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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a chromatographic column analog comprising one or more of a void and block, classified in 210/198.2 or B01D15/12.
II. Claims 18-20, drawn to a method of developing a pre-use assessment protocol for a chromatography operation for analyzing the product quality of a product pool, classified in 436/161 or G01N30/88.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process can be performed with other types of chromatographic apparatus instead of columns having a void and/or a block.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions would require consideration of entirely different groups of prior art references and consideration of different groups of issues.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jason Portis on 02/20/2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Interpretation
In each of claims 1 and 10 , and in all claims respectfully dependent from claims 1 and 10, the terminology “chromatographic column analog” is interpreted as any chromatographic column having one or more features configured to introduce or facilitate specific flow patterns in addition to conventional longitudinal flow through the column media, as is suggested in paragraph [0005] of the instant Specification.
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.
Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 6, the scope of “another material impermeable to water” is undefined and unclear.
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.
Claims 1, 2, 5, 7, 10-15 and 17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Crowley patent 3,436,897 (Crowley).
For independent claim 1, Crowley discloses: A chromatographic column analog (column 1, lines 14-21 and column 2, lines 27-49 regarding large diameter chromatographic columns incorporating features to introduce areas of transverse or lateral movement and improved distribution of fluids in sections of a large diameter column and see figure 1 and column 4, lines 20-22 re column 12) comprising:
chromatography media (figures 1-7 and column 4, lines 22-30 and 53-56 re separatory media of crushed firebrick 40 and column 5, lines 25-29 re particulate layer 42) ; and
one or more of :
a void configured to create a zone of preferential flow within the chromatography media (figure 7 and column 5, lines 61-67 re disc-like empty mixing space 60 for preferential flow of mixing and redistribution of fluids); or
a block configured to create a zone of reduced flow within the chromatography media (donut type partition elements or “blocks” 46/54/56 or 48 to block flow through the outer portions of the column resulting in a reduced flow through a central flow passage as shown in figures 4-6 and described at column 5, lines 34-60).
Crowley further discloses:
for claim 2, wherein the analog includes the void and a tube comprising a top opening and a bottom opening, and the void is between the top opening and the bottom opening of the tube (figure 2 embodiment described at column 5, lines 3-13 describing “connecting tube 52” between a top opening at the outlet of one column and a bottom opening at the inlet of the next column and see column 5, lines 19-24) ;
for claim 5, wherein the tube includes a wall between the top opening and the bottom opening, and the wall is in contact with the chromatography media (the side wall of the chromatographic column(s) illustrated in figures 1-7 also forming a relatively narrow cylindrical tubular passage, i.e. “tube” in contact with chromatographic media 40 as shown in figures 1-7 and column 4, lines 22-30 and 53-56 re separatory media of crushed firebrick 40 and column 5, lines 25-29 re particulate layer 42 ; and,
for claim 7, wherein the analog includes the block, and the block includes a top face, a bottom face, and a thickness between the top face and the bottom face (see figures 4-6 illustrating each of donut type partition elements or “blocks” 46/54/56 or 48 having a substantial thickness between top and bottom faces, as described at column 5, lines 34-60).
For independent claim 10, Crowley discloses: A chromatographic column analog (column 1, lines 14-21 and column 2, lines 27-49 regarding large diameter chromatographic columns incorporating features to introduce areas of transverse or lateral movement and improved distribution of fluids in sections of a large diameter column and see figure 1 and column 4, lines 20-22 re column 12) comprising:
chromatography media (figures 1-7 and column 4, lines 22-30 and 53-56 re separatory media of crushed firebrick 40 and column 5, lines 25-29 re particulate layer 42) ; and
one or more of :
a void that does not include the chromatography media (figure 7 and column 5, lines 61-67 re disc-like empty mixing space 60 for preferential flow of mixing and redistribution of fluids); or
a block that does not include the chromatography media and is impermeable to liquids through the column configured to create a zone of reduced flow within the chromatography media (donut type partition elements or “blocks” 46/54/56 or 48 to block flow through the outer portions of the column resulting in a reduced flow through a central flow passage as shown in figures 4-6 and described at column 5, lines 34-60).
