 0082) to yield the final particles being between 32-53 micrometers (see JP 069 paragraph 0082), which is deemed subjecting a solid phase support to sieve classification.
JP 069 discloses the separating agent comprises porous particles made of a crosslinked synthetic polymer and an affinity-adsorbing ligand covalently bonded and immobilized to the porous particles (paragraph 0011), which is deemed solid phase support being formed of porous particles on which a ligand has or has not been immobilized.
JP 069 does not disclose a variation coefficient of volume particle size distribution of the porous particles when the ligand has been immobilized is adjusted to be in a range of from 1% to 22%, and wherein a skewness of the volume particle size distribution of the porous particles when the ligand has been immobilized is adjusted to be in a range of from -0.1 to 5.
However, in Example 1 of the as-originally filed specification, the sieve classification is done with 32 and 77 micrometer sieves (see as-originally filed specification paragraph 0088/page 37). In the as-originally filed specification, Table 1 discloses that Example 1 has a variation coefficient of 20% and a skewness of -0.003. Since the sieve classification of JP 069 is performed with a sieve having a smaller size range, i.e. 32-53 micrometer, the distribution of porous particles would necessarily be narrower than those of Example 1 in the as-originally filed specification. A narrower distribution would decrease the variation coefficient of volume particle size distribution of the porous particles. Therefore, it is inherent that the coefficient of variation of a volume particle size distribution is between 1% to 22% — unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.
Regarding claim 2, JP 069 discloses the invention as discussed above in claim 1. Further, JP 069 discloses the solid phase support is formed of the porous particles on which the ligand has been immobilized (see rejection of claim 1).
Regarding claim 5, JP 069 discloses the invention as discussed above in claim 1. Further, JP 069 discloses the sieve classification further comprises (2a) performing a sieve classification with a first sieve having a mesh opening to thereby recover a residue over a sieve; (2b) performing a sieve classification of the residue with a second sieve having a mesh opening, to thereby recover a matter having passed through the second sieve, wherein the sieve classification (2a) and the sieve classification (2b)are performed in that order (see rejection of claim 1; see JP 069 paragraphs 0082, 0088). JP 069 does not disclose a “mesh opening of 10% or greater and smaller than 200%, with respect to a mean volume diameter of the solid phase support before sieve classification (2a-d) as 100%” and “mesh opening greater than that of the first sieve of the sieve classification (2a)and smaller than 600% of a particle size of the solid phase support before the sieve classification (2a-d)”. As noted above, the claim language “first sieve having a mesh opening of 10% or greater and smaller than 200%, with respect to a mean volume diameter of the solid phase support before sieve classification (2a-d) as 100%” is deemed indefinite. For the sake of compact prosecution, claim 5 is understood as the first sieve having a mesh opening and second sieve having a mesh opening greater than that of the first sieve. . Herein, JP 069 is deemed to disclose the first sieve having a mesh opening and second sieve having a mesh opening that is greater than that of the first sieve. JP 069 is deemed to disclose the mean volume diameter since the sieve classification of JP 069 is performed with a sieve having a size range, i.e. 32-53 micrometer. It is noted that JP 069 discloses an average particle size of 1-1000 micrometer before performing sieve classification (see JP 069 paragraph 0028). The materials and steps of JP 069 appears to be substantially identical to the claimed material and steps and thus inherently would possess the claimed functional properties—unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.Regarding claim 6, JP 069 discloses the invention as discussed above in claim 1. Further, JP 069 discloses the sieve classification is a wet process (see JP 069 paragraph 0082).
Regarding claim 7, JP 069 discloses the invention as discussed above in claim 1. Further, JP 069 discloses the variation coefficient is in a range of from 5% to 20%, and wherein the skewness is in a range of from 0.01 to 3 (see rejection of claim 1).
Regarding claim 8, JP 069 discloses the invention as discussed above in claim 1. Further, JP 069 discloses dispersing a monomer composition in an aqueous medium and conducting suspension polymerization prior to the subjecting (see JP 069 paragraphs 0024, 0037-0038, 0048-0049).
Regarding claim 13, JP 069 discloses the invention as discussed above in claim 2. Further, JP 069 discloses the solid phase support is a synthetic polymer porous particle onto which the ligand has been immobilized (see rejection of claim 1; see JP 069 paragraphs 0008, 0010-0012, 0016).
