DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 May 2026 has been entered.
Response to Amendment
Amendment to claim 1; cancelation of claims 3 and 15; and addition of new claim 22 are noted.
The claim amendments overcome the rejection under 35 USC 112(b).
Response to Arguments
Applicant's arguments filed 22 May 2026 have been fully considered but they are not persuasive.
Applicant argues that the instant claims are not obvious over Cabello for the following reasons: 1) Cabello does not teach all of the claimed elements; 2) the "drying" in Cabello is different from the "drying" in the instant claims; 3) the size of the microdroplets as claimed cannot be inferred from the size of the generated particles; and 4) the claimed injection angle is not obvious over Cabello because of the difference in how the airflow meets the generated particles in Cabello and the instant invention.
With respect to 1), Applicant argues that Cabello does not teach or suggest at least two elements of claim 1 as previously presented (including the microdroplet size and the ratio of gas to microdroplets) and further does not teach the injection angle as presently amended (from dependent claim 15).
The office maintains the positions taken in the final office action (FOA) with respect to these claim elements. Additionally, the arguments with respect to droplet size and injection angle are addressed in detail below. With respect to the flow ratio of gas to microdroplets, the office respectfully disagrees. As noted in the FOA, Cabello discloses flow rates of gas and microdroplets which correspond to a ratio that is within or overlapping the claimed range (see [0065]; [0067]; [0070]; [0074]; Tables 1-4, 6 & 7).
With respect to 2), Applicant reiterates their position that while drying is mentioned in Cabello, it is ancillary to the objective of the invention, where the objective of Cabello is encapsulation and the objective of the claimed invention is maintaining biological activity without relying on protective encapsulation. Applicant further argues that Cabello’s scope is explicitly limited to processing thermolabile substances, which is defined as substances that must be coated to maintain stability, demonstrating that any “drying” in Cabello is integral to the encapsulation objective. Therefore, Applicant’s position is that Cabello does not contemplate independent drying of bare biological materials, which is the core objective of the present invention.
This argument is not found persuasive. The office maintains the position that Cabello’s disclosure of drying and/or encapsulation is considered to teach the instantly claimed drying. The office does not dispute Applicant’s citation in Cabello defining thermolabile substances. However, just because thermolabile substances, as defined in Cabello, require coating to maintain stability does not mean such coating must be achieved by encapsulation. There are other techniques for providing a coating which could be implemented after drying as opposed to simultaneous drying/encapsulation. Thus, the office maintains that Cabello’s disclosure of “drying and/or encapsulation” (emphasis added) must be given its appropriate weight. Furthermore, the office notes that Cabello does in fact distinguish between drying and encapsulation as alternative embodiments in [0013] by stating “this invention enables the generation of micro, submicro, and nanoparticles in the case of their use for drying or micro, submicro, or nanocapsules in the case of their use for encapsulation.”
Finally, the office notes that the claims are directed to a method comprising (i.e., open-ended) and do not exclude additional, unrecited steps. In other words, encapsulation is not excluded from the instant claims. Therefore, even if one were to adopt Applicant’s position that Cabello requires encapsulation, which the office does not agree for the reasons discussed above, the reference nevertheless remains relevant to the method as claimed.
With respect to 3), Applicant argues that the size of the microdroplets cannot be inferred from the size of the generated particles and further alleges criticality of the claimed range.
This argument is not found persuasive. The office's position does not entail inferring the size of the microdroplets from the size of the generated particles, but rather is based on acknowledging the existence of a relationship between the two. Furthermore, while Cabello does not explicitly disclose the size of the microdroplets, the reference clearly suggests controlling their size and monodispersity, and additionally states that the droplets generated "must be very small in order to reduce subsequent drying times" (see [0023]-[0024]), i.e., establishing a relationship between droplet size and drying times. Based on this disclosure, the office maintains the position that a person of ordinary skill in the art would readily optimize the size of the microdroplets in order to ensure favorable drying times. While Applicant states that the claimed microdroplet size is "critical", this allegation lacks support with objective evidence or proof.
With respect to 4), Applicant argues that there are fundamental and structural differences between Cabello and the claimed invention in how the airflow meets the generated droplets. Applicant contends that even where Cabello refers to projecting gas at a certain angle, this is still within a nozzle-based geometry that presupposes coaxial transport. Applicant's position is that the claimed angle would not work in Cabello, as it would disrupt the transport principle and is incompatible with the coaxial design. Applicant again alleges criticality and unexpected results with the claimed angle.