Crowley further discloses:
for claim 11, wherein the analog includes the void and a lumen comprising a top opening and a bottom opening, and the void is between the top opening and the bottom opening of the lumen (figures 1 and 7 described at column 5, lines 3-13 describing “void 60” between a top opening 16 and bottom opening 18 of the column or “lumen” 12);
for claim 12, wherein the lumen is substantially parallel to a longitudinal axis of the analog (figure 1 illustrating the column or lumen being elongated along a longitudinal axis between a top opening 16 and bottom opening 18, or figure 2 illustrating a void in the form of a connecting tube 52 with connecting top opening to lumen portion 12 and bottom opening to lumen portion 12a, and see column 5, lines 19-24);
for claim 13, wherein a first portion of the chromatography media is above the top opening and a second portion of the chromatography media is below the bottom opening (embodiment of figure illustrating 1st top portion of media 40 above openings of screen 44
for claim 14, wherein the analog includes the block, and the block is below the top opening of the lumen and above the bottom opening of the lumen (see figures 4-6 illustrating each of donut type partition elements or “blocks” 46/54/56 or 48 having a substantial thickness between top and bottom faces, as described at column 5, lines 34-60);
for claim 15, wherein the analog includes the block, and a width of the block is greater than or equal to a thickness of the block, and the thickness of the block is substantially parallel with a longitudinal axis of the analog (see figures 4-6 illustrating each of donut type partition elements or “blocks” 46/54/56 or 48 having a substantial thickness which is parallel with a longitudinal axis of the analog or column, but with greater width than thickness and located between top and bottom faces, as described at column 5, lines 34-60) ; and
for claim 17 dependent upon claim 15, wherein the block is a first block and the analog further comprises a second block (also see column 2, lines 53-58 re there optionally being a series of interconnecting columns and column 2, lines 67-71 re there optionally being plural “donut type elements”, i.e. plural “blocks”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Crowley patent 3,436,897 (Crowley).
For claim 4, Crowley discloses a first filter screen proximate to the top opening and a second filter screen proximate to the bottom opening.
However, Crowley does not explicitly disclose the 1st first filter screen being in contact with the top opening and the 2nd filter screen being in contact with the bottom opening. Crowley does however illustrate media portions 42 being adjacent top opening to inlet/outlet 16 of the column (figure 1) and illustrates media portion 42 being bounded by screens 44 or 50 at both the top and bottom of such media portion in figure 3 and describes screen functioning to facilitate carrier fluid passing through the column to spread laterally and be introduced to the separatory material in plug-like form (column 4, lines 60-66).
Hence, it would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the chromatographic column or analog of Crowley, so as to bound the top media portion by a screen above such portion, hence be in contact with the top opening of the column, so as to facilitate carrier fluid passing through the column to spread laterally and be introduced to the separatory material in plug-like form.
For claim 9, Crowley is silent as to the width of the total volume of the analog or block, hence lacks a teaching of wherein the analog has a total volume of about 15 mL to about 4600 mL .
Crowley suggests chromatographic columns being sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media (column 1, lines 14-50 re objective of maintaining high resolution or resolving power in the column).
In addition, the claimed chromatographic column dimensional parameters of column size or volume is deemed to be a results effective variables, for which it would have been obvious to optimize by routine experimentation in order to be sized and dimensioned so as to be shaped and designed for design facilitating mixing of fluids passing through the column and permitting a more uniform front of fluid to be formed in the column.
The MPEP Section 2144.05, parts I and II cites Case Law which has established precedence that where the prior art teaches or suggests parameter values, ranges, proportions and amounts which overlap, approach or are similar to what is claimed, patentability of the subject matter is not supported, absent finding of unexpected results or verified criticality of what is claimed.
It would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the analog or column volume to have a total volume of about 15ml to about 4600 ml, in order to be sized and dimensioned so as to be scaled up to be a relatively large size and tailored for specific commercial applications, so as to facilitate separation of materials on a commercial scale without losing separatory resolving power.
For claim 16, Crowley is silent as to the width of the block, hence lacks a teaching of wherein the width of the block is about 50 percent to about 90 percent of an inner diameter of the analog. However, Crowley illustrates blocks 48 or 56 having a width or thickness which appears to flare out so as to be a substantial proportion of the inner diameter of the column or analog in figures 5 and 6.
Crowley suggests such shape or design facilitating mixing of fluids passing through the column and permitting a more uniform front of fluid to be formed in the column (column 5, lines 36-49).
In addition, the claimed chromatographic column dimensional parameters of column features are deemed to be a results effective variables, for which it would have been obvious to optimize by routine experimentation in order to be sized and dimensioned so as to be shaped and designed for design facilitating mixing of fluids passing through the column and permitting a more uniform front of fluid to be formed in the column.
The MPEP Section 2144.05, parts I and II cites Case Law which has established precedence that where the prior art teaches or suggests parameter values, ranges, proportions and amounts which overlap, approach or are similar to what is claimed, patentability of the subject matter is not supported, absent finding of unexpected results or verified criticality of what is claimed.
It would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the blocks of Crowley, such that the width of the block is about 50 percent to about 90 percent of an inner diameter of the analog, in order for the column to be sized and dimensioned so as to be scaled up to be a relatively large size so as to facilitate separation of materials on a commercial scale without losing separatory resolving power.
