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 .
Claim Status
Claims 1 and 3-19 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 Claims 12-19 have been withdrawn.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 and 3-5 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).
Bertelo discloses wherein said particles are about 10 microns or less in diameter ([0023], particle size of between 0.01 nm to 1.0 mm).
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 Claim 3, Bertelo discloses wherein said particles are about 1 to about 5 microns in diameter ([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, 3-5 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]).
Shimizu discloses wherein said particles are about 10 microns or less in diameter ([0038], particle size of 1 to 2 microns).
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 Claim 3, Shimizu discloses wherein said particles are about 1 to about 5 microns in diameter ([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.
Response to Arguments
Applicant's arguments filed 20 November 2025 regarding Bertelo and Veregin have been fully considered but they are not persuasive. At the outset, the Examiner notes that in the Non-final rejection dated 22 August 2025, the 103 rejection of Claim 1 over Bertelo in view of Veregin states that Bertelo teaches away from annealing particles. Bertelo teaches that annealing will result in a crystalline structure different from what the authors desire ([0003]-[0005]). The teachings of structural differences resulting from the different processes of annealing and Bertelo’s desired process would also limit the application of product-by-process interpretation as well. Therefore, based on Bertelo, Applicant may choose to amend Claim 1 with the limitations of Claims 7 or 8 to overcome any rejection over Bertelo.
Applicant argues on page 5 of the filing that the evidence of record is that as of the priority date, it was not known in the art how to produce monodisperse populations of substantially spherical populations of polyarylketone polymers, such as PEEK, or of thioether-containing analogues of these. Applicant points to McGrath as failing to produce spherical particle of PEEK.
In response, MPEP § 2121.01(II) states that a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 USC 103. Therefore, McGrath is available as prior art to show that it would have been obvious to make spherical particles.
Furthermore, while it may not have been known how to produce monodisperse populations of substantially spherical particles of PEEK, Applicant has not provided any evidence for the full scope of the claims that it was not known how to produce any substantially spherical polyarylketone particle. Therefore, Applicant’s arguments are not commensurate in scope with the claims.
Applicant argues on page 6 of the filing that Veregin is not reasonably pertinent to the claims as required by MPEP § 2141.01(a). Applicant argues that the Action neither shows nor argues that there is a nexus between the flow properties of metal particles that are coated with polymeric additives, such as latex, and the flow properties of particles of polyarylketone polymers or thioether-containing analogues of such particles. Applicant argues that the Action fails to show that a practitioner seeking to make populations of particles of polyarylketone polymers or thioether-containing analogues of such particles would find art relating to latex-coated metal particles to be reasonably pertinent to the problem.
In response, Bertelo’s requirement for improved powder flow ([0005], [0043]-[0044] and uniform particle size ([0044]) would already suggest to one of ordinary skill in the art that the particles of Bertelo are spherical, such that the incorporation of the teachings of Veregin are merely a formality.
Furthermore, the test for analogous art is not only that the art is reasonably pertinent to the problem at hand. Rather, as shown in MPEP § 2141.01(a), analogous art may be established by showing that the reference is from the same field of endeavor as the claimed invention. In this case, one conception of the field of endeavor is that of creating substantially uniform populations of particles. Both Bertelo and Veregin would be analogous art under this test. See MPEP § 2141.01(a)(I), “the field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field.’” (quoting Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001, 120 USPQ2d 1593, 1597 (Fed. Cir. 2016)).
Applicant argues on page 7 of the filing that Veregin merely states a goal, in the words of the Action, “that [it] is desirable that the particle shape is spherical in order to induce a free flowing powder”. Applicant argues that the Action fails to show or even argue that Veregin teaches or suggests how to actually make the desired spherical particles of polyarylketone polymers or thioether-containing analogues of such particles. Applicant argues that the atomization techniques taught by Veregin, or any modification thereof, to make metal powders could not be used to make the polyarylketone polymers of the instant invention. Applicant argues that the physical and chemical properties of metals and plastics are quite different, such that one of ordinary skill would not expect the atomization techniques Veregin lists for making powders of metals would work equally to make powders of thermoplastics.
In response, the Examiner is not proposing to bodily incorporate the methods of making from Veregin to the particles of Bertelo. Rather the Examiner is proposing that it would be obvious to shape the particles of Bertelo into spherical shapes based on the rationale from Veregin that spherical particles would result in the powder being free flowing, which is an important property of the powder according to Bertelo. Furthermore, as above, Bertelo’s requirement for improved powder flow ([0005], [0043]-[0044] and uniform particle size ([0044]) would already suggest to one of ordinary skill in the art that the particles of Bertelo are spherical. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues on pages 8 and 9 of the filing that Bertelo merely states a goal, a desired characteristic of the powders, and that it does not teach or suggest how to obtain or to make them. Applicant argues that Bertelo fails to refute the evidence provided in the specification that methods of making monodisperse populations of particles of the recited polymers were not known in the art prior to the priority date.
In response, spherical polyarylketone powders are known from at least the commercially available OXPEKKTM-SP powders used in Bertelo ([0037]). Therefore, one of ordinary skill in the art would have sufficient capability and motivation to obtain the claimed particles. Applicant’s arguments are not persuasive.
Applicant argues on page 10 of the filing that Shimizu lists one polyarylketone, PEEK, as one of seventeen different materials suitable for use as particles or beads in its devices, and then states preferred sizes and shapes for particles or beads made from these materials. Applicant argues that Shimizu does not state any method as to have to make particles of poly1 arylketone polymers, of any size, or how to make such particles substantially spherical.
In response, Applicant is reminded that the selected claims are directed to an apparatus, not method of making, such that Applicant is arguing that Shimizu does not teach far beyond what is actually claimed. In addition, as Applicant correctly points out, Shimizu lists PEEK suitable for use as particles or beads in [0038]. MPEP § 2131.02(II) states that a reference that clearly names the claimed species anticipates the claim no matter how many other species are named. Finally, Shimizu discloses PEEK particles and discloses that the particles may be spherical. Therefore, Shimizu positively recites these elements of the claims.
Applicant argues on page 11 of the filing that Henry is only cited to provide a purported motivation to use monodisperse populations of small particles “to evenly fill the space around the monolithic rod” and to “create a more efficient column”. Applicant argues that Henry does not contain any teaching or suggestion as how to make or obtain particles of polyarylketone polymers, such as PEEK, of any size, nor how to make particles of those polymers that are substantially spherical.
In response, the motivation to use the teachings of Henry is based on the classic van Deemter relationship well known to any chromatographer, as set forth in the Non-Final office action on page 6. Furthermore, as above, the Examiner is not required to provide a method of making to show obviousness for an apparatus, especially as Shimizu already discloses that the particles may be PEEK and may be spherical.
With regard to the rejections of Claims 6-8 over Shimizu in view of Henry and further in view of Morrissette, and the rejections of Claims 10-11 over Shimizu in view of Henry and further in view of Berthod, Applicant does not provide any arguments on that have not already been addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Benjamin Lebron
Supervisory Primary Examiner
Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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