Regarding claim 15, JP 069 discloses the invention as discussed above in claim 2. Further, JP 069 discloses mesh opening is of 62% or greater and 90% or less of the particle size of the solid phase support before the sieve classification (2a-d) (see rejection of claim 5; see JP 069 paragraphs 0028, 0082, 0088).
Regarding claim 16, JP 069 discloses the invention as discussed above in claim 2. Further, JP 069 discloses the skewness is in a range of from 0.1 to 3 (see rejection of claim 1).
JP 069 does not disclose the variation coefficient is in a range of from 8% to 18%.
JP 069 discloses the physical properties of the porous particles made of crosslinked synthetic polymers can be controlled, including the particle size of the porous particles, i.e. average particle size (see JP 069 paragraphs 0033, 0050). JP 069 discloses “average particle size of the sample is expressed as the sieve opening used when classifying porous particles in a water-wet state. For example, particles larger than 32 μm were collected using a sieve with a 32 μm mesh opening, and then passed through a sieve with a 53 μm mesh opening, resulting in particles between 32 μm and 53 μm in size. The average particle size at this time was expressed as 32-53 μm” (see JP 069 paragraph 0082).
In Example 1 of the as-originally filed specification, the sieve classification is done with 32 and 77 micrometer sieves (see as-originally filed specification paragraph 0088/page 37). In Examples 2-8 and 10, the mesh opening is modified so that the range between the first mesh opening and the second mesh opening decreased, e.g. in Example 2 the sieve classification is done with 34 and 77 micrometer sieves and in Example 6 the sieve classification is done with 54 and 77 micrometer sieves (see as-originally filed specification pages 38-41).
In the as-originally filed specification, Table 1 discloses that Examples 2-8 and 10 has a variation coefficient is in a range of from 8% to 18%. Since the sieve classification of JP 069 is performed with a sieve having a smaller size range, i.e. 32-53 micrometer, the variation coefficient of porous particles would necessarily be narrower than at least one, if not all, of the disclosed examples in the as-originally filed specification. A narrower distribution would affect the variation coefficient of the porous particles. Therefore, it is inherent that the variation coefficient is in a range of from 8% to 18% — unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.
Regarding claim 17, JP 069 discloses the invention as discussed above in claim 2.
JP 069 does not disclose that during the performing step, the sieve classification is performed so that the volume cumulative 1% particle size d1 is adjusted to be in a range of from 35 µm to 65 µm.
JP 069 discloses the physical properties of the porous particles made of crosslinked synthetic polymers can be controlled, including the particle size of the porous particles, i.e. average particle size (see JP 069 paragraphs 0033, 0050). JP 069 discloses “average particle size of the sample is expressed as the sieve opening used when classifying porous particles in a water-wet state. For example, particles larger than 32 μm were collected using a sieve with a 32 μm mesh opening, and then passed through a sieve with a 53 μm mesh opening, resulting in particles between 32 μm and 53 μm in size. The average particle size at this time was expressed as 32-53 μm” (see JP 069 paragraph 0082).
In Example 1 of the as-originally filed specification, the sieve classification is done with 32 and 77 micrometer sieves (see as-originally filed specification paragraph 0088/page 37). In Examples 2-8 and 10, the mesh opening is modified so that the range between the first mesh opening and the second mesh opening decreased, e.g. in Example 2 the sieve classification is done with 34 and 77 micrometer sieves and in Example 6 the sieve classification is done with 54 and 77 micrometer sieves (see as-originally filed specification pages 38-41).
In the as-originally filed specification, Table 1 discloses that Examples 2-8 and 10 has a volume cumulative 1% particle size d1 is adjusted to be in a range of from 35-59.3 micrometer. Since the sieve classification of JP 069 is performed with a sieve having a smaller size range, i.e. 32-53 micrometer, the volume cumulative 1% particle size d1 of porous particles would necessarily be narrower than at least one, if not all, of the disclosed examples in the as-originally filed specification. A narrower distribution would affect the volume cumulative 1% particle size d1 of the porous particles. Therefore, it is inherent that the volume cumulative 1% particle size d1 is adjusted to be in a range of from 35 µm to 65 µm— unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.
Regarding claim 18, JP 069 discloses the invention as discussed above in claim 2.