This argument is not found persuasive. The office acknowledges that one of the inlets for injection gas in Cabello is arranged such that injection gas flow is projected in a coaxial direction to the solution flow. However, the other inlet is arranged such that the injection gas flow is projected at an angle with respect to the solution flow, impacting against the liquid jet flow (i.e., this inlet is not coaxial) (see [0027]). It is this other inlet that is the basis for the office's position with respect to optimizing the angle of injection and this position is maintained. The office notes that the claims are directed to a method and apparatus "comprising" the claimed elements and do not exclude additional, unrecited elements. Finally, with respect to the allegation of criticality, the allegation is not supported with objective evidence or proof.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-12, 16-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lagaron Cabello et al (US 2019/0336931, hereinafter “Cabello”).
Regarding claims 1 and 18-20, Cabello discloses a method of drying a biological material, comprising (see Fig. 1; [0001]):
a) generating a flow of microdroplets of the biological material (see [0018]; [0023]; [0028]);
b) contacting the microdroplets with a gas flow, thereby drying the biological material to form particles (see [0013]; [0027]; [0030]-[0031]);
c) separating the particles from the gas flow (see [0042]);
d) cooling and drying the gas flow from step c) (see [0045]); and
e) recirculating the dried gas flow from step d) to step b) (see [0045]).
With respect to step a), Cabello discloses a dry matter content of the microdroplets within the claimed range (see Tables 1-4, 6 & 7). Furthermore, Cabello discloses the size of the dried particles being in the range of 1 to 50 microns (see [0070]). While Cabello does not explicitly disclose the size of the microdroplets, the reference suggests controlling the size and monodispersity of the sizes of the droplets generated, wherein the droplets generated “must be very small in order to reduce subsequent drying times” (see [0023]-[0024]). Based on this teaching, a person of ordinary skill in the art would optimize, by routine experimentation, the size of the microdroplets in order to ensure a favorable drying time as well as the formation of particles within the disclosed range. Absent a showing of criticality or unexpected results, the claimed microdroplet size is not considered to patentably distinguish the instant claims over the cited prior art.
With respect to step b), Cabello discloses flow rates of gas and microdroplets which correspond to a ratio that is within or overlapping the claimed range (see [0065]; [0067]; [0070]; [0074]; Tables 1-4, 6 & 7).
Cabello discloses wherein in step b), the flow of microdroplets is supplied to the gas flow at an angle to the direction of the gas flow (see Fig. 1; [0027]). While Cabello does not disclose the specific angle at which the flow of microdroplets is supplied relative to the direction of gas flow, the reference does disclose that the injection gas flow is projected at a certain angle with respect to the solution flow, which enables greater reduction in drop size (see [0027]). Accordingly, a person of ordinary skill in the art would determine, by routine experimentation, the optimum angle at which to supply the microdroplets and gas which achieves the desired reduction in droplet size. Absent a showing of criticality or unexpected results, the claimed angle is not considered the patentably distinguish the instant claim over the cited prior at.
Regarding claim 4, Cabello discloses wherein the direction of the gas flow is essentially horizontal (see Fig. 1).
Regarding claim 5, Cabello does not explicitly disclose the residence time. However, the reference clearly suggests optimizing the residence time in order to ensure sufficient drying of the particles, and is based on the size of the cross-section of the drying unit (see [0038]-[0039]). Accordingly, a person of ordinary skill in the art would optimize, by routine experimentation, the residence time in Cabello consistent with the stated objectives. Absent a showing of criticality or unexpected results, the claimed residence time is not considered to patentably distinguish the instant claims over the cited prior art.
Regarding claim 6, Cabello discloses wherein the rate of gas flow is between 10 and 100,000 m3/h (between 1.67 and 1667 m3/min) (see [0067]), within the claimed range.
Regarding claim 7, Cabello discloses wherein the flow of microdroplets is generated in step a) at a rate overlapping that claimed (see Tables 1-4, 6 & 7).
Regarding claims 8 and 16, Cabello discloses wherein the gas flow supplied to step b) has a temperature below 30°C (see [0025]; [0030], ambient and sub-ambient temperature, such as 5°C for example).
Regarding claim 9, Cabello discloses wherein step c) comprises filtering the gas flow (see [0042]).
