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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 07/14/2025 are acknowledged and have been fully considered. Claims 1-10 and 12-20 are now pending. Claim 11 is canceled; claims 1 and 5 are amended; claims 10 and 12-20 are withdrawn.
Claims 1-9 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Le Corre (2010; as submitted on PTO-892 of 02/13/2025) in view of Oyinloye (2020; as submitted on PTO-892 of 02/13/2025) and CN 109908396 A (Zhu, 2019; machine translation provided by PE2E via FIT).
In regards to claims 1 and 4-5, Le Corre teaches a method of preparing starch nanoparticles by mixing native starch with water, which was completely gelatinized, followed by adding ethanol to the solution, stirring, centrifuging, and drying the settled material (see Le Corre, page 1146, column 2, paragraph 1). Further, Le Corre does teach examples of freeze-drying (see Le Corre, page 1148, paragraph bridging columns 1-2).
In regards to claims 2-3, Le Corre incorporates the reference of Ma et al. (2008; reference 83 of Le Corre), which teaches cross-linked starch (see Ma et al., abstract). Ma et al. also teaches that when the starch is mixed with water, there is 8 g of starch added to 150 mL (150 g) of distilled water (see Ma et al., page 3315, 2.2 preparation of starch nanoparticles (SN) and CA-modified starch nanoparticles (CASN)). Using these numbers the mass ratio is about 1: 18.75. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 6, Le Corre teaches a combination of cellulose whiskers (i.e., a hydrophilic polymer material) with starch nanoparticles is known in the art (see Le Corre, page 1149, column 2, paragraph 2).
In regards to claim 7, it is taught that the stirring is done for 50 minutes (see Le Corre, page 1146, column 2, paragraph 1)
The teachings of Le Corre are silent on freeze-drying, crushing and sieving in that sequence, the starch particles having a particle size from 20µm-500µm, and the rotating speed of the stirring in step (2).
Oyinloye teaches the benefits of freeze-drying and grinding food products, like starch (see Oyinloye, abstract; page 8, paragraph 2). Oyinloye teaches a method of freeze-drying, grinding, and sieving the particles (see Oyinloye, pages 3-4 and pages 11-12).
Zhu teaches a method of making starch microparticles having the size of 50-200 µm (see Zhu, example 1). The method comprises adding starch into water for form a gelatinized starch solution (see Zhu, page 6, paragraph 4), adding a pore-forming agent (i.e., ethanol) and stirring at a speed of 200-1000 rpm (see Zhu, page 6, paragraph 5). It is also taught that an inverse microemulsion technique is used to control the particle size and particle size distribution of the particles (see Zhu, abstract; page 6, final paragraph).
In regards to claims 1-7, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Le Corre with Oyinloye and Zhu to formulate the instant preparation method as Le Corre teaches a method in which the settled starch product after centrifuging is dried and Oyinloye teaches a method of drying (i.e., freeze-drying), grinding, and sieving food (i.e., starch) nanoparticles. Further, the methods of Le Corre and Zhu teach similar steps and compounds for formulating the starch particles. It would be obvious to one with ordinary skill in the art to combine the teachings of Zhu with Le Corre as the method of Zhu creates starch particles that have a porous structure improves the absorbing rate and improves biocompatibility (see Zhu, page 3, paragraph 2). It is also taught that the nanoparticles of Ma et al. have potential applications in the medical field (see Ma et al., conclusions), e.g., the hemostatic material of Zhu. Oyinloye further teaches the benefits of doing so, such as reducing the moisture content of the starch product in order to avoid larger particle sizes, low product yield, higher energy usage for example (see Oyinloye, 3.1 Energy Consumption). One with ordinary skill in the art would be motivated to combine the methods of Le Corre with Oyinloye and Zhu according to the known method of maximizing the benefits of forming food-based particles as taught in Oyinloye and the method of Zhu to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Le Corre (2010; as submitted on PTO-892 of 02/13/2025) in view of Oyinloye (2020; as submitted on PTO-892 of 02/13/2025) and CN 109908396 A (Zhu, 2019; machine translation provided by PE2E via FIT) as applied to claims 1-7 above, and further in view of Altemimi (2018).