JP 069 does not disclose that during the performing step, the sieve classification is performed so that the volume cumulative 5% particle size dl is adjusted to be in a range of from 40 pm to 65 pm.
JP 069 discloses the physical properties of the porous particles made of crosslinked synthetic polymers can be controlled, including the particle size of the porous particles, i.e. average particle size (see JP 069 paragraphs 0033, 0050). JP 069 discloses “average particle size of the sample is expressed as the sieve opening used when classifying porous particles in a water-wet state. For example, particles larger than 32 μm were collected using a sieve with a 32 μm mesh opening, and then passed through a sieve with a 53 μm mesh opening, resulting in particles between 32 μm and 53 μm in size. The average particle size at this time was expressed as 32-53 μm” (see JP 069 paragraph 0082).
In Example 1 of the as-originally filed specification, the sieve classification is done with 32 and 77 micrometer sieves (see as-originally filed specification paragraph 0088/page 37). In Examples 2-8 and 10, the mesh opening is modified so that the range between the first mesh opening and the second mesh opening decreased, e.g. in Example 2 the sieve classification is done with 34 and 77 micrometer sieves and in Example 6 the sieve classification is done with 54 and 77 micrometer sieves (see as-originally filed specification pages 38-41).
In the as-originally filed specification, Table 1 discloses that Examples 2-8 and 10 has a volume cumulative 5% particle size d1 is adjusted to be in a range of from 40 µm to 65 µm. Since the sieve classification of JP 069 is performed with a sieve having a smaller size range, i.e. 32-53 micrometer, the volume cumulative 5% particle size d1 of porous particles would necessarily be narrower than at least one, if not all, of the disclosed examples in the as-originally filed specification. A narrower distribution would affect the volume cumulative 5% particle size d1 of the porous particles. Therefore, it is inherent that the volume cumulative 5% particle size d1 is adjusted to be in a range of from 40 µm to 65 µm — unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.
Regarding claim 19, JP 069 discloses the invention as discussed above in claim 2.
JP 069 does not disclose that during the performing step, the sieve classification is performed so that the ratio (d5/d50) of volume cumulative 5% particle size d5 to volume cumulative 50% particle size d50 is in a range of from 0.70 to 0.95.
JP 069 discloses the physical properties of the porous particles made of crosslinked synthetic polymers can be controlled, including the particle size of the porous particles, i.e. average particle size (see JP 069 paragraphs 0033, 0050). JP 069 discloses “average particle size of the sample is expressed as the sieve opening used when classifying porous particles in a water-wet state. For example, particles larger than 32 μm were collected using a sieve with a 32 μm mesh opening, and then passed through a sieve with a 53 μm mesh opening, resulting in particles between 32 μm and 53 μm in size. The average particle size at this time was expressed as 32-53 μm” (see JP 069 paragraph 0082).
In Example 1 of the as-originally filed specification, the sieve classification is done with 32 and 77 micrometer sieves (see as-originally filed specification paragraph 0088/page 37). In Examples 2-8 and 10, the mesh opening is modified so that the range between the first mesh opening and the second mesh opening decreased, e.g. in Example 2 the sieve classification is done with 34 and 77 micrometer sieves and in Example 6 the sieve classification is done with 54 and 77 micrometer sieves (see as-originally filed specification pages 38-41).
In the as-originally filed specification, Table 1 discloses that Examples 2-8 and 10 has a ratio (d5/d50) of volume cumulative 5% particle size d5 to volume cumulative 50% particle size d50 is in a range of from 0.70 to 0.95. Since the sieve classification of JP 069 is performed with a sieve having a smaller size range, i.e. 32-53 micrometer, the ratio (d5/d50) of volume cumulative 5% particle size d5 to volume cumulative 50% particle size d50 of porous particles would necessarily be narrower than at least one, if not all, of the disclosed examples in the as-originally filed specification. A narrower distribution would affect the ratio (d5/d50) of volume cumulative 5% particle size d5 to volume cumulative 50% particle size d50 of the porous particles. Therefore, it is inherent that the ratio (d5/d50) of volume cumulative 5% particle size d5 to volume cumulative 50% particle size d50 is in a range of from 0.70 to 0.95— unless these properties arise from features not yet claimed. “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.” See MPEP 2112, II.
Claim Rejections - 35 USC § 103
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 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over JP 069.
