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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-11 in the reply filed on 21 July 2025 is acknowledged.
Claim Status
Claims 1-19 are pending in the current application. Claims 12-19 have been withdrawn.
Claim Interpretation
With regard to Claims 7 and 8, “annealed at a temperature of from about 200°C to about 300°C” (Claim 7) and “annealed at a temperature of from about 230°C to about 290°C” (Claim 8) are product-by-process limitations. MPEP § 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. Therefore, the structure implied by the process steps of “annealed at a temperature of from about 200°C to about 300°C” (Claim 7) and “annealed at a temperature of from about 230°C to about 290°C” (Claim 8) will be considered when assessing patentability of Claims 7 and 8. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bertelo et al (US 2013/0323416) in view of Veregin (US 2020/0306830).
With regard to Claim 1, Bertelo et al (Bertelo) discloses heat treatment of polymorphic semi-crystalline or crystallizable polymers to increase the content of the highest melting crystalline form (Abstract). Bertelo discloses a monodisperse population of polyarylketone polymers, wherein said particles have not been sintered or otherwise fused to one another ([0020], [0021], useful polymers for heat treatment include PEEKEK, PEEKK, PEKEKK, or PEEK (where E = ether and K = ketone; Abstract, the invention also includes polymer powders and articles produced by the described processes; [0044], the powder should have a uniform particle size (monodisperse population) and should melt and flow uniformly).
The Examiner notes that Bertelo teaches away from annealing particles ([0003]-[0005]).
While Bertelo is silent to a container holding the polyarylketone polymers, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to hold the polyarylketone polymers in a container, in order to transport them before subjecting the polymer powder to the heat treatment methods of Bertelo.
However, modified Bertelo is silent to the monodisperse population of particles being substantially spherical.
Veregin et al (Veregin) discloses a composition including a three-dimensional metal printing powder having an organic polymeric additive disposed thereon (Abstract). Veregin discloses that is desirable that the particle shape is spherical in order to induce a free flowing powder ([0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the monodisperse population of particles of modified Bertelo to be substantially spherical, as taught by Veregin, in order for the powder to be free flowing, which is an important property of the powder according to Bertelo.
With regard to Claims 2 and 3, Bertelo discloses wherein said particles are about 10 microns or less in diameter (Claim 2), wherein said particles are about 1 to about 5 microns in diameter (Claim 3) ([0023], particle size of between 0.01 nm to 1.0 mm).
With regard to Claims 4 and 5, Bertelo discloses wherein said polyarylketone polymer is PEEK ([0021]).
Claims 1-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 2009/0001007) in view of Henry (“Impact of particle size distribution on HPLC column performance”).
With regard to Claim 1, Shimizu discloses a column having high-pressure resistance and capable of performing high-speed separation and analysis even with a small flow rate (Abstract). Shimizu discloses a container holding a population of substantially spherical particles of polyarylketone polymer, wherein said particles have not been sintered or otherwise fused together (Figure 1, Abstract, [0034], [0037]-[0038], the separation column (container) comprises a monolithic rod with a tube-like filler layer surrounding the rod; the filler layer is formed from spherical particles or beads of materials which may include PEEK).
Shimizu discloses wherein the diameter of such filler particles is 1 to 2 microns, suggesting a very small particle size distribution ([0038]). Shimizu also discloses that the filler layer fill the gap around the monolithic rod, which has thickness of several to several tens of micrometers formed on the outer circumferential surface of the monolithic rod ([0037]).Furthermore, Shimizu discloses that pressure of the liquid is maintained not only by the monolithic rod, but also by the filler layer ([0043]).
However, Shimizu is silent to wherein the population of particles is monodisperse.
Henry discloses that controlling the particle size distribution variable has been examined as a possible route to further improvement in performance of particle-based columns (Page 1). Henry discloses that the van Deemter relationship (H = A + B/µ + Cµ) is a function of column efficiency, with the lower an H value, the greater efficiency a column displays (paragraph between Pages 1-2). Henry discloses that the A term represents contributions from flow and diffusion processes within the mobile phase flowing around particles (Page 2). If a narrower particle distribution can create more uniform beds, it should show up as a smaller A term (Page 2).