Claims 3, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Crowley patent 3,436,897 (Crowley), as applied to claims 1, 2, 4, 5, 7, 10-15 and 17 above, in view of Saxena et al patent 5,462,659 (Saxena).
For claim 3 dependent on claim 2, Crowley is silent regarding void length and width and as to wherein the void has a length of about 1.0 cm to about 10 cm, and the void has a width of about 0.5 cm to about 1.0 cm.
Saxena teaches a large chromatographic column (column 4, lines 20-33 re column body 10 or 15) having dimensions on the order of centimeters, specifically having a length or height of 20-100 cm and inner diameter or width of 10-40 cm (column 11, lines 54-57), hence suggests components therein extending across the width of the column being on the order of having a length of about 1.0 cm to about 10 cm, and the void has a width of about 0.5 cm to about 1.0 cm.
Saxena suggests the column and components therein being sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media (column 1, lines 18-24 re objective of maintaining high resolution or resolving power in the column and column 3, lines 44-47 re columns adaptable for preparative or analytical chromatography).
Crowley also suggests chromatographic columns being sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media (column 1, lines 14-50 re objective of maintaining high resolution or resolving power in the column).
In addition, the claimed chromatographic column dimensional parameters are deemed to be a results effective variables, for which it would have been obvious to optimize by routine experimentation in order to be sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media.
The MPEP Section 2144.05, parts I and II cites Case Law which has established precedence that where the prior art teaches or suggests parameter values, ranges, proportions and amounts which overlap, approach or are similar to what is claimed, patentability of the subject matter is not supported, absent finding of unexpected results or verified criticality of what is claimed.
It would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the void of the chromatographic column or analog of Crowley to have the instantly claimed dimensions, as taught by Saxena, in order to be sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing separatory resolving power.
For claim 6 dependent on claim 2, Crowley is silent as to the material of the tube, hence lacks a teaching of wherein the tube comprises stainless steel, glass, or another material impermeable to water.
Saxena teaches a large, sized-up chromatographic column comprised of glass or other water-impermeable material (column 3, lines 44-50 and column 4, lines 30-33).
It would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the chromatographic column or analog of Crowley of impermeable glass, as taught by Saxena, since such material is inherently readily available and easily manufactured, hence would facilitate sizing up of the column.
For claim 8 dependent on claim 7, Crowley is silent as to the width of the bottom face of the block, hence lacks a teaching of wherein the bottom face has a width of about 0.5 cm to about 2.5 cm.
Saxena teaches a large chromatographic column (column 4, lines 20-33 re column body 10 or 15) having dimensions on the order of centimeters, specifically having a length or height of 20-100 cm and inner diameter or width of 10-40 cm (column 11, lines 54-57), hence suggests components therein extending across a width of about 0.5 cm to about 2.5 cm.
Saxena suggests the column and components therein being sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media (column 1, lines 18-24 re objective of maintaining high resolution or resolving power in the column and column 3, lines 44-47 re columns adaptable for preparative or analytical chromatography).
Crowley also suggests chromatographic columns being sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media (column 1, lines 14-50 re objective of maintaining high resolution or resolving power in the column).
In addition, the claimed chromatographic column dimensional parameters of features are deemed to be results effective variables, for which it would have been obvious to optimize by routine experimentation in order for the analog or column to be sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing resolving power of the chromatographic media.
The MPEP Section 2144.05, parts I and II cites Case Law which has established precedence that where the prior art teaches or suggests parameter values, ranges, proportions and amounts which overlap, approach or are similar to what is claimed, patentability of the subject matter is not supported, absent finding of unexpected results or verified criticality of what is claimed.
It would have been obvious to one of ordinary skill in the art of utilizing or providing chromatographic columns, to have manufactured the block(s) of the chromatographic column or analog of Crowley to have the instantly claimed width proportion or dimensions, as taught by Saxena, in order to be sized and dimensioned so as to be scaled up for relatively large size so as to facilitate separation of materials on a commercial scale without losing separatory resolving power.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional prior art is cited regarding chromatographic columns or analogs wherein voids unintentionally develop in the columns or analogs as a result of accumulation of adsorbed material in the chromatographic media during chromatographic operations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner Joseph Drodge at his direct government formal facsimile phone number telephone number of 571-272-1140. The examiner can normally be reached on Monday-Friday from approximately 8:00 AM to 1:00PM and 2:30 PM to 5:30 PM.
If attempts to reach the examiner are unsuccessful, the examiner' s supervisor, Benjamin Lebron, of Technology Center Unit 1773, can reached at 571-272-0475.
The telephone number, for official, formal communications, for the examining group where this application is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from the Patent Examiner. Unpublished application information in Patent Center is available to registered users. Visit https:///www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https:///www.uspto.gov/patents/apply/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.
JWD
02/21/2026
/JOSEPH W DRODGE/Primary Examiner, Art Unit 1773