Regarding claim 16, JP 069 discloses the invention as discussed above in claim 2. Further, JP 069 discloses the skewness is in a range of from 0.1 to 3 (see rejection of claim 1).
JP 069 does not disclose the variation coefficient is in a range of from 8% to 18%.
A prima facie case of obviousness exists where the claimed range and prior art range do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 069 to reduce the variation coefficient, such as by modifying the mesh opening size of the sieve(s), because it would assist with achieving a more consistent and/or uniform size of particle size distribution for the resulting chromatography carrier.
Claims 3, 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over JP 069 as applied to claims 1, 2, and 5-8 above, and further in view of US 20200360894 (hereinafter US 894).
Regarding claim 3, JP 069 discloses the invention as discussed above in claim 1.
JP 069 does not disclose the solid phase support is formed of porous particles on which the ligand has not been immobilized.
US 894 discloses chromatography carrier having a ligand immobilized thereto and that the carrier is a porous particle (see US 894 paragraphs 0001, 0034, 0035). US 894 discloses the porous particle can have monomers that have no functional group capable of immobilizing a ligand (see US 894 paragraph 0135 (US 894 discloses “Examples of the monomer constituting such a structural unit (hereinafter also referred to as other monomers) include polymerizable unsaturated group-containing monomers having no functional group capable of immobilizing a ligand. The other monomers are roughly classified into non-crosslinkable monomers and crosslinkable monomers, and one of these may be used or used in combination” (see US 894 paragraph 0135).).
US 894 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. chromatography carrier and/or method of producing a chromatography carrier.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to produce the chromatography carrier, as disclosed in JP 069 and US 894, by incorporating porous particles on which the ligand has not been immobilized, as US 894, with the porous particle of JP 069, as disclosed in US 894, and/or to substitute the porous particle of JP 069 with the porous particles on which the ligand has not been immobilized, as US 894, because even without the ligand, “it is possible to satisfy the desired effects of the present invention such as the antifouling properties and it is possible to apply for a composition of a wide range of monomers” (see US 894 paragraph 0135) and/or because the combination of porous particles on which the ligand has and has not been immobilized will increase the impurities and/or target compounds to be captured during the chromatography process and/or because ligand may not be needed if the porous particle is used for size-exclusion chromatography because the carrier’s porous network separates the molecules based on size and/or because the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). This substitution would yield the predictable result of being used in a chromatography process and/or because one of ordinary skill in the art can reasonably expect the resulting porous particles to work as the prior art intended, i.e. being used in a chromatography process.
Hence, JP 069 in view of US 894 is deemed to disclose the solid phase support is formed of porous particles on which the ligand has not been immobilized.
Regarding claim 4, JP 069 in view of US 894 discloses the invention as discussed above in claim 3.
JP 069 in view of US 894 does not disclose immobilizing the ligand onto the porous particles which have undergone the sieve classification. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to try immobilizing after sieving as there are a finite number of ways a chromatography carrier with a ligand immobilized can be produced. Furthermore, one having ordinary skill in the art would have a reasonable expectation of success to have a particle that is capable of passing through the same sieves whether a ligand or has not been immobilized because JP 069 discloses the particle size of the separation agent is determined by the porous particle and not the ligand attached (see JP 069 paragraph 0028).
Regarding claim 14, JP 069 in view of US 894 discloses the invention as discussed above in claim 3. Further, JP 069 in view of US 894 discloses the solid phase support is a synthetic polymer porous particle onto which the ligand has not been immobilized (see rejection of claims 1 and 4).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-8, and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 12 of copending Application No. 18551116 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application 18551116 read on the claims of the present application. The copending claims recite substantially the same application, i.e. a solid phase support, wherein the solid phase support provided is formed of porous particles on which a ligand has or has not been immobilized that is being subjected to sieve classification to achieve a coefficient of variation of a volume particle size distribution of the porous particles when a ligand has been immobilized is adjusted to 1% to 22%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Other Applicable Prior Art
All other art cited not detailed above in a rejection is considered relevant to at least some portion or feature of the current application and is cited for possible future use for reference. Applicant may find it useful to be familiar with all cited art for possible future rejections or discussion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERNADETTE K MCGANN whose telephone number is (571)272-5367. The examiner can normally be reached M-F 7:00 am -3:30 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Lebron can be reached on 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BERNADETTE KAREN MCGANN/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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