The teachings of Le Corre, Oyinloye, and Zhu have been described supra.
The teachings of Le Corre, Oyinloye, and Zhu are silent on the rotating speed of centrifugation in step (2).
Altemimi teaches a method of extracting starch from potatoes comprising putting small chunks of potatoes in distilled water and centrifuging to extract starch at various speeds, such as 1000, 2000, and 4000 rpm (see Altemimi, 2.1 extraction of starch from yellow skin potato). It is also taught that 3000 rpm yielded the optimum amount of starch (see Altemimi, abstract). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 8, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Le Corre, Oyinloye, and Zhu with Altemimi to formulate the instant preparation method as the method of Le Corre teaches centrifugation, yet is silent on the conditions of the centrifugation. Altemimi remedies this deficiency as it teaches a method of centrifugation that would be appropriate for application in the method of Le Le Corre, Oyinloye, and Zhu (i.e., optimizing the extraction of starch via centrifugation). One with ordinary skill in the art would be motivated to combine the teachings of Le Le Corre, Oyinloye, and Zhu with Altemimi according to the known method of formulating starch nanoparticles (see Le Corre, page 1146, column 2, paragraph 1) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Le Corre (2010; as submitted on PTO-892 of 02/13/2025) in view of Oyinloye (2020; as submitted on PTO-892 of 02/13/2025) and CN 109908396 A (Zhu, 2019; machine translation provided by PE2E via FIT) as applied to claims 1-7 above, and further in view of Fonte (2016).
The teachings of Le Corre, Oyinloye, and Zhu have been described supra.
The teachings of Le Corre, Oyinloye, and Zhu are silent on the steps of freeze-drying as instantly claimed.
Fonte teaches that the process of lyophilization (i.e., freeze-drying) has to be optimized to obtain a lyophilizate with good quality (see Fonte, page 78, 2.2. lyophilization process matters, paragraph 1). It is taught that trivial changes in the process are enough to change an acceptable process to into unacceptable (see Fonte, page 78, 2.2. lyophilization process matters, paragraph 2). It is also taught that the best approach to lyophilization is to assess the thermophysical properties of the formulation and the engineering principle of lyophilization, as well as looking at properties such as glass transition and collapse temperatures to maintain the stability of the nanoparticles (see Fonte, page 78, 2.2. lyophilization process matters, paragraph 4).
In regards to claim 9, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Le Corre, Oyinloye, and Zhu with Fonte to formulate the instant preparation method as the method of Le Corre teaches freeze-drying, yet is silent on the conditions of the freeze-drying as instantly claimed. Fonte teaches that in order for optimal lyophilization, careful consideration has to be taken into account in order to lyophilize nanoparticles, specifically looking at variables such as what the formulation is and the conditions in the steps of lyophilization to minimize stress (see Fonte, page 78, 2.2. lyophilization process matters, paragraphs 1-2). As such, the steps of lyophilization would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed steps of lyophilization cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, steps of lyophilization in Le Corre, Oyinloye, and Zhu to obtain the desired balance between the formulation and the amount of stress on the nanoparticles as taught by Fonte (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Response to Arguments
Applicant's arguments filed 07/14/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that the combination of Le Corre and Oyinloye does not teach the claimed particle size and that the particle size of Ma et al. is taught to be outside of the claimed range, it is pointed out that the rejection has been modified as necessitated by amendment to be over Le Corre in view of Oyinloye and Zhu. Zhu teaches the claimed range of particle size as discussed in the rejection above. Further applicant argues that the particles of Ma et al. are prepared by adding ethanol to the solution dropwise to the starch, rather than adding the starch paste into the polar organic solvent (discussed as the first technical feature of the instant claims). First, it is taught in Zhu that adding the ethanol to the starch solution will yield larger starch particles as well (see Zhu, page 6, paragraphs 3-5). Second, Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). In the instant case, as the method of adding ethanol to the starch solution is known to make particles of the instantly claimed size, it is not an unexpected result and as such would prima facie obvious.