A monodisperse packing of particles surrounding the monolithic rod would not only evenly fill the space surrounding the monolithic rod, as suggested by Shimizu, but also create a more efficient column with higher column performance, as taught by Henry, since the pressure of the liquid is maintained by both the monolithic rod and the filler layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the particles having a very small particle size distribution in the filler layer of Shimizu to be monodisperse, as taught by Shimizu and Henry, in order to evenly fill the space surrounding the monolithic rod and also create a more efficient column with higher column performance, since the pressure of the liquid is maintained by both the monolithic rod and the filler layer.
With regard to Claims 2 and 3, Shimizu discloses wherein said particles are about 10 microns or less in diameter (Claim 2), wherein said particles are about 1 to about 5 microns in diameter (Claim 3) ([0038], particle size of 1 to 2 microns).
With regard to Claims 4 and 5, Shimizu discloses wherein said polyarylketone polymer is PEEK ([0038]).
With regard to Claim 9, Shimizu discloses wherein said container is a high-performance liquid chromatography column (Abstract).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 2009/0001007) in view of Henry (“Impact of particle size distribution on HPLC column performance”), as applied to the claims above, and in further view of Morrissette et al (US 2020/0147261).
With regard to Claims 6-8, modified Shimizu discloses all the limitations in the claims as set forth above.
Shimizu discloses that pressure of the liquid is maintained not only by the monolithic rod, but also by the filler layer of particles ([0043]). Shimizu further discloses that the monolithic rod is prevented from being moved relatively in the axial direction with respect to the filter layer by friction generated between the monolithic rod and the filler ([0044]). Shimizu discloses that pressure-resistant performance of the separation column is improved as a result ([0044]).
However, modified Shimizu is silent to wherein said particles have been annealed (Claim 6), wherein said particles have been annealed at a temperature of from about 200°C to about 300°C (Claim 7), and wherein said particles have been annealed at a temperature of from about 230°C to about 290°C (Claim 8).
Morrissette et al (Morrissette) discloses a porous material suitable for implant comprising a large plurality of substantially spherical intercalated hollows in a polymer (Abstract). Morrissette discloses that the porous material is fabricated from a polymer such as PEEK and a fugitive material such as sodium chloride ([0017]). Morrissette discloses that in order to improve the strength of the yield porous part, annealing techniques can be used ([0029]). Typically, the annealing techniques are supplied by the manufacturer of the raw materials ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to anneal the PEEK particles of modified Shimizu at the desired temperature, as taught by Morrissette, in order to improve their strength for use in the high-pressure and high-friction environment in the separation column of modified Shimizu.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 2009/0001007) in view of Henry (“Impact of particle size distribution on HPLC column performance”), as applied to the claims above, and in further view of Berthod et al (“A solid-phase extraction approach for the identification of pharmaceutical-sludge adsorption mechanisms”).
With regard to Claims 10 and 11, modified Shimizu discloses all the limitations in the claims as set forth above.
However, modified Shimizu is silent to wherein said container is a solid-phase extraction cartridge or a capillary column (Claim 10), or wherein said container is a channel or a chamber of a microfluidic device (Claim 11).
As Shimizu discloses the use of PEEK particles for high performance liquid chromatography, so too would PEEK particles be useful for other chromatography platforms including solid phase extraction cartridges for microfluidic separation columns. See for example Berthod et al (Berthod), in which a PEEK stationary phase was selected for its chemical stability for use in retaining active pharmaceutical ingredients in a solid-phase extraction cartridge (Page 117/Introduction, Page 118/Introduction, Page 119/Section 2.2.2, Page 121/Section 3.1.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein said container is a solid-phase extraction cartridge or a capillary column (Claim 10), or wherein said container is a channel or a chamber of a microfluidic device (Claim 11), as taught by Shimizu and Berthod, since as Shimizu discloses the use of PEEK particles for high performance liquid chromatography, so too would PEEK particles be useful for other chromatography platforms including solid phase extraction cartridges for microfluidic separation columns.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN LEBRON whose telephone number is (571)272-0475. The examiner can normally be reached 9 AM - 5:30 PM.
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Benjamin Lebron
Primary Examiner
Art Unit 1777
/BENJAMIN L LEBRON/ Primary Examiner, Art Unit 1777
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