Regarding claim 10, Cabello discloses wherein the biological material is selection from peptides and proteins (see [0076]).
Regarding claim 11, Cabello discloses an apparatus for drying biological material, comprising (see Fig. 1):
i) a nebulizer for generating a flow of microdroplets of the biological material (see [0017]; [0027]-[0028]; [0061]; [0065]);
ii) a fan or pump for generating a gas flow (see [0067], a fan or pump is implied based on the high flow rate of drying gas into the apparatus);
iii) a compartment 2 for contacting the microdroplets generated by the nebulizer with the gas flow and thereby drying the biological material to form particles (see [0062]);
iv) a separation arrangement 2 for separating particles formed in the compartment from the gas flow (see [0063]);
v) a drying arrangement for drying the gas flow from the separation arrangement, which drying arrangement comprises a cooling element (condenser 10) (see [0064]); and
vi) means for recirculating the dried gas flow from the drying arrangement to the compartment (see [0064]).
With respect to the nebulizer, Cabello discloses generating a flow of microdroplets having a dry matter content within the claimed range (see Tables 1-4, 6 & 7). Furthermore, Cabello discloses the size of the dried particles being in the range of 1 to 50 microns (see [0070]). While Cabello does not explicitly disclose the size of the microdroplets formed by the nebulizer, the reference suggests controlling the size and monodispersity of the sizes of the droplets generated, wherein the droplets generated “must be very small in order to reduce subsequent drying times” (see [0023]-[0024]). Based on this teaching, a person of ordinary skill in the art would optimize, by routine experimentation, the size of the microdroplets in order to ensure a favorable drying time as well as the formation of particles within the disclosed range. Absent a showing of criticality or unexpected results, the claimed microdroplet size is not considered to patentably distinguish the instant claims over the cited prior art.
Cabello further discloses flow rates of gas and microdroplets which correspond to a ratio that is within or overlapping the claimed range (see [0065]; [0067]; [0070]; [0074]; Tables 1-4, 6 & 7), i.e., the apparatus is suitable for providing a ratio of gas volumetric flowrate to volumetric flowrate of microdroplets as claimed.
Regarding claim 12, Cabello discloses wherein the separation arrangement comprises a filter (see [0042]).
Regarding claim 17, selection of a suitable material for the filter of Cabello amounts to nothing more than routine experimentation for a person of ordinary skill in the art and would be associated with a reasonable expectation of success. Absent a showing of new or unexpected results, use of a mesh filter as claimed is not considered to provide a patentably distinguishing feature over the cited prior art.
Regarding claim 22, Cabello discloses wherein the gas flow comprises an airflow (see [0027]; [0031]).
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Cabello, as applied to claim 11, in view of Domansky et al (US 2015/0079670).
Regarding claims 13 and 21, Cabello does not disclose wherein the nebulizer is a piezoelectric mesh nebulizer.
Domansky discloses a piezoelectric mesh nebulizer (see Figs. 1 & 2; [0056]), which may be used for spray drying and is able to form fine droplets with a narrow droplet size distribution, overcoming limitations of current bulk spray drying techniques ([0088]-[0090]).
It would have been obvious to a person of ordinary skill in the art at the time of filing the instant claimed invention to modify the apparatus of Cabello by specifically using a piezoelectric mesh nebulizer as the nebulizer component, as suggested by Domansky, where such nebulizer is associated with the formation of micron sized uniform droplets having a narrow droplet size distribution (see [0088]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cabello, as applied to claim 11, in view of Coulter et al (US 2,576,264).
Regarding claim 14, Cabello does not disclose wherein the drying arrangement comprises silica gel.
Coulter is directed to a spray drying apparatus. In particular, Coulter discloses recirculating the gas used for drying. As a part of the recirculation circuit, the gas is passed through silica gel to dry the gas (see col. 6, lines 1-44).
It would have been obvious to a person of ordinary skill in the art at the time of filing the instant claimed invention to modify the apparatus of Cabello to include silica gel as a component of the drying arrangement, as suggested by Coulter, in order to remove any entrained moisture from the drying gas so that it may be recirculated in the system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE ROBINSON whose telephone number is (571)270-7371. The examiner can normally be reached Monday - Thursday 8:00a-5:00p and Friday 8:00a-2:00p.
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/Renee Robinson/Primary Examiner, Art Unit 1772
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