In regards to applicant’s arguments that the instant invention is drawn towards the field of hemostatic materials and the arguments against Le Corre and Oyinloye are not drawn towards hemostatic materials, it is pointed out that the claims are drawn to a method of making starch particles, with no mention of hemostatic materials. The combination of art renders obvious the method of the instant claims as discussed in the rejections above. Further, although Le Corre and Oyinloye are not in the same field of endeavor, it is reasonably pertinent to the problem to be solved with regards to forming starch particles. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023).
In regards to applicant’s arguments of the second technical feature that applicant mentions is the enabling of swelling of the precipitate using a polar organic solvent, it is pointed out that the teachings of Le Corre, Oyinloye, and Zhu teach an identical method as instantly claimed and as such one with ordinary skill in the art would understand that the method would also allow for the swelling of the precipitate. MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” As the prior art renders obvious the instant method a person of ordinary skill in the art would reasonably expect the same method to have the same properties. Further, there is no mention of the swelling of the precipitate in the claims as written. Applicant argues that the combination of swelling and freeze drying allow the particles to have an improved fluffy degree and water absorption capacity, however the method of Zhu teaches that the particles have fast absorbing performance (see Zhu, page 6, paragraph 1) and allows for an increased amount of water adsorbed by the hemostatic material (see Zhu, page 4, final paragraph). Applicant further mentions that the precipitates are stable and hard due to freeze drying, however it is unclear how this is unexpected as freeze drying reduces moisture (see Oyinloye, page 10, relationship between drying and grinding) to form a solid, stable composition. Applicant also points out that Le Corre teaches drying at 50°C and one with ordinary skill in the art would not be motivated to perform the stirring, standing, centrifuging, freeze-drying, crushing, and sieving after precipitation, however it is pointed out that there are known benefits to doing these steps as discussed above, but also that Le Corre teaches most of these steps already, including freeze-drying.
In regards to applicant’s argument that neither Le Corre nor Oyinloye teach centrifugation as a means to remove part of the polar organic solvent or the third technical feature as described by applicant, it is pointed out that the claims recite the steps of “stirring, standing and centrifuging to collect precipitates” and that is what the art teaches as well. It would be within the purview of one with ordinary skill in the art to understand that an identical method would yield identical results (i.e., the swelling of the precipitates due to the leftover solvent during freeze-drying or the fourth technical feature as described by applicant).
Applicant’s arguments with respect to reference Photrio have been considered but are moot because the new ground of rejection does not rely on the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to applicant’s argument against Altemimi, it is pointed out that although Altemimi is not in the same field of endeavor, it is reasonably pertinent to the problem to be solved with regards to optimizing the extraction of starch via centrifugation. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023).
In regards to applicant’s arguments against Fonte, it is pointed out again that the claims are not drawn to a hemostatic material, rather a method of producing starch particles. Further, while Fonte does not explicitly teach the same steps of freeze drying as instantly claimed, it does enable one with ordinary skill in the art to optimize the steps of lyophilization through its teachings. Fonte teaches that in order for optimal lyophilization, careful consideration has to be taken into account in order to lyophilize nanoparticles, specifically looking at variables such as what the formulation is and the conditions in the steps of lyophilization to minimize stress (see Fonte, page 78, 2.2. lyophilization process matters, paragraphs 1-2). As such, the steps of lyophilization would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed steps of lyophilization cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, steps of lyophilization in Le Corre, Oyinloye, and Zhu to obtain the desired balance between the formulation and the amount of stress on the nanoparticles as taught by Fonte (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). As such, the specific conditions of the instant invention are rendered obvious until shown otherwise, for example through unexpected data.
Conclusion
No claims allowed.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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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611